HQPS Competencies

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Hospital quality and patient safety competencies: Development, description, and recommendations for use

Healthcare quality is defined as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.1 Delivering high quality care to patients in the hospital setting is especially challenging, given the rapid pace of clinical care, the severity and multitude of patient conditions, and the interdependence of complex processes within the hospital system. Research has shown that hospitalized patients do not consistently receive recommended care2 and are at risk for experiencing preventable harm.3 In an effort to stimulate improvement, stakeholders have called for increased accountability, including enhanced transparency and differential payment based on performance. A growing number of hospital process and outcome measures are readily available to the public via the Internet.46 The Joint Commission, which accredits US hospitals, requires the collection of core quality measure data7 and sets the expectation that National Patient Safety Goals be met to maintain accreditation.8 Moreover, the Center for Medicare and Medicaid Services (CMS) has developed a Value‐Based Purchasing (VBP) plan intended to adjust hospital payment based on quality measures and the occurrence of certain hospital‐acquired conditions.9, 10

Because of their clinical expertise, understanding of hospital clinical operations, leadership of multidisciplinary inpatient teams, and vested interest to improve the systems in which they work, hospitalists are perfectly positioned to collaborate with their institutions to improve the quality of care delivered to inpatients. However, many hospitalists are inadequately prepared to engage in efforts to improve quality, because medical schools and residency programs have not traditionally included or emphasized healthcare quality and patient safety in their curricula.1113 In a survey of 389 internal medicine‐trained hospitalists, significant educational deficiencies were identified in the area of systems‐based practice.14 Specifically, the topics of quality improvement, team management, practice guideline development, health information systems management, and coordination of care between healthcare settings were listed as essential skills for hospitalist practice but underemphasized in residency training. Recognizing the gap between the needs of practicing physicians and current medical education provided in healthcare quality, professional societies have recently published position papers calling for increased training in quality, safety, and systems, both in medical school11 and residency training.15, 16

The Society of Hospital Medicine (SHM) convened a Quality Summit in December 2008 to develop strategic plans related to healthcare quality. Summit attendees felt that most hospitalists lack the formal training necessary to evaluate, implement, and sustain system changes within the hospital. In response, the SHM Hospital Quality and Patient Safety (HQPS) Committee formed a Quality Improvement Education (QIE) subcommittee in 2009 to assess the needs of hospitalists with respect to hospital quality and patient safety, and to evaluate and expand upon existing educational programs in this area. Membership of the QIE subcommittee consisted of hospitalists with extensive experience in healthcare quality and medical education. The QIE subcommittee refined and expanded upon the healthcare quality and patient safety‐related competencies initially described in the Core Competencies in Hospital Medicine.17 The purpose of this report is to describe the development, provide definitions, and make recommendations on the use of the Hospital Quality and Patient Safety (HQPS) Competencies.

Development of The Hospital Quality and Patient Safety Competencies

The multistep process used by the SHM QIE subcommittee to develop the HQPS Competencies is summarized in Figure 1. We performed an in‐depth evaluation of current educational materials and offerings, including a review of the Core Competencies in Hospital Medicine, past annual SHM Quality Improvement Pre‐Course objectives, and the content of training courses offered by other organizations.1722 Throughout our analysis, we emphasized the identification of gaps in content relevant to hospitalists. We then used the Institute of Medicine's (IOM) 6 aims for healthcare quality as a foundation for developing the HQPS Competencies.1 Specifically, the IOM states that healthcare should be safe, effective, patient‐centered, timely, efficient, and equitable. Additionally, we reviewed and integrated elements of the Practice‐Based Learning and Improvement (PBLI) and Systems‐Based Practice (SBP) competencies as defined by the Accreditation Council for Graduate Medical Education (ACGME).23 We defined general areas of competence and specific standards for knowledge, skills, and attitudes within each area. Subcommittee members reflected on their own experience, as clinicians, educators, and leaders in healthcare quality and patient safety, to inform and refine the competency definitions and standards. Acknowledging that some hospitalists may serve as collaborators or clinical content experts, while others may serve as leaders of hospital quality initiatives, 3 levels of expertise were established: basic, intermediate, and advanced.

Figure 1
Hospital quality and patient safety competency process and timeline. Abbreviations: HQPS, hospital quality and patient safety; QI, quality improvement; SHM, Society of Hospital Medicine.

The QIE subcommittee presented a draft version of the HQPS Competencies to the HQPS Committee in the fall of 2009 and incorporated suggested revisions. The revised set of competencies was then reviewed by members of the Leadership and Education Committees during the winter of 2009‐2010, and additional recommendations were included in the final version now described.

Description of The Competencies

The 8 areas of competence include: Quality Measurement and Stakeholder Interests, Data Acquisition and Interpretation, Organizational Knowledge and Leadership Skills, Patient Safety Principles, Teamwork and Communication, Quality and Safety Improvement Methods, Health Information Systems, and Patient Centeredness. Three levels of competence and standards within each level and area are defined in Table 1. Standards use carefully selected action verbs to reflect educational goals for hospitalists at each level.24 The basic level represents a minimum level of competency for all practicing hospitalists. The intermediate level represents a hospitalist who is prepared to meaningfully engage and collaborate with his or her institution in quality improvement efforts. A hospitalist at this level may also lead uncomplicated improvement projects for his or her medical center and/or hospital medicine group. The advanced level represents a hospitalist prepared to lead quality improvement efforts for his or her institution and/or hospital medicine group. Many hospitalists at this level will have, or will be prepared to have, leadership positions in quality and patient safety at their institutions. Advanced level hospitalists will also have the expertise to teach and mentor other individuals in their quality improvement efforts.

Hospitalist Competencies in Healthcare Quality and Patient Safety
Competency Basic Intermediate Advanced
  • NOTE: The basic level represents a minimum level of competency for all practicing hospitalists. The intermediate level represents a hospitalist prepared to meaningfully collaborate with his or her institution in quality improvement efforts. The advanced level represents a hospitalist prepared to lead quality improvement efforts for his or her institution and/or group.

  • Abbreviation: PDSA, Plan Do Study Act.

Quality measurement and stakeholder interests Define structure, process, and outcome measures Compare and contrast relative benefits of using one type of measure vs another Anticipate and respond to stakeholders' needs and interests
Define stakeholders and understand their interests related to healthcare quality Explain measures as defined by stakeholders (Center for Medicare and Medicaid Services, Leapfrog, etc) Anticipate and respond to changes in quality measures and incentive programs
Identify measures as defined by stakeholders (Center for Medicare and Medicaid Services, Leapfrog, etc) Appreciate variation in quality and utilization performance Lead efforts to reduce variation in care delivery (see also quality improvement methods)
Describe potential unintended consequences of quality measurement and incentive programs Avoid unintended consequences of quality measurement and incentive programs
Data acquisition and interpretation Interpret simple statistical methods to compare populations within a sample (chi‐square, t tests, etc) Describe sources of data for quality measurement Acquire data from internal and external sources
Define basic terms used to describe continuous and categorical data (mean, median, standard deviation, interquartile range, percentages, rates, etc) Identify potential pitfalls in administrative data Create visual representations of data (Bar, Pareto, and Control Charts)
Summarize basic principles of statistical process control Explain variation in data Use simple statistical methods to compare populations within a sample (chi‐square, t tests, etc)
Interpret data displayed in Pareto and Control Charts Administer and interpret a survey
Summarize basic survey techniques (including methods to maximize response, minimize bias, and use of ordinal response scales)
Use appropriate terms to describe continuous and categorical data (mean, median, standard deviation, interquartile range, percentages, rates, etc)
Organizational knowledge and leadership skills Describe the organizational structure of one's institution Define interests of internal and external stakeholders Effectively negotiate with stakeholders
Define leaders within the organization and describe their roles Collaborate as an effective team member of a quality improvement project Assemble a quality improvement project team and effectively lead meetings (setting agendas, hold members accountable, etc)
Exemplify the importance of leading by example Explain principles of change management and how it can positively or negatively impact quality improvement project implementation Motivate change and create vision for ideal state
Effectively communicate quality or safety issues identified during routine patient care to the appropriate parties Communicate effectively in a variety of settings (lead a meeting, public speaking, etc)
Serve as a resource and/or mentor for less‐experienced team members
Patient safety principles Identify potential sources of error encountered during routine patient care Compare methods to measure errors and adverse events, including administrative data analysis, chart review, and incident reporting systems Lead efforts to appropriately measure medical error and/or adverse events
Compare and contrast medical error with adverse event Identify and explain how human factors can contribute to medical errors Lead efforts to redesign systems to reduce errors from occurring; this may include the facilitation of a hospital, departmental, or divisional Root Cause Analysis
Describe how the systems approach to medical error is more productive than assigning individual blame Know the difference between a strong vs a weak action plan for improvement (ie, brief education intervention is weak; skills training with deliberate practice or physical changes are stronger) Lead efforts to advance the culture of patient safety in the hospital
Differentiate among types of error (knowledge/judgment vs systems vs procedural/technical; latent vs active)
Explain the role that incident reporting plays in quality improvement efforts and how reporting can foster a culture of safety
Describe principles of medical error disclosure
Teamwork and communication Explain how poor teamwork and communication failures contribute to adverse events Collaborate on administration and interpretation of teamwork and safety culture measures Lead efforts to improve teamwork and safety culture
Identify the potential for errors during transitions within and between healthcare settings (handoffs, transfers, discharge) Describe the principles of effective teamwork and identify behaviors consistent with effective teamwork Lead efforts to improve teamwork in specific settings (intensive care, medical‐surgical unit, etc)
Identify deficiencies in transitions within and between healthcare settings (handoffs, transfers, discharge) Successfully improve the safety of transitions within and between healthcare settings (handoffs, transfers, discharge)
Quality and safety improvement methods and tools Define the quality improvement methods used and infrastructure in place at one's hospital Compare and contrast various quality improvement methods, including six sigma, lean, and PDSA Lead a quality improvement project using six sigma, lean, or PDSA methodology
Summarize the basic principles and use of Root Cause Analysis as a tool to evaluate medical error Collaborate on a quality improvement project using six sigma, lean, or PDSA Use high level process mapping, fishbone diagrams, etc, to identify areas for opportunity in evaluating a process
Describe and collaborate on Failure Mode and Effects Analysis Lead the development and implementation of clinical protocols to standardize care delivery when appropriate
Actively participate in a Root Cause Analysis Conduct Failure Mode and Effects Analysis
Conduct Root Cause Analysis
Health information systems Identify the potential for information systems to reduce as well as contribute to medical error Define types of clinical decision support Lead or co‐lead efforts to leverage information systems in quality measurement
Describe how information systems fit into provider workflow and care delivery Collaborate on the design of health information systems Lead or co‐lead efforts to leverage information systems to reduce error and/or improve delivery of effective care
Anticipate and prevent unintended consequences of implementation or revision of information systems
Lead or co‐lead efforts to leverage clinical decision support to improve quality and safety
Patient centeredness Explain the clinical benefits of a patient‐centered approach Explain benefits and potential limitations of patient satisfaction surveys Interpret data from patient satisfaction surveys and lead efforts to improve patient satisfaction
Identify system barriers to effective and safe care from the patient's perspective Identify clinical areas with suboptimal efficiency and/or timeliness from the patient's perspective Lead effort to reduce inefficiency and/or improve timeliness from the patient's perspective
Describe the value of patient satisfaction surveys and patient and family partnership in care Promote patient and caregiver education including use of effective education tools Lead efforts to eliminate system barriers to effective and safe care from the patient's perspective
Lead efforts to improve patent and caregiver education including development or implementation of effective education tools
Lead efforts to actively involve patients and families in the redesign of healthcare delivery systems and processes

Recommended Use of The Competencies

The HQPS Competencies provide a framework for curricula and other professional development experiences in healthcare quality and patient safety. We recommend a step‐wise approach to curriculum development which includes conducting a targeted needs assessment, defining goals and specific learning objectives, and evaluation of the curriculum.25 The HQPS Competencies can be used at each step and provide educational targets for learners across a range of interest and experience.

Professional Development

Since residency programs historically have not trained their graduates to achieve a basic level of competence, practicing hospitalists will need to seek out professional development opportunities. Some educational opportunities which already exist include the Quality Track sessions during the SHM Annual Meeting, and the SHM Quality Improvement Pre‐Course. Hospitalist leaders are currently using the HQPS Competencies to review and revise annual meeting and pre‐course objectives and content in an effort to meet the expected level of competence for SHM members. Similarly, local SHM Chapter and regional hospital medicine leaders should look to the competencies to help select topics and objectives for future presentations. Additionally, the SHM Web site offers tools to develop skills, including a resource room and quality improvement primer.26 Mentored‐implementation programs, supported by SHM, can help hospitalists' acquire more advanced experiential training in quality improvement.

New educational opportunities are being developed, including a comprehensive set of Internet‐based modules designed to help practicing hospitalists achieve a basic level of competence. Hospitalists will be able to achieve continuing medical education (CME) credit upon completion of individual modules. Plans are underway to provide Certification in Hospital Quality and Patient Safety, reflecting an advanced level of competence, upon completion of the entire set, and demonstration of knowledge and skill application through an approved quality improvement project. The certification process will leverage the success of the SHM Leadership Academies and Mentored Implementation projects to help hospitalists apply their new skills in a real world setting.

HQPS Competencies and Focused Practice in Hospital Medicine

Recently, the American Board of Internal Medicine (ABIM) has recognized the field of hospital medicine by developing a new program that provides hospitalists the opportunity to earn Maintenance of Certification (MOC) in Internal Medicine with a Focused Practice in Hospital Medicine.27 Appropriately, hospital quality and patient safety content is included among the knowledge questions on the secure exam, and completion of a practice improvement module (commonly known as PIM) is required for the certification. The SHM Education Committee has developed a Self‐Evaluation of Medical Knowledge module related to hospital quality and patient safety for use in the MOC process. ABIM recertification with Focused Practice in Hospital Medicine is an important and visible step for the Hospital Medicine movement; the content of both the secure exam and the MOC reaffirms the notion that the acquisition of knowledge, skills, and attitudes in hospital quality and patient safety is essential to the practice of hospital medicine.

Medical Education

Because teaching hospitalists frequently serve in important roles as educators and physician leaders in quality improvement, they are often responsible for medical student and resident training in healthcare quality and patient safety. Medical schools and residency programs have struggled to integrate healthcare quality and patient safety into their curricula.11, 12, 28 Hospitalists can play a major role in academic medical centers by helping to develop curricular materials and evaluations related to healthcare quality. Though intended primarily for future and current hospitalists, the HQPS Competencies and standards for the basic level may be adapted to provide educational targets for many learners in undergraduate and graduate medical education. Teaching hospitalists may use these standards to evaluate current educational efforts and design new curricula in collaboration with their medical school and residency program leaders.

Beyond the basic level of training in healthcare quality required for all, many residents will benefit from more advanced training experiences, including opportunities to apply knowledge and develop skills related to quality improvement. A recent report from the ACGME concluded that role models and mentors were essential for engaging residents in quality improvement efforts.29 Hospitalists are ideally suited to serve as role models during residents' experiential learning opportunities related to hospital quality. Several residency programs have begun to implement hospitalist tracks13 and quality improvement rotations.3032 Additionally, some academic medical centers have begun to develop and offer fellowship training in Hospital Medicine.33 These hospitalist‐led educational programs are an ideal opportunity to teach the intermediate and advanced training components, of healthcare quality and patient safety, to residents and fellows that wish to incorporate activity or leadership in quality improvement and patient safety science into their generalist or subspecialty careers. Teaching hospitalists should use the HQPS competency standards to define learning objectives for trainees at this stage of development.

To address the enormous educational needs in quality and safety for future physicians, a cadre of expert teachers in quality and safety will need to be developed. In collaboration with the Alliance for Academic Internal Medicine (AAIM), SHM is developing a Quality and Safety Educators Academy which will target academic hospitalists and other medical educators interested in developing advanced skills in quality improvement and patient safety education.

Assessment of Competence

An essential component of a rigorous faculty development program or medical education initiative is the assessment of whether these endeavors are achieving their stated aims. Published literature provides examples of useful assessment methods applicable to the HQPS Competencies. Knowledge in several areas of HQPS competence may be assessed with the use of multiple choice tests.34, 35 Knowledge of quality improvement methods may be assessed using the Quality Improvement Knowledge Application Tool (QIKAT), an instrument in which the learner responds to each of 3 scenarios with an aim, outcome and process measures, and ideas for changes which may result in improved performance.36 Teamwork and communication skills may be assessed using 360‐degree evaluations3739 and direct observation using behaviorally anchored rating scales.4043 Objective structured clinical examinations have been used to assess knowledge and skills related to patient safety principles.44, 45 Notably, few studies have rigorously assessed the validity and reliability of tools designed to evaluate competence related to healthcare quality.46 Additionally, to our knowledge, no prior research has evaluated assessment specifically for hospitalists. Thus, the development and validation of new assessment tools based on the HQPS Competencies for learners at each level is a crucial next step in the educational process. Additionally, evaluation of educational initiatives should include analyses of clinical benefit, as the ultimate goal of these efforts is to improve patient care.47, 48

Conclusion

Hospitalists are poised to have a tremendous impact on improving the quality of care for hospitalized patients. The lack of training in quality improvement in traditional medical education programs, in which most current hospitalists were trained, can be overcome through appropriate use of the HQPS Competencies. Formal incorporation of the HQPS Competencies into professional development programs, and innovative educational initiatives and curricula, will help provide current hospitalists and the next generations of hospitalists with the needed skills to be successful.

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References
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  12. Alper E,Rosenberg EI,O'Brien KE,Fischer M,Durning SJ.Patient safety education at U.S. and Canadian medical schools: results from the 2006 Clerkship Directors in Internal Medicine survey.Acad Med.2009;84(12):16721676.
  13. Glasheen JJ,Siegal EM,Epstein K,Kutner J,Prochazka AV.Fulfilling the promise of hospital medicine: tailoring internal medicine training to address hospitalists' needs.J Gen Intern Med.2008;23(7):11101115.
  14. Plauth WH,Pantilat SZ,Wachter RM,Fenton CL.Hospitalists' perceptions of their residency training needs: results of a national survey.Am J Med.2001;111(3):247254.
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  16. Weinberger SE,Smith LG,Collier VU.Redesigning training for internal medicine.Ann Intern Med.2006;144(12):927932.
  17. Dressler DD,Pistoria MJ,Budnitz TL,McKean SC,Amin AN.Core competencies in hospital medicine: development and methodology.J Hosp Med.2006;1(1):4856.
  18. Intermountain Healthcare. 20‐Day Course for Executives 2001.
  19. Kern DE,Thomas PA,Bass EB,Howard DM.Curriculum Development for Medical Education: A Six‐step Approach.Baltimore, MD:Johns Hopkins Press;1998.
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  21. American Board of Internal Medicine: Questions and Answers Regarding ABIM's Maintenance of Certification in Internal Medicine With a Focused Practice in Hospital Medicine Program. Available at: http://www.abim.org/news/news/focused‐practice‐hospital‐medicine‐qa.aspx. Accessed August 9,2010.
  22. Heard JK,Allen RM,Clardy J.Assessing the needs of residency program directors to meet the ACGME general competencies.Acad Med.2002;77(7):750.
  23. Philibert I.Accreditation Council for Graduate Medical Education and Institute for Healthcare Improvement 90‐Day Project. Involving Residents in Quality Improvement: Contrasting “Top‐Down” and “Bottom‐Up” Approaches.Chicago, IL;ACGME;2008.
  24. Oyler J,Vinci L,Arora V,Johnson J.Teaching internal medicine residents quality improvement techniques using the ABIM's practice improvement modules.J Gen Intern Med.2008;23(7):927930.
  25. Peters AS,Kimura J,Ladden MD,March E,Moore GT.A self‐instructional model to teach systems‐based practice and practice‐based learning and improvement.J Gen Intern Med.2008;23(7):931936.
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  30. Morrison L,Headrick L,Ogrinc G,Foster T.The quality improvement knowledge application tool: an instrument to assess knowledge application in practice‐based learning and improvement.J Gen Intern Med.2003;18(suppl 1):250.
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  32. Massagli TL,Carline JD.Reliability of a 360‐degree evaluation to assess resident competence.Am J Phys Med Rehabil.2007;86(10):845852.
  33. Musick DW,McDowell SM,Clark N,Salcido R.Pilot study of a 360‐degree assessment instrument for physical medicine 82(5):394402.
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  35. Malec JF,Torsher LC,Dunn WF, et al.The Mayo high performance teamwork scale: reliability and validity for evaluating key crew resource management skills.Simul Healthc.2007;2(1):410.
  36. Sevdalis N,Davis R,Koutantji M,Undre S,Darzi A,Vincent CA.Reliability of a revised NOTECHS scale for use in surgical teams.Am J Surg.2008;196(2):184190.
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Healthcare quality is defined as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.1 Delivering high quality care to patients in the hospital setting is especially challenging, given the rapid pace of clinical care, the severity and multitude of patient conditions, and the interdependence of complex processes within the hospital system. Research has shown that hospitalized patients do not consistently receive recommended care2 and are at risk for experiencing preventable harm.3 In an effort to stimulate improvement, stakeholders have called for increased accountability, including enhanced transparency and differential payment based on performance. A growing number of hospital process and outcome measures are readily available to the public via the Internet.46 The Joint Commission, which accredits US hospitals, requires the collection of core quality measure data7 and sets the expectation that National Patient Safety Goals be met to maintain accreditation.8 Moreover, the Center for Medicare and Medicaid Services (CMS) has developed a Value‐Based Purchasing (VBP) plan intended to adjust hospital payment based on quality measures and the occurrence of certain hospital‐acquired conditions.9, 10

Because of their clinical expertise, understanding of hospital clinical operations, leadership of multidisciplinary inpatient teams, and vested interest to improve the systems in which they work, hospitalists are perfectly positioned to collaborate with their institutions to improve the quality of care delivered to inpatients. However, many hospitalists are inadequately prepared to engage in efforts to improve quality, because medical schools and residency programs have not traditionally included or emphasized healthcare quality and patient safety in their curricula.1113 In a survey of 389 internal medicine‐trained hospitalists, significant educational deficiencies were identified in the area of systems‐based practice.14 Specifically, the topics of quality improvement, team management, practice guideline development, health information systems management, and coordination of care between healthcare settings were listed as essential skills for hospitalist practice but underemphasized in residency training. Recognizing the gap between the needs of practicing physicians and current medical education provided in healthcare quality, professional societies have recently published position papers calling for increased training in quality, safety, and systems, both in medical school11 and residency training.15, 16

The Society of Hospital Medicine (SHM) convened a Quality Summit in December 2008 to develop strategic plans related to healthcare quality. Summit attendees felt that most hospitalists lack the formal training necessary to evaluate, implement, and sustain system changes within the hospital. In response, the SHM Hospital Quality and Patient Safety (HQPS) Committee formed a Quality Improvement Education (QIE) subcommittee in 2009 to assess the needs of hospitalists with respect to hospital quality and patient safety, and to evaluate and expand upon existing educational programs in this area. Membership of the QIE subcommittee consisted of hospitalists with extensive experience in healthcare quality and medical education. The QIE subcommittee refined and expanded upon the healthcare quality and patient safety‐related competencies initially described in the Core Competencies in Hospital Medicine.17 The purpose of this report is to describe the development, provide definitions, and make recommendations on the use of the Hospital Quality and Patient Safety (HQPS) Competencies.

Development of The Hospital Quality and Patient Safety Competencies

The multistep process used by the SHM QIE subcommittee to develop the HQPS Competencies is summarized in Figure 1. We performed an in‐depth evaluation of current educational materials and offerings, including a review of the Core Competencies in Hospital Medicine, past annual SHM Quality Improvement Pre‐Course objectives, and the content of training courses offered by other organizations.1722 Throughout our analysis, we emphasized the identification of gaps in content relevant to hospitalists. We then used the Institute of Medicine's (IOM) 6 aims for healthcare quality as a foundation for developing the HQPS Competencies.1 Specifically, the IOM states that healthcare should be safe, effective, patient‐centered, timely, efficient, and equitable. Additionally, we reviewed and integrated elements of the Practice‐Based Learning and Improvement (PBLI) and Systems‐Based Practice (SBP) competencies as defined by the Accreditation Council for Graduate Medical Education (ACGME).23 We defined general areas of competence and specific standards for knowledge, skills, and attitudes within each area. Subcommittee members reflected on their own experience, as clinicians, educators, and leaders in healthcare quality and patient safety, to inform and refine the competency definitions and standards. Acknowledging that some hospitalists may serve as collaborators or clinical content experts, while others may serve as leaders of hospital quality initiatives, 3 levels of expertise were established: basic, intermediate, and advanced.

Figure 1
Hospital quality and patient safety competency process and timeline. Abbreviations: HQPS, hospital quality and patient safety; QI, quality improvement; SHM, Society of Hospital Medicine.

The QIE subcommittee presented a draft version of the HQPS Competencies to the HQPS Committee in the fall of 2009 and incorporated suggested revisions. The revised set of competencies was then reviewed by members of the Leadership and Education Committees during the winter of 2009‐2010, and additional recommendations were included in the final version now described.

Description of The Competencies

The 8 areas of competence include: Quality Measurement and Stakeholder Interests, Data Acquisition and Interpretation, Organizational Knowledge and Leadership Skills, Patient Safety Principles, Teamwork and Communication, Quality and Safety Improvement Methods, Health Information Systems, and Patient Centeredness. Three levels of competence and standards within each level and area are defined in Table 1. Standards use carefully selected action verbs to reflect educational goals for hospitalists at each level.24 The basic level represents a minimum level of competency for all practicing hospitalists. The intermediate level represents a hospitalist who is prepared to meaningfully engage and collaborate with his or her institution in quality improvement efforts. A hospitalist at this level may also lead uncomplicated improvement projects for his or her medical center and/or hospital medicine group. The advanced level represents a hospitalist prepared to lead quality improvement efforts for his or her institution and/or hospital medicine group. Many hospitalists at this level will have, or will be prepared to have, leadership positions in quality and patient safety at their institutions. Advanced level hospitalists will also have the expertise to teach and mentor other individuals in their quality improvement efforts.

Hospitalist Competencies in Healthcare Quality and Patient Safety
Competency Basic Intermediate Advanced
  • NOTE: The basic level represents a minimum level of competency for all practicing hospitalists. The intermediate level represents a hospitalist prepared to meaningfully collaborate with his or her institution in quality improvement efforts. The advanced level represents a hospitalist prepared to lead quality improvement efforts for his or her institution and/or group.

  • Abbreviation: PDSA, Plan Do Study Act.

Quality measurement and stakeholder interests Define structure, process, and outcome measures Compare and contrast relative benefits of using one type of measure vs another Anticipate and respond to stakeholders' needs and interests
Define stakeholders and understand their interests related to healthcare quality Explain measures as defined by stakeholders (Center for Medicare and Medicaid Services, Leapfrog, etc) Anticipate and respond to changes in quality measures and incentive programs
Identify measures as defined by stakeholders (Center for Medicare and Medicaid Services, Leapfrog, etc) Appreciate variation in quality and utilization performance Lead efforts to reduce variation in care delivery (see also quality improvement methods)
Describe potential unintended consequences of quality measurement and incentive programs Avoid unintended consequences of quality measurement and incentive programs
Data acquisition and interpretation Interpret simple statistical methods to compare populations within a sample (chi‐square, t tests, etc) Describe sources of data for quality measurement Acquire data from internal and external sources
Define basic terms used to describe continuous and categorical data (mean, median, standard deviation, interquartile range, percentages, rates, etc) Identify potential pitfalls in administrative data Create visual representations of data (Bar, Pareto, and Control Charts)
Summarize basic principles of statistical process control Explain variation in data Use simple statistical methods to compare populations within a sample (chi‐square, t tests, etc)
Interpret data displayed in Pareto and Control Charts Administer and interpret a survey
Summarize basic survey techniques (including methods to maximize response, minimize bias, and use of ordinal response scales)
Use appropriate terms to describe continuous and categorical data (mean, median, standard deviation, interquartile range, percentages, rates, etc)
Organizational knowledge and leadership skills Describe the organizational structure of one's institution Define interests of internal and external stakeholders Effectively negotiate with stakeholders
Define leaders within the organization and describe their roles Collaborate as an effective team member of a quality improvement project Assemble a quality improvement project team and effectively lead meetings (setting agendas, hold members accountable, etc)
Exemplify the importance of leading by example Explain principles of change management and how it can positively or negatively impact quality improvement project implementation Motivate change and create vision for ideal state
Effectively communicate quality or safety issues identified during routine patient care to the appropriate parties Communicate effectively in a variety of settings (lead a meeting, public speaking, etc)
Serve as a resource and/or mentor for less‐experienced team members
Patient safety principles Identify potential sources of error encountered during routine patient care Compare methods to measure errors and adverse events, including administrative data analysis, chart review, and incident reporting systems Lead efforts to appropriately measure medical error and/or adverse events
Compare and contrast medical error with adverse event Identify and explain how human factors can contribute to medical errors Lead efforts to redesign systems to reduce errors from occurring; this may include the facilitation of a hospital, departmental, or divisional Root Cause Analysis
Describe how the systems approach to medical error is more productive than assigning individual blame Know the difference between a strong vs a weak action plan for improvement (ie, brief education intervention is weak; skills training with deliberate practice or physical changes are stronger) Lead efforts to advance the culture of patient safety in the hospital
Differentiate among types of error (knowledge/judgment vs systems vs procedural/technical; latent vs active)
Explain the role that incident reporting plays in quality improvement efforts and how reporting can foster a culture of safety
Describe principles of medical error disclosure
Teamwork and communication Explain how poor teamwork and communication failures contribute to adverse events Collaborate on administration and interpretation of teamwork and safety culture measures Lead efforts to improve teamwork and safety culture
Identify the potential for errors during transitions within and between healthcare settings (handoffs, transfers, discharge) Describe the principles of effective teamwork and identify behaviors consistent with effective teamwork Lead efforts to improve teamwork in specific settings (intensive care, medical‐surgical unit, etc)
Identify deficiencies in transitions within and between healthcare settings (handoffs, transfers, discharge) Successfully improve the safety of transitions within and between healthcare settings (handoffs, transfers, discharge)
Quality and safety improvement methods and tools Define the quality improvement methods used and infrastructure in place at one's hospital Compare and contrast various quality improvement methods, including six sigma, lean, and PDSA Lead a quality improvement project using six sigma, lean, or PDSA methodology
Summarize the basic principles and use of Root Cause Analysis as a tool to evaluate medical error Collaborate on a quality improvement project using six sigma, lean, or PDSA Use high level process mapping, fishbone diagrams, etc, to identify areas for opportunity in evaluating a process
Describe and collaborate on Failure Mode and Effects Analysis Lead the development and implementation of clinical protocols to standardize care delivery when appropriate
Actively participate in a Root Cause Analysis Conduct Failure Mode and Effects Analysis
Conduct Root Cause Analysis
Health information systems Identify the potential for information systems to reduce as well as contribute to medical error Define types of clinical decision support Lead or co‐lead efforts to leverage information systems in quality measurement
Describe how information systems fit into provider workflow and care delivery Collaborate on the design of health information systems Lead or co‐lead efforts to leverage information systems to reduce error and/or improve delivery of effective care
Anticipate and prevent unintended consequences of implementation or revision of information systems
Lead or co‐lead efforts to leverage clinical decision support to improve quality and safety
Patient centeredness Explain the clinical benefits of a patient‐centered approach Explain benefits and potential limitations of patient satisfaction surveys Interpret data from patient satisfaction surveys and lead efforts to improve patient satisfaction
Identify system barriers to effective and safe care from the patient's perspective Identify clinical areas with suboptimal efficiency and/or timeliness from the patient's perspective Lead effort to reduce inefficiency and/or improve timeliness from the patient's perspective
Describe the value of patient satisfaction surveys and patient and family partnership in care Promote patient and caregiver education including use of effective education tools Lead efforts to eliminate system barriers to effective and safe care from the patient's perspective
Lead efforts to improve patent and caregiver education including development or implementation of effective education tools
Lead efforts to actively involve patients and families in the redesign of healthcare delivery systems and processes

Recommended Use of The Competencies

The HQPS Competencies provide a framework for curricula and other professional development experiences in healthcare quality and patient safety. We recommend a step‐wise approach to curriculum development which includes conducting a targeted needs assessment, defining goals and specific learning objectives, and evaluation of the curriculum.25 The HQPS Competencies can be used at each step and provide educational targets for learners across a range of interest and experience.

Professional Development

Since residency programs historically have not trained their graduates to achieve a basic level of competence, practicing hospitalists will need to seek out professional development opportunities. Some educational opportunities which already exist include the Quality Track sessions during the SHM Annual Meeting, and the SHM Quality Improvement Pre‐Course. Hospitalist leaders are currently using the HQPS Competencies to review and revise annual meeting and pre‐course objectives and content in an effort to meet the expected level of competence for SHM members. Similarly, local SHM Chapter and regional hospital medicine leaders should look to the competencies to help select topics and objectives for future presentations. Additionally, the SHM Web site offers tools to develop skills, including a resource room and quality improvement primer.26 Mentored‐implementation programs, supported by SHM, can help hospitalists' acquire more advanced experiential training in quality improvement.

New educational opportunities are being developed, including a comprehensive set of Internet‐based modules designed to help practicing hospitalists achieve a basic level of competence. Hospitalists will be able to achieve continuing medical education (CME) credit upon completion of individual modules. Plans are underway to provide Certification in Hospital Quality and Patient Safety, reflecting an advanced level of competence, upon completion of the entire set, and demonstration of knowledge and skill application through an approved quality improvement project. The certification process will leverage the success of the SHM Leadership Academies and Mentored Implementation projects to help hospitalists apply their new skills in a real world setting.

HQPS Competencies and Focused Practice in Hospital Medicine

Recently, the American Board of Internal Medicine (ABIM) has recognized the field of hospital medicine by developing a new program that provides hospitalists the opportunity to earn Maintenance of Certification (MOC) in Internal Medicine with a Focused Practice in Hospital Medicine.27 Appropriately, hospital quality and patient safety content is included among the knowledge questions on the secure exam, and completion of a practice improvement module (commonly known as PIM) is required for the certification. The SHM Education Committee has developed a Self‐Evaluation of Medical Knowledge module related to hospital quality and patient safety for use in the MOC process. ABIM recertification with Focused Practice in Hospital Medicine is an important and visible step for the Hospital Medicine movement; the content of both the secure exam and the MOC reaffirms the notion that the acquisition of knowledge, skills, and attitudes in hospital quality and patient safety is essential to the practice of hospital medicine.

Medical Education

Because teaching hospitalists frequently serve in important roles as educators and physician leaders in quality improvement, they are often responsible for medical student and resident training in healthcare quality and patient safety. Medical schools and residency programs have struggled to integrate healthcare quality and patient safety into their curricula.11, 12, 28 Hospitalists can play a major role in academic medical centers by helping to develop curricular materials and evaluations related to healthcare quality. Though intended primarily for future and current hospitalists, the HQPS Competencies and standards for the basic level may be adapted to provide educational targets for many learners in undergraduate and graduate medical education. Teaching hospitalists may use these standards to evaluate current educational efforts and design new curricula in collaboration with their medical school and residency program leaders.

Beyond the basic level of training in healthcare quality required for all, many residents will benefit from more advanced training experiences, including opportunities to apply knowledge and develop skills related to quality improvement. A recent report from the ACGME concluded that role models and mentors were essential for engaging residents in quality improvement efforts.29 Hospitalists are ideally suited to serve as role models during residents' experiential learning opportunities related to hospital quality. Several residency programs have begun to implement hospitalist tracks13 and quality improvement rotations.3032 Additionally, some academic medical centers have begun to develop and offer fellowship training in Hospital Medicine.33 These hospitalist‐led educational programs are an ideal opportunity to teach the intermediate and advanced training components, of healthcare quality and patient safety, to residents and fellows that wish to incorporate activity or leadership in quality improvement and patient safety science into their generalist or subspecialty careers. Teaching hospitalists should use the HQPS competency standards to define learning objectives for trainees at this stage of development.

To address the enormous educational needs in quality and safety for future physicians, a cadre of expert teachers in quality and safety will need to be developed. In collaboration with the Alliance for Academic Internal Medicine (AAIM), SHM is developing a Quality and Safety Educators Academy which will target academic hospitalists and other medical educators interested in developing advanced skills in quality improvement and patient safety education.

Assessment of Competence

An essential component of a rigorous faculty development program or medical education initiative is the assessment of whether these endeavors are achieving their stated aims. Published literature provides examples of useful assessment methods applicable to the HQPS Competencies. Knowledge in several areas of HQPS competence may be assessed with the use of multiple choice tests.34, 35 Knowledge of quality improvement methods may be assessed using the Quality Improvement Knowledge Application Tool (QIKAT), an instrument in which the learner responds to each of 3 scenarios with an aim, outcome and process measures, and ideas for changes which may result in improved performance.36 Teamwork and communication skills may be assessed using 360‐degree evaluations3739 and direct observation using behaviorally anchored rating scales.4043 Objective structured clinical examinations have been used to assess knowledge and skills related to patient safety principles.44, 45 Notably, few studies have rigorously assessed the validity and reliability of tools designed to evaluate competence related to healthcare quality.46 Additionally, to our knowledge, no prior research has evaluated assessment specifically for hospitalists. Thus, the development and validation of new assessment tools based on the HQPS Competencies for learners at each level is a crucial next step in the educational process. Additionally, evaluation of educational initiatives should include analyses of clinical benefit, as the ultimate goal of these efforts is to improve patient care.47, 48

Conclusion

Hospitalists are poised to have a tremendous impact on improving the quality of care for hospitalized patients. The lack of training in quality improvement in traditional medical education programs, in which most current hospitalists were trained, can be overcome through appropriate use of the HQPS Competencies. Formal incorporation of the HQPS Competencies into professional development programs, and innovative educational initiatives and curricula, will help provide current hospitalists and the next generations of hospitalists with the needed skills to be successful.

Healthcare quality is defined as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.1 Delivering high quality care to patients in the hospital setting is especially challenging, given the rapid pace of clinical care, the severity and multitude of patient conditions, and the interdependence of complex processes within the hospital system. Research has shown that hospitalized patients do not consistently receive recommended care2 and are at risk for experiencing preventable harm.3 In an effort to stimulate improvement, stakeholders have called for increased accountability, including enhanced transparency and differential payment based on performance. A growing number of hospital process and outcome measures are readily available to the public via the Internet.46 The Joint Commission, which accredits US hospitals, requires the collection of core quality measure data7 and sets the expectation that National Patient Safety Goals be met to maintain accreditation.8 Moreover, the Center for Medicare and Medicaid Services (CMS) has developed a Value‐Based Purchasing (VBP) plan intended to adjust hospital payment based on quality measures and the occurrence of certain hospital‐acquired conditions.9, 10

Because of their clinical expertise, understanding of hospital clinical operations, leadership of multidisciplinary inpatient teams, and vested interest to improve the systems in which they work, hospitalists are perfectly positioned to collaborate with their institutions to improve the quality of care delivered to inpatients. However, many hospitalists are inadequately prepared to engage in efforts to improve quality, because medical schools and residency programs have not traditionally included or emphasized healthcare quality and patient safety in their curricula.1113 In a survey of 389 internal medicine‐trained hospitalists, significant educational deficiencies were identified in the area of systems‐based practice.14 Specifically, the topics of quality improvement, team management, practice guideline development, health information systems management, and coordination of care between healthcare settings were listed as essential skills for hospitalist practice but underemphasized in residency training. Recognizing the gap between the needs of practicing physicians and current medical education provided in healthcare quality, professional societies have recently published position papers calling for increased training in quality, safety, and systems, both in medical school11 and residency training.15, 16

The Society of Hospital Medicine (SHM) convened a Quality Summit in December 2008 to develop strategic plans related to healthcare quality. Summit attendees felt that most hospitalists lack the formal training necessary to evaluate, implement, and sustain system changes within the hospital. In response, the SHM Hospital Quality and Patient Safety (HQPS) Committee formed a Quality Improvement Education (QIE) subcommittee in 2009 to assess the needs of hospitalists with respect to hospital quality and patient safety, and to evaluate and expand upon existing educational programs in this area. Membership of the QIE subcommittee consisted of hospitalists with extensive experience in healthcare quality and medical education. The QIE subcommittee refined and expanded upon the healthcare quality and patient safety‐related competencies initially described in the Core Competencies in Hospital Medicine.17 The purpose of this report is to describe the development, provide definitions, and make recommendations on the use of the Hospital Quality and Patient Safety (HQPS) Competencies.

Development of The Hospital Quality and Patient Safety Competencies

The multistep process used by the SHM QIE subcommittee to develop the HQPS Competencies is summarized in Figure 1. We performed an in‐depth evaluation of current educational materials and offerings, including a review of the Core Competencies in Hospital Medicine, past annual SHM Quality Improvement Pre‐Course objectives, and the content of training courses offered by other organizations.1722 Throughout our analysis, we emphasized the identification of gaps in content relevant to hospitalists. We then used the Institute of Medicine's (IOM) 6 aims for healthcare quality as a foundation for developing the HQPS Competencies.1 Specifically, the IOM states that healthcare should be safe, effective, patient‐centered, timely, efficient, and equitable. Additionally, we reviewed and integrated elements of the Practice‐Based Learning and Improvement (PBLI) and Systems‐Based Practice (SBP) competencies as defined by the Accreditation Council for Graduate Medical Education (ACGME).23 We defined general areas of competence and specific standards for knowledge, skills, and attitudes within each area. Subcommittee members reflected on their own experience, as clinicians, educators, and leaders in healthcare quality and patient safety, to inform and refine the competency definitions and standards. Acknowledging that some hospitalists may serve as collaborators or clinical content experts, while others may serve as leaders of hospital quality initiatives, 3 levels of expertise were established: basic, intermediate, and advanced.

Figure 1
Hospital quality and patient safety competency process and timeline. Abbreviations: HQPS, hospital quality and patient safety; QI, quality improvement; SHM, Society of Hospital Medicine.

The QIE subcommittee presented a draft version of the HQPS Competencies to the HQPS Committee in the fall of 2009 and incorporated suggested revisions. The revised set of competencies was then reviewed by members of the Leadership and Education Committees during the winter of 2009‐2010, and additional recommendations were included in the final version now described.

Description of The Competencies

The 8 areas of competence include: Quality Measurement and Stakeholder Interests, Data Acquisition and Interpretation, Organizational Knowledge and Leadership Skills, Patient Safety Principles, Teamwork and Communication, Quality and Safety Improvement Methods, Health Information Systems, and Patient Centeredness. Three levels of competence and standards within each level and area are defined in Table 1. Standards use carefully selected action verbs to reflect educational goals for hospitalists at each level.24 The basic level represents a minimum level of competency for all practicing hospitalists. The intermediate level represents a hospitalist who is prepared to meaningfully engage and collaborate with his or her institution in quality improvement efforts. A hospitalist at this level may also lead uncomplicated improvement projects for his or her medical center and/or hospital medicine group. The advanced level represents a hospitalist prepared to lead quality improvement efforts for his or her institution and/or hospital medicine group. Many hospitalists at this level will have, or will be prepared to have, leadership positions in quality and patient safety at their institutions. Advanced level hospitalists will also have the expertise to teach and mentor other individuals in their quality improvement efforts.

Hospitalist Competencies in Healthcare Quality and Patient Safety
Competency Basic Intermediate Advanced
  • NOTE: The basic level represents a minimum level of competency for all practicing hospitalists. The intermediate level represents a hospitalist prepared to meaningfully collaborate with his or her institution in quality improvement efforts. The advanced level represents a hospitalist prepared to lead quality improvement efforts for his or her institution and/or group.

  • Abbreviation: PDSA, Plan Do Study Act.

Quality measurement and stakeholder interests Define structure, process, and outcome measures Compare and contrast relative benefits of using one type of measure vs another Anticipate and respond to stakeholders' needs and interests
Define stakeholders and understand their interests related to healthcare quality Explain measures as defined by stakeholders (Center for Medicare and Medicaid Services, Leapfrog, etc) Anticipate and respond to changes in quality measures and incentive programs
Identify measures as defined by stakeholders (Center for Medicare and Medicaid Services, Leapfrog, etc) Appreciate variation in quality and utilization performance Lead efforts to reduce variation in care delivery (see also quality improvement methods)
Describe potential unintended consequences of quality measurement and incentive programs Avoid unintended consequences of quality measurement and incentive programs
Data acquisition and interpretation Interpret simple statistical methods to compare populations within a sample (chi‐square, t tests, etc) Describe sources of data for quality measurement Acquire data from internal and external sources
Define basic terms used to describe continuous and categorical data (mean, median, standard deviation, interquartile range, percentages, rates, etc) Identify potential pitfalls in administrative data Create visual representations of data (Bar, Pareto, and Control Charts)
Summarize basic principles of statistical process control Explain variation in data Use simple statistical methods to compare populations within a sample (chi‐square, t tests, etc)
Interpret data displayed in Pareto and Control Charts Administer and interpret a survey
Summarize basic survey techniques (including methods to maximize response, minimize bias, and use of ordinal response scales)
Use appropriate terms to describe continuous and categorical data (mean, median, standard deviation, interquartile range, percentages, rates, etc)
Organizational knowledge and leadership skills Describe the organizational structure of one's institution Define interests of internal and external stakeholders Effectively negotiate with stakeholders
Define leaders within the organization and describe their roles Collaborate as an effective team member of a quality improvement project Assemble a quality improvement project team and effectively lead meetings (setting agendas, hold members accountable, etc)
Exemplify the importance of leading by example Explain principles of change management and how it can positively or negatively impact quality improvement project implementation Motivate change and create vision for ideal state
Effectively communicate quality or safety issues identified during routine patient care to the appropriate parties Communicate effectively in a variety of settings (lead a meeting, public speaking, etc)
Serve as a resource and/or mentor for less‐experienced team members
Patient safety principles Identify potential sources of error encountered during routine patient care Compare methods to measure errors and adverse events, including administrative data analysis, chart review, and incident reporting systems Lead efforts to appropriately measure medical error and/or adverse events
Compare and contrast medical error with adverse event Identify and explain how human factors can contribute to medical errors Lead efforts to redesign systems to reduce errors from occurring; this may include the facilitation of a hospital, departmental, or divisional Root Cause Analysis
Describe how the systems approach to medical error is more productive than assigning individual blame Know the difference between a strong vs a weak action plan for improvement (ie, brief education intervention is weak; skills training with deliberate practice or physical changes are stronger) Lead efforts to advance the culture of patient safety in the hospital
Differentiate among types of error (knowledge/judgment vs systems vs procedural/technical; latent vs active)
Explain the role that incident reporting plays in quality improvement efforts and how reporting can foster a culture of safety
Describe principles of medical error disclosure
Teamwork and communication Explain how poor teamwork and communication failures contribute to adverse events Collaborate on administration and interpretation of teamwork and safety culture measures Lead efforts to improve teamwork and safety culture
Identify the potential for errors during transitions within and between healthcare settings (handoffs, transfers, discharge) Describe the principles of effective teamwork and identify behaviors consistent with effective teamwork Lead efforts to improve teamwork in specific settings (intensive care, medical‐surgical unit, etc)
Identify deficiencies in transitions within and between healthcare settings (handoffs, transfers, discharge) Successfully improve the safety of transitions within and between healthcare settings (handoffs, transfers, discharge)
Quality and safety improvement methods and tools Define the quality improvement methods used and infrastructure in place at one's hospital Compare and contrast various quality improvement methods, including six sigma, lean, and PDSA Lead a quality improvement project using six sigma, lean, or PDSA methodology
Summarize the basic principles and use of Root Cause Analysis as a tool to evaluate medical error Collaborate on a quality improvement project using six sigma, lean, or PDSA Use high level process mapping, fishbone diagrams, etc, to identify areas for opportunity in evaluating a process
Describe and collaborate on Failure Mode and Effects Analysis Lead the development and implementation of clinical protocols to standardize care delivery when appropriate
Actively participate in a Root Cause Analysis Conduct Failure Mode and Effects Analysis
Conduct Root Cause Analysis
Health information systems Identify the potential for information systems to reduce as well as contribute to medical error Define types of clinical decision support Lead or co‐lead efforts to leverage information systems in quality measurement
Describe how information systems fit into provider workflow and care delivery Collaborate on the design of health information systems Lead or co‐lead efforts to leverage information systems to reduce error and/or improve delivery of effective care
Anticipate and prevent unintended consequences of implementation or revision of information systems
Lead or co‐lead efforts to leverage clinical decision support to improve quality and safety
Patient centeredness Explain the clinical benefits of a patient‐centered approach Explain benefits and potential limitations of patient satisfaction surveys Interpret data from patient satisfaction surveys and lead efforts to improve patient satisfaction
Identify system barriers to effective and safe care from the patient's perspective Identify clinical areas with suboptimal efficiency and/or timeliness from the patient's perspective Lead effort to reduce inefficiency and/or improve timeliness from the patient's perspective
Describe the value of patient satisfaction surveys and patient and family partnership in care Promote patient and caregiver education including use of effective education tools Lead efforts to eliminate system barriers to effective and safe care from the patient's perspective
Lead efforts to improve patent and caregiver education including development or implementation of effective education tools
Lead efforts to actively involve patients and families in the redesign of healthcare delivery systems and processes

Recommended Use of The Competencies

The HQPS Competencies provide a framework for curricula and other professional development experiences in healthcare quality and patient safety. We recommend a step‐wise approach to curriculum development which includes conducting a targeted needs assessment, defining goals and specific learning objectives, and evaluation of the curriculum.25 The HQPS Competencies can be used at each step and provide educational targets for learners across a range of interest and experience.

Professional Development

Since residency programs historically have not trained their graduates to achieve a basic level of competence, practicing hospitalists will need to seek out professional development opportunities. Some educational opportunities which already exist include the Quality Track sessions during the SHM Annual Meeting, and the SHM Quality Improvement Pre‐Course. Hospitalist leaders are currently using the HQPS Competencies to review and revise annual meeting and pre‐course objectives and content in an effort to meet the expected level of competence for SHM members. Similarly, local SHM Chapter and regional hospital medicine leaders should look to the competencies to help select topics and objectives for future presentations. Additionally, the SHM Web site offers tools to develop skills, including a resource room and quality improvement primer.26 Mentored‐implementation programs, supported by SHM, can help hospitalists' acquire more advanced experiential training in quality improvement.

New educational opportunities are being developed, including a comprehensive set of Internet‐based modules designed to help practicing hospitalists achieve a basic level of competence. Hospitalists will be able to achieve continuing medical education (CME) credit upon completion of individual modules. Plans are underway to provide Certification in Hospital Quality and Patient Safety, reflecting an advanced level of competence, upon completion of the entire set, and demonstration of knowledge and skill application through an approved quality improvement project. The certification process will leverage the success of the SHM Leadership Academies and Mentored Implementation projects to help hospitalists apply their new skills in a real world setting.

HQPS Competencies and Focused Practice in Hospital Medicine

Recently, the American Board of Internal Medicine (ABIM) has recognized the field of hospital medicine by developing a new program that provides hospitalists the opportunity to earn Maintenance of Certification (MOC) in Internal Medicine with a Focused Practice in Hospital Medicine.27 Appropriately, hospital quality and patient safety content is included among the knowledge questions on the secure exam, and completion of a practice improvement module (commonly known as PIM) is required for the certification. The SHM Education Committee has developed a Self‐Evaluation of Medical Knowledge module related to hospital quality and patient safety for use in the MOC process. ABIM recertification with Focused Practice in Hospital Medicine is an important and visible step for the Hospital Medicine movement; the content of both the secure exam and the MOC reaffirms the notion that the acquisition of knowledge, skills, and attitudes in hospital quality and patient safety is essential to the practice of hospital medicine.

Medical Education

Because teaching hospitalists frequently serve in important roles as educators and physician leaders in quality improvement, they are often responsible for medical student and resident training in healthcare quality and patient safety. Medical schools and residency programs have struggled to integrate healthcare quality and patient safety into their curricula.11, 12, 28 Hospitalists can play a major role in academic medical centers by helping to develop curricular materials and evaluations related to healthcare quality. Though intended primarily for future and current hospitalists, the HQPS Competencies and standards for the basic level may be adapted to provide educational targets for many learners in undergraduate and graduate medical education. Teaching hospitalists may use these standards to evaluate current educational efforts and design new curricula in collaboration with their medical school and residency program leaders.

Beyond the basic level of training in healthcare quality required for all, many residents will benefit from more advanced training experiences, including opportunities to apply knowledge and develop skills related to quality improvement. A recent report from the ACGME concluded that role models and mentors were essential for engaging residents in quality improvement efforts.29 Hospitalists are ideally suited to serve as role models during residents' experiential learning opportunities related to hospital quality. Several residency programs have begun to implement hospitalist tracks13 and quality improvement rotations.3032 Additionally, some academic medical centers have begun to develop and offer fellowship training in Hospital Medicine.33 These hospitalist‐led educational programs are an ideal opportunity to teach the intermediate and advanced training components, of healthcare quality and patient safety, to residents and fellows that wish to incorporate activity or leadership in quality improvement and patient safety science into their generalist or subspecialty careers. Teaching hospitalists should use the HQPS competency standards to define learning objectives for trainees at this stage of development.

To address the enormous educational needs in quality and safety for future physicians, a cadre of expert teachers in quality and safety will need to be developed. In collaboration with the Alliance for Academic Internal Medicine (AAIM), SHM is developing a Quality and Safety Educators Academy which will target academic hospitalists and other medical educators interested in developing advanced skills in quality improvement and patient safety education.

Assessment of Competence

An essential component of a rigorous faculty development program or medical education initiative is the assessment of whether these endeavors are achieving their stated aims. Published literature provides examples of useful assessment methods applicable to the HQPS Competencies. Knowledge in several areas of HQPS competence may be assessed with the use of multiple choice tests.34, 35 Knowledge of quality improvement methods may be assessed using the Quality Improvement Knowledge Application Tool (QIKAT), an instrument in which the learner responds to each of 3 scenarios with an aim, outcome and process measures, and ideas for changes which may result in improved performance.36 Teamwork and communication skills may be assessed using 360‐degree evaluations3739 and direct observation using behaviorally anchored rating scales.4043 Objective structured clinical examinations have been used to assess knowledge and skills related to patient safety principles.44, 45 Notably, few studies have rigorously assessed the validity and reliability of tools designed to evaluate competence related to healthcare quality.46 Additionally, to our knowledge, no prior research has evaluated assessment specifically for hospitalists. Thus, the development and validation of new assessment tools based on the HQPS Competencies for learners at each level is a crucial next step in the educational process. Additionally, evaluation of educational initiatives should include analyses of clinical benefit, as the ultimate goal of these efforts is to improve patient care.47, 48

Conclusion

Hospitalists are poised to have a tremendous impact on improving the quality of care for hospitalized patients. The lack of training in quality improvement in traditional medical education programs, in which most current hospitalists were trained, can be overcome through appropriate use of the HQPS Competencies. Formal incorporation of the HQPS Competencies into professional development programs, and innovative educational initiatives and curricula, will help provide current hospitalists and the next generations of hospitalists with the needed skills to be successful.

References
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  26. Weingart SN,Tess A,Driver J,Aronson MD,Sands K.Creating a quality improvement elective for medical house officers.J Gen Intern Med.2004;19(8):861867.
  27. Ranji SR,Rosenman DJ,Amin AN,Kripalani S.Hospital medicine fellowships: works in progress.Am J Med.2006;119(1):72.e1e7.
  28. Kerfoot BP,Conlin PR,Travison T,McMahon GT.Web‐based education in systems‐based practice: a randomized trial.Arch Intern Med.2007;167(4):361366.
  29. Peters AS,Kimura J,Ladden MD,March E,Moore GT.A self‐instructional model to teach systems‐based practice and practice‐based learning and improvement.J Gen Intern Med.2008;23(7):931936.
  30. Morrison L,Headrick L,Ogrinc G,Foster T.The quality improvement knowledge application tool: an instrument to assess knowledge application in practice‐based learning and improvement.J Gen Intern Med.2003;18(suppl 1):250.
  31. Brinkman WB,Geraghty SR,Lanphear BP, et al.Effect of multisource feedback on resident communication skills and professionalism: a randomized controlled trial.Arch Pediatr Adolesc Med.2007;161(1):4449.
  32. Massagli TL,Carline JD.Reliability of a 360‐degree evaluation to assess resident competence.Am J Phys Med Rehabil.2007;86(10):845852.
  33. Musick DW,McDowell SM,Clark N,Salcido R.Pilot study of a 360‐degree assessment instrument for physical medicine 82(5):394402.
  34. Fletcher G,Flin R,McGeorge P,Glavin R,Maran N,Patey R.Anaesthetists' non‐technical skills (ANTS): evaluation of a behavioural marker system.Br J Anaesth.2003;90(5):580588.
  35. Malec JF,Torsher LC,Dunn WF, et al.The Mayo high performance teamwork scale: reliability and validity for evaluating key crew resource management skills.Simul Healthc.2007;2(1):410.
  36. Sevdalis N,Davis R,Koutantji M,Undre S,Darzi A,Vincent CA.Reliability of a revised NOTECHS scale for use in surgical teams.Am J Surg.2008;196(2):184190.
  37. Sevdalis N,Lyons M,Healey AN,Undre S,Darzi A,Vincent CA.Observational teamwork assessment for surgery: construct validation with expert versus novice raters.Ann Surg.2009;249(6):10471051.
  38. Singh R,Singh A,Fish R,McLean D,Anderson DR,Singh G.A patient safety objective structured clinical examination.J Patient Saf.2009;5(2):5560.
  39. Varkey P,Natt N.The Objective Structured Clinical Examination as an educational tool in patient safety.Jt Comm J Qual Patient Saf.2007;33(1):4853.
  40. Lurie SJ,Mooney CJ,Lyness JM.Measurement of the general competencies of the Accreditation Council for Graduate Medical Education: a systematic review.Acad Med.2009;84(3):301309.
  41. Boonyasai RT,Windish DM,Chakraborti C,Feldman LS,Rubin HR,Bass EB.Effectiveness of teaching quality improvement to clinicians: a systematic review.JAMA.2007;298(9):10231037.
  42. Windish DM,Reed DA,Boonyasai RT,Chakraborti C,Bass EB.Methodological rigor of quality improvement curricula for physician trainees: a systematic review and recommendations for change.Acad Med.2009;84(12):16771692.
References
  1. Crossing the Quality Chasm: A New Health System for the Twenty‐first Century.Washington, DC:Institute of Medicine;2001.
  2. Jha AK,Li Z,Orav EJ,Epstein AM.Care in U.S. hospitals—the Hospital Quality Alliance program.N Engl J Med.2005;353(3):265274.
  3. Zhan C,Miller MR.Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization.JAMA.2003;290(14):18681874.
  4. Hospital Compare—A quality tool provided by Medicare. Available at: http://www.hospitalcompare.hhs.gov/. Accessed April 23,2010.
  5. The Leapfrog Group: Hospital Quality Ratings. Available at: http://www.leapfroggroup.org/cp. Accessed April 30,2010.
  6. Why Not the Best? A Healthcare Quality Improvement Resource. Available at: http://www.whynotthebest.org/. Accessed April 30,2010.
  7. The Joint Commission: Facts about ORYX for hospitals (National Hospital Quality Measures). Available at: http://www.jointcommission.org/accreditationprograms/hospitals/oryx/oryx_facts.htm. Accessed August 19,2010.
  8. The Joint Commission: National Patient Safety Goals. Available at: http://www.jointcommission.org/patientsafety/nationalpatientsafetygoals/. Accessed August 9,2010.
  9. Hospital Acquired Conditions: Overview. Available at: http://www.cms.gov/HospitalAcqCond/01_Overview.asp. Accessed April 30,2010.
  10. Report to Congress:Plan to Implement a Medicare Hospital Value‐based Purchasing Program. Washington, DC: US Department of Health and Human Services, Center for Medicare and Medicaid Services;2007.
  11. Unmet Needs: Teaching Physicians to Provide Safe Patient Care.Boston, MA:Lucian Leape Institute at the National Patient Safety Foundation;2010.
  12. Alper E,Rosenberg EI,O'Brien KE,Fischer M,Durning SJ.Patient safety education at U.S. and Canadian medical schools: results from the 2006 Clerkship Directors in Internal Medicine survey.Acad Med.2009;84(12):16721676.
  13. Glasheen JJ,Siegal EM,Epstein K,Kutner J,Prochazka AV.Fulfilling the promise of hospital medicine: tailoring internal medicine training to address hospitalists' needs.J Gen Intern Med.2008;23(7):11101115.
  14. Plauth WH,Pantilat SZ,Wachter RM,Fenton CL.Hospitalists' perceptions of their residency training needs: results of a national survey.Am J Med.2001;111(3):247254.
  15. Fitzgibbons JP,Bordley DR,Berkowitz LR,Miller BW,Henderson MC.Redesigning residency education in internal medicine: a position paper from the Association of Program Directors in Internal Medicine.Ann Intern Med.2006;144(12):920926.
  16. Weinberger SE,Smith LG,Collier VU.Redesigning training for internal medicine.Ann Intern Med.2006;144(12):927932.
  17. Dressler DD,Pistoria MJ,Budnitz TL,McKean SC,Amin AN.Core competencies in hospital medicine: development and methodology.J Hosp Med.2006;1(1):4856.
  18. Intermountain Healthcare. 20‐Day Course for Executives 2001.
  19. Kern DE,Thomas PA,Bass EB,Howard DM.Curriculum Development for Medical Education: A Six‐step Approach.Baltimore, MD:Johns Hopkins Press;1998.
  20. Society of Hospital Medicine Quality Improvement Basics. Available at: http://www.hospitalmedicine.org/Content/NavigationMenu/QualityImprovement/QIPrimer/QI_Primer_Landing_Pa.htm. Accessed June 4,2010.
  21. American Board of Internal Medicine: Questions and Answers Regarding ABIM's Maintenance of Certification in Internal Medicine With a Focused Practice in Hospital Medicine Program. Available at: http://www.abim.org/news/news/focused‐practice‐hospital‐medicine‐qa.aspx. Accessed August 9,2010.
  22. Heard JK,Allen RM,Clardy J.Assessing the needs of residency program directors to meet the ACGME general competencies.Acad Med.2002;77(7):750.
  23. Philibert I.Accreditation Council for Graduate Medical Education and Institute for Healthcare Improvement 90‐Day Project. Involving Residents in Quality Improvement: Contrasting “Top‐Down” and “Bottom‐Up” Approaches.Chicago, IL;ACGME;2008.
  24. Oyler J,Vinci L,Arora V,Johnson J.Teaching internal medicine residents quality improvement techniques using the ABIM's practice improvement modules.J Gen Intern Med.2008;23(7):927930.
  25. Peters AS,Kimura J,Ladden MD,March E,Moore GT.A self‐instructional model to teach systems‐based practice and practice‐based learning and improvement.J Gen Intern Med.2008;23(7):931936.
  26. Weingart SN,Tess A,Driver J,Aronson MD,Sands K.Creating a quality improvement elective for medical house officers.J Gen Intern Med.2004;19(8):861867.
  27. Ranji SR,Rosenman DJ,Amin AN,Kripalani S.Hospital medicine fellowships: works in progress.Am J Med.2006;119(1):72.e1e7.
  28. Kerfoot BP,Conlin PR,Travison T,McMahon GT.Web‐based education in systems‐based practice: a randomized trial.Arch Intern Med.2007;167(4):361366.
  29. Peters AS,Kimura J,Ladden MD,March E,Moore GT.A self‐instructional model to teach systems‐based practice and practice‐based learning and improvement.J Gen Intern Med.2008;23(7):931936.
  30. Morrison L,Headrick L,Ogrinc G,Foster T.The quality improvement knowledge application tool: an instrument to assess knowledge application in practice‐based learning and improvement.J Gen Intern Med.2003;18(suppl 1):250.
  31. Brinkman WB,Geraghty SR,Lanphear BP, et al.Effect of multisource feedback on resident communication skills and professionalism: a randomized controlled trial.Arch Pediatr Adolesc Med.2007;161(1):4449.
  32. Massagli TL,Carline JD.Reliability of a 360‐degree evaluation to assess resident competence.Am J Phys Med Rehabil.2007;86(10):845852.
  33. Musick DW,McDowell SM,Clark N,Salcido R.Pilot study of a 360‐degree assessment instrument for physical medicine 82(5):394402.
  34. Fletcher G,Flin R,McGeorge P,Glavin R,Maran N,Patey R.Anaesthetists' non‐technical skills (ANTS): evaluation of a behavioural marker system.Br J Anaesth.2003;90(5):580588.
  35. Malec JF,Torsher LC,Dunn WF, et al.The Mayo high performance teamwork scale: reliability and validity for evaluating key crew resource management skills.Simul Healthc.2007;2(1):410.
  36. Sevdalis N,Davis R,Koutantji M,Undre S,Darzi A,Vincent CA.Reliability of a revised NOTECHS scale for use in surgical teams.Am J Surg.2008;196(2):184190.
  37. Sevdalis N,Lyons M,Healey AN,Undre S,Darzi A,Vincent CA.Observational teamwork assessment for surgery: construct validation with expert versus novice raters.Ann Surg.2009;249(6):10471051.
  38. Singh R,Singh A,Fish R,McLean D,Anderson DR,Singh G.A patient safety objective structured clinical examination.J Patient Saf.2009;5(2):5560.
  39. Varkey P,Natt N.The Objective Structured Clinical Examination as an educational tool in patient safety.Jt Comm J Qual Patient Saf.2007;33(1):4853.
  40. Lurie SJ,Mooney CJ,Lyness JM.Measurement of the general competencies of the Accreditation Council for Graduate Medical Education: a systematic review.Acad Med.2009;84(3):301309.
  41. Boonyasai RT,Windish DM,Chakraborti C,Feldman LS,Rubin HR,Bass EB.Effectiveness of teaching quality improvement to clinicians: a systematic review.JAMA.2007;298(9):10231037.
  42. Windish DM,Reed DA,Boonyasai RT,Chakraborti C,Bass EB.Methodological rigor of quality improvement curricula for physician trainees: a systematic review and recommendations for change.Acad Med.2009;84(12):16771692.
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Heart Failure and Hip Fracture Repair

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Impact of heart failure on hip fracture outcomes: A population‐based study

As the population ages, hip fractures and heart failure increase in prevalence.1, 2 Heart failure prevalence is also increasing in hospitalized patients.3 Indeed, hospitalizations involving heart failure as an active issue tripled in the last 30 years.4 Heart failure has been associated with an increased risk for hip fracture,5, 6 and previous studies report a 6%20% prevalence of preoperative heart failure in hip fracture patients.710 While exacerbation of heart failure increases the mortality risk in patients admitted for hip fractures,8 the incidence of new heart failure, as well as the preoperative factors that predict postoperative heart failure in this patient population remain unclear.

American College of Cardiology/American Heart Association (ACC/AHA) perioperative guidelines identify orthopedic surgeries, including hip fracture repair, as intermediate risk procedures.11 Compared to other intermediate risk operations, however, postoperative outcomes following hip fracture repair differ significantly.1216 Overall mortality in hip fracture patients has been reported at 29% at one year,8 with the excess mortality from hip fracture alone at nearly 20%.10, 13 However, the exact factors that contribute to this excess mortality, particularly with regard to heart failure, remain unclear.

To examine the preoperative prevalence, subsequent incidence, and predictors of heart failure in patients undergoing hip fracture repair operations, this study used an established, population‐based database to compare the postoperative consequences in hip fracture repair patients with and without preexisting heart failure. We hypothesized that preoperative heart failure worsens postoperative outcomes in hip fracture patients.

METHODS

Case Ascertainment

Following approval by the Institutional Review Boards of Mayo Clinic and the Olmsted Medical Center, we used the Rochester Epidemiology Project (REP) to identify the patients for this study. The REP is a population‐based medical records linkage system that records all diagnoses, surgical procedures, laboratory data, and death information from hospital, emergency room, outpatient, and nursing home care in the community.17

All Olmsted County, Minnesota, residents who sustained a hip fracture and underwent surgical repair from 1988 through 2002 were evaluated. Patients with more than one hip fracture during the study period (96 occurrences) were censored from the data analysis at the time of the subsequent hip fracture and then included as new cases. The complete enumeration of hip fracture episodes managed in the three Olmsted County hospital facilities (Mayo Clinic's Saint Mary's and Rochester Methodist Hospitals, and the Olmsted Medical Center Hospital) occurred in three phases: First, all hospitalizations with the surgical procedure (International Statistical Classification of Diseases, 9th Revision [ICD‐9]) codes 79.15 (reduction, fracture, femur, closed with internal fixation), 79.25 (reduction, fracture, femur, open, without internal fixation), 79.35 (reduction, fracture, femur, open with internal fixation), 79.95 (operation, unspecified bone injury, femur), 80.05 (arthrotomy for removal of hip prosthesis), 80.15 (arthrotomy, other, hip), 80.95 (excision, hip joint), 81.21 (arthrodesis, hip), 81.40 (repair hip, not elsewhere classified), 81.51 (total hip replacement), 81.52 (partial hip replacement), and 81.53 (revision hip replacement) were identified. Second, through review of the original inpatient and outpatient medical records, we confirmed that a fracture was associated with the index hospitalization. Finally, radiology reports of each index hospitalization verified the presence and exact anatomical location of each fracture. Of those with fractures on admission x‐rays, only patients with a proximal femur (femoral neck or intertrochanteric) fracture as the primary indication for the surgery were included in the study. Surgical report or radiographic evidence of hip fracture was available for all patients. Secondary fractures due to a specific pathological lesion (eg, malignancy) or high‐energy trauma (by convention, motor vehicle accidents or falls from significant heights) were excluded. Only patients who had provided an authorization to review their medical records for research were ultimately included in the study cohort.18 Medical records were search manually, if indicated.

Criteria for Heart Failure and Death

Preoperative heart failure was based on clinical documentation of heart failure in a patient's medical record prior to the time of the hip fracture repair. Postoperative heart failure, including acute exacerbations, was defined according to Framingham criteria.19 Framingham criteria included clinical evidence of increased central venous pressure, pulmonary edema, an S3 gallop, radiographic pulmonary edema, and response to diuresis. Heart failure was not graded on clinical severity (ie, New York Heart Association classification). We did not distinguish between systolic and diastolic heart failure. Mortality was defined as death from any cause within the first year following hip fracture repair. Deaths were identified either through REP resources or the National Death Index.

Statistical Methods

Continuous variables are presented as mean standard deviation and categorical variables as number (percent). Two‐sample t tests or Wilcoxon rank sum tests were used to test for significant differences in continuous variables. Chi‐square or Fisher's exact tests were used for categorical variables. Rates of postoperative outcomes were calculated using the KaplanMeier method for the overall group and for those with and without preoperative heart failure. A landmark survival curve was used to evaluate postoperative mortality among patients who experienced heart failure in the first seven postoperative days versus those who did not. Patients who died or underwent another hip operation within the first seven postoperative days were excluded from this analysis. Univariate Cox proportional hazards models were used to evaluate the predictors of postoperative heart failure and mortality. Patients who died or experienced a second hip surgery within one year of their first were censored at that time. Any subsequent hip fracture repair was treated as a new case. To account for the inclusion of multiple hip fracture repairs for a given patient, the Cox proportional hazards model included a robust variance estimator. This provided an accurate calculation of the standard error in the presence of within‐subject correlation.20 Statistical tests were two‐sided, and P values were considered significant if less than 0.05. Statistical analyses were performed using SAS (version 9.1.3, SAS Institute, Cary, NC).

RESULTS

From among 1327 potential hip fracture repairs, we excluded 115 cases involving multiple injuries or operations (19), pathological fractures (20), in‐hospital fractures (3), or an operation >72 hours after the initial fracture (5). Three patients under 65 years of age were also excluded, as were cases with missing information (9) or cases managed nonoperatively (56). The final analysis included 1212 surgical cases in 1116 subjects. No subjects were lost to surveillance for 1 year following their hip fracture repair.

Table 1 summarizes the baseline characteristics of the study population. The overall prevalence of preoperative heart failure was 27.0% (327 of 1212). Those with preoperative heart failure were older, heavier, more likely male and white, and less likely to live independently preoperatively. They were also more likely to suffer from preexisting cardiovascular comorbidities.

Baseline Characteristics and Outcomes Among Olmsted County, Minnesota, Residents Undergoing Hip Fracture Repair, 19882002, by Preoperative Heart Failure Status
 All (N = 1,212)HF (N = 327)No HF (N = 885)P Value*
  • Abbreviations: BMI, body mass index; HF, heart failure; SD, standard deviation.

  • P values for those with, vs without, preoperative heart failure (1Rank sum, 2Chi‐square, 3Fisher's exact).

  • BMI data were missing for 15 cases, preoperative ambulatory status was missing for 2 cases, and discharge disposition was missing for 1 case.

  • All values are N (%) unless otherwise noted.

  • Chronic renal insufficiency was defined as a creatinine >2.0 mg/dL.

Demographics    
Mean age (years) (SD)84.2 (7.44)85.5 (6.54)83.7 (7.70)0.00101
Male gender237 (19.6)76 (23.2)161 (18.2)0.04912
Mean BMI (kg/m2) (SD)23.3 (4.97)24.1 (5.68)23.0 (4.65)0.01231
White1,204 (99.3)322 (98.5)882 (99.7)0.03713
Preoperative living situation    
Nursing facility468 (38.6)144 (44)324 (36.6)0.01842
Home744 (61.4)183 (56)561 (63.4)0.05192
Preoperative ambulatory status    
Dependent149 (12.3)50 (15.3)99 (11.2) 
Independent1,061 (87.7)276 (84.7)785 (88.8) 
Medical history    
Hypertension705 (58.2)226 (69.1)479 (54.1)<0.00012
Diabetes mellitus143 (11.8)63 (19.3)80 (9)<0.00012
Cerebrovascular disease331 (27.3)129 (39.4)202 (22.8)<0.00012
Peripheral vascular disease195 (16.1)80 (24.5)115 (13)<0.00012
Coronary artery disease464 (38.3)237 (72.5)227 (25.6)<0.00012
Atrial fibrillation/flutter254 (21)133 (40.7)121 (13.7)<0.00012
Complete heart block18 (1.5)9 (2.8)9 (1)0.03373
Pacer at time of admission32 (2.6)16 (4.9)16 (1.8)0.00292
Chronic obstructive pulmonary disease196 (16.2)78 (23.9)118 (13.3)<0.00012
Liver disease15 (1.2)7 (2.1)8 (0.9)0.13753
Chronic renal insufficiency131 (10.8)61 (18.7)70 (7.9)<0.00012
Mean length of hospitalization (days) (SD)10.0 (7.57)11.1 (8.82)9.6 (7.01)0.00101
Discharge disposition   0.00192
Home150 (12.4)26 (8.0)124 (14.0) 
Skilled nursing facility1,004 (82.9)278 (85.0)726 (82.1) 
Dead57 (4.7)23 (7.0)34 (3.9) 

Table 1 also summarizes the main outcome characteristics of the study population. Those with preoperative heart failure had longer mean lengths of stay (LOS), were more often discharged to a skilled facility, and demonstrated higher inpatient mortality rates.

Table 2 summarizes the outcomes associated with preoperative heart failure. The overall rate of postoperative heart failure was 6.7% within 7 postoperative days and 21.3% within 1 postoperative year. Postoperative heart failure was significantly more common among those with preoperative heart failure (hazard ratio [HR], 3.0; 95% confidence interval [CI], 2.3 to 3.9; P < 0.001). Among those without preoperative heart failure, rates of postoperative incident heart failure were 4.8% at 7 days and 15.0% at 1 year. Compared to patients without preoperative heart failure, those with preoperative heart failure demonstrated higher one year mortality rates and higher rates of postoperative heart failure at 7 days and 1 year.

Association of Preoperative Heart Failure With Postoperative Outcomes Among Olmsted County, Minnesota, Residents Undergoing Hip Fracture Repair, 19882002
 Preoperative Heart Failure (Subjects)
OutcomeAll (N = 1212)No (N = 885)Yes (N = 327)Risk ratio* (95% CI)P Value
  • Abbreviations: CI, confidence interval.

  • Risk ratio for those with vs without preoperative heart failure. Odds ratios were calculated using logistic regression for the outcome of heart failure exacerbation within seven postoperative days; hazard ratios were calculated using Cox proportional hazards models for each of the one‐year outcomes.

  • Excluded 26 cases in which a patient died in hospital without postoperative heart failure.

  • One‐year rates were estimated using the KaplanMeier method.

Heart failure exacerbation within seven postoperative days6.7% (5.4, 8.3)4.8% (3.5, 6.5)12.1% (8.7, 16.2)2.72 (1.72, 4.31)<0.0001
One‐year postoperative heart failure exacerbation21.3% (18.8, 23.7)15.0% (12.5, 17.4)39.3% (33.3, 44.9)3.00 (2.32, 3.87)<0.0001
One‐year postoperative mortality24.5% (22.0, 26.9)19.8% (17.1, 22.4)37.2% (31.6, 42.3)2.11 (1.67, 2.67)<0.0001
One‐year postoperative mortality or heart failure exacerbation36.5% (33.7, 39.2)29.7% (26.6, 32.6)55.0% (49.3, 60.2)2.28 (1.88, 2.76)<0.0001

Figure 1 displays the outcomes to 1 year of surveillance. Rates of postoperative heart failure and postoperative mortality were consistently higher among those with, versus without, preoperative heart failure. Figure 2 displays similar data stratified by gender. Postoperative heart failure rates did not differ significantly between genders (HR, 1.0; 95% CI, 0.8 to 1.4), but postoperative mortality rates were significantly higher among males than females (HR, 1.9; 95% CI, 1.5 to 2.5; P < 0.001).

Figure 1
Cumulative incidence of postoperative outcomes among Olmsted County, Minnesota, residents undergoing hip fracture repair, 1988–2002, by preoperative heart failure status. Abbreviations: HF, heart failure.
Figure 2
Cumulative incidence of postoperative outcomes among Olmsted County, Minnesota, residents undergoing hip fracture repair, 1988–2002, by gender. Abbreviations: HF, heart failure.

Figure 3 displays survival rates to 1 year based on the occurrence of incident or recurrent heart failure within the first 7 postoperative days. Survival rates were lowest among patients with recurrent heart failure in the first 7 postoperative days and highest among those with no preoperative or postoperative heart failure. Subjects with incident heart failure in the first postoperative week, and those with preoperative heart failure who did not suffer a recurrence, demonstrated intermediate survival rates (P < 0.001 for trend across all four groups).

Figure 3
Landmark survival curve to outcome of survival, by heart failure status; excluded 30 records where the patient died or underwent a second surgery before postoperative day 7. Abbreviations: HF, heart failure.

DISCUSSION

This population‐based study found that heart failure represents a highly prevalent condition in elderly patients undergoing hip fracture repairs. It demonstrates that those with preoperative heart failure typically suffer from more cardiovascular comorbidities and carry a higher risk of postoperative heart failure and postoperative mortality.

While many studies have focused on the epidemiology of hip fractures,21 population‐based data on cardiac complications following hip fracture repair are significantly less common. The ACC/AHA preoperative cardiac evaluation guidelines classify orthopedic procedures, including hip fracture repair, as intermediate risk.11 Consequently, some may assume that all orthopedic patients will have a mortality rate less than 5%. Indeed, the 30‐day postoperative mortality rate published from our institution's Total Joint Registry was 0.6% following elective total hip arthroplasty.22 However, the present study demonstrates that current ACC/AHA preoperative cardiac evaluation guidelines may not apply to the population of frail patients undergoing hip fracture repair. Particularly among those who experience new heart failure within the first seven days following surgery, outcomes are substantially worse than the ACC/AHA perioperative guidelines may suggest.11

Preoperative heart failure has been associated with adverse risk for postoperative mortality after hip fracture.9, 10, 12 However, these studies did not report heart failure as a complication of hip fracture repair. A prospective cohort study of 2448 hip fracture patients at an academic hospital in Great Britain found a 5% rate of inpatient heart failure as a postoperative complication.23 The hazard ratio for one‐year mortality was 11.3 with postoperative heart failure.23 However, the British study did not distinguish heart failure from other cardiovascular diseases as a preoperative comorbidity or stratify the risk for postoperative mortality by preoperative heart failure status.23 Our findings add to previous literature by measuring heart failure as a specific complication of hip fracture repair and examining the association of preoperative heart failure with postoperative heart failure and mortality.

Length of stay after hip fracture repair varies in the literature, but previous work has not clearly associated heart failure with length of hospitalization in the setting of hip fracture repair.24, 25 Our study found a significantly higher mean length of stay among those with preoperative heart failure. This adds to previous work by delineating an association between heart failure and increased length of stay after hip fracture repair.

We found a higher rate of postoperative mortality among men compared to women. Rates of postoperative heart failure, however, were more similar (Figure 2). Previous studies have found a consistently higher mortality rate among men versus women after hip fracture.9, 23, 2529 Possible explanations for these findings include the overall increased burden of cardiovascular disease among men, lower treatment rates of osteoporosis in men,30 and increased susceptibility to other postoperative complications, such as infection.25

The findings of this study carry important clinical implications for the perioperative care of hip fracture patients with, or at risk for, heart failure. They suggest that current risk stratification guidelines classifying orthopedic operations as intermediate risk procedures do not reflect the high risk for morbidity that hip fracture patients face.11 The association of heart failure with adverse outcomes implies the need for heightened surveillance in the perioperative period, particularly with regard to volume status and medication reconciliation. Hip fracture patients and their families must be counseled about the ramifications of perioperative heart failure, including higher rates of postoperative heart failure, longer hospitalizations, and ultimate mortality.

This research carries several limitations and remains subject to biases inherent in retrospective cohort studies. The reported effects of heart failure on outcomes after hip fracture repair may be due to confounding from age, functional status, and other comorbidities. We attempted to minimize sampling bias through complete enumeration of hip fracture surgeries among Olmsted County residents. Completeness of follow‐up (100% at one year) was possible given the availability of documentation of all inpatient and outpatient medical care in the community.17 We used objectively defined outcomes to minimize measurement bias. Applicability to a more diverse population may be limited because >95% of the research population was from a single, predominantly white community. However, prior studies have documented that hip fracture incidence rates31 and socioeconomic factors17 in Olmsted County are similar to those for other white residents of the United States. Heart failure rates were determined clinically according to the Framingham criteria. However, the Framingham criteria may inappropriately diagnose individuals with heart failure32 and falsely elevate the prevalence of heart failure as a preoperative comorbidity or postoperative complication.

The statistical analysis included patients counted multiple times if they underwent subsequent hip fracture repair during the study period. Including these patients may inaccurately inflate event rates or contribute to incorrect estimates of standard error. However, we felt it was appropriate to include recurrent hip fracture repair cases in the analysis because they represent a clinically distinct patient from both a medical and functional perspective. We used a robust variance estimator in the Cox proportional hazards models to provide an accurate calculation of the standard error given the possibility for correlation within subjects.20 Finally, the proportion of these patients was low (94 of 1116 unique patients; 8.4%).

Future work must involve further risk stratification and therapeutic interventions in perioperative hip fracture patients. A more robust analysis of heart failure, with differentiation between systolic and diastolic dysfunction, may facilitate risk stratification. Assessment of compliance with standard preoperative heart failure medications and the impact of heightened clinical vigilance may enlighten means to improve postoperative outcomes. Studies on risk stratification and therapeutic interventions may then inform policy regarding length of stay and reimbursement in hip fracture patients.

CONCLUSION

In summary, our population‐based findings reveal that heart failure represents a prevalent and serious comorbidity in patients undergoing hip fracture repair. Clinicians caring for perioperative hip fracture patients must pay particular attention to risk for, and implications of, new or recurrent heart failure.

Acknowledgements

The authors thank Donna K. Lawson, LPN, Kathy Wolfert, and Cherie Dolliver for their assistance in data collection and management.

Files
References
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  5. van Diepen S,Majumdar SR,Bakal JA,McAlister FA,Ezekowitz JA.Heart failure is a risk factor for orthopedic fracture: A population‐based analysis of 16,294 patients.Circulation.2008;118(19):19461952.
  6. Sennerby U,Melhus H,Gedeborg R, et al.Cardiovascular diseases and risk of hip fracture.JAMA.2009;302(15):16661673.
  7. Nigwekar SU,Job AV,Kouides RW,Polashenski W.Effectiveness of hospitalist involvement in hip fracture management questioned.South Med J.2007;100(9):912913.
  8. Batsis JA,Phy MP,Melton LJ, et al.Effects of a hospitalist care model on mortality of elderly patients with hip fractures.J Hosp Med.2007;2(4):219225.
  9. Kannegaard PN,van der Mark S,Eiken P,Abrahamsen B.Excess mortality in men compared with women following a hip fracture. National analysis of comedications, comorbidity and survival.Age Ageing.2010;39(2):203209.
  10. Vestergaard P,Rejnmark L,Mosekilde L.Increased mortality in patients with a hip fracture—Effect of pre‐morbid conditions and post‐fracture complications.Osteoporos Int.2007;18(12):15831593.
  11. Fleisher LA,Beckman JA,Brown KA, et al.ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: Executive summary: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): Developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery.J Am Coll Cardiol.2007;50(17):17071732.
  12. Tosteson ANA,Gottlieb DJ,Radley DC,Fisher ES,Melton LJ.Excess mortality following hip fracture: The role of underlying health status.Osteoporos Int.2007;18(11):14631472.
  13. Giversen IM.Time trends of mortality after first hip fractures.Osteoporos Int.2007;18(6):721732.
  14. Hannan EL,Magaziner J,Wang JJ, et al.Mortality and locomotion 6 months after hospitalization for hip fracture: Risk factors and risk‐adjusted hospital outcomes.JAMA.2001;285(21):27362742.
  15. Meyer HE,Tverdal A,Falch JA,Pedersen JI.Factors associated with mortality after hip fracture.Osteoporos Int.2000;11(3):228232.
  16. Myers AH,Robinson EG,Natta MLV,Michelson JD,Collins K,Baker SP.Hip fractures among the elderly: Factors associated with in‐hospital mortality.Am J Epidemiol.1991;134(10):11281137.
  17. Melton LJ.History of the Rochester Epidemiology Project.Mayo Clin Proc.1996;71(3):266274.
  18. Melton LJ.The threat to medical‐records research.N Engl J Med.1997;337(20):14661470.
  19. McKee PA,Castelli WP,McNamara PM,Kannel WB.The natural history of congestive heart failure: The Framingham Study.N Engl J Med.1971;285(26):14411446.
  20. Lin DY,Wei LJ.The robust inference for the Cox proportional hazards model.J Am Stat Assoc.1989;84(408):10741078.
  21. Marks R.Hip fracture epidemiological trends, outcomes, and risk factors, 1970–2009.Int J Gen Med.2010;3:117.
  22. Wood M,Mantilla CB,Horlocker TT,Schroeder DR,Berry DJ,Brown DL.Frequency of myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or knee arthroplasty.Anesthesiology.2002;96(5):11401146.
  23. Roche JJW,Wenn RT,Sahota O,Moran CG.Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: Prospective observational cohort study.BMJ.2005;331(7529):13741376.
  24. Bentler SE,Liu L,Obrizan M, et al.The aftermath of hip fracture: Discharge placement, functional status change, and mortality.Am J Epidemiol.2009;170(10):12901299.
  25. Wehren LE,Hawkes WG,Orwig DL,Hebel JR,Zimmerman SI,Magaziner J.Gender differences in mortality after hip fracture: The role of infection.J Bone Miner Res.2003;18(12):22312237.
  26. Center JR,Nguyen TV,Schneider D,Sambrook PN,Eisman JA.Mortality after all major types of osteoporotic fracture in men and women: An observational study.Lancet.1999;353(9156):878882.
  27. Robbins JA,Biggs ML,Cauley J.Adjusted mortality after hip fracture: From the Cardiovascular Health Study.J Am Geriatr Soc.2006;54(12):18851891.
  28. Haentjens P,Magaziner J,Colon‐Emeric CS, et al.Meta‐analysis: Excess mortality after hip fracture among older women and men.Ann Intern Med.2010;152(6):380390.
  29. Poór G,Atkinson EJ,O'Fallon WM,Melton LJ.Predictors of hip fractures in elderly men.J Bone Miner Res.1995;10(12):19001907.
  30. Curtis J,McClure L,Delzell E, et al.Population‐based fracture risk assessment and osteoporosis treatment disparities by race and gender.J Gen Intern Med.2009;24(8):956962.
  31. Melton LJ,Therneau TM,Larson DR.Long‐term trends in hip fracture prevalence: The influence of hip fracture incidence and survival.Osteoporos Int.1998;8(1):6874.
  32. Maestre A,Gil V,Gallego J,Aznar J,Mora A,Martin‐Hidalgo A.diagnostic accuracy of clinical criteria for identifying systolic and diastolic heart failure: Cross‐sectional study.J Eval Clin Pract.2009;15(1):5561.
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Journal of Hospital Medicine - 6(9)
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507-512
Legacy Keywords
heart failure, postoperative evaluation and care, cardiovascular risk assessment
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As the population ages, hip fractures and heart failure increase in prevalence.1, 2 Heart failure prevalence is also increasing in hospitalized patients.3 Indeed, hospitalizations involving heart failure as an active issue tripled in the last 30 years.4 Heart failure has been associated with an increased risk for hip fracture,5, 6 and previous studies report a 6%20% prevalence of preoperative heart failure in hip fracture patients.710 While exacerbation of heart failure increases the mortality risk in patients admitted for hip fractures,8 the incidence of new heart failure, as well as the preoperative factors that predict postoperative heart failure in this patient population remain unclear.

American College of Cardiology/American Heart Association (ACC/AHA) perioperative guidelines identify orthopedic surgeries, including hip fracture repair, as intermediate risk procedures.11 Compared to other intermediate risk operations, however, postoperative outcomes following hip fracture repair differ significantly.1216 Overall mortality in hip fracture patients has been reported at 29% at one year,8 with the excess mortality from hip fracture alone at nearly 20%.10, 13 However, the exact factors that contribute to this excess mortality, particularly with regard to heart failure, remain unclear.

To examine the preoperative prevalence, subsequent incidence, and predictors of heart failure in patients undergoing hip fracture repair operations, this study used an established, population‐based database to compare the postoperative consequences in hip fracture repair patients with and without preexisting heart failure. We hypothesized that preoperative heart failure worsens postoperative outcomes in hip fracture patients.

METHODS

Case Ascertainment

Following approval by the Institutional Review Boards of Mayo Clinic and the Olmsted Medical Center, we used the Rochester Epidemiology Project (REP) to identify the patients for this study. The REP is a population‐based medical records linkage system that records all diagnoses, surgical procedures, laboratory data, and death information from hospital, emergency room, outpatient, and nursing home care in the community.17

All Olmsted County, Minnesota, residents who sustained a hip fracture and underwent surgical repair from 1988 through 2002 were evaluated. Patients with more than one hip fracture during the study period (96 occurrences) were censored from the data analysis at the time of the subsequent hip fracture and then included as new cases. The complete enumeration of hip fracture episodes managed in the three Olmsted County hospital facilities (Mayo Clinic's Saint Mary's and Rochester Methodist Hospitals, and the Olmsted Medical Center Hospital) occurred in three phases: First, all hospitalizations with the surgical procedure (International Statistical Classification of Diseases, 9th Revision [ICD‐9]) codes 79.15 (reduction, fracture, femur, closed with internal fixation), 79.25 (reduction, fracture, femur, open, without internal fixation), 79.35 (reduction, fracture, femur, open with internal fixation), 79.95 (operation, unspecified bone injury, femur), 80.05 (arthrotomy for removal of hip prosthesis), 80.15 (arthrotomy, other, hip), 80.95 (excision, hip joint), 81.21 (arthrodesis, hip), 81.40 (repair hip, not elsewhere classified), 81.51 (total hip replacement), 81.52 (partial hip replacement), and 81.53 (revision hip replacement) were identified. Second, through review of the original inpatient and outpatient medical records, we confirmed that a fracture was associated with the index hospitalization. Finally, radiology reports of each index hospitalization verified the presence and exact anatomical location of each fracture. Of those with fractures on admission x‐rays, only patients with a proximal femur (femoral neck or intertrochanteric) fracture as the primary indication for the surgery were included in the study. Surgical report or radiographic evidence of hip fracture was available for all patients. Secondary fractures due to a specific pathological lesion (eg, malignancy) or high‐energy trauma (by convention, motor vehicle accidents or falls from significant heights) were excluded. Only patients who had provided an authorization to review their medical records for research were ultimately included in the study cohort.18 Medical records were search manually, if indicated.

Criteria for Heart Failure and Death

Preoperative heart failure was based on clinical documentation of heart failure in a patient's medical record prior to the time of the hip fracture repair. Postoperative heart failure, including acute exacerbations, was defined according to Framingham criteria.19 Framingham criteria included clinical evidence of increased central venous pressure, pulmonary edema, an S3 gallop, radiographic pulmonary edema, and response to diuresis. Heart failure was not graded on clinical severity (ie, New York Heart Association classification). We did not distinguish between systolic and diastolic heart failure. Mortality was defined as death from any cause within the first year following hip fracture repair. Deaths were identified either through REP resources or the National Death Index.

Statistical Methods

Continuous variables are presented as mean standard deviation and categorical variables as number (percent). Two‐sample t tests or Wilcoxon rank sum tests were used to test for significant differences in continuous variables. Chi‐square or Fisher's exact tests were used for categorical variables. Rates of postoperative outcomes were calculated using the KaplanMeier method for the overall group and for those with and without preoperative heart failure. A landmark survival curve was used to evaluate postoperative mortality among patients who experienced heart failure in the first seven postoperative days versus those who did not. Patients who died or underwent another hip operation within the first seven postoperative days were excluded from this analysis. Univariate Cox proportional hazards models were used to evaluate the predictors of postoperative heart failure and mortality. Patients who died or experienced a second hip surgery within one year of their first were censored at that time. Any subsequent hip fracture repair was treated as a new case. To account for the inclusion of multiple hip fracture repairs for a given patient, the Cox proportional hazards model included a robust variance estimator. This provided an accurate calculation of the standard error in the presence of within‐subject correlation.20 Statistical tests were two‐sided, and P values were considered significant if less than 0.05. Statistical analyses were performed using SAS (version 9.1.3, SAS Institute, Cary, NC).

RESULTS

From among 1327 potential hip fracture repairs, we excluded 115 cases involving multiple injuries or operations (19), pathological fractures (20), in‐hospital fractures (3), or an operation >72 hours after the initial fracture (5). Three patients under 65 years of age were also excluded, as were cases with missing information (9) or cases managed nonoperatively (56). The final analysis included 1212 surgical cases in 1116 subjects. No subjects were lost to surveillance for 1 year following their hip fracture repair.

Table 1 summarizes the baseline characteristics of the study population. The overall prevalence of preoperative heart failure was 27.0% (327 of 1212). Those with preoperative heart failure were older, heavier, more likely male and white, and less likely to live independently preoperatively. They were also more likely to suffer from preexisting cardiovascular comorbidities.

Baseline Characteristics and Outcomes Among Olmsted County, Minnesota, Residents Undergoing Hip Fracture Repair, 19882002, by Preoperative Heart Failure Status
 All (N = 1,212)HF (N = 327)No HF (N = 885)P Value*
  • Abbreviations: BMI, body mass index; HF, heart failure; SD, standard deviation.

  • P values for those with, vs without, preoperative heart failure (1Rank sum, 2Chi‐square, 3Fisher's exact).

  • BMI data were missing for 15 cases, preoperative ambulatory status was missing for 2 cases, and discharge disposition was missing for 1 case.

  • All values are N (%) unless otherwise noted.

  • Chronic renal insufficiency was defined as a creatinine >2.0 mg/dL.

Demographics    
Mean age (years) (SD)84.2 (7.44)85.5 (6.54)83.7 (7.70)0.00101
Male gender237 (19.6)76 (23.2)161 (18.2)0.04912
Mean BMI (kg/m2) (SD)23.3 (4.97)24.1 (5.68)23.0 (4.65)0.01231
White1,204 (99.3)322 (98.5)882 (99.7)0.03713
Preoperative living situation    
Nursing facility468 (38.6)144 (44)324 (36.6)0.01842
Home744 (61.4)183 (56)561 (63.4)0.05192
Preoperative ambulatory status    
Dependent149 (12.3)50 (15.3)99 (11.2) 
Independent1,061 (87.7)276 (84.7)785 (88.8) 
Medical history    
Hypertension705 (58.2)226 (69.1)479 (54.1)<0.00012
Diabetes mellitus143 (11.8)63 (19.3)80 (9)<0.00012
Cerebrovascular disease331 (27.3)129 (39.4)202 (22.8)<0.00012
Peripheral vascular disease195 (16.1)80 (24.5)115 (13)<0.00012
Coronary artery disease464 (38.3)237 (72.5)227 (25.6)<0.00012
Atrial fibrillation/flutter254 (21)133 (40.7)121 (13.7)<0.00012
Complete heart block18 (1.5)9 (2.8)9 (1)0.03373
Pacer at time of admission32 (2.6)16 (4.9)16 (1.8)0.00292
Chronic obstructive pulmonary disease196 (16.2)78 (23.9)118 (13.3)<0.00012
Liver disease15 (1.2)7 (2.1)8 (0.9)0.13753
Chronic renal insufficiency131 (10.8)61 (18.7)70 (7.9)<0.00012
Mean length of hospitalization (days) (SD)10.0 (7.57)11.1 (8.82)9.6 (7.01)0.00101
Discharge disposition   0.00192
Home150 (12.4)26 (8.0)124 (14.0) 
Skilled nursing facility1,004 (82.9)278 (85.0)726 (82.1) 
Dead57 (4.7)23 (7.0)34 (3.9) 

Table 1 also summarizes the main outcome characteristics of the study population. Those with preoperative heart failure had longer mean lengths of stay (LOS), were more often discharged to a skilled facility, and demonstrated higher inpatient mortality rates.

Table 2 summarizes the outcomes associated with preoperative heart failure. The overall rate of postoperative heart failure was 6.7% within 7 postoperative days and 21.3% within 1 postoperative year. Postoperative heart failure was significantly more common among those with preoperative heart failure (hazard ratio [HR], 3.0; 95% confidence interval [CI], 2.3 to 3.9; P < 0.001). Among those without preoperative heart failure, rates of postoperative incident heart failure were 4.8% at 7 days and 15.0% at 1 year. Compared to patients without preoperative heart failure, those with preoperative heart failure demonstrated higher one year mortality rates and higher rates of postoperative heart failure at 7 days and 1 year.

Association of Preoperative Heart Failure With Postoperative Outcomes Among Olmsted County, Minnesota, Residents Undergoing Hip Fracture Repair, 19882002
 Preoperative Heart Failure (Subjects)
OutcomeAll (N = 1212)No (N = 885)Yes (N = 327)Risk ratio* (95% CI)P Value
  • Abbreviations: CI, confidence interval.

  • Risk ratio for those with vs without preoperative heart failure. Odds ratios were calculated using logistic regression for the outcome of heart failure exacerbation within seven postoperative days; hazard ratios were calculated using Cox proportional hazards models for each of the one‐year outcomes.

  • Excluded 26 cases in which a patient died in hospital without postoperative heart failure.

  • One‐year rates were estimated using the KaplanMeier method.

Heart failure exacerbation within seven postoperative days6.7% (5.4, 8.3)4.8% (3.5, 6.5)12.1% (8.7, 16.2)2.72 (1.72, 4.31)<0.0001
One‐year postoperative heart failure exacerbation21.3% (18.8, 23.7)15.0% (12.5, 17.4)39.3% (33.3, 44.9)3.00 (2.32, 3.87)<0.0001
One‐year postoperative mortality24.5% (22.0, 26.9)19.8% (17.1, 22.4)37.2% (31.6, 42.3)2.11 (1.67, 2.67)<0.0001
One‐year postoperative mortality or heart failure exacerbation36.5% (33.7, 39.2)29.7% (26.6, 32.6)55.0% (49.3, 60.2)2.28 (1.88, 2.76)<0.0001

Figure 1 displays the outcomes to 1 year of surveillance. Rates of postoperative heart failure and postoperative mortality were consistently higher among those with, versus without, preoperative heart failure. Figure 2 displays similar data stratified by gender. Postoperative heart failure rates did not differ significantly between genders (HR, 1.0; 95% CI, 0.8 to 1.4), but postoperative mortality rates were significantly higher among males than females (HR, 1.9; 95% CI, 1.5 to 2.5; P < 0.001).

Figure 1
Cumulative incidence of postoperative outcomes among Olmsted County, Minnesota, residents undergoing hip fracture repair, 1988–2002, by preoperative heart failure status. Abbreviations: HF, heart failure.
Figure 2
Cumulative incidence of postoperative outcomes among Olmsted County, Minnesota, residents undergoing hip fracture repair, 1988–2002, by gender. Abbreviations: HF, heart failure.

Figure 3 displays survival rates to 1 year based on the occurrence of incident or recurrent heart failure within the first 7 postoperative days. Survival rates were lowest among patients with recurrent heart failure in the first 7 postoperative days and highest among those with no preoperative or postoperative heart failure. Subjects with incident heart failure in the first postoperative week, and those with preoperative heart failure who did not suffer a recurrence, demonstrated intermediate survival rates (P < 0.001 for trend across all four groups).

Figure 3
Landmark survival curve to outcome of survival, by heart failure status; excluded 30 records where the patient died or underwent a second surgery before postoperative day 7. Abbreviations: HF, heart failure.

DISCUSSION

This population‐based study found that heart failure represents a highly prevalent condition in elderly patients undergoing hip fracture repairs. It demonstrates that those with preoperative heart failure typically suffer from more cardiovascular comorbidities and carry a higher risk of postoperative heart failure and postoperative mortality.

While many studies have focused on the epidemiology of hip fractures,21 population‐based data on cardiac complications following hip fracture repair are significantly less common. The ACC/AHA preoperative cardiac evaluation guidelines classify orthopedic procedures, including hip fracture repair, as intermediate risk.11 Consequently, some may assume that all orthopedic patients will have a mortality rate less than 5%. Indeed, the 30‐day postoperative mortality rate published from our institution's Total Joint Registry was 0.6% following elective total hip arthroplasty.22 However, the present study demonstrates that current ACC/AHA preoperative cardiac evaluation guidelines may not apply to the population of frail patients undergoing hip fracture repair. Particularly among those who experience new heart failure within the first seven days following surgery, outcomes are substantially worse than the ACC/AHA perioperative guidelines may suggest.11

Preoperative heart failure has been associated with adverse risk for postoperative mortality after hip fracture.9, 10, 12 However, these studies did not report heart failure as a complication of hip fracture repair. A prospective cohort study of 2448 hip fracture patients at an academic hospital in Great Britain found a 5% rate of inpatient heart failure as a postoperative complication.23 The hazard ratio for one‐year mortality was 11.3 with postoperative heart failure.23 However, the British study did not distinguish heart failure from other cardiovascular diseases as a preoperative comorbidity or stratify the risk for postoperative mortality by preoperative heart failure status.23 Our findings add to previous literature by measuring heart failure as a specific complication of hip fracture repair and examining the association of preoperative heart failure with postoperative heart failure and mortality.

Length of stay after hip fracture repair varies in the literature, but previous work has not clearly associated heart failure with length of hospitalization in the setting of hip fracture repair.24, 25 Our study found a significantly higher mean length of stay among those with preoperative heart failure. This adds to previous work by delineating an association between heart failure and increased length of stay after hip fracture repair.

We found a higher rate of postoperative mortality among men compared to women. Rates of postoperative heart failure, however, were more similar (Figure 2). Previous studies have found a consistently higher mortality rate among men versus women after hip fracture.9, 23, 2529 Possible explanations for these findings include the overall increased burden of cardiovascular disease among men, lower treatment rates of osteoporosis in men,30 and increased susceptibility to other postoperative complications, such as infection.25

The findings of this study carry important clinical implications for the perioperative care of hip fracture patients with, or at risk for, heart failure. They suggest that current risk stratification guidelines classifying orthopedic operations as intermediate risk procedures do not reflect the high risk for morbidity that hip fracture patients face.11 The association of heart failure with adverse outcomes implies the need for heightened surveillance in the perioperative period, particularly with regard to volume status and medication reconciliation. Hip fracture patients and their families must be counseled about the ramifications of perioperative heart failure, including higher rates of postoperative heart failure, longer hospitalizations, and ultimate mortality.

This research carries several limitations and remains subject to biases inherent in retrospective cohort studies. The reported effects of heart failure on outcomes after hip fracture repair may be due to confounding from age, functional status, and other comorbidities. We attempted to minimize sampling bias through complete enumeration of hip fracture surgeries among Olmsted County residents. Completeness of follow‐up (100% at one year) was possible given the availability of documentation of all inpatient and outpatient medical care in the community.17 We used objectively defined outcomes to minimize measurement bias. Applicability to a more diverse population may be limited because >95% of the research population was from a single, predominantly white community. However, prior studies have documented that hip fracture incidence rates31 and socioeconomic factors17 in Olmsted County are similar to those for other white residents of the United States. Heart failure rates were determined clinically according to the Framingham criteria. However, the Framingham criteria may inappropriately diagnose individuals with heart failure32 and falsely elevate the prevalence of heart failure as a preoperative comorbidity or postoperative complication.

The statistical analysis included patients counted multiple times if they underwent subsequent hip fracture repair during the study period. Including these patients may inaccurately inflate event rates or contribute to incorrect estimates of standard error. However, we felt it was appropriate to include recurrent hip fracture repair cases in the analysis because they represent a clinically distinct patient from both a medical and functional perspective. We used a robust variance estimator in the Cox proportional hazards models to provide an accurate calculation of the standard error given the possibility for correlation within subjects.20 Finally, the proportion of these patients was low (94 of 1116 unique patients; 8.4%).

Future work must involve further risk stratification and therapeutic interventions in perioperative hip fracture patients. A more robust analysis of heart failure, with differentiation between systolic and diastolic dysfunction, may facilitate risk stratification. Assessment of compliance with standard preoperative heart failure medications and the impact of heightened clinical vigilance may enlighten means to improve postoperative outcomes. Studies on risk stratification and therapeutic interventions may then inform policy regarding length of stay and reimbursement in hip fracture patients.

CONCLUSION

In summary, our population‐based findings reveal that heart failure represents a prevalent and serious comorbidity in patients undergoing hip fracture repair. Clinicians caring for perioperative hip fracture patients must pay particular attention to risk for, and implications of, new or recurrent heart failure.

Acknowledgements

The authors thank Donna K. Lawson, LPN, Kathy Wolfert, and Cherie Dolliver for their assistance in data collection and management.

As the population ages, hip fractures and heart failure increase in prevalence.1, 2 Heart failure prevalence is also increasing in hospitalized patients.3 Indeed, hospitalizations involving heart failure as an active issue tripled in the last 30 years.4 Heart failure has been associated with an increased risk for hip fracture,5, 6 and previous studies report a 6%20% prevalence of preoperative heart failure in hip fracture patients.710 While exacerbation of heart failure increases the mortality risk in patients admitted for hip fractures,8 the incidence of new heart failure, as well as the preoperative factors that predict postoperative heart failure in this patient population remain unclear.

American College of Cardiology/American Heart Association (ACC/AHA) perioperative guidelines identify orthopedic surgeries, including hip fracture repair, as intermediate risk procedures.11 Compared to other intermediate risk operations, however, postoperative outcomes following hip fracture repair differ significantly.1216 Overall mortality in hip fracture patients has been reported at 29% at one year,8 with the excess mortality from hip fracture alone at nearly 20%.10, 13 However, the exact factors that contribute to this excess mortality, particularly with regard to heart failure, remain unclear.

To examine the preoperative prevalence, subsequent incidence, and predictors of heart failure in patients undergoing hip fracture repair operations, this study used an established, population‐based database to compare the postoperative consequences in hip fracture repair patients with and without preexisting heart failure. We hypothesized that preoperative heart failure worsens postoperative outcomes in hip fracture patients.

METHODS

Case Ascertainment

Following approval by the Institutional Review Boards of Mayo Clinic and the Olmsted Medical Center, we used the Rochester Epidemiology Project (REP) to identify the patients for this study. The REP is a population‐based medical records linkage system that records all diagnoses, surgical procedures, laboratory data, and death information from hospital, emergency room, outpatient, and nursing home care in the community.17

All Olmsted County, Minnesota, residents who sustained a hip fracture and underwent surgical repair from 1988 through 2002 were evaluated. Patients with more than one hip fracture during the study period (96 occurrences) were censored from the data analysis at the time of the subsequent hip fracture and then included as new cases. The complete enumeration of hip fracture episodes managed in the three Olmsted County hospital facilities (Mayo Clinic's Saint Mary's and Rochester Methodist Hospitals, and the Olmsted Medical Center Hospital) occurred in three phases: First, all hospitalizations with the surgical procedure (International Statistical Classification of Diseases, 9th Revision [ICD‐9]) codes 79.15 (reduction, fracture, femur, closed with internal fixation), 79.25 (reduction, fracture, femur, open, without internal fixation), 79.35 (reduction, fracture, femur, open with internal fixation), 79.95 (operation, unspecified bone injury, femur), 80.05 (arthrotomy for removal of hip prosthesis), 80.15 (arthrotomy, other, hip), 80.95 (excision, hip joint), 81.21 (arthrodesis, hip), 81.40 (repair hip, not elsewhere classified), 81.51 (total hip replacement), 81.52 (partial hip replacement), and 81.53 (revision hip replacement) were identified. Second, through review of the original inpatient and outpatient medical records, we confirmed that a fracture was associated with the index hospitalization. Finally, radiology reports of each index hospitalization verified the presence and exact anatomical location of each fracture. Of those with fractures on admission x‐rays, only patients with a proximal femur (femoral neck or intertrochanteric) fracture as the primary indication for the surgery were included in the study. Surgical report or radiographic evidence of hip fracture was available for all patients. Secondary fractures due to a specific pathological lesion (eg, malignancy) or high‐energy trauma (by convention, motor vehicle accidents or falls from significant heights) were excluded. Only patients who had provided an authorization to review their medical records for research were ultimately included in the study cohort.18 Medical records were search manually, if indicated.

Criteria for Heart Failure and Death

Preoperative heart failure was based on clinical documentation of heart failure in a patient's medical record prior to the time of the hip fracture repair. Postoperative heart failure, including acute exacerbations, was defined according to Framingham criteria.19 Framingham criteria included clinical evidence of increased central venous pressure, pulmonary edema, an S3 gallop, radiographic pulmonary edema, and response to diuresis. Heart failure was not graded on clinical severity (ie, New York Heart Association classification). We did not distinguish between systolic and diastolic heart failure. Mortality was defined as death from any cause within the first year following hip fracture repair. Deaths were identified either through REP resources or the National Death Index.

Statistical Methods

Continuous variables are presented as mean standard deviation and categorical variables as number (percent). Two‐sample t tests or Wilcoxon rank sum tests were used to test for significant differences in continuous variables. Chi‐square or Fisher's exact tests were used for categorical variables. Rates of postoperative outcomes were calculated using the KaplanMeier method for the overall group and for those with and without preoperative heart failure. A landmark survival curve was used to evaluate postoperative mortality among patients who experienced heart failure in the first seven postoperative days versus those who did not. Patients who died or underwent another hip operation within the first seven postoperative days were excluded from this analysis. Univariate Cox proportional hazards models were used to evaluate the predictors of postoperative heart failure and mortality. Patients who died or experienced a second hip surgery within one year of their first were censored at that time. Any subsequent hip fracture repair was treated as a new case. To account for the inclusion of multiple hip fracture repairs for a given patient, the Cox proportional hazards model included a robust variance estimator. This provided an accurate calculation of the standard error in the presence of within‐subject correlation.20 Statistical tests were two‐sided, and P values were considered significant if less than 0.05. Statistical analyses were performed using SAS (version 9.1.3, SAS Institute, Cary, NC).

RESULTS

From among 1327 potential hip fracture repairs, we excluded 115 cases involving multiple injuries or operations (19), pathological fractures (20), in‐hospital fractures (3), or an operation >72 hours after the initial fracture (5). Three patients under 65 years of age were also excluded, as were cases with missing information (9) or cases managed nonoperatively (56). The final analysis included 1212 surgical cases in 1116 subjects. No subjects were lost to surveillance for 1 year following their hip fracture repair.

Table 1 summarizes the baseline characteristics of the study population. The overall prevalence of preoperative heart failure was 27.0% (327 of 1212). Those with preoperative heart failure were older, heavier, more likely male and white, and less likely to live independently preoperatively. They were also more likely to suffer from preexisting cardiovascular comorbidities.

Baseline Characteristics and Outcomes Among Olmsted County, Minnesota, Residents Undergoing Hip Fracture Repair, 19882002, by Preoperative Heart Failure Status
 All (N = 1,212)HF (N = 327)No HF (N = 885)P Value*
  • Abbreviations: BMI, body mass index; HF, heart failure; SD, standard deviation.

  • P values for those with, vs without, preoperative heart failure (1Rank sum, 2Chi‐square, 3Fisher's exact).

  • BMI data were missing for 15 cases, preoperative ambulatory status was missing for 2 cases, and discharge disposition was missing for 1 case.

  • All values are N (%) unless otherwise noted.

  • Chronic renal insufficiency was defined as a creatinine >2.0 mg/dL.

Demographics    
Mean age (years) (SD)84.2 (7.44)85.5 (6.54)83.7 (7.70)0.00101
Male gender237 (19.6)76 (23.2)161 (18.2)0.04912
Mean BMI (kg/m2) (SD)23.3 (4.97)24.1 (5.68)23.0 (4.65)0.01231
White1,204 (99.3)322 (98.5)882 (99.7)0.03713
Preoperative living situation    
Nursing facility468 (38.6)144 (44)324 (36.6)0.01842
Home744 (61.4)183 (56)561 (63.4)0.05192
Preoperative ambulatory status    
Dependent149 (12.3)50 (15.3)99 (11.2) 
Independent1,061 (87.7)276 (84.7)785 (88.8) 
Medical history    
Hypertension705 (58.2)226 (69.1)479 (54.1)<0.00012
Diabetes mellitus143 (11.8)63 (19.3)80 (9)<0.00012
Cerebrovascular disease331 (27.3)129 (39.4)202 (22.8)<0.00012
Peripheral vascular disease195 (16.1)80 (24.5)115 (13)<0.00012
Coronary artery disease464 (38.3)237 (72.5)227 (25.6)<0.00012
Atrial fibrillation/flutter254 (21)133 (40.7)121 (13.7)<0.00012
Complete heart block18 (1.5)9 (2.8)9 (1)0.03373
Pacer at time of admission32 (2.6)16 (4.9)16 (1.8)0.00292
Chronic obstructive pulmonary disease196 (16.2)78 (23.9)118 (13.3)<0.00012
Liver disease15 (1.2)7 (2.1)8 (0.9)0.13753
Chronic renal insufficiency131 (10.8)61 (18.7)70 (7.9)<0.00012
Mean length of hospitalization (days) (SD)10.0 (7.57)11.1 (8.82)9.6 (7.01)0.00101
Discharge disposition   0.00192
Home150 (12.4)26 (8.0)124 (14.0) 
Skilled nursing facility1,004 (82.9)278 (85.0)726 (82.1) 
Dead57 (4.7)23 (7.0)34 (3.9) 

Table 1 also summarizes the main outcome characteristics of the study population. Those with preoperative heart failure had longer mean lengths of stay (LOS), were more often discharged to a skilled facility, and demonstrated higher inpatient mortality rates.

Table 2 summarizes the outcomes associated with preoperative heart failure. The overall rate of postoperative heart failure was 6.7% within 7 postoperative days and 21.3% within 1 postoperative year. Postoperative heart failure was significantly more common among those with preoperative heart failure (hazard ratio [HR], 3.0; 95% confidence interval [CI], 2.3 to 3.9; P < 0.001). Among those without preoperative heart failure, rates of postoperative incident heart failure were 4.8% at 7 days and 15.0% at 1 year. Compared to patients without preoperative heart failure, those with preoperative heart failure demonstrated higher one year mortality rates and higher rates of postoperative heart failure at 7 days and 1 year.

Association of Preoperative Heart Failure With Postoperative Outcomes Among Olmsted County, Minnesota, Residents Undergoing Hip Fracture Repair, 19882002
 Preoperative Heart Failure (Subjects)
OutcomeAll (N = 1212)No (N = 885)Yes (N = 327)Risk ratio* (95% CI)P Value
  • Abbreviations: CI, confidence interval.

  • Risk ratio for those with vs without preoperative heart failure. Odds ratios were calculated using logistic regression for the outcome of heart failure exacerbation within seven postoperative days; hazard ratios were calculated using Cox proportional hazards models for each of the one‐year outcomes.

  • Excluded 26 cases in which a patient died in hospital without postoperative heart failure.

  • One‐year rates were estimated using the KaplanMeier method.

Heart failure exacerbation within seven postoperative days6.7% (5.4, 8.3)4.8% (3.5, 6.5)12.1% (8.7, 16.2)2.72 (1.72, 4.31)<0.0001
One‐year postoperative heart failure exacerbation21.3% (18.8, 23.7)15.0% (12.5, 17.4)39.3% (33.3, 44.9)3.00 (2.32, 3.87)<0.0001
One‐year postoperative mortality24.5% (22.0, 26.9)19.8% (17.1, 22.4)37.2% (31.6, 42.3)2.11 (1.67, 2.67)<0.0001
One‐year postoperative mortality or heart failure exacerbation36.5% (33.7, 39.2)29.7% (26.6, 32.6)55.0% (49.3, 60.2)2.28 (1.88, 2.76)<0.0001

Figure 1 displays the outcomes to 1 year of surveillance. Rates of postoperative heart failure and postoperative mortality were consistently higher among those with, versus without, preoperative heart failure. Figure 2 displays similar data stratified by gender. Postoperative heart failure rates did not differ significantly between genders (HR, 1.0; 95% CI, 0.8 to 1.4), but postoperative mortality rates were significantly higher among males than females (HR, 1.9; 95% CI, 1.5 to 2.5; P < 0.001).

Figure 1
Cumulative incidence of postoperative outcomes among Olmsted County, Minnesota, residents undergoing hip fracture repair, 1988–2002, by preoperative heart failure status. Abbreviations: HF, heart failure.
Figure 2
Cumulative incidence of postoperative outcomes among Olmsted County, Minnesota, residents undergoing hip fracture repair, 1988–2002, by gender. Abbreviations: HF, heart failure.

Figure 3 displays survival rates to 1 year based on the occurrence of incident or recurrent heart failure within the first 7 postoperative days. Survival rates were lowest among patients with recurrent heart failure in the first 7 postoperative days and highest among those with no preoperative or postoperative heart failure. Subjects with incident heart failure in the first postoperative week, and those with preoperative heart failure who did not suffer a recurrence, demonstrated intermediate survival rates (P < 0.001 for trend across all four groups).

Figure 3
Landmark survival curve to outcome of survival, by heart failure status; excluded 30 records where the patient died or underwent a second surgery before postoperative day 7. Abbreviations: HF, heart failure.

DISCUSSION

This population‐based study found that heart failure represents a highly prevalent condition in elderly patients undergoing hip fracture repairs. It demonstrates that those with preoperative heart failure typically suffer from more cardiovascular comorbidities and carry a higher risk of postoperative heart failure and postoperative mortality.

While many studies have focused on the epidemiology of hip fractures,21 population‐based data on cardiac complications following hip fracture repair are significantly less common. The ACC/AHA preoperative cardiac evaluation guidelines classify orthopedic procedures, including hip fracture repair, as intermediate risk.11 Consequently, some may assume that all orthopedic patients will have a mortality rate less than 5%. Indeed, the 30‐day postoperative mortality rate published from our institution's Total Joint Registry was 0.6% following elective total hip arthroplasty.22 However, the present study demonstrates that current ACC/AHA preoperative cardiac evaluation guidelines may not apply to the population of frail patients undergoing hip fracture repair. Particularly among those who experience new heart failure within the first seven days following surgery, outcomes are substantially worse than the ACC/AHA perioperative guidelines may suggest.11

Preoperative heart failure has been associated with adverse risk for postoperative mortality after hip fracture.9, 10, 12 However, these studies did not report heart failure as a complication of hip fracture repair. A prospective cohort study of 2448 hip fracture patients at an academic hospital in Great Britain found a 5% rate of inpatient heart failure as a postoperative complication.23 The hazard ratio for one‐year mortality was 11.3 with postoperative heart failure.23 However, the British study did not distinguish heart failure from other cardiovascular diseases as a preoperative comorbidity or stratify the risk for postoperative mortality by preoperative heart failure status.23 Our findings add to previous literature by measuring heart failure as a specific complication of hip fracture repair and examining the association of preoperative heart failure with postoperative heart failure and mortality.

Length of stay after hip fracture repair varies in the literature, but previous work has not clearly associated heart failure with length of hospitalization in the setting of hip fracture repair.24, 25 Our study found a significantly higher mean length of stay among those with preoperative heart failure. This adds to previous work by delineating an association between heart failure and increased length of stay after hip fracture repair.

We found a higher rate of postoperative mortality among men compared to women. Rates of postoperative heart failure, however, were more similar (Figure 2). Previous studies have found a consistently higher mortality rate among men versus women after hip fracture.9, 23, 2529 Possible explanations for these findings include the overall increased burden of cardiovascular disease among men, lower treatment rates of osteoporosis in men,30 and increased susceptibility to other postoperative complications, such as infection.25

The findings of this study carry important clinical implications for the perioperative care of hip fracture patients with, or at risk for, heart failure. They suggest that current risk stratification guidelines classifying orthopedic operations as intermediate risk procedures do not reflect the high risk for morbidity that hip fracture patients face.11 The association of heart failure with adverse outcomes implies the need for heightened surveillance in the perioperative period, particularly with regard to volume status and medication reconciliation. Hip fracture patients and their families must be counseled about the ramifications of perioperative heart failure, including higher rates of postoperative heart failure, longer hospitalizations, and ultimate mortality.

This research carries several limitations and remains subject to biases inherent in retrospective cohort studies. The reported effects of heart failure on outcomes after hip fracture repair may be due to confounding from age, functional status, and other comorbidities. We attempted to minimize sampling bias through complete enumeration of hip fracture surgeries among Olmsted County residents. Completeness of follow‐up (100% at one year) was possible given the availability of documentation of all inpatient and outpatient medical care in the community.17 We used objectively defined outcomes to minimize measurement bias. Applicability to a more diverse population may be limited because >95% of the research population was from a single, predominantly white community. However, prior studies have documented that hip fracture incidence rates31 and socioeconomic factors17 in Olmsted County are similar to those for other white residents of the United States. Heart failure rates were determined clinically according to the Framingham criteria. However, the Framingham criteria may inappropriately diagnose individuals with heart failure32 and falsely elevate the prevalence of heart failure as a preoperative comorbidity or postoperative complication.

The statistical analysis included patients counted multiple times if they underwent subsequent hip fracture repair during the study period. Including these patients may inaccurately inflate event rates or contribute to incorrect estimates of standard error. However, we felt it was appropriate to include recurrent hip fracture repair cases in the analysis because they represent a clinically distinct patient from both a medical and functional perspective. We used a robust variance estimator in the Cox proportional hazards models to provide an accurate calculation of the standard error given the possibility for correlation within subjects.20 Finally, the proportion of these patients was low (94 of 1116 unique patients; 8.4%).

Future work must involve further risk stratification and therapeutic interventions in perioperative hip fracture patients. A more robust analysis of heart failure, with differentiation between systolic and diastolic dysfunction, may facilitate risk stratification. Assessment of compliance with standard preoperative heart failure medications and the impact of heightened clinical vigilance may enlighten means to improve postoperative outcomes. Studies on risk stratification and therapeutic interventions may then inform policy regarding length of stay and reimbursement in hip fracture patients.

CONCLUSION

In summary, our population‐based findings reveal that heart failure represents a prevalent and serious comorbidity in patients undergoing hip fracture repair. Clinicians caring for perioperative hip fracture patients must pay particular attention to risk for, and implications of, new or recurrent heart failure.

Acknowledgements

The authors thank Donna K. Lawson, LPN, Kathy Wolfert, and Cherie Dolliver for their assistance in data collection and management.

References
  1. Melton LJ.Epidemiology of hip fractures: Implications of the exponential increase with age.Bone.1996;18(3 suppl):121S125S.
  2. Bueno H,Ross JS,Wang Y, et al.Trends in length of stay and short‐term outcomes among Medicare patients hospitalized for heart failure, 1993–2006.JAMA.2010;303(21):21412147.
  3. Koelling TM,Chen RS,Lubwama RN,L'Italien GJ,Eagle KA.The expanding national burden of heart failure in the United States: The influence of heart failure in women.Am Heart J.2004;147(1):7478.
  4. Fang J,Mensah GA,Croft JB,Keenan NL.Heart failure‐related hospitalization in the U.S., 1979 to 2004.J Am Coll Cardiol.2008;52(6):428434.
  5. van Diepen S,Majumdar SR,Bakal JA,McAlister FA,Ezekowitz JA.Heart failure is a risk factor for orthopedic fracture: A population‐based analysis of 16,294 patients.Circulation.2008;118(19):19461952.
  6. Sennerby U,Melhus H,Gedeborg R, et al.Cardiovascular diseases and risk of hip fracture.JAMA.2009;302(15):16661673.
  7. Nigwekar SU,Job AV,Kouides RW,Polashenski W.Effectiveness of hospitalist involvement in hip fracture management questioned.South Med J.2007;100(9):912913.
  8. Batsis JA,Phy MP,Melton LJ, et al.Effects of a hospitalist care model on mortality of elderly patients with hip fractures.J Hosp Med.2007;2(4):219225.
  9. Kannegaard PN,van der Mark S,Eiken P,Abrahamsen B.Excess mortality in men compared with women following a hip fracture. National analysis of comedications, comorbidity and survival.Age Ageing.2010;39(2):203209.
  10. Vestergaard P,Rejnmark L,Mosekilde L.Increased mortality in patients with a hip fracture—Effect of pre‐morbid conditions and post‐fracture complications.Osteoporos Int.2007;18(12):15831593.
  11. Fleisher LA,Beckman JA,Brown KA, et al.ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: Executive summary: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): Developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery.J Am Coll Cardiol.2007;50(17):17071732.
  12. Tosteson ANA,Gottlieb DJ,Radley DC,Fisher ES,Melton LJ.Excess mortality following hip fracture: The role of underlying health status.Osteoporos Int.2007;18(11):14631472.
  13. Giversen IM.Time trends of mortality after first hip fractures.Osteoporos Int.2007;18(6):721732.
  14. Hannan EL,Magaziner J,Wang JJ, et al.Mortality and locomotion 6 months after hospitalization for hip fracture: Risk factors and risk‐adjusted hospital outcomes.JAMA.2001;285(21):27362742.
  15. Meyer HE,Tverdal A,Falch JA,Pedersen JI.Factors associated with mortality after hip fracture.Osteoporos Int.2000;11(3):228232.
  16. Myers AH,Robinson EG,Natta MLV,Michelson JD,Collins K,Baker SP.Hip fractures among the elderly: Factors associated with in‐hospital mortality.Am J Epidemiol.1991;134(10):11281137.
  17. Melton LJ.History of the Rochester Epidemiology Project.Mayo Clin Proc.1996;71(3):266274.
  18. Melton LJ.The threat to medical‐records research.N Engl J Med.1997;337(20):14661470.
  19. McKee PA,Castelli WP,McNamara PM,Kannel WB.The natural history of congestive heart failure: The Framingham Study.N Engl J Med.1971;285(26):14411446.
  20. Lin DY,Wei LJ.The robust inference for the Cox proportional hazards model.J Am Stat Assoc.1989;84(408):10741078.
  21. Marks R.Hip fracture epidemiological trends, outcomes, and risk factors, 1970–2009.Int J Gen Med.2010;3:117.
  22. Wood M,Mantilla CB,Horlocker TT,Schroeder DR,Berry DJ,Brown DL.Frequency of myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or knee arthroplasty.Anesthesiology.2002;96(5):11401146.
  23. Roche JJW,Wenn RT,Sahota O,Moran CG.Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: Prospective observational cohort study.BMJ.2005;331(7529):13741376.
  24. Bentler SE,Liu L,Obrizan M, et al.The aftermath of hip fracture: Discharge placement, functional status change, and mortality.Am J Epidemiol.2009;170(10):12901299.
  25. Wehren LE,Hawkes WG,Orwig DL,Hebel JR,Zimmerman SI,Magaziner J.Gender differences in mortality after hip fracture: The role of infection.J Bone Miner Res.2003;18(12):22312237.
  26. Center JR,Nguyen TV,Schneider D,Sambrook PN,Eisman JA.Mortality after all major types of osteoporotic fracture in men and women: An observational study.Lancet.1999;353(9156):878882.
  27. Robbins JA,Biggs ML,Cauley J.Adjusted mortality after hip fracture: From the Cardiovascular Health Study.J Am Geriatr Soc.2006;54(12):18851891.
  28. Haentjens P,Magaziner J,Colon‐Emeric CS, et al.Meta‐analysis: Excess mortality after hip fracture among older women and men.Ann Intern Med.2010;152(6):380390.
  29. Poór G,Atkinson EJ,O'Fallon WM,Melton LJ.Predictors of hip fractures in elderly men.J Bone Miner Res.1995;10(12):19001907.
  30. Curtis J,McClure L,Delzell E, et al.Population‐based fracture risk assessment and osteoporosis treatment disparities by race and gender.J Gen Intern Med.2009;24(8):956962.
  31. Melton LJ,Therneau TM,Larson DR.Long‐term trends in hip fracture prevalence: The influence of hip fracture incidence and survival.Osteoporos Int.1998;8(1):6874.
  32. Maestre A,Gil V,Gallego J,Aznar J,Mora A,Martin‐Hidalgo A.diagnostic accuracy of clinical criteria for identifying systolic and diastolic heart failure: Cross‐sectional study.J Eval Clin Pract.2009;15(1):5561.
References
  1. Melton LJ.Epidemiology of hip fractures: Implications of the exponential increase with age.Bone.1996;18(3 suppl):121S125S.
  2. Bueno H,Ross JS,Wang Y, et al.Trends in length of stay and short‐term outcomes among Medicare patients hospitalized for heart failure, 1993–2006.JAMA.2010;303(21):21412147.
  3. Koelling TM,Chen RS,Lubwama RN,L'Italien GJ,Eagle KA.The expanding national burden of heart failure in the United States: The influence of heart failure in women.Am Heart J.2004;147(1):7478.
  4. Fang J,Mensah GA,Croft JB,Keenan NL.Heart failure‐related hospitalization in the U.S., 1979 to 2004.J Am Coll Cardiol.2008;52(6):428434.
  5. van Diepen S,Majumdar SR,Bakal JA,McAlister FA,Ezekowitz JA.Heart failure is a risk factor for orthopedic fracture: A population‐based analysis of 16,294 patients.Circulation.2008;118(19):19461952.
  6. Sennerby U,Melhus H,Gedeborg R, et al.Cardiovascular diseases and risk of hip fracture.JAMA.2009;302(15):16661673.
  7. Nigwekar SU,Job AV,Kouides RW,Polashenski W.Effectiveness of hospitalist involvement in hip fracture management questioned.South Med J.2007;100(9):912913.
  8. Batsis JA,Phy MP,Melton LJ, et al.Effects of a hospitalist care model on mortality of elderly patients with hip fractures.J Hosp Med.2007;2(4):219225.
  9. Kannegaard PN,van der Mark S,Eiken P,Abrahamsen B.Excess mortality in men compared with women following a hip fracture. National analysis of comedications, comorbidity and survival.Age Ageing.2010;39(2):203209.
  10. Vestergaard P,Rejnmark L,Mosekilde L.Increased mortality in patients with a hip fracture—Effect of pre‐morbid conditions and post‐fracture complications.Osteoporos Int.2007;18(12):15831593.
  11. Fleisher LA,Beckman JA,Brown KA, et al.ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: Executive summary: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): Developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery.J Am Coll Cardiol.2007;50(17):17071732.
  12. Tosteson ANA,Gottlieb DJ,Radley DC,Fisher ES,Melton LJ.Excess mortality following hip fracture: The role of underlying health status.Osteoporos Int.2007;18(11):14631472.
  13. Giversen IM.Time trends of mortality after first hip fractures.Osteoporos Int.2007;18(6):721732.
  14. Hannan EL,Magaziner J,Wang JJ, et al.Mortality and locomotion 6 months after hospitalization for hip fracture: Risk factors and risk‐adjusted hospital outcomes.JAMA.2001;285(21):27362742.
  15. Meyer HE,Tverdal A,Falch JA,Pedersen JI.Factors associated with mortality after hip fracture.Osteoporos Int.2000;11(3):228232.
  16. Myers AH,Robinson EG,Natta MLV,Michelson JD,Collins K,Baker SP.Hip fractures among the elderly: Factors associated with in‐hospital mortality.Am J Epidemiol.1991;134(10):11281137.
  17. Melton LJ.History of the Rochester Epidemiology Project.Mayo Clin Proc.1996;71(3):266274.
  18. Melton LJ.The threat to medical‐records research.N Engl J Med.1997;337(20):14661470.
  19. McKee PA,Castelli WP,McNamara PM,Kannel WB.The natural history of congestive heart failure: The Framingham Study.N Engl J Med.1971;285(26):14411446.
  20. Lin DY,Wei LJ.The robust inference for the Cox proportional hazards model.J Am Stat Assoc.1989;84(408):10741078.
  21. Marks R.Hip fracture epidemiological trends, outcomes, and risk factors, 1970–2009.Int J Gen Med.2010;3:117.
  22. Wood M,Mantilla CB,Horlocker TT,Schroeder DR,Berry DJ,Brown DL.Frequency of myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or knee arthroplasty.Anesthesiology.2002;96(5):11401146.
  23. Roche JJW,Wenn RT,Sahota O,Moran CG.Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: Prospective observational cohort study.BMJ.2005;331(7529):13741376.
  24. Bentler SE,Liu L,Obrizan M, et al.The aftermath of hip fracture: Discharge placement, functional status change, and mortality.Am J Epidemiol.2009;170(10):12901299.
  25. Wehren LE,Hawkes WG,Orwig DL,Hebel JR,Zimmerman SI,Magaziner J.Gender differences in mortality after hip fracture: The role of infection.J Bone Miner Res.2003;18(12):22312237.
  26. Center JR,Nguyen TV,Schneider D,Sambrook PN,Eisman JA.Mortality after all major types of osteoporotic fracture in men and women: An observational study.Lancet.1999;353(9156):878882.
  27. Robbins JA,Biggs ML,Cauley J.Adjusted mortality after hip fracture: From the Cardiovascular Health Study.J Am Geriatr Soc.2006;54(12):18851891.
  28. Haentjens P,Magaziner J,Colon‐Emeric CS, et al.Meta‐analysis: Excess mortality after hip fracture among older women and men.Ann Intern Med.2010;152(6):380390.
  29. Poór G,Atkinson EJ,O'Fallon WM,Melton LJ.Predictors of hip fractures in elderly men.J Bone Miner Res.1995;10(12):19001907.
  30. Curtis J,McClure L,Delzell E, et al.Population‐based fracture risk assessment and osteoporosis treatment disparities by race and gender.J Gen Intern Med.2009;24(8):956962.
  31. Melton LJ,Therneau TM,Larson DR.Long‐term trends in hip fracture prevalence: The influence of hip fracture incidence and survival.Osteoporos Int.1998;8(1):6874.
  32. Maestre A,Gil V,Gallego J,Aznar J,Mora A,Martin‐Hidalgo A.diagnostic accuracy of clinical criteria for identifying systolic and diastolic heart failure: Cross‐sectional study.J Eval Clin Pract.2009;15(1):5561.
Issue
Journal of Hospital Medicine - 6(9)
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Journal of Hospital Medicine - 6(9)
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507-512
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507-512
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Impact of heart failure on hip fracture outcomes: A population‐based study
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Impact of heart failure on hip fracture outcomes: A population‐based study
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heart failure, postoperative evaluation and care, cardiovascular risk assessment
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heart failure, postoperative evaluation and care, cardiovascular risk assessment
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Health Literacy and Medication Use

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Health literacy and medication understanding among hospitalized adults

With the aging of the US population, complex medication regimens to treat multiple comorbidities are increasingly common.1 Nevertheless, patients often do not fully understand the instructions for safe and effective medication use. Aspects of medication understanding include knowledge of the drug indication, dose, frequency, and for certain medications, special instructions.2 Medication understanding is associated with better medication adherence, fewer drug‐related problems, and fewer emergency department visits.3 Among patients with chronic conditions, such as cardiovascular disease (CVD), understanding and adherence to the medication regimen are critical for successful disease control and clinical outcomes.4

Patients' understanding of their medication regimen is also vitally important upon admission to the hospital. Patients often are the main source of information for the admission medication history and subsequent medication reconciliation.5 Poor patient understanding of the preadmission medication regimen can contribute to errors in inpatient and postdischarge medication orders, and adversely affect patient safety.6 However, little research has examined patients' understanding of the preadmission medication regimen and factors that affect it.

In the outpatient setting, previous investigations have suggested that low health literacy, advanced age, and impaired cognitive function adversely affect patients' understanding of medication instructions.2, 7, 8 These studies were limited by a small sample size, single site, or focus on a specific population, such as inner‐city patients. Additionally, the measures used to assess medication understanding were time‐consuming and required patients' medications to be present for testing, thus limiting their utility.2

To address these gaps in the literature, we developed and implemented the Medication Understanding Questionnaire (MUQ), an original and relatively rapid measure that does not require patients' medications be present for testing. In a study of adults at 2 large teaching hospitals, we examined the association of health literacy, age, cognitive function, number of preadmission medications, and other factors on patients' understanding of their preadmission medication regimen. We hypothesized that lower health literacy would be independently associated with lower medication understanding as assessed using the MUQ.

METHODS

The present study was a cross‐sectional assessment conducted using baseline interview data from the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL‐CVD) Study (ClinicalTrials.gov Registration #NCT00632021; available at: http://clinicaltrials.gov/show/NCT00632021). The PILL‐CVD Study is a randomized controlled trial of a pharmacist‐based intervention, consisting of pharmacist‐assisted medication reconciliation, inpatient counseling, low‐literacy adherence aids, and postdischarge telephone follow‐up. It was conducted at 2 academic medical centersVanderbilt University Hospital (VUH) in Nashville, Tennessee, and Brigham and Women's Hospital (BWH) in Boston, Massachusetts.9 This study was approved by the Institutional Review Board at each site, and all participants provided written informed consent.

Population

The PILL‐CVD study protocol and eligibility criteria has been previously published.9 Briefly, patients were eligible if they were at least 18 years old and admitted with acute coronary syndrome or acute decompensated heart failure. Patients were excluded if they: were too ill to complete an interview; were not oriented to person, place, or time; had a corrected visual acuity worse than 20/200; had impaired hearing; could not communicate in English or Spanish; were not responsible for managing their own medications; had no phone; were unlikely to be discharged to home; were in police custody; or had been previously enrolled in the study. For the present analysis, we also excluded any patient who was not on at least 1 prescription medication prior to admission. Saline nasal spray, saline eye drops, herbal products, nutritional supplements, vitamins, and over the counter (OTC) lotions and creams were not counted as prescription medications. Oral medications available both OTC and by prescription (eg, aspirin, nonsteroidal anti‐inflammatory drugs, and acid reflux medications) were counted as prescription medications.

Measures

At enrollment, which was usually within 24 to 48 hours of admission, participants completed the short form of the Test of Functional Health Literacy in Adults (s‐TOFHLA) in English or Spanish,10 the Mini‐Cog test of cognition,11 and the Medication Understanding Questionnaire (MUQ), as well as demographic information. The number of prescription medications prior to hospital admission was abstracted from the best available reference listthat documented by the treating physicians in the electronic health record (EHR). The EHR at each site was a home‐grown system and included both inpatient and outpatient records, which facilitated physicians' documentation of the medication list.

The s‐TOFHLA consists of 2 short reading‐comprehension passages. Scores on the s‐TOFHLA range from 0 to 36, and can be categorized as inadequate (0‐16), marginal (17‐22), or adequate (23‐36) health literacy.10 The Mini‐Cog includes 3‐item recall and clock‐drawing tests. It provides a brief measure of cognitive function and performs well among patients with limited literacy or educational attainment.11 Scores range from 0 to 5, with a score <3 indicating possible dementia.

The MUQ was administered verbally and assessed patients' understanding of their own preadmission medication regimen. It was developed for this study, based on published measures of medication understanding.2, 12 To administer the MUQ, research assistants (RAs) accessed the patient's preadmission medication list from the EHR and used a random number table to select up to 5 prescription medications from the list. If the patient was taking 5 or fewer medications, all of their medications were selected. Saline nasal spray, saline eye drops, herbal products, nutritional supplements, vitamins, and OTC lotions and creams were excluded from testing. The RA provided the brand and generic name of each medication, and then asked the patient for the drug's purpose, strength per unit (eg, 20 mg tablet), number of units taken at a time (eg, 2 tablets), and dosing frequency (eg, twice a day). For drugs prescribed on an as‐needed basis, the RA asked patients for the maximum allowable dose and frequency. Patients were instructed to not refer to a medication list or bottles when responding. The RA documented the patient's responses on the MUQ, along with the dosing information from the EHR for each selected medication.

One clinical pharmacist (MM) scored all MUQ forms by applying a set of scoring rules. Each medication score could range from 0 to 3. The components of the score included indication (1 point), strength (0.5 point), units (0.5 point), and frequency (1 point). The patient's overall MUQ score was an average of the MUQ scores for each tested medication.

Statistical Analysis

We summarized patient characteristics, number of preadmission medications, and MUQ scores using median and interquartile range (IRQ) for continuous variables, and frequencies and proportions for categorical variables. We conducted proportional odds logistic regression (ordinal regression) to estimate the effect of s‐TOFHLA score, other patient characteristics, and number of medications on MUQ scores.13

Important covariates were selected a priori based on clinical significance. These included age (continuous), gender, patient self‐reported race (white, black, other nonwhite), Mini‐Cog score (continuous), primary language (English or Spanish), years of education (continuous), number of preadmission medications (continuous), income (ordinal categories), insurance type (categorical), and study site. Covariates with missing data (household income, health literacy, and years of education) were imputed using multiple imputation techniques.14 The relationship between number of preadmission medications and MUQ scores was found to be nonlinear, and it was modeled using restricted cubic splines.14 We also fit models which treated health literacy and cognition as categorical variables. Results are reported as odds ratios (OR) with 95% confidence intervals (CI). Wald tests were used to test for the statistical significance of predictor variables. Two‐sided P values less than 0.05 were considered statistically significant. All analyses were performed using statistical language R (R Foundation, available at: http://www.r‐project.org).

RESULTS

Baseline Characteristics

Among the 862 patients enrolled in PILL‐CVD, 790 (91.7 %) had at least 1 preadmission medication and were included in this analysis (Table 1). Forty‐seven percent were admitted to VUH (N = 373) and 53% to BWH (N = 417). The median age was 61 (interquartile range [IQR] 52, 71), 77% were white, and 57% were male. Inadequate or marginal health literacy was identified among 11% and 9% of patients, respectively. The median number of preadmission medications was 8 (IQR 5, 11). Patients excluded from the analysis for not having preadmission medications were similar to included patients, except they were more likely to be male (76% vs 57%) and less likely to have health insurance (23% self‐pay vs 4%). (Data available upon request.)

Baseline Patient Characteristics
CharacteristicN = 790
  • Abbreviations: IQR, interquartile range; s‐TOFHLA, Test of Functional Health Literacy in Adults.

  • Missing s‐TOFHLA, N = 19; missing household income, N = 4; missing years of school, N = 1.

Study hospital, N (%) 
Vanderbilt University Hospital373 (47.2)
Brigham and Women's Hospital417 (52.8)
Age in years, median (IQR)61 (52, 71)
Gender, N (%) 
Male452 (57.2)
Female338 (42.8)
Primary language, N (%) 
English779 (98.6)
Spanish11 (1.4)
Race, N (%) 
White610 (77.2)
Black or African American136 (17.2)
Other44 (5.6)
Health literacy, s‐TOFHLA score, median (IQR)33 (25, 35)
Health literacy, N (%)& 
Inadequate84 (10.6)
Marginal74 (9.4)
Adequate613 (77.6)
Mini‐Cog score, median (IQR)4 (3, 5)
Dementia, N (%) 
No692 (87.6)
Yes98 (12.4)
Number of medications, median (IQR)8 (5, 11)
Health insurance type, N (%) 
Medicaid74 (9.4)
Medicare337 (42.6)
Private334 (42.3)
Self‐pay35 (4.4)
Other10 (1.3)
Self‐reported household income, N (%)& 
<$10,00038 (4.8)
$10,000 to <$15,00045 (5.7)
$15,000 to <$20,00042 (5.3)
$20,000 to <$25,000105 (13.3)
$25,000 to <$35,00099 (12.5)
$35,000 to <$50,000112 (14.2)
$50,000 to <$75,000118 (14.9)
$75,000+227 (28.7)
Years of school, median (IQR)&14 (12, 16)

MUQ Scores

The MUQ was administered in approximately 5 minutes. The median MUQ score was 2.5 (IQR 2.2, 2.8) (Table 2); 16.3% of patients scored less than 2. Subjects typically achieved high scores for the domains of indication, units, and frequency, while scores on the strength domain were lower (median = 0.2 [IQR 0.1, 0.4], maximum possible = 0.5).

MUQ Scores and Components at Baseline Among 790 Patients Using at Least 1 Medication
 Median (IQR)
  • Abbreviations: MUQ, Medication Understanding Questionnaire.

  • Each medication score could range from 0 to 3. For each medication tested, the components of the score included indication (1 point), strength (0.5 point), units (0.5 point), and frequency (1 point). The patient's overall MUQ score was then the average of the MUQ scores for each medication.

No. of drugs tested5 (4, 5)
MUQ score*2.5 (2.2, 2.8)
Indication1.0 (0.8, 1.0)
Strength0.2 (0.1, 0.4)
Units0.5 (0.4, 0.5)
Frequency1.0 (0.8, 1.0)

Predictors of Medication Understanding

Unadjusted relationships of health literacy, cognition, and number of medications with medication understanding are shown in Figure 1 (panels A, B, and C, respectively). The figure demonstrates a linear relationship with both health literacy (Figure 1A) and cognition (Figure 1B), and a nonlinear relationship between number of preadmission medications and MUQ score (Figure 1C).

Figure 1
Unadjusted relationships of Medication Understanding Questionnaire (MUQ) scores with: (A) health literacy, (B) cognition, and (C) number of preadmission medications. Abbreviations: s‐TOFHLA, Test of Functional Health Literacy in Adults.

Adjusted relationships using imputed data for missing covariates are shown in Figure 2. Lower health literacy, cognitive impairment, male gender, and black race were independently associated with lower understanding of preadmission medications. Each 1 point increase in s‐TOFHLA or Mini‐Cog score led to an increase in medication understanding (OR = 1.04; 95% CI, 1.02 to 1.06; P = 0.0001; and OR = 1.24; 95% CI, 1.1 to 1.4; P = 0.001; respectively). Patients with marginal or inadequate health literacy had lower odds of understanding their regimen (OR = 0.53; 95% CI, 0.34 to 0.84; and OR = 0.49; 95% CI, 0.31 to 0.78, respectively) compared to those with adequate health literacy. Impaired cognitive function (Mini‐Cog score <3, indicating dementia) was also associated with lower odds of medication understanding (OR = 0.57; 95% CI, 0.38 to 0.86) compared to those with no cognitive impairment. An increase in the number of preadmission medications (up to 10) was also strongly associated with lower MUQ scores. For each increase by 1 medication, there was a significant decrease in medication understanding, up to 10 medications, beyond which understanding did not significantly decrease further. Patients on 6 medications were about half as likely to understand their medication regimen as patients on only 1 medication (OR = 0.52; 95% CI, 0.36 to 0.75). For patients on 11 medications, the odds of medication understanding were 24% lower than for patients on 6 medications (OR = 0.76; 95% CI, 0.65 to 0.89). Patients' age, years of schooling, and household income were not independently associated with medication understanding. Results were similar using data without multiple imputation.

Figure 2
Forest plot of the adjusted odds of a higher Medication Understanding Questionnaire (MUQ) score compared to an average patient. Odds ratios (OR) of <1 represent lower medication understanding; OR of >1 represent higher medication understanding. Model includes: age, gender, patient self‐reported race, Test of Functional Health Literacy in Adults (s‐TOFHLA) score, cognitive function, primary language, years of education, number of preadmission medications (nonlinear restricted cubic spline with 3 knots), income, insurance type, and study site. Diamonds represent point estimate, and shaded gray bars represent 95% confidence intervals.

Examples of Misunderstanding of Common Medications

Table 3 provides examples of incorrect patient responses for several commonly prescribed medications or drug classes, including aspirin, digoxin, nitroglycerin, and HMG‐CoA reductase inhibitors (statins). For aspirin, many patients were not aware of the strength. For digoxin, several participants reported splitting a higher‐strength pill to obtain the prescribed dose, which should not be done given the imprecision of splitting and narrow therapeutic index of this drug. Patients prescribed nitroglycerin sublingual tablets were commonly unable to report the correct dosing and frequency for angina treatment. Medications for cholesterol were often reported as being taken in the morning; this was scored strictly as a frequency error if the medication timing in the EHR was listed as evening or bedtime. We also identified many patients with poor understanding of opioid analgesics, particularly regarding their dosing and frequency.

Common Incorrect Responses for Frequent Medications and Resulting Error Code on MUQ
MedicationsCommon Incorrect ResponsesCorrect InformationCoded Error
  • Abbreviations: MUQ, Medication Understanding Questionnaire.

Aspirintablet twice a day1 tablet once a dayUnits and frequency
 I am not aware what aspirin I am taking81 mg once a dayStrength
 I am taking 6‐something every day81 mg once a dayStrength
 31 mg a day81 mg once a dayStrength
 180 mg a day81 mg once a dayStrength
 1 low‐dose daily325 mg once a dayStrength
 125 mg a day325 mg once a dayStrength
 I am taking it for my blood pressureHeart medicationIndication
Nitroglycerin sublingualAs needed, I have taken up to 4 a dayDissolve 1 tablet under the tongue, every 5 min as needed, up to 3 dosesFrequency
 As needed every 15 min Frequency
 As needed up to 4 doses every 10 min Frequency
 Dissolve couple units under the tongue, as needed Units and frequency
 As many as I want, every 5 min Frequency
Digoxintablet daily1 tablet dailyUnits
 1 tablet daily1 tablet every other dayFrequency
 I am taking it for my blood pressureHeart medicationIndication
HMG‐CoA reductase inhibitors1 tablet every morning1 tablet every eveningFrequency
 tablet twice a day1 tablet once a dayUnits and frequency
 I do not know the indicationHigh cholesterolIndication
Propoxyphene/acetaminophentablet as needed1 tablet every 4‐6 hr as neededUnits and frequency
Hydrocodone/acetaminophenI do not know the strength of this medication5 mg/500 mgStrength
 1 tablet as I need it1 tablet every 4‐6 hr as neededFrequency

DISCUSSION

We used a novel four‐component medication understanding questionnaire, developed for this study, to assess patients' understanding of up to 5 drugs selected randomly from the participant's preadmission medication list. The MUQ proved to be easy to administer by nonmedical staff within a short period of time (approximately 5 minutes per patient). It was well understood by patients. By limiting the assessment to 5 or fewer medications, the MUQ has a distinct advantage over existing measures of medication understanding that require testing the entire regimen. We did not find any limitations related to cutting off the assessment at 5 medications. In addition, this tool affords assessment of medication understanding without requiring medication bottles be present, enhancing its utility in the inpatient setting.

MUQ scores were associated with health literacy and other patient characteristics in an expected manner. We demonstrated that inadequate or marginal health literacy, as well as impaired cognitive function, were associated with low medication understanding. We also were able to demonstrate a relationship between increasing number of medications and lower medication understanding. Interestingly, in our patient population, understanding continued to decrease until reaching 10 medications, beyond which further increases in the number of medications had no additional detrimental effect on medication understanding. This nonlinear relationship between number of medications and medication understanding has potential implications for prescribing practice.

Our findings which utilize the MUQ among inpatients are consistent with prior literature in other settings.2, 7, 8 In a previous outpatient study, we identified that health literacy plays an important role in a patient's ability to successfully report and manage their daily medications.2 Other studies have also shown that patients with low health literacy have more difficulty understanding prescription drug information, and that they often experience medication‐related problems after hospital discharge.15, 16 The number and often the types of medications an individual takes have also been shown to increase the risk for adverse events and nonadherence to the treatment plan.1720 We postulate that this risk of adverse drug events is related at least in part to a patient's understanding of their medication regimen.

There are several limitations to this study. First, the MUQ did not assess certain aspects of medication understanding, such as knowledge of pill appearance or side effects, nor did it assess components of patients' actual drug‐taking behavior, such as organization of medications or behavioral cues. Thus, adaptive behaviors that patients may perform to improve their medication management, such as writing on labels or memory cues, are not captured by this test. Second, in administering and scoring the MUQ, we used the patient's preadmission medication list documented in the EHR as the reference standard. This was the best available reference list, and was generally accurate, as both hospitals had medication reconciliation systems in use at the time of the study21; nevertheless, it may contain inaccuracies. Documentation for certain medications, such as warfarin, in which dose can change frequently, often did not reflect the latest prescribed dose. In such cases, we scored the patient's answer as correct if the dose appeared reasonable and appropriate to the clinical pharmacist. As a result, a patient's MUQ score may have been overestimated in these cases.

Additional research will be needed to further validate the MUQ in other settings. In particular, studies should establish the relationship between the MUQ, serious medication errors after discharge, and potential to benefit from educational interventions. Also, as noted above, the nonlinear relationship between number of medications and medication understanding should be confirmed in other studies.

In conclusion, we demonstrated that patients with low health literacy, impaired cognition, or a higher number of medications had significantly poorer understanding of their preadmission medication regimen. These findings have important clinical implications. It would be appropriate to exercise greater caution when taking a medication history from patients who cannot readily provide the purpose, strength, units, and frequency of their medications. Attempts to validate the information obtained from patients with other sources of data, such as family members, inpatient or outpatient health records, and community pharmacy records should be considered. Patients at high risk for poor medication understanding, either measured directly using the MUQ or identified via risk factors such as polypharmacy, low cognition, or low health literacy, may warrant more intensive medication reconciliation interventions and/or educational counseling and follow‐up to prevent postdischarge adverse drug events. Further research is needed to determine if targeting these populations for interventions improves medication safety during transitions in care.

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References
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  2. Kripalani S,Henderson LE,Chiu EY,Robertson R,Kolm P,Jacobson TA.Predictors of medication self‐management skill in a low‐literacy population.J Gen Intern Med.2006;21(8):852856.
  3. Osterberg L,Blaschke T.Adherence to medication.N Engl J Med.2005;353(5):487497.
  4. Ho PM,Bryson CL,Rumsfeld JS.Medication adherence: its importance in cardiovascular outcomes.Circulation.2009;119(23):30283035.
  5. Pippins JR,Gandhi TK,Hamann C, et al.Classifying and predicting errors of inpatient medication reconciliation.J Gen Intern Med.2008;23(9):14141422.
  6. Tsilimingras D,Bates DW.Addressing postdischarge adverse events: a neglected area.Jt Comm J Qual Patient Saf.2008;34(2):8597.
  7. Edelberg HK,Shallenberger E,Wei JY.Medication management capacity in highly functioning community‐living older adults: detection of early deficits.J Am Geriatr Soc.1999;47(5):592596.
  8. Spiers MV,Kutzik DM,Lamar M.Variation in medication understanding among the elderly.Am J Health‐Syst Pharm.2004;61(4):373380.
  9. Schnipper JL,Roumie CL,Cawthon C, et al.The rationale and design of the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL‐CVD) study.Circ Cardiovasc Qual Outcomes.2010;3:212219.
  10. Nurss JR,Parker RM,Williams MV,Baker DW.Short Test of Functional Health Literacy in Adults.Snow Camp, NC:Peppercorn Books and Press;1998.
  11. Borson S,Scanlan JM,Watanabe J,Tu SP,Lessig M.Simplifying detection of cognitive impairment: comparison of the Mini‐Cog and Mini‐Mental State Examination in a multiethnic sample.J Am Geriatr Soc.2005;53(5):871874.
  12. Farris KB,Phillips BB.Instruments assessing capacity to manage medications.Ann Pharmacother.2008;42(7):10261036.
  13. Walker SH,Duncan DB.Estimation of the probability of an event as a function of several independent variables.Biometrika.1967;54(1):167179.
  14. Harrell FE,Shih YC.Using full probability models to compute probabilities of actual interest to decision makers.Int J Technol Assess Health Care.2001;17(1):1726.
  15. Davis TC,Wolf MS,Bass PF, et al.Literacy and misunderstanding prescription drug labels.Ann Intern Med.2006;145(12):887894.
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Journal of Hospital Medicine - 6(9)
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With the aging of the US population, complex medication regimens to treat multiple comorbidities are increasingly common.1 Nevertheless, patients often do not fully understand the instructions for safe and effective medication use. Aspects of medication understanding include knowledge of the drug indication, dose, frequency, and for certain medications, special instructions.2 Medication understanding is associated with better medication adherence, fewer drug‐related problems, and fewer emergency department visits.3 Among patients with chronic conditions, such as cardiovascular disease (CVD), understanding and adherence to the medication regimen are critical for successful disease control and clinical outcomes.4

Patients' understanding of their medication regimen is also vitally important upon admission to the hospital. Patients often are the main source of information for the admission medication history and subsequent medication reconciliation.5 Poor patient understanding of the preadmission medication regimen can contribute to errors in inpatient and postdischarge medication orders, and adversely affect patient safety.6 However, little research has examined patients' understanding of the preadmission medication regimen and factors that affect it.

In the outpatient setting, previous investigations have suggested that low health literacy, advanced age, and impaired cognitive function adversely affect patients' understanding of medication instructions.2, 7, 8 These studies were limited by a small sample size, single site, or focus on a specific population, such as inner‐city patients. Additionally, the measures used to assess medication understanding were time‐consuming and required patients' medications to be present for testing, thus limiting their utility.2

To address these gaps in the literature, we developed and implemented the Medication Understanding Questionnaire (MUQ), an original and relatively rapid measure that does not require patients' medications be present for testing. In a study of adults at 2 large teaching hospitals, we examined the association of health literacy, age, cognitive function, number of preadmission medications, and other factors on patients' understanding of their preadmission medication regimen. We hypothesized that lower health literacy would be independently associated with lower medication understanding as assessed using the MUQ.

METHODS

The present study was a cross‐sectional assessment conducted using baseline interview data from the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL‐CVD) Study (ClinicalTrials.gov Registration #NCT00632021; available at: http://clinicaltrials.gov/show/NCT00632021). The PILL‐CVD Study is a randomized controlled trial of a pharmacist‐based intervention, consisting of pharmacist‐assisted medication reconciliation, inpatient counseling, low‐literacy adherence aids, and postdischarge telephone follow‐up. It was conducted at 2 academic medical centersVanderbilt University Hospital (VUH) in Nashville, Tennessee, and Brigham and Women's Hospital (BWH) in Boston, Massachusetts.9 This study was approved by the Institutional Review Board at each site, and all participants provided written informed consent.

Population

The PILL‐CVD study protocol and eligibility criteria has been previously published.9 Briefly, patients were eligible if they were at least 18 years old and admitted with acute coronary syndrome or acute decompensated heart failure. Patients were excluded if they: were too ill to complete an interview; were not oriented to person, place, or time; had a corrected visual acuity worse than 20/200; had impaired hearing; could not communicate in English or Spanish; were not responsible for managing their own medications; had no phone; were unlikely to be discharged to home; were in police custody; or had been previously enrolled in the study. For the present analysis, we also excluded any patient who was not on at least 1 prescription medication prior to admission. Saline nasal spray, saline eye drops, herbal products, nutritional supplements, vitamins, and over the counter (OTC) lotions and creams were not counted as prescription medications. Oral medications available both OTC and by prescription (eg, aspirin, nonsteroidal anti‐inflammatory drugs, and acid reflux medications) were counted as prescription medications.

Measures

At enrollment, which was usually within 24 to 48 hours of admission, participants completed the short form of the Test of Functional Health Literacy in Adults (s‐TOFHLA) in English or Spanish,10 the Mini‐Cog test of cognition,11 and the Medication Understanding Questionnaire (MUQ), as well as demographic information. The number of prescription medications prior to hospital admission was abstracted from the best available reference listthat documented by the treating physicians in the electronic health record (EHR). The EHR at each site was a home‐grown system and included both inpatient and outpatient records, which facilitated physicians' documentation of the medication list.

The s‐TOFHLA consists of 2 short reading‐comprehension passages. Scores on the s‐TOFHLA range from 0 to 36, and can be categorized as inadequate (0‐16), marginal (17‐22), or adequate (23‐36) health literacy.10 The Mini‐Cog includes 3‐item recall and clock‐drawing tests. It provides a brief measure of cognitive function and performs well among patients with limited literacy or educational attainment.11 Scores range from 0 to 5, with a score <3 indicating possible dementia.

The MUQ was administered verbally and assessed patients' understanding of their own preadmission medication regimen. It was developed for this study, based on published measures of medication understanding.2, 12 To administer the MUQ, research assistants (RAs) accessed the patient's preadmission medication list from the EHR and used a random number table to select up to 5 prescription medications from the list. If the patient was taking 5 or fewer medications, all of their medications were selected. Saline nasal spray, saline eye drops, herbal products, nutritional supplements, vitamins, and OTC lotions and creams were excluded from testing. The RA provided the brand and generic name of each medication, and then asked the patient for the drug's purpose, strength per unit (eg, 20 mg tablet), number of units taken at a time (eg, 2 tablets), and dosing frequency (eg, twice a day). For drugs prescribed on an as‐needed basis, the RA asked patients for the maximum allowable dose and frequency. Patients were instructed to not refer to a medication list or bottles when responding. The RA documented the patient's responses on the MUQ, along with the dosing information from the EHR for each selected medication.

One clinical pharmacist (MM) scored all MUQ forms by applying a set of scoring rules. Each medication score could range from 0 to 3. The components of the score included indication (1 point), strength (0.5 point), units (0.5 point), and frequency (1 point). The patient's overall MUQ score was an average of the MUQ scores for each tested medication.

Statistical Analysis

We summarized patient characteristics, number of preadmission medications, and MUQ scores using median and interquartile range (IRQ) for continuous variables, and frequencies and proportions for categorical variables. We conducted proportional odds logistic regression (ordinal regression) to estimate the effect of s‐TOFHLA score, other patient characteristics, and number of medications on MUQ scores.13

Important covariates were selected a priori based on clinical significance. These included age (continuous), gender, patient self‐reported race (white, black, other nonwhite), Mini‐Cog score (continuous), primary language (English or Spanish), years of education (continuous), number of preadmission medications (continuous), income (ordinal categories), insurance type (categorical), and study site. Covariates with missing data (household income, health literacy, and years of education) were imputed using multiple imputation techniques.14 The relationship between number of preadmission medications and MUQ scores was found to be nonlinear, and it was modeled using restricted cubic splines.14 We also fit models which treated health literacy and cognition as categorical variables. Results are reported as odds ratios (OR) with 95% confidence intervals (CI). Wald tests were used to test for the statistical significance of predictor variables. Two‐sided P values less than 0.05 were considered statistically significant. All analyses were performed using statistical language R (R Foundation, available at: http://www.r‐project.org).

RESULTS

Baseline Characteristics

Among the 862 patients enrolled in PILL‐CVD, 790 (91.7 %) had at least 1 preadmission medication and were included in this analysis (Table 1). Forty‐seven percent were admitted to VUH (N = 373) and 53% to BWH (N = 417). The median age was 61 (interquartile range [IQR] 52, 71), 77% were white, and 57% were male. Inadequate or marginal health literacy was identified among 11% and 9% of patients, respectively. The median number of preadmission medications was 8 (IQR 5, 11). Patients excluded from the analysis for not having preadmission medications were similar to included patients, except they were more likely to be male (76% vs 57%) and less likely to have health insurance (23% self‐pay vs 4%). (Data available upon request.)

Baseline Patient Characteristics
CharacteristicN = 790
  • Abbreviations: IQR, interquartile range; s‐TOFHLA, Test of Functional Health Literacy in Adults.

  • Missing s‐TOFHLA, N = 19; missing household income, N = 4; missing years of school, N = 1.

Study hospital, N (%) 
Vanderbilt University Hospital373 (47.2)
Brigham and Women's Hospital417 (52.8)
Age in years, median (IQR)61 (52, 71)
Gender, N (%) 
Male452 (57.2)
Female338 (42.8)
Primary language, N (%) 
English779 (98.6)
Spanish11 (1.4)
Race, N (%) 
White610 (77.2)
Black or African American136 (17.2)
Other44 (5.6)
Health literacy, s‐TOFHLA score, median (IQR)33 (25, 35)
Health literacy, N (%)& 
Inadequate84 (10.6)
Marginal74 (9.4)
Adequate613 (77.6)
Mini‐Cog score, median (IQR)4 (3, 5)
Dementia, N (%) 
No692 (87.6)
Yes98 (12.4)
Number of medications, median (IQR)8 (5, 11)
Health insurance type, N (%) 
Medicaid74 (9.4)
Medicare337 (42.6)
Private334 (42.3)
Self‐pay35 (4.4)
Other10 (1.3)
Self‐reported household income, N (%)& 
<$10,00038 (4.8)
$10,000 to <$15,00045 (5.7)
$15,000 to <$20,00042 (5.3)
$20,000 to <$25,000105 (13.3)
$25,000 to <$35,00099 (12.5)
$35,000 to <$50,000112 (14.2)
$50,000 to <$75,000118 (14.9)
$75,000+227 (28.7)
Years of school, median (IQR)&14 (12, 16)

MUQ Scores

The MUQ was administered in approximately 5 minutes. The median MUQ score was 2.5 (IQR 2.2, 2.8) (Table 2); 16.3% of patients scored less than 2. Subjects typically achieved high scores for the domains of indication, units, and frequency, while scores on the strength domain were lower (median = 0.2 [IQR 0.1, 0.4], maximum possible = 0.5).

MUQ Scores and Components at Baseline Among 790 Patients Using at Least 1 Medication
 Median (IQR)
  • Abbreviations: MUQ, Medication Understanding Questionnaire.

  • Each medication score could range from 0 to 3. For each medication tested, the components of the score included indication (1 point), strength (0.5 point), units (0.5 point), and frequency (1 point). The patient's overall MUQ score was then the average of the MUQ scores for each medication.

No. of drugs tested5 (4, 5)
MUQ score*2.5 (2.2, 2.8)
Indication1.0 (0.8, 1.0)
Strength0.2 (0.1, 0.4)
Units0.5 (0.4, 0.5)
Frequency1.0 (0.8, 1.0)

Predictors of Medication Understanding

Unadjusted relationships of health literacy, cognition, and number of medications with medication understanding are shown in Figure 1 (panels A, B, and C, respectively). The figure demonstrates a linear relationship with both health literacy (Figure 1A) and cognition (Figure 1B), and a nonlinear relationship between number of preadmission medications and MUQ score (Figure 1C).

Figure 1
Unadjusted relationships of Medication Understanding Questionnaire (MUQ) scores with: (A) health literacy, (B) cognition, and (C) number of preadmission medications. Abbreviations: s‐TOFHLA, Test of Functional Health Literacy in Adults.

Adjusted relationships using imputed data for missing covariates are shown in Figure 2. Lower health literacy, cognitive impairment, male gender, and black race were independently associated with lower understanding of preadmission medications. Each 1 point increase in s‐TOFHLA or Mini‐Cog score led to an increase in medication understanding (OR = 1.04; 95% CI, 1.02 to 1.06; P = 0.0001; and OR = 1.24; 95% CI, 1.1 to 1.4; P = 0.001; respectively). Patients with marginal or inadequate health literacy had lower odds of understanding their regimen (OR = 0.53; 95% CI, 0.34 to 0.84; and OR = 0.49; 95% CI, 0.31 to 0.78, respectively) compared to those with adequate health literacy. Impaired cognitive function (Mini‐Cog score <3, indicating dementia) was also associated with lower odds of medication understanding (OR = 0.57; 95% CI, 0.38 to 0.86) compared to those with no cognitive impairment. An increase in the number of preadmission medications (up to 10) was also strongly associated with lower MUQ scores. For each increase by 1 medication, there was a significant decrease in medication understanding, up to 10 medications, beyond which understanding did not significantly decrease further. Patients on 6 medications were about half as likely to understand their medication regimen as patients on only 1 medication (OR = 0.52; 95% CI, 0.36 to 0.75). For patients on 11 medications, the odds of medication understanding were 24% lower than for patients on 6 medications (OR = 0.76; 95% CI, 0.65 to 0.89). Patients' age, years of schooling, and household income were not independently associated with medication understanding. Results were similar using data without multiple imputation.

Figure 2
Forest plot of the adjusted odds of a higher Medication Understanding Questionnaire (MUQ) score compared to an average patient. Odds ratios (OR) of <1 represent lower medication understanding; OR of >1 represent higher medication understanding. Model includes: age, gender, patient self‐reported race, Test of Functional Health Literacy in Adults (s‐TOFHLA) score, cognitive function, primary language, years of education, number of preadmission medications (nonlinear restricted cubic spline with 3 knots), income, insurance type, and study site. Diamonds represent point estimate, and shaded gray bars represent 95% confidence intervals.

Examples of Misunderstanding of Common Medications

Table 3 provides examples of incorrect patient responses for several commonly prescribed medications or drug classes, including aspirin, digoxin, nitroglycerin, and HMG‐CoA reductase inhibitors (statins). For aspirin, many patients were not aware of the strength. For digoxin, several participants reported splitting a higher‐strength pill to obtain the prescribed dose, which should not be done given the imprecision of splitting and narrow therapeutic index of this drug. Patients prescribed nitroglycerin sublingual tablets were commonly unable to report the correct dosing and frequency for angina treatment. Medications for cholesterol were often reported as being taken in the morning; this was scored strictly as a frequency error if the medication timing in the EHR was listed as evening or bedtime. We also identified many patients with poor understanding of opioid analgesics, particularly regarding their dosing and frequency.

Common Incorrect Responses for Frequent Medications and Resulting Error Code on MUQ
MedicationsCommon Incorrect ResponsesCorrect InformationCoded Error
  • Abbreviations: MUQ, Medication Understanding Questionnaire.

Aspirintablet twice a day1 tablet once a dayUnits and frequency
 I am not aware what aspirin I am taking81 mg once a dayStrength
 I am taking 6‐something every day81 mg once a dayStrength
 31 mg a day81 mg once a dayStrength
 180 mg a day81 mg once a dayStrength
 1 low‐dose daily325 mg once a dayStrength
 125 mg a day325 mg once a dayStrength
 I am taking it for my blood pressureHeart medicationIndication
Nitroglycerin sublingualAs needed, I have taken up to 4 a dayDissolve 1 tablet under the tongue, every 5 min as needed, up to 3 dosesFrequency
 As needed every 15 min Frequency
 As needed up to 4 doses every 10 min Frequency
 Dissolve couple units under the tongue, as needed Units and frequency
 As many as I want, every 5 min Frequency
Digoxintablet daily1 tablet dailyUnits
 1 tablet daily1 tablet every other dayFrequency
 I am taking it for my blood pressureHeart medicationIndication
HMG‐CoA reductase inhibitors1 tablet every morning1 tablet every eveningFrequency
 tablet twice a day1 tablet once a dayUnits and frequency
 I do not know the indicationHigh cholesterolIndication
Propoxyphene/acetaminophentablet as needed1 tablet every 4‐6 hr as neededUnits and frequency
Hydrocodone/acetaminophenI do not know the strength of this medication5 mg/500 mgStrength
 1 tablet as I need it1 tablet every 4‐6 hr as neededFrequency

DISCUSSION

We used a novel four‐component medication understanding questionnaire, developed for this study, to assess patients' understanding of up to 5 drugs selected randomly from the participant's preadmission medication list. The MUQ proved to be easy to administer by nonmedical staff within a short period of time (approximately 5 minutes per patient). It was well understood by patients. By limiting the assessment to 5 or fewer medications, the MUQ has a distinct advantage over existing measures of medication understanding that require testing the entire regimen. We did not find any limitations related to cutting off the assessment at 5 medications. In addition, this tool affords assessment of medication understanding without requiring medication bottles be present, enhancing its utility in the inpatient setting.

MUQ scores were associated with health literacy and other patient characteristics in an expected manner. We demonstrated that inadequate or marginal health literacy, as well as impaired cognitive function, were associated with low medication understanding. We also were able to demonstrate a relationship between increasing number of medications and lower medication understanding. Interestingly, in our patient population, understanding continued to decrease until reaching 10 medications, beyond which further increases in the number of medications had no additional detrimental effect on medication understanding. This nonlinear relationship between number of medications and medication understanding has potential implications for prescribing practice.

Our findings which utilize the MUQ among inpatients are consistent with prior literature in other settings.2, 7, 8 In a previous outpatient study, we identified that health literacy plays an important role in a patient's ability to successfully report and manage their daily medications.2 Other studies have also shown that patients with low health literacy have more difficulty understanding prescription drug information, and that they often experience medication‐related problems after hospital discharge.15, 16 The number and often the types of medications an individual takes have also been shown to increase the risk for adverse events and nonadherence to the treatment plan.1720 We postulate that this risk of adverse drug events is related at least in part to a patient's understanding of their medication regimen.

There are several limitations to this study. First, the MUQ did not assess certain aspects of medication understanding, such as knowledge of pill appearance or side effects, nor did it assess components of patients' actual drug‐taking behavior, such as organization of medications or behavioral cues. Thus, adaptive behaviors that patients may perform to improve their medication management, such as writing on labels or memory cues, are not captured by this test. Second, in administering and scoring the MUQ, we used the patient's preadmission medication list documented in the EHR as the reference standard. This was the best available reference list, and was generally accurate, as both hospitals had medication reconciliation systems in use at the time of the study21; nevertheless, it may contain inaccuracies. Documentation for certain medications, such as warfarin, in which dose can change frequently, often did not reflect the latest prescribed dose. In such cases, we scored the patient's answer as correct if the dose appeared reasonable and appropriate to the clinical pharmacist. As a result, a patient's MUQ score may have been overestimated in these cases.

Additional research will be needed to further validate the MUQ in other settings. In particular, studies should establish the relationship between the MUQ, serious medication errors after discharge, and potential to benefit from educational interventions. Also, as noted above, the nonlinear relationship between number of medications and medication understanding should be confirmed in other studies.

In conclusion, we demonstrated that patients with low health literacy, impaired cognition, or a higher number of medications had significantly poorer understanding of their preadmission medication regimen. These findings have important clinical implications. It would be appropriate to exercise greater caution when taking a medication history from patients who cannot readily provide the purpose, strength, units, and frequency of their medications. Attempts to validate the information obtained from patients with other sources of data, such as family members, inpatient or outpatient health records, and community pharmacy records should be considered. Patients at high risk for poor medication understanding, either measured directly using the MUQ or identified via risk factors such as polypharmacy, low cognition, or low health literacy, may warrant more intensive medication reconciliation interventions and/or educational counseling and follow‐up to prevent postdischarge adverse drug events. Further research is needed to determine if targeting these populations for interventions improves medication safety during transitions in care.

With the aging of the US population, complex medication regimens to treat multiple comorbidities are increasingly common.1 Nevertheless, patients often do not fully understand the instructions for safe and effective medication use. Aspects of medication understanding include knowledge of the drug indication, dose, frequency, and for certain medications, special instructions.2 Medication understanding is associated with better medication adherence, fewer drug‐related problems, and fewer emergency department visits.3 Among patients with chronic conditions, such as cardiovascular disease (CVD), understanding and adherence to the medication regimen are critical for successful disease control and clinical outcomes.4

Patients' understanding of their medication regimen is also vitally important upon admission to the hospital. Patients often are the main source of information for the admission medication history and subsequent medication reconciliation.5 Poor patient understanding of the preadmission medication regimen can contribute to errors in inpatient and postdischarge medication orders, and adversely affect patient safety.6 However, little research has examined patients' understanding of the preadmission medication regimen and factors that affect it.

In the outpatient setting, previous investigations have suggested that low health literacy, advanced age, and impaired cognitive function adversely affect patients' understanding of medication instructions.2, 7, 8 These studies were limited by a small sample size, single site, or focus on a specific population, such as inner‐city patients. Additionally, the measures used to assess medication understanding were time‐consuming and required patients' medications to be present for testing, thus limiting their utility.2

To address these gaps in the literature, we developed and implemented the Medication Understanding Questionnaire (MUQ), an original and relatively rapid measure that does not require patients' medications be present for testing. In a study of adults at 2 large teaching hospitals, we examined the association of health literacy, age, cognitive function, number of preadmission medications, and other factors on patients' understanding of their preadmission medication regimen. We hypothesized that lower health literacy would be independently associated with lower medication understanding as assessed using the MUQ.

METHODS

The present study was a cross‐sectional assessment conducted using baseline interview data from the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL‐CVD) Study (ClinicalTrials.gov Registration #NCT00632021; available at: http://clinicaltrials.gov/show/NCT00632021). The PILL‐CVD Study is a randomized controlled trial of a pharmacist‐based intervention, consisting of pharmacist‐assisted medication reconciliation, inpatient counseling, low‐literacy adherence aids, and postdischarge telephone follow‐up. It was conducted at 2 academic medical centersVanderbilt University Hospital (VUH) in Nashville, Tennessee, and Brigham and Women's Hospital (BWH) in Boston, Massachusetts.9 This study was approved by the Institutional Review Board at each site, and all participants provided written informed consent.

Population

The PILL‐CVD study protocol and eligibility criteria has been previously published.9 Briefly, patients were eligible if they were at least 18 years old and admitted with acute coronary syndrome or acute decompensated heart failure. Patients were excluded if they: were too ill to complete an interview; were not oriented to person, place, or time; had a corrected visual acuity worse than 20/200; had impaired hearing; could not communicate in English or Spanish; were not responsible for managing their own medications; had no phone; were unlikely to be discharged to home; were in police custody; or had been previously enrolled in the study. For the present analysis, we also excluded any patient who was not on at least 1 prescription medication prior to admission. Saline nasal spray, saline eye drops, herbal products, nutritional supplements, vitamins, and over the counter (OTC) lotions and creams were not counted as prescription medications. Oral medications available both OTC and by prescription (eg, aspirin, nonsteroidal anti‐inflammatory drugs, and acid reflux medications) were counted as prescription medications.

Measures

At enrollment, which was usually within 24 to 48 hours of admission, participants completed the short form of the Test of Functional Health Literacy in Adults (s‐TOFHLA) in English or Spanish,10 the Mini‐Cog test of cognition,11 and the Medication Understanding Questionnaire (MUQ), as well as demographic information. The number of prescription medications prior to hospital admission was abstracted from the best available reference listthat documented by the treating physicians in the electronic health record (EHR). The EHR at each site was a home‐grown system and included both inpatient and outpatient records, which facilitated physicians' documentation of the medication list.

The s‐TOFHLA consists of 2 short reading‐comprehension passages. Scores on the s‐TOFHLA range from 0 to 36, and can be categorized as inadequate (0‐16), marginal (17‐22), or adequate (23‐36) health literacy.10 The Mini‐Cog includes 3‐item recall and clock‐drawing tests. It provides a brief measure of cognitive function and performs well among patients with limited literacy or educational attainment.11 Scores range from 0 to 5, with a score <3 indicating possible dementia.

The MUQ was administered verbally and assessed patients' understanding of their own preadmission medication regimen. It was developed for this study, based on published measures of medication understanding.2, 12 To administer the MUQ, research assistants (RAs) accessed the patient's preadmission medication list from the EHR and used a random number table to select up to 5 prescription medications from the list. If the patient was taking 5 or fewer medications, all of their medications were selected. Saline nasal spray, saline eye drops, herbal products, nutritional supplements, vitamins, and OTC lotions and creams were excluded from testing. The RA provided the brand and generic name of each medication, and then asked the patient for the drug's purpose, strength per unit (eg, 20 mg tablet), number of units taken at a time (eg, 2 tablets), and dosing frequency (eg, twice a day). For drugs prescribed on an as‐needed basis, the RA asked patients for the maximum allowable dose and frequency. Patients were instructed to not refer to a medication list or bottles when responding. The RA documented the patient's responses on the MUQ, along with the dosing information from the EHR for each selected medication.

One clinical pharmacist (MM) scored all MUQ forms by applying a set of scoring rules. Each medication score could range from 0 to 3. The components of the score included indication (1 point), strength (0.5 point), units (0.5 point), and frequency (1 point). The patient's overall MUQ score was an average of the MUQ scores for each tested medication.

Statistical Analysis

We summarized patient characteristics, number of preadmission medications, and MUQ scores using median and interquartile range (IRQ) for continuous variables, and frequencies and proportions for categorical variables. We conducted proportional odds logistic regression (ordinal regression) to estimate the effect of s‐TOFHLA score, other patient characteristics, and number of medications on MUQ scores.13

Important covariates were selected a priori based on clinical significance. These included age (continuous), gender, patient self‐reported race (white, black, other nonwhite), Mini‐Cog score (continuous), primary language (English or Spanish), years of education (continuous), number of preadmission medications (continuous), income (ordinal categories), insurance type (categorical), and study site. Covariates with missing data (household income, health literacy, and years of education) were imputed using multiple imputation techniques.14 The relationship between number of preadmission medications and MUQ scores was found to be nonlinear, and it was modeled using restricted cubic splines.14 We also fit models which treated health literacy and cognition as categorical variables. Results are reported as odds ratios (OR) with 95% confidence intervals (CI). Wald tests were used to test for the statistical significance of predictor variables. Two‐sided P values less than 0.05 were considered statistically significant. All analyses were performed using statistical language R (R Foundation, available at: http://www.r‐project.org).

RESULTS

Baseline Characteristics

Among the 862 patients enrolled in PILL‐CVD, 790 (91.7 %) had at least 1 preadmission medication and were included in this analysis (Table 1). Forty‐seven percent were admitted to VUH (N = 373) and 53% to BWH (N = 417). The median age was 61 (interquartile range [IQR] 52, 71), 77% were white, and 57% were male. Inadequate or marginal health literacy was identified among 11% and 9% of patients, respectively. The median number of preadmission medications was 8 (IQR 5, 11). Patients excluded from the analysis for not having preadmission medications were similar to included patients, except they were more likely to be male (76% vs 57%) and less likely to have health insurance (23% self‐pay vs 4%). (Data available upon request.)

Baseline Patient Characteristics
CharacteristicN = 790
  • Abbreviations: IQR, interquartile range; s‐TOFHLA, Test of Functional Health Literacy in Adults.

  • Missing s‐TOFHLA, N = 19; missing household income, N = 4; missing years of school, N = 1.

Study hospital, N (%) 
Vanderbilt University Hospital373 (47.2)
Brigham and Women's Hospital417 (52.8)
Age in years, median (IQR)61 (52, 71)
Gender, N (%) 
Male452 (57.2)
Female338 (42.8)
Primary language, N (%) 
English779 (98.6)
Spanish11 (1.4)
Race, N (%) 
White610 (77.2)
Black or African American136 (17.2)
Other44 (5.6)
Health literacy, s‐TOFHLA score, median (IQR)33 (25, 35)
Health literacy, N (%)& 
Inadequate84 (10.6)
Marginal74 (9.4)
Adequate613 (77.6)
Mini‐Cog score, median (IQR)4 (3, 5)
Dementia, N (%) 
No692 (87.6)
Yes98 (12.4)
Number of medications, median (IQR)8 (5, 11)
Health insurance type, N (%) 
Medicaid74 (9.4)
Medicare337 (42.6)
Private334 (42.3)
Self‐pay35 (4.4)
Other10 (1.3)
Self‐reported household income, N (%)& 
<$10,00038 (4.8)
$10,000 to <$15,00045 (5.7)
$15,000 to <$20,00042 (5.3)
$20,000 to <$25,000105 (13.3)
$25,000 to <$35,00099 (12.5)
$35,000 to <$50,000112 (14.2)
$50,000 to <$75,000118 (14.9)
$75,000+227 (28.7)
Years of school, median (IQR)&14 (12, 16)

MUQ Scores

The MUQ was administered in approximately 5 minutes. The median MUQ score was 2.5 (IQR 2.2, 2.8) (Table 2); 16.3% of patients scored less than 2. Subjects typically achieved high scores for the domains of indication, units, and frequency, while scores on the strength domain were lower (median = 0.2 [IQR 0.1, 0.4], maximum possible = 0.5).

MUQ Scores and Components at Baseline Among 790 Patients Using at Least 1 Medication
 Median (IQR)
  • Abbreviations: MUQ, Medication Understanding Questionnaire.

  • Each medication score could range from 0 to 3. For each medication tested, the components of the score included indication (1 point), strength (0.5 point), units (0.5 point), and frequency (1 point). The patient's overall MUQ score was then the average of the MUQ scores for each medication.

No. of drugs tested5 (4, 5)
MUQ score*2.5 (2.2, 2.8)
Indication1.0 (0.8, 1.0)
Strength0.2 (0.1, 0.4)
Units0.5 (0.4, 0.5)
Frequency1.0 (0.8, 1.0)

Predictors of Medication Understanding

Unadjusted relationships of health literacy, cognition, and number of medications with medication understanding are shown in Figure 1 (panels A, B, and C, respectively). The figure demonstrates a linear relationship with both health literacy (Figure 1A) and cognition (Figure 1B), and a nonlinear relationship between number of preadmission medications and MUQ score (Figure 1C).

Figure 1
Unadjusted relationships of Medication Understanding Questionnaire (MUQ) scores with: (A) health literacy, (B) cognition, and (C) number of preadmission medications. Abbreviations: s‐TOFHLA, Test of Functional Health Literacy in Adults.

Adjusted relationships using imputed data for missing covariates are shown in Figure 2. Lower health literacy, cognitive impairment, male gender, and black race were independently associated with lower understanding of preadmission medications. Each 1 point increase in s‐TOFHLA or Mini‐Cog score led to an increase in medication understanding (OR = 1.04; 95% CI, 1.02 to 1.06; P = 0.0001; and OR = 1.24; 95% CI, 1.1 to 1.4; P = 0.001; respectively). Patients with marginal or inadequate health literacy had lower odds of understanding their regimen (OR = 0.53; 95% CI, 0.34 to 0.84; and OR = 0.49; 95% CI, 0.31 to 0.78, respectively) compared to those with adequate health literacy. Impaired cognitive function (Mini‐Cog score <3, indicating dementia) was also associated with lower odds of medication understanding (OR = 0.57; 95% CI, 0.38 to 0.86) compared to those with no cognitive impairment. An increase in the number of preadmission medications (up to 10) was also strongly associated with lower MUQ scores. For each increase by 1 medication, there was a significant decrease in medication understanding, up to 10 medications, beyond which understanding did not significantly decrease further. Patients on 6 medications were about half as likely to understand their medication regimen as patients on only 1 medication (OR = 0.52; 95% CI, 0.36 to 0.75). For patients on 11 medications, the odds of medication understanding were 24% lower than for patients on 6 medications (OR = 0.76; 95% CI, 0.65 to 0.89). Patients' age, years of schooling, and household income were not independently associated with medication understanding. Results were similar using data without multiple imputation.

Figure 2
Forest plot of the adjusted odds of a higher Medication Understanding Questionnaire (MUQ) score compared to an average patient. Odds ratios (OR) of <1 represent lower medication understanding; OR of >1 represent higher medication understanding. Model includes: age, gender, patient self‐reported race, Test of Functional Health Literacy in Adults (s‐TOFHLA) score, cognitive function, primary language, years of education, number of preadmission medications (nonlinear restricted cubic spline with 3 knots), income, insurance type, and study site. Diamonds represent point estimate, and shaded gray bars represent 95% confidence intervals.

Examples of Misunderstanding of Common Medications

Table 3 provides examples of incorrect patient responses for several commonly prescribed medications or drug classes, including aspirin, digoxin, nitroglycerin, and HMG‐CoA reductase inhibitors (statins). For aspirin, many patients were not aware of the strength. For digoxin, several participants reported splitting a higher‐strength pill to obtain the prescribed dose, which should not be done given the imprecision of splitting and narrow therapeutic index of this drug. Patients prescribed nitroglycerin sublingual tablets were commonly unable to report the correct dosing and frequency for angina treatment. Medications for cholesterol were often reported as being taken in the morning; this was scored strictly as a frequency error if the medication timing in the EHR was listed as evening or bedtime. We also identified many patients with poor understanding of opioid analgesics, particularly regarding their dosing and frequency.

Common Incorrect Responses for Frequent Medications and Resulting Error Code on MUQ
MedicationsCommon Incorrect ResponsesCorrect InformationCoded Error
  • Abbreviations: MUQ, Medication Understanding Questionnaire.

Aspirintablet twice a day1 tablet once a dayUnits and frequency
 I am not aware what aspirin I am taking81 mg once a dayStrength
 I am taking 6‐something every day81 mg once a dayStrength
 31 mg a day81 mg once a dayStrength
 180 mg a day81 mg once a dayStrength
 1 low‐dose daily325 mg once a dayStrength
 125 mg a day325 mg once a dayStrength
 I am taking it for my blood pressureHeart medicationIndication
Nitroglycerin sublingualAs needed, I have taken up to 4 a dayDissolve 1 tablet under the tongue, every 5 min as needed, up to 3 dosesFrequency
 As needed every 15 min Frequency
 As needed up to 4 doses every 10 min Frequency
 Dissolve couple units under the tongue, as needed Units and frequency
 As many as I want, every 5 min Frequency
Digoxintablet daily1 tablet dailyUnits
 1 tablet daily1 tablet every other dayFrequency
 I am taking it for my blood pressureHeart medicationIndication
HMG‐CoA reductase inhibitors1 tablet every morning1 tablet every eveningFrequency
 tablet twice a day1 tablet once a dayUnits and frequency
 I do not know the indicationHigh cholesterolIndication
Propoxyphene/acetaminophentablet as needed1 tablet every 4‐6 hr as neededUnits and frequency
Hydrocodone/acetaminophenI do not know the strength of this medication5 mg/500 mgStrength
 1 tablet as I need it1 tablet every 4‐6 hr as neededFrequency

DISCUSSION

We used a novel four‐component medication understanding questionnaire, developed for this study, to assess patients' understanding of up to 5 drugs selected randomly from the participant's preadmission medication list. The MUQ proved to be easy to administer by nonmedical staff within a short period of time (approximately 5 minutes per patient). It was well understood by patients. By limiting the assessment to 5 or fewer medications, the MUQ has a distinct advantage over existing measures of medication understanding that require testing the entire regimen. We did not find any limitations related to cutting off the assessment at 5 medications. In addition, this tool affords assessment of medication understanding without requiring medication bottles be present, enhancing its utility in the inpatient setting.

MUQ scores were associated with health literacy and other patient characteristics in an expected manner. We demonstrated that inadequate or marginal health literacy, as well as impaired cognitive function, were associated with low medication understanding. We also were able to demonstrate a relationship between increasing number of medications and lower medication understanding. Interestingly, in our patient population, understanding continued to decrease until reaching 10 medications, beyond which further increases in the number of medications had no additional detrimental effect on medication understanding. This nonlinear relationship between number of medications and medication understanding has potential implications for prescribing practice.

Our findings which utilize the MUQ among inpatients are consistent with prior literature in other settings.2, 7, 8 In a previous outpatient study, we identified that health literacy plays an important role in a patient's ability to successfully report and manage their daily medications.2 Other studies have also shown that patients with low health literacy have more difficulty understanding prescription drug information, and that they often experience medication‐related problems after hospital discharge.15, 16 The number and often the types of medications an individual takes have also been shown to increase the risk for adverse events and nonadherence to the treatment plan.1720 We postulate that this risk of adverse drug events is related at least in part to a patient's understanding of their medication regimen.

There are several limitations to this study. First, the MUQ did not assess certain aspects of medication understanding, such as knowledge of pill appearance or side effects, nor did it assess components of patients' actual drug‐taking behavior, such as organization of medications or behavioral cues. Thus, adaptive behaviors that patients may perform to improve their medication management, such as writing on labels or memory cues, are not captured by this test. Second, in administering and scoring the MUQ, we used the patient's preadmission medication list documented in the EHR as the reference standard. This was the best available reference list, and was generally accurate, as both hospitals had medication reconciliation systems in use at the time of the study21; nevertheless, it may contain inaccuracies. Documentation for certain medications, such as warfarin, in which dose can change frequently, often did not reflect the latest prescribed dose. In such cases, we scored the patient's answer as correct if the dose appeared reasonable and appropriate to the clinical pharmacist. As a result, a patient's MUQ score may have been overestimated in these cases.

Additional research will be needed to further validate the MUQ in other settings. In particular, studies should establish the relationship between the MUQ, serious medication errors after discharge, and potential to benefit from educational interventions. Also, as noted above, the nonlinear relationship between number of medications and medication understanding should be confirmed in other studies.

In conclusion, we demonstrated that patients with low health literacy, impaired cognition, or a higher number of medications had significantly poorer understanding of their preadmission medication regimen. These findings have important clinical implications. It would be appropriate to exercise greater caution when taking a medication history from patients who cannot readily provide the purpose, strength, units, and frequency of their medications. Attempts to validate the information obtained from patients with other sources of data, such as family members, inpatient or outpatient health records, and community pharmacy records should be considered. Patients at high risk for poor medication understanding, either measured directly using the MUQ or identified via risk factors such as polypharmacy, low cognition, or low health literacy, may warrant more intensive medication reconciliation interventions and/or educational counseling and follow‐up to prevent postdischarge adverse drug events. Further research is needed to determine if targeting these populations for interventions improves medication safety during transitions in care.

References
  1. Wolff JL,Starfield B,Anderson G.Prevalence, expenditures, and complications of multiple chronic conditions in the elderly.Arch Intern Med.2002;162(20):22692276.
  2. Kripalani S,Henderson LE,Chiu EY,Robertson R,Kolm P,Jacobson TA.Predictors of medication self‐management skill in a low‐literacy population.J Gen Intern Med.2006;21(8):852856.
  3. Osterberg L,Blaschke T.Adherence to medication.N Engl J Med.2005;353(5):487497.
  4. Ho PM,Bryson CL,Rumsfeld JS.Medication adherence: its importance in cardiovascular outcomes.Circulation.2009;119(23):30283035.
  5. Pippins JR,Gandhi TK,Hamann C, et al.Classifying and predicting errors of inpatient medication reconciliation.J Gen Intern Med.2008;23(9):14141422.
  6. Tsilimingras D,Bates DW.Addressing postdischarge adverse events: a neglected area.Jt Comm J Qual Patient Saf.2008;34(2):8597.
  7. Edelberg HK,Shallenberger E,Wei JY.Medication management capacity in highly functioning community‐living older adults: detection of early deficits.J Am Geriatr Soc.1999;47(5):592596.
  8. Spiers MV,Kutzik DM,Lamar M.Variation in medication understanding among the elderly.Am J Health‐Syst Pharm.2004;61(4):373380.
  9. Schnipper JL,Roumie CL,Cawthon C, et al.The rationale and design of the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL‐CVD) study.Circ Cardiovasc Qual Outcomes.2010;3:212219.
  10. Nurss JR,Parker RM,Williams MV,Baker DW.Short Test of Functional Health Literacy in Adults.Snow Camp, NC:Peppercorn Books and Press;1998.
  11. Borson S,Scanlan JM,Watanabe J,Tu SP,Lessig M.Simplifying detection of cognitive impairment: comparison of the Mini‐Cog and Mini‐Mental State Examination in a multiethnic sample.J Am Geriatr Soc.2005;53(5):871874.
  12. Farris KB,Phillips BB.Instruments assessing capacity to manage medications.Ann Pharmacother.2008;42(7):10261036.
  13. Walker SH,Duncan DB.Estimation of the probability of an event as a function of several independent variables.Biometrika.1967;54(1):167179.
  14. Harrell FE,Shih YC.Using full probability models to compute probabilities of actual interest to decision makers.Int J Technol Assess Health Care.2001;17(1):1726.
  15. Davis TC,Wolf MS,Bass PF, et al.Literacy and misunderstanding prescription drug labels.Ann Intern Med.2006;145(12):887894.
  16. Kripalani S,Henderson LE,Jacobson TA,Vaccarino V.Medication use among inner‐city patients after hospital discharge: patient reported barriers and solutions.Mayo Clin Proc.2008;83(5):529535.
  17. Budnitz DS,Pollock DA,Weidenbach KN,Mendelsohn AB,Schroeder TJ,Annest JL.National surveillance of emergency department visits for outpatient adverse drug events.JAMA.2006;296(15):18581866.
  18. Budnitz DS,Shehab N,Kegler SR,Richards CL.Medication use leading to emergency department visits for adverse drug events in older adults.Ann Intern Med.2007;147(11):755765.
  19. Forster AJ,Murff HJ,Peterson JF,Gandhi TK,Bates DW.Adverse drug events occurring following hospital discharge.J Gen Intern Med.2005;20:317323.
  20. Gandhi TK,Weingart SN,Borus J, et al.Adverse drug events in ambulatory care.N Engl J Med.2003;348(16):15561564.
  21. Schnipper JL,Hamann C,Ndumele CD, et al.Effect of an electronic medication reconciliation application and process redesign on potential adverse drug events: a cluster‐randomized trial.Arch Intern Med.2009;169(8):771780.
References
  1. Wolff JL,Starfield B,Anderson G.Prevalence, expenditures, and complications of multiple chronic conditions in the elderly.Arch Intern Med.2002;162(20):22692276.
  2. Kripalani S,Henderson LE,Chiu EY,Robertson R,Kolm P,Jacobson TA.Predictors of medication self‐management skill in a low‐literacy population.J Gen Intern Med.2006;21(8):852856.
  3. Osterberg L,Blaschke T.Adherence to medication.N Engl J Med.2005;353(5):487497.
  4. Ho PM,Bryson CL,Rumsfeld JS.Medication adherence: its importance in cardiovascular outcomes.Circulation.2009;119(23):30283035.
  5. Pippins JR,Gandhi TK,Hamann C, et al.Classifying and predicting errors of inpatient medication reconciliation.J Gen Intern Med.2008;23(9):14141422.
  6. Tsilimingras D,Bates DW.Addressing postdischarge adverse events: a neglected area.Jt Comm J Qual Patient Saf.2008;34(2):8597.
  7. Edelberg HK,Shallenberger E,Wei JY.Medication management capacity in highly functioning community‐living older adults: detection of early deficits.J Am Geriatr Soc.1999;47(5):592596.
  8. Spiers MV,Kutzik DM,Lamar M.Variation in medication understanding among the elderly.Am J Health‐Syst Pharm.2004;61(4):373380.
  9. Schnipper JL,Roumie CL,Cawthon C, et al.The rationale and design of the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL‐CVD) study.Circ Cardiovasc Qual Outcomes.2010;3:212219.
  10. Nurss JR,Parker RM,Williams MV,Baker DW.Short Test of Functional Health Literacy in Adults.Snow Camp, NC:Peppercorn Books and Press;1998.
  11. Borson S,Scanlan JM,Watanabe J,Tu SP,Lessig M.Simplifying detection of cognitive impairment: comparison of the Mini‐Cog and Mini‐Mental State Examination in a multiethnic sample.J Am Geriatr Soc.2005;53(5):871874.
  12. Farris KB,Phillips BB.Instruments assessing capacity to manage medications.Ann Pharmacother.2008;42(7):10261036.
  13. Walker SH,Duncan DB.Estimation of the probability of an event as a function of several independent variables.Biometrika.1967;54(1):167179.
  14. Harrell FE,Shih YC.Using full probability models to compute probabilities of actual interest to decision makers.Int J Technol Assess Health Care.2001;17(1):1726.
  15. Davis TC,Wolf MS,Bass PF, et al.Literacy and misunderstanding prescription drug labels.Ann Intern Med.2006;145(12):887894.
  16. Kripalani S,Henderson LE,Jacobson TA,Vaccarino V.Medication use among inner‐city patients after hospital discharge: patient reported barriers and solutions.Mayo Clin Proc.2008;83(5):529535.
  17. Budnitz DS,Pollock DA,Weidenbach KN,Mendelsohn AB,Schroeder TJ,Annest JL.National surveillance of emergency department visits for outpatient adverse drug events.JAMA.2006;296(15):18581866.
  18. Budnitz DS,Shehab N,Kegler SR,Richards CL.Medication use leading to emergency department visits for adverse drug events in older adults.Ann Intern Med.2007;147(11):755765.
  19. Forster AJ,Murff HJ,Peterson JF,Gandhi TK,Bates DW.Adverse drug events occurring following hospital discharge.J Gen Intern Med.2005;20:317323.
  20. Gandhi TK,Weingart SN,Borus J, et al.Adverse drug events in ambulatory care.N Engl J Med.2003;348(16):15561564.
  21. Schnipper JL,Hamann C,Ndumele CD, et al.Effect of an electronic medication reconciliation application and process redesign on potential adverse drug events: a cluster‐randomized trial.Arch Intern Med.2009;169(8):771780.
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Health literacy and medication understanding among hospitalized adults
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Health literacy and medication understanding among hospitalized adults
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Embedding a Discharge Facilitator

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Improving the discharge process by embedding a discharge facilitator in a resident team

Recent studies have shown that a patient's discharge from the hospital is a vulnerable period for patient safety.14 With the reduction in length of stay (LOS) and the increase in patient acuity over the past decade, patients are discharged from acute care settings quicker and sicker, resulting in management of ongoing illness in a less‐monitored environment.5, 6 In addition, in teaching hospitals, residents are supervised by hospital‐based physicians who are rarely the primary care physician (PCP) for the residents' patients, which creates discontinuity of care.

One in 5 medical discharges is complicated by an adverse event believed, in part, to be due to poor communication between caregivers during this transition time.2 Discharge summaries, a key form of that communication, are not always done in a timely fashion and may lack key pieces of information.7, 8 For approximately 68% of patient discharges, the PCP will not have a discharge summary available for the patient's first follow‐up visit.911 In a survey of PCPs whose patients were in the hospital, only 23% reported direct communication with the hospital care team.12 This leaves PCPs unaware of pending test results or recommended follow‐up evaluations.10, 11, 13, 14 All of these factors are believed to contribute to adverse events, emergency department (ED) visits, and readmissions.

A recently published consensus statement on transitions of care by 6 major medical societies emphasizes the need for timely communication and transfer of information.15 These important processes are especially challenging to meet at academic medical centers, where discharge summaries and transition communication are done by residents in a hectic and challenging work environment, with multiple simultaneous and competing demands including outpatient clinic and required conferences.12 Residents have little formal training in how to write an effective discharge summary or how to systematically approach discharge planning. One study found higher error rates in discharge summaries written by residents compared with attending physicians.16 While the Accreditation Council for Graduate Medical Education (ACGME) limits the number of admissions per intern for both patient safety and educational reasons, the number of discharges per day is not limited despite the considerable amount of time required for appropriate discharge planning and communication.

Many interventions have been tried to improve the discharge process and reduce patient adverse events.17 Arranging early follow‐up appointments to reduce emergency department visits and readmissions has shown mixed results.13, 1820 Interventions that focus on specific populations, such as the elderly or patients with congestive heart failure, have been more successful.2123 Some interventions employed additional resources, such as a discharge form, transition coach, or discharge advocate, again with varying impact on results.18, 2427 A recent study by Jack et al. used nurse discharge advocates (DAs) to help with discharge planning and communication at an academic medical center.25 These DAs were independent of the care team, and focused on patient education and follow‐up plans, and reduced hospital reutilization in a selected population.

No studies have assessed the potential benefit of helping residents with the physician components of the discharge process. Prior studies have mainly focused on patient communication and follow‐up appointments, yet safe transitions also involve timely discharge summaries, physician‐to‐physician communication, physician‐to‐nurse communication, and medication reconciliation. Without support and time, these tasks can be very challenging for resident physicians with work‐hour limitations. We undertook a randomized, controlled trial to evaluate the impact on the discharge process of embedding a discharge facilitator in a resident medical team to help with the physician discharge process. We studied the effect for all the patients discharged from the resident team, rather than focusing on a select group or patients with a single diagnosis.

METHODS

Study Setting and Participants

This study was conducted on 2 of the 5 resident general medical teams on the inpatient teaching service at Massachusetts General Hospital (MGH), Boston, Massachusettsa large, 907‐bed, urban hospital. The residents' teams are regionalized and each care for approximately 20 patients on a single floor. Each of the study teams consists of a junior resident, 4 interns, and 1 to 2 attendings who rotate on the floor for 2‐week or 4‐week blocks. Attending rounds, which occur 10 AM to 12 PM weekdays, are for new patient presentations and discussion of plans. Interdisciplinary rounds occur 9:30 AM to 10 AM. Sign‐out rounds occur in the afternoon whenever all work is complete. The junior resident is responsible for all the discharge orders and communication with PCPs, and the discharge summaries for patients going to facilities. The interns are responsible for discharge summaries for patients discharged home; these summaries are not mandatory at the time of discharge. The majority of patients were admitted under the team attending(s). Patients were assigned to the teams by the admitting office, based on bed availability. All patients discharged from both resident medical teams over a 5‐month period were included in this study. Those who were not discharged from the hospital by the study teams (ie, transfers to intensive care units or deaths) were excluded. These exclusions accounted for less than 12% of all team patients. Partners Healthcare System Institutional Review Board approved all study activities.

Intervention

We randomly assigned a discharge facilitator (DF), a master's level nurse practitioner with prior inpatient medicine experience, to 1 of the 5 resident medical teams. She had no prior experience on this specific floor. A similar resident team, on a different floor, served as the control. For the intervention team, the DF attended daily resident work rounds and interdisciplinary discharge rounds. The resident and DF collaborated in identifying patients being discharged in the next 1 to 3 days, and the DF scheduled all follow‐up appointments and tests. The DF performed medication reconciliation, wrote prescriptions and faxed them to pharmacies, and arranged all anticoagulation services. In collaboration with the resident, the DF called PCPs' offices with discharge information and faxed discharge summaries to PCPs' offices outside the Partners Healthcare System. The DF wrote part or all of the computer discharge orders and discharge summaries at the request of the resident and interns. All discharge summaries still needed to be reviewed, edited, and signed by the resident or interns. The DF also noted pending tests and studies at time of discharge, and followed up on these tests for the team. The DF met with all patients to answer any questions about their discharge plan, medications, and appointments; while residents are encouraged to do this, it is not done as consistently. She provided her business card for any questions after their discharge. Follow‐up patient calls to the DF were either answered by her or triaged to the appropriate person. The DF also communicated with the patient's nurse about the discharge plans. For all patients discharged over a weekend, the DF would arrange the follow‐up appointments on Mondays and call the patients at home.

For both teams, residents received letters at the start of their rotation notifying them of the study and asking them to complete discharge summaries within 24 hours. All residents in the program were expected to do an online discharge tutorial and attend a didactic lecture on discharge summaries. The residents on the intervention team received a 5‐minute orientation on how best to work with the DF. Residents were given the autonomy to decide how much to use the DF's services. The scheduling of follow‐up appointments on the control team was the responsibility of the team resident as per usual care. The nursing component of the discharge process, including patient discharge education, was the same on both teams. Nurses on both floors are identically trained on these aspects of care. The nurses on both teams were surveyed about perception of the discharge process prior to the intervention and after the intervention. A research assistant (RA) called patients discharged home on both teams, 1 week after discharge, to ask about satisfaction with the discharge process, to determine if the patients had any questions, and to verify patient knowledge regarding whom they should contact for problems. The RA also noted the end time of attending rounds each day and the start time of resident sign‐out.

Outcome Measures and Follow‐Up

At the time of discharge, the RA collected baseline data on all patients discharged from both teams, including the number of follow‐up appointments scheduled. Patients were tracked through electronic medical records to see if and when they attended their follow‐up appointments, whether they changed the appointment, and whether patients returned to a hospital emergency department or were readmitted to MGH or an affiliated Partners hospital within 30 days. For patients outside the MGHPartners system, the research assistant contacted primary care physician offices to document follow‐up. The remaining patient data was obtained through the MGHPartners computerized information system.

The primary outcomes of the study were length of stay, time of discharge, number of emergency department visits, hospital readmissions, numbers of discharge summaries completed in 24 hours, time from discharge to discharge summary completion, and whether the discharge summary was completed before follow‐up. Secondary outcomes were number of follow‐up PCP appointments made at time of discharge, percentage of follow‐up appointments attended and time from discharge to attending a follow‐up appointment, patient phone survey results, and nursing perception of the discharge process, as well as the percentage of attending rounds that ended on time and the time of resident sign‐out.

Statistical Analyses

Patient characteristics were compared between intervention and control teams using 2‐sample t tests or Wilcoxon rank sum tests for continuous variables, and chi‐square tests for categorical variables. Hours to discharge summary completion and hospital length of stay were summarized using median and interquartiles (IQR), and compared between the 2 teams using Wilcoxon rank sum tests. Categorical outcomes were compared using chi‐square tests. Two‐sided P values 0.05 were considered statistically significant. SAS version 9.2 (SAS Institute Inc, Cary, NC) was used for all statistical analyses.

RESULTS

Study Sample

During the 5‐month intervention (November 12, 2008 to April 14, 2009), a combined total of 999 patients were admitted to the intervention and control general medical teams. We excluded 96 patients who were not discharged but transferred to another service or intensive care units, and 24 patients who died. We also excluded 7 patients who were discharged from both teams the first day of the study, because the DF was not involved with the patients' discharge planning. That left 872 patients discharged to either home, a facility, or having left against medical advice (AMA) included in the study: 440 patients on the intervention team and 432 patients on the control team (Figure 1). Baseline patient demographic and clinical characteristics were similar across both teams with only gender being significantly different (Table 1). The mean age was 63 years (range, 1896) and the mean comorbidity score was 2.3 (range, 012). Of note, about a quarter of patients were discharged to facilities, about half were Medicare recipients, and approximately 80% had a PCP. The DF participated in the discharge process for nearly all of the intervention patients; she reported contributing approximately 50% of the content to the discharge summaries.

Figure 1
Enrollment of Patients.
Baseline Participant Characteristics
CharacteristicsIntervention TeamControl Team
 n = 440n = 432
  • Abbreviations: AMA, against medical advice; COPD, chronic obstructive pulmonary disease; PCP, primary care physician; SD, standard deviation.

  • P < 0.05; no other comparisons were statistically significant.

  • Deyo Modification of the Charlson Comorbidity Index.

Mean age (SD), year63 (18)63 (18)
Women, n (%)*181 (41)207 (48)
Race, n (%)  
White non‐Hispanic267 (61)243 (56)
Black non‐Hispanic24 (5)33 (8)
Hispanic21 (5)17 (4)
Unknown/other128 (29)139 (32)
Health insurance, n (%)  
Medicare213 (48)226 (52)
Medicaid85 (19)81 (19)
Private110 (25)91 (21)
Other32 (7)34 (8)
PCP on admission, n (%)370 (84)356 (82)
Discharge disposition, n (%)  
AMA12 (3)14 (3)
Home305 (69)315 (73)
Facility123 (28)103 (24)
Mean comorbidity index score (SD)2.3 (2.4)2.3 (2.4)
Diagnoses  
Congestive heart failure30 (6%)27 (5%)
COPD/asthma34 (7%)47 (9%)
Cardiovascular disease54 (11%)50 (8%)
Alcohol/substance abuse29 (6%)34 (7%)
Gastrointestinal bleeds/ulcers38 (8%)41 (8%)
Hepatobiliary disease30 (6%)36 (7%)
Renal failure/kidney disease33 (7%)37 (7%)
Pneumonia36 (7%)22 (4%)
Musculoskeletal disease26 (5%)23 (5%)
Neurologic disease22 (4%)25 (5%)
Other163 (33%)172 (35%)

Primary Outcomes

Primary outcomes from the 2 medical teams are listed in Table 2. In the intervention group, significantly more discharge summaries were completed within 24 hours compared to the control group (293 [67%] vs 207 [48%]; P < 0.0001). Since nearly all patients discharged to facilities must have a discharge summary at the time of discharge, the overall difference in completion rates came mainly from patients discharged home or having left AMA from the intervention team (177 [56%] vs 112 [34%]; P < 0.0001). For all discharge summaries, the median time to completion on the intervention team was 18.9 hours compared with 73.1 hours on the control team (P < 0.0001). More discharge summaries were completed before the first follow‐up appointment on the intervention team (393 [89%] vs 330 [76%]; P < 0.001). The DF intervention had no effect on 30‐day readmission or emergency department visits. For patients on the DF team, 88 (20%) were readmitted within 30 days of discharge, as compared with 79 (18%) on the control team (P = 0.55). Similarly, 40 (9%) of the intervention team patients, as compared with 39 (9%) of the control team patients, visited the emergency department at least once within 30 days (P = 1.0). There was no difference in length of stay (LOS) between the 2 teams (median 4.0 days for both teams, P = 0.84).

Primary Outcomes
 Intervention TeamControl Team 
Variablesn = 440n = 432P Value
  • Abbreviations: AMA, against medical advice; IQR, interquartile range.

Discharge summaries completed 24 hr, n (%)293 (67)207 (48)<0.0001
Discharges to facilities116 (94)95 (92)0.60
Discharges to home/AMA177 (56)112 (34)<0.0001
Median hours to discharge summary completion for discharges to home/AMA (IQR)18.9 (0138)73.1 (4.3286)<0.0001
Discharge summary complete before time of follow‐up appointment.393 (89)330 (76)<0.0001
Emergency department visits in 30 days, n (%)40 (9)39 (9)1.0
Readmissions in 30 days, n (%)88 (20)79 (18)0.55
Median length of stay, days (IQR)4.0 (37)4.0 (28)0.84
Discharges to facilities6.0 (511)8.0 (513)0.17
Discharges to home/AMA4.0 (26)3.0 (26)0.61
Discharged by noon, n (%)38 (9)42 (10)0.64

Secondary Outcomes

Table 3 shows secondary outcomes from the 2 medical teams. Among the patients discharged from the DF team, 264 (62%) had scheduled follow‐up appointments with PCPs compared to the control team 151 (36%) (P < 0.0001). (Many patients going to rehabilitation hospitals are not given PCP appointments at the time of discharge.) Despite having more scheduled appointments, patients' actual follow‐up with PCPs was similar during the 5‐month study period among both intervention and control group (234 [65%] vs 223 [63%]; P = 0.58). However, there was earlier follow‐up with the primary provider in the first 2 or 4 weeks in the intervention group. At 2 weeks, 129 (36%) patients in the intervention group saw their provider compared to 81 (23%) patients in the control group (P < 0.0002), and at 4 weeks, 159 (44%) of the intervention group was seen compared to 99 (28%) of the control group (P < 0.0001). Of note, among the 415 patients on both teams discharged with scheduled appointments, only 53 (13%) of patients did not show up for the scheduled appointment and this no‐show rate was the same on both teams.

Secondary Outcomes
VariablesIntervention TeamControl TeamP Value
  • Against medical advice (AMA) patients excluded.

  • Patients excluded if AMA, readmitted, died after discharge, or discharged to hospice.

No. of eligible patients*428418 
Patients with follow‐up appointments to primary providers, n (%)264 (62)151 (36)<0.0001
No. of eligible patients359354 
Attended follow‐up appointment with primary provider during study, n (%)234 (65)223 (63)0.58
Within 2 weeks of discharge129 (36)81 (23)0.0002
Within 4 weeks of discharge159 (44)99 (28)<0.0001
No. of days round times were recorded10099 
No. of attending rounds ending by 12 PM45 (45%)31 (31%)0.058
Mean start time of sign‐out rounds16:3817:240.0007

Attending rounds ended on time (12 PM) 45% of the time in the intervention group compared to 31% in the control group (P = 0.058). Mean start time of resident sign‐out rounds was 1638 hours on the intervention team and 1724 hours on the control team (P = 0.0007).

We obtained patient reported outcome data by telephone within 2 to 4 weeks of discharge. Of the 620 patients discharged to home, 6 died or were readmitted to the hospital before being reached by phone. For the remaining 614 patients, we were able to contact 444 (72%). Of those, 321 (52%) agreed to participate in the phone interview. We surveyed similar proportions of intervention and control group patients (158 [52%] vs 163 [52%]) (Table 4). Both groups reported similar rates of having questions about their hospital stay after discharge (43 [27%] vs 49 [30%]; P = 0.62). The intervention group could better identify whom to call with questions (150 [95%] vs 138 [85%]; P = 0.003). The intervention group reported better understanding of their follow‐up plans (157 [99%] vs 141 [87%]; P = 0.001) and better understanding of their discharge medications (152 [96%] vs 142 [87%]; P = 0.001). More patients in the intervention group were satisfied with the discharge process (153 [97%] vs 124 [76%]; P < 0.0001).

Secondary Outcomes Continued: Patient Survey Results
 Intervention TeamControl TeamP Value
  • Patients excluded if died or readmitted prior to phone call.

  • Questions were answered on a 5‐point Likert scale. The number/percentage reflects participants who responded with the top 2 categories on the scale.

Patients discharged home*304310 
Patients contacted by phone after discharge, n (%)213 (70)231 (75)0.24
Agreed to participate in phone interview, n (%)158 (52)163 (53)0.94
Among those agreed to participate, n (%)   
Did you have questions about your hospital stay?43 (27)49 (30)0.62
Would you know who to call if you had questions after discharge?150 (95)138 (85)0.003
Satisfied with the discharge process?153 (97)124 (76)<0.0001
Did you understand your follow‐up plans?157 (99)141 (87)<0.0001
Did you understand your medications?152 (96)142 (87)0.001
Did you feel safe going home?153 (97)151 (92)0.07

Compared with nurses on the control team, nurses on the intervention team more often reported paperwork being completed in a timely fashion (56% vs 29%; P = 0.041) and being less worried about the discharge plan (44% vs 57%; P = 0.027). The intervention team nurses also reported fewer issues with medications/prescriptions (61% vs 82%) and being included more often in the discharge planning (50% vs 38%). However, neither of these results reached statistical significance (P = 0.81 and 0.50, respectively).

DISCUSSION

Our study embedded a nurse practitioner on a busy resident general medical team to help with all aspects of the discharge process for which physicians are responsible. Previous studies have been limited to patients with specific diagnoses, age, or disposition plans.1825 In this study, we included all general medical patients. Our intervention improved several important quality of care elements: the timeliness of completion of discharge summaries; and increased number of early follow‐up appointments, with more patients seen within 2 and 4 weeks after discharge. Patients reported better understanding of their follow‐up plans and more satisfaction with the discharge process. While not statistically significant, there was a trend towards better communication with nurses. For residents with work‐hour limitations, there was time savings with a trend towards finishing attending rounds on time and statistically significant earlier sign‐out rounds (46 minutes earlier). This intervention had no effect on patient length of stay, readmissions, or emergency department visits in the 30 days after discharge.

Despite improving many aspects of the discharge process and communication that have previously been raised as areas of concern for patient safety, there was no improvement in readmissions rates and ED utilization which are often used as the quality indicators for effective discharge planning. Similar types of interventions on general medical patients have generally also failed to show improvement in readmission rates.1820, 25 Weinberger et al. arranged follow‐up appointments within 1 week for patients discharged from a Veterans Administrative hospital; while patients were seen more often, the intervention actually increased readmission rates.20 Fitzgerald et al. had a case manager contact patients at home and encourage follow‐up, which increased follow‐up visits, but again had no effect on readmission.19 Einstadter et al. had a nurse case manager coordinate outpatient follow‐up on a resident team and also did not effect readmission rates or ED visits.18 Jack et al. in project reengineered discharge (RED) did show a significant reduction in combined hospital utilization measures. However, their study focused on a more limited patient population, and employed both a discharge advocate to arrange follow‐up and improve patient education, and a pharmacist to make postdischarge phone calls.25

So why did readmissions rates and ED visits not change in our study? It would be reasonable to think that having earlier follow‐up appointments, better and timely physician‐to‐physician communication, and a facilitator for patient questions should improve the quality of the discharge process. In a recent study, Jha et al. found there was no association between chart‐based measures of discharge quality and readmissions rates, and only a modest association for patient‐reported measures of discharge quality and readmission rates.28 The authors suggest readmission rates are driven by many factors beyond just improved discharge safety. Perhaps readmission rates are too complex a measure to use to assess discharge process improvement. For fiscal reasons, it is understandable that hospitals, insurance companies, and the Centers for Medicare and Medicaid want to reduce readmission rates and ED utilization. Jencks et al. noted the cost of readmissions in 2004 was 17.4 billion dollars.29 However, sweeping efforts to improve the discharge process for all general medical patients may not yield significant reductions in readmissions, as this study suggests. We may need to focus aggressive intervention on smaller target populations, as prior studies on focused groups suggest.2123

There are no evidence‐based studies to suggest when optimal follow‐up should occur after discharge.26 Several medical society guidelines recommend 2 weeks. More patients on the intervention team were seen within 2 weeks, but readmission rates were not affected. The University Health System Consortium recently reported that the majority of readmissions occurred within 6 days, with the average being about 2 to 3 days.30 In this study, the median days to readmit were 12 for the intervention team and 10 for the control. It is possible that even with our improved 2‐week follow‐up, this was not early enough to reduce readmissions. Follow‐up may need to be within 13 days of discharge for highly vulnerable patients, to significantly change readmission rates. Further studies focusing on this question would be helpful.

Finally, with ACGME limitation of work hours, many residency programs are looking for ways to reduce residents' workload and increase time for education. With a significant trend towards finishing attending rounds on time, it is likely that more residents on the intervention team were able to attend the noon‐time educational conferences. We speculate that this was due to fewer interruptions during rounds because the DF was available for nurses' questions. Sign‐out rounds occurred significantly earlier, possibly because of improved resident efficiency due to the DF's help with the discharge process. While residents may lose some educational experience from not performing all discharge tasks, they gain experience working in interdisciplinary teams, have increased time for education, and reduced work hours. Since the ACGME limits the number of residents per program and increasing the residency size is not an option, a DF should be considered as a possible solution to ACGME work‐hour restrictions.

This study had several limitations. First, the intervention team had 1 specific person embedded, and therefore the results of this study may have limited generalizability. Second, the limited number of residents working with the DF could have biased the intervention, as not all residents worked equally well with the DF. However, this may represent the real‐world experience on any teaching service, given variation in working styles and learning curves of residents over their training. Third, this study was done at 1 university‐affiliated urban Academic Medical Center, making it potentially less generalizable to resident teams in community hospitals. Fourth, we were not able to capture readmissions and ED visits at institutions outside the MGHPartners Healthcare System. However, given that patients were assigned at random to either team, this factor should have impacted both teams equally. Fifth, the study occurred during Massachusetts healthcare reform which requires everyone to have health insurance. This may have affected the rates of ED visits and readmission rates, especially with a shortage of primary care physicians and office visits. Finally, this intervention was not cost‐neutral. Paying for a nurse practitioner to help residents with the work of discharge and providing patients with additional services had many advantages, but this quality improvement project did not pay for itself through shorter LOS, or decreases in ED visits or readmissions.

While readmission rates and ED utilization are important patient outcomes, especially in the current healthcare climate, what determines readmissions and ED visits is likely complex and multifactorial. This study suggests that, in the nationwide effort to reduce readmissions, solely improving the discharge process for all general medical patients may not produce the hoped‐for financial savings. Improving the discharge process, however, is something valuable in its own right. Adding a DF to a resident team does improve some quality markers of the discharge process and decreases work hours for residents.

Acknowledgements

Sara Macchiano, RN for her help with the data gathering of this study.

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References
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Recent studies have shown that a patient's discharge from the hospital is a vulnerable period for patient safety.14 With the reduction in length of stay (LOS) and the increase in patient acuity over the past decade, patients are discharged from acute care settings quicker and sicker, resulting in management of ongoing illness in a less‐monitored environment.5, 6 In addition, in teaching hospitals, residents are supervised by hospital‐based physicians who are rarely the primary care physician (PCP) for the residents' patients, which creates discontinuity of care.

One in 5 medical discharges is complicated by an adverse event believed, in part, to be due to poor communication between caregivers during this transition time.2 Discharge summaries, a key form of that communication, are not always done in a timely fashion and may lack key pieces of information.7, 8 For approximately 68% of patient discharges, the PCP will not have a discharge summary available for the patient's first follow‐up visit.911 In a survey of PCPs whose patients were in the hospital, only 23% reported direct communication with the hospital care team.12 This leaves PCPs unaware of pending test results or recommended follow‐up evaluations.10, 11, 13, 14 All of these factors are believed to contribute to adverse events, emergency department (ED) visits, and readmissions.

A recently published consensus statement on transitions of care by 6 major medical societies emphasizes the need for timely communication and transfer of information.15 These important processes are especially challenging to meet at academic medical centers, where discharge summaries and transition communication are done by residents in a hectic and challenging work environment, with multiple simultaneous and competing demands including outpatient clinic and required conferences.12 Residents have little formal training in how to write an effective discharge summary or how to systematically approach discharge planning. One study found higher error rates in discharge summaries written by residents compared with attending physicians.16 While the Accreditation Council for Graduate Medical Education (ACGME) limits the number of admissions per intern for both patient safety and educational reasons, the number of discharges per day is not limited despite the considerable amount of time required for appropriate discharge planning and communication.

Many interventions have been tried to improve the discharge process and reduce patient adverse events.17 Arranging early follow‐up appointments to reduce emergency department visits and readmissions has shown mixed results.13, 1820 Interventions that focus on specific populations, such as the elderly or patients with congestive heart failure, have been more successful.2123 Some interventions employed additional resources, such as a discharge form, transition coach, or discharge advocate, again with varying impact on results.18, 2427 A recent study by Jack et al. used nurse discharge advocates (DAs) to help with discharge planning and communication at an academic medical center.25 These DAs were independent of the care team, and focused on patient education and follow‐up plans, and reduced hospital reutilization in a selected population.

No studies have assessed the potential benefit of helping residents with the physician components of the discharge process. Prior studies have mainly focused on patient communication and follow‐up appointments, yet safe transitions also involve timely discharge summaries, physician‐to‐physician communication, physician‐to‐nurse communication, and medication reconciliation. Without support and time, these tasks can be very challenging for resident physicians with work‐hour limitations. We undertook a randomized, controlled trial to evaluate the impact on the discharge process of embedding a discharge facilitator in a resident medical team to help with the physician discharge process. We studied the effect for all the patients discharged from the resident team, rather than focusing on a select group or patients with a single diagnosis.

METHODS

Study Setting and Participants

This study was conducted on 2 of the 5 resident general medical teams on the inpatient teaching service at Massachusetts General Hospital (MGH), Boston, Massachusettsa large, 907‐bed, urban hospital. The residents' teams are regionalized and each care for approximately 20 patients on a single floor. Each of the study teams consists of a junior resident, 4 interns, and 1 to 2 attendings who rotate on the floor for 2‐week or 4‐week blocks. Attending rounds, which occur 10 AM to 12 PM weekdays, are for new patient presentations and discussion of plans. Interdisciplinary rounds occur 9:30 AM to 10 AM. Sign‐out rounds occur in the afternoon whenever all work is complete. The junior resident is responsible for all the discharge orders and communication with PCPs, and the discharge summaries for patients going to facilities. The interns are responsible for discharge summaries for patients discharged home; these summaries are not mandatory at the time of discharge. The majority of patients were admitted under the team attending(s). Patients were assigned to the teams by the admitting office, based on bed availability. All patients discharged from both resident medical teams over a 5‐month period were included in this study. Those who were not discharged from the hospital by the study teams (ie, transfers to intensive care units or deaths) were excluded. These exclusions accounted for less than 12% of all team patients. Partners Healthcare System Institutional Review Board approved all study activities.

Intervention

We randomly assigned a discharge facilitator (DF), a master's level nurse practitioner with prior inpatient medicine experience, to 1 of the 5 resident medical teams. She had no prior experience on this specific floor. A similar resident team, on a different floor, served as the control. For the intervention team, the DF attended daily resident work rounds and interdisciplinary discharge rounds. The resident and DF collaborated in identifying patients being discharged in the next 1 to 3 days, and the DF scheduled all follow‐up appointments and tests. The DF performed medication reconciliation, wrote prescriptions and faxed them to pharmacies, and arranged all anticoagulation services. In collaboration with the resident, the DF called PCPs' offices with discharge information and faxed discharge summaries to PCPs' offices outside the Partners Healthcare System. The DF wrote part or all of the computer discharge orders and discharge summaries at the request of the resident and interns. All discharge summaries still needed to be reviewed, edited, and signed by the resident or interns. The DF also noted pending tests and studies at time of discharge, and followed up on these tests for the team. The DF met with all patients to answer any questions about their discharge plan, medications, and appointments; while residents are encouraged to do this, it is not done as consistently. She provided her business card for any questions after their discharge. Follow‐up patient calls to the DF were either answered by her or triaged to the appropriate person. The DF also communicated with the patient's nurse about the discharge plans. For all patients discharged over a weekend, the DF would arrange the follow‐up appointments on Mondays and call the patients at home.

For both teams, residents received letters at the start of their rotation notifying them of the study and asking them to complete discharge summaries within 24 hours. All residents in the program were expected to do an online discharge tutorial and attend a didactic lecture on discharge summaries. The residents on the intervention team received a 5‐minute orientation on how best to work with the DF. Residents were given the autonomy to decide how much to use the DF's services. The scheduling of follow‐up appointments on the control team was the responsibility of the team resident as per usual care. The nursing component of the discharge process, including patient discharge education, was the same on both teams. Nurses on both floors are identically trained on these aspects of care. The nurses on both teams were surveyed about perception of the discharge process prior to the intervention and after the intervention. A research assistant (RA) called patients discharged home on both teams, 1 week after discharge, to ask about satisfaction with the discharge process, to determine if the patients had any questions, and to verify patient knowledge regarding whom they should contact for problems. The RA also noted the end time of attending rounds each day and the start time of resident sign‐out.

Outcome Measures and Follow‐Up

At the time of discharge, the RA collected baseline data on all patients discharged from both teams, including the number of follow‐up appointments scheduled. Patients were tracked through electronic medical records to see if and when they attended their follow‐up appointments, whether they changed the appointment, and whether patients returned to a hospital emergency department or were readmitted to MGH or an affiliated Partners hospital within 30 days. For patients outside the MGHPartners system, the research assistant contacted primary care physician offices to document follow‐up. The remaining patient data was obtained through the MGHPartners computerized information system.

The primary outcomes of the study were length of stay, time of discharge, number of emergency department visits, hospital readmissions, numbers of discharge summaries completed in 24 hours, time from discharge to discharge summary completion, and whether the discharge summary was completed before follow‐up. Secondary outcomes were number of follow‐up PCP appointments made at time of discharge, percentage of follow‐up appointments attended and time from discharge to attending a follow‐up appointment, patient phone survey results, and nursing perception of the discharge process, as well as the percentage of attending rounds that ended on time and the time of resident sign‐out.

Statistical Analyses

Patient characteristics were compared between intervention and control teams using 2‐sample t tests or Wilcoxon rank sum tests for continuous variables, and chi‐square tests for categorical variables. Hours to discharge summary completion and hospital length of stay were summarized using median and interquartiles (IQR), and compared between the 2 teams using Wilcoxon rank sum tests. Categorical outcomes were compared using chi‐square tests. Two‐sided P values 0.05 were considered statistically significant. SAS version 9.2 (SAS Institute Inc, Cary, NC) was used for all statistical analyses.

RESULTS

Study Sample

During the 5‐month intervention (November 12, 2008 to April 14, 2009), a combined total of 999 patients were admitted to the intervention and control general medical teams. We excluded 96 patients who were not discharged but transferred to another service or intensive care units, and 24 patients who died. We also excluded 7 patients who were discharged from both teams the first day of the study, because the DF was not involved with the patients' discharge planning. That left 872 patients discharged to either home, a facility, or having left against medical advice (AMA) included in the study: 440 patients on the intervention team and 432 patients on the control team (Figure 1). Baseline patient demographic and clinical characteristics were similar across both teams with only gender being significantly different (Table 1). The mean age was 63 years (range, 1896) and the mean comorbidity score was 2.3 (range, 012). Of note, about a quarter of patients were discharged to facilities, about half were Medicare recipients, and approximately 80% had a PCP. The DF participated in the discharge process for nearly all of the intervention patients; she reported contributing approximately 50% of the content to the discharge summaries.

Figure 1
Enrollment of Patients.
Baseline Participant Characteristics
CharacteristicsIntervention TeamControl Team
 n = 440n = 432
  • Abbreviations: AMA, against medical advice; COPD, chronic obstructive pulmonary disease; PCP, primary care physician; SD, standard deviation.

  • P < 0.05; no other comparisons were statistically significant.

  • Deyo Modification of the Charlson Comorbidity Index.

Mean age (SD), year63 (18)63 (18)
Women, n (%)*181 (41)207 (48)
Race, n (%)  
White non‐Hispanic267 (61)243 (56)
Black non‐Hispanic24 (5)33 (8)
Hispanic21 (5)17 (4)
Unknown/other128 (29)139 (32)
Health insurance, n (%)  
Medicare213 (48)226 (52)
Medicaid85 (19)81 (19)
Private110 (25)91 (21)
Other32 (7)34 (8)
PCP on admission, n (%)370 (84)356 (82)
Discharge disposition, n (%)  
AMA12 (3)14 (3)
Home305 (69)315 (73)
Facility123 (28)103 (24)
Mean comorbidity index score (SD)2.3 (2.4)2.3 (2.4)
Diagnoses  
Congestive heart failure30 (6%)27 (5%)
COPD/asthma34 (7%)47 (9%)
Cardiovascular disease54 (11%)50 (8%)
Alcohol/substance abuse29 (6%)34 (7%)
Gastrointestinal bleeds/ulcers38 (8%)41 (8%)
Hepatobiliary disease30 (6%)36 (7%)
Renal failure/kidney disease33 (7%)37 (7%)
Pneumonia36 (7%)22 (4%)
Musculoskeletal disease26 (5%)23 (5%)
Neurologic disease22 (4%)25 (5%)
Other163 (33%)172 (35%)

Primary Outcomes

Primary outcomes from the 2 medical teams are listed in Table 2. In the intervention group, significantly more discharge summaries were completed within 24 hours compared to the control group (293 [67%] vs 207 [48%]; P < 0.0001). Since nearly all patients discharged to facilities must have a discharge summary at the time of discharge, the overall difference in completion rates came mainly from patients discharged home or having left AMA from the intervention team (177 [56%] vs 112 [34%]; P < 0.0001). For all discharge summaries, the median time to completion on the intervention team was 18.9 hours compared with 73.1 hours on the control team (P < 0.0001). More discharge summaries were completed before the first follow‐up appointment on the intervention team (393 [89%] vs 330 [76%]; P < 0.001). The DF intervention had no effect on 30‐day readmission or emergency department visits. For patients on the DF team, 88 (20%) were readmitted within 30 days of discharge, as compared with 79 (18%) on the control team (P = 0.55). Similarly, 40 (9%) of the intervention team patients, as compared with 39 (9%) of the control team patients, visited the emergency department at least once within 30 days (P = 1.0). There was no difference in length of stay (LOS) between the 2 teams (median 4.0 days for both teams, P = 0.84).

Primary Outcomes
 Intervention TeamControl Team 
Variablesn = 440n = 432P Value
  • Abbreviations: AMA, against medical advice; IQR, interquartile range.

Discharge summaries completed 24 hr, n (%)293 (67)207 (48)<0.0001
Discharges to facilities116 (94)95 (92)0.60
Discharges to home/AMA177 (56)112 (34)<0.0001
Median hours to discharge summary completion for discharges to home/AMA (IQR)18.9 (0138)73.1 (4.3286)<0.0001
Discharge summary complete before time of follow‐up appointment.393 (89)330 (76)<0.0001
Emergency department visits in 30 days, n (%)40 (9)39 (9)1.0
Readmissions in 30 days, n (%)88 (20)79 (18)0.55
Median length of stay, days (IQR)4.0 (37)4.0 (28)0.84
Discharges to facilities6.0 (511)8.0 (513)0.17
Discharges to home/AMA4.0 (26)3.0 (26)0.61
Discharged by noon, n (%)38 (9)42 (10)0.64

Secondary Outcomes

Table 3 shows secondary outcomes from the 2 medical teams. Among the patients discharged from the DF team, 264 (62%) had scheduled follow‐up appointments with PCPs compared to the control team 151 (36%) (P < 0.0001). (Many patients going to rehabilitation hospitals are not given PCP appointments at the time of discharge.) Despite having more scheduled appointments, patients' actual follow‐up with PCPs was similar during the 5‐month study period among both intervention and control group (234 [65%] vs 223 [63%]; P = 0.58). However, there was earlier follow‐up with the primary provider in the first 2 or 4 weeks in the intervention group. At 2 weeks, 129 (36%) patients in the intervention group saw their provider compared to 81 (23%) patients in the control group (P < 0.0002), and at 4 weeks, 159 (44%) of the intervention group was seen compared to 99 (28%) of the control group (P < 0.0001). Of note, among the 415 patients on both teams discharged with scheduled appointments, only 53 (13%) of patients did not show up for the scheduled appointment and this no‐show rate was the same on both teams.

Secondary Outcomes
VariablesIntervention TeamControl TeamP Value
  • Against medical advice (AMA) patients excluded.

  • Patients excluded if AMA, readmitted, died after discharge, or discharged to hospice.

No. of eligible patients*428418 
Patients with follow‐up appointments to primary providers, n (%)264 (62)151 (36)<0.0001
No. of eligible patients359354 
Attended follow‐up appointment with primary provider during study, n (%)234 (65)223 (63)0.58
Within 2 weeks of discharge129 (36)81 (23)0.0002
Within 4 weeks of discharge159 (44)99 (28)<0.0001
No. of days round times were recorded10099 
No. of attending rounds ending by 12 PM45 (45%)31 (31%)0.058
Mean start time of sign‐out rounds16:3817:240.0007

Attending rounds ended on time (12 PM) 45% of the time in the intervention group compared to 31% in the control group (P = 0.058). Mean start time of resident sign‐out rounds was 1638 hours on the intervention team and 1724 hours on the control team (P = 0.0007).

We obtained patient reported outcome data by telephone within 2 to 4 weeks of discharge. Of the 620 patients discharged to home, 6 died or were readmitted to the hospital before being reached by phone. For the remaining 614 patients, we were able to contact 444 (72%). Of those, 321 (52%) agreed to participate in the phone interview. We surveyed similar proportions of intervention and control group patients (158 [52%] vs 163 [52%]) (Table 4). Both groups reported similar rates of having questions about their hospital stay after discharge (43 [27%] vs 49 [30%]; P = 0.62). The intervention group could better identify whom to call with questions (150 [95%] vs 138 [85%]; P = 0.003). The intervention group reported better understanding of their follow‐up plans (157 [99%] vs 141 [87%]; P = 0.001) and better understanding of their discharge medications (152 [96%] vs 142 [87%]; P = 0.001). More patients in the intervention group were satisfied with the discharge process (153 [97%] vs 124 [76%]; P < 0.0001).

Secondary Outcomes Continued: Patient Survey Results
 Intervention TeamControl TeamP Value
  • Patients excluded if died or readmitted prior to phone call.

  • Questions were answered on a 5‐point Likert scale. The number/percentage reflects participants who responded with the top 2 categories on the scale.

Patients discharged home*304310 
Patients contacted by phone after discharge, n (%)213 (70)231 (75)0.24
Agreed to participate in phone interview, n (%)158 (52)163 (53)0.94
Among those agreed to participate, n (%)   
Did you have questions about your hospital stay?43 (27)49 (30)0.62
Would you know who to call if you had questions after discharge?150 (95)138 (85)0.003
Satisfied with the discharge process?153 (97)124 (76)<0.0001
Did you understand your follow‐up plans?157 (99)141 (87)<0.0001
Did you understand your medications?152 (96)142 (87)0.001
Did you feel safe going home?153 (97)151 (92)0.07

Compared with nurses on the control team, nurses on the intervention team more often reported paperwork being completed in a timely fashion (56% vs 29%; P = 0.041) and being less worried about the discharge plan (44% vs 57%; P = 0.027). The intervention team nurses also reported fewer issues with medications/prescriptions (61% vs 82%) and being included more often in the discharge planning (50% vs 38%). However, neither of these results reached statistical significance (P = 0.81 and 0.50, respectively).

DISCUSSION

Our study embedded a nurse practitioner on a busy resident general medical team to help with all aspects of the discharge process for which physicians are responsible. Previous studies have been limited to patients with specific diagnoses, age, or disposition plans.1825 In this study, we included all general medical patients. Our intervention improved several important quality of care elements: the timeliness of completion of discharge summaries; and increased number of early follow‐up appointments, with more patients seen within 2 and 4 weeks after discharge. Patients reported better understanding of their follow‐up plans and more satisfaction with the discharge process. While not statistically significant, there was a trend towards better communication with nurses. For residents with work‐hour limitations, there was time savings with a trend towards finishing attending rounds on time and statistically significant earlier sign‐out rounds (46 minutes earlier). This intervention had no effect on patient length of stay, readmissions, or emergency department visits in the 30 days after discharge.

Despite improving many aspects of the discharge process and communication that have previously been raised as areas of concern for patient safety, there was no improvement in readmissions rates and ED utilization which are often used as the quality indicators for effective discharge planning. Similar types of interventions on general medical patients have generally also failed to show improvement in readmission rates.1820, 25 Weinberger et al. arranged follow‐up appointments within 1 week for patients discharged from a Veterans Administrative hospital; while patients were seen more often, the intervention actually increased readmission rates.20 Fitzgerald et al. had a case manager contact patients at home and encourage follow‐up, which increased follow‐up visits, but again had no effect on readmission.19 Einstadter et al. had a nurse case manager coordinate outpatient follow‐up on a resident team and also did not effect readmission rates or ED visits.18 Jack et al. in project reengineered discharge (RED) did show a significant reduction in combined hospital utilization measures. However, their study focused on a more limited patient population, and employed both a discharge advocate to arrange follow‐up and improve patient education, and a pharmacist to make postdischarge phone calls.25

So why did readmissions rates and ED visits not change in our study? It would be reasonable to think that having earlier follow‐up appointments, better and timely physician‐to‐physician communication, and a facilitator for patient questions should improve the quality of the discharge process. In a recent study, Jha et al. found there was no association between chart‐based measures of discharge quality and readmissions rates, and only a modest association for patient‐reported measures of discharge quality and readmission rates.28 The authors suggest readmission rates are driven by many factors beyond just improved discharge safety. Perhaps readmission rates are too complex a measure to use to assess discharge process improvement. For fiscal reasons, it is understandable that hospitals, insurance companies, and the Centers for Medicare and Medicaid want to reduce readmission rates and ED utilization. Jencks et al. noted the cost of readmissions in 2004 was 17.4 billion dollars.29 However, sweeping efforts to improve the discharge process for all general medical patients may not yield significant reductions in readmissions, as this study suggests. We may need to focus aggressive intervention on smaller target populations, as prior studies on focused groups suggest.2123

There are no evidence‐based studies to suggest when optimal follow‐up should occur after discharge.26 Several medical society guidelines recommend 2 weeks. More patients on the intervention team were seen within 2 weeks, but readmission rates were not affected. The University Health System Consortium recently reported that the majority of readmissions occurred within 6 days, with the average being about 2 to 3 days.30 In this study, the median days to readmit were 12 for the intervention team and 10 for the control. It is possible that even with our improved 2‐week follow‐up, this was not early enough to reduce readmissions. Follow‐up may need to be within 13 days of discharge for highly vulnerable patients, to significantly change readmission rates. Further studies focusing on this question would be helpful.

Finally, with ACGME limitation of work hours, many residency programs are looking for ways to reduce residents' workload and increase time for education. With a significant trend towards finishing attending rounds on time, it is likely that more residents on the intervention team were able to attend the noon‐time educational conferences. We speculate that this was due to fewer interruptions during rounds because the DF was available for nurses' questions. Sign‐out rounds occurred significantly earlier, possibly because of improved resident efficiency due to the DF's help with the discharge process. While residents may lose some educational experience from not performing all discharge tasks, they gain experience working in interdisciplinary teams, have increased time for education, and reduced work hours. Since the ACGME limits the number of residents per program and increasing the residency size is not an option, a DF should be considered as a possible solution to ACGME work‐hour restrictions.

This study had several limitations. First, the intervention team had 1 specific person embedded, and therefore the results of this study may have limited generalizability. Second, the limited number of residents working with the DF could have biased the intervention, as not all residents worked equally well with the DF. However, this may represent the real‐world experience on any teaching service, given variation in working styles and learning curves of residents over their training. Third, this study was done at 1 university‐affiliated urban Academic Medical Center, making it potentially less generalizable to resident teams in community hospitals. Fourth, we were not able to capture readmissions and ED visits at institutions outside the MGHPartners Healthcare System. However, given that patients were assigned at random to either team, this factor should have impacted both teams equally. Fifth, the study occurred during Massachusetts healthcare reform which requires everyone to have health insurance. This may have affected the rates of ED visits and readmission rates, especially with a shortage of primary care physicians and office visits. Finally, this intervention was not cost‐neutral. Paying for a nurse practitioner to help residents with the work of discharge and providing patients with additional services had many advantages, but this quality improvement project did not pay for itself through shorter LOS, or decreases in ED visits or readmissions.

While readmission rates and ED utilization are important patient outcomes, especially in the current healthcare climate, what determines readmissions and ED visits is likely complex and multifactorial. This study suggests that, in the nationwide effort to reduce readmissions, solely improving the discharge process for all general medical patients may not produce the hoped‐for financial savings. Improving the discharge process, however, is something valuable in its own right. Adding a DF to a resident team does improve some quality markers of the discharge process and decreases work hours for residents.

Acknowledgements

Sara Macchiano, RN for her help with the data gathering of this study.

Recent studies have shown that a patient's discharge from the hospital is a vulnerable period for patient safety.14 With the reduction in length of stay (LOS) and the increase in patient acuity over the past decade, patients are discharged from acute care settings quicker and sicker, resulting in management of ongoing illness in a less‐monitored environment.5, 6 In addition, in teaching hospitals, residents are supervised by hospital‐based physicians who are rarely the primary care physician (PCP) for the residents' patients, which creates discontinuity of care.

One in 5 medical discharges is complicated by an adverse event believed, in part, to be due to poor communication between caregivers during this transition time.2 Discharge summaries, a key form of that communication, are not always done in a timely fashion and may lack key pieces of information.7, 8 For approximately 68% of patient discharges, the PCP will not have a discharge summary available for the patient's first follow‐up visit.911 In a survey of PCPs whose patients were in the hospital, only 23% reported direct communication with the hospital care team.12 This leaves PCPs unaware of pending test results or recommended follow‐up evaluations.10, 11, 13, 14 All of these factors are believed to contribute to adverse events, emergency department (ED) visits, and readmissions.

A recently published consensus statement on transitions of care by 6 major medical societies emphasizes the need for timely communication and transfer of information.15 These important processes are especially challenging to meet at academic medical centers, where discharge summaries and transition communication are done by residents in a hectic and challenging work environment, with multiple simultaneous and competing demands including outpatient clinic and required conferences.12 Residents have little formal training in how to write an effective discharge summary or how to systematically approach discharge planning. One study found higher error rates in discharge summaries written by residents compared with attending physicians.16 While the Accreditation Council for Graduate Medical Education (ACGME) limits the number of admissions per intern for both patient safety and educational reasons, the number of discharges per day is not limited despite the considerable amount of time required for appropriate discharge planning and communication.

Many interventions have been tried to improve the discharge process and reduce patient adverse events.17 Arranging early follow‐up appointments to reduce emergency department visits and readmissions has shown mixed results.13, 1820 Interventions that focus on specific populations, such as the elderly or patients with congestive heart failure, have been more successful.2123 Some interventions employed additional resources, such as a discharge form, transition coach, or discharge advocate, again with varying impact on results.18, 2427 A recent study by Jack et al. used nurse discharge advocates (DAs) to help with discharge planning and communication at an academic medical center.25 These DAs were independent of the care team, and focused on patient education and follow‐up plans, and reduced hospital reutilization in a selected population.

No studies have assessed the potential benefit of helping residents with the physician components of the discharge process. Prior studies have mainly focused on patient communication and follow‐up appointments, yet safe transitions also involve timely discharge summaries, physician‐to‐physician communication, physician‐to‐nurse communication, and medication reconciliation. Without support and time, these tasks can be very challenging for resident physicians with work‐hour limitations. We undertook a randomized, controlled trial to evaluate the impact on the discharge process of embedding a discharge facilitator in a resident medical team to help with the physician discharge process. We studied the effect for all the patients discharged from the resident team, rather than focusing on a select group or patients with a single diagnosis.

METHODS

Study Setting and Participants

This study was conducted on 2 of the 5 resident general medical teams on the inpatient teaching service at Massachusetts General Hospital (MGH), Boston, Massachusettsa large, 907‐bed, urban hospital. The residents' teams are regionalized and each care for approximately 20 patients on a single floor. Each of the study teams consists of a junior resident, 4 interns, and 1 to 2 attendings who rotate on the floor for 2‐week or 4‐week blocks. Attending rounds, which occur 10 AM to 12 PM weekdays, are for new patient presentations and discussion of plans. Interdisciplinary rounds occur 9:30 AM to 10 AM. Sign‐out rounds occur in the afternoon whenever all work is complete. The junior resident is responsible for all the discharge orders and communication with PCPs, and the discharge summaries for patients going to facilities. The interns are responsible for discharge summaries for patients discharged home; these summaries are not mandatory at the time of discharge. The majority of patients were admitted under the team attending(s). Patients were assigned to the teams by the admitting office, based on bed availability. All patients discharged from both resident medical teams over a 5‐month period were included in this study. Those who were not discharged from the hospital by the study teams (ie, transfers to intensive care units or deaths) were excluded. These exclusions accounted for less than 12% of all team patients. Partners Healthcare System Institutional Review Board approved all study activities.

Intervention

We randomly assigned a discharge facilitator (DF), a master's level nurse practitioner with prior inpatient medicine experience, to 1 of the 5 resident medical teams. She had no prior experience on this specific floor. A similar resident team, on a different floor, served as the control. For the intervention team, the DF attended daily resident work rounds and interdisciplinary discharge rounds. The resident and DF collaborated in identifying patients being discharged in the next 1 to 3 days, and the DF scheduled all follow‐up appointments and tests. The DF performed medication reconciliation, wrote prescriptions and faxed them to pharmacies, and arranged all anticoagulation services. In collaboration with the resident, the DF called PCPs' offices with discharge information and faxed discharge summaries to PCPs' offices outside the Partners Healthcare System. The DF wrote part or all of the computer discharge orders and discharge summaries at the request of the resident and interns. All discharge summaries still needed to be reviewed, edited, and signed by the resident or interns. The DF also noted pending tests and studies at time of discharge, and followed up on these tests for the team. The DF met with all patients to answer any questions about their discharge plan, medications, and appointments; while residents are encouraged to do this, it is not done as consistently. She provided her business card for any questions after their discharge. Follow‐up patient calls to the DF were either answered by her or triaged to the appropriate person. The DF also communicated with the patient's nurse about the discharge plans. For all patients discharged over a weekend, the DF would arrange the follow‐up appointments on Mondays and call the patients at home.

For both teams, residents received letters at the start of their rotation notifying them of the study and asking them to complete discharge summaries within 24 hours. All residents in the program were expected to do an online discharge tutorial and attend a didactic lecture on discharge summaries. The residents on the intervention team received a 5‐minute orientation on how best to work with the DF. Residents were given the autonomy to decide how much to use the DF's services. The scheduling of follow‐up appointments on the control team was the responsibility of the team resident as per usual care. The nursing component of the discharge process, including patient discharge education, was the same on both teams. Nurses on both floors are identically trained on these aspects of care. The nurses on both teams were surveyed about perception of the discharge process prior to the intervention and after the intervention. A research assistant (RA) called patients discharged home on both teams, 1 week after discharge, to ask about satisfaction with the discharge process, to determine if the patients had any questions, and to verify patient knowledge regarding whom they should contact for problems. The RA also noted the end time of attending rounds each day and the start time of resident sign‐out.

Outcome Measures and Follow‐Up

At the time of discharge, the RA collected baseline data on all patients discharged from both teams, including the number of follow‐up appointments scheduled. Patients were tracked through electronic medical records to see if and when they attended their follow‐up appointments, whether they changed the appointment, and whether patients returned to a hospital emergency department or were readmitted to MGH or an affiliated Partners hospital within 30 days. For patients outside the MGHPartners system, the research assistant contacted primary care physician offices to document follow‐up. The remaining patient data was obtained through the MGHPartners computerized information system.

The primary outcomes of the study were length of stay, time of discharge, number of emergency department visits, hospital readmissions, numbers of discharge summaries completed in 24 hours, time from discharge to discharge summary completion, and whether the discharge summary was completed before follow‐up. Secondary outcomes were number of follow‐up PCP appointments made at time of discharge, percentage of follow‐up appointments attended and time from discharge to attending a follow‐up appointment, patient phone survey results, and nursing perception of the discharge process, as well as the percentage of attending rounds that ended on time and the time of resident sign‐out.

Statistical Analyses

Patient characteristics were compared between intervention and control teams using 2‐sample t tests or Wilcoxon rank sum tests for continuous variables, and chi‐square tests for categorical variables. Hours to discharge summary completion and hospital length of stay were summarized using median and interquartiles (IQR), and compared between the 2 teams using Wilcoxon rank sum tests. Categorical outcomes were compared using chi‐square tests. Two‐sided P values 0.05 were considered statistically significant. SAS version 9.2 (SAS Institute Inc, Cary, NC) was used for all statistical analyses.

RESULTS

Study Sample

During the 5‐month intervention (November 12, 2008 to April 14, 2009), a combined total of 999 patients were admitted to the intervention and control general medical teams. We excluded 96 patients who were not discharged but transferred to another service or intensive care units, and 24 patients who died. We also excluded 7 patients who were discharged from both teams the first day of the study, because the DF was not involved with the patients' discharge planning. That left 872 patients discharged to either home, a facility, or having left against medical advice (AMA) included in the study: 440 patients on the intervention team and 432 patients on the control team (Figure 1). Baseline patient demographic and clinical characteristics were similar across both teams with only gender being significantly different (Table 1). The mean age was 63 years (range, 1896) and the mean comorbidity score was 2.3 (range, 012). Of note, about a quarter of patients were discharged to facilities, about half were Medicare recipients, and approximately 80% had a PCP. The DF participated in the discharge process for nearly all of the intervention patients; she reported contributing approximately 50% of the content to the discharge summaries.

Figure 1
Enrollment of Patients.
Baseline Participant Characteristics
CharacteristicsIntervention TeamControl Team
 n = 440n = 432
  • Abbreviations: AMA, against medical advice; COPD, chronic obstructive pulmonary disease; PCP, primary care physician; SD, standard deviation.

  • P < 0.05; no other comparisons were statistically significant.

  • Deyo Modification of the Charlson Comorbidity Index.

Mean age (SD), year63 (18)63 (18)
Women, n (%)*181 (41)207 (48)
Race, n (%)  
White non‐Hispanic267 (61)243 (56)
Black non‐Hispanic24 (5)33 (8)
Hispanic21 (5)17 (4)
Unknown/other128 (29)139 (32)
Health insurance, n (%)  
Medicare213 (48)226 (52)
Medicaid85 (19)81 (19)
Private110 (25)91 (21)
Other32 (7)34 (8)
PCP on admission, n (%)370 (84)356 (82)
Discharge disposition, n (%)  
AMA12 (3)14 (3)
Home305 (69)315 (73)
Facility123 (28)103 (24)
Mean comorbidity index score (SD)2.3 (2.4)2.3 (2.4)
Diagnoses  
Congestive heart failure30 (6%)27 (5%)
COPD/asthma34 (7%)47 (9%)
Cardiovascular disease54 (11%)50 (8%)
Alcohol/substance abuse29 (6%)34 (7%)
Gastrointestinal bleeds/ulcers38 (8%)41 (8%)
Hepatobiliary disease30 (6%)36 (7%)
Renal failure/kidney disease33 (7%)37 (7%)
Pneumonia36 (7%)22 (4%)
Musculoskeletal disease26 (5%)23 (5%)
Neurologic disease22 (4%)25 (5%)
Other163 (33%)172 (35%)

Primary Outcomes

Primary outcomes from the 2 medical teams are listed in Table 2. In the intervention group, significantly more discharge summaries were completed within 24 hours compared to the control group (293 [67%] vs 207 [48%]; P < 0.0001). Since nearly all patients discharged to facilities must have a discharge summary at the time of discharge, the overall difference in completion rates came mainly from patients discharged home or having left AMA from the intervention team (177 [56%] vs 112 [34%]; P < 0.0001). For all discharge summaries, the median time to completion on the intervention team was 18.9 hours compared with 73.1 hours on the control team (P < 0.0001). More discharge summaries were completed before the first follow‐up appointment on the intervention team (393 [89%] vs 330 [76%]; P < 0.001). The DF intervention had no effect on 30‐day readmission or emergency department visits. For patients on the DF team, 88 (20%) were readmitted within 30 days of discharge, as compared with 79 (18%) on the control team (P = 0.55). Similarly, 40 (9%) of the intervention team patients, as compared with 39 (9%) of the control team patients, visited the emergency department at least once within 30 days (P = 1.0). There was no difference in length of stay (LOS) between the 2 teams (median 4.0 days for both teams, P = 0.84).

Primary Outcomes
 Intervention TeamControl Team 
Variablesn = 440n = 432P Value
  • Abbreviations: AMA, against medical advice; IQR, interquartile range.

Discharge summaries completed 24 hr, n (%)293 (67)207 (48)<0.0001
Discharges to facilities116 (94)95 (92)0.60
Discharges to home/AMA177 (56)112 (34)<0.0001
Median hours to discharge summary completion for discharges to home/AMA (IQR)18.9 (0138)73.1 (4.3286)<0.0001
Discharge summary complete before time of follow‐up appointment.393 (89)330 (76)<0.0001
Emergency department visits in 30 days, n (%)40 (9)39 (9)1.0
Readmissions in 30 days, n (%)88 (20)79 (18)0.55
Median length of stay, days (IQR)4.0 (37)4.0 (28)0.84
Discharges to facilities6.0 (511)8.0 (513)0.17
Discharges to home/AMA4.0 (26)3.0 (26)0.61
Discharged by noon, n (%)38 (9)42 (10)0.64

Secondary Outcomes

Table 3 shows secondary outcomes from the 2 medical teams. Among the patients discharged from the DF team, 264 (62%) had scheduled follow‐up appointments with PCPs compared to the control team 151 (36%) (P < 0.0001). (Many patients going to rehabilitation hospitals are not given PCP appointments at the time of discharge.) Despite having more scheduled appointments, patients' actual follow‐up with PCPs was similar during the 5‐month study period among both intervention and control group (234 [65%] vs 223 [63%]; P = 0.58). However, there was earlier follow‐up with the primary provider in the first 2 or 4 weeks in the intervention group. At 2 weeks, 129 (36%) patients in the intervention group saw their provider compared to 81 (23%) patients in the control group (P < 0.0002), and at 4 weeks, 159 (44%) of the intervention group was seen compared to 99 (28%) of the control group (P < 0.0001). Of note, among the 415 patients on both teams discharged with scheduled appointments, only 53 (13%) of patients did not show up for the scheduled appointment and this no‐show rate was the same on both teams.

Secondary Outcomes
VariablesIntervention TeamControl TeamP Value
  • Against medical advice (AMA) patients excluded.

  • Patients excluded if AMA, readmitted, died after discharge, or discharged to hospice.

No. of eligible patients*428418 
Patients with follow‐up appointments to primary providers, n (%)264 (62)151 (36)<0.0001
No. of eligible patients359354 
Attended follow‐up appointment with primary provider during study, n (%)234 (65)223 (63)0.58
Within 2 weeks of discharge129 (36)81 (23)0.0002
Within 4 weeks of discharge159 (44)99 (28)<0.0001
No. of days round times were recorded10099 
No. of attending rounds ending by 12 PM45 (45%)31 (31%)0.058
Mean start time of sign‐out rounds16:3817:240.0007

Attending rounds ended on time (12 PM) 45% of the time in the intervention group compared to 31% in the control group (P = 0.058). Mean start time of resident sign‐out rounds was 1638 hours on the intervention team and 1724 hours on the control team (P = 0.0007).

We obtained patient reported outcome data by telephone within 2 to 4 weeks of discharge. Of the 620 patients discharged to home, 6 died or were readmitted to the hospital before being reached by phone. For the remaining 614 patients, we were able to contact 444 (72%). Of those, 321 (52%) agreed to participate in the phone interview. We surveyed similar proportions of intervention and control group patients (158 [52%] vs 163 [52%]) (Table 4). Both groups reported similar rates of having questions about their hospital stay after discharge (43 [27%] vs 49 [30%]; P = 0.62). The intervention group could better identify whom to call with questions (150 [95%] vs 138 [85%]; P = 0.003). The intervention group reported better understanding of their follow‐up plans (157 [99%] vs 141 [87%]; P = 0.001) and better understanding of their discharge medications (152 [96%] vs 142 [87%]; P = 0.001). More patients in the intervention group were satisfied with the discharge process (153 [97%] vs 124 [76%]; P < 0.0001).

Secondary Outcomes Continued: Patient Survey Results
 Intervention TeamControl TeamP Value
  • Patients excluded if died or readmitted prior to phone call.

  • Questions were answered on a 5‐point Likert scale. The number/percentage reflects participants who responded with the top 2 categories on the scale.

Patients discharged home*304310 
Patients contacted by phone after discharge, n (%)213 (70)231 (75)0.24
Agreed to participate in phone interview, n (%)158 (52)163 (53)0.94
Among those agreed to participate, n (%)   
Did you have questions about your hospital stay?43 (27)49 (30)0.62
Would you know who to call if you had questions after discharge?150 (95)138 (85)0.003
Satisfied with the discharge process?153 (97)124 (76)<0.0001
Did you understand your follow‐up plans?157 (99)141 (87)<0.0001
Did you understand your medications?152 (96)142 (87)0.001
Did you feel safe going home?153 (97)151 (92)0.07

Compared with nurses on the control team, nurses on the intervention team more often reported paperwork being completed in a timely fashion (56% vs 29%; P = 0.041) and being less worried about the discharge plan (44% vs 57%; P = 0.027). The intervention team nurses also reported fewer issues with medications/prescriptions (61% vs 82%) and being included more often in the discharge planning (50% vs 38%). However, neither of these results reached statistical significance (P = 0.81 and 0.50, respectively).

DISCUSSION

Our study embedded a nurse practitioner on a busy resident general medical team to help with all aspects of the discharge process for which physicians are responsible. Previous studies have been limited to patients with specific diagnoses, age, or disposition plans.1825 In this study, we included all general medical patients. Our intervention improved several important quality of care elements: the timeliness of completion of discharge summaries; and increased number of early follow‐up appointments, with more patients seen within 2 and 4 weeks after discharge. Patients reported better understanding of their follow‐up plans and more satisfaction with the discharge process. While not statistically significant, there was a trend towards better communication with nurses. For residents with work‐hour limitations, there was time savings with a trend towards finishing attending rounds on time and statistically significant earlier sign‐out rounds (46 minutes earlier). This intervention had no effect on patient length of stay, readmissions, or emergency department visits in the 30 days after discharge.

Despite improving many aspects of the discharge process and communication that have previously been raised as areas of concern for patient safety, there was no improvement in readmissions rates and ED utilization which are often used as the quality indicators for effective discharge planning. Similar types of interventions on general medical patients have generally also failed to show improvement in readmission rates.1820, 25 Weinberger et al. arranged follow‐up appointments within 1 week for patients discharged from a Veterans Administrative hospital; while patients were seen more often, the intervention actually increased readmission rates.20 Fitzgerald et al. had a case manager contact patients at home and encourage follow‐up, which increased follow‐up visits, but again had no effect on readmission.19 Einstadter et al. had a nurse case manager coordinate outpatient follow‐up on a resident team and also did not effect readmission rates or ED visits.18 Jack et al. in project reengineered discharge (RED) did show a significant reduction in combined hospital utilization measures. However, their study focused on a more limited patient population, and employed both a discharge advocate to arrange follow‐up and improve patient education, and a pharmacist to make postdischarge phone calls.25

So why did readmissions rates and ED visits not change in our study? It would be reasonable to think that having earlier follow‐up appointments, better and timely physician‐to‐physician communication, and a facilitator for patient questions should improve the quality of the discharge process. In a recent study, Jha et al. found there was no association between chart‐based measures of discharge quality and readmissions rates, and only a modest association for patient‐reported measures of discharge quality and readmission rates.28 The authors suggest readmission rates are driven by many factors beyond just improved discharge safety. Perhaps readmission rates are too complex a measure to use to assess discharge process improvement. For fiscal reasons, it is understandable that hospitals, insurance companies, and the Centers for Medicare and Medicaid want to reduce readmission rates and ED utilization. Jencks et al. noted the cost of readmissions in 2004 was 17.4 billion dollars.29 However, sweeping efforts to improve the discharge process for all general medical patients may not yield significant reductions in readmissions, as this study suggests. We may need to focus aggressive intervention on smaller target populations, as prior studies on focused groups suggest.2123

There are no evidence‐based studies to suggest when optimal follow‐up should occur after discharge.26 Several medical society guidelines recommend 2 weeks. More patients on the intervention team were seen within 2 weeks, but readmission rates were not affected. The University Health System Consortium recently reported that the majority of readmissions occurred within 6 days, with the average being about 2 to 3 days.30 In this study, the median days to readmit were 12 for the intervention team and 10 for the control. It is possible that even with our improved 2‐week follow‐up, this was not early enough to reduce readmissions. Follow‐up may need to be within 13 days of discharge for highly vulnerable patients, to significantly change readmission rates. Further studies focusing on this question would be helpful.

Finally, with ACGME limitation of work hours, many residency programs are looking for ways to reduce residents' workload and increase time for education. With a significant trend towards finishing attending rounds on time, it is likely that more residents on the intervention team were able to attend the noon‐time educational conferences. We speculate that this was due to fewer interruptions during rounds because the DF was available for nurses' questions. Sign‐out rounds occurred significantly earlier, possibly because of improved resident efficiency due to the DF's help with the discharge process. While residents may lose some educational experience from not performing all discharge tasks, they gain experience working in interdisciplinary teams, have increased time for education, and reduced work hours. Since the ACGME limits the number of residents per program and increasing the residency size is not an option, a DF should be considered as a possible solution to ACGME work‐hour restrictions.

This study had several limitations. First, the intervention team had 1 specific person embedded, and therefore the results of this study may have limited generalizability. Second, the limited number of residents working with the DF could have biased the intervention, as not all residents worked equally well with the DF. However, this may represent the real‐world experience on any teaching service, given variation in working styles and learning curves of residents over their training. Third, this study was done at 1 university‐affiliated urban Academic Medical Center, making it potentially less generalizable to resident teams in community hospitals. Fourth, we were not able to capture readmissions and ED visits at institutions outside the MGHPartners Healthcare System. However, given that patients were assigned at random to either team, this factor should have impacted both teams equally. Fifth, the study occurred during Massachusetts healthcare reform which requires everyone to have health insurance. This may have affected the rates of ED visits and readmission rates, especially with a shortage of primary care physicians and office visits. Finally, this intervention was not cost‐neutral. Paying for a nurse practitioner to help residents with the work of discharge and providing patients with additional services had many advantages, but this quality improvement project did not pay for itself through shorter LOS, or decreases in ED visits or readmissions.

While readmission rates and ED utilization are important patient outcomes, especially in the current healthcare climate, what determines readmissions and ED visits is likely complex and multifactorial. This study suggests that, in the nationwide effort to reduce readmissions, solely improving the discharge process for all general medical patients may not produce the hoped‐for financial savings. Improving the discharge process, however, is something valuable in its own right. Adding a DF to a resident team does improve some quality markers of the discharge process and decreases work hours for residents.

Acknowledgements

Sara Macchiano, RN for her help with the data gathering of this study.

References
  1. Forster AJ,Murff HJ,Peterson JF,Gandhi TK,Bates DW.Adverse drug events occurring following hospital discharge.J Gen Intern Med.2005;20(4):317323.
  2. Forster AJ,Murff HJ,Peterson JF,Gandhi TK,Bates DW.The incidence and severity of adverse events affecting patients after discharge from the hospital.Ann Intern Med.2003;138(3):161167.
  3. Moore C,Wisnivesky J,Williams S,McGinn T.Medical errors related to discontinuity of care from an inpatient to an outpatient setting.J Gen Intern Med.2003;18(8):646651.
  4. Coleman EA,Smith JD,Raha D,Min SJ.Posthospital medication discrepancies: Prevalence and contributing factors.Arch Intern Med.2005;165(16):18421847.
  5. Kosecoff J,Kahn KL,Rogers WH, et al.Prospective payment system and impairment at discharge. The ‘quicker‐and‐sicker’ story revisited.JAMA.1990;264(15):19801983.
  6. Cutler D.The incidence of adverse medical outcomes under prospective payment.Econometrica. 1995;63:2950.
  7. Solomon JK,Maxwell RB,Hopkins AP.Content of a discharge summary from a medical ward: Views of general practitioners and hospital doctors.J R Coll Physicians Lond.1995;29(4):307310.
  8. van Walraven C,Weinberg AL.Quality assessment of a discharge summary system.Can Med Assoc J.1995;152(9):14371442.
  9. van Walraven C,Seth R,Laupacis A.Dissemination of discharge summaries. Not reaching follow‐up physicians.Can Fam Physician.2002;48:737742.
  10. van Walraven C,Seth R,Austin PC,Laupacis A.Effect of discharge summary availability during post‐discharge visits on hospital readmission.J Gen Intern Med.2002;17(3):186192.
  11. Kripalani S,LeFevre F,Phillips CO,Williams MV,Basaviah P,Baker DW.Deficits in communication and information transfer between hospital‐based and primary care physicians: Implications for patient safety and continuity of care.JAMA.2007;297(8):831841.
  12. Bell CM,Schnipper JL,Auerbach AD, et al.Association of communication between hospital‐based physicians and primary care providers with patient outcomes.J Gen Intern Med.2009;24(3):381386.
  13. Moore C,McGinn T,Halm E.Tying up loose ends: Discharging patients with unresolved medical issues.Arch Intern Med.2007;167(12):13051311.
  14. Roy CL,Poon EG,Karson AS, et al.Patient safety concerns arising from test results that return after hospital discharge.Ann Intern Med.2005;143(2):121128.
  15. Snow V,Beck D,Budnitz T, et al.Transitions of care consensus policy statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine.J Hosp Med.2009;4(6):364370.
  16. Macaulay EM,Cooper GG,Engeset J,Naylor AR.Prospective audit of discharge summary errors.Br J Surg.1996;83(6):788790.
  17. Coleman EA,Berenson RA.Lost in transition: Challenges and opportunities for improving the quality of transitional care.Ann Intern Med.2004;141(7):533536.
  18. Einstadter D,Cebul RD,Franta PR.Effect of a nurse case manager on postdischarge follow‐up.J Gen Intern Med.1996;11(11):684688.
  19. Fitzgerald JF,Smith DM,Martin DK,Freedman JA,Katz BP.A case manager intervention to reduce readmissions.Arch Intern Med.1994;154(15):17211729.
  20. Weinberger M,Oddone EZ,Henderson WG.Does increased access to primary care reduce hospital readmissions? Veterans Affairs Cooperative Study Group on Primary Care and Hospital Readmission.N Engl J Med.1996;334(22):14411447.
  21. Phillips CO,Wright SM,Kern DE,Singa RM,Shepperd S,Rubin HR.Comprehensive discharge planning with postdischarge support for older patients with congestive heart failure: A meta‐analysis.JAMA.2004;291(11):13581367.
  22. Naylor MD,Brooten DA,Campbell RL,Maislin G,McCauley KM,Schwartz JS.Transitional care of older adults hospitalized with heart failure: A randomized, controlled trial.J Am Geriatr Soc.2004;52(5):675684.
  23. Coleman EA,Smith JD,Frank JC,Min SJ,Parry C,Kramer AM.Preparing patients and caregivers to participate in care delivered across settings: The Care Transitions Intervention.J Am Geriatr Soc.2004;52(11):18171825.
  24. Coleman EA,Parry C,Chalmers S,Min SJ.The care transitions intervention: Results of a randomized controlled trial.Arch Intern Med.2006;166(17):18221828.
  25. Jack BW,Chetty VK,Anthony D, et al.A reengineered hospital discharge program to decrease rehospitalization: A randomized trial.Ann Intern Med.2009;150(3):178187.
  26. Balaban RB,Weissman JS,Samuel PA,Woolhandler S.Redefining and redesigning hospital discharge to enhance patient care: A randomized controlled study.J Gen Intern Med.2008;23(8):12281233.
  27. Forster AJ,Clark HD,Menard A, et al.Effect of a nurse team coordinator on outcomes for hospitalized medicine patients.Am J Med.2005;118(10):11481153.
  28. Jha AK,Orav EJ,Epstein AM.Public reporting of discharge planning and rates of readmissions.N Engl J Med.2009;361(27):26372645.
  29. Jencks SF,Williams MV,Coleman EA.Rehospitalizations among patients in the Medicare fee‐for‐service program.N Engl J Med.2009;360(14):14181428.
  30. Consortium UHS. Reducing Readmissions SC22009. Available at: https://www.uhc.edu/1244.htm
References
  1. Forster AJ,Murff HJ,Peterson JF,Gandhi TK,Bates DW.Adverse drug events occurring following hospital discharge.J Gen Intern Med.2005;20(4):317323.
  2. Forster AJ,Murff HJ,Peterson JF,Gandhi TK,Bates DW.The incidence and severity of adverse events affecting patients after discharge from the hospital.Ann Intern Med.2003;138(3):161167.
  3. Moore C,Wisnivesky J,Williams S,McGinn T.Medical errors related to discontinuity of care from an inpatient to an outpatient setting.J Gen Intern Med.2003;18(8):646651.
  4. Coleman EA,Smith JD,Raha D,Min SJ.Posthospital medication discrepancies: Prevalence and contributing factors.Arch Intern Med.2005;165(16):18421847.
  5. Kosecoff J,Kahn KL,Rogers WH, et al.Prospective payment system and impairment at discharge. The ‘quicker‐and‐sicker’ story revisited.JAMA.1990;264(15):19801983.
  6. Cutler D.The incidence of adverse medical outcomes under prospective payment.Econometrica. 1995;63:2950.
  7. Solomon JK,Maxwell RB,Hopkins AP.Content of a discharge summary from a medical ward: Views of general practitioners and hospital doctors.J R Coll Physicians Lond.1995;29(4):307310.
  8. van Walraven C,Weinberg AL.Quality assessment of a discharge summary system.Can Med Assoc J.1995;152(9):14371442.
  9. van Walraven C,Seth R,Laupacis A.Dissemination of discharge summaries. Not reaching follow‐up physicians.Can Fam Physician.2002;48:737742.
  10. van Walraven C,Seth R,Austin PC,Laupacis A.Effect of discharge summary availability during post‐discharge visits on hospital readmission.J Gen Intern Med.2002;17(3):186192.
  11. Kripalani S,LeFevre F,Phillips CO,Williams MV,Basaviah P,Baker DW.Deficits in communication and information transfer between hospital‐based and primary care physicians: Implications for patient safety and continuity of care.JAMA.2007;297(8):831841.
  12. Bell CM,Schnipper JL,Auerbach AD, et al.Association of communication between hospital‐based physicians and primary care providers with patient outcomes.J Gen Intern Med.2009;24(3):381386.
  13. Moore C,McGinn T,Halm E.Tying up loose ends: Discharging patients with unresolved medical issues.Arch Intern Med.2007;167(12):13051311.
  14. Roy CL,Poon EG,Karson AS, et al.Patient safety concerns arising from test results that return after hospital discharge.Ann Intern Med.2005;143(2):121128.
  15. Snow V,Beck D,Budnitz T, et al.Transitions of care consensus policy statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine.J Hosp Med.2009;4(6):364370.
  16. Macaulay EM,Cooper GG,Engeset J,Naylor AR.Prospective audit of discharge summary errors.Br J Surg.1996;83(6):788790.
  17. Coleman EA,Berenson RA.Lost in transition: Challenges and opportunities for improving the quality of transitional care.Ann Intern Med.2004;141(7):533536.
  18. Einstadter D,Cebul RD,Franta PR.Effect of a nurse case manager on postdischarge follow‐up.J Gen Intern Med.1996;11(11):684688.
  19. Fitzgerald JF,Smith DM,Martin DK,Freedman JA,Katz BP.A case manager intervention to reduce readmissions.Arch Intern Med.1994;154(15):17211729.
  20. Weinberger M,Oddone EZ,Henderson WG.Does increased access to primary care reduce hospital readmissions? Veterans Affairs Cooperative Study Group on Primary Care and Hospital Readmission.N Engl J Med.1996;334(22):14411447.
  21. Phillips CO,Wright SM,Kern DE,Singa RM,Shepperd S,Rubin HR.Comprehensive discharge planning with postdischarge support for older patients with congestive heart failure: A meta‐analysis.JAMA.2004;291(11):13581367.
  22. Naylor MD,Brooten DA,Campbell RL,Maislin G,McCauley KM,Schwartz JS.Transitional care of older adults hospitalized with heart failure: A randomized, controlled trial.J Am Geriatr Soc.2004;52(5):675684.
  23. Coleman EA,Smith JD,Frank JC,Min SJ,Parry C,Kramer AM.Preparing patients and caregivers to participate in care delivered across settings: The Care Transitions Intervention.J Am Geriatr Soc.2004;52(11):18171825.
  24. Coleman EA,Parry C,Chalmers S,Min SJ.The care transitions intervention: Results of a randomized controlled trial.Arch Intern Med.2006;166(17):18221828.
  25. Jack BW,Chetty VK,Anthony D, et al.A reengineered hospital discharge program to decrease rehospitalization: A randomized trial.Ann Intern Med.2009;150(3):178187.
  26. Balaban RB,Weissman JS,Samuel PA,Woolhandler S.Redefining and redesigning hospital discharge to enhance patient care: A randomized controlled study.J Gen Intern Med.2008;23(8):12281233.
  27. Forster AJ,Clark HD,Menard A, et al.Effect of a nurse team coordinator on outcomes for hospitalized medicine patients.Am J Med.2005;118(10):11481153.
  28. Jha AK,Orav EJ,Epstein AM.Public reporting of discharge planning and rates of readmissions.N Engl J Med.2009;361(27):26372645.
  29. Jencks SF,Williams MV,Coleman EA.Rehospitalizations among patients in the Medicare fee‐for‐service program.N Engl J Med.2009;360(14):14181428.
  30. Consortium UHS. Reducing Readmissions SC22009. Available at: https://www.uhc.edu/1244.htm
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Journal of Hospital Medicine - 6(9)
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Journal of Hospital Medicine - 6(9)
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Improving the discharge process by embedding a discharge facilitator in a resident team
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Improving the discharge process by embedding a discharge facilitator in a resident team
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Hospitalist Sedation Service

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Development of a pediatric hospitalist sedation service: Training and implementation

There is growing demand for safe and effective procedural sedation in pediatric facilities around the country. Multiple articles published in the last 10 years have addressed the shortage of pediatric anesthesiologists to meet this rising need.14 In 2005, Lalwani and Michel published results of a survey of North American children's hospitals that showed 87% of institutions reporting barriers to development of a pediatric sedation service, and that the most common barrier was shortage of anesthesiologists.5 In our hospital, the wait time for an outpatient sedated pediatric magnetic resonance imaging (MRI) grew to as long as 6 weeks. Many institutions have had to look for unique ways to solve this problem. Pediatric sedation programs have been developed which utilize intensivists, emergency medicine physicians, nurse anesthetists, or trained sedation nurses to provide safe pediatric sedation.611 Each of these programs has grown from the particular strengths and needs at each institution. In many institutions, hospitalists are the best candidates to meet this need because of their knowledge of patient needs and safety. They are accessible and receptive to obtaining additional training and, therefore, are a natural fit to provide this service.

As more non‐anesthesiologists are called upon to meet this growing need, the principles and practice of safe sedation must be followed. The Pediatric Sedation Research Consortium, a collaborative group of 37 locations that provide data on pediatric sedations, has published their findings on the safety of pediatric sedation/anesthesia outside of the operating room (OR) performed by anesthesiologists and non‐anesthesiologists.1213 This data has been very valuable, given that studies from single institutions will often lack the power to investigate the rare, but potentially devastating, adverse events which can occur in pediatric sedation/anesthesia.

Despite the widespread use of propofol by non‐anesthesiologists, the lack of substantial data regarding safety by these providers makes its use controversial. A search of the literature finds only 1 prior article that describes the use of propofol by general pediatricians. This was sedation for endoscopy, and the sedation was performed by specially trained pediatric residents in Italy.14 A recently published study from the Consortium regarding the use of propofol showed that the majority of propofol sedations were being performed by intensivists (49%), emergency medicine physicians (36%), or anesthesiologists (10%). General pediatricians or hospitalists performed just 2% of the cases in this series.13

In 2003, a large group of experienced pediatric hospitalists were already providing sedation in the Emergency Unit (EU) and Center for After‐hours Referrals for Emergency Services (CARES) at St Louis Children's Hospital. The Division of Hospital Medicine was approached to meet the demand for increased sedation services at our institution. The Division of Pediatric Anesthesia agreed to provide our physicians with the appropriate training to provide safe, effective, and efficient sedations for painful and non‐painful procedures outside of the OR. One of our sedation units, the Ambulatory Procedure Center (APC), has been described in detail in a prior publication by Strauser Sterni et al.15 Here, we will describe the operations of our sedation services, and specifically describe the training required for our hospitalists to provide sedation services.

METHODS

St Louis Children's Hospital is a 250‐bed tertiary‐care teaching hospital affiliated with Washington University School of Medicine. The Division of Hospitalist Medicine is today comprised of 43 physicians who provide care in the EU, CARES, inpatient units, Transport, and Sedation Services at St Louis Children's Hospital. Our division also provides pediatric care in the EU, inpatient units, newborn nursery, and labor and delivery at 3 affiliated hospitals. In 2003, we developed a dedicated program in our division to meet our institutional need for sedation, with training and oversight by the Division of Pediatric Anesthesia. We developed a structured 3‐tiered program of sedation providers to manage all of our sedation needs. We then designed a training program for these 3 tiers of sedation providers. The 3‐tired program is based on the level of sedation training of each member.

Current American Academy of Pediatrics (AAP) guidelines state:

The practitioner responsible for the treatment of the patient and/or the administration of drugs for sedation must be competent to use such techniques, provide the level of monitoring provided in these guidelines, and manage complications of these techniques (ie, to be able to rescue the patient). Because the level of intended sedation may be exceeded, the practitioner must be sufficiently skilled to provide rescue should the child progress to a level of deep sedation. The practitioner must be trained in, and capable of providing, at the minimum, bag‐valve‐mask ventilation to be able to oxygenate a child who develops airway obstruction or apnea. Training in, and maintenance of, advanced pediatric airway skills is required; regular skills reinforcement is strongly encouraged.16

Our first‐tier sedation providers are junior faculty who provide sedation in the EU and CARES, and in the EU at our community hospitals. The first tier completes sedation training as part of overall hospitalist orientation in order to provide this service. The second tier goes through an advanced sedation provider program to provide sedation in the APC, Pediatric Acute Wound Service (PAWS), inpatient units, and After Hours sedation call, as well as the locations from the first tier. The third tier completes a more complex advanced sedation training program, specifically using propofol, and provides propofol sedation in the APC only, as well as providing sedation in all of the units from the first and second tiers. The responsibilities of the hospitalist providing sedation are described in detail by tier below, including the specific training requirements necessary for each tier (Table 1).

Tiered Sedation Training in a Hospitalist Program
  • Abbreviations: APC, Ambulatory Procedure Center; EU, Emergency Unit; PAWS, Pediatric Acute Wound Service.

Tier One
Provides sedation services in the EU
Drugs: ketamine, nitrous oxide
Training consists of:
1‐hr didactic hospitalist orientation
4 days of shadowing a hospitalist on the sedation service
Continuing on‐the‐job training
Tier Two
Provides sedation throughout the hospital: EU, APC, PAWS, and night/weekend call for urgent needs
Drugs: ketamine, nitrous oxide, plus pentobarbital or dexmedetomidine for radiologic procedures for both inpatients and outpatients
Training consists of:
1 yr of first tier experience
2‐hr didactic session with anesthesia
1‐hr advanced hospitalist sedation orientation
5 days of operating room training with an anesthesiologist
Tier Three
Provides sedation throughout the hospital: EU, APC, PAWS, and night/weekend call
Drugs: ketamine, nitrous oxide, pentobarbital, dexmedetomidine, and propofol
Training consists of:
1 yr of second tier experience
3‐hr didactic lecture with anesthesia
10 days of operating room training
25 supervised propofol sedations
Maintenance of certification requires >75 propofol sedations every 2 yr

Tier One

First‐tier hospitalist sedation providers perform sedation services in the EU and CARES. The staffing model in St Louis Children's Hospital EU is comprised of a pediatric emergency medicine‐trained attending or fellow and a pediatric hospitalist who both help to oversee care within the unit. The unit is also staffed by pediatric residents, emergency medicine residents, medical students, and nurse practitioners. One of the main responsibilities of the pediatric hospitalist, however, is sedation within the unit. In CARES, the pediatric hospitalist is the attending providing direct care to patients without trainees. Any procedure requiring sedation in CARES would be performed by the hospitalist. The hospitalist providing care in the EU at both of our community hospitals would also be the physician to perform procedural sedation within the unit. Procedural sedation in all of these units are primarily for fracture reduction, laceration repair, abscess incision and drainage, foreign body removal, lumbar puncture, joint aspiration, burn debridement, and radiology imaging. Sedations performed within these units are classified as moderate or deep sedation.16 Common medications used by Tier‐One sedation providers are intravenous ketamine, inhaled nitrous oxide in combination with oral oxycodone or oral/ intravenous midazolam, intravenous pentobarbital, and occasional intravenous fentanyl in combination with intravenous midazolam.

For a hospitalist to perform any pediatric sedation within the 4 hospitals in our program, the physician must be credentialed in accordance with the specific criteria of each institution. There are varied institutional policies across all hospitals nationally. At St Louis Children's Hospital, sedation credentialing criteria states that a sedation provider must review the specific institutional policies governing sedation and perform 25 supervised sedations, before any independent sedation is attempted. The type of procedure requiring sedation and the medications used for the sedation may vary among these 25 supervised sedations. Given the structure of our program, the majority of supervised sedations are for painful procedures utilizing ketamine or a combination of oxycodone and nitrous oxide.

Our division also requires the Tier‐One group to shadow at least 4 shifts with senior hospitalists in Tiers Two or Three providing sedation, in a unit where there is an average of 6 sedations performed per day. The Tier‐One sedation hospitalist must also attend a 1‐hour didactic orientation session where the principles and practice of sedation are taught. This didactic session provides the principles of pediatric sedation and defines the important skills necessary to provide safe sedation and recovery. In addition, hospitalists are trained to recognize which children can be safely sedated by a hospitalist, and manage common side effects and adverse events during and after sedation.

The Tier‐One hospitalist performing sedation in the EU/CARES is responsible for performing pre‐procedure sedation evaluation, developing a sedation plan, and delivering procedural sedation. A dedicated sedation‐trained nurse is available throughout the procedure to record vital signs, leaving the hospitalist free to monitor the patient directly, titrate sedation medications, and manage airway or adverse events as they arise. A separate provider is responsible for performing the actual procedure. The patient continues to be monitored by the sedation nurse during the recovery period, while the hospitalist remains immediately available in the unit to address any problems. At St Louis Children's Hospital, specific monitoring and documentation criteria, using standard forms and sedation scores, are strictly adhered to for every sedation, both during the sedation and throughout the recovery phase. These criteria are based upon the AAP guidelines for monitoring and management of pediatric sedation as described by Cot and Wilson.16 Hospital Medicine provides services in the EU 17 hours per day, 7 days a week. On average, 3 sedations are provided by the hospitalist per 8‐hour shift in the EU.

Tier Two

Second‐tier providers perform all services provided by Tier‐One providers, as well as expanded sedation services on the inpatient units, APC, and PAWS. Tier‐Two providers also provide on‐call services for urgent night, weekend, and holiday sedation needs.

APC and PAWS provide more specialized sedation care than that provided in the EU. PAWS is a separate and dedicated wound care unit housed on the surgical/post‐op floor where children are sedated for painful wound care, primarily burn debridement, abscess incision and drainage (I&D), and dressing changes. Sedation services are occasionally provided for other wound care issues or procedures. Both inpatients and outpatients are seen in this unit. The unit operates 10 hours per day, 7 days a week. The PAWS unit has 2 rooms specifically equipped for sedation, monitoring, and rescue, as well as 2 additional rooms for recovery or for patients not requiring sedation. Sedations in PAWS generally utilize intravenous ketamine or inhaled nitrous oxide coupled with premedication of oxycodone. Responsibilities of the hospitalist in the unit include completing and documenting the pre‐sedation evaluation, developing an appropriate sedation plan, delivering sedation medications, ongoing monitoring and documenting of vital signs throughout the case, and recovery of the patient. All nursing staff in this unit are sedation‐trained and are responsible for continued patient monitoring during the recovery period, until the patient has returned to baseline and is safe for discharge or transfer.

The APC has been described in a prior publication.15 Hospitalist sedations in the APC are performed primarily for radiology procedures, the majority of which are MRI but also include computed tomographic (CT) and nuclear medicine scans. Sedation is also provided for automated brainstem response (ABR), electromyogram (EMG), and peripherally inserted central catheter (PICC) placements. Like PAWS, APC serves both inpatients and outpatients. The APC is staffed 10 hours per day, 5 days per week. The primary sedation medications used in this unit are ketamine, dexmedetomidine, and occasionally fentanyl and midazolam. There are 11 patient beds, all equipped for patient monitoring and recovery. Hospitalists in the APC may provide direct patient care or supervise sedation‐trained nurses delivering sedation services after having a pre‐sedation evaluation performed by the hospitalist. If a sedation‐trained nurse is delivering sedation, the hospitalist may be doing other interruptible tasks, but is immediately available on the unit to respond to any concerns from the sedation nurse. All units are fully equipped with resuscitation equipment/crash carts, and an anesthesiologist is readily available to come to the unit from the OR in the event of an issue. A rapid response team that consists of a pediatric intensive care unit (ICU) fellow, respiratory therapist, and pediatric ICU charge nurse is also always on call.

Urgent sedations on the inpatient wards are common and can usually be accommodated in PAWS or APC. Rarely, however, an MRI, CT, joint aspiration, abscess drainage, or lumbar puncture must be completed urgently in the evenings, weekends, or holidays. In this situation, the hospitalist is responsible for performing the pre‐sedation evaluation, developing an appropriate sedation technique, delivering the sedation medications, monitoring and documenting during the procedure as well as throughout the recovery period, until the patient has returned to baseline. Sedation‐trained nursing staff are available to provide assistance. The sedation medications commonly used in these after‐hours sedations include ketamine for short or painful procedures and dexmedetomidine for longer radiology studies.

Training for second‐tier services consists of a minimum of 1 year of first‐tier sedation experience, a 2‐hour didactic lecture with Pediatric Anesthesia, a 1‐hour hospitalist orientation for advanced sedation providers, and 5 days of OR training with an anesthesiologist. Operating room training focuses on building skills in bag‐mask ventilation, intravenous (IV) placement, endotracheal intubation, and laryngeal mask airway (LMA) placement.

Tier Three

Third‐tier sedation providers have completed all of the training of a Tier‐Two provider and have had additional training to prepare them to deliver propofol for non‐painful procedures. Hospitalist‐delivered propofol sedation is provided exclusively in the APC for non‐painful procedures. The hospitalist is responsible for the pre‐sedation evaluation, induction and maintenance of sedation, and patient monitoring and documentation of vital signs. Monitoring for propofol sedation includes end‐tidal carbon dioxide monitoring in addition to electrocardiogram (EKG), respiratory rate (RR), pulse oximetry, and non‐invasive blood pressure (NIBP). A sedation‐trained nurse is present during induction and assists with patient positioning within the scanner. The nurse will then assume care of the patient at the completion of the procedure to continue patient monitoring during recovery.

Training for Tier‐Three providers consists of a 3‐hour didactic session with Anesthesia, 10 days of OR training, use of simulation scenarios, and a written exam. The hospitalist must then perform 25 supervised propofol sedations before being credentialed to provide propofol sedation independently. To maintain certification for Tier‐Three services, hospitalists must perform at least 75 propofol sedations every 2 years.

RESULTS

Utilizing this design and training method, we have developed a successful pediatric hospitalist sedation program. Based on fiscal year 2009 billing data, the Division of Hospital Medicine performed 2471 sedations. There were 2069 sedations performed in APC or PAWS; of those, 1017 were performed on inpatients and 1052 were performed on outpatients. Hospitalists performed 402 sedations on patients in the EU. The EU numbers are likely much larger given that, for over half the year, billing data was not collected from the EU. Unfortunately, we did not have billing data regarding night and weekend sedations, but our best estimate is 1 to 2 per week. The wait time for an outpatient sedated pediatric MRI has gone from 6 weeks to 2 days or less. As of July 2010, we have trained 90 providers at Tier One, 32 at Tier Two, and 11 at Tier Three. We currently have 43 hospitalists providing Tier‐One sedation, 18 providing Tier‐Two, and 6 providing Tier‐Three. Average cumulative hospitalist experience is 1 year for Tier One, 5 years for Tier Two, and 10 years for Tier Three.

DISCUSSION

We believe this is the first description of a pediatric hospitalist training program for a sedation service. However, it is clear that many other pediatric hospitalists are performing sedation and developing similar training programs. When starting a program such as this, there are many things to consider. First, patient volume/demand must allow for each hospitalist to perform sedations on a regular basis, both for training and Maintenance of Certification. Second, Anesthesia must be willing to provide training and oversight. Third, the hospital or university must be willing to support the cost associated with the training period. Finally, negotiating with third party payers for reimbursement is critical to financial sustainability.

The success of our program hinged upon the ability to develop a strong and collaborative relationship with Anesthesiology. Many factors played into making this relationship work. Initially, Anesthesia approached us to help them meet an unmet clinical need. Because of this, we were viewed as helpful and as problem solvers, rather than as a threat. Additionally, each division had a sedation service champion that pushed for the development of a hospitalist sedation service. Lastly, regular meetings with Anesthesia, and the intense training program itself, helped to develop a sense of collegiality between the divisions.

We have faced many challenges and learned many lessons while developing this program. There is a significant cost to training sedation providers; 47 hospitalists trained to provide Tier‐One sedation have left the program. Of those, 16 hospitalists completed training for Tier‐Two sedation, and 5 completed Tier Three. The Tier‐Two training described earlier requires approximately 50 hours of dedicated time away from other hospitalist duties, while Tier Three requires an additional 125 hours. The majority of our turnover occurred in the first few years of the program. From a financial perspective, we have had to reserve sedation training beyond Tier One to hospitalists who are able to demonstrate evidence of a long‐term commitment to our division. Every person providing Tier‐Three sedation has been with the division over 6 years. From a broader perspective, we are providing hospitalists with an important and useful skill that may enhance their careerssafe and effective sedation.

Balancing the volume of cases is another issue to consider. Our goal is to provide safe and timely sedation, therefore we need to have enough scheduled cases to maintain competency and financial viability, but we must also leave adequate flexibility in the schedule for urgent cases.

In addition to the operating room training, we are beginning to incorporate pediatric simulation as an adjunct to our training. We have designed simulation scenarios which address issues of obstruction, apnea, hypotension, bronchospasm, and aspiration. However, OR training remains a mandatory requirement for sedation training and, at times, can be challenging to schedule.

We complete a post‐sedation assessment on all patients; we are currently performing a chart review of over 1600 patients sedated with propofol, to look at the rate of planned and unplanned interventions. We believe this data will show that our training has been successful, and that with analysis of our Quality Improvement data, we can improve the safety and efficacy of our sedation program even further.

CONCLUSIONS

A pediatric hospitalist sedation service, with proper training and oversight, can successfully augment sedation services provided by anesthesiologists. As has been stated in prior publications, a defined system, and the use of a dedicated well‐trained team makes a sedation service a success.1719 A collegial and mutually respectful relationship between Anesthesia and non‐Anesthesia sedation providers is critical in developing and maintaining a successful sedation program.

Files
References
  1. Adams K,Pennock N,Phelps B,Rose W,Peters M.Anesthesia services outside of the operating room.Pediatr Nurs.2007;33(3):232,234,236237.
  2. Gozal D,Gozal Y.Pediatric sedation/anesthesia outside the operating room.Curr Opin Anaesthesiol.2008;21(4):494498.
  3. Shankar V,Deshpande JK.Procedural sedation in the pediatric patient.Anesthesiol Clin North Am.2005;23(4):635654, viii.
  4. Smallman B.Pediatric sedation: can it be safely performed by non‐anesthesiologists?Curr Opin Anaesthesiol.2002;15(4):455459.
  5. Lalwani K,Michel M.Pediatric sedation in North American children's hospitals: a survey of anesthesia providers.Paediatr Anaesth.2005;15(3):209213.
  6. Larsen R,Galloway D,Wadera S, et al.Safety of propofol sedation for pediatric outpatient procedures.Clin Pediatr (Phila).2009;48(8):819823.
  7. Mason KP,Zurakowski D,Zgleszewski SE, et al.High dose dexmedetomidine as the sole sedative for pediatric MRI.Paediatr Anaesth.2008;18(5):403411.
  8. Pershad J,Gilmore B.Successful implementation of a radiology sedation service staffed exclusively by pediatric emergency physicians.Pediatrics.2006;117(3):e413e422.
  9. Shavit I,Hershman E.Management of children undergoing painful procedures in the emergency department by non‐anesthesiologists.Isr Med Assoc J.2004;6(6):350355.
  10. Sury MR,Hatch DJ,Deeley T,Dicks‐Mireaux C,Chong WK.Development of a nurse‐led sedation service for paediatric magnetic resonance imaging.Lancet.1999;353(9165):16671671.
  11. Vespasiano M,Finkelstein M,Kurachek S.Propofol sedation: intensivists' experience with 7304 cases in a children's hospital.Pediatrics.2007;120(6):e1411e1417.
  12. Cravero JP.Risk and safety of pediatric sedation/anesthesia for procedures outside the operating room.Curr Opin Anaesthesiol.2009;22(4):509513.
  13. Cravero JP,Beach ML,Blike GT,Gallagher SM,Hertzog JH.The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium.Anesth Analg.2009;108(3):795804.
  14. Barbi E,Petaros P,Badina L, et al.Deep sedation with propofol for upper gastrointestinal endoscopy in children, administered by specially trained pediatricians: a prospective case series with emphasis on side effects.Endoscopy.2006;38(4):368375.
  15. Strauser Sterni L,Beck S,Cole J,Carlson D,Turmelle M.A model for pediatric sedation centers using pharmacologic sedation for successful completion of radiologic and procedural studies.J Radiol Nurs2008;27(2):4660.
  16. Coté CJ,Wilson S.Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update.Pediatrics.2006;118(6):25872602.
  17. Hertzog JH,Havidich JE.Non‐anesthesiologist‐provided pediatric procedural sedation: an update.Curr Opin Anaesthesiol.2007;20(4):365372.
  18. Leroy PL,Schipper DM,Knape HJ.Professional skills and competence for safe and effective procedural sedation in children: recommendations based on a systematic review of the literature.Int J Pediatr.2010; doi://10.1155/2010/934298.
  19. Twite MD,Friesen RH.Pediatric sedation outside the operating room: the year in review.Curr Opin Anaesthesiol.2005;18(4):442446.
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Journal of Hospital Medicine - 7(4)
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335-339
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There is growing demand for safe and effective procedural sedation in pediatric facilities around the country. Multiple articles published in the last 10 years have addressed the shortage of pediatric anesthesiologists to meet this rising need.14 In 2005, Lalwani and Michel published results of a survey of North American children's hospitals that showed 87% of institutions reporting barriers to development of a pediatric sedation service, and that the most common barrier was shortage of anesthesiologists.5 In our hospital, the wait time for an outpatient sedated pediatric magnetic resonance imaging (MRI) grew to as long as 6 weeks. Many institutions have had to look for unique ways to solve this problem. Pediatric sedation programs have been developed which utilize intensivists, emergency medicine physicians, nurse anesthetists, or trained sedation nurses to provide safe pediatric sedation.611 Each of these programs has grown from the particular strengths and needs at each institution. In many institutions, hospitalists are the best candidates to meet this need because of their knowledge of patient needs and safety. They are accessible and receptive to obtaining additional training and, therefore, are a natural fit to provide this service.

As more non‐anesthesiologists are called upon to meet this growing need, the principles and practice of safe sedation must be followed. The Pediatric Sedation Research Consortium, a collaborative group of 37 locations that provide data on pediatric sedations, has published their findings on the safety of pediatric sedation/anesthesia outside of the operating room (OR) performed by anesthesiologists and non‐anesthesiologists.1213 This data has been very valuable, given that studies from single institutions will often lack the power to investigate the rare, but potentially devastating, adverse events which can occur in pediatric sedation/anesthesia.

Despite the widespread use of propofol by non‐anesthesiologists, the lack of substantial data regarding safety by these providers makes its use controversial. A search of the literature finds only 1 prior article that describes the use of propofol by general pediatricians. This was sedation for endoscopy, and the sedation was performed by specially trained pediatric residents in Italy.14 A recently published study from the Consortium regarding the use of propofol showed that the majority of propofol sedations were being performed by intensivists (49%), emergency medicine physicians (36%), or anesthesiologists (10%). General pediatricians or hospitalists performed just 2% of the cases in this series.13

In 2003, a large group of experienced pediatric hospitalists were already providing sedation in the Emergency Unit (EU) and Center for After‐hours Referrals for Emergency Services (CARES) at St Louis Children's Hospital. The Division of Hospital Medicine was approached to meet the demand for increased sedation services at our institution. The Division of Pediatric Anesthesia agreed to provide our physicians with the appropriate training to provide safe, effective, and efficient sedations for painful and non‐painful procedures outside of the OR. One of our sedation units, the Ambulatory Procedure Center (APC), has been described in detail in a prior publication by Strauser Sterni et al.15 Here, we will describe the operations of our sedation services, and specifically describe the training required for our hospitalists to provide sedation services.

METHODS

St Louis Children's Hospital is a 250‐bed tertiary‐care teaching hospital affiliated with Washington University School of Medicine. The Division of Hospitalist Medicine is today comprised of 43 physicians who provide care in the EU, CARES, inpatient units, Transport, and Sedation Services at St Louis Children's Hospital. Our division also provides pediatric care in the EU, inpatient units, newborn nursery, and labor and delivery at 3 affiliated hospitals. In 2003, we developed a dedicated program in our division to meet our institutional need for sedation, with training and oversight by the Division of Pediatric Anesthesia. We developed a structured 3‐tiered program of sedation providers to manage all of our sedation needs. We then designed a training program for these 3 tiers of sedation providers. The 3‐tired program is based on the level of sedation training of each member.

Current American Academy of Pediatrics (AAP) guidelines state:

The practitioner responsible for the treatment of the patient and/or the administration of drugs for sedation must be competent to use such techniques, provide the level of monitoring provided in these guidelines, and manage complications of these techniques (ie, to be able to rescue the patient). Because the level of intended sedation may be exceeded, the practitioner must be sufficiently skilled to provide rescue should the child progress to a level of deep sedation. The practitioner must be trained in, and capable of providing, at the minimum, bag‐valve‐mask ventilation to be able to oxygenate a child who develops airway obstruction or apnea. Training in, and maintenance of, advanced pediatric airway skills is required; regular skills reinforcement is strongly encouraged.16

Our first‐tier sedation providers are junior faculty who provide sedation in the EU and CARES, and in the EU at our community hospitals. The first tier completes sedation training as part of overall hospitalist orientation in order to provide this service. The second tier goes through an advanced sedation provider program to provide sedation in the APC, Pediatric Acute Wound Service (PAWS), inpatient units, and After Hours sedation call, as well as the locations from the first tier. The third tier completes a more complex advanced sedation training program, specifically using propofol, and provides propofol sedation in the APC only, as well as providing sedation in all of the units from the first and second tiers. The responsibilities of the hospitalist providing sedation are described in detail by tier below, including the specific training requirements necessary for each tier (Table 1).

Tiered Sedation Training in a Hospitalist Program
  • Abbreviations: APC, Ambulatory Procedure Center; EU, Emergency Unit; PAWS, Pediatric Acute Wound Service.

Tier One
Provides sedation services in the EU
Drugs: ketamine, nitrous oxide
Training consists of:
1‐hr didactic hospitalist orientation
4 days of shadowing a hospitalist on the sedation service
Continuing on‐the‐job training
Tier Two
Provides sedation throughout the hospital: EU, APC, PAWS, and night/weekend call for urgent needs
Drugs: ketamine, nitrous oxide, plus pentobarbital or dexmedetomidine for radiologic procedures for both inpatients and outpatients
Training consists of:
1 yr of first tier experience
2‐hr didactic session with anesthesia
1‐hr advanced hospitalist sedation orientation
5 days of operating room training with an anesthesiologist
Tier Three
Provides sedation throughout the hospital: EU, APC, PAWS, and night/weekend call
Drugs: ketamine, nitrous oxide, pentobarbital, dexmedetomidine, and propofol
Training consists of:
1 yr of second tier experience
3‐hr didactic lecture with anesthesia
10 days of operating room training
25 supervised propofol sedations
Maintenance of certification requires >75 propofol sedations every 2 yr

Tier One

First‐tier hospitalist sedation providers perform sedation services in the EU and CARES. The staffing model in St Louis Children's Hospital EU is comprised of a pediatric emergency medicine‐trained attending or fellow and a pediatric hospitalist who both help to oversee care within the unit. The unit is also staffed by pediatric residents, emergency medicine residents, medical students, and nurse practitioners. One of the main responsibilities of the pediatric hospitalist, however, is sedation within the unit. In CARES, the pediatric hospitalist is the attending providing direct care to patients without trainees. Any procedure requiring sedation in CARES would be performed by the hospitalist. The hospitalist providing care in the EU at both of our community hospitals would also be the physician to perform procedural sedation within the unit. Procedural sedation in all of these units are primarily for fracture reduction, laceration repair, abscess incision and drainage, foreign body removal, lumbar puncture, joint aspiration, burn debridement, and radiology imaging. Sedations performed within these units are classified as moderate or deep sedation.16 Common medications used by Tier‐One sedation providers are intravenous ketamine, inhaled nitrous oxide in combination with oral oxycodone or oral/ intravenous midazolam, intravenous pentobarbital, and occasional intravenous fentanyl in combination with intravenous midazolam.

For a hospitalist to perform any pediatric sedation within the 4 hospitals in our program, the physician must be credentialed in accordance with the specific criteria of each institution. There are varied institutional policies across all hospitals nationally. At St Louis Children's Hospital, sedation credentialing criteria states that a sedation provider must review the specific institutional policies governing sedation and perform 25 supervised sedations, before any independent sedation is attempted. The type of procedure requiring sedation and the medications used for the sedation may vary among these 25 supervised sedations. Given the structure of our program, the majority of supervised sedations are for painful procedures utilizing ketamine or a combination of oxycodone and nitrous oxide.

Our division also requires the Tier‐One group to shadow at least 4 shifts with senior hospitalists in Tiers Two or Three providing sedation, in a unit where there is an average of 6 sedations performed per day. The Tier‐One sedation hospitalist must also attend a 1‐hour didactic orientation session where the principles and practice of sedation are taught. This didactic session provides the principles of pediatric sedation and defines the important skills necessary to provide safe sedation and recovery. In addition, hospitalists are trained to recognize which children can be safely sedated by a hospitalist, and manage common side effects and adverse events during and after sedation.

The Tier‐One hospitalist performing sedation in the EU/CARES is responsible for performing pre‐procedure sedation evaluation, developing a sedation plan, and delivering procedural sedation. A dedicated sedation‐trained nurse is available throughout the procedure to record vital signs, leaving the hospitalist free to monitor the patient directly, titrate sedation medications, and manage airway or adverse events as they arise. A separate provider is responsible for performing the actual procedure. The patient continues to be monitored by the sedation nurse during the recovery period, while the hospitalist remains immediately available in the unit to address any problems. At St Louis Children's Hospital, specific monitoring and documentation criteria, using standard forms and sedation scores, are strictly adhered to for every sedation, both during the sedation and throughout the recovery phase. These criteria are based upon the AAP guidelines for monitoring and management of pediatric sedation as described by Cot and Wilson.16 Hospital Medicine provides services in the EU 17 hours per day, 7 days a week. On average, 3 sedations are provided by the hospitalist per 8‐hour shift in the EU.

Tier Two

Second‐tier providers perform all services provided by Tier‐One providers, as well as expanded sedation services on the inpatient units, APC, and PAWS. Tier‐Two providers also provide on‐call services for urgent night, weekend, and holiday sedation needs.

APC and PAWS provide more specialized sedation care than that provided in the EU. PAWS is a separate and dedicated wound care unit housed on the surgical/post‐op floor where children are sedated for painful wound care, primarily burn debridement, abscess incision and drainage (I&D), and dressing changes. Sedation services are occasionally provided for other wound care issues or procedures. Both inpatients and outpatients are seen in this unit. The unit operates 10 hours per day, 7 days a week. The PAWS unit has 2 rooms specifically equipped for sedation, monitoring, and rescue, as well as 2 additional rooms for recovery or for patients not requiring sedation. Sedations in PAWS generally utilize intravenous ketamine or inhaled nitrous oxide coupled with premedication of oxycodone. Responsibilities of the hospitalist in the unit include completing and documenting the pre‐sedation evaluation, developing an appropriate sedation plan, delivering sedation medications, ongoing monitoring and documenting of vital signs throughout the case, and recovery of the patient. All nursing staff in this unit are sedation‐trained and are responsible for continued patient monitoring during the recovery period, until the patient has returned to baseline and is safe for discharge or transfer.

The APC has been described in a prior publication.15 Hospitalist sedations in the APC are performed primarily for radiology procedures, the majority of which are MRI but also include computed tomographic (CT) and nuclear medicine scans. Sedation is also provided for automated brainstem response (ABR), electromyogram (EMG), and peripherally inserted central catheter (PICC) placements. Like PAWS, APC serves both inpatients and outpatients. The APC is staffed 10 hours per day, 5 days per week. The primary sedation medications used in this unit are ketamine, dexmedetomidine, and occasionally fentanyl and midazolam. There are 11 patient beds, all equipped for patient monitoring and recovery. Hospitalists in the APC may provide direct patient care or supervise sedation‐trained nurses delivering sedation services after having a pre‐sedation evaluation performed by the hospitalist. If a sedation‐trained nurse is delivering sedation, the hospitalist may be doing other interruptible tasks, but is immediately available on the unit to respond to any concerns from the sedation nurse. All units are fully equipped with resuscitation equipment/crash carts, and an anesthesiologist is readily available to come to the unit from the OR in the event of an issue. A rapid response team that consists of a pediatric intensive care unit (ICU) fellow, respiratory therapist, and pediatric ICU charge nurse is also always on call.

Urgent sedations on the inpatient wards are common and can usually be accommodated in PAWS or APC. Rarely, however, an MRI, CT, joint aspiration, abscess drainage, or lumbar puncture must be completed urgently in the evenings, weekends, or holidays. In this situation, the hospitalist is responsible for performing the pre‐sedation evaluation, developing an appropriate sedation technique, delivering the sedation medications, monitoring and documenting during the procedure as well as throughout the recovery period, until the patient has returned to baseline. Sedation‐trained nursing staff are available to provide assistance. The sedation medications commonly used in these after‐hours sedations include ketamine for short or painful procedures and dexmedetomidine for longer radiology studies.

Training for second‐tier services consists of a minimum of 1 year of first‐tier sedation experience, a 2‐hour didactic lecture with Pediatric Anesthesia, a 1‐hour hospitalist orientation for advanced sedation providers, and 5 days of OR training with an anesthesiologist. Operating room training focuses on building skills in bag‐mask ventilation, intravenous (IV) placement, endotracheal intubation, and laryngeal mask airway (LMA) placement.

Tier Three

Third‐tier sedation providers have completed all of the training of a Tier‐Two provider and have had additional training to prepare them to deliver propofol for non‐painful procedures. Hospitalist‐delivered propofol sedation is provided exclusively in the APC for non‐painful procedures. The hospitalist is responsible for the pre‐sedation evaluation, induction and maintenance of sedation, and patient monitoring and documentation of vital signs. Monitoring for propofol sedation includes end‐tidal carbon dioxide monitoring in addition to electrocardiogram (EKG), respiratory rate (RR), pulse oximetry, and non‐invasive blood pressure (NIBP). A sedation‐trained nurse is present during induction and assists with patient positioning within the scanner. The nurse will then assume care of the patient at the completion of the procedure to continue patient monitoring during recovery.

Training for Tier‐Three providers consists of a 3‐hour didactic session with Anesthesia, 10 days of OR training, use of simulation scenarios, and a written exam. The hospitalist must then perform 25 supervised propofol sedations before being credentialed to provide propofol sedation independently. To maintain certification for Tier‐Three services, hospitalists must perform at least 75 propofol sedations every 2 years.

RESULTS

Utilizing this design and training method, we have developed a successful pediatric hospitalist sedation program. Based on fiscal year 2009 billing data, the Division of Hospital Medicine performed 2471 sedations. There were 2069 sedations performed in APC or PAWS; of those, 1017 were performed on inpatients and 1052 were performed on outpatients. Hospitalists performed 402 sedations on patients in the EU. The EU numbers are likely much larger given that, for over half the year, billing data was not collected from the EU. Unfortunately, we did not have billing data regarding night and weekend sedations, but our best estimate is 1 to 2 per week. The wait time for an outpatient sedated pediatric MRI has gone from 6 weeks to 2 days or less. As of July 2010, we have trained 90 providers at Tier One, 32 at Tier Two, and 11 at Tier Three. We currently have 43 hospitalists providing Tier‐One sedation, 18 providing Tier‐Two, and 6 providing Tier‐Three. Average cumulative hospitalist experience is 1 year for Tier One, 5 years for Tier Two, and 10 years for Tier Three.

DISCUSSION

We believe this is the first description of a pediatric hospitalist training program for a sedation service. However, it is clear that many other pediatric hospitalists are performing sedation and developing similar training programs. When starting a program such as this, there are many things to consider. First, patient volume/demand must allow for each hospitalist to perform sedations on a regular basis, both for training and Maintenance of Certification. Second, Anesthesia must be willing to provide training and oversight. Third, the hospital or university must be willing to support the cost associated with the training period. Finally, negotiating with third party payers for reimbursement is critical to financial sustainability.

The success of our program hinged upon the ability to develop a strong and collaborative relationship with Anesthesiology. Many factors played into making this relationship work. Initially, Anesthesia approached us to help them meet an unmet clinical need. Because of this, we were viewed as helpful and as problem solvers, rather than as a threat. Additionally, each division had a sedation service champion that pushed for the development of a hospitalist sedation service. Lastly, regular meetings with Anesthesia, and the intense training program itself, helped to develop a sense of collegiality between the divisions.

We have faced many challenges and learned many lessons while developing this program. There is a significant cost to training sedation providers; 47 hospitalists trained to provide Tier‐One sedation have left the program. Of those, 16 hospitalists completed training for Tier‐Two sedation, and 5 completed Tier Three. The Tier‐Two training described earlier requires approximately 50 hours of dedicated time away from other hospitalist duties, while Tier Three requires an additional 125 hours. The majority of our turnover occurred in the first few years of the program. From a financial perspective, we have had to reserve sedation training beyond Tier One to hospitalists who are able to demonstrate evidence of a long‐term commitment to our division. Every person providing Tier‐Three sedation has been with the division over 6 years. From a broader perspective, we are providing hospitalists with an important and useful skill that may enhance their careerssafe and effective sedation.

Balancing the volume of cases is another issue to consider. Our goal is to provide safe and timely sedation, therefore we need to have enough scheduled cases to maintain competency and financial viability, but we must also leave adequate flexibility in the schedule for urgent cases.

In addition to the operating room training, we are beginning to incorporate pediatric simulation as an adjunct to our training. We have designed simulation scenarios which address issues of obstruction, apnea, hypotension, bronchospasm, and aspiration. However, OR training remains a mandatory requirement for sedation training and, at times, can be challenging to schedule.

We complete a post‐sedation assessment on all patients; we are currently performing a chart review of over 1600 patients sedated with propofol, to look at the rate of planned and unplanned interventions. We believe this data will show that our training has been successful, and that with analysis of our Quality Improvement data, we can improve the safety and efficacy of our sedation program even further.

CONCLUSIONS

A pediatric hospitalist sedation service, with proper training and oversight, can successfully augment sedation services provided by anesthesiologists. As has been stated in prior publications, a defined system, and the use of a dedicated well‐trained team makes a sedation service a success.1719 A collegial and mutually respectful relationship between Anesthesia and non‐Anesthesia sedation providers is critical in developing and maintaining a successful sedation program.

There is growing demand for safe and effective procedural sedation in pediatric facilities around the country. Multiple articles published in the last 10 years have addressed the shortage of pediatric anesthesiologists to meet this rising need.14 In 2005, Lalwani and Michel published results of a survey of North American children's hospitals that showed 87% of institutions reporting barriers to development of a pediatric sedation service, and that the most common barrier was shortage of anesthesiologists.5 In our hospital, the wait time for an outpatient sedated pediatric magnetic resonance imaging (MRI) grew to as long as 6 weeks. Many institutions have had to look for unique ways to solve this problem. Pediatric sedation programs have been developed which utilize intensivists, emergency medicine physicians, nurse anesthetists, or trained sedation nurses to provide safe pediatric sedation.611 Each of these programs has grown from the particular strengths and needs at each institution. In many institutions, hospitalists are the best candidates to meet this need because of their knowledge of patient needs and safety. They are accessible and receptive to obtaining additional training and, therefore, are a natural fit to provide this service.

As more non‐anesthesiologists are called upon to meet this growing need, the principles and practice of safe sedation must be followed. The Pediatric Sedation Research Consortium, a collaborative group of 37 locations that provide data on pediatric sedations, has published their findings on the safety of pediatric sedation/anesthesia outside of the operating room (OR) performed by anesthesiologists and non‐anesthesiologists.1213 This data has been very valuable, given that studies from single institutions will often lack the power to investigate the rare, but potentially devastating, adverse events which can occur in pediatric sedation/anesthesia.

Despite the widespread use of propofol by non‐anesthesiologists, the lack of substantial data regarding safety by these providers makes its use controversial. A search of the literature finds only 1 prior article that describes the use of propofol by general pediatricians. This was sedation for endoscopy, and the sedation was performed by specially trained pediatric residents in Italy.14 A recently published study from the Consortium regarding the use of propofol showed that the majority of propofol sedations were being performed by intensivists (49%), emergency medicine physicians (36%), or anesthesiologists (10%). General pediatricians or hospitalists performed just 2% of the cases in this series.13

In 2003, a large group of experienced pediatric hospitalists were already providing sedation in the Emergency Unit (EU) and Center for After‐hours Referrals for Emergency Services (CARES) at St Louis Children's Hospital. The Division of Hospital Medicine was approached to meet the demand for increased sedation services at our institution. The Division of Pediatric Anesthesia agreed to provide our physicians with the appropriate training to provide safe, effective, and efficient sedations for painful and non‐painful procedures outside of the OR. One of our sedation units, the Ambulatory Procedure Center (APC), has been described in detail in a prior publication by Strauser Sterni et al.15 Here, we will describe the operations of our sedation services, and specifically describe the training required for our hospitalists to provide sedation services.

METHODS

St Louis Children's Hospital is a 250‐bed tertiary‐care teaching hospital affiliated with Washington University School of Medicine. The Division of Hospitalist Medicine is today comprised of 43 physicians who provide care in the EU, CARES, inpatient units, Transport, and Sedation Services at St Louis Children's Hospital. Our division also provides pediatric care in the EU, inpatient units, newborn nursery, and labor and delivery at 3 affiliated hospitals. In 2003, we developed a dedicated program in our division to meet our institutional need for sedation, with training and oversight by the Division of Pediatric Anesthesia. We developed a structured 3‐tiered program of sedation providers to manage all of our sedation needs. We then designed a training program for these 3 tiers of sedation providers. The 3‐tired program is based on the level of sedation training of each member.

Current American Academy of Pediatrics (AAP) guidelines state:

The practitioner responsible for the treatment of the patient and/or the administration of drugs for sedation must be competent to use such techniques, provide the level of monitoring provided in these guidelines, and manage complications of these techniques (ie, to be able to rescue the patient). Because the level of intended sedation may be exceeded, the practitioner must be sufficiently skilled to provide rescue should the child progress to a level of deep sedation. The practitioner must be trained in, and capable of providing, at the minimum, bag‐valve‐mask ventilation to be able to oxygenate a child who develops airway obstruction or apnea. Training in, and maintenance of, advanced pediatric airway skills is required; regular skills reinforcement is strongly encouraged.16

Our first‐tier sedation providers are junior faculty who provide sedation in the EU and CARES, and in the EU at our community hospitals. The first tier completes sedation training as part of overall hospitalist orientation in order to provide this service. The second tier goes through an advanced sedation provider program to provide sedation in the APC, Pediatric Acute Wound Service (PAWS), inpatient units, and After Hours sedation call, as well as the locations from the first tier. The third tier completes a more complex advanced sedation training program, specifically using propofol, and provides propofol sedation in the APC only, as well as providing sedation in all of the units from the first and second tiers. The responsibilities of the hospitalist providing sedation are described in detail by tier below, including the specific training requirements necessary for each tier (Table 1).

Tiered Sedation Training in a Hospitalist Program
  • Abbreviations: APC, Ambulatory Procedure Center; EU, Emergency Unit; PAWS, Pediatric Acute Wound Service.

Tier One
Provides sedation services in the EU
Drugs: ketamine, nitrous oxide
Training consists of:
1‐hr didactic hospitalist orientation
4 days of shadowing a hospitalist on the sedation service
Continuing on‐the‐job training
Tier Two
Provides sedation throughout the hospital: EU, APC, PAWS, and night/weekend call for urgent needs
Drugs: ketamine, nitrous oxide, plus pentobarbital or dexmedetomidine for radiologic procedures for both inpatients and outpatients
Training consists of:
1 yr of first tier experience
2‐hr didactic session with anesthesia
1‐hr advanced hospitalist sedation orientation
5 days of operating room training with an anesthesiologist
Tier Three
Provides sedation throughout the hospital: EU, APC, PAWS, and night/weekend call
Drugs: ketamine, nitrous oxide, pentobarbital, dexmedetomidine, and propofol
Training consists of:
1 yr of second tier experience
3‐hr didactic lecture with anesthesia
10 days of operating room training
25 supervised propofol sedations
Maintenance of certification requires >75 propofol sedations every 2 yr

Tier One

First‐tier hospitalist sedation providers perform sedation services in the EU and CARES. The staffing model in St Louis Children's Hospital EU is comprised of a pediatric emergency medicine‐trained attending or fellow and a pediatric hospitalist who both help to oversee care within the unit. The unit is also staffed by pediatric residents, emergency medicine residents, medical students, and nurse practitioners. One of the main responsibilities of the pediatric hospitalist, however, is sedation within the unit. In CARES, the pediatric hospitalist is the attending providing direct care to patients without trainees. Any procedure requiring sedation in CARES would be performed by the hospitalist. The hospitalist providing care in the EU at both of our community hospitals would also be the physician to perform procedural sedation within the unit. Procedural sedation in all of these units are primarily for fracture reduction, laceration repair, abscess incision and drainage, foreign body removal, lumbar puncture, joint aspiration, burn debridement, and radiology imaging. Sedations performed within these units are classified as moderate or deep sedation.16 Common medications used by Tier‐One sedation providers are intravenous ketamine, inhaled nitrous oxide in combination with oral oxycodone or oral/ intravenous midazolam, intravenous pentobarbital, and occasional intravenous fentanyl in combination with intravenous midazolam.

For a hospitalist to perform any pediatric sedation within the 4 hospitals in our program, the physician must be credentialed in accordance with the specific criteria of each institution. There are varied institutional policies across all hospitals nationally. At St Louis Children's Hospital, sedation credentialing criteria states that a sedation provider must review the specific institutional policies governing sedation and perform 25 supervised sedations, before any independent sedation is attempted. The type of procedure requiring sedation and the medications used for the sedation may vary among these 25 supervised sedations. Given the structure of our program, the majority of supervised sedations are for painful procedures utilizing ketamine or a combination of oxycodone and nitrous oxide.

Our division also requires the Tier‐One group to shadow at least 4 shifts with senior hospitalists in Tiers Two or Three providing sedation, in a unit where there is an average of 6 sedations performed per day. The Tier‐One sedation hospitalist must also attend a 1‐hour didactic orientation session where the principles and practice of sedation are taught. This didactic session provides the principles of pediatric sedation and defines the important skills necessary to provide safe sedation and recovery. In addition, hospitalists are trained to recognize which children can be safely sedated by a hospitalist, and manage common side effects and adverse events during and after sedation.

The Tier‐One hospitalist performing sedation in the EU/CARES is responsible for performing pre‐procedure sedation evaluation, developing a sedation plan, and delivering procedural sedation. A dedicated sedation‐trained nurse is available throughout the procedure to record vital signs, leaving the hospitalist free to monitor the patient directly, titrate sedation medications, and manage airway or adverse events as they arise. A separate provider is responsible for performing the actual procedure. The patient continues to be monitored by the sedation nurse during the recovery period, while the hospitalist remains immediately available in the unit to address any problems. At St Louis Children's Hospital, specific monitoring and documentation criteria, using standard forms and sedation scores, are strictly adhered to for every sedation, both during the sedation and throughout the recovery phase. These criteria are based upon the AAP guidelines for monitoring and management of pediatric sedation as described by Cot and Wilson.16 Hospital Medicine provides services in the EU 17 hours per day, 7 days a week. On average, 3 sedations are provided by the hospitalist per 8‐hour shift in the EU.

Tier Two

Second‐tier providers perform all services provided by Tier‐One providers, as well as expanded sedation services on the inpatient units, APC, and PAWS. Tier‐Two providers also provide on‐call services for urgent night, weekend, and holiday sedation needs.

APC and PAWS provide more specialized sedation care than that provided in the EU. PAWS is a separate and dedicated wound care unit housed on the surgical/post‐op floor where children are sedated for painful wound care, primarily burn debridement, abscess incision and drainage (I&D), and dressing changes. Sedation services are occasionally provided for other wound care issues or procedures. Both inpatients and outpatients are seen in this unit. The unit operates 10 hours per day, 7 days a week. The PAWS unit has 2 rooms specifically equipped for sedation, monitoring, and rescue, as well as 2 additional rooms for recovery or for patients not requiring sedation. Sedations in PAWS generally utilize intravenous ketamine or inhaled nitrous oxide coupled with premedication of oxycodone. Responsibilities of the hospitalist in the unit include completing and documenting the pre‐sedation evaluation, developing an appropriate sedation plan, delivering sedation medications, ongoing monitoring and documenting of vital signs throughout the case, and recovery of the patient. All nursing staff in this unit are sedation‐trained and are responsible for continued patient monitoring during the recovery period, until the patient has returned to baseline and is safe for discharge or transfer.

The APC has been described in a prior publication.15 Hospitalist sedations in the APC are performed primarily for radiology procedures, the majority of which are MRI but also include computed tomographic (CT) and nuclear medicine scans. Sedation is also provided for automated brainstem response (ABR), electromyogram (EMG), and peripherally inserted central catheter (PICC) placements. Like PAWS, APC serves both inpatients and outpatients. The APC is staffed 10 hours per day, 5 days per week. The primary sedation medications used in this unit are ketamine, dexmedetomidine, and occasionally fentanyl and midazolam. There are 11 patient beds, all equipped for patient monitoring and recovery. Hospitalists in the APC may provide direct patient care or supervise sedation‐trained nurses delivering sedation services after having a pre‐sedation evaluation performed by the hospitalist. If a sedation‐trained nurse is delivering sedation, the hospitalist may be doing other interruptible tasks, but is immediately available on the unit to respond to any concerns from the sedation nurse. All units are fully equipped with resuscitation equipment/crash carts, and an anesthesiologist is readily available to come to the unit from the OR in the event of an issue. A rapid response team that consists of a pediatric intensive care unit (ICU) fellow, respiratory therapist, and pediatric ICU charge nurse is also always on call.

Urgent sedations on the inpatient wards are common and can usually be accommodated in PAWS or APC. Rarely, however, an MRI, CT, joint aspiration, abscess drainage, or lumbar puncture must be completed urgently in the evenings, weekends, or holidays. In this situation, the hospitalist is responsible for performing the pre‐sedation evaluation, developing an appropriate sedation technique, delivering the sedation medications, monitoring and documenting during the procedure as well as throughout the recovery period, until the patient has returned to baseline. Sedation‐trained nursing staff are available to provide assistance. The sedation medications commonly used in these after‐hours sedations include ketamine for short or painful procedures and dexmedetomidine for longer radiology studies.

Training for second‐tier services consists of a minimum of 1 year of first‐tier sedation experience, a 2‐hour didactic lecture with Pediatric Anesthesia, a 1‐hour hospitalist orientation for advanced sedation providers, and 5 days of OR training with an anesthesiologist. Operating room training focuses on building skills in bag‐mask ventilation, intravenous (IV) placement, endotracheal intubation, and laryngeal mask airway (LMA) placement.

Tier Three

Third‐tier sedation providers have completed all of the training of a Tier‐Two provider and have had additional training to prepare them to deliver propofol for non‐painful procedures. Hospitalist‐delivered propofol sedation is provided exclusively in the APC for non‐painful procedures. The hospitalist is responsible for the pre‐sedation evaluation, induction and maintenance of sedation, and patient monitoring and documentation of vital signs. Monitoring for propofol sedation includes end‐tidal carbon dioxide monitoring in addition to electrocardiogram (EKG), respiratory rate (RR), pulse oximetry, and non‐invasive blood pressure (NIBP). A sedation‐trained nurse is present during induction and assists with patient positioning within the scanner. The nurse will then assume care of the patient at the completion of the procedure to continue patient monitoring during recovery.

Training for Tier‐Three providers consists of a 3‐hour didactic session with Anesthesia, 10 days of OR training, use of simulation scenarios, and a written exam. The hospitalist must then perform 25 supervised propofol sedations before being credentialed to provide propofol sedation independently. To maintain certification for Tier‐Three services, hospitalists must perform at least 75 propofol sedations every 2 years.

RESULTS

Utilizing this design and training method, we have developed a successful pediatric hospitalist sedation program. Based on fiscal year 2009 billing data, the Division of Hospital Medicine performed 2471 sedations. There were 2069 sedations performed in APC or PAWS; of those, 1017 were performed on inpatients and 1052 were performed on outpatients. Hospitalists performed 402 sedations on patients in the EU. The EU numbers are likely much larger given that, for over half the year, billing data was not collected from the EU. Unfortunately, we did not have billing data regarding night and weekend sedations, but our best estimate is 1 to 2 per week. The wait time for an outpatient sedated pediatric MRI has gone from 6 weeks to 2 days or less. As of July 2010, we have trained 90 providers at Tier One, 32 at Tier Two, and 11 at Tier Three. We currently have 43 hospitalists providing Tier‐One sedation, 18 providing Tier‐Two, and 6 providing Tier‐Three. Average cumulative hospitalist experience is 1 year for Tier One, 5 years for Tier Two, and 10 years for Tier Three.

DISCUSSION

We believe this is the first description of a pediatric hospitalist training program for a sedation service. However, it is clear that many other pediatric hospitalists are performing sedation and developing similar training programs. When starting a program such as this, there are many things to consider. First, patient volume/demand must allow for each hospitalist to perform sedations on a regular basis, both for training and Maintenance of Certification. Second, Anesthesia must be willing to provide training and oversight. Third, the hospital or university must be willing to support the cost associated with the training period. Finally, negotiating with third party payers for reimbursement is critical to financial sustainability.

The success of our program hinged upon the ability to develop a strong and collaborative relationship with Anesthesiology. Many factors played into making this relationship work. Initially, Anesthesia approached us to help them meet an unmet clinical need. Because of this, we were viewed as helpful and as problem solvers, rather than as a threat. Additionally, each division had a sedation service champion that pushed for the development of a hospitalist sedation service. Lastly, regular meetings with Anesthesia, and the intense training program itself, helped to develop a sense of collegiality between the divisions.

We have faced many challenges and learned many lessons while developing this program. There is a significant cost to training sedation providers; 47 hospitalists trained to provide Tier‐One sedation have left the program. Of those, 16 hospitalists completed training for Tier‐Two sedation, and 5 completed Tier Three. The Tier‐Two training described earlier requires approximately 50 hours of dedicated time away from other hospitalist duties, while Tier Three requires an additional 125 hours. The majority of our turnover occurred in the first few years of the program. From a financial perspective, we have had to reserve sedation training beyond Tier One to hospitalists who are able to demonstrate evidence of a long‐term commitment to our division. Every person providing Tier‐Three sedation has been with the division over 6 years. From a broader perspective, we are providing hospitalists with an important and useful skill that may enhance their careerssafe and effective sedation.

Balancing the volume of cases is another issue to consider. Our goal is to provide safe and timely sedation, therefore we need to have enough scheduled cases to maintain competency and financial viability, but we must also leave adequate flexibility in the schedule for urgent cases.

In addition to the operating room training, we are beginning to incorporate pediatric simulation as an adjunct to our training. We have designed simulation scenarios which address issues of obstruction, apnea, hypotension, bronchospasm, and aspiration. However, OR training remains a mandatory requirement for sedation training and, at times, can be challenging to schedule.

We complete a post‐sedation assessment on all patients; we are currently performing a chart review of over 1600 patients sedated with propofol, to look at the rate of planned and unplanned interventions. We believe this data will show that our training has been successful, and that with analysis of our Quality Improvement data, we can improve the safety and efficacy of our sedation program even further.

CONCLUSIONS

A pediatric hospitalist sedation service, with proper training and oversight, can successfully augment sedation services provided by anesthesiologists. As has been stated in prior publications, a defined system, and the use of a dedicated well‐trained team makes a sedation service a success.1719 A collegial and mutually respectful relationship between Anesthesia and non‐Anesthesia sedation providers is critical in developing and maintaining a successful sedation program.

References
  1. Adams K,Pennock N,Phelps B,Rose W,Peters M.Anesthesia services outside of the operating room.Pediatr Nurs.2007;33(3):232,234,236237.
  2. Gozal D,Gozal Y.Pediatric sedation/anesthesia outside the operating room.Curr Opin Anaesthesiol.2008;21(4):494498.
  3. Shankar V,Deshpande JK.Procedural sedation in the pediatric patient.Anesthesiol Clin North Am.2005;23(4):635654, viii.
  4. Smallman B.Pediatric sedation: can it be safely performed by non‐anesthesiologists?Curr Opin Anaesthesiol.2002;15(4):455459.
  5. Lalwani K,Michel M.Pediatric sedation in North American children's hospitals: a survey of anesthesia providers.Paediatr Anaesth.2005;15(3):209213.
  6. Larsen R,Galloway D,Wadera S, et al.Safety of propofol sedation for pediatric outpatient procedures.Clin Pediatr (Phila).2009;48(8):819823.
  7. Mason KP,Zurakowski D,Zgleszewski SE, et al.High dose dexmedetomidine as the sole sedative for pediatric MRI.Paediatr Anaesth.2008;18(5):403411.
  8. Pershad J,Gilmore B.Successful implementation of a radiology sedation service staffed exclusively by pediatric emergency physicians.Pediatrics.2006;117(3):e413e422.
  9. Shavit I,Hershman E.Management of children undergoing painful procedures in the emergency department by non‐anesthesiologists.Isr Med Assoc J.2004;6(6):350355.
  10. Sury MR,Hatch DJ,Deeley T,Dicks‐Mireaux C,Chong WK.Development of a nurse‐led sedation service for paediatric magnetic resonance imaging.Lancet.1999;353(9165):16671671.
  11. Vespasiano M,Finkelstein M,Kurachek S.Propofol sedation: intensivists' experience with 7304 cases in a children's hospital.Pediatrics.2007;120(6):e1411e1417.
  12. Cravero JP.Risk and safety of pediatric sedation/anesthesia for procedures outside the operating room.Curr Opin Anaesthesiol.2009;22(4):509513.
  13. Cravero JP,Beach ML,Blike GT,Gallagher SM,Hertzog JH.The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium.Anesth Analg.2009;108(3):795804.
  14. Barbi E,Petaros P,Badina L, et al.Deep sedation with propofol for upper gastrointestinal endoscopy in children, administered by specially trained pediatricians: a prospective case series with emphasis on side effects.Endoscopy.2006;38(4):368375.
  15. Strauser Sterni L,Beck S,Cole J,Carlson D,Turmelle M.A model for pediatric sedation centers using pharmacologic sedation for successful completion of radiologic and procedural studies.J Radiol Nurs2008;27(2):4660.
  16. Coté CJ,Wilson S.Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update.Pediatrics.2006;118(6):25872602.
  17. Hertzog JH,Havidich JE.Non‐anesthesiologist‐provided pediatric procedural sedation: an update.Curr Opin Anaesthesiol.2007;20(4):365372.
  18. Leroy PL,Schipper DM,Knape HJ.Professional skills and competence for safe and effective procedural sedation in children: recommendations based on a systematic review of the literature.Int J Pediatr.2010; doi://10.1155/2010/934298.
  19. Twite MD,Friesen RH.Pediatric sedation outside the operating room: the year in review.Curr Opin Anaesthesiol.2005;18(4):442446.
References
  1. Adams K,Pennock N,Phelps B,Rose W,Peters M.Anesthesia services outside of the operating room.Pediatr Nurs.2007;33(3):232,234,236237.
  2. Gozal D,Gozal Y.Pediatric sedation/anesthesia outside the operating room.Curr Opin Anaesthesiol.2008;21(4):494498.
  3. Shankar V,Deshpande JK.Procedural sedation in the pediatric patient.Anesthesiol Clin North Am.2005;23(4):635654, viii.
  4. Smallman B.Pediatric sedation: can it be safely performed by non‐anesthesiologists?Curr Opin Anaesthesiol.2002;15(4):455459.
  5. Lalwani K,Michel M.Pediatric sedation in North American children's hospitals: a survey of anesthesia providers.Paediatr Anaesth.2005;15(3):209213.
  6. Larsen R,Galloway D,Wadera S, et al.Safety of propofol sedation for pediatric outpatient procedures.Clin Pediatr (Phila).2009;48(8):819823.
  7. Mason KP,Zurakowski D,Zgleszewski SE, et al.High dose dexmedetomidine as the sole sedative for pediatric MRI.Paediatr Anaesth.2008;18(5):403411.
  8. Pershad J,Gilmore B.Successful implementation of a radiology sedation service staffed exclusively by pediatric emergency physicians.Pediatrics.2006;117(3):e413e422.
  9. Shavit I,Hershman E.Management of children undergoing painful procedures in the emergency department by non‐anesthesiologists.Isr Med Assoc J.2004;6(6):350355.
  10. Sury MR,Hatch DJ,Deeley T,Dicks‐Mireaux C,Chong WK.Development of a nurse‐led sedation service for paediatric magnetic resonance imaging.Lancet.1999;353(9165):16671671.
  11. Vespasiano M,Finkelstein M,Kurachek S.Propofol sedation: intensivists' experience with 7304 cases in a children's hospital.Pediatrics.2007;120(6):e1411e1417.
  12. Cravero JP.Risk and safety of pediatric sedation/anesthesia for procedures outside the operating room.Curr Opin Anaesthesiol.2009;22(4):509513.
  13. Cravero JP,Beach ML,Blike GT,Gallagher SM,Hertzog JH.The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium.Anesth Analg.2009;108(3):795804.
  14. Barbi E,Petaros P,Badina L, et al.Deep sedation with propofol for upper gastrointestinal endoscopy in children, administered by specially trained pediatricians: a prospective case series with emphasis on side effects.Endoscopy.2006;38(4):368375.
  15. Strauser Sterni L,Beck S,Cole J,Carlson D,Turmelle M.A model for pediatric sedation centers using pharmacologic sedation for successful completion of radiologic and procedural studies.J Radiol Nurs2008;27(2):4660.
  16. Coté CJ,Wilson S.Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update.Pediatrics.2006;118(6):25872602.
  17. Hertzog JH,Havidich JE.Non‐anesthesiologist‐provided pediatric procedural sedation: an update.Curr Opin Anaesthesiol.2007;20(4):365372.
  18. Leroy PL,Schipper DM,Knape HJ.Professional skills and competence for safe and effective procedural sedation in children: recommendations based on a systematic review of the literature.Int J Pediatr.2010; doi://10.1155/2010/934298.
  19. Twite MD,Friesen RH.Pediatric sedation outside the operating room: the year in review.Curr Opin Anaesthesiol.2005;18(4):442446.
Issue
Journal of Hospital Medicine - 7(4)
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Journal of Hospital Medicine - 7(4)
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335-339
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Development of a pediatric hospitalist sedation service: Training and implementation
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Interdisciplinary teamwork in hospitals: A review and practical recommendations for improvement

Teamwork is important in providing high‐quality hospital care. Despite tremendous efforts in the 10 years since publication of the Institute of Medicine's To Err is Human report,1 hospitalized patients remain at risk for adverse events (AEs).2 Although many AEs are not preventable, a large portion of those which are identified as preventable can be attributed to communication and teamwork failures.35 A Joint Commission study indicated that communication failures were the root cause for two‐thirds of the 3548 sentinel events reported from 1995 to 2005.6 Another study, involving interviews of resident physicians about recent medical mishaps, found that communication failures contributed to 91% of the AEs they reported.5

Teamwork also plays an important role in other aspects of hospital care delivery. Patients' ratings of nurse‐physician coordination correlate with their overall perception of the quality of care received.7, 8 A study of Veterans Health Administration (VHA) hospitals found that teamwork culture was significantly and positively associated with overall patient satisfaction.9 Another VHA study found that hospitals with higher teamwork culture ratings had lower nurse resignations rates.10 Furthermore, poor teamwork within hospitals may have an adverse effect on financial performance, as a result of inefficiencies in physician and nurse workflow.11

Some organizations are capable of operating in complex, hazardous environments while maintaining exceptional performance over long periods of time. These high reliability organizations (HRO) include aircraft carriers, air traffic control systems, and nuclear power plants, and are characterized by their preoccupation with failure, reluctance to simplify interpretations, sensitivity to operations, commitment to resilience, and deference to expertise.12, 13 Preoccupation with failure is manifested by an organization's efforts to avoid complacency and persist in the search for additional risks. Reluctance to simplify interpretations is exemplified by an interest in pursuing a deep understanding of the issues that arise. Sensitivity to operations is the close attention paid to input from front‐line personnel and processes. Commitment to resilience relates to an organization's ability to contain errors once they occur and mitigate harm. Deference to expertise describes the practice of having authority migrate to the people with the most expertise, regardless of rank. Collectively, these qualities produce a state of mindfulness, allowing teams to anticipate and become aware of unexpected events, yet also quickly contain and learn from them. Recent publications have highlighted the need for hospitals to learn from HROs and the teams within them.14, 15

Recognizing the importance of teamwork in hospitals, senior leadership from the American College of Physician Executives (ACPE), the American Hospital Association (AHA), the American Organization of Nurse Executives (AONE), and the Society of Hospital Medicine (SHM) established the High Performance Teams and the Hospital of the Future project. This collaborative learning effort aims to redesign care delivery to provide optimal value to hospitalized patients. As an initial step, the High Performance Teams and the Hospital of the Future project team completed a literature review related to teamwork in hospitals. The purpose of this report is to summarize the current understanding of teamwork, describe interventions designed to improve teamwork, and make practical recommendations for hospitals to assess and improve teamwork‐related performance. We approach teamwork from the hospitalized patient's perspective, and restrict our discussion to interactions occurring among healthcare professionals within the hospital. We recognize the importance of teamwork at all points in the continuum of patient care. Highly functional inpatient teams should be integrated into an overall system of coordinated and collaborative care.

TEAMWORK: DEFINITION AND CONSTRUCTS

Physicians, nurses, and other healthcare professionals spend a great deal of their time on communication and coordination of care activities.1618 In spite of this and the patient safety concerns previously noted, interpersonal communication skills and teamwork have been historically underemphasized in professional training.1922 A team is defined as 2 or more individuals with specified roles interacting adaptively, interdependently, and dynamically toward a shared and common goal.23 Elements of effective teamwork have been identified through research conducted in aviation, the military, and more recently, healthcare. Salas and colleagues have synthesized this research into 5 core components: team leadership, mutual performance monitoring, backup behavior, adaptability, and team orientation (see Table 1).23 Additionally, 3 supporting and coordinating mechanisms are essential for effective teamwork: shared mental model, closed‐loop communication, and mutual trust (see Table 1).23 High‐performing teams use these elements to develop a culture for speaking up, and situational awareness among team members. Situational awareness refers to a person's perception and understanding of their dynamic environment, and human errors often result from a lack of such awareness.24 These teamwork constructs provide the foundational basis for understanding how hospitals can identify teamwork challenges, assess team performance, and design effective interventions.

Teamwork Components and Coordinating Mechanisms
Teamwork Definition Behavioral Examples
  • NOTE: Adapted from Baker et al.22

Component
Team leadership The leader directs and coordinates team members activities Facilitate team problem solving;
Provide performance expectations;
Clarify team member roles;
Assist in conflict resolution
Mutual performance monitoring Team members are able to monitor one another's performance Identify mistakes and lapses in other team member actions;
Provide feedback to fellow team members to facilitate self‐correction
Backup behavior Team members anticipate and respond to one another's needs Recognize workload distribution problem;
Shift work responsibilities to underutilized members
Adaptability The team adjusts strategies based on new information Identify cues that change has occurred and develop plan to deal with changes;
Remain vigilant to change in internal and external environment
Team orientation Team members prioritize team goals above individual goals Take into account alternate solutions by teammates;
Increased task involvement, information sharing, and participatory goal setting
Coordinating mechanism
Shared mental model An organizing knowledge of the task of the team and how members will interact to achieve their goal Anticipate and predict each other's needs;
Identify changes in team, task, or teammates
Closed‐loop communication Acknowledgement and confirmation of information received Follow up with team members to ensure message received;
Acknowledge that message was received;
Clarify information received
Mutual trust Shared belief that team members will perform their roles Share information;
Willingly admit mistakes and accept feedback

CHALLENGES TO EFFECTIVE TEAMWORK

Several important and unique barriers to teamwork exist in hospitals. Teams are large and formed in an ad hoc fashion. On a given day, a patient's hospital team might include a hospitalist, a nurse, a case manager, a pharmacist, and 1 or more consulting physicians and therapists. Team members in each respective discipline care for multiple patients at the same time, yet few hospitals align team membership (ie, patient assignment). Therefore, a nurse caring for 4 patients may interact with 4 different hospitalists. Similarly, a hospitalist caring for 14 patients may interact with multiple nurses in a given day. Team membership is ever changing because hospital professionals work in shifts and rotations. Finally, team members are seldom in the same place at the same time because physicians often care for patients on multiple units and floors, while nurses and other team members are often unit‐based. Salas and others have noted that team size, instability, and geographic dispersion of membership serve as important barriers to improving teamwork.25, 26 As a result of these barriers, nurses and physicians do not communicate consistently, and often disagree on the daily plan of care for their patients.27, 28 When communication does occur, clinicians may overestimate how well their messages are understood by other team members, reflecting a phenomenon well known in communication psychology related to egocentric thought processes.29, 30

The traditionally steep hierarchy within medicine may also serve as a barrier to teamwork. Studies in intensive care units (ICUs), operating rooms, and general medical units reveal widely discrepant views on the quality of collaboration and communication between healthcare professionals.3133 Although physicians generally give high ratings to the quality of collaboration with nurses, nurses consistently rate the quality of collaboration with physicians as poor. Similarly, specialist physicians rate collaboration with hospitalists higher than hospitalists rate collaboration with specialists.33 Effective teams in other high‐risk industries, like aviation, strive to flatten hierarchy so that team members feel comfortable raising concerns and engaging in open and respectful communications.34

The effect of technology on communication practices and teamwork is complex and incompletely understood. The implementation of electronic heath records and computerized provider order entry systems fundamentally changes work‐flow, and may result in less synchronization and feedback during nurse‐physician collaboration.35 Similarly, the expanded use of text messages delivered via alphanumeric paging or mobile phone results in a transition toward asynchronous modes of communication. These asynchronous modes allow healthcare professionals to review and respond to messages at their convenience, and may reduce unnecessary interruptions. Research shows that these systems are popular among clinicians.3638 However, receipt and understanding of the intended message may not be confirmed with the use of asynchronous modes of communication. Moreover, important face‐to‐face communication elements (tone of voice, expression, gesture, eye contract)39, 40 are lacking. One promising approach is a system which sends low‐priority messages to a Web‐based task list for periodic review, while allowing higher priority messages to pass through to an alphanumeric pager and interrupt the intended recipient.41 Another common frustration in hospitals, despite advancing technology, is difficulty identifying the correct physician(s) and nurse(s) caring for a particular patient at a given point in time.33 Wong and colleagues found that 14% of pages in their hospital were initially sent to the wrong physician.42

ASSESSMENT OF TEAMWORK

One of the challenges in improving teamwork is the difficulty in measuring it. Teamwork assessment entails measuring the performance of teams composed of multiple individuals. Methods of teamwork assessment can be broadly categorized as self assessment, peer assessment, direct observation, survey of team climate or culture, and measurement of the outcome of effective teamwork. While self‐report tools are easy to administer and can capture affective components influencing team performance, they may not reflect actual skills on the part of individuals or teams. Peer assessment includes the use of 360‐degree evaluations or multisource feedback, and provides an evaluation of individual performance.4347

Direct observation provides a more accurate assessment of team‐related behaviors using trained observers. Observers use checklists and/or behaviorally anchored rating scales (BARS) to evaluate individual and team performance. A number of BARS have been developed and validated for the evaluation of team performance.4852 Of note, direct observation may be difficult in settings in which team members are not in the same place at the same time. An alternative method, which may be better suited for general medical units, is the use of survey instruments designed to assess attitudes and teamwork climate.5355 Importantly, higher survey ratings of collaboration and teamwork have been associated with better patient outcomes in observational studies.5658

The ultimate goal of teamwork efforts is to improve patient outcomes. Because patient outcomes are affected by a number of factors and because hospitals frequently engage in multiple, simultaneous efforts to improve care, it is often difficult to clearly link improved outcomes with teamwork interventions. Continued efforts to rigorously evaluate teamwork interventions should remain a priority, particularly as the cost of these interventions must be weighed against other interventions and investments.

EXAMPLES OF SUCCESSFUL INTERVENTIONS

A number of interventions have been used to improve teamwork in hospitals (see Table 2).

Interventions to Improve Teamwork in Hospitals
Intervention Advantages Disadvantages
Localization of physicians Increases frequency of nurse‐physician communication; provides foundation for additional interventions Insufficient in creating a shared mental model; does not specifically enhance communication skills
Daily goals‐of‐care forms and checklists Provides structure to interdisciplinary discussions and ensures input from all team members May be completed in a perfunctory manner and may not be updated as plans of care evolve
Teamwork training Emphasizes improved communication behaviors relevant across a range of team member interactions Requires time and deliberate practice of new skills; effect may be attenuated if members are dispersed.
Interdisciplinary rounds Provides a forum for regular interdisciplinary communication Requires leadership to organize discussion and does not address need for updates as plans of care evolve

Geographic Localization of Physicians

As mentioned earlier, physicians in large hospitals may care for patients on multiple units or floors. Designating certain physicians to care for patients admitted to specific units may improve efficiency and communication among healthcare professionals. One study recently reported on the effect of localization of hospital physicians to specific patient care units. Localization resulted in an increase in the rate of nurse‐physician communication, but did not improve providers' shared understanding of the plan of care.56 Notably, localizing physicians may improve the feasibility of additional interventions, like teamwork training and interdisciplinary rounds.

Daily Goals of Care and Surgery Safety Checklists

In ICU and operating room settings, physicians and nurses work in proximity, allowing interdisciplinary discussions to occur at the bedside. The finding that professionals in ICUs and operating rooms have widely discrepant views on the quality of collaboration31, 32 indicates that proximity, alone, is not sufficient for effective communication. Pronovost et al. used a daily goals form for bedside ICU rounds in an effort to standardize communication about the daily plan of care.57 The form defined essential goals of care for patients, and its use resulted in a significant improvement in the team's understanding of the daily goals. Narasimhan et al. performed a similar study using a daily goals worksheet during ICU rounds,58 and also found a significant improvement in physicians' and nurses' ratings of their understanding of the goals of care. The forms used in these studies provided structure to the interdisciplinary conversations during rounds to create a shared understanding of patients' plans of care.

Haynes and colleagues recently reported on the use of a surgical safety checklist in a large, multicenter pre‐post study.59 The checklist consisted of verbal confirmation of the completion of basic steps essential to safe care in the operating room, and provided structure to communication among surgical team members to ensure a shared understanding of the operative plan. The intervention resulted in a significant reduction in inpatient complications and mortality.

Team Training

Formalized team training, based on crew resource management, has been studied as a potential method to improve teamwork in a variety of medical settings.6062 Training emphasizes the core components of successful teamwork and essential coordinating mechanisms previously mentioned.23 Team training appears to positively influence culture, as assessed by teamwork and patient safety climate survey instruments.60 Based on these findings and extensive research demonstrating the success of teamwork training in aviation,63 the Agency for Healthcare Research and Quality (AHRQ) and the Department of Defense (DoD) have partnered in offering the Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) program, designed to improve teamwork skills for healthcare professionals.64, 65

Only a handful of studies have evaluated the effectiveness of teamwork training programs on patient outcomes, and the results are mixed.66 Morey et al. found a reduction in the rate of observed errors as a result of teamwork training in emergency departments, but observers in the study were not blinded with regard to whether teams had undergone training.61 A research group in the United Kingdom evaluated the benefit of simulation‐based team training on outcomes in an obstetrical setting.67, 68 Training included management of specific complications, including shoulder dystocia and uterine cord prolapse. Using retrospective chart review, the investigators found a significant reduction in the proportion of babies born with an obstetric brachial palsy injury and a reduction in the time from diagnosis of uterine cord prolapse to infant delivery. Nielsen and colleagues also evaluated the use of teamwork training in an obstetric setting.62 In a cluster randomized controlled trial, the investigators found no reduction in the rate of adverse outcomes. Differences in the duration of teamwork training and the degree of emphasis on deliberate practice of new skills (eg, with the use of simulation‐based training) likely explains the lack of consistent results.

Very little research has evaluated teamwork training in the general medical environment.69, 70 Sehgal and colleagues recently published an evaluation of the effect of teamwork training delivered to internal medicine residents, hospitalists, nurses, pharmacists, case managers, and social workers on medical services in 3 Northern California hospitals.69 The 4‐hour training sessions covered topical areas of safety culture, teamwork, and communication through didactics, videos, facilitated discussions, and small group role plays to practice new skills and behaviors. The intervention was rated highly among participants,69 and the training along with subsequent follow‐up interventions resulted in improved patient perceptions of teamwork and communication but had no impact on key patient outcomes.71

Interdisciplinary Rounds

Interdisciplinary rounds (IDR) have been used for many years as a means to assemble team members in a single location,7275 and the use of IDR has been associated with lower mortality among ICU patients.76 Interdisciplinary rounds may be particularly useful for clinical settings in which team members are traditionally dispersed in time and place, such as medical‐surgical units. Recent studies have evaluated the effect of structured inter‐disciplinary rounds (SIDR),77, 78 which combine a structured format for communication, similar to a daily goals‐of‐care form, with a forum for daily interdisciplinary meetings. Though no effect was seen on length of stay or cost, SIDR resulted in significantly higher ratings of the quality of collaboration and teamwork climate, and a reduction in the rate of AEs.79 Importantly, the majority of clinicians in the studies agreed that SIDR improved the efficiency of their work day, and expressed a desire that SIDR continue indefinitely. Many investigators have emphasized the importance of leadership during IDR, often by a medical director, nurse manager, or both.74, 77, 78

Summary of Interventions to Improve Teamwork

Localization of physicians increases the frequency of nurse‐physician communication, but is insufficient in creating a shared understanding of patients' plans of care. Providing structure for the discussion among team members (eg, daily goals of care forms and checklists) ensures that critical elements of the plan of care are communicated. Teamwork training is based upon a strong foundation of research both inside and outside of healthcare, and has demonstrated improved knowledge of teamwork principles, attitudes about the importance of teamwork, and overall safety climate. Creating a forum for team members to assemble and discuss their patients (eg, IDR) can overcome some of the unique barriers to collaboration in settings where members are dispersed in time and space. Leaders wishing to improve interdisciplinary teamwork should consider implementing a combination of complementary interventions. For example, localization may increase the frequency of team member interactions, the quality of which may be enhanced with teamwork training and reinforced with the use of structured communication tools and IDR. Future research should evaluate the effect of these combined interventions.

CONCLUSIONS

In summary, teamwork is critically important to provide safe and effective care. Important and unique barriers to teamwork exist in hospitals. We recommend the use of survey instruments, such as those mentioned earlier, as the most feasible method to assess teamwork in the general medical setting. Because each intervention addresses only a portion of the barriers to optimal teamwork, we encourage leaders to use a multifaceted approach. We recommend the implementation of a combination of interventions with adaptations to fit unique clinical settings and local culture.

Acknowledgements

This manuscript was prepared as part of the High Performance Teams and the Hospital of the Future project, a collaborative effort including senior leadership from the American College of Physician Executives, the American Hospital Association, the American Organization of Nurse Executives, and the Society of Hospital Medicine. The authors thank Taylor Marsh for her administrative support and help in coordinating project meetings.

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  78. O'Leary KJ,Wayne DB,Haviley C,Slade ME,Lee J,Williams MV.Improving teamwork: impact of structured interdisciplinary rounds on a medical teaching unit.J Gen Intern Med.2010;25(8):826832.
  79. O'Leary KJ,Buck R,Fligiel HM, et al.Structured interdisciplinary rounds in a medical teaching unit: improving patient safety.Arch Intern Med.2011;171(7):678684.
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Teamwork is important in providing high‐quality hospital care. Despite tremendous efforts in the 10 years since publication of the Institute of Medicine's To Err is Human report,1 hospitalized patients remain at risk for adverse events (AEs).2 Although many AEs are not preventable, a large portion of those which are identified as preventable can be attributed to communication and teamwork failures.35 A Joint Commission study indicated that communication failures were the root cause for two‐thirds of the 3548 sentinel events reported from 1995 to 2005.6 Another study, involving interviews of resident physicians about recent medical mishaps, found that communication failures contributed to 91% of the AEs they reported.5

Teamwork also plays an important role in other aspects of hospital care delivery. Patients' ratings of nurse‐physician coordination correlate with their overall perception of the quality of care received.7, 8 A study of Veterans Health Administration (VHA) hospitals found that teamwork culture was significantly and positively associated with overall patient satisfaction.9 Another VHA study found that hospitals with higher teamwork culture ratings had lower nurse resignations rates.10 Furthermore, poor teamwork within hospitals may have an adverse effect on financial performance, as a result of inefficiencies in physician and nurse workflow.11

Some organizations are capable of operating in complex, hazardous environments while maintaining exceptional performance over long periods of time. These high reliability organizations (HRO) include aircraft carriers, air traffic control systems, and nuclear power plants, and are characterized by their preoccupation with failure, reluctance to simplify interpretations, sensitivity to operations, commitment to resilience, and deference to expertise.12, 13 Preoccupation with failure is manifested by an organization's efforts to avoid complacency and persist in the search for additional risks. Reluctance to simplify interpretations is exemplified by an interest in pursuing a deep understanding of the issues that arise. Sensitivity to operations is the close attention paid to input from front‐line personnel and processes. Commitment to resilience relates to an organization's ability to contain errors once they occur and mitigate harm. Deference to expertise describes the practice of having authority migrate to the people with the most expertise, regardless of rank. Collectively, these qualities produce a state of mindfulness, allowing teams to anticipate and become aware of unexpected events, yet also quickly contain and learn from them. Recent publications have highlighted the need for hospitals to learn from HROs and the teams within them.14, 15

Recognizing the importance of teamwork in hospitals, senior leadership from the American College of Physician Executives (ACPE), the American Hospital Association (AHA), the American Organization of Nurse Executives (AONE), and the Society of Hospital Medicine (SHM) established the High Performance Teams and the Hospital of the Future project. This collaborative learning effort aims to redesign care delivery to provide optimal value to hospitalized patients. As an initial step, the High Performance Teams and the Hospital of the Future project team completed a literature review related to teamwork in hospitals. The purpose of this report is to summarize the current understanding of teamwork, describe interventions designed to improve teamwork, and make practical recommendations for hospitals to assess and improve teamwork‐related performance. We approach teamwork from the hospitalized patient's perspective, and restrict our discussion to interactions occurring among healthcare professionals within the hospital. We recognize the importance of teamwork at all points in the continuum of patient care. Highly functional inpatient teams should be integrated into an overall system of coordinated and collaborative care.

TEAMWORK: DEFINITION AND CONSTRUCTS

Physicians, nurses, and other healthcare professionals spend a great deal of their time on communication and coordination of care activities.1618 In spite of this and the patient safety concerns previously noted, interpersonal communication skills and teamwork have been historically underemphasized in professional training.1922 A team is defined as 2 or more individuals with specified roles interacting adaptively, interdependently, and dynamically toward a shared and common goal.23 Elements of effective teamwork have been identified through research conducted in aviation, the military, and more recently, healthcare. Salas and colleagues have synthesized this research into 5 core components: team leadership, mutual performance monitoring, backup behavior, adaptability, and team orientation (see Table 1).23 Additionally, 3 supporting and coordinating mechanisms are essential for effective teamwork: shared mental model, closed‐loop communication, and mutual trust (see Table 1).23 High‐performing teams use these elements to develop a culture for speaking up, and situational awareness among team members. Situational awareness refers to a person's perception and understanding of their dynamic environment, and human errors often result from a lack of such awareness.24 These teamwork constructs provide the foundational basis for understanding how hospitals can identify teamwork challenges, assess team performance, and design effective interventions.

Teamwork Components and Coordinating Mechanisms
Teamwork Definition Behavioral Examples
  • NOTE: Adapted from Baker et al.22

Component
Team leadership The leader directs and coordinates team members activities Facilitate team problem solving;
Provide performance expectations;
Clarify team member roles;
Assist in conflict resolution
Mutual performance monitoring Team members are able to monitor one another's performance Identify mistakes and lapses in other team member actions;
Provide feedback to fellow team members to facilitate self‐correction
Backup behavior Team members anticipate and respond to one another's needs Recognize workload distribution problem;
Shift work responsibilities to underutilized members
Adaptability The team adjusts strategies based on new information Identify cues that change has occurred and develop plan to deal with changes;
Remain vigilant to change in internal and external environment
Team orientation Team members prioritize team goals above individual goals Take into account alternate solutions by teammates;
Increased task involvement, information sharing, and participatory goal setting
Coordinating mechanism
Shared mental model An organizing knowledge of the task of the team and how members will interact to achieve their goal Anticipate and predict each other's needs;
Identify changes in team, task, or teammates
Closed‐loop communication Acknowledgement and confirmation of information received Follow up with team members to ensure message received;
Acknowledge that message was received;
Clarify information received
Mutual trust Shared belief that team members will perform their roles Share information;
Willingly admit mistakes and accept feedback

CHALLENGES TO EFFECTIVE TEAMWORK

Several important and unique barriers to teamwork exist in hospitals. Teams are large and formed in an ad hoc fashion. On a given day, a patient's hospital team might include a hospitalist, a nurse, a case manager, a pharmacist, and 1 or more consulting physicians and therapists. Team members in each respective discipline care for multiple patients at the same time, yet few hospitals align team membership (ie, patient assignment). Therefore, a nurse caring for 4 patients may interact with 4 different hospitalists. Similarly, a hospitalist caring for 14 patients may interact with multiple nurses in a given day. Team membership is ever changing because hospital professionals work in shifts and rotations. Finally, team members are seldom in the same place at the same time because physicians often care for patients on multiple units and floors, while nurses and other team members are often unit‐based. Salas and others have noted that team size, instability, and geographic dispersion of membership serve as important barriers to improving teamwork.25, 26 As a result of these barriers, nurses and physicians do not communicate consistently, and often disagree on the daily plan of care for their patients.27, 28 When communication does occur, clinicians may overestimate how well their messages are understood by other team members, reflecting a phenomenon well known in communication psychology related to egocentric thought processes.29, 30

The traditionally steep hierarchy within medicine may also serve as a barrier to teamwork. Studies in intensive care units (ICUs), operating rooms, and general medical units reveal widely discrepant views on the quality of collaboration and communication between healthcare professionals.3133 Although physicians generally give high ratings to the quality of collaboration with nurses, nurses consistently rate the quality of collaboration with physicians as poor. Similarly, specialist physicians rate collaboration with hospitalists higher than hospitalists rate collaboration with specialists.33 Effective teams in other high‐risk industries, like aviation, strive to flatten hierarchy so that team members feel comfortable raising concerns and engaging in open and respectful communications.34

The effect of technology on communication practices and teamwork is complex and incompletely understood. The implementation of electronic heath records and computerized provider order entry systems fundamentally changes work‐flow, and may result in less synchronization and feedback during nurse‐physician collaboration.35 Similarly, the expanded use of text messages delivered via alphanumeric paging or mobile phone results in a transition toward asynchronous modes of communication. These asynchronous modes allow healthcare professionals to review and respond to messages at their convenience, and may reduce unnecessary interruptions. Research shows that these systems are popular among clinicians.3638 However, receipt and understanding of the intended message may not be confirmed with the use of asynchronous modes of communication. Moreover, important face‐to‐face communication elements (tone of voice, expression, gesture, eye contract)39, 40 are lacking. One promising approach is a system which sends low‐priority messages to a Web‐based task list for periodic review, while allowing higher priority messages to pass through to an alphanumeric pager and interrupt the intended recipient.41 Another common frustration in hospitals, despite advancing technology, is difficulty identifying the correct physician(s) and nurse(s) caring for a particular patient at a given point in time.33 Wong and colleagues found that 14% of pages in their hospital were initially sent to the wrong physician.42

ASSESSMENT OF TEAMWORK

One of the challenges in improving teamwork is the difficulty in measuring it. Teamwork assessment entails measuring the performance of teams composed of multiple individuals. Methods of teamwork assessment can be broadly categorized as self assessment, peer assessment, direct observation, survey of team climate or culture, and measurement of the outcome of effective teamwork. While self‐report tools are easy to administer and can capture affective components influencing team performance, they may not reflect actual skills on the part of individuals or teams. Peer assessment includes the use of 360‐degree evaluations or multisource feedback, and provides an evaluation of individual performance.4347

Direct observation provides a more accurate assessment of team‐related behaviors using trained observers. Observers use checklists and/or behaviorally anchored rating scales (BARS) to evaluate individual and team performance. A number of BARS have been developed and validated for the evaluation of team performance.4852 Of note, direct observation may be difficult in settings in which team members are not in the same place at the same time. An alternative method, which may be better suited for general medical units, is the use of survey instruments designed to assess attitudes and teamwork climate.5355 Importantly, higher survey ratings of collaboration and teamwork have been associated with better patient outcomes in observational studies.5658

The ultimate goal of teamwork efforts is to improve patient outcomes. Because patient outcomes are affected by a number of factors and because hospitals frequently engage in multiple, simultaneous efforts to improve care, it is often difficult to clearly link improved outcomes with teamwork interventions. Continued efforts to rigorously evaluate teamwork interventions should remain a priority, particularly as the cost of these interventions must be weighed against other interventions and investments.

EXAMPLES OF SUCCESSFUL INTERVENTIONS

A number of interventions have been used to improve teamwork in hospitals (see Table 2).

Interventions to Improve Teamwork in Hospitals
Intervention Advantages Disadvantages
Localization of physicians Increases frequency of nurse‐physician communication; provides foundation for additional interventions Insufficient in creating a shared mental model; does not specifically enhance communication skills
Daily goals‐of‐care forms and checklists Provides structure to interdisciplinary discussions and ensures input from all team members May be completed in a perfunctory manner and may not be updated as plans of care evolve
Teamwork training Emphasizes improved communication behaviors relevant across a range of team member interactions Requires time and deliberate practice of new skills; effect may be attenuated if members are dispersed.
Interdisciplinary rounds Provides a forum for regular interdisciplinary communication Requires leadership to organize discussion and does not address need for updates as plans of care evolve

Geographic Localization of Physicians

As mentioned earlier, physicians in large hospitals may care for patients on multiple units or floors. Designating certain physicians to care for patients admitted to specific units may improve efficiency and communication among healthcare professionals. One study recently reported on the effect of localization of hospital physicians to specific patient care units. Localization resulted in an increase in the rate of nurse‐physician communication, but did not improve providers' shared understanding of the plan of care.56 Notably, localizing physicians may improve the feasibility of additional interventions, like teamwork training and interdisciplinary rounds.

Daily Goals of Care and Surgery Safety Checklists

In ICU and operating room settings, physicians and nurses work in proximity, allowing interdisciplinary discussions to occur at the bedside. The finding that professionals in ICUs and operating rooms have widely discrepant views on the quality of collaboration31, 32 indicates that proximity, alone, is not sufficient for effective communication. Pronovost et al. used a daily goals form for bedside ICU rounds in an effort to standardize communication about the daily plan of care.57 The form defined essential goals of care for patients, and its use resulted in a significant improvement in the team's understanding of the daily goals. Narasimhan et al. performed a similar study using a daily goals worksheet during ICU rounds,58 and also found a significant improvement in physicians' and nurses' ratings of their understanding of the goals of care. The forms used in these studies provided structure to the interdisciplinary conversations during rounds to create a shared understanding of patients' plans of care.

Haynes and colleagues recently reported on the use of a surgical safety checklist in a large, multicenter pre‐post study.59 The checklist consisted of verbal confirmation of the completion of basic steps essential to safe care in the operating room, and provided structure to communication among surgical team members to ensure a shared understanding of the operative plan. The intervention resulted in a significant reduction in inpatient complications and mortality.

Team Training

Formalized team training, based on crew resource management, has been studied as a potential method to improve teamwork in a variety of medical settings.6062 Training emphasizes the core components of successful teamwork and essential coordinating mechanisms previously mentioned.23 Team training appears to positively influence culture, as assessed by teamwork and patient safety climate survey instruments.60 Based on these findings and extensive research demonstrating the success of teamwork training in aviation,63 the Agency for Healthcare Research and Quality (AHRQ) and the Department of Defense (DoD) have partnered in offering the Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) program, designed to improve teamwork skills for healthcare professionals.64, 65

Only a handful of studies have evaluated the effectiveness of teamwork training programs on patient outcomes, and the results are mixed.66 Morey et al. found a reduction in the rate of observed errors as a result of teamwork training in emergency departments, but observers in the study were not blinded with regard to whether teams had undergone training.61 A research group in the United Kingdom evaluated the benefit of simulation‐based team training on outcomes in an obstetrical setting.67, 68 Training included management of specific complications, including shoulder dystocia and uterine cord prolapse. Using retrospective chart review, the investigators found a significant reduction in the proportion of babies born with an obstetric brachial palsy injury and a reduction in the time from diagnosis of uterine cord prolapse to infant delivery. Nielsen and colleagues also evaluated the use of teamwork training in an obstetric setting.62 In a cluster randomized controlled trial, the investigators found no reduction in the rate of adverse outcomes. Differences in the duration of teamwork training and the degree of emphasis on deliberate practice of new skills (eg, with the use of simulation‐based training) likely explains the lack of consistent results.

Very little research has evaluated teamwork training in the general medical environment.69, 70 Sehgal and colleagues recently published an evaluation of the effect of teamwork training delivered to internal medicine residents, hospitalists, nurses, pharmacists, case managers, and social workers on medical services in 3 Northern California hospitals.69 The 4‐hour training sessions covered topical areas of safety culture, teamwork, and communication through didactics, videos, facilitated discussions, and small group role plays to practice new skills and behaviors. The intervention was rated highly among participants,69 and the training along with subsequent follow‐up interventions resulted in improved patient perceptions of teamwork and communication but had no impact on key patient outcomes.71

Interdisciplinary Rounds

Interdisciplinary rounds (IDR) have been used for many years as a means to assemble team members in a single location,7275 and the use of IDR has been associated with lower mortality among ICU patients.76 Interdisciplinary rounds may be particularly useful for clinical settings in which team members are traditionally dispersed in time and place, such as medical‐surgical units. Recent studies have evaluated the effect of structured inter‐disciplinary rounds (SIDR),77, 78 which combine a structured format for communication, similar to a daily goals‐of‐care form, with a forum for daily interdisciplinary meetings. Though no effect was seen on length of stay or cost, SIDR resulted in significantly higher ratings of the quality of collaboration and teamwork climate, and a reduction in the rate of AEs.79 Importantly, the majority of clinicians in the studies agreed that SIDR improved the efficiency of their work day, and expressed a desire that SIDR continue indefinitely. Many investigators have emphasized the importance of leadership during IDR, often by a medical director, nurse manager, or both.74, 77, 78

Summary of Interventions to Improve Teamwork

Localization of physicians increases the frequency of nurse‐physician communication, but is insufficient in creating a shared understanding of patients' plans of care. Providing structure for the discussion among team members (eg, daily goals of care forms and checklists) ensures that critical elements of the plan of care are communicated. Teamwork training is based upon a strong foundation of research both inside and outside of healthcare, and has demonstrated improved knowledge of teamwork principles, attitudes about the importance of teamwork, and overall safety climate. Creating a forum for team members to assemble and discuss their patients (eg, IDR) can overcome some of the unique barriers to collaboration in settings where members are dispersed in time and space. Leaders wishing to improve interdisciplinary teamwork should consider implementing a combination of complementary interventions. For example, localization may increase the frequency of team member interactions, the quality of which may be enhanced with teamwork training and reinforced with the use of structured communication tools and IDR. Future research should evaluate the effect of these combined interventions.

CONCLUSIONS

In summary, teamwork is critically important to provide safe and effective care. Important and unique barriers to teamwork exist in hospitals. We recommend the use of survey instruments, such as those mentioned earlier, as the most feasible method to assess teamwork in the general medical setting. Because each intervention addresses only a portion of the barriers to optimal teamwork, we encourage leaders to use a multifaceted approach. We recommend the implementation of a combination of interventions with adaptations to fit unique clinical settings and local culture.

Acknowledgements

This manuscript was prepared as part of the High Performance Teams and the Hospital of the Future project, a collaborative effort including senior leadership from the American College of Physician Executives, the American Hospital Association, the American Organization of Nurse Executives, and the Society of Hospital Medicine. The authors thank Taylor Marsh for her administrative support and help in coordinating project meetings.

Teamwork is important in providing high‐quality hospital care. Despite tremendous efforts in the 10 years since publication of the Institute of Medicine's To Err is Human report,1 hospitalized patients remain at risk for adverse events (AEs).2 Although many AEs are not preventable, a large portion of those which are identified as preventable can be attributed to communication and teamwork failures.35 A Joint Commission study indicated that communication failures were the root cause for two‐thirds of the 3548 sentinel events reported from 1995 to 2005.6 Another study, involving interviews of resident physicians about recent medical mishaps, found that communication failures contributed to 91% of the AEs they reported.5

Teamwork also plays an important role in other aspects of hospital care delivery. Patients' ratings of nurse‐physician coordination correlate with their overall perception of the quality of care received.7, 8 A study of Veterans Health Administration (VHA) hospitals found that teamwork culture was significantly and positively associated with overall patient satisfaction.9 Another VHA study found that hospitals with higher teamwork culture ratings had lower nurse resignations rates.10 Furthermore, poor teamwork within hospitals may have an adverse effect on financial performance, as a result of inefficiencies in physician and nurse workflow.11

Some organizations are capable of operating in complex, hazardous environments while maintaining exceptional performance over long periods of time. These high reliability organizations (HRO) include aircraft carriers, air traffic control systems, and nuclear power plants, and are characterized by their preoccupation with failure, reluctance to simplify interpretations, sensitivity to operations, commitment to resilience, and deference to expertise.12, 13 Preoccupation with failure is manifested by an organization's efforts to avoid complacency and persist in the search for additional risks. Reluctance to simplify interpretations is exemplified by an interest in pursuing a deep understanding of the issues that arise. Sensitivity to operations is the close attention paid to input from front‐line personnel and processes. Commitment to resilience relates to an organization's ability to contain errors once they occur and mitigate harm. Deference to expertise describes the practice of having authority migrate to the people with the most expertise, regardless of rank. Collectively, these qualities produce a state of mindfulness, allowing teams to anticipate and become aware of unexpected events, yet also quickly contain and learn from them. Recent publications have highlighted the need for hospitals to learn from HROs and the teams within them.14, 15

Recognizing the importance of teamwork in hospitals, senior leadership from the American College of Physician Executives (ACPE), the American Hospital Association (AHA), the American Organization of Nurse Executives (AONE), and the Society of Hospital Medicine (SHM) established the High Performance Teams and the Hospital of the Future project. This collaborative learning effort aims to redesign care delivery to provide optimal value to hospitalized patients. As an initial step, the High Performance Teams and the Hospital of the Future project team completed a literature review related to teamwork in hospitals. The purpose of this report is to summarize the current understanding of teamwork, describe interventions designed to improve teamwork, and make practical recommendations for hospitals to assess and improve teamwork‐related performance. We approach teamwork from the hospitalized patient's perspective, and restrict our discussion to interactions occurring among healthcare professionals within the hospital. We recognize the importance of teamwork at all points in the continuum of patient care. Highly functional inpatient teams should be integrated into an overall system of coordinated and collaborative care.

TEAMWORK: DEFINITION AND CONSTRUCTS

Physicians, nurses, and other healthcare professionals spend a great deal of their time on communication and coordination of care activities.1618 In spite of this and the patient safety concerns previously noted, interpersonal communication skills and teamwork have been historically underemphasized in professional training.1922 A team is defined as 2 or more individuals with specified roles interacting adaptively, interdependently, and dynamically toward a shared and common goal.23 Elements of effective teamwork have been identified through research conducted in aviation, the military, and more recently, healthcare. Salas and colleagues have synthesized this research into 5 core components: team leadership, mutual performance monitoring, backup behavior, adaptability, and team orientation (see Table 1).23 Additionally, 3 supporting and coordinating mechanisms are essential for effective teamwork: shared mental model, closed‐loop communication, and mutual trust (see Table 1).23 High‐performing teams use these elements to develop a culture for speaking up, and situational awareness among team members. Situational awareness refers to a person's perception and understanding of their dynamic environment, and human errors often result from a lack of such awareness.24 These teamwork constructs provide the foundational basis for understanding how hospitals can identify teamwork challenges, assess team performance, and design effective interventions.

Teamwork Components and Coordinating Mechanisms
Teamwork Definition Behavioral Examples
  • NOTE: Adapted from Baker et al.22

Component
Team leadership The leader directs and coordinates team members activities Facilitate team problem solving;
Provide performance expectations;
Clarify team member roles;
Assist in conflict resolution
Mutual performance monitoring Team members are able to monitor one another's performance Identify mistakes and lapses in other team member actions;
Provide feedback to fellow team members to facilitate self‐correction
Backup behavior Team members anticipate and respond to one another's needs Recognize workload distribution problem;
Shift work responsibilities to underutilized members
Adaptability The team adjusts strategies based on new information Identify cues that change has occurred and develop plan to deal with changes;
Remain vigilant to change in internal and external environment
Team orientation Team members prioritize team goals above individual goals Take into account alternate solutions by teammates;
Increased task involvement, information sharing, and participatory goal setting
Coordinating mechanism
Shared mental model An organizing knowledge of the task of the team and how members will interact to achieve their goal Anticipate and predict each other's needs;
Identify changes in team, task, or teammates
Closed‐loop communication Acknowledgement and confirmation of information received Follow up with team members to ensure message received;
Acknowledge that message was received;
Clarify information received
Mutual trust Shared belief that team members will perform their roles Share information;
Willingly admit mistakes and accept feedback

CHALLENGES TO EFFECTIVE TEAMWORK

Several important and unique barriers to teamwork exist in hospitals. Teams are large and formed in an ad hoc fashion. On a given day, a patient's hospital team might include a hospitalist, a nurse, a case manager, a pharmacist, and 1 or more consulting physicians and therapists. Team members in each respective discipline care for multiple patients at the same time, yet few hospitals align team membership (ie, patient assignment). Therefore, a nurse caring for 4 patients may interact with 4 different hospitalists. Similarly, a hospitalist caring for 14 patients may interact with multiple nurses in a given day. Team membership is ever changing because hospital professionals work in shifts and rotations. Finally, team members are seldom in the same place at the same time because physicians often care for patients on multiple units and floors, while nurses and other team members are often unit‐based. Salas and others have noted that team size, instability, and geographic dispersion of membership serve as important barriers to improving teamwork.25, 26 As a result of these barriers, nurses and physicians do not communicate consistently, and often disagree on the daily plan of care for their patients.27, 28 When communication does occur, clinicians may overestimate how well their messages are understood by other team members, reflecting a phenomenon well known in communication psychology related to egocentric thought processes.29, 30

The traditionally steep hierarchy within medicine may also serve as a barrier to teamwork. Studies in intensive care units (ICUs), operating rooms, and general medical units reveal widely discrepant views on the quality of collaboration and communication between healthcare professionals.3133 Although physicians generally give high ratings to the quality of collaboration with nurses, nurses consistently rate the quality of collaboration with physicians as poor. Similarly, specialist physicians rate collaboration with hospitalists higher than hospitalists rate collaboration with specialists.33 Effective teams in other high‐risk industries, like aviation, strive to flatten hierarchy so that team members feel comfortable raising concerns and engaging in open and respectful communications.34

The effect of technology on communication practices and teamwork is complex and incompletely understood. The implementation of electronic heath records and computerized provider order entry systems fundamentally changes work‐flow, and may result in less synchronization and feedback during nurse‐physician collaboration.35 Similarly, the expanded use of text messages delivered via alphanumeric paging or mobile phone results in a transition toward asynchronous modes of communication. These asynchronous modes allow healthcare professionals to review and respond to messages at their convenience, and may reduce unnecessary interruptions. Research shows that these systems are popular among clinicians.3638 However, receipt and understanding of the intended message may not be confirmed with the use of asynchronous modes of communication. Moreover, important face‐to‐face communication elements (tone of voice, expression, gesture, eye contract)39, 40 are lacking. One promising approach is a system which sends low‐priority messages to a Web‐based task list for periodic review, while allowing higher priority messages to pass through to an alphanumeric pager and interrupt the intended recipient.41 Another common frustration in hospitals, despite advancing technology, is difficulty identifying the correct physician(s) and nurse(s) caring for a particular patient at a given point in time.33 Wong and colleagues found that 14% of pages in their hospital were initially sent to the wrong physician.42

ASSESSMENT OF TEAMWORK

One of the challenges in improving teamwork is the difficulty in measuring it. Teamwork assessment entails measuring the performance of teams composed of multiple individuals. Methods of teamwork assessment can be broadly categorized as self assessment, peer assessment, direct observation, survey of team climate or culture, and measurement of the outcome of effective teamwork. While self‐report tools are easy to administer and can capture affective components influencing team performance, they may not reflect actual skills on the part of individuals or teams. Peer assessment includes the use of 360‐degree evaluations or multisource feedback, and provides an evaluation of individual performance.4347

Direct observation provides a more accurate assessment of team‐related behaviors using trained observers. Observers use checklists and/or behaviorally anchored rating scales (BARS) to evaluate individual and team performance. A number of BARS have been developed and validated for the evaluation of team performance.4852 Of note, direct observation may be difficult in settings in which team members are not in the same place at the same time. An alternative method, which may be better suited for general medical units, is the use of survey instruments designed to assess attitudes and teamwork climate.5355 Importantly, higher survey ratings of collaboration and teamwork have been associated with better patient outcomes in observational studies.5658

The ultimate goal of teamwork efforts is to improve patient outcomes. Because patient outcomes are affected by a number of factors and because hospitals frequently engage in multiple, simultaneous efforts to improve care, it is often difficult to clearly link improved outcomes with teamwork interventions. Continued efforts to rigorously evaluate teamwork interventions should remain a priority, particularly as the cost of these interventions must be weighed against other interventions and investments.

EXAMPLES OF SUCCESSFUL INTERVENTIONS

A number of interventions have been used to improve teamwork in hospitals (see Table 2).

Interventions to Improve Teamwork in Hospitals
Intervention Advantages Disadvantages
Localization of physicians Increases frequency of nurse‐physician communication; provides foundation for additional interventions Insufficient in creating a shared mental model; does not specifically enhance communication skills
Daily goals‐of‐care forms and checklists Provides structure to interdisciplinary discussions and ensures input from all team members May be completed in a perfunctory manner and may not be updated as plans of care evolve
Teamwork training Emphasizes improved communication behaviors relevant across a range of team member interactions Requires time and deliberate practice of new skills; effect may be attenuated if members are dispersed.
Interdisciplinary rounds Provides a forum for regular interdisciplinary communication Requires leadership to organize discussion and does not address need for updates as plans of care evolve

Geographic Localization of Physicians

As mentioned earlier, physicians in large hospitals may care for patients on multiple units or floors. Designating certain physicians to care for patients admitted to specific units may improve efficiency and communication among healthcare professionals. One study recently reported on the effect of localization of hospital physicians to specific patient care units. Localization resulted in an increase in the rate of nurse‐physician communication, but did not improve providers' shared understanding of the plan of care.56 Notably, localizing physicians may improve the feasibility of additional interventions, like teamwork training and interdisciplinary rounds.

Daily Goals of Care and Surgery Safety Checklists

In ICU and operating room settings, physicians and nurses work in proximity, allowing interdisciplinary discussions to occur at the bedside. The finding that professionals in ICUs and operating rooms have widely discrepant views on the quality of collaboration31, 32 indicates that proximity, alone, is not sufficient for effective communication. Pronovost et al. used a daily goals form for bedside ICU rounds in an effort to standardize communication about the daily plan of care.57 The form defined essential goals of care for patients, and its use resulted in a significant improvement in the team's understanding of the daily goals. Narasimhan et al. performed a similar study using a daily goals worksheet during ICU rounds,58 and also found a significant improvement in physicians' and nurses' ratings of their understanding of the goals of care. The forms used in these studies provided structure to the interdisciplinary conversations during rounds to create a shared understanding of patients' plans of care.

Haynes and colleagues recently reported on the use of a surgical safety checklist in a large, multicenter pre‐post study.59 The checklist consisted of verbal confirmation of the completion of basic steps essential to safe care in the operating room, and provided structure to communication among surgical team members to ensure a shared understanding of the operative plan. The intervention resulted in a significant reduction in inpatient complications and mortality.

Team Training

Formalized team training, based on crew resource management, has been studied as a potential method to improve teamwork in a variety of medical settings.6062 Training emphasizes the core components of successful teamwork and essential coordinating mechanisms previously mentioned.23 Team training appears to positively influence culture, as assessed by teamwork and patient safety climate survey instruments.60 Based on these findings and extensive research demonstrating the success of teamwork training in aviation,63 the Agency for Healthcare Research and Quality (AHRQ) and the Department of Defense (DoD) have partnered in offering the Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) program, designed to improve teamwork skills for healthcare professionals.64, 65

Only a handful of studies have evaluated the effectiveness of teamwork training programs on patient outcomes, and the results are mixed.66 Morey et al. found a reduction in the rate of observed errors as a result of teamwork training in emergency departments, but observers in the study were not blinded with regard to whether teams had undergone training.61 A research group in the United Kingdom evaluated the benefit of simulation‐based team training on outcomes in an obstetrical setting.67, 68 Training included management of specific complications, including shoulder dystocia and uterine cord prolapse. Using retrospective chart review, the investigators found a significant reduction in the proportion of babies born with an obstetric brachial palsy injury and a reduction in the time from diagnosis of uterine cord prolapse to infant delivery. Nielsen and colleagues also evaluated the use of teamwork training in an obstetric setting.62 In a cluster randomized controlled trial, the investigators found no reduction in the rate of adverse outcomes. Differences in the duration of teamwork training and the degree of emphasis on deliberate practice of new skills (eg, with the use of simulation‐based training) likely explains the lack of consistent results.

Very little research has evaluated teamwork training in the general medical environment.69, 70 Sehgal and colleagues recently published an evaluation of the effect of teamwork training delivered to internal medicine residents, hospitalists, nurses, pharmacists, case managers, and social workers on medical services in 3 Northern California hospitals.69 The 4‐hour training sessions covered topical areas of safety culture, teamwork, and communication through didactics, videos, facilitated discussions, and small group role plays to practice new skills and behaviors. The intervention was rated highly among participants,69 and the training along with subsequent follow‐up interventions resulted in improved patient perceptions of teamwork and communication but had no impact on key patient outcomes.71

Interdisciplinary Rounds

Interdisciplinary rounds (IDR) have been used for many years as a means to assemble team members in a single location,7275 and the use of IDR has been associated with lower mortality among ICU patients.76 Interdisciplinary rounds may be particularly useful for clinical settings in which team members are traditionally dispersed in time and place, such as medical‐surgical units. Recent studies have evaluated the effect of structured inter‐disciplinary rounds (SIDR),77, 78 which combine a structured format for communication, similar to a daily goals‐of‐care form, with a forum for daily interdisciplinary meetings. Though no effect was seen on length of stay or cost, SIDR resulted in significantly higher ratings of the quality of collaboration and teamwork climate, and a reduction in the rate of AEs.79 Importantly, the majority of clinicians in the studies agreed that SIDR improved the efficiency of their work day, and expressed a desire that SIDR continue indefinitely. Many investigators have emphasized the importance of leadership during IDR, often by a medical director, nurse manager, or both.74, 77, 78

Summary of Interventions to Improve Teamwork

Localization of physicians increases the frequency of nurse‐physician communication, but is insufficient in creating a shared understanding of patients' plans of care. Providing structure for the discussion among team members (eg, daily goals of care forms and checklists) ensures that critical elements of the plan of care are communicated. Teamwork training is based upon a strong foundation of research both inside and outside of healthcare, and has demonstrated improved knowledge of teamwork principles, attitudes about the importance of teamwork, and overall safety climate. Creating a forum for team members to assemble and discuss their patients (eg, IDR) can overcome some of the unique barriers to collaboration in settings where members are dispersed in time and space. Leaders wishing to improve interdisciplinary teamwork should consider implementing a combination of complementary interventions. For example, localization may increase the frequency of team member interactions, the quality of which may be enhanced with teamwork training and reinforced with the use of structured communication tools and IDR. Future research should evaluate the effect of these combined interventions.

CONCLUSIONS

In summary, teamwork is critically important to provide safe and effective care. Important and unique barriers to teamwork exist in hospitals. We recommend the use of survey instruments, such as those mentioned earlier, as the most feasible method to assess teamwork in the general medical setting. Because each intervention addresses only a portion of the barriers to optimal teamwork, we encourage leaders to use a multifaceted approach. We recommend the implementation of a combination of interventions with adaptations to fit unique clinical settings and local culture.

Acknowledgements

This manuscript was prepared as part of the High Performance Teams and the Hospital of the Future project, a collaborative effort including senior leadership from the American College of Physician Executives, the American Hospital Association, the American Organization of Nurse Executives, and the Society of Hospital Medicine. The authors thank Taylor Marsh for her administrative support and help in coordinating project meetings.

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References
  1. To Err Is Human: Building a Safer Health System.Washington, DC:Institute of Medicine;1999.
  2. Landrigan CP,Parry GJ,Bones CB,Hackbarth AD,Goldmann DA,Sharek PJ.Temporal trends in rates of patient harm resulting from medical care.N Engl J Med.2010;363(22):21242134.
  3. Neale G,Woloshynowych M,Vincent C.Exploring the causes of adverse events in NHS hospital practice.J R Soc Med.2001;94(7):322330.
  4. Wilson RM,Runciman WB,Gibberd RW,Harrison BT,Newby L,Hamilton JD.The Quality in Australian Health Care Study.Med J Aust.1995;163(9):458471.
  5. Sutcliffe KM,Lewton E,Rosenthal MM.Communication failures: an insidious contributor to medical mishaps.Acad Med.2004;79(2):186194.
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  7. Beaudin CL,Lammers JC,Pedroja AT.Patient perceptions of coordinated care: the importance of organized communication in hospitals.J Healthc Qual.1999;21(5):1823.
  8. Wolosin RJ,Vercler L,Matthews JL.Am I safe here? Improving patients' perceptions of safety in hospitals.J Nurs Care Qual.2006;21(1):3040.
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  47. Musick DW,McDowell SM,Clark N,Salcido R.Pilot study of a 360‐degree assessment instrument for physical medicine 82(5):394402.
  48. Fletcher G,Flin R,McGeorge P,Glavin R,Maran N,Patey R.Anaesthetists' Non‐Technical Skills (ANTS): evaluation of a behavioural marker system.Br J Anaesth.2003;90(5):580588.
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  52. Sevdalis N,Lyons M,Healey AN,Undre S,Darzi A,Vincent CA.Observational teamwork assessment for surgery: construct validation with expert versus novice raters.Ann Surg.2009;249(6):10471051.
  53. Sexton JB,Helmreich RL,Neilands TB, et al.The Safety Attitudes Questionnaire: psychometric properties, benchmarking data, and emerging research.BMC Health Serv Res.2006;6:44.
  54. Baggs JG.Development of an instrument to measure collaboration and satisfaction about care decisions.J Adv Nurs.1994;20(1):176182.
  55. Hojat M,Fields SK,Veloski JJ,Griffiths M,Cohen MJ,Plumb JD.Psychometric properties of an attitude scale measuring physician‐nurse collaboration.Eval Health Prof.1999;22(2):208220.
  56. O'Leary KJ,Wayne DB,Landler MP, et al.Impact of localizing physicians to hospital units on nurse‐physician communication and agreement on the plan of care.J Gen Intern Med.2009;24(11):12231227.
  57. Pronovost P,Berenholtz S,Dorman T,Lipsett PA,Simmonds T,Haraden C.Improving communication in the ICU using daily goals.J Crit Care.2003;18(2):7175.
  58. Narasimhan M,Eisen LA,Mahoney CD,Acerra FL,Rosen MJ.Improving nurse‐physician communication and satisfaction in the intensive care unit with a daily goals worksheet.Am J Crit Care.2006;15(2):217222.
  59. Haynes AB,Weiser TG,Berry WR, et al.A surgical safety checklist to reduce morbidity and mortality in a global population.N Engl J Med.2009;360(5):491499.
  60. Haller G,Garnerin P,Morales MA, et al.Effect of crew resource management training in a multidisciplinary obstetrical setting.Int J Qual Health Care.2008;20(4):254263.
  61. Morey JC,Simon R,Jay GD, et al.Error reduction and performance improvement in the emergency department through formal teamwork training: evaluation results of the MedTeams project.Health Serv Res.2002;37(6):15531581.
  62. Nielsen PE,Goldman MB,Mann S, et al.Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial.Obstet Gynecol.2007;109(1):4855.
  63. Baker DP,Gustafson S,Beaubien J,Salas E,Barach P.Medical Teamwork and Patient Safety: The Evidence‐Based Relation.Rockville, MD:Agency for Healthcare Research and Quality;2005.
  64. Agency for Healthcare Research and Quality. TeamSTEPPS Home. Available at: http://teamstepps.ahrq.gov/index.htm. Accessed January 18,2010.
  65. Clancy CM,Tornberg DN.TeamSTEPPS: assuring optimal teamwork in clinical settings.Am J Med Qual.2007;22(3):214217.
  66. Salas E,Wilson KA,Burke CS,Wightman DC.Does crew resource management training work? An update, an extension, and some critical needs.Hum Factors.2006;48(2):392412.
  67. Draycott TJ,Crofts JF,Ash JP, et al.Improving neonatal outcome through practical shoulder dystocia training.Obstet Gynecol.2008;112(1):1420.
  68. Siassakos D,Hasafa Z,Sibanda T, et al.Retrospective cohort study of diagnosis‐delivery interval with umbilical cord prolapse: the effect of team training.Br J Obstet Gynaecol.2009;116(8):10891096.
  69. Sehgal NL,Fox M,Vidyarthi AR, et al.A multidisciplinary teamwork training program: the Triad for Optimal Patient Safety (TOPS) experience.J Gen Intern Med.2008;23(12):20532057.
  70. Stoller JK,Rose M,Lee R,Dolgan C,Hoogwerf BJ.Teambuilding and leadership training in an internal medicine residency training program.J Gen Intern Med.2004;19(6):692697.
  71. Auerbach AA,Sehgal NL,Blegen MA, et al. Effects of a multicenter teamwork and communication program on patient outcomes: results from the Triad for Optimal Patient Safety (TOPS) project. In press.
  72. Cowan MJ,Shapiro M,Hays RD, et al.The effect of a multidisciplinary hospitalist/physician and advanced practice nurse collaboration on hospital costs.J Nurs Adm.2006;36(2):7985.
  73. Curley C,McEachern JE,Speroff T.A firm trial of interdisciplinary rounds on the inpatient medical wards: an intervention designed using continuous quality improvement.Med Care.1998;36(8 suppl):AS4A12.
  74. O'Mahony S,Mazur E,Charney P,Wang Y,Fine J.Use of multidisciplinary rounds to simultaneously improve quality outcomes, enhance resident education, and shorten length of stay.J Gen Intern Med.2007;22(8):10731079.
  75. Vazirani S,Hays RD,Shapiro MF,Cowan M.Effect of a multidisciplinary intervention on communication and collaboration among physicians and nurses.Am J Crit Care.2005;14(1):7177.
  76. Kim MM,Barnato AE,Angus DC,Fleisher LF,Kahn JM.The effect of multidisciplinary care teams on intensive care unit mortality.Arch Intern Med.2010;170(4):369376.
  77. O'Leary KJ,Haviley C,Slade ME,Shah HM,Lee J,Williams MV.Improving teamwork: impact of structured interdisciplinary rounds on a hospitalist unit.J Hosp Med.2011;6(2):8893.
  78. O'Leary KJ,Wayne DB,Haviley C,Slade ME,Lee J,Williams MV.Improving teamwork: impact of structured interdisciplinary rounds on a medical teaching unit.J Gen Intern Med.2010;25(8):826832.
  79. O'Leary KJ,Buck R,Fligiel HM, et al.Structured interdisciplinary rounds in a medical teaching unit: improving patient safety.Arch Intern Med.2011;171(7):678684.
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Comparing the pulmonary embolism severity index and the prognosis in pulmonary embolism scores as risk stratification tools

Acute pulmonary embolism (PE) is associated with significant morbidity and mortality.1 While expeditious diagnosis and management results in reduced mortality, the ability to rapidly and accurately identify those at increased risk for death remains elusive. Multiple studies have utilized various biomarkers as risk stratification tools, however, these approaches have proven to have many limitations. For example, both serum brain natriuretic peptide (BNP) and troponin levels have been studied as possible risk stratification tools. Those with elevated levels of these following a PE may have concomitant right ventricular (RV) dysfunction and/or hemodynamic instability. Thus, they may face a greater risk for cardiovascular collapse and death. The low positive predictive value of these biomarkers (14%‐44%) has limited their clinical utility.24 Furthermore, imaging modalities, such as echocardiography, which is considered the clinical gold standard for determining the presence of acute RV dysfunction in PE, may not be readily available and may require special expertise for interpretation.5

Conversely, the need to identify acute PE patients at low risk for death is just as important. Recent studies suggest that carefully selected patients can successfully be managed as outpatients which can subsequently lead to significant cost savings and patient satisfaction. Movement towards enhanced outpatient resources and the advent of subcutaneous anticoagulants have made outpatient management of acute PE an appealing possibility. However, proper education, close follow‐up, and a rigorous selection process to recognize those at minimal risk for a fatal complication must all be available before clinicians prematurely discharge these patients to home.

Recently, clinical scoring tools have been developed to aid in risk stratifying patients with acute PE to accurately determine patient outcome. The pulmonary embolism severity index (PESI) is a reproducible scoring system that accurately predicts 30‐day and 90‐day mortality.6, 7 It consists of 11 clinical variables that can be quickly assessed at the time of diagnosis (Table 1A). The fact that biomarkers and imaging technology, such as echocardiography, are unnecessary to compute a PESI score demonstrates the appeal of this system. Similar to the PESI, Sanchez et al.8 have proposed the prognosis in pulmonary embolism (PREP) score as an alternate clinical risk tool in PE (Table 1B). Contrary to PESI, the PREP only uses 3 clinical variables to accurately predict vital outcome with an area under the receiver operating characteristic (AUROC) curve of 0.73 (95% confidence interval [CI], 0.65‐0.82). While both scoring systems have been developed to predict 30‐day mortality in acute PE, the comparative validity of these prognostic tools has not been assessed.

Pulmonary Embolism Severity Index
PredictorsPoints Assigned
  • Defined as disorientation, lethargy, stupor, or coma.

  • With or without use of supplemental oxygenation.

Demographic characteristics 
Age (yr)Age (yr)
Male sex+10
Comorbid conditions 
Cancer+30
Heart failure+10
Chronic lung disease+10
Clinical findings 
Pulse 110 beats/min+20
Systolic blood pressure <100 mm Hg+30
Respiratory rate 30 breaths/min+20
Temperature <36C+20
Altered mental status*+60
Arterial oxygen saturation <90%+20
Prognosis in Pulmonary Embolism Score
Prognostic FactorPoints Assigned
  • Altered mental status defined as disorientation, stupor, or coma.

Altered mental status*+10
Cardiogenic shock (systolic blood pressure <90 mm Hg)+6
Cancer+6

We hypothesized that the PESI more precisely risk stratifies the risk for death in acute PE compared to the PREP. Furthermore, we theorized that the PESI more reliably predicts not only 30‐day but also 90‐day mortality. To test our hypothesis, we performed a retrospective analysis, of all consecutive patients diagnosed with acute PE at our hospital, to compare the prognostic accuracy of these 2 scoring systems.

METHODS

Subjects and Definitions

Between October 2007 and February 2009, adults (age 18 years) diagnosed the day prior with acute PE were identified on a daily basis. This study cohort has been described elsewhere.7 Patients with newly diagnosed PE were eligible for enrollment. Those expected to die within 30 days of their acute PE, such as individuals suffering from a terminal condition (metastatic cancer) or critical illness being transitioned to comfort care, were excluded (n = 32). Patients with multiple admissions for acute PE were included only during the first episode. PE was diagnosed using objective criteria through 1 of the following modalities: high probability ventilation‐perfusion (V/Q) scintigraphy, computed tomography (CT) of the chest with PE protocol, or magnetic resonance imaging (MRI) of the chest. A list of patients who had the above imaging studies to evaluate for PE was provided to study personnel daily by the radiology department; this list was generated every morning and consisted of the day prior's studies. Patient management was not influenced by the research team and was the responsibility of the primary team. This study was approved by our local institutional review board and consent was not required.

We calculated the PESI as described by Aujesky and colleagues.6 For outpatients admitted with acute PE, clinical findings available just prior to, and after, diagnosis were used for scoring. For inpatients diagnosed with PE, clinical findings available during the 24 hours just prior to diagnosis were included. Raw PESI scores were converted to risk class (I‐V), and then further dichotomized into low‐risk (class I‐II) and high‐risk (class III‐V) groups (Table 2). The PREP score was computed based on the presence of altered mental status (AMS), cancer, and cardiogenic shock defined as a systolic blood pressure <90 mm Hg (Table 1B). A raw PREP score of <7 was then characterized as low risk for mortality, while scores 7 were considered high risk.

Class Stratification and Dichotimization of the PESI Score
PESI ScoreClassn30‐Day Mortality by Class (%)90‐Day Mortality by Class (%)Low vs High Risk
  • Abbreviations: PESI, pulmonary embolism severity index.

65I490 (0.0)0 (0.0)Low
66‐85II590 (0.0)0 (0.0)
86‐105III600 (0.0)0 (0.0)High
106‐125IV562 (3.4)4 (6.9)
>125V697 (9.2)8 (10.5)

Finally, the PESI and PREP scores were compared based on their ability to predict all‐cause 30‐day and 90‐day mortality. To determine vital status and date of death, we reviewed the Social Security Death Index 90 days after enrollment of all subjects was completed.

Statistical Analysis

To assess the predictive ability of the 2 scoring tools for death, we determined the negative predictive value and computed the AUROC curves for both scoring systems. AUROC curves were constructed for raw scores and when scores were further segregated by class and risk groups. Additionally, 95% CIs were estimated to determine the accuracy of the discriminatory power of the PESI score versus the PREP score.

Post hoc, we calculated the power of our study to assess whether the difference noted in AUROC curves between the PESI and PREP was adequate to truly determine statistical significance. We used methodology described by Hanley and McNeil to compare continuous values.9 Assuming an alpha of 0.05 and a 20% difference in the AUROC curves, as described in our results, the power in our study was 0.35. Therefore, an approximate sample size of 1000 would be necessary to determine statistical significance. This analysis was performed using Power Analysis and Sample Size (PASS) 11.

RESULTS

The final cohort included 302 subjects (mean age: 59.7 17.2 years; 44.0% males). As Table 3 reveals, the majority of PEs was diagnosed via CT scan (76%). On presentation, 6.6% had cardiogenic shock, while 5.0% had altered censorium. In terms of comorbid conditions, 25.2% had congestive heart failure, 25.2% had cancer, and 22.2% had a prior venous thromboembolic event. Overall, 3.0% and 4.0% met our primary outcomes of death within 30‐days and 90‐days of their acute PEs, respectively.

Baseline Demographics
  • Abbreviations: CT, computed tomography; MRA, magnetic resonance angiography; SD, standard deviation; V/Q, ventilation perfusion.

Demographics 
Age (yr), mean SD59.7 17.2
Male sex, %44%
Diagnostic methodology 
CT chest, n (%)230 (76.2)
V/Q scan, n (%)71 (23.5)
MRA chest, n (%)1 (0.3)
Comorbidities 
Malignancy, n (%)76 (25.2)
Congestive heart failure, n (%)76 (25.2)
Chronic lung disease, n (%)72 (23.8)
Recent orthopedic surgery, n (%)22 (7.3)
Prior cerebrovascular accident, n (%)31 (10.3)
Prior venous thromboembolic disease, n (%)67 (22.2)

The rates of 30‐day and 90‐day mortality, respectively, increased with increasing score for both the PESI and the PREP. No patients in PESI class I died by either time point, while 9.2% of PESI class V subjects expired by 30 days (P < 0.0001) and 10.5% died by 90 days (P = 0.003) (Table 2). Based on PESI, 30‐day death rates were 4.6% in the high‐risk cohort versus 0% in the low‐risk group (P = 0.023). Conversely, 7.1% of high‐risk PREP subjects died by day 30 versus 1% of low‐risk subjects (P = 0.004) (Figure 1A). Those stratified into the PESI high‐risk group had a 90‐day mortality of 6.2% versus 0% for the low‐risk group (P = 0.008) versus 9.1% in those deemed high risk by PREP, as compared to 1.5% of those scored as low risk by PREP (P = 0.001) (Figure 1B).

Figure 1
(A) Short‐term mortality rates comparing the PESI and the PREP risk groups. (B) Intermediate‐term mortality rate comparing the PESI and PREP risk groups. Abbreviations: PESI, pulmonary embolism severity index; PREP, prognosis in pulmonary embolism.

Regarding the 30‐day mortality, the negative predictive value of the PESI was 100% (95% CI, 98.6%‐100%) while that for PREP was 99.0% (95% CI, 97.6%‐99.7%); the ability of the PREP to predict 30‐day mortality was similar to the PESI (Table 4). The AUROCs for PESI and PREP for predicting 30‐day death were also equivalent; for the raw PESI score, this measured 0.858 (95% CI, 0.773‐0.943), compared to 0.719 (95% CI, 0.563‐0.875) for PREP. When these scores were dichotomized to high‐risk versus low‐risk groups, the AUROC for the PESI was 0.684 (95% CI, 0.559‐0.810) and 0.732 (95% CI, 0.571‐0.893) for PREP.

Area Under the Receiver Operating Characteristic and 95% Confidence Intervals for PESI and PREP for Determining 30‐Day and 90‐Day Mortalities
 30‐Day Mortality90‐Day Mortality
Scoring SystemAUROC95% CIAUROC95% CI
  • Abbreviations: AUROC, area under the receiver operating characteristic; CI, confidence interval; PESI, pulmonary embolism severity index; PREP, prognosis in pulmonary embolism.

Raw PESI0.8580.773‐0.9430.8350.762‐0.907
PESI class0.8350.756‐0.9140.8130.738‐0.888
PESI high vs low risk0.6840.559‐0.8100.6860.576‐0.796
Raw PREP0.7190.563‐0.8750.7040.564‐0.844
PREP high vs low risk0.7320.571‐0.8930.7200.574‐0.865

In terms of 90‐day mortality, the negative predictive values of PESI and PREP did not change: 100% (95% CI, 97.4%‐100%) and 98.5% (95% CI, 96.9%‐99.5%), respectively. The ability of PESI and PREP as predictors of 90‐day mortality was equivalent (Table 4). Here, the AUROC for the raw PESI score remained excellent at 0.835 (97% CI, 0.762‐0.907). The AUROC for PREP was akin to that of PESI at 0.704 (95% CI, 0.564‐0.844). Segregating scores into high‐risk versus low‐risk groups demonstrated that the AUROC for PESI was 0.686 (95% CI, 0.576‐0.796) compared to 0.720 (95% CI, 0.574‐0.865) for PREP.

DISCUSSION

This retrospective analysis of patients with acute PE confirms that both the PESI and the PREP are accurate scoring tools for identifying patients at low risk of death. Under both rubrics, as the score increases, the likelihood of death also increases. More importantly, we demonstrate that the negative predictive value for both the PREP and PESI are excellent. Thus, these scoring tools can distinguish those at higher risk for death versus those at low risk in a simple‐to‐apply manner. In comparing these 2 scoring systems, the PREP comparably identifies acute PE patients at risk for death when contrasted with the PESI. Given the fewer required scoring points to calculate PREP and its ability to accurately predict clinically relevant outcomes, this simpler scoring system may have greater clinical utility.

Prior studies have validated the PESI as a risk stratification tool to predict 30‐day and 90‐day mortalities. In their original derivation of the PESI, Aujesky et al. demonstrated that higher PESI scores correlated with death at 30 days.6 Acute PE patients classified into risk class I had a short‐term mortality rate of 1.1% compared to nearly 25% of patients risk stratified into risk class V. The same authors subsequently verified that there is a linear relationship between PESI score and risk of death at 90 days.10 We have also confirmed the accuracy of the PESI for identifying persons at high risk for death and documented the limited interobserver variability in this tool.7 In combination, there is evidence that the PESI can accurately predict vital outcome. Despite the effectiveness of the PESI, it is a somewhat cumbersome scoring system. It requires gathering information on 11 clinical variables, each with a different score allocation to ultimately compute the PESI score. In contrast, the PREP only requires knowing 3 clinical variables: presence of cancer, mental status, and the presence of cardiogenic shock. Akin to the PESI, the PREP and mortality are linearly related, where higher PREP scores result in higher 30‐day and 90‐day mortalities.

Our analysis helps expand the evidence regarding clinical risk stratification in PE in several ways. First, we verify that both the PESI and PREP are accurate predictors of short‐term mortality. While this has been accomplished for the PESI in prior studies, to our knowledge, this is the first confirmatory study for PREP's utility as a risk stratification tool. Second, we demonstrate that PREP is also an accurate predictor of intermediate‐term mortality. If the eventual goal is to develop tools that allow for the initial outpatient management of acute PE, clinicians require data on longer‐term outcomes to ensure that later harms do not arise based on a decision to defer hospitalization. Prior observational studies and randomized controlled clinical trials have proven that appropriately selected individuals face similar rates of complications following acute PE, whether they are managed in or outside of a hospital setting.1116 The key limitation of these earlier efforts, though, was that there was no clear standardized approach to determining whom could be safely managed solely as an outpatient. Finally, our study is unique in that we compare the discriminatory power of these 2 risk‐scoring schemes and illustrate their equivalence. As a scoring system that only requires 3 variables, the PREP is easier and simpler, and may therefore have more clinical utility than the PESI. The high negative predictive value of the PREP suggests that it has potential in identifying patients with acute PE who can safely be managed on an outpatient basis. However, given the complexity of factors associated with the decision for early discharge, these scores should be used in conjunction with, and not supplant, clinical judgment for outpatient management. Of course, formal prospective management trials incorporating both the PREP and PESI are needed to validate this concept.

Why does PREP perform so well despite the fact that it focuses on so few clinical variables? Essentially, the PREP is an effective scoring tool for acute PE because of its ability to identify individuals at risk for progressing to shock. The presence of AMS in acute PE has been associated with a greater likelihood of death, as it likely arises as a consequence of severe shock or RV strain resulting in decreased cerebral blood flow. Alternatively, altered censorium could represent a manifestation of hypoxemia from significant V/Q mismatching and/or pulmonary shunting due to the obstructive clot. This, too, portends a poorer prognosis secondary to impending respiratory failure from hypoxemia. Thus, individuals with an acute PE presenting with altered mentation merit very close observation. Similarly, pending hemodynamic instability is a concerning manifestation that warrants inpatient monitoring.5, 17, 18 At the very minimum, these individuals have RV strain and should therefore be admitted to the hospital to potentially administer more aggressive treatment modalities (ie, thrombolytics or thrombectomy). The last clinical criteria involves the presence of malignancy. The presence of a cancer may serve as a surrogate marker for those at increased risk for early recurrent thromboembolic phenomena, since malignancy is associated with a hypercoagulable state.17, 19 Perhaps there is a threshold whereby accumulating clot resulting in RV strain ensues with subsequent poorer outcomes. Thus, it clinically and physiologically seems logical that, in the absence of any of these findings, patients with acute PE will have lower mortality rates.

Thus far, other methods used for risk stratification may either be expensive, not really obtainable, or not routinely available at the time of presentation. For example, confirmation of RV strain with an echocardiogram requires a skilled technician and interpreter. In contrast, both the PESI and PREP are scored based on multiple clinical findings. Hence, they are not dependent upon a single test to determine outcome, but on various clinical variables making these scoring tools comprehensive, simple, and reliable approaches of recognizing low‐risk patients.

Our analysis has several limitations. First, the retrospective nature of this analysis subjects it to multiple forms of bias. We attempted to eliminate these biases by defining, a priori, the time frame from which vital signs can be used during scoring. We also used all‐cause mortality as our primary endpoint to minimize the possibility of ascertainment bias. However, this type of bias could not be completely eliminated since data collected was not specifically for the purpose of this study. Second, this single‐center study may limit the generalizability of these findings; yet, the diversity of patients admitted to this 900‐bed, tertiary care facility, as well as the inclusion of both inpatients and outpatients, helps to mitigate this concern. Third, the exclusion of individuals with expectant deaths within <30 days limits the applicability of these findings to this group. We chose to exclude persons with anticipated short‐term mortality to reduce the tally of patients who did not receive therapeutic treatment (ie, those transitioned to comfort care). Fourth, the use of the Social Security Death Index objectively determines death status for all‐cause mortality but cannot delineate cause‐specific death. Consequently, death strictly due to PE could not be assessed. Fifth, the original investigators for PREP assessed the PREP score with and without BNP and left‐to‐right ventricular diameter ratios. Although their results demonstrated similar AUROCs for the PREP score with and without BNP to predict 30‐day outcomes, this was a finding we could not confirm due to inconsistencies in measuring BNP and echocardiograms in our cohort. Also, our post hoc power analysis demonstrates that our findings may be limited by sample size. The lack of statistically significant differences between the PESI and the PREP may, in fact, be due to the small sample size versus true effect. Finally, tolerance for medical therapy and compliance with treatment were not documented and, therefore, were immeasurable. Poor compliance to anticoagulants or intolerability increases risk for recurrent PE, while excessive anticoagulation increases likelihood of bleeding.

In summary, the PREP and PESI can both safely predict 30‐day and 90‐day outcomes. However, the simplicity of the PREP renders it more clinician friendly. The fact that only 3 clinical noninvasive variables are required would ultimately make it the preferred bedside tool to risk stratify patients for acute PE. The high negative predictive value and comparable AUROCs establishes the effectiveness of these 2 scoring systems in recognizing low‐risk patients. Irrespective of the clinician's choice to use 1 tool over the other, both have potential for clinical application at the bedside and in clinical trials. Nevertheless, further evidence is required before they are utilized to triage patients for outpatient therapy.

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References
  1. Dalen JE.Pulmonary embolism: what have we learned since Virchow? Natural history, pathophysiology, and diagnosis.Chest.2002;122:14401456.
  2. Douketis JD,Leeuwenkamp O,Grobara P, et al.The incidence and prognostic significance of elevated cardiac troponins in patients with submassive pulmonary embolism.J Thromb Haemost.2005;3:508513.
  3. Kostrubiec M,Pruszczyk P,Bochowicz A, et al.Biomarker‐based risk assessment model in acute pulmonary embolism.Eur Heart J.2005;26:21662172.
  4. Kucher N,Goldhaber SZ.Cardiac biomarkers for risk stratification of patients with acute pulmonary embolism.Circulation.2003;108:21912194.
  5. Kucher N,Rossi E,De Rosa M, et al.Prognostic role of echocardiography among patients with acute pulmonary embolism and a systolic arterial pressure of 90 mm Hg or higher.Arch Intern Med.2005;165:17771781.
  6. Aujesky D,Obrosky DS,Stone RA, et al.Derivation and validation of a prognostic model for pulmonary embolism.Am J Respir Crit Care Med.2005;172:10411046.
  7. Chan CM,Woods C,Shorr AF.The validation and reproducibility of the pulmonary embolism severity index.J Thromb Haemost.2010;8:15091514.
  8. Sanchez O,Trinquart L,Caille V, et al.Prognostic factors for pulmonary embolism: the prep study, a prospective multicenter cohort study.Am J Respir Crit Care Med.2010;181:168173.
  9. Hanley JA,McNeil BJ.A method of comparing the areas under receiver operating characteristic curves derived from the same cases.Radiology.1983;148:839843.
  10. Donze J,Le Gal G,Fine MJ, et al.Prospective validation of the pulmonary embolism severity index. A clinical prognostic model for pulmonary embolism.Thromb Haemost.2008;100:943948.
  11. Wells PS,Kovacs MJ,Bormanis J, et al.Expanding eligibility for outpatient treatment of deep venous thrombosis and pulmonary embolism with low‐molecular‐weight heparin: a comparison of patient self‐injection with homecare injection.Arch Intern Med.1998;158:18091812.
  12. Kovacs MJ,Anderson D,Morrow B, et al.Outpatient treatment of pulmonary embolism with dalteparin.Thromb Haemost.2000;83:209211.
  13. Beer JH,Burger M,Gretener S, et al.Outpatient treatment of pulmonary embolism is feasible and safe in a substantial proportion of patients.J Thromb Haemost.2003;1:186187.
  14. Wells PS,Anderson DR,Rodger MA, et al.A randomized trial comparing 2 low‐molecular‐weight heparins for the outpatient treatment of deep vein thrombosis and pulmonary embolism.Arch Intern Med.2005;165:733738.
  15. Davies CW,Wimperis J,Green ES, et al.Early discharge of patients with pulmonary embolism: a two‐phase observational study.Eur Respir J.2007;30:708714.
  16. Otero R,Uresandi F,Jimenez D, et al.Home treatment in pulmonary embolism.Thromb Res.2010;126:e1e5.
  17. Goldhaber SZ,Visani L,De Rosa M.Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER).Lancet.1999;353:13861389.
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Acute pulmonary embolism (PE) is associated with significant morbidity and mortality.1 While expeditious diagnosis and management results in reduced mortality, the ability to rapidly and accurately identify those at increased risk for death remains elusive. Multiple studies have utilized various biomarkers as risk stratification tools, however, these approaches have proven to have many limitations. For example, both serum brain natriuretic peptide (BNP) and troponin levels have been studied as possible risk stratification tools. Those with elevated levels of these following a PE may have concomitant right ventricular (RV) dysfunction and/or hemodynamic instability. Thus, they may face a greater risk for cardiovascular collapse and death. The low positive predictive value of these biomarkers (14%‐44%) has limited their clinical utility.24 Furthermore, imaging modalities, such as echocardiography, which is considered the clinical gold standard for determining the presence of acute RV dysfunction in PE, may not be readily available and may require special expertise for interpretation.5

Conversely, the need to identify acute PE patients at low risk for death is just as important. Recent studies suggest that carefully selected patients can successfully be managed as outpatients which can subsequently lead to significant cost savings and patient satisfaction. Movement towards enhanced outpatient resources and the advent of subcutaneous anticoagulants have made outpatient management of acute PE an appealing possibility. However, proper education, close follow‐up, and a rigorous selection process to recognize those at minimal risk for a fatal complication must all be available before clinicians prematurely discharge these patients to home.

Recently, clinical scoring tools have been developed to aid in risk stratifying patients with acute PE to accurately determine patient outcome. The pulmonary embolism severity index (PESI) is a reproducible scoring system that accurately predicts 30‐day and 90‐day mortality.6, 7 It consists of 11 clinical variables that can be quickly assessed at the time of diagnosis (Table 1A). The fact that biomarkers and imaging technology, such as echocardiography, are unnecessary to compute a PESI score demonstrates the appeal of this system. Similar to the PESI, Sanchez et al.8 have proposed the prognosis in pulmonary embolism (PREP) score as an alternate clinical risk tool in PE (Table 1B). Contrary to PESI, the PREP only uses 3 clinical variables to accurately predict vital outcome with an area under the receiver operating characteristic (AUROC) curve of 0.73 (95% confidence interval [CI], 0.65‐0.82). While both scoring systems have been developed to predict 30‐day mortality in acute PE, the comparative validity of these prognostic tools has not been assessed.

Pulmonary Embolism Severity Index
PredictorsPoints Assigned
  • Defined as disorientation, lethargy, stupor, or coma.

  • With or without use of supplemental oxygenation.

Demographic characteristics 
Age (yr)Age (yr)
Male sex+10
Comorbid conditions 
Cancer+30
Heart failure+10
Chronic lung disease+10
Clinical findings 
Pulse 110 beats/min+20
Systolic blood pressure <100 mm Hg+30
Respiratory rate 30 breaths/min+20
Temperature <36C+20
Altered mental status*+60
Arterial oxygen saturation <90%+20
Prognosis in Pulmonary Embolism Score
Prognostic FactorPoints Assigned
  • Altered mental status defined as disorientation, stupor, or coma.

Altered mental status*+10
Cardiogenic shock (systolic blood pressure <90 mm Hg)+6
Cancer+6

We hypothesized that the PESI more precisely risk stratifies the risk for death in acute PE compared to the PREP. Furthermore, we theorized that the PESI more reliably predicts not only 30‐day but also 90‐day mortality. To test our hypothesis, we performed a retrospective analysis, of all consecutive patients diagnosed with acute PE at our hospital, to compare the prognostic accuracy of these 2 scoring systems.

METHODS

Subjects and Definitions

Between October 2007 and February 2009, adults (age 18 years) diagnosed the day prior with acute PE were identified on a daily basis. This study cohort has been described elsewhere.7 Patients with newly diagnosed PE were eligible for enrollment. Those expected to die within 30 days of their acute PE, such as individuals suffering from a terminal condition (metastatic cancer) or critical illness being transitioned to comfort care, were excluded (n = 32). Patients with multiple admissions for acute PE were included only during the first episode. PE was diagnosed using objective criteria through 1 of the following modalities: high probability ventilation‐perfusion (V/Q) scintigraphy, computed tomography (CT) of the chest with PE protocol, or magnetic resonance imaging (MRI) of the chest. A list of patients who had the above imaging studies to evaluate for PE was provided to study personnel daily by the radiology department; this list was generated every morning and consisted of the day prior's studies. Patient management was not influenced by the research team and was the responsibility of the primary team. This study was approved by our local institutional review board and consent was not required.

We calculated the PESI as described by Aujesky and colleagues.6 For outpatients admitted with acute PE, clinical findings available just prior to, and after, diagnosis were used for scoring. For inpatients diagnosed with PE, clinical findings available during the 24 hours just prior to diagnosis were included. Raw PESI scores were converted to risk class (I‐V), and then further dichotomized into low‐risk (class I‐II) and high‐risk (class III‐V) groups (Table 2). The PREP score was computed based on the presence of altered mental status (AMS), cancer, and cardiogenic shock defined as a systolic blood pressure <90 mm Hg (Table 1B). A raw PREP score of <7 was then characterized as low risk for mortality, while scores 7 were considered high risk.

Class Stratification and Dichotimization of the PESI Score
PESI ScoreClassn30‐Day Mortality by Class (%)90‐Day Mortality by Class (%)Low vs High Risk
  • Abbreviations: PESI, pulmonary embolism severity index.

65I490 (0.0)0 (0.0)Low
66‐85II590 (0.0)0 (0.0)
86‐105III600 (0.0)0 (0.0)High
106‐125IV562 (3.4)4 (6.9)
>125V697 (9.2)8 (10.5)

Finally, the PESI and PREP scores were compared based on their ability to predict all‐cause 30‐day and 90‐day mortality. To determine vital status and date of death, we reviewed the Social Security Death Index 90 days after enrollment of all subjects was completed.

Statistical Analysis

To assess the predictive ability of the 2 scoring tools for death, we determined the negative predictive value and computed the AUROC curves for both scoring systems. AUROC curves were constructed for raw scores and when scores were further segregated by class and risk groups. Additionally, 95% CIs were estimated to determine the accuracy of the discriminatory power of the PESI score versus the PREP score.

Post hoc, we calculated the power of our study to assess whether the difference noted in AUROC curves between the PESI and PREP was adequate to truly determine statistical significance. We used methodology described by Hanley and McNeil to compare continuous values.9 Assuming an alpha of 0.05 and a 20% difference in the AUROC curves, as described in our results, the power in our study was 0.35. Therefore, an approximate sample size of 1000 would be necessary to determine statistical significance. This analysis was performed using Power Analysis and Sample Size (PASS) 11.

RESULTS

The final cohort included 302 subjects (mean age: 59.7 17.2 years; 44.0% males). As Table 3 reveals, the majority of PEs was diagnosed via CT scan (76%). On presentation, 6.6% had cardiogenic shock, while 5.0% had altered censorium. In terms of comorbid conditions, 25.2% had congestive heart failure, 25.2% had cancer, and 22.2% had a prior venous thromboembolic event. Overall, 3.0% and 4.0% met our primary outcomes of death within 30‐days and 90‐days of their acute PEs, respectively.

Baseline Demographics
  • Abbreviations: CT, computed tomography; MRA, magnetic resonance angiography; SD, standard deviation; V/Q, ventilation perfusion.

Demographics 
Age (yr), mean SD59.7 17.2
Male sex, %44%
Diagnostic methodology 
CT chest, n (%)230 (76.2)
V/Q scan, n (%)71 (23.5)
MRA chest, n (%)1 (0.3)
Comorbidities 
Malignancy, n (%)76 (25.2)
Congestive heart failure, n (%)76 (25.2)
Chronic lung disease, n (%)72 (23.8)
Recent orthopedic surgery, n (%)22 (7.3)
Prior cerebrovascular accident, n (%)31 (10.3)
Prior venous thromboembolic disease, n (%)67 (22.2)

The rates of 30‐day and 90‐day mortality, respectively, increased with increasing score for both the PESI and the PREP. No patients in PESI class I died by either time point, while 9.2% of PESI class V subjects expired by 30 days (P < 0.0001) and 10.5% died by 90 days (P = 0.003) (Table 2). Based on PESI, 30‐day death rates were 4.6% in the high‐risk cohort versus 0% in the low‐risk group (P = 0.023). Conversely, 7.1% of high‐risk PREP subjects died by day 30 versus 1% of low‐risk subjects (P = 0.004) (Figure 1A). Those stratified into the PESI high‐risk group had a 90‐day mortality of 6.2% versus 0% for the low‐risk group (P = 0.008) versus 9.1% in those deemed high risk by PREP, as compared to 1.5% of those scored as low risk by PREP (P = 0.001) (Figure 1B).

Figure 1
(A) Short‐term mortality rates comparing the PESI and the PREP risk groups. (B) Intermediate‐term mortality rate comparing the PESI and PREP risk groups. Abbreviations: PESI, pulmonary embolism severity index; PREP, prognosis in pulmonary embolism.

Regarding the 30‐day mortality, the negative predictive value of the PESI was 100% (95% CI, 98.6%‐100%) while that for PREP was 99.0% (95% CI, 97.6%‐99.7%); the ability of the PREP to predict 30‐day mortality was similar to the PESI (Table 4). The AUROCs for PESI and PREP for predicting 30‐day death were also equivalent; for the raw PESI score, this measured 0.858 (95% CI, 0.773‐0.943), compared to 0.719 (95% CI, 0.563‐0.875) for PREP. When these scores were dichotomized to high‐risk versus low‐risk groups, the AUROC for the PESI was 0.684 (95% CI, 0.559‐0.810) and 0.732 (95% CI, 0.571‐0.893) for PREP.

Area Under the Receiver Operating Characteristic and 95% Confidence Intervals for PESI and PREP for Determining 30‐Day and 90‐Day Mortalities
 30‐Day Mortality90‐Day Mortality
Scoring SystemAUROC95% CIAUROC95% CI
  • Abbreviations: AUROC, area under the receiver operating characteristic; CI, confidence interval; PESI, pulmonary embolism severity index; PREP, prognosis in pulmonary embolism.

Raw PESI0.8580.773‐0.9430.8350.762‐0.907
PESI class0.8350.756‐0.9140.8130.738‐0.888
PESI high vs low risk0.6840.559‐0.8100.6860.576‐0.796
Raw PREP0.7190.563‐0.8750.7040.564‐0.844
PREP high vs low risk0.7320.571‐0.8930.7200.574‐0.865

In terms of 90‐day mortality, the negative predictive values of PESI and PREP did not change: 100% (95% CI, 97.4%‐100%) and 98.5% (95% CI, 96.9%‐99.5%), respectively. The ability of PESI and PREP as predictors of 90‐day mortality was equivalent (Table 4). Here, the AUROC for the raw PESI score remained excellent at 0.835 (97% CI, 0.762‐0.907). The AUROC for PREP was akin to that of PESI at 0.704 (95% CI, 0.564‐0.844). Segregating scores into high‐risk versus low‐risk groups demonstrated that the AUROC for PESI was 0.686 (95% CI, 0.576‐0.796) compared to 0.720 (95% CI, 0.574‐0.865) for PREP.

DISCUSSION

This retrospective analysis of patients with acute PE confirms that both the PESI and the PREP are accurate scoring tools for identifying patients at low risk of death. Under both rubrics, as the score increases, the likelihood of death also increases. More importantly, we demonstrate that the negative predictive value for both the PREP and PESI are excellent. Thus, these scoring tools can distinguish those at higher risk for death versus those at low risk in a simple‐to‐apply manner. In comparing these 2 scoring systems, the PREP comparably identifies acute PE patients at risk for death when contrasted with the PESI. Given the fewer required scoring points to calculate PREP and its ability to accurately predict clinically relevant outcomes, this simpler scoring system may have greater clinical utility.

Prior studies have validated the PESI as a risk stratification tool to predict 30‐day and 90‐day mortalities. In their original derivation of the PESI, Aujesky et al. demonstrated that higher PESI scores correlated with death at 30 days.6 Acute PE patients classified into risk class I had a short‐term mortality rate of 1.1% compared to nearly 25% of patients risk stratified into risk class V. The same authors subsequently verified that there is a linear relationship between PESI score and risk of death at 90 days.10 We have also confirmed the accuracy of the PESI for identifying persons at high risk for death and documented the limited interobserver variability in this tool.7 In combination, there is evidence that the PESI can accurately predict vital outcome. Despite the effectiveness of the PESI, it is a somewhat cumbersome scoring system. It requires gathering information on 11 clinical variables, each with a different score allocation to ultimately compute the PESI score. In contrast, the PREP only requires knowing 3 clinical variables: presence of cancer, mental status, and the presence of cardiogenic shock. Akin to the PESI, the PREP and mortality are linearly related, where higher PREP scores result in higher 30‐day and 90‐day mortalities.

Our analysis helps expand the evidence regarding clinical risk stratification in PE in several ways. First, we verify that both the PESI and PREP are accurate predictors of short‐term mortality. While this has been accomplished for the PESI in prior studies, to our knowledge, this is the first confirmatory study for PREP's utility as a risk stratification tool. Second, we demonstrate that PREP is also an accurate predictor of intermediate‐term mortality. If the eventual goal is to develop tools that allow for the initial outpatient management of acute PE, clinicians require data on longer‐term outcomes to ensure that later harms do not arise based on a decision to defer hospitalization. Prior observational studies and randomized controlled clinical trials have proven that appropriately selected individuals face similar rates of complications following acute PE, whether they are managed in or outside of a hospital setting.1116 The key limitation of these earlier efforts, though, was that there was no clear standardized approach to determining whom could be safely managed solely as an outpatient. Finally, our study is unique in that we compare the discriminatory power of these 2 risk‐scoring schemes and illustrate their equivalence. As a scoring system that only requires 3 variables, the PREP is easier and simpler, and may therefore have more clinical utility than the PESI. The high negative predictive value of the PREP suggests that it has potential in identifying patients with acute PE who can safely be managed on an outpatient basis. However, given the complexity of factors associated with the decision for early discharge, these scores should be used in conjunction with, and not supplant, clinical judgment for outpatient management. Of course, formal prospective management trials incorporating both the PREP and PESI are needed to validate this concept.

Why does PREP perform so well despite the fact that it focuses on so few clinical variables? Essentially, the PREP is an effective scoring tool for acute PE because of its ability to identify individuals at risk for progressing to shock. The presence of AMS in acute PE has been associated with a greater likelihood of death, as it likely arises as a consequence of severe shock or RV strain resulting in decreased cerebral blood flow. Alternatively, altered censorium could represent a manifestation of hypoxemia from significant V/Q mismatching and/or pulmonary shunting due to the obstructive clot. This, too, portends a poorer prognosis secondary to impending respiratory failure from hypoxemia. Thus, individuals with an acute PE presenting with altered mentation merit very close observation. Similarly, pending hemodynamic instability is a concerning manifestation that warrants inpatient monitoring.5, 17, 18 At the very minimum, these individuals have RV strain and should therefore be admitted to the hospital to potentially administer more aggressive treatment modalities (ie, thrombolytics or thrombectomy). The last clinical criteria involves the presence of malignancy. The presence of a cancer may serve as a surrogate marker for those at increased risk for early recurrent thromboembolic phenomena, since malignancy is associated with a hypercoagulable state.17, 19 Perhaps there is a threshold whereby accumulating clot resulting in RV strain ensues with subsequent poorer outcomes. Thus, it clinically and physiologically seems logical that, in the absence of any of these findings, patients with acute PE will have lower mortality rates.

Thus far, other methods used for risk stratification may either be expensive, not really obtainable, or not routinely available at the time of presentation. For example, confirmation of RV strain with an echocardiogram requires a skilled technician and interpreter. In contrast, both the PESI and PREP are scored based on multiple clinical findings. Hence, they are not dependent upon a single test to determine outcome, but on various clinical variables making these scoring tools comprehensive, simple, and reliable approaches of recognizing low‐risk patients.

Our analysis has several limitations. First, the retrospective nature of this analysis subjects it to multiple forms of bias. We attempted to eliminate these biases by defining, a priori, the time frame from which vital signs can be used during scoring. We also used all‐cause mortality as our primary endpoint to minimize the possibility of ascertainment bias. However, this type of bias could not be completely eliminated since data collected was not specifically for the purpose of this study. Second, this single‐center study may limit the generalizability of these findings; yet, the diversity of patients admitted to this 900‐bed, tertiary care facility, as well as the inclusion of both inpatients and outpatients, helps to mitigate this concern. Third, the exclusion of individuals with expectant deaths within <30 days limits the applicability of these findings to this group. We chose to exclude persons with anticipated short‐term mortality to reduce the tally of patients who did not receive therapeutic treatment (ie, those transitioned to comfort care). Fourth, the use of the Social Security Death Index objectively determines death status for all‐cause mortality but cannot delineate cause‐specific death. Consequently, death strictly due to PE could not be assessed. Fifth, the original investigators for PREP assessed the PREP score with and without BNP and left‐to‐right ventricular diameter ratios. Although their results demonstrated similar AUROCs for the PREP score with and without BNP to predict 30‐day outcomes, this was a finding we could not confirm due to inconsistencies in measuring BNP and echocardiograms in our cohort. Also, our post hoc power analysis demonstrates that our findings may be limited by sample size. The lack of statistically significant differences between the PESI and the PREP may, in fact, be due to the small sample size versus true effect. Finally, tolerance for medical therapy and compliance with treatment were not documented and, therefore, were immeasurable. Poor compliance to anticoagulants or intolerability increases risk for recurrent PE, while excessive anticoagulation increases likelihood of bleeding.

In summary, the PREP and PESI can both safely predict 30‐day and 90‐day outcomes. However, the simplicity of the PREP renders it more clinician friendly. The fact that only 3 clinical noninvasive variables are required would ultimately make it the preferred bedside tool to risk stratify patients for acute PE. The high negative predictive value and comparable AUROCs establishes the effectiveness of these 2 scoring systems in recognizing low‐risk patients. Irrespective of the clinician's choice to use 1 tool over the other, both have potential for clinical application at the bedside and in clinical trials. Nevertheless, further evidence is required before they are utilized to triage patients for outpatient therapy.

Acute pulmonary embolism (PE) is associated with significant morbidity and mortality.1 While expeditious diagnosis and management results in reduced mortality, the ability to rapidly and accurately identify those at increased risk for death remains elusive. Multiple studies have utilized various biomarkers as risk stratification tools, however, these approaches have proven to have many limitations. For example, both serum brain natriuretic peptide (BNP) and troponin levels have been studied as possible risk stratification tools. Those with elevated levels of these following a PE may have concomitant right ventricular (RV) dysfunction and/or hemodynamic instability. Thus, they may face a greater risk for cardiovascular collapse and death. The low positive predictive value of these biomarkers (14%‐44%) has limited their clinical utility.24 Furthermore, imaging modalities, such as echocardiography, which is considered the clinical gold standard for determining the presence of acute RV dysfunction in PE, may not be readily available and may require special expertise for interpretation.5

Conversely, the need to identify acute PE patients at low risk for death is just as important. Recent studies suggest that carefully selected patients can successfully be managed as outpatients which can subsequently lead to significant cost savings and patient satisfaction. Movement towards enhanced outpatient resources and the advent of subcutaneous anticoagulants have made outpatient management of acute PE an appealing possibility. However, proper education, close follow‐up, and a rigorous selection process to recognize those at minimal risk for a fatal complication must all be available before clinicians prematurely discharge these patients to home.

Recently, clinical scoring tools have been developed to aid in risk stratifying patients with acute PE to accurately determine patient outcome. The pulmonary embolism severity index (PESI) is a reproducible scoring system that accurately predicts 30‐day and 90‐day mortality.6, 7 It consists of 11 clinical variables that can be quickly assessed at the time of diagnosis (Table 1A). The fact that biomarkers and imaging technology, such as echocardiography, are unnecessary to compute a PESI score demonstrates the appeal of this system. Similar to the PESI, Sanchez et al.8 have proposed the prognosis in pulmonary embolism (PREP) score as an alternate clinical risk tool in PE (Table 1B). Contrary to PESI, the PREP only uses 3 clinical variables to accurately predict vital outcome with an area under the receiver operating characteristic (AUROC) curve of 0.73 (95% confidence interval [CI], 0.65‐0.82). While both scoring systems have been developed to predict 30‐day mortality in acute PE, the comparative validity of these prognostic tools has not been assessed.

Pulmonary Embolism Severity Index
PredictorsPoints Assigned
  • Defined as disorientation, lethargy, stupor, or coma.

  • With or without use of supplemental oxygenation.

Demographic characteristics 
Age (yr)Age (yr)
Male sex+10
Comorbid conditions 
Cancer+30
Heart failure+10
Chronic lung disease+10
Clinical findings 
Pulse 110 beats/min+20
Systolic blood pressure <100 mm Hg+30
Respiratory rate 30 breaths/min+20
Temperature <36C+20
Altered mental status*+60
Arterial oxygen saturation <90%+20
Prognosis in Pulmonary Embolism Score
Prognostic FactorPoints Assigned
  • Altered mental status defined as disorientation, stupor, or coma.

Altered mental status*+10
Cardiogenic shock (systolic blood pressure <90 mm Hg)+6
Cancer+6

We hypothesized that the PESI more precisely risk stratifies the risk for death in acute PE compared to the PREP. Furthermore, we theorized that the PESI more reliably predicts not only 30‐day but also 90‐day mortality. To test our hypothesis, we performed a retrospective analysis, of all consecutive patients diagnosed with acute PE at our hospital, to compare the prognostic accuracy of these 2 scoring systems.

METHODS

Subjects and Definitions

Between October 2007 and February 2009, adults (age 18 years) diagnosed the day prior with acute PE were identified on a daily basis. This study cohort has been described elsewhere.7 Patients with newly diagnosed PE were eligible for enrollment. Those expected to die within 30 days of their acute PE, such as individuals suffering from a terminal condition (metastatic cancer) or critical illness being transitioned to comfort care, were excluded (n = 32). Patients with multiple admissions for acute PE were included only during the first episode. PE was diagnosed using objective criteria through 1 of the following modalities: high probability ventilation‐perfusion (V/Q) scintigraphy, computed tomography (CT) of the chest with PE protocol, or magnetic resonance imaging (MRI) of the chest. A list of patients who had the above imaging studies to evaluate for PE was provided to study personnel daily by the radiology department; this list was generated every morning and consisted of the day prior's studies. Patient management was not influenced by the research team and was the responsibility of the primary team. This study was approved by our local institutional review board and consent was not required.

We calculated the PESI as described by Aujesky and colleagues.6 For outpatients admitted with acute PE, clinical findings available just prior to, and after, diagnosis were used for scoring. For inpatients diagnosed with PE, clinical findings available during the 24 hours just prior to diagnosis were included. Raw PESI scores were converted to risk class (I‐V), and then further dichotomized into low‐risk (class I‐II) and high‐risk (class III‐V) groups (Table 2). The PREP score was computed based on the presence of altered mental status (AMS), cancer, and cardiogenic shock defined as a systolic blood pressure <90 mm Hg (Table 1B). A raw PREP score of <7 was then characterized as low risk for mortality, while scores 7 were considered high risk.

Class Stratification and Dichotimization of the PESI Score
PESI ScoreClassn30‐Day Mortality by Class (%)90‐Day Mortality by Class (%)Low vs High Risk
  • Abbreviations: PESI, pulmonary embolism severity index.

65I490 (0.0)0 (0.0)Low
66‐85II590 (0.0)0 (0.0)
86‐105III600 (0.0)0 (0.0)High
106‐125IV562 (3.4)4 (6.9)
>125V697 (9.2)8 (10.5)

Finally, the PESI and PREP scores were compared based on their ability to predict all‐cause 30‐day and 90‐day mortality. To determine vital status and date of death, we reviewed the Social Security Death Index 90 days after enrollment of all subjects was completed.

Statistical Analysis

To assess the predictive ability of the 2 scoring tools for death, we determined the negative predictive value and computed the AUROC curves for both scoring systems. AUROC curves were constructed for raw scores and when scores were further segregated by class and risk groups. Additionally, 95% CIs were estimated to determine the accuracy of the discriminatory power of the PESI score versus the PREP score.

Post hoc, we calculated the power of our study to assess whether the difference noted in AUROC curves between the PESI and PREP was adequate to truly determine statistical significance. We used methodology described by Hanley and McNeil to compare continuous values.9 Assuming an alpha of 0.05 and a 20% difference in the AUROC curves, as described in our results, the power in our study was 0.35. Therefore, an approximate sample size of 1000 would be necessary to determine statistical significance. This analysis was performed using Power Analysis and Sample Size (PASS) 11.

RESULTS

The final cohort included 302 subjects (mean age: 59.7 17.2 years; 44.0% males). As Table 3 reveals, the majority of PEs was diagnosed via CT scan (76%). On presentation, 6.6% had cardiogenic shock, while 5.0% had altered censorium. In terms of comorbid conditions, 25.2% had congestive heart failure, 25.2% had cancer, and 22.2% had a prior venous thromboembolic event. Overall, 3.0% and 4.0% met our primary outcomes of death within 30‐days and 90‐days of their acute PEs, respectively.

Baseline Demographics
  • Abbreviations: CT, computed tomography; MRA, magnetic resonance angiography; SD, standard deviation; V/Q, ventilation perfusion.

Demographics 
Age (yr), mean SD59.7 17.2
Male sex, %44%
Diagnostic methodology 
CT chest, n (%)230 (76.2)
V/Q scan, n (%)71 (23.5)
MRA chest, n (%)1 (0.3)
Comorbidities 
Malignancy, n (%)76 (25.2)
Congestive heart failure, n (%)76 (25.2)
Chronic lung disease, n (%)72 (23.8)
Recent orthopedic surgery, n (%)22 (7.3)
Prior cerebrovascular accident, n (%)31 (10.3)
Prior venous thromboembolic disease, n (%)67 (22.2)

The rates of 30‐day and 90‐day mortality, respectively, increased with increasing score for both the PESI and the PREP. No patients in PESI class I died by either time point, while 9.2% of PESI class V subjects expired by 30 days (P < 0.0001) and 10.5% died by 90 days (P = 0.003) (Table 2). Based on PESI, 30‐day death rates were 4.6% in the high‐risk cohort versus 0% in the low‐risk group (P = 0.023). Conversely, 7.1% of high‐risk PREP subjects died by day 30 versus 1% of low‐risk subjects (P = 0.004) (Figure 1A). Those stratified into the PESI high‐risk group had a 90‐day mortality of 6.2% versus 0% for the low‐risk group (P = 0.008) versus 9.1% in those deemed high risk by PREP, as compared to 1.5% of those scored as low risk by PREP (P = 0.001) (Figure 1B).

Figure 1
(A) Short‐term mortality rates comparing the PESI and the PREP risk groups. (B) Intermediate‐term mortality rate comparing the PESI and PREP risk groups. Abbreviations: PESI, pulmonary embolism severity index; PREP, prognosis in pulmonary embolism.

Regarding the 30‐day mortality, the negative predictive value of the PESI was 100% (95% CI, 98.6%‐100%) while that for PREP was 99.0% (95% CI, 97.6%‐99.7%); the ability of the PREP to predict 30‐day mortality was similar to the PESI (Table 4). The AUROCs for PESI and PREP for predicting 30‐day death were also equivalent; for the raw PESI score, this measured 0.858 (95% CI, 0.773‐0.943), compared to 0.719 (95% CI, 0.563‐0.875) for PREP. When these scores were dichotomized to high‐risk versus low‐risk groups, the AUROC for the PESI was 0.684 (95% CI, 0.559‐0.810) and 0.732 (95% CI, 0.571‐0.893) for PREP.

Area Under the Receiver Operating Characteristic and 95% Confidence Intervals for PESI and PREP for Determining 30‐Day and 90‐Day Mortalities
 30‐Day Mortality90‐Day Mortality
Scoring SystemAUROC95% CIAUROC95% CI
  • Abbreviations: AUROC, area under the receiver operating characteristic; CI, confidence interval; PESI, pulmonary embolism severity index; PREP, prognosis in pulmonary embolism.

Raw PESI0.8580.773‐0.9430.8350.762‐0.907
PESI class0.8350.756‐0.9140.8130.738‐0.888
PESI high vs low risk0.6840.559‐0.8100.6860.576‐0.796
Raw PREP0.7190.563‐0.8750.7040.564‐0.844
PREP high vs low risk0.7320.571‐0.8930.7200.574‐0.865

In terms of 90‐day mortality, the negative predictive values of PESI and PREP did not change: 100% (95% CI, 97.4%‐100%) and 98.5% (95% CI, 96.9%‐99.5%), respectively. The ability of PESI and PREP as predictors of 90‐day mortality was equivalent (Table 4). Here, the AUROC for the raw PESI score remained excellent at 0.835 (97% CI, 0.762‐0.907). The AUROC for PREP was akin to that of PESI at 0.704 (95% CI, 0.564‐0.844). Segregating scores into high‐risk versus low‐risk groups demonstrated that the AUROC for PESI was 0.686 (95% CI, 0.576‐0.796) compared to 0.720 (95% CI, 0.574‐0.865) for PREP.

DISCUSSION

This retrospective analysis of patients with acute PE confirms that both the PESI and the PREP are accurate scoring tools for identifying patients at low risk of death. Under both rubrics, as the score increases, the likelihood of death also increases. More importantly, we demonstrate that the negative predictive value for both the PREP and PESI are excellent. Thus, these scoring tools can distinguish those at higher risk for death versus those at low risk in a simple‐to‐apply manner. In comparing these 2 scoring systems, the PREP comparably identifies acute PE patients at risk for death when contrasted with the PESI. Given the fewer required scoring points to calculate PREP and its ability to accurately predict clinically relevant outcomes, this simpler scoring system may have greater clinical utility.

Prior studies have validated the PESI as a risk stratification tool to predict 30‐day and 90‐day mortalities. In their original derivation of the PESI, Aujesky et al. demonstrated that higher PESI scores correlated with death at 30 days.6 Acute PE patients classified into risk class I had a short‐term mortality rate of 1.1% compared to nearly 25% of patients risk stratified into risk class V. The same authors subsequently verified that there is a linear relationship between PESI score and risk of death at 90 days.10 We have also confirmed the accuracy of the PESI for identifying persons at high risk for death and documented the limited interobserver variability in this tool.7 In combination, there is evidence that the PESI can accurately predict vital outcome. Despite the effectiveness of the PESI, it is a somewhat cumbersome scoring system. It requires gathering information on 11 clinical variables, each with a different score allocation to ultimately compute the PESI score. In contrast, the PREP only requires knowing 3 clinical variables: presence of cancer, mental status, and the presence of cardiogenic shock. Akin to the PESI, the PREP and mortality are linearly related, where higher PREP scores result in higher 30‐day and 90‐day mortalities.

Our analysis helps expand the evidence regarding clinical risk stratification in PE in several ways. First, we verify that both the PESI and PREP are accurate predictors of short‐term mortality. While this has been accomplished for the PESI in prior studies, to our knowledge, this is the first confirmatory study for PREP's utility as a risk stratification tool. Second, we demonstrate that PREP is also an accurate predictor of intermediate‐term mortality. If the eventual goal is to develop tools that allow for the initial outpatient management of acute PE, clinicians require data on longer‐term outcomes to ensure that later harms do not arise based on a decision to defer hospitalization. Prior observational studies and randomized controlled clinical trials have proven that appropriately selected individuals face similar rates of complications following acute PE, whether they are managed in or outside of a hospital setting.1116 The key limitation of these earlier efforts, though, was that there was no clear standardized approach to determining whom could be safely managed solely as an outpatient. Finally, our study is unique in that we compare the discriminatory power of these 2 risk‐scoring schemes and illustrate their equivalence. As a scoring system that only requires 3 variables, the PREP is easier and simpler, and may therefore have more clinical utility than the PESI. The high negative predictive value of the PREP suggests that it has potential in identifying patients with acute PE who can safely be managed on an outpatient basis. However, given the complexity of factors associated with the decision for early discharge, these scores should be used in conjunction with, and not supplant, clinical judgment for outpatient management. Of course, formal prospective management trials incorporating both the PREP and PESI are needed to validate this concept.

Why does PREP perform so well despite the fact that it focuses on so few clinical variables? Essentially, the PREP is an effective scoring tool for acute PE because of its ability to identify individuals at risk for progressing to shock. The presence of AMS in acute PE has been associated with a greater likelihood of death, as it likely arises as a consequence of severe shock or RV strain resulting in decreased cerebral blood flow. Alternatively, altered censorium could represent a manifestation of hypoxemia from significant V/Q mismatching and/or pulmonary shunting due to the obstructive clot. This, too, portends a poorer prognosis secondary to impending respiratory failure from hypoxemia. Thus, individuals with an acute PE presenting with altered mentation merit very close observation. Similarly, pending hemodynamic instability is a concerning manifestation that warrants inpatient monitoring.5, 17, 18 At the very minimum, these individuals have RV strain and should therefore be admitted to the hospital to potentially administer more aggressive treatment modalities (ie, thrombolytics or thrombectomy). The last clinical criteria involves the presence of malignancy. The presence of a cancer may serve as a surrogate marker for those at increased risk for early recurrent thromboembolic phenomena, since malignancy is associated with a hypercoagulable state.17, 19 Perhaps there is a threshold whereby accumulating clot resulting in RV strain ensues with subsequent poorer outcomes. Thus, it clinically and physiologically seems logical that, in the absence of any of these findings, patients with acute PE will have lower mortality rates.

Thus far, other methods used for risk stratification may either be expensive, not really obtainable, or not routinely available at the time of presentation. For example, confirmation of RV strain with an echocardiogram requires a skilled technician and interpreter. In contrast, both the PESI and PREP are scored based on multiple clinical findings. Hence, they are not dependent upon a single test to determine outcome, but on various clinical variables making these scoring tools comprehensive, simple, and reliable approaches of recognizing low‐risk patients.

Our analysis has several limitations. First, the retrospective nature of this analysis subjects it to multiple forms of bias. We attempted to eliminate these biases by defining, a priori, the time frame from which vital signs can be used during scoring. We also used all‐cause mortality as our primary endpoint to minimize the possibility of ascertainment bias. However, this type of bias could not be completely eliminated since data collected was not specifically for the purpose of this study. Second, this single‐center study may limit the generalizability of these findings; yet, the diversity of patients admitted to this 900‐bed, tertiary care facility, as well as the inclusion of both inpatients and outpatients, helps to mitigate this concern. Third, the exclusion of individuals with expectant deaths within <30 days limits the applicability of these findings to this group. We chose to exclude persons with anticipated short‐term mortality to reduce the tally of patients who did not receive therapeutic treatment (ie, those transitioned to comfort care). Fourth, the use of the Social Security Death Index objectively determines death status for all‐cause mortality but cannot delineate cause‐specific death. Consequently, death strictly due to PE could not be assessed. Fifth, the original investigators for PREP assessed the PREP score with and without BNP and left‐to‐right ventricular diameter ratios. Although their results demonstrated similar AUROCs for the PREP score with and without BNP to predict 30‐day outcomes, this was a finding we could not confirm due to inconsistencies in measuring BNP and echocardiograms in our cohort. Also, our post hoc power analysis demonstrates that our findings may be limited by sample size. The lack of statistically significant differences between the PESI and the PREP may, in fact, be due to the small sample size versus true effect. Finally, tolerance for medical therapy and compliance with treatment were not documented and, therefore, were immeasurable. Poor compliance to anticoagulants or intolerability increases risk for recurrent PE, while excessive anticoagulation increases likelihood of bleeding.

In summary, the PREP and PESI can both safely predict 30‐day and 90‐day outcomes. However, the simplicity of the PREP renders it more clinician friendly. The fact that only 3 clinical noninvasive variables are required would ultimately make it the preferred bedside tool to risk stratify patients for acute PE. The high negative predictive value and comparable AUROCs establishes the effectiveness of these 2 scoring systems in recognizing low‐risk patients. Irrespective of the clinician's choice to use 1 tool over the other, both have potential for clinical application at the bedside and in clinical trials. Nevertheless, further evidence is required before they are utilized to triage patients for outpatient therapy.

References
  1. Dalen JE.Pulmonary embolism: what have we learned since Virchow? Natural history, pathophysiology, and diagnosis.Chest.2002;122:14401456.
  2. Douketis JD,Leeuwenkamp O,Grobara P, et al.The incidence and prognostic significance of elevated cardiac troponins in patients with submassive pulmonary embolism.J Thromb Haemost.2005;3:508513.
  3. Kostrubiec M,Pruszczyk P,Bochowicz A, et al.Biomarker‐based risk assessment model in acute pulmonary embolism.Eur Heart J.2005;26:21662172.
  4. Kucher N,Goldhaber SZ.Cardiac biomarkers for risk stratification of patients with acute pulmonary embolism.Circulation.2003;108:21912194.
  5. Kucher N,Rossi E,De Rosa M, et al.Prognostic role of echocardiography among patients with acute pulmonary embolism and a systolic arterial pressure of 90 mm Hg or higher.Arch Intern Med.2005;165:17771781.
  6. Aujesky D,Obrosky DS,Stone RA, et al.Derivation and validation of a prognostic model for pulmonary embolism.Am J Respir Crit Care Med.2005;172:10411046.
  7. Chan CM,Woods C,Shorr AF.The validation and reproducibility of the pulmonary embolism severity index.J Thromb Haemost.2010;8:15091514.
  8. Sanchez O,Trinquart L,Caille V, et al.Prognostic factors for pulmonary embolism: the prep study, a prospective multicenter cohort study.Am J Respir Crit Care Med.2010;181:168173.
  9. Hanley JA,McNeil BJ.A method of comparing the areas under receiver operating characteristic curves derived from the same cases.Radiology.1983;148:839843.
  10. Donze J,Le Gal G,Fine MJ, et al.Prospective validation of the pulmonary embolism severity index. A clinical prognostic model for pulmonary embolism.Thromb Haemost.2008;100:943948.
  11. Wells PS,Kovacs MJ,Bormanis J, et al.Expanding eligibility for outpatient treatment of deep venous thrombosis and pulmonary embolism with low‐molecular‐weight heparin: a comparison of patient self‐injection with homecare injection.Arch Intern Med.1998;158:18091812.
  12. Kovacs MJ,Anderson D,Morrow B, et al.Outpatient treatment of pulmonary embolism with dalteparin.Thromb Haemost.2000;83:209211.
  13. Beer JH,Burger M,Gretener S, et al.Outpatient treatment of pulmonary embolism is feasible and safe in a substantial proportion of patients.J Thromb Haemost.2003;1:186187.
  14. Wells PS,Anderson DR,Rodger MA, et al.A randomized trial comparing 2 low‐molecular‐weight heparins for the outpatient treatment of deep vein thrombosis and pulmonary embolism.Arch Intern Med.2005;165:733738.
  15. Davies CW,Wimperis J,Green ES, et al.Early discharge of patients with pulmonary embolism: a two‐phase observational study.Eur Respir J.2007;30:708714.
  16. Otero R,Uresandi F,Jimenez D, et al.Home treatment in pulmonary embolism.Thromb Res.2010;126:e1e5.
  17. Goldhaber SZ,Visani L,De Rosa M.Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER).Lancet.1999;353:13861389.
  18. Wan S,Quinlan DJ,Agnelli G, et al.Thrombolysis compared with heparin for the initial treatment of pulmonary embolism: a meta‐analysis of the randomized controlled trials.Circulation.2004;110:744749.
  19. Heit JA,Silverstein MD,Mohr DN, et al.Predictors of survival after deep vein thrombosis and pulmonary embolism: a population‐based, cohort study.Arch Intern Med.1999;159:445453.
References
  1. Dalen JE.Pulmonary embolism: what have we learned since Virchow? Natural history, pathophysiology, and diagnosis.Chest.2002;122:14401456.
  2. Douketis JD,Leeuwenkamp O,Grobara P, et al.The incidence and prognostic significance of elevated cardiac troponins in patients with submassive pulmonary embolism.J Thromb Haemost.2005;3:508513.
  3. Kostrubiec M,Pruszczyk P,Bochowicz A, et al.Biomarker‐based risk assessment model in acute pulmonary embolism.Eur Heart J.2005;26:21662172.
  4. Kucher N,Goldhaber SZ.Cardiac biomarkers for risk stratification of patients with acute pulmonary embolism.Circulation.2003;108:21912194.
  5. Kucher N,Rossi E,De Rosa M, et al.Prognostic role of echocardiography among patients with acute pulmonary embolism and a systolic arterial pressure of 90 mm Hg or higher.Arch Intern Med.2005;165:17771781.
  6. Aujesky D,Obrosky DS,Stone RA, et al.Derivation and validation of a prognostic model for pulmonary embolism.Am J Respir Crit Care Med.2005;172:10411046.
  7. Chan CM,Woods C,Shorr AF.The validation and reproducibility of the pulmonary embolism severity index.J Thromb Haemost.2010;8:15091514.
  8. Sanchez O,Trinquart L,Caille V, et al.Prognostic factors for pulmonary embolism: the prep study, a prospective multicenter cohort study.Am J Respir Crit Care Med.2010;181:168173.
  9. Hanley JA,McNeil BJ.A method of comparing the areas under receiver operating characteristic curves derived from the same cases.Radiology.1983;148:839843.
  10. Donze J,Le Gal G,Fine MJ, et al.Prospective validation of the pulmonary embolism severity index. A clinical prognostic model for pulmonary embolism.Thromb Haemost.2008;100:943948.
  11. Wells PS,Kovacs MJ,Bormanis J, et al.Expanding eligibility for outpatient treatment of deep venous thrombosis and pulmonary embolism with low‐molecular‐weight heparin: a comparison of patient self‐injection with homecare injection.Arch Intern Med.1998;158:18091812.
  12. Kovacs MJ,Anderson D,Morrow B, et al.Outpatient treatment of pulmonary embolism with dalteparin.Thromb Haemost.2000;83:209211.
  13. Beer JH,Burger M,Gretener S, et al.Outpatient treatment of pulmonary embolism is feasible and safe in a substantial proportion of patients.J Thromb Haemost.2003;1:186187.
  14. Wells PS,Anderson DR,Rodger MA, et al.A randomized trial comparing 2 low‐molecular‐weight heparins for the outpatient treatment of deep vein thrombosis and pulmonary embolism.Arch Intern Med.2005;165:733738.
  15. Davies CW,Wimperis J,Green ES, et al.Early discharge of patients with pulmonary embolism: a two‐phase observational study.Eur Respir J.2007;30:708714.
  16. Otero R,Uresandi F,Jimenez D, et al.Home treatment in pulmonary embolism.Thromb Res.2010;126:e1e5.
  17. Goldhaber SZ,Visani L,De Rosa M.Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER).Lancet.1999;353:13861389.
  18. Wan S,Quinlan DJ,Agnelli G, et al.Thrombolysis compared with heparin for the initial treatment of pulmonary embolism: a meta‐analysis of the randomized controlled trials.Circulation.2004;110:744749.
  19. Heit JA,Silverstein MD,Mohr DN, et al.Predictors of survival after deep vein thrombosis and pulmonary embolism: a population‐based, cohort study.Arch Intern Med.1999;159:445453.
Issue
Journal of Hospital Medicine - 7(1)
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Comparing the pulmonary embolism severity index and the prognosis in pulmonary embolism scores as risk stratification tools
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Predicting Antibiotic Resistance in HCAP

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Predicting antibiotic resistance to community‐acquired pneumonia antibiotics in culture‐positive patients with healthcare‐associated pneumonia

Healthcare associated pneumonia (HCAP) is defined as pneumonia that is present upon admission, and occurs in patients that have recently been hospitalized, reside in a nursing home, or have had other recent healthcare exposures. Practice guidelines developed by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA), recommend strategies for the diagnosis and treatment of patients with HCAP.1 A premise of the guidelines is that recent healthcare exposure places patients at risk for infection due to multi‐drug resistant (MDR) pathogens such as methicillin‐resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa. In addition to criteria utilized to define HCAP, the guidelines state that recent immunosuppression and antibiotic exposure are risk factors for pneumonia due to MDR pathogens. In contrast to the treatment of community‐acquired pneumonia (CAP), the guidelines recommend empirical administration of antibiotics with activity against MRSA and Pseudomonas aeruginosa for all patients with HCAP.

We recently reported that antimicrobial resistance to CAP antibiotics (CAP‐resistance) was identified in one‐third of culture‐positive patients with HCAP.2 Data regarding the predictive ability of the guideline‐defined criteria specific to HCAP are limited.3 Evaluation and potential refinement of the criteria to identify patients at risk for MDR pathogens can aid in making antibiotic‐related treatment decisions.

The purposes of this study are to: 1) develop and validate a model to predict CAP‐resistance among patients with HCAP, and to compare the model's predictive performance to a model that includes traditional guideline‐defined risk factors; and 2) develop models to predict recovery of pathogen‐specific etiology (MRSA and Pseudomonas aeruginosa), and to compare the predictive performance of the pathogen‐specific and CAP‐resistance models.

METHODS

Patients with HCAP who were admitted to 6 Veterans Affairs Medical Centers (VAMC) in the northwestern United States between January 1, 2003 and December 31, 2008 were included in the retrospective cohort study. The cohort was identified utilizing medical records data extracted from the Veterans Integrated Service Network (VISN20) Data Warehouse. The Data Warehouse is a centralized open architecture relational database that houses medical and administrative records data for VISN20 patients. This research complies with all federal guidelines and VAMC policies relative to human subjects and clinical research.

Subjects were identified by the following pneumonia‐related discharge International Classification of Diseases (ICD‐9 CM) codes: 1) a primary diagnosis of 480‐483; 485‐487.0 (pneumonia); or 2) a primary diagnosis of 507.0 (pneumonitis), 518.8 (respiratory failure), or 0.38 (septicemia), and a secondary diagnosis of 480‐483; 485‐487.0.4 Eligibility required that patients received antibiotic therapy for pneumonia within 24 hours of admission, continue inpatient treatment for >24 hours, and meet any of the following guideline‐defined criteria: 1) hospitalization during the preceding 90 days; 2) admission from a nursing home; 3) outpatient or home wound care, outpatient or home infusion therapy, or chronic hemodialysis.1 In addition, patients not meeting guideline‐defined criteria, who had frequent healthcare system exposure, defined as 12 Emergency Department, Medicine, or Surgery clinic visits within 90 days of admission, were also included. Patients were excluded if they were directly transferred from another hospital, or had pneumonia‐related ICD‐9 codes but received inpatient care for pneumonia in a non‐VA hospital.

Study data included medical records for the year prior to admission for HCAP through 30 days afterwards. Data included: demographics; domicile preceding admission; healthcare utilization including diagnosis and procedure codes; inpatient medications administered, and outpatient prescription fills; vital signs; and laboratory test results, including cultures and susceptibilities.

Guideline‐defined criteria for predicting CAP‐resistance were similar to those used to identify the study cohort. Nursing home admission included patients who were directly admitted from a nursing home, skilled nursing facility, or domiciliary. Prior hospitalization 2 days within 90 days was calculated by summing the length of stay for all admissions during the preceding 90 days. Outpatient intravenous therapy, chronic hemodialysis, and wound care therapy was determined from medication administration records and relevant Current Procedural Terminology (CPT) or ICD‐9 procedure codes for care administered within 30 days. Antibiotic exposure was defined as administration of 1 dose of antibiotic during inpatient care, or fill of an outpatient prescription for 1 antibiotic dose within 90 days preceding admission. Immunosuppression was defined as: human immunodeficiency virus (HIV) diagnosis; white blood cell (WBC) count of 2500 cells/mm3 within 30 days of admission; corticosteroid ingestion during prior admission, or outpatient prescription fills for a corticosteroid with quantity sufficient to last 14 days preceding admission; or inpatient ingestion of, or outpatient prescription fills for, transplant or rheumatologic‐related immunosuppressants within 90 days preceding admission.

Additional variables assessed to predict CAP‐resistance were obtained as follows. First, modifications of guideline‐defined criteria were constructed. These included: direct nursing home admission, or recent nursing home stay preceding admission; total days of hospitalization within 90 days preceding admission; specific antibiotic exposures, including dates since last exposure preceding admission; and individual components of the immunosuppression criterion. Other cohort‐developed variables included: demographics; substance use history; chronic comorbidity determined by individual and composite measures of Charlson score; pulmonary disease history (eg, bronchiectasis); type and frequency of outpatient visits; consecutive (2) prescription fills for chronic medications of interest; clinical and surveillance culture results preceding admission; admitting ward; vital signs; and relevant hematology and chemistry labs.5

Sputum, blood, and bronchoscopy‐collected cultures obtained within 48 hours after admission were assessed to determine specimen acceptability. Poor sputum specimens were defined by Gram stain quantitative results indicating >10 epithelial cells (EPI) per low power field (LPF), or in the absence of quantitative results, semi‐quantitative results indicating 2‐4+EPI. Single positive blood cultures with results indicating likely contaminants were considered poor specimens. All bronchoscopy‐obtained specimens were considered acceptable. All cultures classified as poor specimens were excluded, and microbiology results were evaluated for the remaining specimens.2, 6 Organisms thought to represent colonization or contamination were excluded: coagulase‐negative (CN) Staphylococcus, Enterococcus sp, Bacillus sp, Proprionibacterium sp, and Candida sp. Recovery of a potential pneumonia pathogen from 1 acceptable culture constituted a culture‐positive admission.

CAP‐resistance was determined for each isolate. CAP‐resistance was defined as non‐susceptibility to non‐pseudomonal third generation cephalosporins (ceftriaxone or cefotaxime) or non‐pseudomonal 8‐methoxy fluoroquinolones (moxifloxacin, gatifloxacin), the VA preferred agents for treatment of CAP.7 There were differences between facilities in susceptibility reporting criteria; therefore, the following approach was used to determine CAP‐resistance. First, MRSA and Pseudomonas aeruginosa isolates were classified as CAP‐resistant. Second, susceptibility results were directly utilized to determine CAP‐resistance if both antibiotic results were available. Third, if only a surrogate antibiotic from a class was reported, a representative antibiotic consistent with Clinical Laboratory Standards Institute reporting criteria was utilized.8 Finally, expert rules determined CAP‐resistance for select potential pneumonia pathogens (eg, Haemophilus sp) if antibiotic susceptibility results for both cephalosporin and fluoroquinolone classes were not reported.815 Presence of 1 CAP‐resistant isolate resulted in a CAP‐resistant classification for an admission. MRSA and Pseudomonas aeruginosa endpoints were defined in a similar manner. Only the first admission for each patient was utilized in the analysis.

The probability of CAP‐resistance was predicted from guideline‐defined criteria (guideline‐defined model) with logistic regression. Next, non‐guideline variables were classified as high, medium, or low interest for association with CAP‐resistance. Variables were assessed for collinearity. A model of CAP‐resistance was developed from variables of high interest. Guideline‐defined criteria were omitted to allow consideration of more specific measures (eg, specific antibiotic exposures as opposed to receipt of antibiotics within the preceding 90 days) during this stage. Next, guideline‐defined criteria, and subsequently variables of lesser interest, were added in an attempt to improve the model. Annual trends and plausible interactions were considered. Model selection was by Akaike's Information Criterion (AIC).16 To promote model reliability, the final model was required to lack evidence of over‐fitting in bootstrapped internal validation.17 The guideline‐defined and cohort‐developed models were compared by difference in area under receiver operating characteristic (aROC) curves. The model development process was repeated for MRSA and Pseudomonas aeruginosa endpoints. Finally, to determine if the CAP‐resistance model sufficiently predicted pathogen‐specific MDR, the CAP‐resistance model was re‐estimated for MRSA and Pseudomonas aeruginosa endpoints. Statistical analysis was performed with R version 2.10.0 (The R Foundation for Statistical Computing, Vienna, Austria).

RESULTS

The cohort was comprised of 1300 patients with HCAP. Of these, 375 (28.8% [26.4‐31.4]) met culture‐positive criteria for potential pneumonia pathogens. CAP‐resistant organisms were identified in 118 (31.5% [26.8‐36.4]) patients within 48 hours of admission. CAP‐resistant organisms included: MRSA (49.2% [40.4‐58.1]), Pseudomonas aeruginosa (29.5% [21.9‐38.1]), Enterobacteriaceae (11.4% [6.5‐18.0]), Gram‐negative non‐enterics (8.3% [4.2‐14.4]), Streptococcus pneumoniae (1.5% [0.2‐5.4]), and opportunistic organisms (eg, Mycobacterium spp) (8.3% [4.2‐14.4]). Differences in select characteristics and exposures between culture‐positive and culture‐negative admissions, as well as CAP‐resistant and CAP‐sensitive admissions, were evident (Table 1).

Cohort Demographics of HCAP Admissions
CharacteristicCulture‐Negative Admissions (n = 925)Culture‐Positive Admissions (n = 375)P ValueCAP‐Sensitive Admissions (n = 257)CAP‐Resistant Admissions (n = 118)P Value
  • Abbreviations: CAP, community‐acquired pneumonia; ED, emergency department; HCAP, healthcare‐associated pneumonia; ICU, intensive care unit; MDR, multi‐drug resistant; MRSA, methicillin‐resistant Staphylococcus aureus; SD, standard deviation.

Demographics
Age (mean/SD)71.9 (12.1)71.4 (12.4)0.4470.4 (12.4)72.9 (12.3)0.07
Gender (% male)97.198.80.0798.499.21.00
Primary inclusion diagnosis (%)
Pneumonia93.185.9<0.0187.283.10.87
Aspiration pneumonitis with pneumonia pneumonia witpneumonia1.54.30.024.63.30.48
Septicemia with pneumonia2.66.2<0.015.18.50.25
Respiratory failure with pneumonia2.83.50.503.15.10.38
HCAP inclusion criteria (%)
Nursing home residence31.235.90.0830.446.6<0.01
Hospitalization of >2 days in last 90 days58.757.60.7352.162.70.06
Intravenous therapy in last 30 days19.520.70.6119.521.20.68
Outpatient wound care in last 30 days2.72.71.003.11.70.73
Chronic dialysis in last 30 days2.51.70.451.22.50.38
Hospitalization duration 0‐2 days in last 90 days10.211.20.5712.55.90.22
>12 ED or clinic visits in last 90 days44.144.60.8644.041.50.74
Other guideline‐defined MDR criteria (%)
Antibiotics in last 90 days63.861.60.4757.266.10.11
Recent immunosuppression19.323.90.5324.122.00.70
Severity of illness (%)
Admitted to the ICU21.841.6<0.0126.338.6*<0.01
Mechanical ventilation5.612.7<0.0112.112.70.87
Comorbidity (%)
Charlson comorbidity score (mean/SD)4.3 (3.0)4.3 (3.0)0.854.1 (3.1)4.5 (2.8)0.20
Diabetes33.829.20.1027.239.00.07
Prior antibiotic use (%)
Any cephalosporin42.039.90.4832.351.7<0.01
Third generation cephalosporin24.523.70.7818.330.50.01
Anti‐pseudomonal fluoroquinolone28.528.41.023.337.30.02
8‐Methoxy fluoroquinolone20.123.90.1024.124.51.00
Prior corticosteroid use (%)
Systemic steroids (>10 mg/day prednisone)11.113.20.2811.316.10.24
Inhaled steroids7.510.00.118.910.20.71
Prior MDR cultured (%)
MRSA within <90 days4.27.7<0.012.715.3<0.01
MRSA >90 days but <365 days5.66.50.543.910.20.03
P. aeruginosa within 365 days5.711.5<0.015.819.5<0.01

Of the guideline‐defined criteria, direct admission from a nursing home, prior hospitalization, and recent antibiotic exposure were associated with CAP‐resistance (Table 2). The cohort‐derived CAP‐resistance model included 6 variables. Prior MRSA colonization or infection within 90 days preceding admission was strongly predictive of CAP‐resistance. A composite variable consisting of direct admission from a nursing home or admission from the community after recent discharge from a nursing home was more predictive than direct admission from a nursing home alone. Exposure to cephalosporin antibiotics within the prior year was also predictive of CAP‐resistance. Subcategorizing cephalosporins by class or by most recent exposure in 90‐day increments did not improve the model. The remaining predictors in the model were guideline‐defined infusion therapy criterion, diabetes, and intensive care unit (ICU) admission.

Comparison of Guideline‐Defined and Cohort‐Developed Models of CAP‐Resistant HCAP
Guidelinedefined model of CAPResistant HCAPAIC 461.1CohortDeveloped Model of CAPresistant HCAPAIC 431.1
VariableOR95% CIP ValueVariableOR95% CIP Value
  • Abbreviations: AIC, Akaike's Information Criterion; CAP, community‐acquired pneumonia; CI, confidence interval; HCAP, healthcare‐associated pneumonia; ICU, intensive care unit; MRSA, methicillin‐resistant Staphylococcus aureus; NA, not applicable; OR, odds ratio.

(Intercept)NANANA(Intercept)NANANA
Nursing home residence at time of admission2.61.64.4<0.001Nursing home residence or discharge 180 days prior to admission2.31.43.80.002
Antibiotic exposure 90 days prior to admission1.71.02.80.054Positive MRSA status: 90 days prior to admission6.42.617.8<0.001
Hospitalization 2 days, 90 days prior to admission1.61.02.60.066>90 days but 365 days prior to admission2.30.95.90.074
Infusion therapy 30 days prior to admission1.50.82.80.173Cephalosporin exposure 365 days prior to admission1.81.12.90.019
Wound care therapy 30 days prior to admission0.50.12.10.370Infusion therapy 30 days prior to admission1.91.03.50.044
Hemodialysis therapy 30 days prior to admission1.80.311.20.497Diabetes1.71.02.80.044
Recent immunosuppression0.90.51.60.670Direct ICU admission upon hospitalization1.61.02.60.053

Of the guideline‐defined criteria, direct admission from a nursing home was most predictive of MRSA HCAP (n = 57), followed by prior hospitalization and recent antibiotic exposure (Table 3). The cohort‐developed model of MRSA HCAP included predictors common to the CAP‐resistance model: direct admission from a nursing home or patients who were recently discharged from a nursing home, history of prior MRSA, and diabetes. Positive MRSA status within 90 days preceding admission exhibited the strongest prediction of MRSA HCAP. Exposure to anti‐pseudomonal fluoroquinolones (ciprofloxacin and levofloxacin) within the prior year was also predictive of MRSA HCAP, however, exposure to 8‐methoxy fluoroquinolone was not (crude odds ratio (OR) = 0.7 [0.3‐1.4]; final model adjusted OR = 0.6 [0.2‐1.2]). Exposure to third generation cephalosporins within the previous year was more predictive than other cephalosporin exposures, and more predictive than exposure times categorized in 90‐day increments.

Comparison of Guideline‐Defined and Cohort‐Developed Models of MRSA HCAP
Guideline‐Defined Model of MRSA HCAPAIC 316.3Cohort‐Developed Model of MRSA HCAPAIC 279.2
VariableOR95% CIP ValueVariableOR95% CIP Value
  • Abbreviations: AIC, Akaike's Information Criterion; CI, confidence interval; HCAP, healthcare‐associated pneumonia; MRSA, methicillin‐resistant Staphylococcus aureus; NA, not applicable; OR, odds ratio.

  • Not included in model. No patient receiving chronic hemodialysis within 30 days of admission was identified as MRSA HCAP.

(Intercept)NANANA(Intercept)NANANA
Nursing home residence at time of admission2.61.44.80.003Nursing home residence or discharge 180 days prior to admission2.81.55.30.002
Hospitalization 2 days, 90 days prior to admission1.81.03.50.075Positive MRSA status: 90 days prior to admission7.73.119.6<0.001
Antibiotic exposure 90 days prior to admission1.60.93.30.143>90 days but 365 days prior to admission1.40.54.10.507
Recent immunosuppression0.60.31.30.244Anti‐pseudomonal fluoroquinolone exposure 365 days prior to admission2.41.24.60.009
Wound care therapy 30 days prior to admission0.50.03.30.582Diabetes2.21.24.30.012
Infusion therapy 30 days prior to admission0.90.42.00.793Chronic inhaled corticosteroids2.81.17.10.031
Chronic hemodialysis 30 days prior to admission*   Third generation cephalosporin exposure 365 days prior to admission2.11.04.10.040

Of the guideline‐defined criteria, only prior hospitalization within 90 days and admission from a nursing home were predictive of Pseudomonas aeruginosa HCAP (n = 36) (Table 4). In the cohort‐developed model of Pseudomonas aeruginosa HCAP, Pseudomonas aeruginosa was predicted by prior cephalosporin exposure within the preceding year, prior culture of Pseudomonas aeruginosa from any anatomical source within the preceding year, and chronic steroid use of 10 mg/day prednisone equivalents. Again, the model was not improved by subcategorizing cephalosporin by class or by most recent exposure time. Finally, a negative annual trend in Pseudomonas aeruginosa HCAP was evident.

Comparison of Guideline‐Defined and Cohort‐Developed Models of Pseudomonas aeruginosa HCAP
Guideline‐defined model of Pseudomonas aeruginosa HCAPAIC 234.8Cohort‐developed model of Pseudomonas aeruginosa HCAPAIC 211.1
VariableOR95% CIP ValueVariableOR95% CIP value
  • Abbreviations: AIC, Akaike's Information Criterion; CI, confidence interval; HCAP, healthcare‐associated pneumonia; NA, not applicable; OR, odds ratio.

  • Not included in model. No patient receiving wound care therapy within 30 days prior to admission was identified as Pseudomonas aeruginosa HCAP.

(Intercept)NANANA(Intercept)NANANA
Hospitalization 2 days, 90 days prior to admission2.51.16.00.034Cephalosporin exposure 365 days prior to admission3.81.88.8<0.001
Nursing home residence at time of admission2.11.04.60.059Positive Pseudomonas aeruginosa culture 365 days prior to admission3.31.47.80.006
Chronic hemodialysis 30 days prior to admission5.00.631.20.093Chronic steroid dose of 10 mg/day prednisone equivalents prior to admission3.01.36.90.010
Antibiotic exposure 90 days prior to admission1.90.84.70.150Year of study0.80.71.00.069
Infusion therapy 30 days prior to admission1.80.74.20.172    
Recent immunosuppression1.10.52.50.764    
Wound care therapy 30 days prior to admission*       

The cohort‐developed model of CAP‐resistance was re‐estimated for MRSA and Pseudomonas aeruginosa endpoints. Only positive MRSA status within 90 days preceding admission was associated with both endpoints (OR = 8.7 [3.5‐22.1] for MRSA; OR = 4.3 [1.4‐12.2] for Pseudomonas aeruginosa). Direct or recent nursing home residence (OR = 2.4 [1.3‐4.6]) and diabetes (OR = 2.4 [1.3‐4.5]) were highly predictive of MRSA, but not Pseudomonas aeruginosa (OR = 1.8 [0.8‐3.9] for nursing home residence; OR = 1.3 [0.6‐2.7] for diabetes), respectively. Cephalosporin exposure preceding admission was highly predictive of Pseudomonas aeruginosa (OR = 4.0 [1.9‐9.3]), but not with MRSA (OR = 1.1 [0.6‐2.1]). In these models, all estimated odds ratios were >1.0, consistent with the cohort‐developed model of CAP‐resistance.

For each endpoint, the cohort‐developed model was more predictive than the guideline‐defined model (Table 5) (to view ROC curves see Supporting Figures 1 to 3 in the online version of the article.). The cohort‐developed model of CAP‐resistance re‐estimated for pathogen‐specific endpoints resulted in similar predictive performance. To assess performance of the cohort developed models by facility, aROC was calculated for each of the 3 larger sites separately and for the 3 smaller facilities combined due to limited counts. Site specific aROC ranged from 0.652 to 0.762 for CAP‐resistance, 0.725 to 0.815 for MRSA, and 0.719 to 0.801 for Pseudomonas aeruginosa. The cohort‐developed model of CAP‐resistance re‐estimated for pathogen‐specific endpoints resulted in similar predictive performance.

Area Under the Receiver Operator Characteristic Curve for Guideline‐Defined and Cohort‐Developed Regression Models
ModelOutcome VariablePredictive VariablesaROC(95% CI)Model ComparisonaROC Difference(95% CI)P Value
  • Abbreviations: aROC, area under the receiver operator characteristic; CAP, community acquired pneumonia; CI, confidence interval; MRSA, methicillin‐resistant Staphylococcus aureus.

1CAP‐resistanceGuideline‐defined0.630(0.570, 0.691)2‐10.079(0.018, 0.139)0.011
2CAP‐resistanceCohort‐developed0.709(0.650, 0.768)    
3MRSAGuideline‐defined0.638(0.560, 0.712)4‐30.135(0.057, 0.213)<0.001
4MRSACohort‐developed0.773(0.703, 0.844)    
5Pseudomonas aeruginosaGuideline‐defined0.680(0.593, 0.768)6‐50.090(0.193, 0.193)0.090
6Pseudomonas aeruginosaCohort‐developed0.770(0.683, 0.857)    
7MRSACohort‐developed from CAP‐resistance model0.755(0.682, 0.828)7‐40.018(0.067, 0.031)0.467
8Pseudomonas aeruginosaCohort‐developed from CAP‐resistance model0.755(0.665, 0.845)8‐60.015(0.079, 0.049)0.650

A nomogram for the cohort‐developed model of CAP‐resistance can provide the predicted probability of culturing a CAP‐resistant organism for an individual patient (Table 6). Point scores assigned to levels of variables, are summed to obtain a total score, and the total score corresponds to a predicted probability of CAP‐resistance. The prevalence of CAP‐resistance (%) from highest to lowest quartile of predicted probability was 92.9, 58.8, 32.9, and 18.5, respectively.

Nomogram for Logistic Regression Model of CAP‐Resistance
A. Scoring
VariableScore
B. Predicted Probability of CAP‐Resistance*
Total Score% Chance of CAP‐Resistance
  • Abbreviations: CAP, community‐acquired pneumonia; ICU, intensive care unit; MRSA, methicillin‐resistant Staphylococcus aureus.

  • The minimum total score observed was 0 and the maximum total score observed was 230, which corresponded to 11% and 90% chance of CAP‐resistance, respectively.

Positive MRSA status prior to admission 
90 days+100
>90 days but 365 days+45
Nursing home residence or discharge 180 days prior to admission+45
Infusion therapy 30 days prior to admission+35
Cephalosporin exposure 365 days prior to admission+30
Diabetes+30
Direct ICU admission upon hospitalization+25
<35<20
35652030
65903040
901104050
1101305060
1301556070
1551857080
1852308090
>230>90

DISCUSSION

In this study, select ATS/IDSA guideline‐defined criteria predicted identification of CAP‐resistant organisms in patients with HCAP. Admission from a nursing home was most predictive of CAP‐resistant organisms, whereas recent hospitalization and antibiotic exposure were predictive to a lesser extent. There was weak evidence of associations between recent infusion and chronic hemodialysis criteria with MDR endpoints. Recent wound care and a composite definition of immunosuppression were not predictive of these endpoints.

The cohort‐developed model resulted in improved prediction of CAP‐resistance endpoints. Culture history, particularly history of MRSA within 90 days preceding admission, was a strong predictor of MDR endpoints. The MRSA history variable definition included cultures from all anatomical sources and nares polymerase chain reaction surveillance results, the latter increasing in 2007‐2008 due to the implementation of the VA MRSA initiative.18 This finding suggests that prior culture results should be considered when selecting empirical antimicrobial therapy, and the rapid proliferation of electronic medical records increases potential to utilize this information routinely. While the guideline‐defined nursing home admission criterion was a strong predictor of CAP‐resistance, admission from the community after recent discharge from a nursing home, in addition to direct admission from a nursing home, was also important.

Similarities in variables included in the pathogen‐specific and CAP‐resistance models reflect the importance of MRSA in defining the CAP‐resistance endpoint. Both CAP‐resistance and MRSA models included prior MRSA status, diabetes, and ICU admission, whereas cephalosporin exposure was common to the Pseudomonas aeruginosa and CAP‐resistance models. Annual trends in CAP‐resistance and MRSA recovery were not identified. The negative annual trend in Pseudomonas aeruginosa HCAP is unexplained and beyond the scope of this study. The percentage of culture‐positive admissions with Pseudomonas aeruginosa HCAP averaged 12% in 2003‐2006, but dropped to <5% in 2007‐2008. A potential explanation is that identification and isolation of patients with MRSA, as a result of the VA‐wide MRSA initiative, may have impacted Pseudomonas aeruginosa colonization by isolating patients co‐colonized with these pathogens during prior healthcare exposures. This is consistent with the observation that when the cohort‐derived CAP‐resistance model was refit with the Pseudomonas aeruginosa endpoint, recent MRSA colonization was strongly predictive of Pseudomonas aeruginosa. Despite differences between variables in pathogen‐specific and CAP‐resistant models, the CAP‐resistance model provided a similar degree of MRSA and Pseudomonas aeruginosa prediction. Finally, as a study purpose included developing best predictive models for each endpoint, and not merely identifying associations, there were other plausible models not reported.

Study strengths included use of the VISN20 Data Warehouse, which provided an integrated outpatient and inpatient medical record. This facilitated analysis of prior healthcare exposures and inpatient study endpoints. In addition, poor blood and sputum specimens and unlikely pneumonia pathogens were not included in establishing MDR endpoints. The variable set explored in regression modeling was extensive and detailed, and analysis included time and intensity‐based components of the variables. Importantly, a standardized approach to regression modeling was specified in advance, which included identification of variables with high potential for association with MDR endpoints, model selection by AIC, re‐evaluation of guideline‐defined criteria and variables of lower interest, and bootstrapped internal model validation.19

Study limitations included the use of ICD‐9 codes to establish a pneumonia diagnosis, which may lack sensitivity and specificity. However, an enhanced ICD‐9based algorithm superior to other claims‐based definitions of pneumonia was utilized.4, 20 Veterans may have received care at non‐VA facilities impacting identification of all healthcare system exposures preceding admission. Data for microbial endpoints were obtained from sterile and non‐sterile site cultures, and it was not possible to determine if the cultured organisms were truly pathogenic. While pathogen‐specific endpoints were not affected, the use of expert rules in select cases to establish CAP‐resistance may have impacted precision for this endpoint. It is also possible that refitting the cohort‐developed CAP‐resistance model for pathogen‐specific endpoints resulted in optimistic aROC due to model over‐fitting. Finally, the cohort was comprised of elderly males, and caution is warranted in extrapolating the results to other populations.

The predictive ability of the guideline‐defined criteria to identify patients with MDR pathogens has been studied. A prospective observational cohort study of 625 consecutive ICU admissions determined that the guideline‐defined criteriaprior antimicrobial treatment, nursing home residence, and prior hospitalizationwere associated with recovery of MDR colonization.21 Shorr et al., investigating a retrospective cohort of 619 patients with HCAP, reported that recent hospitalization, nursing home residence, hemodialysis, and ICU admission were associated with infections caused by CAP‐resistant organisms.22 This study did not report antimicrobial exposures. Our study complements these studies by evaluating existing HCAP guideline criteria, and identifying specific antibiotic exposure, prior culture data, comorbid illness, and immunosuppressive medications that are predictive of MDR infection.

Studies comparing the bacterial etiology of patients with pneumonia in nursing homes relative to CAP, have demonstrated mixed results in recovery of Gram‐negative MDR pathogens, but generally increased MRSA pneumonia.3 Our study suggests that a nursing home stay in the last 6 months is associated with an increased risk for MRSA, but not Pseudomonas aeruginosa, although this was limited by small sample size. Recent infusion therapy has not been previously reported to be associated with MDR pathogens in an HCAP population. In our study, this criterion was predictive of CAP‐resistance in the cohort‐developed model, but not in conjunction with other variables in the guideline‐defined model. Predictors of pathogen‐specific HCAP are limited to an aforementioned single prior study, which identified recent hospitalization, nursing home residence, and ICU admission as risk factors for MRSA HCAP.22

Many studies have investigated risks for infection with MRSA and Pseudomonas aeruginosa outside of the context of HCAP. Predictor variables in cohort‐developed pathogen‐specific models in our study are known risk factors for colonization or infection with these pathogens. For example, antecedent MRSA colonization has been noted as a strong risk factor for MRSA infection, particularly pneumonia.23, 24 Further, patients with diabetes and inhaled corticosteroid exposure are immunosuppressed and at increased risk for colonization with MRSA.25, 26 Likewise, bronchiolar colonization and corticosteroid exposures are known risk factors for pneumonia due to Pseudomonas aeruginosa.27

Many studies have identified prior antibiotic use as a risk factor for infections caused by MRSA and Pseudomonas aeruginosa. However, this criterion is excessively broad and specific antimicrobial exposures carry different magnitudes of risk. Third generation cephalosporins and anti‐pseudomonal fluoroquinolones are commonly reported antibiotics associated with risk for MRSA infection, whereas 8‐methoxy fluoroquinolones appear not to possess the same effect.2831 Likewise, cephalosporins have been reported as risk factors for MDR Pseudomonas aeruginosa infections.32

Several areas of research involving HCAP MDR risk should be investigated. First, the predictive models developed in our and other studies should be evaluated in larger, more diverse populations to establish generalizability. Second, empirical broad‐spectrum antibiotic therapy in all patients with HCAP results in overtreatment of many patients. To date, no reported models provided optimal performance for selecting empirical therapy for unstable ICU patients with HCAP, and many patients do not receive de‐escalation therapy. Thus, models to identify patients with low probability of MDR pathogens upon admission and to aid in de‐escalation are warranted. Finally, the negative trend in Pseudomonas aeruginosa HCAP requires confirmation and further study.

In conclusion, of the ATS/IDSA guideline‐defined criteria for MDR, nursing home admission, recent hospitalization, and antibiotic exposure were predictive of the recovery of CAP‐resistant organisms. Alternative models primarily based on prior culture data, specific antibiotic exposures, and immunosuppression‐related variables improved predictive performance of HCAP associated with MDR.

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References
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Journal of Hospital Medicine - 7(3)
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Healthcare associated pneumonia (HCAP) is defined as pneumonia that is present upon admission, and occurs in patients that have recently been hospitalized, reside in a nursing home, or have had other recent healthcare exposures. Practice guidelines developed by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA), recommend strategies for the diagnosis and treatment of patients with HCAP.1 A premise of the guidelines is that recent healthcare exposure places patients at risk for infection due to multi‐drug resistant (MDR) pathogens such as methicillin‐resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa. In addition to criteria utilized to define HCAP, the guidelines state that recent immunosuppression and antibiotic exposure are risk factors for pneumonia due to MDR pathogens. In contrast to the treatment of community‐acquired pneumonia (CAP), the guidelines recommend empirical administration of antibiotics with activity against MRSA and Pseudomonas aeruginosa for all patients with HCAP.

We recently reported that antimicrobial resistance to CAP antibiotics (CAP‐resistance) was identified in one‐third of culture‐positive patients with HCAP.2 Data regarding the predictive ability of the guideline‐defined criteria specific to HCAP are limited.3 Evaluation and potential refinement of the criteria to identify patients at risk for MDR pathogens can aid in making antibiotic‐related treatment decisions.

The purposes of this study are to: 1) develop and validate a model to predict CAP‐resistance among patients with HCAP, and to compare the model's predictive performance to a model that includes traditional guideline‐defined risk factors; and 2) develop models to predict recovery of pathogen‐specific etiology (MRSA and Pseudomonas aeruginosa), and to compare the predictive performance of the pathogen‐specific and CAP‐resistance models.

METHODS

Patients with HCAP who were admitted to 6 Veterans Affairs Medical Centers (VAMC) in the northwestern United States between January 1, 2003 and December 31, 2008 were included in the retrospective cohort study. The cohort was identified utilizing medical records data extracted from the Veterans Integrated Service Network (VISN20) Data Warehouse. The Data Warehouse is a centralized open architecture relational database that houses medical and administrative records data for VISN20 patients. This research complies with all federal guidelines and VAMC policies relative to human subjects and clinical research.

Subjects were identified by the following pneumonia‐related discharge International Classification of Diseases (ICD‐9 CM) codes: 1) a primary diagnosis of 480‐483; 485‐487.0 (pneumonia); or 2) a primary diagnosis of 507.0 (pneumonitis), 518.8 (respiratory failure), or 0.38 (septicemia), and a secondary diagnosis of 480‐483; 485‐487.0.4 Eligibility required that patients received antibiotic therapy for pneumonia within 24 hours of admission, continue inpatient treatment for >24 hours, and meet any of the following guideline‐defined criteria: 1) hospitalization during the preceding 90 days; 2) admission from a nursing home; 3) outpatient or home wound care, outpatient or home infusion therapy, or chronic hemodialysis.1 In addition, patients not meeting guideline‐defined criteria, who had frequent healthcare system exposure, defined as 12 Emergency Department, Medicine, or Surgery clinic visits within 90 days of admission, were also included. Patients were excluded if they were directly transferred from another hospital, or had pneumonia‐related ICD‐9 codes but received inpatient care for pneumonia in a non‐VA hospital.

Study data included medical records for the year prior to admission for HCAP through 30 days afterwards. Data included: demographics; domicile preceding admission; healthcare utilization including diagnosis and procedure codes; inpatient medications administered, and outpatient prescription fills; vital signs; and laboratory test results, including cultures and susceptibilities.

Guideline‐defined criteria for predicting CAP‐resistance were similar to those used to identify the study cohort. Nursing home admission included patients who were directly admitted from a nursing home, skilled nursing facility, or domiciliary. Prior hospitalization 2 days within 90 days was calculated by summing the length of stay for all admissions during the preceding 90 days. Outpatient intravenous therapy, chronic hemodialysis, and wound care therapy was determined from medication administration records and relevant Current Procedural Terminology (CPT) or ICD‐9 procedure codes for care administered within 30 days. Antibiotic exposure was defined as administration of 1 dose of antibiotic during inpatient care, or fill of an outpatient prescription for 1 antibiotic dose within 90 days preceding admission. Immunosuppression was defined as: human immunodeficiency virus (HIV) diagnosis; white blood cell (WBC) count of 2500 cells/mm3 within 30 days of admission; corticosteroid ingestion during prior admission, or outpatient prescription fills for a corticosteroid with quantity sufficient to last 14 days preceding admission; or inpatient ingestion of, or outpatient prescription fills for, transplant or rheumatologic‐related immunosuppressants within 90 days preceding admission.

Additional variables assessed to predict CAP‐resistance were obtained as follows. First, modifications of guideline‐defined criteria were constructed. These included: direct nursing home admission, or recent nursing home stay preceding admission; total days of hospitalization within 90 days preceding admission; specific antibiotic exposures, including dates since last exposure preceding admission; and individual components of the immunosuppression criterion. Other cohort‐developed variables included: demographics; substance use history; chronic comorbidity determined by individual and composite measures of Charlson score; pulmonary disease history (eg, bronchiectasis); type and frequency of outpatient visits; consecutive (2) prescription fills for chronic medications of interest; clinical and surveillance culture results preceding admission; admitting ward; vital signs; and relevant hematology and chemistry labs.5

Sputum, blood, and bronchoscopy‐collected cultures obtained within 48 hours after admission were assessed to determine specimen acceptability. Poor sputum specimens were defined by Gram stain quantitative results indicating >10 epithelial cells (EPI) per low power field (LPF), or in the absence of quantitative results, semi‐quantitative results indicating 2‐4+EPI. Single positive blood cultures with results indicating likely contaminants were considered poor specimens. All bronchoscopy‐obtained specimens were considered acceptable. All cultures classified as poor specimens were excluded, and microbiology results were evaluated for the remaining specimens.2, 6 Organisms thought to represent colonization or contamination were excluded: coagulase‐negative (CN) Staphylococcus, Enterococcus sp, Bacillus sp, Proprionibacterium sp, and Candida sp. Recovery of a potential pneumonia pathogen from 1 acceptable culture constituted a culture‐positive admission.

CAP‐resistance was determined for each isolate. CAP‐resistance was defined as non‐susceptibility to non‐pseudomonal third generation cephalosporins (ceftriaxone or cefotaxime) or non‐pseudomonal 8‐methoxy fluoroquinolones (moxifloxacin, gatifloxacin), the VA preferred agents for treatment of CAP.7 There were differences between facilities in susceptibility reporting criteria; therefore, the following approach was used to determine CAP‐resistance. First, MRSA and Pseudomonas aeruginosa isolates were classified as CAP‐resistant. Second, susceptibility results were directly utilized to determine CAP‐resistance if both antibiotic results were available. Third, if only a surrogate antibiotic from a class was reported, a representative antibiotic consistent with Clinical Laboratory Standards Institute reporting criteria was utilized.8 Finally, expert rules determined CAP‐resistance for select potential pneumonia pathogens (eg, Haemophilus sp) if antibiotic susceptibility results for both cephalosporin and fluoroquinolone classes were not reported.815 Presence of 1 CAP‐resistant isolate resulted in a CAP‐resistant classification for an admission. MRSA and Pseudomonas aeruginosa endpoints were defined in a similar manner. Only the first admission for each patient was utilized in the analysis.

The probability of CAP‐resistance was predicted from guideline‐defined criteria (guideline‐defined model) with logistic regression. Next, non‐guideline variables were classified as high, medium, or low interest for association with CAP‐resistance. Variables were assessed for collinearity. A model of CAP‐resistance was developed from variables of high interest. Guideline‐defined criteria were omitted to allow consideration of more specific measures (eg, specific antibiotic exposures as opposed to receipt of antibiotics within the preceding 90 days) during this stage. Next, guideline‐defined criteria, and subsequently variables of lesser interest, were added in an attempt to improve the model. Annual trends and plausible interactions were considered. Model selection was by Akaike's Information Criterion (AIC).16 To promote model reliability, the final model was required to lack evidence of over‐fitting in bootstrapped internal validation.17 The guideline‐defined and cohort‐developed models were compared by difference in area under receiver operating characteristic (aROC) curves. The model development process was repeated for MRSA and Pseudomonas aeruginosa endpoints. Finally, to determine if the CAP‐resistance model sufficiently predicted pathogen‐specific MDR, the CAP‐resistance model was re‐estimated for MRSA and Pseudomonas aeruginosa endpoints. Statistical analysis was performed with R version 2.10.0 (The R Foundation for Statistical Computing, Vienna, Austria).

RESULTS

The cohort was comprised of 1300 patients with HCAP. Of these, 375 (28.8% [26.4‐31.4]) met culture‐positive criteria for potential pneumonia pathogens. CAP‐resistant organisms were identified in 118 (31.5% [26.8‐36.4]) patients within 48 hours of admission. CAP‐resistant organisms included: MRSA (49.2% [40.4‐58.1]), Pseudomonas aeruginosa (29.5% [21.9‐38.1]), Enterobacteriaceae (11.4% [6.5‐18.0]), Gram‐negative non‐enterics (8.3% [4.2‐14.4]), Streptococcus pneumoniae (1.5% [0.2‐5.4]), and opportunistic organisms (eg, Mycobacterium spp) (8.3% [4.2‐14.4]). Differences in select characteristics and exposures between culture‐positive and culture‐negative admissions, as well as CAP‐resistant and CAP‐sensitive admissions, were evident (Table 1).

Cohort Demographics of HCAP Admissions
CharacteristicCulture‐Negative Admissions (n = 925)Culture‐Positive Admissions (n = 375)P ValueCAP‐Sensitive Admissions (n = 257)CAP‐Resistant Admissions (n = 118)P Value
  • Abbreviations: CAP, community‐acquired pneumonia; ED, emergency department; HCAP, healthcare‐associated pneumonia; ICU, intensive care unit; MDR, multi‐drug resistant; MRSA, methicillin‐resistant Staphylococcus aureus; SD, standard deviation.

Demographics
Age (mean/SD)71.9 (12.1)71.4 (12.4)0.4470.4 (12.4)72.9 (12.3)0.07
Gender (% male)97.198.80.0798.499.21.00
Primary inclusion diagnosis (%)
Pneumonia93.185.9<0.0187.283.10.87
Aspiration pneumonitis with pneumonia pneumonia witpneumonia1.54.30.024.63.30.48
Septicemia with pneumonia2.66.2<0.015.18.50.25
Respiratory failure with pneumonia2.83.50.503.15.10.38
HCAP inclusion criteria (%)
Nursing home residence31.235.90.0830.446.6<0.01
Hospitalization of >2 days in last 90 days58.757.60.7352.162.70.06
Intravenous therapy in last 30 days19.520.70.6119.521.20.68
Outpatient wound care in last 30 days2.72.71.003.11.70.73
Chronic dialysis in last 30 days2.51.70.451.22.50.38
Hospitalization duration 0‐2 days in last 90 days10.211.20.5712.55.90.22
>12 ED or clinic visits in last 90 days44.144.60.8644.041.50.74
Other guideline‐defined MDR criteria (%)
Antibiotics in last 90 days63.861.60.4757.266.10.11
Recent immunosuppression19.323.90.5324.122.00.70
Severity of illness (%)
Admitted to the ICU21.841.6<0.0126.338.6*<0.01
Mechanical ventilation5.612.7<0.0112.112.70.87
Comorbidity (%)
Charlson comorbidity score (mean/SD)4.3 (3.0)4.3 (3.0)0.854.1 (3.1)4.5 (2.8)0.20
Diabetes33.829.20.1027.239.00.07
Prior antibiotic use (%)
Any cephalosporin42.039.90.4832.351.7<0.01
Third generation cephalosporin24.523.70.7818.330.50.01
Anti‐pseudomonal fluoroquinolone28.528.41.023.337.30.02
8‐Methoxy fluoroquinolone20.123.90.1024.124.51.00
Prior corticosteroid use (%)
Systemic steroids (>10 mg/day prednisone)11.113.20.2811.316.10.24
Inhaled steroids7.510.00.118.910.20.71
Prior MDR cultured (%)
MRSA within <90 days4.27.7<0.012.715.3<0.01
MRSA >90 days but <365 days5.66.50.543.910.20.03
P. aeruginosa within 365 days5.711.5<0.015.819.5<0.01

Of the guideline‐defined criteria, direct admission from a nursing home, prior hospitalization, and recent antibiotic exposure were associated with CAP‐resistance (Table 2). The cohort‐derived CAP‐resistance model included 6 variables. Prior MRSA colonization or infection within 90 days preceding admission was strongly predictive of CAP‐resistance. A composite variable consisting of direct admission from a nursing home or admission from the community after recent discharge from a nursing home was more predictive than direct admission from a nursing home alone. Exposure to cephalosporin antibiotics within the prior year was also predictive of CAP‐resistance. Subcategorizing cephalosporins by class or by most recent exposure in 90‐day increments did not improve the model. The remaining predictors in the model were guideline‐defined infusion therapy criterion, diabetes, and intensive care unit (ICU) admission.

Comparison of Guideline‐Defined and Cohort‐Developed Models of CAP‐Resistant HCAP
Guidelinedefined model of CAPResistant HCAPAIC 461.1CohortDeveloped Model of CAPresistant HCAPAIC 431.1
VariableOR95% CIP ValueVariableOR95% CIP Value
  • Abbreviations: AIC, Akaike's Information Criterion; CAP, community‐acquired pneumonia; CI, confidence interval; HCAP, healthcare‐associated pneumonia; ICU, intensive care unit; MRSA, methicillin‐resistant Staphylococcus aureus; NA, not applicable; OR, odds ratio.

(Intercept)NANANA(Intercept)NANANA
Nursing home residence at time of admission2.61.64.4<0.001Nursing home residence or discharge 180 days prior to admission2.31.43.80.002
Antibiotic exposure 90 days prior to admission1.71.02.80.054Positive MRSA status: 90 days prior to admission6.42.617.8<0.001
Hospitalization 2 days, 90 days prior to admission1.61.02.60.066>90 days but 365 days prior to admission2.30.95.90.074
Infusion therapy 30 days prior to admission1.50.82.80.173Cephalosporin exposure 365 days prior to admission1.81.12.90.019
Wound care therapy 30 days prior to admission0.50.12.10.370Infusion therapy 30 days prior to admission1.91.03.50.044
Hemodialysis therapy 30 days prior to admission1.80.311.20.497Diabetes1.71.02.80.044
Recent immunosuppression0.90.51.60.670Direct ICU admission upon hospitalization1.61.02.60.053

Of the guideline‐defined criteria, direct admission from a nursing home was most predictive of MRSA HCAP (n = 57), followed by prior hospitalization and recent antibiotic exposure (Table 3). The cohort‐developed model of MRSA HCAP included predictors common to the CAP‐resistance model: direct admission from a nursing home or patients who were recently discharged from a nursing home, history of prior MRSA, and diabetes. Positive MRSA status within 90 days preceding admission exhibited the strongest prediction of MRSA HCAP. Exposure to anti‐pseudomonal fluoroquinolones (ciprofloxacin and levofloxacin) within the prior year was also predictive of MRSA HCAP, however, exposure to 8‐methoxy fluoroquinolone was not (crude odds ratio (OR) = 0.7 [0.3‐1.4]; final model adjusted OR = 0.6 [0.2‐1.2]). Exposure to third generation cephalosporins within the previous year was more predictive than other cephalosporin exposures, and more predictive than exposure times categorized in 90‐day increments.

Comparison of Guideline‐Defined and Cohort‐Developed Models of MRSA HCAP
Guideline‐Defined Model of MRSA HCAPAIC 316.3Cohort‐Developed Model of MRSA HCAPAIC 279.2
VariableOR95% CIP ValueVariableOR95% CIP Value
  • Abbreviations: AIC, Akaike's Information Criterion; CI, confidence interval; HCAP, healthcare‐associated pneumonia; MRSA, methicillin‐resistant Staphylococcus aureus; NA, not applicable; OR, odds ratio.

  • Not included in model. No patient receiving chronic hemodialysis within 30 days of admission was identified as MRSA HCAP.

(Intercept)NANANA(Intercept)NANANA
Nursing home residence at time of admission2.61.44.80.003Nursing home residence or discharge 180 days prior to admission2.81.55.30.002
Hospitalization 2 days, 90 days prior to admission1.81.03.50.075Positive MRSA status: 90 days prior to admission7.73.119.6<0.001
Antibiotic exposure 90 days prior to admission1.60.93.30.143>90 days but 365 days prior to admission1.40.54.10.507
Recent immunosuppression0.60.31.30.244Anti‐pseudomonal fluoroquinolone exposure 365 days prior to admission2.41.24.60.009
Wound care therapy 30 days prior to admission0.50.03.30.582Diabetes2.21.24.30.012
Infusion therapy 30 days prior to admission0.90.42.00.793Chronic inhaled corticosteroids2.81.17.10.031
Chronic hemodialysis 30 days prior to admission*   Third generation cephalosporin exposure 365 days prior to admission2.11.04.10.040

Of the guideline‐defined criteria, only prior hospitalization within 90 days and admission from a nursing home were predictive of Pseudomonas aeruginosa HCAP (n = 36) (Table 4). In the cohort‐developed model of Pseudomonas aeruginosa HCAP, Pseudomonas aeruginosa was predicted by prior cephalosporin exposure within the preceding year, prior culture of Pseudomonas aeruginosa from any anatomical source within the preceding year, and chronic steroid use of 10 mg/day prednisone equivalents. Again, the model was not improved by subcategorizing cephalosporin by class or by most recent exposure time. Finally, a negative annual trend in Pseudomonas aeruginosa HCAP was evident.

Comparison of Guideline‐Defined and Cohort‐Developed Models of Pseudomonas aeruginosa HCAP
Guideline‐defined model of Pseudomonas aeruginosa HCAPAIC 234.8Cohort‐developed model of Pseudomonas aeruginosa HCAPAIC 211.1
VariableOR95% CIP ValueVariableOR95% CIP value
  • Abbreviations: AIC, Akaike's Information Criterion; CI, confidence interval; HCAP, healthcare‐associated pneumonia; NA, not applicable; OR, odds ratio.

  • Not included in model. No patient receiving wound care therapy within 30 days prior to admission was identified as Pseudomonas aeruginosa HCAP.

(Intercept)NANANA(Intercept)NANANA
Hospitalization 2 days, 90 days prior to admission2.51.16.00.034Cephalosporin exposure 365 days prior to admission3.81.88.8<0.001
Nursing home residence at time of admission2.11.04.60.059Positive Pseudomonas aeruginosa culture 365 days prior to admission3.31.47.80.006
Chronic hemodialysis 30 days prior to admission5.00.631.20.093Chronic steroid dose of 10 mg/day prednisone equivalents prior to admission3.01.36.90.010
Antibiotic exposure 90 days prior to admission1.90.84.70.150Year of study0.80.71.00.069
Infusion therapy 30 days prior to admission1.80.74.20.172    
Recent immunosuppression1.10.52.50.764    
Wound care therapy 30 days prior to admission*       

The cohort‐developed model of CAP‐resistance was re‐estimated for MRSA and Pseudomonas aeruginosa endpoints. Only positive MRSA status within 90 days preceding admission was associated with both endpoints (OR = 8.7 [3.5‐22.1] for MRSA; OR = 4.3 [1.4‐12.2] for Pseudomonas aeruginosa). Direct or recent nursing home residence (OR = 2.4 [1.3‐4.6]) and diabetes (OR = 2.4 [1.3‐4.5]) were highly predictive of MRSA, but not Pseudomonas aeruginosa (OR = 1.8 [0.8‐3.9] for nursing home residence; OR = 1.3 [0.6‐2.7] for diabetes), respectively. Cephalosporin exposure preceding admission was highly predictive of Pseudomonas aeruginosa (OR = 4.0 [1.9‐9.3]), but not with MRSA (OR = 1.1 [0.6‐2.1]). In these models, all estimated odds ratios were >1.0, consistent with the cohort‐developed model of CAP‐resistance.

For each endpoint, the cohort‐developed model was more predictive than the guideline‐defined model (Table 5) (to view ROC curves see Supporting Figures 1 to 3 in the online version of the article.). The cohort‐developed model of CAP‐resistance re‐estimated for pathogen‐specific endpoints resulted in similar predictive performance. To assess performance of the cohort developed models by facility, aROC was calculated for each of the 3 larger sites separately and for the 3 smaller facilities combined due to limited counts. Site specific aROC ranged from 0.652 to 0.762 for CAP‐resistance, 0.725 to 0.815 for MRSA, and 0.719 to 0.801 for Pseudomonas aeruginosa. The cohort‐developed model of CAP‐resistance re‐estimated for pathogen‐specific endpoints resulted in similar predictive performance.

Area Under the Receiver Operator Characteristic Curve for Guideline‐Defined and Cohort‐Developed Regression Models
ModelOutcome VariablePredictive VariablesaROC(95% CI)Model ComparisonaROC Difference(95% CI)P Value
  • Abbreviations: aROC, area under the receiver operator characteristic; CAP, community acquired pneumonia; CI, confidence interval; MRSA, methicillin‐resistant Staphylococcus aureus.

1CAP‐resistanceGuideline‐defined0.630(0.570, 0.691)2‐10.079(0.018, 0.139)0.011
2CAP‐resistanceCohort‐developed0.709(0.650, 0.768)    
3MRSAGuideline‐defined0.638(0.560, 0.712)4‐30.135(0.057, 0.213)<0.001
4MRSACohort‐developed0.773(0.703, 0.844)    
5Pseudomonas aeruginosaGuideline‐defined0.680(0.593, 0.768)6‐50.090(0.193, 0.193)0.090
6Pseudomonas aeruginosaCohort‐developed0.770(0.683, 0.857)    
7MRSACohort‐developed from CAP‐resistance model0.755(0.682, 0.828)7‐40.018(0.067, 0.031)0.467
8Pseudomonas aeruginosaCohort‐developed from CAP‐resistance model0.755(0.665, 0.845)8‐60.015(0.079, 0.049)0.650

A nomogram for the cohort‐developed model of CAP‐resistance can provide the predicted probability of culturing a CAP‐resistant organism for an individual patient (Table 6). Point scores assigned to levels of variables, are summed to obtain a total score, and the total score corresponds to a predicted probability of CAP‐resistance. The prevalence of CAP‐resistance (%) from highest to lowest quartile of predicted probability was 92.9, 58.8, 32.9, and 18.5, respectively.

Nomogram for Logistic Regression Model of CAP‐Resistance
A. Scoring
VariableScore
B. Predicted Probability of CAP‐Resistance*
Total Score% Chance of CAP‐Resistance
  • Abbreviations: CAP, community‐acquired pneumonia; ICU, intensive care unit; MRSA, methicillin‐resistant Staphylococcus aureus.

  • The minimum total score observed was 0 and the maximum total score observed was 230, which corresponded to 11% and 90% chance of CAP‐resistance, respectively.

Positive MRSA status prior to admission 
90 days+100
>90 days but 365 days+45
Nursing home residence or discharge 180 days prior to admission+45
Infusion therapy 30 days prior to admission+35
Cephalosporin exposure 365 days prior to admission+30
Diabetes+30
Direct ICU admission upon hospitalization+25
<35<20
35652030
65903040
901104050
1101305060
1301556070
1551857080
1852308090
>230>90

DISCUSSION

In this study, select ATS/IDSA guideline‐defined criteria predicted identification of CAP‐resistant organisms in patients with HCAP. Admission from a nursing home was most predictive of CAP‐resistant organisms, whereas recent hospitalization and antibiotic exposure were predictive to a lesser extent. There was weak evidence of associations between recent infusion and chronic hemodialysis criteria with MDR endpoints. Recent wound care and a composite definition of immunosuppression were not predictive of these endpoints.

The cohort‐developed model resulted in improved prediction of CAP‐resistance endpoints. Culture history, particularly history of MRSA within 90 days preceding admission, was a strong predictor of MDR endpoints. The MRSA history variable definition included cultures from all anatomical sources and nares polymerase chain reaction surveillance results, the latter increasing in 2007‐2008 due to the implementation of the VA MRSA initiative.18 This finding suggests that prior culture results should be considered when selecting empirical antimicrobial therapy, and the rapid proliferation of electronic medical records increases potential to utilize this information routinely. While the guideline‐defined nursing home admission criterion was a strong predictor of CAP‐resistance, admission from the community after recent discharge from a nursing home, in addition to direct admission from a nursing home, was also important.

Similarities in variables included in the pathogen‐specific and CAP‐resistance models reflect the importance of MRSA in defining the CAP‐resistance endpoint. Both CAP‐resistance and MRSA models included prior MRSA status, diabetes, and ICU admission, whereas cephalosporin exposure was common to the Pseudomonas aeruginosa and CAP‐resistance models. Annual trends in CAP‐resistance and MRSA recovery were not identified. The negative annual trend in Pseudomonas aeruginosa HCAP is unexplained and beyond the scope of this study. The percentage of culture‐positive admissions with Pseudomonas aeruginosa HCAP averaged 12% in 2003‐2006, but dropped to <5% in 2007‐2008. A potential explanation is that identification and isolation of patients with MRSA, as a result of the VA‐wide MRSA initiative, may have impacted Pseudomonas aeruginosa colonization by isolating patients co‐colonized with these pathogens during prior healthcare exposures. This is consistent with the observation that when the cohort‐derived CAP‐resistance model was refit with the Pseudomonas aeruginosa endpoint, recent MRSA colonization was strongly predictive of Pseudomonas aeruginosa. Despite differences between variables in pathogen‐specific and CAP‐resistant models, the CAP‐resistance model provided a similar degree of MRSA and Pseudomonas aeruginosa prediction. Finally, as a study purpose included developing best predictive models for each endpoint, and not merely identifying associations, there were other plausible models not reported.

Study strengths included use of the VISN20 Data Warehouse, which provided an integrated outpatient and inpatient medical record. This facilitated analysis of prior healthcare exposures and inpatient study endpoints. In addition, poor blood and sputum specimens and unlikely pneumonia pathogens were not included in establishing MDR endpoints. The variable set explored in regression modeling was extensive and detailed, and analysis included time and intensity‐based components of the variables. Importantly, a standardized approach to regression modeling was specified in advance, which included identification of variables with high potential for association with MDR endpoints, model selection by AIC, re‐evaluation of guideline‐defined criteria and variables of lower interest, and bootstrapped internal model validation.19

Study limitations included the use of ICD‐9 codes to establish a pneumonia diagnosis, which may lack sensitivity and specificity. However, an enhanced ICD‐9based algorithm superior to other claims‐based definitions of pneumonia was utilized.4, 20 Veterans may have received care at non‐VA facilities impacting identification of all healthcare system exposures preceding admission. Data for microbial endpoints were obtained from sterile and non‐sterile site cultures, and it was not possible to determine if the cultured organisms were truly pathogenic. While pathogen‐specific endpoints were not affected, the use of expert rules in select cases to establish CAP‐resistance may have impacted precision for this endpoint. It is also possible that refitting the cohort‐developed CAP‐resistance model for pathogen‐specific endpoints resulted in optimistic aROC due to model over‐fitting. Finally, the cohort was comprised of elderly males, and caution is warranted in extrapolating the results to other populations.

The predictive ability of the guideline‐defined criteria to identify patients with MDR pathogens has been studied. A prospective observational cohort study of 625 consecutive ICU admissions determined that the guideline‐defined criteriaprior antimicrobial treatment, nursing home residence, and prior hospitalizationwere associated with recovery of MDR colonization.21 Shorr et al., investigating a retrospective cohort of 619 patients with HCAP, reported that recent hospitalization, nursing home residence, hemodialysis, and ICU admission were associated with infections caused by CAP‐resistant organisms.22 This study did not report antimicrobial exposures. Our study complements these studies by evaluating existing HCAP guideline criteria, and identifying specific antibiotic exposure, prior culture data, comorbid illness, and immunosuppressive medications that are predictive of MDR infection.

Studies comparing the bacterial etiology of patients with pneumonia in nursing homes relative to CAP, have demonstrated mixed results in recovery of Gram‐negative MDR pathogens, but generally increased MRSA pneumonia.3 Our study suggests that a nursing home stay in the last 6 months is associated with an increased risk for MRSA, but not Pseudomonas aeruginosa, although this was limited by small sample size. Recent infusion therapy has not been previously reported to be associated with MDR pathogens in an HCAP population. In our study, this criterion was predictive of CAP‐resistance in the cohort‐developed model, but not in conjunction with other variables in the guideline‐defined model. Predictors of pathogen‐specific HCAP are limited to an aforementioned single prior study, which identified recent hospitalization, nursing home residence, and ICU admission as risk factors for MRSA HCAP.22

Many studies have investigated risks for infection with MRSA and Pseudomonas aeruginosa outside of the context of HCAP. Predictor variables in cohort‐developed pathogen‐specific models in our study are known risk factors for colonization or infection with these pathogens. For example, antecedent MRSA colonization has been noted as a strong risk factor for MRSA infection, particularly pneumonia.23, 24 Further, patients with diabetes and inhaled corticosteroid exposure are immunosuppressed and at increased risk for colonization with MRSA.25, 26 Likewise, bronchiolar colonization and corticosteroid exposures are known risk factors for pneumonia due to Pseudomonas aeruginosa.27

Many studies have identified prior antibiotic use as a risk factor for infections caused by MRSA and Pseudomonas aeruginosa. However, this criterion is excessively broad and specific antimicrobial exposures carry different magnitudes of risk. Third generation cephalosporins and anti‐pseudomonal fluoroquinolones are commonly reported antibiotics associated with risk for MRSA infection, whereas 8‐methoxy fluoroquinolones appear not to possess the same effect.2831 Likewise, cephalosporins have been reported as risk factors for MDR Pseudomonas aeruginosa infections.32

Several areas of research involving HCAP MDR risk should be investigated. First, the predictive models developed in our and other studies should be evaluated in larger, more diverse populations to establish generalizability. Second, empirical broad‐spectrum antibiotic therapy in all patients with HCAP results in overtreatment of many patients. To date, no reported models provided optimal performance for selecting empirical therapy for unstable ICU patients with HCAP, and many patients do not receive de‐escalation therapy. Thus, models to identify patients with low probability of MDR pathogens upon admission and to aid in de‐escalation are warranted. Finally, the negative trend in Pseudomonas aeruginosa HCAP requires confirmation and further study.

In conclusion, of the ATS/IDSA guideline‐defined criteria for MDR, nursing home admission, recent hospitalization, and antibiotic exposure were predictive of the recovery of CAP‐resistant organisms. Alternative models primarily based on prior culture data, specific antibiotic exposures, and immunosuppression‐related variables improved predictive performance of HCAP associated with MDR.

Healthcare associated pneumonia (HCAP) is defined as pneumonia that is present upon admission, and occurs in patients that have recently been hospitalized, reside in a nursing home, or have had other recent healthcare exposures. Practice guidelines developed by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA), recommend strategies for the diagnosis and treatment of patients with HCAP.1 A premise of the guidelines is that recent healthcare exposure places patients at risk for infection due to multi‐drug resistant (MDR) pathogens such as methicillin‐resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa. In addition to criteria utilized to define HCAP, the guidelines state that recent immunosuppression and antibiotic exposure are risk factors for pneumonia due to MDR pathogens. In contrast to the treatment of community‐acquired pneumonia (CAP), the guidelines recommend empirical administration of antibiotics with activity against MRSA and Pseudomonas aeruginosa for all patients with HCAP.

We recently reported that antimicrobial resistance to CAP antibiotics (CAP‐resistance) was identified in one‐third of culture‐positive patients with HCAP.2 Data regarding the predictive ability of the guideline‐defined criteria specific to HCAP are limited.3 Evaluation and potential refinement of the criteria to identify patients at risk for MDR pathogens can aid in making antibiotic‐related treatment decisions.

The purposes of this study are to: 1) develop and validate a model to predict CAP‐resistance among patients with HCAP, and to compare the model's predictive performance to a model that includes traditional guideline‐defined risk factors; and 2) develop models to predict recovery of pathogen‐specific etiology (MRSA and Pseudomonas aeruginosa), and to compare the predictive performance of the pathogen‐specific and CAP‐resistance models.

METHODS

Patients with HCAP who were admitted to 6 Veterans Affairs Medical Centers (VAMC) in the northwestern United States between January 1, 2003 and December 31, 2008 were included in the retrospective cohort study. The cohort was identified utilizing medical records data extracted from the Veterans Integrated Service Network (VISN20) Data Warehouse. The Data Warehouse is a centralized open architecture relational database that houses medical and administrative records data for VISN20 patients. This research complies with all federal guidelines and VAMC policies relative to human subjects and clinical research.

Subjects were identified by the following pneumonia‐related discharge International Classification of Diseases (ICD‐9 CM) codes: 1) a primary diagnosis of 480‐483; 485‐487.0 (pneumonia); or 2) a primary diagnosis of 507.0 (pneumonitis), 518.8 (respiratory failure), or 0.38 (septicemia), and a secondary diagnosis of 480‐483; 485‐487.0.4 Eligibility required that patients received antibiotic therapy for pneumonia within 24 hours of admission, continue inpatient treatment for >24 hours, and meet any of the following guideline‐defined criteria: 1) hospitalization during the preceding 90 days; 2) admission from a nursing home; 3) outpatient or home wound care, outpatient or home infusion therapy, or chronic hemodialysis.1 In addition, patients not meeting guideline‐defined criteria, who had frequent healthcare system exposure, defined as 12 Emergency Department, Medicine, or Surgery clinic visits within 90 days of admission, were also included. Patients were excluded if they were directly transferred from another hospital, or had pneumonia‐related ICD‐9 codes but received inpatient care for pneumonia in a non‐VA hospital.

Study data included medical records for the year prior to admission for HCAP through 30 days afterwards. Data included: demographics; domicile preceding admission; healthcare utilization including diagnosis and procedure codes; inpatient medications administered, and outpatient prescription fills; vital signs; and laboratory test results, including cultures and susceptibilities.

Guideline‐defined criteria for predicting CAP‐resistance were similar to those used to identify the study cohort. Nursing home admission included patients who were directly admitted from a nursing home, skilled nursing facility, or domiciliary. Prior hospitalization 2 days within 90 days was calculated by summing the length of stay for all admissions during the preceding 90 days. Outpatient intravenous therapy, chronic hemodialysis, and wound care therapy was determined from medication administration records and relevant Current Procedural Terminology (CPT) or ICD‐9 procedure codes for care administered within 30 days. Antibiotic exposure was defined as administration of 1 dose of antibiotic during inpatient care, or fill of an outpatient prescription for 1 antibiotic dose within 90 days preceding admission. Immunosuppression was defined as: human immunodeficiency virus (HIV) diagnosis; white blood cell (WBC) count of 2500 cells/mm3 within 30 days of admission; corticosteroid ingestion during prior admission, or outpatient prescription fills for a corticosteroid with quantity sufficient to last 14 days preceding admission; or inpatient ingestion of, or outpatient prescription fills for, transplant or rheumatologic‐related immunosuppressants within 90 days preceding admission.

Additional variables assessed to predict CAP‐resistance were obtained as follows. First, modifications of guideline‐defined criteria were constructed. These included: direct nursing home admission, or recent nursing home stay preceding admission; total days of hospitalization within 90 days preceding admission; specific antibiotic exposures, including dates since last exposure preceding admission; and individual components of the immunosuppression criterion. Other cohort‐developed variables included: demographics; substance use history; chronic comorbidity determined by individual and composite measures of Charlson score; pulmonary disease history (eg, bronchiectasis); type and frequency of outpatient visits; consecutive (2) prescription fills for chronic medications of interest; clinical and surveillance culture results preceding admission; admitting ward; vital signs; and relevant hematology and chemistry labs.5

Sputum, blood, and bronchoscopy‐collected cultures obtained within 48 hours after admission were assessed to determine specimen acceptability. Poor sputum specimens were defined by Gram stain quantitative results indicating >10 epithelial cells (EPI) per low power field (LPF), or in the absence of quantitative results, semi‐quantitative results indicating 2‐4+EPI. Single positive blood cultures with results indicating likely contaminants were considered poor specimens. All bronchoscopy‐obtained specimens were considered acceptable. All cultures classified as poor specimens were excluded, and microbiology results were evaluated for the remaining specimens.2, 6 Organisms thought to represent colonization or contamination were excluded: coagulase‐negative (CN) Staphylococcus, Enterococcus sp, Bacillus sp, Proprionibacterium sp, and Candida sp. Recovery of a potential pneumonia pathogen from 1 acceptable culture constituted a culture‐positive admission.

CAP‐resistance was determined for each isolate. CAP‐resistance was defined as non‐susceptibility to non‐pseudomonal third generation cephalosporins (ceftriaxone or cefotaxime) or non‐pseudomonal 8‐methoxy fluoroquinolones (moxifloxacin, gatifloxacin), the VA preferred agents for treatment of CAP.7 There were differences between facilities in susceptibility reporting criteria; therefore, the following approach was used to determine CAP‐resistance. First, MRSA and Pseudomonas aeruginosa isolates were classified as CAP‐resistant. Second, susceptibility results were directly utilized to determine CAP‐resistance if both antibiotic results were available. Third, if only a surrogate antibiotic from a class was reported, a representative antibiotic consistent with Clinical Laboratory Standards Institute reporting criteria was utilized.8 Finally, expert rules determined CAP‐resistance for select potential pneumonia pathogens (eg, Haemophilus sp) if antibiotic susceptibility results for both cephalosporin and fluoroquinolone classes were not reported.815 Presence of 1 CAP‐resistant isolate resulted in a CAP‐resistant classification for an admission. MRSA and Pseudomonas aeruginosa endpoints were defined in a similar manner. Only the first admission for each patient was utilized in the analysis.

The probability of CAP‐resistance was predicted from guideline‐defined criteria (guideline‐defined model) with logistic regression. Next, non‐guideline variables were classified as high, medium, or low interest for association with CAP‐resistance. Variables were assessed for collinearity. A model of CAP‐resistance was developed from variables of high interest. Guideline‐defined criteria were omitted to allow consideration of more specific measures (eg, specific antibiotic exposures as opposed to receipt of antibiotics within the preceding 90 days) during this stage. Next, guideline‐defined criteria, and subsequently variables of lesser interest, were added in an attempt to improve the model. Annual trends and plausible interactions were considered. Model selection was by Akaike's Information Criterion (AIC).16 To promote model reliability, the final model was required to lack evidence of over‐fitting in bootstrapped internal validation.17 The guideline‐defined and cohort‐developed models were compared by difference in area under receiver operating characteristic (aROC) curves. The model development process was repeated for MRSA and Pseudomonas aeruginosa endpoints. Finally, to determine if the CAP‐resistance model sufficiently predicted pathogen‐specific MDR, the CAP‐resistance model was re‐estimated for MRSA and Pseudomonas aeruginosa endpoints. Statistical analysis was performed with R version 2.10.0 (The R Foundation for Statistical Computing, Vienna, Austria).

RESULTS

The cohort was comprised of 1300 patients with HCAP. Of these, 375 (28.8% [26.4‐31.4]) met culture‐positive criteria for potential pneumonia pathogens. CAP‐resistant organisms were identified in 118 (31.5% [26.8‐36.4]) patients within 48 hours of admission. CAP‐resistant organisms included: MRSA (49.2% [40.4‐58.1]), Pseudomonas aeruginosa (29.5% [21.9‐38.1]), Enterobacteriaceae (11.4% [6.5‐18.0]), Gram‐negative non‐enterics (8.3% [4.2‐14.4]), Streptococcus pneumoniae (1.5% [0.2‐5.4]), and opportunistic organisms (eg, Mycobacterium spp) (8.3% [4.2‐14.4]). Differences in select characteristics and exposures between culture‐positive and culture‐negative admissions, as well as CAP‐resistant and CAP‐sensitive admissions, were evident (Table 1).

Cohort Demographics of HCAP Admissions
CharacteristicCulture‐Negative Admissions (n = 925)Culture‐Positive Admissions (n = 375)P ValueCAP‐Sensitive Admissions (n = 257)CAP‐Resistant Admissions (n = 118)P Value
  • Abbreviations: CAP, community‐acquired pneumonia; ED, emergency department; HCAP, healthcare‐associated pneumonia; ICU, intensive care unit; MDR, multi‐drug resistant; MRSA, methicillin‐resistant Staphylococcus aureus; SD, standard deviation.

Demographics
Age (mean/SD)71.9 (12.1)71.4 (12.4)0.4470.4 (12.4)72.9 (12.3)0.07
Gender (% male)97.198.80.0798.499.21.00
Primary inclusion diagnosis (%)
Pneumonia93.185.9<0.0187.283.10.87
Aspiration pneumonitis with pneumonia pneumonia witpneumonia1.54.30.024.63.30.48
Septicemia with pneumonia2.66.2<0.015.18.50.25
Respiratory failure with pneumonia2.83.50.503.15.10.38
HCAP inclusion criteria (%)
Nursing home residence31.235.90.0830.446.6<0.01
Hospitalization of >2 days in last 90 days58.757.60.7352.162.70.06
Intravenous therapy in last 30 days19.520.70.6119.521.20.68
Outpatient wound care in last 30 days2.72.71.003.11.70.73
Chronic dialysis in last 30 days2.51.70.451.22.50.38
Hospitalization duration 0‐2 days in last 90 days10.211.20.5712.55.90.22
>12 ED or clinic visits in last 90 days44.144.60.8644.041.50.74
Other guideline‐defined MDR criteria (%)
Antibiotics in last 90 days63.861.60.4757.266.10.11
Recent immunosuppression19.323.90.5324.122.00.70
Severity of illness (%)
Admitted to the ICU21.841.6<0.0126.338.6*<0.01
Mechanical ventilation5.612.7<0.0112.112.70.87
Comorbidity (%)
Charlson comorbidity score (mean/SD)4.3 (3.0)4.3 (3.0)0.854.1 (3.1)4.5 (2.8)0.20
Diabetes33.829.20.1027.239.00.07
Prior antibiotic use (%)
Any cephalosporin42.039.90.4832.351.7<0.01
Third generation cephalosporin24.523.70.7818.330.50.01
Anti‐pseudomonal fluoroquinolone28.528.41.023.337.30.02
8‐Methoxy fluoroquinolone20.123.90.1024.124.51.00
Prior corticosteroid use (%)
Systemic steroids (>10 mg/day prednisone)11.113.20.2811.316.10.24
Inhaled steroids7.510.00.118.910.20.71
Prior MDR cultured (%)
MRSA within <90 days4.27.7<0.012.715.3<0.01
MRSA >90 days but <365 days5.66.50.543.910.20.03
P. aeruginosa within 365 days5.711.5<0.015.819.5<0.01

Of the guideline‐defined criteria, direct admission from a nursing home, prior hospitalization, and recent antibiotic exposure were associated with CAP‐resistance (Table 2). The cohort‐derived CAP‐resistance model included 6 variables. Prior MRSA colonization or infection within 90 days preceding admission was strongly predictive of CAP‐resistance. A composite variable consisting of direct admission from a nursing home or admission from the community after recent discharge from a nursing home was more predictive than direct admission from a nursing home alone. Exposure to cephalosporin antibiotics within the prior year was also predictive of CAP‐resistance. Subcategorizing cephalosporins by class or by most recent exposure in 90‐day increments did not improve the model. The remaining predictors in the model were guideline‐defined infusion therapy criterion, diabetes, and intensive care unit (ICU) admission.

Comparison of Guideline‐Defined and Cohort‐Developed Models of CAP‐Resistant HCAP
Guidelinedefined model of CAPResistant HCAPAIC 461.1CohortDeveloped Model of CAPresistant HCAPAIC 431.1
VariableOR95% CIP ValueVariableOR95% CIP Value
  • Abbreviations: AIC, Akaike's Information Criterion; CAP, community‐acquired pneumonia; CI, confidence interval; HCAP, healthcare‐associated pneumonia; ICU, intensive care unit; MRSA, methicillin‐resistant Staphylococcus aureus; NA, not applicable; OR, odds ratio.

(Intercept)NANANA(Intercept)NANANA
Nursing home residence at time of admission2.61.64.4<0.001Nursing home residence or discharge 180 days prior to admission2.31.43.80.002
Antibiotic exposure 90 days prior to admission1.71.02.80.054Positive MRSA status: 90 days prior to admission6.42.617.8<0.001
Hospitalization 2 days, 90 days prior to admission1.61.02.60.066>90 days but 365 days prior to admission2.30.95.90.074
Infusion therapy 30 days prior to admission1.50.82.80.173Cephalosporin exposure 365 days prior to admission1.81.12.90.019
Wound care therapy 30 days prior to admission0.50.12.10.370Infusion therapy 30 days prior to admission1.91.03.50.044
Hemodialysis therapy 30 days prior to admission1.80.311.20.497Diabetes1.71.02.80.044
Recent immunosuppression0.90.51.60.670Direct ICU admission upon hospitalization1.61.02.60.053

Of the guideline‐defined criteria, direct admission from a nursing home was most predictive of MRSA HCAP (n = 57), followed by prior hospitalization and recent antibiotic exposure (Table 3). The cohort‐developed model of MRSA HCAP included predictors common to the CAP‐resistance model: direct admission from a nursing home or patients who were recently discharged from a nursing home, history of prior MRSA, and diabetes. Positive MRSA status within 90 days preceding admission exhibited the strongest prediction of MRSA HCAP. Exposure to anti‐pseudomonal fluoroquinolones (ciprofloxacin and levofloxacin) within the prior year was also predictive of MRSA HCAP, however, exposure to 8‐methoxy fluoroquinolone was not (crude odds ratio (OR) = 0.7 [0.3‐1.4]; final model adjusted OR = 0.6 [0.2‐1.2]). Exposure to third generation cephalosporins within the previous year was more predictive than other cephalosporin exposures, and more predictive than exposure times categorized in 90‐day increments.

Comparison of Guideline‐Defined and Cohort‐Developed Models of MRSA HCAP
Guideline‐Defined Model of MRSA HCAPAIC 316.3Cohort‐Developed Model of MRSA HCAPAIC 279.2
VariableOR95% CIP ValueVariableOR95% CIP Value
  • Abbreviations: AIC, Akaike's Information Criterion; CI, confidence interval; HCAP, healthcare‐associated pneumonia; MRSA, methicillin‐resistant Staphylococcus aureus; NA, not applicable; OR, odds ratio.

  • Not included in model. No patient receiving chronic hemodialysis within 30 days of admission was identified as MRSA HCAP.

(Intercept)NANANA(Intercept)NANANA
Nursing home residence at time of admission2.61.44.80.003Nursing home residence or discharge 180 days prior to admission2.81.55.30.002
Hospitalization 2 days, 90 days prior to admission1.81.03.50.075Positive MRSA status: 90 days prior to admission7.73.119.6<0.001
Antibiotic exposure 90 days prior to admission1.60.93.30.143>90 days but 365 days prior to admission1.40.54.10.507
Recent immunosuppression0.60.31.30.244Anti‐pseudomonal fluoroquinolone exposure 365 days prior to admission2.41.24.60.009
Wound care therapy 30 days prior to admission0.50.03.30.582Diabetes2.21.24.30.012
Infusion therapy 30 days prior to admission0.90.42.00.793Chronic inhaled corticosteroids2.81.17.10.031
Chronic hemodialysis 30 days prior to admission*   Third generation cephalosporin exposure 365 days prior to admission2.11.04.10.040

Of the guideline‐defined criteria, only prior hospitalization within 90 days and admission from a nursing home were predictive of Pseudomonas aeruginosa HCAP (n = 36) (Table 4). In the cohort‐developed model of Pseudomonas aeruginosa HCAP, Pseudomonas aeruginosa was predicted by prior cephalosporin exposure within the preceding year, prior culture of Pseudomonas aeruginosa from any anatomical source within the preceding year, and chronic steroid use of 10 mg/day prednisone equivalents. Again, the model was not improved by subcategorizing cephalosporin by class or by most recent exposure time. Finally, a negative annual trend in Pseudomonas aeruginosa HCAP was evident.

Comparison of Guideline‐Defined and Cohort‐Developed Models of Pseudomonas aeruginosa HCAP
Guideline‐defined model of Pseudomonas aeruginosa HCAPAIC 234.8Cohort‐developed model of Pseudomonas aeruginosa HCAPAIC 211.1
VariableOR95% CIP ValueVariableOR95% CIP value
  • Abbreviations: AIC, Akaike's Information Criterion; CI, confidence interval; HCAP, healthcare‐associated pneumonia; NA, not applicable; OR, odds ratio.

  • Not included in model. No patient receiving wound care therapy within 30 days prior to admission was identified as Pseudomonas aeruginosa HCAP.

(Intercept)NANANA(Intercept)NANANA
Hospitalization 2 days, 90 days prior to admission2.51.16.00.034Cephalosporin exposure 365 days prior to admission3.81.88.8<0.001
Nursing home residence at time of admission2.11.04.60.059Positive Pseudomonas aeruginosa culture 365 days prior to admission3.31.47.80.006
Chronic hemodialysis 30 days prior to admission5.00.631.20.093Chronic steroid dose of 10 mg/day prednisone equivalents prior to admission3.01.36.90.010
Antibiotic exposure 90 days prior to admission1.90.84.70.150Year of study0.80.71.00.069
Infusion therapy 30 days prior to admission1.80.74.20.172    
Recent immunosuppression1.10.52.50.764    
Wound care therapy 30 days prior to admission*       

The cohort‐developed model of CAP‐resistance was re‐estimated for MRSA and Pseudomonas aeruginosa endpoints. Only positive MRSA status within 90 days preceding admission was associated with both endpoints (OR = 8.7 [3.5‐22.1] for MRSA; OR = 4.3 [1.4‐12.2] for Pseudomonas aeruginosa). Direct or recent nursing home residence (OR = 2.4 [1.3‐4.6]) and diabetes (OR = 2.4 [1.3‐4.5]) were highly predictive of MRSA, but not Pseudomonas aeruginosa (OR = 1.8 [0.8‐3.9] for nursing home residence; OR = 1.3 [0.6‐2.7] for diabetes), respectively. Cephalosporin exposure preceding admission was highly predictive of Pseudomonas aeruginosa (OR = 4.0 [1.9‐9.3]), but not with MRSA (OR = 1.1 [0.6‐2.1]). In these models, all estimated odds ratios were >1.0, consistent with the cohort‐developed model of CAP‐resistance.

For each endpoint, the cohort‐developed model was more predictive than the guideline‐defined model (Table 5) (to view ROC curves see Supporting Figures 1 to 3 in the online version of the article.). The cohort‐developed model of CAP‐resistance re‐estimated for pathogen‐specific endpoints resulted in similar predictive performance. To assess performance of the cohort developed models by facility, aROC was calculated for each of the 3 larger sites separately and for the 3 smaller facilities combined due to limited counts. Site specific aROC ranged from 0.652 to 0.762 for CAP‐resistance, 0.725 to 0.815 for MRSA, and 0.719 to 0.801 for Pseudomonas aeruginosa. The cohort‐developed model of CAP‐resistance re‐estimated for pathogen‐specific endpoints resulted in similar predictive performance.

Area Under the Receiver Operator Characteristic Curve for Guideline‐Defined and Cohort‐Developed Regression Models
ModelOutcome VariablePredictive VariablesaROC(95% CI)Model ComparisonaROC Difference(95% CI)P Value
  • Abbreviations: aROC, area under the receiver operator characteristic; CAP, community acquired pneumonia; CI, confidence interval; MRSA, methicillin‐resistant Staphylococcus aureus.

1CAP‐resistanceGuideline‐defined0.630(0.570, 0.691)2‐10.079(0.018, 0.139)0.011
2CAP‐resistanceCohort‐developed0.709(0.650, 0.768)    
3MRSAGuideline‐defined0.638(0.560, 0.712)4‐30.135(0.057, 0.213)<0.001
4MRSACohort‐developed0.773(0.703, 0.844)    
5Pseudomonas aeruginosaGuideline‐defined0.680(0.593, 0.768)6‐50.090(0.193, 0.193)0.090
6Pseudomonas aeruginosaCohort‐developed0.770(0.683, 0.857)    
7MRSACohort‐developed from CAP‐resistance model0.755(0.682, 0.828)7‐40.018(0.067, 0.031)0.467
8Pseudomonas aeruginosaCohort‐developed from CAP‐resistance model0.755(0.665, 0.845)8‐60.015(0.079, 0.049)0.650

A nomogram for the cohort‐developed model of CAP‐resistance can provide the predicted probability of culturing a CAP‐resistant organism for an individual patient (Table 6). Point scores assigned to levels of variables, are summed to obtain a total score, and the total score corresponds to a predicted probability of CAP‐resistance. The prevalence of CAP‐resistance (%) from highest to lowest quartile of predicted probability was 92.9, 58.8, 32.9, and 18.5, respectively.

Nomogram for Logistic Regression Model of CAP‐Resistance
A. Scoring
VariableScore
B. Predicted Probability of CAP‐Resistance*
Total Score% Chance of CAP‐Resistance
  • Abbreviations: CAP, community‐acquired pneumonia; ICU, intensive care unit; MRSA, methicillin‐resistant Staphylococcus aureus.

  • The minimum total score observed was 0 and the maximum total score observed was 230, which corresponded to 11% and 90% chance of CAP‐resistance, respectively.

Positive MRSA status prior to admission 
90 days+100
>90 days but 365 days+45
Nursing home residence or discharge 180 days prior to admission+45
Infusion therapy 30 days prior to admission+35
Cephalosporin exposure 365 days prior to admission+30
Diabetes+30
Direct ICU admission upon hospitalization+25
<35<20
35652030
65903040
901104050
1101305060
1301556070
1551857080
1852308090
>230>90

DISCUSSION

In this study, select ATS/IDSA guideline‐defined criteria predicted identification of CAP‐resistant organisms in patients with HCAP. Admission from a nursing home was most predictive of CAP‐resistant organisms, whereas recent hospitalization and antibiotic exposure were predictive to a lesser extent. There was weak evidence of associations between recent infusion and chronic hemodialysis criteria with MDR endpoints. Recent wound care and a composite definition of immunosuppression were not predictive of these endpoints.

The cohort‐developed model resulted in improved prediction of CAP‐resistance endpoints. Culture history, particularly history of MRSA within 90 days preceding admission, was a strong predictor of MDR endpoints. The MRSA history variable definition included cultures from all anatomical sources and nares polymerase chain reaction surveillance results, the latter increasing in 2007‐2008 due to the implementation of the VA MRSA initiative.18 This finding suggests that prior culture results should be considered when selecting empirical antimicrobial therapy, and the rapid proliferation of electronic medical records increases potential to utilize this information routinely. While the guideline‐defined nursing home admission criterion was a strong predictor of CAP‐resistance, admission from the community after recent discharge from a nursing home, in addition to direct admission from a nursing home, was also important.

Similarities in variables included in the pathogen‐specific and CAP‐resistance models reflect the importance of MRSA in defining the CAP‐resistance endpoint. Both CAP‐resistance and MRSA models included prior MRSA status, diabetes, and ICU admission, whereas cephalosporin exposure was common to the Pseudomonas aeruginosa and CAP‐resistance models. Annual trends in CAP‐resistance and MRSA recovery were not identified. The negative annual trend in Pseudomonas aeruginosa HCAP is unexplained and beyond the scope of this study. The percentage of culture‐positive admissions with Pseudomonas aeruginosa HCAP averaged 12% in 2003‐2006, but dropped to <5% in 2007‐2008. A potential explanation is that identification and isolation of patients with MRSA, as a result of the VA‐wide MRSA initiative, may have impacted Pseudomonas aeruginosa colonization by isolating patients co‐colonized with these pathogens during prior healthcare exposures. This is consistent with the observation that when the cohort‐derived CAP‐resistance model was refit with the Pseudomonas aeruginosa endpoint, recent MRSA colonization was strongly predictive of Pseudomonas aeruginosa. Despite differences between variables in pathogen‐specific and CAP‐resistant models, the CAP‐resistance model provided a similar degree of MRSA and Pseudomonas aeruginosa prediction. Finally, as a study purpose included developing best predictive models for each endpoint, and not merely identifying associations, there were other plausible models not reported.

Study strengths included use of the VISN20 Data Warehouse, which provided an integrated outpatient and inpatient medical record. This facilitated analysis of prior healthcare exposures and inpatient study endpoints. In addition, poor blood and sputum specimens and unlikely pneumonia pathogens were not included in establishing MDR endpoints. The variable set explored in regression modeling was extensive and detailed, and analysis included time and intensity‐based components of the variables. Importantly, a standardized approach to regression modeling was specified in advance, which included identification of variables with high potential for association with MDR endpoints, model selection by AIC, re‐evaluation of guideline‐defined criteria and variables of lower interest, and bootstrapped internal model validation.19

Study limitations included the use of ICD‐9 codes to establish a pneumonia diagnosis, which may lack sensitivity and specificity. However, an enhanced ICD‐9based algorithm superior to other claims‐based definitions of pneumonia was utilized.4, 20 Veterans may have received care at non‐VA facilities impacting identification of all healthcare system exposures preceding admission. Data for microbial endpoints were obtained from sterile and non‐sterile site cultures, and it was not possible to determine if the cultured organisms were truly pathogenic. While pathogen‐specific endpoints were not affected, the use of expert rules in select cases to establish CAP‐resistance may have impacted precision for this endpoint. It is also possible that refitting the cohort‐developed CAP‐resistance model for pathogen‐specific endpoints resulted in optimistic aROC due to model over‐fitting. Finally, the cohort was comprised of elderly males, and caution is warranted in extrapolating the results to other populations.

The predictive ability of the guideline‐defined criteria to identify patients with MDR pathogens has been studied. A prospective observational cohort study of 625 consecutive ICU admissions determined that the guideline‐defined criteriaprior antimicrobial treatment, nursing home residence, and prior hospitalizationwere associated with recovery of MDR colonization.21 Shorr et al., investigating a retrospective cohort of 619 patients with HCAP, reported that recent hospitalization, nursing home residence, hemodialysis, and ICU admission were associated with infections caused by CAP‐resistant organisms.22 This study did not report antimicrobial exposures. Our study complements these studies by evaluating existing HCAP guideline criteria, and identifying specific antibiotic exposure, prior culture data, comorbid illness, and immunosuppressive medications that are predictive of MDR infection.

Studies comparing the bacterial etiology of patients with pneumonia in nursing homes relative to CAP, have demonstrated mixed results in recovery of Gram‐negative MDR pathogens, but generally increased MRSA pneumonia.3 Our study suggests that a nursing home stay in the last 6 months is associated with an increased risk for MRSA, but not Pseudomonas aeruginosa, although this was limited by small sample size. Recent infusion therapy has not been previously reported to be associated with MDR pathogens in an HCAP population. In our study, this criterion was predictive of CAP‐resistance in the cohort‐developed model, but not in conjunction with other variables in the guideline‐defined model. Predictors of pathogen‐specific HCAP are limited to an aforementioned single prior study, which identified recent hospitalization, nursing home residence, and ICU admission as risk factors for MRSA HCAP.22

Many studies have investigated risks for infection with MRSA and Pseudomonas aeruginosa outside of the context of HCAP. Predictor variables in cohort‐developed pathogen‐specific models in our study are known risk factors for colonization or infection with these pathogens. For example, antecedent MRSA colonization has been noted as a strong risk factor for MRSA infection, particularly pneumonia.23, 24 Further, patients with diabetes and inhaled corticosteroid exposure are immunosuppressed and at increased risk for colonization with MRSA.25, 26 Likewise, bronchiolar colonization and corticosteroid exposures are known risk factors for pneumonia due to Pseudomonas aeruginosa.27

Many studies have identified prior antibiotic use as a risk factor for infections caused by MRSA and Pseudomonas aeruginosa. However, this criterion is excessively broad and specific antimicrobial exposures carry different magnitudes of risk. Third generation cephalosporins and anti‐pseudomonal fluoroquinolones are commonly reported antibiotics associated with risk for MRSA infection, whereas 8‐methoxy fluoroquinolones appear not to possess the same effect.2831 Likewise, cephalosporins have been reported as risk factors for MDR Pseudomonas aeruginosa infections.32

Several areas of research involving HCAP MDR risk should be investigated. First, the predictive models developed in our and other studies should be evaluated in larger, more diverse populations to establish generalizability. Second, empirical broad‐spectrum antibiotic therapy in all patients with HCAP results in overtreatment of many patients. To date, no reported models provided optimal performance for selecting empirical therapy for unstable ICU patients with HCAP, and many patients do not receive de‐escalation therapy. Thus, models to identify patients with low probability of MDR pathogens upon admission and to aid in de‐escalation are warranted. Finally, the negative trend in Pseudomonas aeruginosa HCAP requires confirmation and further study.

In conclusion, of the ATS/IDSA guideline‐defined criteria for MDR, nursing home admission, recent hospitalization, and antibiotic exposure were predictive of the recovery of CAP‐resistant organisms. Alternative models primarily based on prior culture data, specific antibiotic exposures, and immunosuppression‐related variables improved predictive performance of HCAP associated with MDR.

References
  1. American Thoracic Society; Infectious Diseases Society of America.Guidelines for the management of adults with hospital‐acquired, ventilator‐associated, and healthcare‐associated pneumonia.Am J Respir Crit Care Med.2005;171(4):388416.
  2. Madaras‐Kelly KJ,Remington RE,Fan VS,Sloan KL.The etiology of health care associated pneumonia (HCAP) [abstract K‐282]. Presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; September2009; San Francisco, CA.
  3. Poch DS,Ost DE.What are the important risk factors for healthcare‐associated pneumonia?Semin Respir Crit Care Med.2009;30(1):2635.
  4. Aronsky D,Haug PJ,Lagor C,Dean NC.Accuracy of administrative data for identifying patients with pneumonia.Am J Med Qual.2005;20(6):319328.
  5. Deyo RA,Cherkin DC,Ciol MA.Adapting a clinical comorbidity index for use with ICD‐9‐CM administrative databases.J Clin Epidemiol.1992;45:613619.
  6. Madaras‐Kelly KJ,Remington RE,Fan VS,Sloan KL.How often is a microbial etiology identified in health care associated pneumonia (HCAP)? [abstract K‐289]. Presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; September2009; San Francisco, CA.
  7. Fluoroquinolone use criteria. Washington D.C. Guidelines Developed by the Pharmacy Benefits Management Strategic Health Care Group and Medical Advisory Panel, Veterans Health Administration, Department of Veterans Affairs. Last update, November2006. http://www.pbm.va.gov/Clinical%20Guidance/Criteria%20For%20Use/Fluoroquinolone,%20Criteria%20for%20Use.pdf. Last accessed August 20th, 2011.
  8. Performance Standards for Antimicrobial Susceptibility Testing; 18th Informational Supplement. M100‐S18.Wayne, PA:Clinical Laboratory Standards Institute;2009.
  9. Jones RN,Fritsche TR,Sader HS.Antimicrobial activity of DC‐159a, a new fluoroquinolone, against 1,149 recently collected clinical isolates.Antimicrob Agents Chemother.2008;52(10):37633775.
  10. Feikin DR,Chuchat A,Kolczak M, et al.Mortality from invasive pneumococcal pneumonia in the era of antibiotic resistance, 1995–1997.Am J Public Health.2000;90(2):223229.
  11. Hoogkamp‐Korstanje JA,Roelsofs‐Willemse J.Comparative activity of moxifloxacin against Gram‐positive clinical isolates.J Antimicrob Chemother.2000;45(1):3139.
  12. Hoban DJ,Bouchillon SK,Dowzicky MJ.Antimicrobial susceptibility of extended‐spectrum‐beta‐lactamase producers and multi‐drug resistant Acinetobacter baumannii throughout the United States and comparative in vitro activity of tigecycline, a new glycylcycline antimicrobial.Diagn Microbiol Infect Dis.2007;57(4):423428.
  13. Galles AC,Jones RN,Sader HS.Antimicrobial susceptibility profile of contemporary clinical strains of Stenotropomonas maltophila isolates: can moxifloxacin activity be predicted by levofloxacin MIC results?J Chemother.2008;20(1):3842.
  14. Mandell LA,Wunderink RG,Anzueto A, et al.Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community‐acquired pneumonia in adults.Clin Infect Dis.2007;44(suppl 2):S27S72.
  15. Gilbert DN, Moellering RC, Eliopoulos GM, Sande, MA, eds.The Sanford Guide to Antimicrobial Therapy.38th ed.Speryville, VA:Antimicrobial Therapy;2008.
  16. Akaike H.A new look at the statistical model identification.IEEE Trans Automat Contr.1974;19(6):716723.
  17. Efron B.Estimating the error rate of a prediction rule: improvement on cross‐validation.J Am Stat Assoc.1987;78:316331.
  18. Garcia‐Williams AG,Miller LJ,Burkitt KH, et. Al.Beyond beta: lessons learned from implementation of the Department of Veterans Affairs Methicillin‐Resistant Staphylococcus aureus Prevention Initiative.Infect Control Hosp Epidemiol.2010;31(7):763765.
  19. Moss M,Wellman DA,Cotsonis GA.An appraisal of multivariable logistic models in the pulmonary and critical care literature.Chest.2003;123(3):923928.
  20. Dean NC,Bateman KA,Donnelly SM,Silver MP,Snow GL,Hale D.Improved clinical outcomes with utilization of a community‐acquired pneumonia guideline.Chest.2006;130(3):794799.
  21. Nseir S,Grailles G,Soury‐Lavergne A,Minacori F,Alves I,Durocher A.Accuracy of American Thoracic Society/Infectious Diseases Society of America criteria in predicting infection or colonization with multidrug‐resistant bacteria at intensive‐care unit admission.Clin Microbiol Infect.2009;16(7):902908.
  22. Shorr AF,Zilberberg MD,Micek ST,Kollef MH.Prediction of infections due to antibiotic resistant bacteria by select risk factors for healthcare associated pneumonia.Arch Intern Med.2008;168(20):22052210.
  23. Davis KA,Stewart JJ,Crouch HK,Florez CE,Hospenthal DR.Methicillin‐resistant Staphylococcus aureus (MRSA) nares colonization at hospital admission and its effect on subsequent MRSA infection.Clin Infect Dis.2004;39(6):776782.
  24. Datta R,Huang SS.Risk of infection and death due to methicillin‐resistant Staphylococcus aureus in long‐term carriers.Clin Infect Dis.2008;47(2):176181.
  25. Hewlett AL,Falk PS,Hughes KS,Mayhall CG.Epidemiology of methicillin‐resistant Staphylococcus aureus in a university medical center day care facility.Infect Control Hosp Epidemiol.2009;30(10):985992.
  26. Terpenning MS,Bradley SF,Wan JY,Chenoweth CE,Jorgensen KA,Kauffman CA.Colonization and infection with antibiotic‐resistant bacteria in a long‐term care facility.J Am Geriatr Soc.1994;42(10):10621069.
  27. Niederman MS,Mandell LA,Anzueto A, et al.American Thoracic Society. Guidelines for the management of adults with community‐acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention.Am J Respir Crit Care Med.2001;163(7):17301754.
  28. Liebowitz LD,Blunt MC.Modification in prescribing practices for third‐generation cephalosporins and ciprofloxacin is associated with a reduction in methicillin‐resistant Staphylococcus aureus bacteraemia rate.J Hosp Infect.2008;69(4):328336.
  29. Madaras‐Kelly KJ,Remington RE,Lewis PG,Stevens DL.Evaluation of an intervention designed to decrease the rate of nosocomial methicillin‐resistant Staphylococcus aureus infection by encouraging decreased fluoroquinolone use.Infect Control Hosp Epidemiol.2006;27(2):155169.
  30. Bosso JA,Mauldin PD.Using interrupted time series analysis to assess associations of fluoroquinolone formulary changes with susceptibility of gram‐negative pathogens and isolation rates of methicillin‐resistant Staphylococcus aureus.Antimicrob Agents Chemother.2006;50(6):21062112.
  31. Dalhoff A,Schubert S.Dichotomous selection of high‐level oxacillin resistance in Staphylococcus aureus by fluoroquinolones.Int J Antimicrob Agents.2010;36(3):216221.
  32. Aloush V,Navon‐Venezia S,Seigman‐Igra Y,Cabili S,Carmeli Y.Multidrug‐resistant Pseudomonas aeruginosa: risk factors and clinical impact.Antimicrob Agents Chemother.2006;50(1):4348.
References
  1. American Thoracic Society; Infectious Diseases Society of America.Guidelines for the management of adults with hospital‐acquired, ventilator‐associated, and healthcare‐associated pneumonia.Am J Respir Crit Care Med.2005;171(4):388416.
  2. Madaras‐Kelly KJ,Remington RE,Fan VS,Sloan KL.The etiology of health care associated pneumonia (HCAP) [abstract K‐282]. Presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; September2009; San Francisco, CA.
  3. Poch DS,Ost DE.What are the important risk factors for healthcare‐associated pneumonia?Semin Respir Crit Care Med.2009;30(1):2635.
  4. Aronsky D,Haug PJ,Lagor C,Dean NC.Accuracy of administrative data for identifying patients with pneumonia.Am J Med Qual.2005;20(6):319328.
  5. Deyo RA,Cherkin DC,Ciol MA.Adapting a clinical comorbidity index for use with ICD‐9‐CM administrative databases.J Clin Epidemiol.1992;45:613619.
  6. Madaras‐Kelly KJ,Remington RE,Fan VS,Sloan KL.How often is a microbial etiology identified in health care associated pneumonia (HCAP)? [abstract K‐289]. Presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; September2009; San Francisco, CA.
  7. Fluoroquinolone use criteria. Washington D.C. Guidelines Developed by the Pharmacy Benefits Management Strategic Health Care Group and Medical Advisory Panel, Veterans Health Administration, Department of Veterans Affairs. Last update, November2006. http://www.pbm.va.gov/Clinical%20Guidance/Criteria%20For%20Use/Fluoroquinolone,%20Criteria%20for%20Use.pdf. Last accessed August 20th, 2011.
  8. Performance Standards for Antimicrobial Susceptibility Testing; 18th Informational Supplement. M100‐S18.Wayne, PA:Clinical Laboratory Standards Institute;2009.
  9. Jones RN,Fritsche TR,Sader HS.Antimicrobial activity of DC‐159a, a new fluoroquinolone, against 1,149 recently collected clinical isolates.Antimicrob Agents Chemother.2008;52(10):37633775.
  10. Feikin DR,Chuchat A,Kolczak M, et al.Mortality from invasive pneumococcal pneumonia in the era of antibiotic resistance, 1995–1997.Am J Public Health.2000;90(2):223229.
  11. Hoogkamp‐Korstanje JA,Roelsofs‐Willemse J.Comparative activity of moxifloxacin against Gram‐positive clinical isolates.J Antimicrob Chemother.2000;45(1):3139.
  12. Hoban DJ,Bouchillon SK,Dowzicky MJ.Antimicrobial susceptibility of extended‐spectrum‐beta‐lactamase producers and multi‐drug resistant Acinetobacter baumannii throughout the United States and comparative in vitro activity of tigecycline, a new glycylcycline antimicrobial.Diagn Microbiol Infect Dis.2007;57(4):423428.
  13. Galles AC,Jones RN,Sader HS.Antimicrobial susceptibility profile of contemporary clinical strains of Stenotropomonas maltophila isolates: can moxifloxacin activity be predicted by levofloxacin MIC results?J Chemother.2008;20(1):3842.
  14. Mandell LA,Wunderink RG,Anzueto A, et al.Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community‐acquired pneumonia in adults.Clin Infect Dis.2007;44(suppl 2):S27S72.
  15. Gilbert DN, Moellering RC, Eliopoulos GM, Sande, MA, eds.The Sanford Guide to Antimicrobial Therapy.38th ed.Speryville, VA:Antimicrobial Therapy;2008.
  16. Akaike H.A new look at the statistical model identification.IEEE Trans Automat Contr.1974;19(6):716723.
  17. Efron B.Estimating the error rate of a prediction rule: improvement on cross‐validation.J Am Stat Assoc.1987;78:316331.
  18. Garcia‐Williams AG,Miller LJ,Burkitt KH, et. Al.Beyond beta: lessons learned from implementation of the Department of Veterans Affairs Methicillin‐Resistant Staphylococcus aureus Prevention Initiative.Infect Control Hosp Epidemiol.2010;31(7):763765.
  19. Moss M,Wellman DA,Cotsonis GA.An appraisal of multivariable logistic models in the pulmonary and critical care literature.Chest.2003;123(3):923928.
  20. Dean NC,Bateman KA,Donnelly SM,Silver MP,Snow GL,Hale D.Improved clinical outcomes with utilization of a community‐acquired pneumonia guideline.Chest.2006;130(3):794799.
  21. Nseir S,Grailles G,Soury‐Lavergne A,Minacori F,Alves I,Durocher A.Accuracy of American Thoracic Society/Infectious Diseases Society of America criteria in predicting infection or colonization with multidrug‐resistant bacteria at intensive‐care unit admission.Clin Microbiol Infect.2009;16(7):902908.
  22. Shorr AF,Zilberberg MD,Micek ST,Kollef MH.Prediction of infections due to antibiotic resistant bacteria by select risk factors for healthcare associated pneumonia.Arch Intern Med.2008;168(20):22052210.
  23. Davis KA,Stewart JJ,Crouch HK,Florez CE,Hospenthal DR.Methicillin‐resistant Staphylococcus aureus (MRSA) nares colonization at hospital admission and its effect on subsequent MRSA infection.Clin Infect Dis.2004;39(6):776782.
  24. Datta R,Huang SS.Risk of infection and death due to methicillin‐resistant Staphylococcus aureus in long‐term carriers.Clin Infect Dis.2008;47(2):176181.
  25. Hewlett AL,Falk PS,Hughes KS,Mayhall CG.Epidemiology of methicillin‐resistant Staphylococcus aureus in a university medical center day care facility.Infect Control Hosp Epidemiol.2009;30(10):985992.
  26. Terpenning MS,Bradley SF,Wan JY,Chenoweth CE,Jorgensen KA,Kauffman CA.Colonization and infection with antibiotic‐resistant bacteria in a long‐term care facility.J Am Geriatr Soc.1994;42(10):10621069.
  27. Niederman MS,Mandell LA,Anzueto A, et al.American Thoracic Society. Guidelines for the management of adults with community‐acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention.Am J Respir Crit Care Med.2001;163(7):17301754.
  28. Liebowitz LD,Blunt MC.Modification in prescribing practices for third‐generation cephalosporins and ciprofloxacin is associated with a reduction in methicillin‐resistant Staphylococcus aureus bacteraemia rate.J Hosp Infect.2008;69(4):328336.
  29. Madaras‐Kelly KJ,Remington RE,Lewis PG,Stevens DL.Evaluation of an intervention designed to decrease the rate of nosocomial methicillin‐resistant Staphylococcus aureus infection by encouraging decreased fluoroquinolone use.Infect Control Hosp Epidemiol.2006;27(2):155169.
  30. Bosso JA,Mauldin PD.Using interrupted time series analysis to assess associations of fluoroquinolone formulary changes with susceptibility of gram‐negative pathogens and isolation rates of methicillin‐resistant Staphylococcus aureus.Antimicrob Agents Chemother.2006;50(6):21062112.
  31. Dalhoff A,Schubert S.Dichotomous selection of high‐level oxacillin resistance in Staphylococcus aureus by fluoroquinolones.Int J Antimicrob Agents.2010;36(3):216221.
  32. Aloush V,Navon‐Venezia S,Seigman‐Igra Y,Cabili S,Carmeli Y.Multidrug‐resistant Pseudomonas aeruginosa: risk factors and clinical impact.Antimicrob Agents Chemother.2006;50(1):4348.
Issue
Journal of Hospital Medicine - 7(3)
Issue
Journal of Hospital Medicine - 7(3)
Page Number
195-202
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195-202
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Predicting antibiotic resistance to community‐acquired pneumonia antibiotics in culture‐positive patients with healthcare‐associated pneumonia
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Predicting antibiotic resistance to community‐acquired pneumonia antibiotics in culture‐positive patients with healthcare‐associated pneumonia
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Outcomes of Delayed ICU Transfer

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Adverse outcomes associated with delayed intensive care unit transfers in an integrated healthcare system

Hospitalized patients who require transfer from medical wards to the intensive care unit (ICU) have high in‐hospital mortality, in some reports exceeding 55%.14 In a previous report in this journal, we found that while these unplanned ICU transfers occurred in only 4% of hospitalizations, they were present in nearly one‐quarter of fatal hospitalizations and were associated with substantial increases in resource utilization.4 For these reasons, interventions aimed at identifying and treating this high‐risk group have received considerable attention and have been proposed as measures of inpatient safety.2, 49

Notably, mortality among patients with unplanned ICU transfers exceeds mortality among patients admitted to the ICU directly from the emergency department (ED)a group traditionally considered to have the highest risk of death.13, 10 Previous single‐center studies suggest that increased mortality rates are present even among patients transferred within 24 hours of hospital admission, and reinforce the notion that earlier recognition of critical illness may result in improved outcomes.1113 However, these studies have been performed primarily in small cohorts of heterogeneous patients, and may obscure the independent effect of unplanned transfers on mortality and hamper efforts to use unplanned transfer rates as a metric of healthcare quality.1, 2, 4, 9

In this study, we evaluated early unplanned ICU transfers drawn from a cohort of 499,995 hospitalizations in an integrated healthcare delivery system. Using patient data, extracted from the automated electronic medical record, we matched unplanned transfer cases to patients directly admitted to the ICU and described the association between delayed ICU transfers and adverse outcomes.

METHODS

Setting and Participants

We performed a retrospective analysis of adult patient (age 18 years) hospitalizations at 21 Northern California Kaiser Permanente (KP) Medical Care Program hospitals between January 2007 and December 2009. This work expanded on our previous report of hospital stays from November 2006 to January 2008.4 The 21 study hospitals used the same electronic health information systems; databases captured admission, discharge, and bed history data. The use of these databases for research has been described in our previous study and other reports; hospital characteristics, unit staffing, and resource levels have also been detailed previously.4, 1417 This study was approved by the KP Institutional Review Board.

Identifying Unplanned Transfers

We evaluated patients with medical hospitalizationsdefined as those whose first hospital location was not in a surgical setting such as the operating room or post‐anesthesia recovery areawhose admission originated in the ED; patients admitted for surgery were removed because of significant differences in observed mortality (see Supporting Information Appendix Figure 1 and Appendix Table 1 in the online version of this article). Patients whose admission did not originate in the ED were excluded to eliminate confounding resulting from differences in preadmission care. We also excluded patients admitted for gynecological and pregnancy‐related care because of low hospital mortality.

Initial patient locations included the medical wards (wards); the transitional care unit (TCU); and the intensive care unit (ICU). Bed history data, based on time stamps and available for all patients, were used to track patient locations from the time of admission, defined as the first non‐ED hospital location, until discharge. Patient length of stay (LOS) was calculated at each location and for the entire hospitalization.

Transfers to the ICU after a patient's initial admission to the ward or TCU were termed unplanned (or delayed) ICU transfers; patients admitted from the ED to the ICU were termed direct ICU admit patients. Direct ICU admit patients were excluded from the unplanned transfer group even if they required a readmission to the ICU later in their hospital course. We focused on patients with unplanned ICU transfers early after hospitalization to identify those in whom prompt recognition and intervention could be effective; thus, our primary analyses were on patients with transfers within 24 hours of admission. In secondary analysis, we also evaluated patients with unplanned ICU transfers occurring within 48 hours after hospital admission.

Admission Severity of Illness

To account for severity of illness at admission, we used a predicted mortality measure developed at KP.14 This method strictly utilizes information available prior to hospital admissionincluding that from the ED; variables included age, gender, admitting diagnosis, and measures of laboratory test and comorbid disease burden. The method, derived using 259,669 KP hospitalizations, produced a c‐statistic of 0.88 for inpatient mortality; external validation, based on 188,724 hospitalizations in Ottawa, produced a c‐statistic of 0.92.14, 18

Admitting diagnoses were based on admission International Classification of Diseases, 9th revision (ICD‐9) codes, and grouped into 44 broad Primary Conditions based on pathophysiologic plausibility and mortality rates.14 The method also quantified each patient's physiologic derangement and preexisting disease burden based on automated laboratory and comorbidity measuresthe Laboratory Acute Physiology Score (LAPS) and the Comorbidity Point Score (COPS).14

In brief, the LAPS was derived from 14 possible test results obtained in the 24‐hour time period preceding hospitalization, including: anion gap; arterial pH, PaCO2, and PaO2; bicarbonate; serum levels of albumin, total bilirubin, creatinine, glucose, sodium, and troponin I; blood urea nitrogen; creatinine; hematocrit; and total white blood cell count.14 The COPS was calculated from each subject's inpatient and outpatient diagnoses, based on Diagnostic Cost Groups software,19 during the 12‐month period preceding hospitalization.14 Increasing LAPS and COPS values were associated with increases in hospital mortality; detailed information about the development, application, and validation are available in previous work.14, 18

Statistical Analysis

Evaluating excess adverse outcomes associated with unplanned transfers requires adequate control of confounding variables. Our approach to reduce confounding was multivariable case matchinga technique used for assessing treatment effects in observational data.20, 21 Patients with unplanned transfersidentified as caseswere matched with similar controls based on observed variables at the time of hospital admission.

We first matched patients with unplanned ICU transfers within 24 hours of hospital admission to direct ICU admit controls based on predicted in‐hospital mortality (to within 1%); age (by decade); gender; and admitting diagnosis. If a case was matched to multiple controls, we selected 1 control with the most similar admission characteristics (weekday or weekend admission and nursing shift). The risk of death associated with unplanned transfers was estimated using multivariable conditional logistic regression. In secondary analysis, we repeated this analysis only among case‐control pairs within the same hospital facilities.

To cross‐validate the results from multivariable matching techniques, we also performed mixed‐effects multivariable logistic regression including all early unplanned transfer patients and direct ICU admit patients, while adjusting for predicted hospital mortality, age, gender, admitting diagnosis, LAPS, COPS, weekend versus weekday admission, nursing shift, and hospital facility random effects. We repeated these same analyses where cases were defined as patients transferred to the ICU within 48 hours of hospitalization.

Unplanned Transfer Timing

Using bed history data, we identified the elapsed time from admission to unplanned transfer, and categorized patients in increments of elapsed time from admission to unplanned transfer. Time‐to‐unplanned transfer was summarized using Kaplan‐Meier curve.

All analyses were performed in Stata/IC 11.0 for Mac (StataCorp LP, College Station, TX). Continuous variables were reported as mean standard deviation (SD). Cohort comparisons were performed with analysis of variance (ANOVA). Categorical variables were summarized using frequencies and compared with chi‐squared testing. A P value <0.05 was considered statistically significant.

RESULTS

During the study period, 313,797 medical hospitalizations originated in the ED (Table 1). Overall, patients' mean age was 67 18 years; 53.7% were female. Patient characteristics differed significantly based on the need for ICU admission. For example, average LAPS was highest among patients admitted directly to the ICU and lowest among patients who never required ICU care (P < 0.01). Patients with unplanned ICU transfers during hospitalization had longer length of stay and higher hospital mortality than direct ICU admit patients (P < 0.01). Overall, more than 1 in 15 patients experienced an unplanned transfer to the ICU.

Baseline Characteristics of Patients by Initial Hospital Location and Need for Unplanned ICU Transfer
  Early Delayed ICU Transfer (by Elapsed Time Since Hospital Admission) 
VariableOverallWithin 24 hrWithin 48 hrDirect ICU Admit
  • NOTE: Values are mean SD or number (%).

  • Abbreviations: COPS, Comorbidity Point Score; ICU, intensive care unit; LAPS, Laboratory Acute Physiology Score.

  • P < 0.001 for comparison by analysis of variance (ANOVA) or chi‐squared test between groups.

No. (%)313,7976,369 (2.0)9,816 (3.1)29,929 (9.5)
Age*67 1867 1668 1664 17
Female*169,358 (53.7)3,125 (49.1)4,882 (49.7)14,488 (48.4)
Weekend admission*83,327 (26.6)1,783 (28.0)2,733 (27.8)8,152 (27.2)
Nursing shift at admission*    
Day (7 AM‐3 PM)65,303 (20.8)1,335 (21.0)2,112 (21.5)7,065 (23.6)
Evening (3 PM‐11 PM)155,037 (49.4)2,990 (47.0)4,691 (47.8)13,158 (44.0)
Night (11 PM‐7 AM)93,457 (29.8)2,044 (32.1)3,013 (30.7)9,706 (32.4)
Initial hospital location*    
Ward234,915 (82.8)5,177 (81.3)7,987 (81.4) 
Transitional care unit48,953 (17.2)1,192 (18.7)1,829 (18.6) 
LAPS*24 1928 2028 2035 25
COPS*98 67105 70106 7099 71
Length of stay (days)4.6 7.58.4 12.29.1 13.46.4 9.5
In‐hospital mortality12,686 (4.0)800 (12.6)1,388 (14.1)3,602 (12.0)

The majority of unplanned transfers occurred within the first 48 hours of hospitalization (57.6%, Figure 1); nearly 80% occurred within the first 4 days. The rate of unplanned transfer peaked within 24 hours of hospital admission and decreased gradually as elapsed hospital LOS increased (Figure 1). While most patients experienced a single unplanned ICU transfer, 12.7% required multiple transfers to the ICU throughout their hospitalization.

Figure 1
Cumulative incidence (solid line) and 12‐hour rate (dashed line) of unplanned intensive care unit (ICU) transfers.

Multivariable case matching between unplanned transfer cases within 24 hours of admission and direct ICU admit controls resulted in 5839 (92%) case‐control pairs (Table 2). Matched pairs were most frequently admitted with diagnoses in Primary Condition groups that included respiratory infections and pneumonia (15.6%); angina, acute myocardial infarction (AMI), and heart failure (15.6%); or gastrointestinal bleeding (13.8%).

Characteristics and Outcomes of Patients With Unplanned ICU Transfers and Matched Patients Directly Admitted to the ICU
 ICU Cohorts (by Elapsed Time to Transfer Since Hospital Admission)
 Within 24 hr (n = 5,839)Within 48 hr (n = 8,976)
 Delayed ICU Transfer (Case)Direct ICU Admit (Control)Delayed ICU Transfer (Case)Direct ICU Admit (Control)
  • NOTE: Admitting diagnosis includes the 4 most frequent conditions. Pneumonia includes other respiratory infections.

  • Abbreviations: ICU, intensive care unit; MI, myocardial infarction.

  • P < 0.01.

Age67 1666 1667 1667 16
Female2,868 (49.1)2,868 (49.1)4,477 (49.9)4,477 (49.9)
Admitting diagnosis    
Pneumonia911 (15.6)911 (15.6)1,526 (17.0)1,526 (17.0)
Heart failure or MI909 (15.6)909 (15.6)1,331 (14.8)1,331 (14.8)
Gastrointestinal bleeding806 (13.8)806 (13.8)1,191 (13.3)1,191 (13.3)
Infections (including sepsis)295 (5.1)295 (5.1)474 (5.3)474 (5.3)
Outcomes    
Length of stay (days)*8 126 99 136 9
In‐hospital mortality*678 (11.6)498 (8.5)1,181 (13.2)814 (9.1)

In‐hospital mortality was significantly higher among cases (11.6%) than among ICU controls (8.5%, P < 0.001); mean LOS was also longer among cases (8 12 days) than among controls (6 9 days, P < 0.001). Unplanned transfer cases were at an increased odds of death when compared with ICU controls (adjusted odds ratio [OR], 1.44; 95% confidence interval [CI], 1.26‐1.64; P < 0.001); they also had a significantly higher observed‐to‐expected mortality ratio. When cases and controls were matched by hospital facility, the number of case‐control pairs decreased (2949 pairs; 42% matching frequency) but the odds of death was of similar magnitude (OR, 1.43; 95% CI, 1.21‐1.68; P < 0.001). Multivariable mixed‐effects logistic regression including all early unplanned transfer and direct ICU admit patients produced an effect size of similar magnitude (OR, 1.37; 95% CI, 1.24‐1.50; P < 0.001).

Results were similar when cases were limited to patients with transfers within 12 hours of admission; mortality was 10.9% among cases and 9.1% among controls (P = 0.02). When including patients with unplanned transfers within 48 hours of hospital admission, the difference in mortality between cases and controls increased (13.2% vs 9.1%, P < 0.001). The odds of death among patients with unplanned transfers increased as the elapsed time between admission and ICU transfer lengthened (Figure 2); the adjusted OR was statistically significant at each point between 8 and 48 hours.

Figure 2
Multivariable odds ratio for mortality among patients with unplanned intensive care unit (ICU) transfers, compared with those with direct ICU admissions, based on elapsed time between hospital admission and ICU transfer. Dashed line represents a linear regression fitted line of point estimates (slope = 0.08 per hour; model R2 0.84). P value <0.05 at each timepoint.

When stratified by admitting diagnosis groups, cases with unplanned transfers within the first 48 hours had increased mortality compared with matched controls in some categories (Table 3). For example, for patients in the respiratory infection and pneumonia group, mortality was 16.8% among unplanned transfer cases and 13.0% among early matched ICU controls (P < 0.01). A similar pattern was present in groups including: gastrointestinal bleeding, chronic obstructive pulmonary disease (COPD) exacerbation, and seizure groups (Table 3). However, for patients with AMI alone, mortality was 5.0% among cases and 3.7% among matched controls (P = 0.12). Patients with sepsis had a mortality rate of 15.2% among cases and 20.8% among matched controls (P = 0.07). Similarly, patients with stroke had a mortality rate of 12.4% among unplanned transfer cases and 11.4% in the matched controls (P = 0.54).

Hospital Mortality Among Selected Primary Condition Groups
Primary Condition GroupMortality in ICU Case‐Control Cohorts, No. (%)
Within 24 hrWithin 48 hr
Delayed ICU Transfer (Case)Direct ICU Admit (Control)Delayed ICU Transfer (Case)Direct ICU Admit (Control)
  • Abbreviations: COPD, chronic obstructive pulmonary disease; ICU, intensive care unit; MI, myocardial infarction.

Respiratory infections143 (15.7)126 (13.8)493 (16.8)380 (13.0)
Angina, heart failure, or MI60 (6.6)41 (4.5)324 (7.7)152 (3.6)
Acute MI alone16 (5.7)17 (6.1)82 (5.0)61 (3.7)
Gastrointestinal bleeding96 (11.9)55 (6.8)549 (19.3)188 (6.6)
Infections including sepsis20 (9.8)52 (11.2)228 (14.8)220 (14.2)
Sepsis alone32 (18.9)31 (18.3)123 (15.2)168 (20.8)
COPD exacerbation20 (9.8)12 (5.9)74 (10.8)43 (6.3)
Stroke18 (10.2)19 (10.8)77 (12.4)71 (11.4)
Seizure21 (8.6)9 (3.7)68 (7.1)34 (3.6)

DISCUSSION

This study found that unplanned ICU transfers were common among medical patients, occurring in 5% of all hospitalizations originating in the ED. The majority of unplanned transfers occurred within 48 hours of admission; the rate of ICU transfers peaked within 24 hours after hospitalization. Compared with patients admitted directly from the ED to the ICU, those transferred early after admission had significantly increased mortality; for example, patients transferred within 24 hours were at a 44% increased odds of hospital death. The adverse outcomes associated with unplanned transfers varied considerably by admission diagnosis subgroups.

Our findings confirm previous reports of increased mortality among patients with unplanned ICU transfers. Escarce and Kelley reported that patients admitted to the ICU from non‐ED locationsincluding wards, intermediate care units, and other hospitalswere at an increased risk of hospital death.1 Multiple subsequent studies have confirmed the increased mortality among patients with unplanned transfers.24, 10, 13, 22, 23 We previously evaluated patients who required a transfer to any higher level of care and reported an observed‐to‐expected mortality ratio of 2.93.4

Fewer studies, however, have evaluated the association between the timing of unplanned transfers and inpatient outcomes; previous small reports suggest that delays in ICU transfer adversely affect mortality and length of stay.12, 13, 24 Parkhe et al. compared 99 direct ICU admit patients with 23 who experienced early unplanned transfers; mortality at 30 days was significantly higher among patients with unplanned transfers.13 The current multifacility study included considerably more patients and confirmed an in‐hospital mortality gapalbeit a smaller onebetween patients with early transfers and those directly admitted to the ICU.

We focused on unplanned transfers during the earliest phase of hospitalization to identify patients who might benefit from improved recognition of, and intervention for, impending critical illness. We found that even patients requiring transfers within 8 hours of hospital admission were at an increased risk of death. Bapoje et al. recently reported that as many as 80% of early unplanned transfers were preventable and that most resulted from inappropriate admission triage.11 Together, these findings suggest that heightened attention to identifying such patients at admission or within the first day of hospitalizationwhen the rates of unplanned transfers peakis critical.

Several important limitations should be recognized in interpreting these results. First, this study was not designed to specifically identify the reasons for unplanned transfers, limiting our ability to characterize episodes in which timely care could have prevented excess mortality. Notably, while previous work suggests that many early unplanned transfers might be prevented with appropriate triage, it is likely that some excess deaths are not preventable even if every patient could be admitted to the ICU directly.

We were able to characterize patient outcomes by admitting diagnoses. Patients admitted for pneumonia and respiratory infection, gastrointestinal bleeding, COPD exacerbation, or seizures demonstrated excess mortality compared with matched ICU controls, while those with AMI, sepsis, and stroke did not. It is possible that differences in diagnosis‐specific excess mortality resulted from increasing adherence to well‐defined practice guidelines for specific high‐risk conditions.2527 For example, international awareness campaigns for the treatment of sepsis, AMI, and strokeSurviving Sepsis, Door‐to‐Balloon, and F.A.S.T.emphasize early interventions to minimize morbidity and mortality.

Second, the data utilized in this study were based on automated variables extracted from the electronic medical record. Mortality prediction models based on automated variables have demonstrated excellent performance among ICU and non‐ICU populations14, 18, 28; however, the inclusion of additional data (eg, vital signs or neurological status) would likely improve baseline risk adjustment.5, 10, 2931 Multiple studies have demonstrated that vital signs and clinician judgment can predict patients at an increased risk of deterioration.5, 10, 2931 Such data might also provide insight into residual factors that influenced clinicians' decisions to triage patients to an ICU versus non‐ICU admissiona focus area of our ongoing research efforts. Utilizing electronically available data, however, facilitated the identification of a cohort of patients far larger than that in prior studies. Where previous work has also been limited by substantial variability in baseline characteristics among study subjects,1, 2, 12, 13 our large sample produced a high percentage of multivariable case matches.

Third, we chose to match patients with a severity of illness index based on variables available at the time of hospital admission. While this mortality prediction model has demonstrated excellent performance in internal and external populations,14, 18 it is calibrated for general inpatient, rather than critically ill, populations. It remains possible that case matching with ICU‐specific severity of illness scores might alter matching characteristics, however, previous studies suggest that severity of illness, as measured by these scores, is comparable between direct ICU admits and early ICU transfers.13 Importantly, our matching procedure avoided the potential confounding known to exist with the use of prediction models based on discharge or intra‐hospitalization data.32, 33

Finally, while we were able to evaluate unplanned transfer timing in a multifacility sample, all patient care occurred within a large integrated healthcare delivery system. The overall observed mortality in our study was lower than that reported in prior studies which considered more limited patient cohorts.1, 2, 12, 13, 22 Thus, differences in patient case‐mix or ICU structure must be considered when applying our results to other healthcare delivery systems.

This hypothesis‐generating study, based on a large, multifacility sample of hospitalizations, suggests several areas of future investigation. Future work should detail specific aspects of care among patients with unplanned transfer, including: evaluating the structures and processes involved in triage decisions, measuring the effects on mortality through implementation of interventions (eg, rapid response teams or diagnosis‐specific treatment protocols), and defining the causes and risk factors for unplanned transfers by elapsed time.

In conclusion, the risk of an unplanned ICU transfera common event among hospitalized patientsis highest within 24 hours of hospitalization. Patients with early unplanned transfers have increased mortality and length of stay compared to those admitted directly to the ICU. Even patients transferred to the ICU within 8 hours of hospital admission are at an increased risk of death when compared with those admitted directly. Substantial variability in unplanned transfer outcomes exists based on admitting diagnoses. Future research should characterize unplanned transfers in greater detail with the goal of identifying patients that would benefit from improved triage and early ICU transfer.

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References
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Hospitalized patients who require transfer from medical wards to the intensive care unit (ICU) have high in‐hospital mortality, in some reports exceeding 55%.14 In a previous report in this journal, we found that while these unplanned ICU transfers occurred in only 4% of hospitalizations, they were present in nearly one‐quarter of fatal hospitalizations and were associated with substantial increases in resource utilization.4 For these reasons, interventions aimed at identifying and treating this high‐risk group have received considerable attention and have been proposed as measures of inpatient safety.2, 49

Notably, mortality among patients with unplanned ICU transfers exceeds mortality among patients admitted to the ICU directly from the emergency department (ED)a group traditionally considered to have the highest risk of death.13, 10 Previous single‐center studies suggest that increased mortality rates are present even among patients transferred within 24 hours of hospital admission, and reinforce the notion that earlier recognition of critical illness may result in improved outcomes.1113 However, these studies have been performed primarily in small cohorts of heterogeneous patients, and may obscure the independent effect of unplanned transfers on mortality and hamper efforts to use unplanned transfer rates as a metric of healthcare quality.1, 2, 4, 9

In this study, we evaluated early unplanned ICU transfers drawn from a cohort of 499,995 hospitalizations in an integrated healthcare delivery system. Using patient data, extracted from the automated electronic medical record, we matched unplanned transfer cases to patients directly admitted to the ICU and described the association between delayed ICU transfers and adverse outcomes.

METHODS

Setting and Participants

We performed a retrospective analysis of adult patient (age 18 years) hospitalizations at 21 Northern California Kaiser Permanente (KP) Medical Care Program hospitals between January 2007 and December 2009. This work expanded on our previous report of hospital stays from November 2006 to January 2008.4 The 21 study hospitals used the same electronic health information systems; databases captured admission, discharge, and bed history data. The use of these databases for research has been described in our previous study and other reports; hospital characteristics, unit staffing, and resource levels have also been detailed previously.4, 1417 This study was approved by the KP Institutional Review Board.

Identifying Unplanned Transfers

We evaluated patients with medical hospitalizationsdefined as those whose first hospital location was not in a surgical setting such as the operating room or post‐anesthesia recovery areawhose admission originated in the ED; patients admitted for surgery were removed because of significant differences in observed mortality (see Supporting Information Appendix Figure 1 and Appendix Table 1 in the online version of this article). Patients whose admission did not originate in the ED were excluded to eliminate confounding resulting from differences in preadmission care. We also excluded patients admitted for gynecological and pregnancy‐related care because of low hospital mortality.

Initial patient locations included the medical wards (wards); the transitional care unit (TCU); and the intensive care unit (ICU). Bed history data, based on time stamps and available for all patients, were used to track patient locations from the time of admission, defined as the first non‐ED hospital location, until discharge. Patient length of stay (LOS) was calculated at each location and for the entire hospitalization.

Transfers to the ICU after a patient's initial admission to the ward or TCU were termed unplanned (or delayed) ICU transfers; patients admitted from the ED to the ICU were termed direct ICU admit patients. Direct ICU admit patients were excluded from the unplanned transfer group even if they required a readmission to the ICU later in their hospital course. We focused on patients with unplanned ICU transfers early after hospitalization to identify those in whom prompt recognition and intervention could be effective; thus, our primary analyses were on patients with transfers within 24 hours of admission. In secondary analysis, we also evaluated patients with unplanned ICU transfers occurring within 48 hours after hospital admission.

Admission Severity of Illness

To account for severity of illness at admission, we used a predicted mortality measure developed at KP.14 This method strictly utilizes information available prior to hospital admissionincluding that from the ED; variables included age, gender, admitting diagnosis, and measures of laboratory test and comorbid disease burden. The method, derived using 259,669 KP hospitalizations, produced a c‐statistic of 0.88 for inpatient mortality; external validation, based on 188,724 hospitalizations in Ottawa, produced a c‐statistic of 0.92.14, 18

Admitting diagnoses were based on admission International Classification of Diseases, 9th revision (ICD‐9) codes, and grouped into 44 broad Primary Conditions based on pathophysiologic plausibility and mortality rates.14 The method also quantified each patient's physiologic derangement and preexisting disease burden based on automated laboratory and comorbidity measuresthe Laboratory Acute Physiology Score (LAPS) and the Comorbidity Point Score (COPS).14

In brief, the LAPS was derived from 14 possible test results obtained in the 24‐hour time period preceding hospitalization, including: anion gap; arterial pH, PaCO2, and PaO2; bicarbonate; serum levels of albumin, total bilirubin, creatinine, glucose, sodium, and troponin I; blood urea nitrogen; creatinine; hematocrit; and total white blood cell count.14 The COPS was calculated from each subject's inpatient and outpatient diagnoses, based on Diagnostic Cost Groups software,19 during the 12‐month period preceding hospitalization.14 Increasing LAPS and COPS values were associated with increases in hospital mortality; detailed information about the development, application, and validation are available in previous work.14, 18

Statistical Analysis

Evaluating excess adverse outcomes associated with unplanned transfers requires adequate control of confounding variables. Our approach to reduce confounding was multivariable case matchinga technique used for assessing treatment effects in observational data.20, 21 Patients with unplanned transfersidentified as caseswere matched with similar controls based on observed variables at the time of hospital admission.

We first matched patients with unplanned ICU transfers within 24 hours of hospital admission to direct ICU admit controls based on predicted in‐hospital mortality (to within 1%); age (by decade); gender; and admitting diagnosis. If a case was matched to multiple controls, we selected 1 control with the most similar admission characteristics (weekday or weekend admission and nursing shift). The risk of death associated with unplanned transfers was estimated using multivariable conditional logistic regression. In secondary analysis, we repeated this analysis only among case‐control pairs within the same hospital facilities.

To cross‐validate the results from multivariable matching techniques, we also performed mixed‐effects multivariable logistic regression including all early unplanned transfer patients and direct ICU admit patients, while adjusting for predicted hospital mortality, age, gender, admitting diagnosis, LAPS, COPS, weekend versus weekday admission, nursing shift, and hospital facility random effects. We repeated these same analyses where cases were defined as patients transferred to the ICU within 48 hours of hospitalization.

Unplanned Transfer Timing

Using bed history data, we identified the elapsed time from admission to unplanned transfer, and categorized patients in increments of elapsed time from admission to unplanned transfer. Time‐to‐unplanned transfer was summarized using Kaplan‐Meier curve.

All analyses were performed in Stata/IC 11.0 for Mac (StataCorp LP, College Station, TX). Continuous variables were reported as mean standard deviation (SD). Cohort comparisons were performed with analysis of variance (ANOVA). Categorical variables were summarized using frequencies and compared with chi‐squared testing. A P value <0.05 was considered statistically significant.

RESULTS

During the study period, 313,797 medical hospitalizations originated in the ED (Table 1). Overall, patients' mean age was 67 18 years; 53.7% were female. Patient characteristics differed significantly based on the need for ICU admission. For example, average LAPS was highest among patients admitted directly to the ICU and lowest among patients who never required ICU care (P < 0.01). Patients with unplanned ICU transfers during hospitalization had longer length of stay and higher hospital mortality than direct ICU admit patients (P < 0.01). Overall, more than 1 in 15 patients experienced an unplanned transfer to the ICU.

Baseline Characteristics of Patients by Initial Hospital Location and Need for Unplanned ICU Transfer
  Early Delayed ICU Transfer (by Elapsed Time Since Hospital Admission) 
VariableOverallWithin 24 hrWithin 48 hrDirect ICU Admit
  • NOTE: Values are mean SD or number (%).

  • Abbreviations: COPS, Comorbidity Point Score; ICU, intensive care unit; LAPS, Laboratory Acute Physiology Score.

  • P < 0.001 for comparison by analysis of variance (ANOVA) or chi‐squared test between groups.

No. (%)313,7976,369 (2.0)9,816 (3.1)29,929 (9.5)
Age*67 1867 1668 1664 17
Female*169,358 (53.7)3,125 (49.1)4,882 (49.7)14,488 (48.4)
Weekend admission*83,327 (26.6)1,783 (28.0)2,733 (27.8)8,152 (27.2)
Nursing shift at admission*    
Day (7 AM‐3 PM)65,303 (20.8)1,335 (21.0)2,112 (21.5)7,065 (23.6)
Evening (3 PM‐11 PM)155,037 (49.4)2,990 (47.0)4,691 (47.8)13,158 (44.0)
Night (11 PM‐7 AM)93,457 (29.8)2,044 (32.1)3,013 (30.7)9,706 (32.4)
Initial hospital location*    
Ward234,915 (82.8)5,177 (81.3)7,987 (81.4) 
Transitional care unit48,953 (17.2)1,192 (18.7)1,829 (18.6) 
LAPS*24 1928 2028 2035 25
COPS*98 67105 70106 7099 71
Length of stay (days)4.6 7.58.4 12.29.1 13.46.4 9.5
In‐hospital mortality12,686 (4.0)800 (12.6)1,388 (14.1)3,602 (12.0)

The majority of unplanned transfers occurred within the first 48 hours of hospitalization (57.6%, Figure 1); nearly 80% occurred within the first 4 days. The rate of unplanned transfer peaked within 24 hours of hospital admission and decreased gradually as elapsed hospital LOS increased (Figure 1). While most patients experienced a single unplanned ICU transfer, 12.7% required multiple transfers to the ICU throughout their hospitalization.

Figure 1
Cumulative incidence (solid line) and 12‐hour rate (dashed line) of unplanned intensive care unit (ICU) transfers.

Multivariable case matching between unplanned transfer cases within 24 hours of admission and direct ICU admit controls resulted in 5839 (92%) case‐control pairs (Table 2). Matched pairs were most frequently admitted with diagnoses in Primary Condition groups that included respiratory infections and pneumonia (15.6%); angina, acute myocardial infarction (AMI), and heart failure (15.6%); or gastrointestinal bleeding (13.8%).

Characteristics and Outcomes of Patients With Unplanned ICU Transfers and Matched Patients Directly Admitted to the ICU
 ICU Cohorts (by Elapsed Time to Transfer Since Hospital Admission)
 Within 24 hr (n = 5,839)Within 48 hr (n = 8,976)
 Delayed ICU Transfer (Case)Direct ICU Admit (Control)Delayed ICU Transfer (Case)Direct ICU Admit (Control)
  • NOTE: Admitting diagnosis includes the 4 most frequent conditions. Pneumonia includes other respiratory infections.

  • Abbreviations: ICU, intensive care unit; MI, myocardial infarction.

  • P < 0.01.

Age67 1666 1667 1667 16
Female2,868 (49.1)2,868 (49.1)4,477 (49.9)4,477 (49.9)
Admitting diagnosis    
Pneumonia911 (15.6)911 (15.6)1,526 (17.0)1,526 (17.0)
Heart failure or MI909 (15.6)909 (15.6)1,331 (14.8)1,331 (14.8)
Gastrointestinal bleeding806 (13.8)806 (13.8)1,191 (13.3)1,191 (13.3)
Infections (including sepsis)295 (5.1)295 (5.1)474 (5.3)474 (5.3)
Outcomes    
Length of stay (days)*8 126 99 136 9
In‐hospital mortality*678 (11.6)498 (8.5)1,181 (13.2)814 (9.1)

In‐hospital mortality was significantly higher among cases (11.6%) than among ICU controls (8.5%, P < 0.001); mean LOS was also longer among cases (8 12 days) than among controls (6 9 days, P < 0.001). Unplanned transfer cases were at an increased odds of death when compared with ICU controls (adjusted odds ratio [OR], 1.44; 95% confidence interval [CI], 1.26‐1.64; P < 0.001); they also had a significantly higher observed‐to‐expected mortality ratio. When cases and controls were matched by hospital facility, the number of case‐control pairs decreased (2949 pairs; 42% matching frequency) but the odds of death was of similar magnitude (OR, 1.43; 95% CI, 1.21‐1.68; P < 0.001). Multivariable mixed‐effects logistic regression including all early unplanned transfer and direct ICU admit patients produced an effect size of similar magnitude (OR, 1.37; 95% CI, 1.24‐1.50; P < 0.001).

Results were similar when cases were limited to patients with transfers within 12 hours of admission; mortality was 10.9% among cases and 9.1% among controls (P = 0.02). When including patients with unplanned transfers within 48 hours of hospital admission, the difference in mortality between cases and controls increased (13.2% vs 9.1%, P < 0.001). The odds of death among patients with unplanned transfers increased as the elapsed time between admission and ICU transfer lengthened (Figure 2); the adjusted OR was statistically significant at each point between 8 and 48 hours.

Figure 2
Multivariable odds ratio for mortality among patients with unplanned intensive care unit (ICU) transfers, compared with those with direct ICU admissions, based on elapsed time between hospital admission and ICU transfer. Dashed line represents a linear regression fitted line of point estimates (slope = 0.08 per hour; model R2 0.84). P value <0.05 at each timepoint.

When stratified by admitting diagnosis groups, cases with unplanned transfers within the first 48 hours had increased mortality compared with matched controls in some categories (Table 3). For example, for patients in the respiratory infection and pneumonia group, mortality was 16.8% among unplanned transfer cases and 13.0% among early matched ICU controls (P < 0.01). A similar pattern was present in groups including: gastrointestinal bleeding, chronic obstructive pulmonary disease (COPD) exacerbation, and seizure groups (Table 3). However, for patients with AMI alone, mortality was 5.0% among cases and 3.7% among matched controls (P = 0.12). Patients with sepsis had a mortality rate of 15.2% among cases and 20.8% among matched controls (P = 0.07). Similarly, patients with stroke had a mortality rate of 12.4% among unplanned transfer cases and 11.4% in the matched controls (P = 0.54).

Hospital Mortality Among Selected Primary Condition Groups
Primary Condition GroupMortality in ICU Case‐Control Cohorts, No. (%)
Within 24 hrWithin 48 hr
Delayed ICU Transfer (Case)Direct ICU Admit (Control)Delayed ICU Transfer (Case)Direct ICU Admit (Control)
  • Abbreviations: COPD, chronic obstructive pulmonary disease; ICU, intensive care unit; MI, myocardial infarction.

Respiratory infections143 (15.7)126 (13.8)493 (16.8)380 (13.0)
Angina, heart failure, or MI60 (6.6)41 (4.5)324 (7.7)152 (3.6)
Acute MI alone16 (5.7)17 (6.1)82 (5.0)61 (3.7)
Gastrointestinal bleeding96 (11.9)55 (6.8)549 (19.3)188 (6.6)
Infections including sepsis20 (9.8)52 (11.2)228 (14.8)220 (14.2)
Sepsis alone32 (18.9)31 (18.3)123 (15.2)168 (20.8)
COPD exacerbation20 (9.8)12 (5.9)74 (10.8)43 (6.3)
Stroke18 (10.2)19 (10.8)77 (12.4)71 (11.4)
Seizure21 (8.6)9 (3.7)68 (7.1)34 (3.6)

DISCUSSION

This study found that unplanned ICU transfers were common among medical patients, occurring in 5% of all hospitalizations originating in the ED. The majority of unplanned transfers occurred within 48 hours of admission; the rate of ICU transfers peaked within 24 hours after hospitalization. Compared with patients admitted directly from the ED to the ICU, those transferred early after admission had significantly increased mortality; for example, patients transferred within 24 hours were at a 44% increased odds of hospital death. The adverse outcomes associated with unplanned transfers varied considerably by admission diagnosis subgroups.

Our findings confirm previous reports of increased mortality among patients with unplanned ICU transfers. Escarce and Kelley reported that patients admitted to the ICU from non‐ED locationsincluding wards, intermediate care units, and other hospitalswere at an increased risk of hospital death.1 Multiple subsequent studies have confirmed the increased mortality among patients with unplanned transfers.24, 10, 13, 22, 23 We previously evaluated patients who required a transfer to any higher level of care and reported an observed‐to‐expected mortality ratio of 2.93.4

Fewer studies, however, have evaluated the association between the timing of unplanned transfers and inpatient outcomes; previous small reports suggest that delays in ICU transfer adversely affect mortality and length of stay.12, 13, 24 Parkhe et al. compared 99 direct ICU admit patients with 23 who experienced early unplanned transfers; mortality at 30 days was significantly higher among patients with unplanned transfers.13 The current multifacility study included considerably more patients and confirmed an in‐hospital mortality gapalbeit a smaller onebetween patients with early transfers and those directly admitted to the ICU.

We focused on unplanned transfers during the earliest phase of hospitalization to identify patients who might benefit from improved recognition of, and intervention for, impending critical illness. We found that even patients requiring transfers within 8 hours of hospital admission were at an increased risk of death. Bapoje et al. recently reported that as many as 80% of early unplanned transfers were preventable and that most resulted from inappropriate admission triage.11 Together, these findings suggest that heightened attention to identifying such patients at admission or within the first day of hospitalizationwhen the rates of unplanned transfers peakis critical.

Several important limitations should be recognized in interpreting these results. First, this study was not designed to specifically identify the reasons for unplanned transfers, limiting our ability to characterize episodes in which timely care could have prevented excess mortality. Notably, while previous work suggests that many early unplanned transfers might be prevented with appropriate triage, it is likely that some excess deaths are not preventable even if every patient could be admitted to the ICU directly.

We were able to characterize patient outcomes by admitting diagnoses. Patients admitted for pneumonia and respiratory infection, gastrointestinal bleeding, COPD exacerbation, or seizures demonstrated excess mortality compared with matched ICU controls, while those with AMI, sepsis, and stroke did not. It is possible that differences in diagnosis‐specific excess mortality resulted from increasing adherence to well‐defined practice guidelines for specific high‐risk conditions.2527 For example, international awareness campaigns for the treatment of sepsis, AMI, and strokeSurviving Sepsis, Door‐to‐Balloon, and F.A.S.T.emphasize early interventions to minimize morbidity and mortality.

Second, the data utilized in this study were based on automated variables extracted from the electronic medical record. Mortality prediction models based on automated variables have demonstrated excellent performance among ICU and non‐ICU populations14, 18, 28; however, the inclusion of additional data (eg, vital signs or neurological status) would likely improve baseline risk adjustment.5, 10, 2931 Multiple studies have demonstrated that vital signs and clinician judgment can predict patients at an increased risk of deterioration.5, 10, 2931 Such data might also provide insight into residual factors that influenced clinicians' decisions to triage patients to an ICU versus non‐ICU admissiona focus area of our ongoing research efforts. Utilizing electronically available data, however, facilitated the identification of a cohort of patients far larger than that in prior studies. Where previous work has also been limited by substantial variability in baseline characteristics among study subjects,1, 2, 12, 13 our large sample produced a high percentage of multivariable case matches.

Third, we chose to match patients with a severity of illness index based on variables available at the time of hospital admission. While this mortality prediction model has demonstrated excellent performance in internal and external populations,14, 18 it is calibrated for general inpatient, rather than critically ill, populations. It remains possible that case matching with ICU‐specific severity of illness scores might alter matching characteristics, however, previous studies suggest that severity of illness, as measured by these scores, is comparable between direct ICU admits and early ICU transfers.13 Importantly, our matching procedure avoided the potential confounding known to exist with the use of prediction models based on discharge or intra‐hospitalization data.32, 33

Finally, while we were able to evaluate unplanned transfer timing in a multifacility sample, all patient care occurred within a large integrated healthcare delivery system. The overall observed mortality in our study was lower than that reported in prior studies which considered more limited patient cohorts.1, 2, 12, 13, 22 Thus, differences in patient case‐mix or ICU structure must be considered when applying our results to other healthcare delivery systems.

This hypothesis‐generating study, based on a large, multifacility sample of hospitalizations, suggests several areas of future investigation. Future work should detail specific aspects of care among patients with unplanned transfer, including: evaluating the structures and processes involved in triage decisions, measuring the effects on mortality through implementation of interventions (eg, rapid response teams or diagnosis‐specific treatment protocols), and defining the causes and risk factors for unplanned transfers by elapsed time.

In conclusion, the risk of an unplanned ICU transfera common event among hospitalized patientsis highest within 24 hours of hospitalization. Patients with early unplanned transfers have increased mortality and length of stay compared to those admitted directly to the ICU. Even patients transferred to the ICU within 8 hours of hospital admission are at an increased risk of death when compared with those admitted directly. Substantial variability in unplanned transfer outcomes exists based on admitting diagnoses. Future research should characterize unplanned transfers in greater detail with the goal of identifying patients that would benefit from improved triage and early ICU transfer.

Hospitalized patients who require transfer from medical wards to the intensive care unit (ICU) have high in‐hospital mortality, in some reports exceeding 55%.14 In a previous report in this journal, we found that while these unplanned ICU transfers occurred in only 4% of hospitalizations, they were present in nearly one‐quarter of fatal hospitalizations and were associated with substantial increases in resource utilization.4 For these reasons, interventions aimed at identifying and treating this high‐risk group have received considerable attention and have been proposed as measures of inpatient safety.2, 49

Notably, mortality among patients with unplanned ICU transfers exceeds mortality among patients admitted to the ICU directly from the emergency department (ED)a group traditionally considered to have the highest risk of death.13, 10 Previous single‐center studies suggest that increased mortality rates are present even among patients transferred within 24 hours of hospital admission, and reinforce the notion that earlier recognition of critical illness may result in improved outcomes.1113 However, these studies have been performed primarily in small cohorts of heterogeneous patients, and may obscure the independent effect of unplanned transfers on mortality and hamper efforts to use unplanned transfer rates as a metric of healthcare quality.1, 2, 4, 9

In this study, we evaluated early unplanned ICU transfers drawn from a cohort of 499,995 hospitalizations in an integrated healthcare delivery system. Using patient data, extracted from the automated electronic medical record, we matched unplanned transfer cases to patients directly admitted to the ICU and described the association between delayed ICU transfers and adverse outcomes.

METHODS

Setting and Participants

We performed a retrospective analysis of adult patient (age 18 years) hospitalizations at 21 Northern California Kaiser Permanente (KP) Medical Care Program hospitals between January 2007 and December 2009. This work expanded on our previous report of hospital stays from November 2006 to January 2008.4 The 21 study hospitals used the same electronic health information systems; databases captured admission, discharge, and bed history data. The use of these databases for research has been described in our previous study and other reports; hospital characteristics, unit staffing, and resource levels have also been detailed previously.4, 1417 This study was approved by the KP Institutional Review Board.

Identifying Unplanned Transfers

We evaluated patients with medical hospitalizationsdefined as those whose first hospital location was not in a surgical setting such as the operating room or post‐anesthesia recovery areawhose admission originated in the ED; patients admitted for surgery were removed because of significant differences in observed mortality (see Supporting Information Appendix Figure 1 and Appendix Table 1 in the online version of this article). Patients whose admission did not originate in the ED were excluded to eliminate confounding resulting from differences in preadmission care. We also excluded patients admitted for gynecological and pregnancy‐related care because of low hospital mortality.

Initial patient locations included the medical wards (wards); the transitional care unit (TCU); and the intensive care unit (ICU). Bed history data, based on time stamps and available for all patients, were used to track patient locations from the time of admission, defined as the first non‐ED hospital location, until discharge. Patient length of stay (LOS) was calculated at each location and for the entire hospitalization.

Transfers to the ICU after a patient's initial admission to the ward or TCU were termed unplanned (or delayed) ICU transfers; patients admitted from the ED to the ICU were termed direct ICU admit patients. Direct ICU admit patients were excluded from the unplanned transfer group even if they required a readmission to the ICU later in their hospital course. We focused on patients with unplanned ICU transfers early after hospitalization to identify those in whom prompt recognition and intervention could be effective; thus, our primary analyses were on patients with transfers within 24 hours of admission. In secondary analysis, we also evaluated patients with unplanned ICU transfers occurring within 48 hours after hospital admission.

Admission Severity of Illness

To account for severity of illness at admission, we used a predicted mortality measure developed at KP.14 This method strictly utilizes information available prior to hospital admissionincluding that from the ED; variables included age, gender, admitting diagnosis, and measures of laboratory test and comorbid disease burden. The method, derived using 259,669 KP hospitalizations, produced a c‐statistic of 0.88 for inpatient mortality; external validation, based on 188,724 hospitalizations in Ottawa, produced a c‐statistic of 0.92.14, 18

Admitting diagnoses were based on admission International Classification of Diseases, 9th revision (ICD‐9) codes, and grouped into 44 broad Primary Conditions based on pathophysiologic plausibility and mortality rates.14 The method also quantified each patient's physiologic derangement and preexisting disease burden based on automated laboratory and comorbidity measuresthe Laboratory Acute Physiology Score (LAPS) and the Comorbidity Point Score (COPS).14

In brief, the LAPS was derived from 14 possible test results obtained in the 24‐hour time period preceding hospitalization, including: anion gap; arterial pH, PaCO2, and PaO2; bicarbonate; serum levels of albumin, total bilirubin, creatinine, glucose, sodium, and troponin I; blood urea nitrogen; creatinine; hematocrit; and total white blood cell count.14 The COPS was calculated from each subject's inpatient and outpatient diagnoses, based on Diagnostic Cost Groups software,19 during the 12‐month period preceding hospitalization.14 Increasing LAPS and COPS values were associated with increases in hospital mortality; detailed information about the development, application, and validation are available in previous work.14, 18

Statistical Analysis

Evaluating excess adverse outcomes associated with unplanned transfers requires adequate control of confounding variables. Our approach to reduce confounding was multivariable case matchinga technique used for assessing treatment effects in observational data.20, 21 Patients with unplanned transfersidentified as caseswere matched with similar controls based on observed variables at the time of hospital admission.

We first matched patients with unplanned ICU transfers within 24 hours of hospital admission to direct ICU admit controls based on predicted in‐hospital mortality (to within 1%); age (by decade); gender; and admitting diagnosis. If a case was matched to multiple controls, we selected 1 control with the most similar admission characteristics (weekday or weekend admission and nursing shift). The risk of death associated with unplanned transfers was estimated using multivariable conditional logistic regression. In secondary analysis, we repeated this analysis only among case‐control pairs within the same hospital facilities.

To cross‐validate the results from multivariable matching techniques, we also performed mixed‐effects multivariable logistic regression including all early unplanned transfer patients and direct ICU admit patients, while adjusting for predicted hospital mortality, age, gender, admitting diagnosis, LAPS, COPS, weekend versus weekday admission, nursing shift, and hospital facility random effects. We repeated these same analyses where cases were defined as patients transferred to the ICU within 48 hours of hospitalization.

Unplanned Transfer Timing

Using bed history data, we identified the elapsed time from admission to unplanned transfer, and categorized patients in increments of elapsed time from admission to unplanned transfer. Time‐to‐unplanned transfer was summarized using Kaplan‐Meier curve.

All analyses were performed in Stata/IC 11.0 for Mac (StataCorp LP, College Station, TX). Continuous variables were reported as mean standard deviation (SD). Cohort comparisons were performed with analysis of variance (ANOVA). Categorical variables were summarized using frequencies and compared with chi‐squared testing. A P value <0.05 was considered statistically significant.

RESULTS

During the study period, 313,797 medical hospitalizations originated in the ED (Table 1). Overall, patients' mean age was 67 18 years; 53.7% were female. Patient characteristics differed significantly based on the need for ICU admission. For example, average LAPS was highest among patients admitted directly to the ICU and lowest among patients who never required ICU care (P < 0.01). Patients with unplanned ICU transfers during hospitalization had longer length of stay and higher hospital mortality than direct ICU admit patients (P < 0.01). Overall, more than 1 in 15 patients experienced an unplanned transfer to the ICU.

Baseline Characteristics of Patients by Initial Hospital Location and Need for Unplanned ICU Transfer
  Early Delayed ICU Transfer (by Elapsed Time Since Hospital Admission) 
VariableOverallWithin 24 hrWithin 48 hrDirect ICU Admit
  • NOTE: Values are mean SD or number (%).

  • Abbreviations: COPS, Comorbidity Point Score; ICU, intensive care unit; LAPS, Laboratory Acute Physiology Score.

  • P < 0.001 for comparison by analysis of variance (ANOVA) or chi‐squared test between groups.

No. (%)313,7976,369 (2.0)9,816 (3.1)29,929 (9.5)
Age*67 1867 1668 1664 17
Female*169,358 (53.7)3,125 (49.1)4,882 (49.7)14,488 (48.4)
Weekend admission*83,327 (26.6)1,783 (28.0)2,733 (27.8)8,152 (27.2)
Nursing shift at admission*    
Day (7 AM‐3 PM)65,303 (20.8)1,335 (21.0)2,112 (21.5)7,065 (23.6)
Evening (3 PM‐11 PM)155,037 (49.4)2,990 (47.0)4,691 (47.8)13,158 (44.0)
Night (11 PM‐7 AM)93,457 (29.8)2,044 (32.1)3,013 (30.7)9,706 (32.4)
Initial hospital location*    
Ward234,915 (82.8)5,177 (81.3)7,987 (81.4) 
Transitional care unit48,953 (17.2)1,192 (18.7)1,829 (18.6) 
LAPS*24 1928 2028 2035 25
COPS*98 67105 70106 7099 71
Length of stay (days)4.6 7.58.4 12.29.1 13.46.4 9.5
In‐hospital mortality12,686 (4.0)800 (12.6)1,388 (14.1)3,602 (12.0)

The majority of unplanned transfers occurred within the first 48 hours of hospitalization (57.6%, Figure 1); nearly 80% occurred within the first 4 days. The rate of unplanned transfer peaked within 24 hours of hospital admission and decreased gradually as elapsed hospital LOS increased (Figure 1). While most patients experienced a single unplanned ICU transfer, 12.7% required multiple transfers to the ICU throughout their hospitalization.

Figure 1
Cumulative incidence (solid line) and 12‐hour rate (dashed line) of unplanned intensive care unit (ICU) transfers.

Multivariable case matching between unplanned transfer cases within 24 hours of admission and direct ICU admit controls resulted in 5839 (92%) case‐control pairs (Table 2). Matched pairs were most frequently admitted with diagnoses in Primary Condition groups that included respiratory infections and pneumonia (15.6%); angina, acute myocardial infarction (AMI), and heart failure (15.6%); or gastrointestinal bleeding (13.8%).

Characteristics and Outcomes of Patients With Unplanned ICU Transfers and Matched Patients Directly Admitted to the ICU
 ICU Cohorts (by Elapsed Time to Transfer Since Hospital Admission)
 Within 24 hr (n = 5,839)Within 48 hr (n = 8,976)
 Delayed ICU Transfer (Case)Direct ICU Admit (Control)Delayed ICU Transfer (Case)Direct ICU Admit (Control)
  • NOTE: Admitting diagnosis includes the 4 most frequent conditions. Pneumonia includes other respiratory infections.

  • Abbreviations: ICU, intensive care unit; MI, myocardial infarction.

  • P < 0.01.

Age67 1666 1667 1667 16
Female2,868 (49.1)2,868 (49.1)4,477 (49.9)4,477 (49.9)
Admitting diagnosis    
Pneumonia911 (15.6)911 (15.6)1,526 (17.0)1,526 (17.0)
Heart failure or MI909 (15.6)909 (15.6)1,331 (14.8)1,331 (14.8)
Gastrointestinal bleeding806 (13.8)806 (13.8)1,191 (13.3)1,191 (13.3)
Infections (including sepsis)295 (5.1)295 (5.1)474 (5.3)474 (5.3)
Outcomes    
Length of stay (days)*8 126 99 136 9
In‐hospital mortality*678 (11.6)498 (8.5)1,181 (13.2)814 (9.1)

In‐hospital mortality was significantly higher among cases (11.6%) than among ICU controls (8.5%, P < 0.001); mean LOS was also longer among cases (8 12 days) than among controls (6 9 days, P < 0.001). Unplanned transfer cases were at an increased odds of death when compared with ICU controls (adjusted odds ratio [OR], 1.44; 95% confidence interval [CI], 1.26‐1.64; P < 0.001); they also had a significantly higher observed‐to‐expected mortality ratio. When cases and controls were matched by hospital facility, the number of case‐control pairs decreased (2949 pairs; 42% matching frequency) but the odds of death was of similar magnitude (OR, 1.43; 95% CI, 1.21‐1.68; P < 0.001). Multivariable mixed‐effects logistic regression including all early unplanned transfer and direct ICU admit patients produced an effect size of similar magnitude (OR, 1.37; 95% CI, 1.24‐1.50; P < 0.001).

Results were similar when cases were limited to patients with transfers within 12 hours of admission; mortality was 10.9% among cases and 9.1% among controls (P = 0.02). When including patients with unplanned transfers within 48 hours of hospital admission, the difference in mortality between cases and controls increased (13.2% vs 9.1%, P < 0.001). The odds of death among patients with unplanned transfers increased as the elapsed time between admission and ICU transfer lengthened (Figure 2); the adjusted OR was statistically significant at each point between 8 and 48 hours.

Figure 2
Multivariable odds ratio for mortality among patients with unplanned intensive care unit (ICU) transfers, compared with those with direct ICU admissions, based on elapsed time between hospital admission and ICU transfer. Dashed line represents a linear regression fitted line of point estimates (slope = 0.08 per hour; model R2 0.84). P value <0.05 at each timepoint.

When stratified by admitting diagnosis groups, cases with unplanned transfers within the first 48 hours had increased mortality compared with matched controls in some categories (Table 3). For example, for patients in the respiratory infection and pneumonia group, mortality was 16.8% among unplanned transfer cases and 13.0% among early matched ICU controls (P < 0.01). A similar pattern was present in groups including: gastrointestinal bleeding, chronic obstructive pulmonary disease (COPD) exacerbation, and seizure groups (Table 3). However, for patients with AMI alone, mortality was 5.0% among cases and 3.7% among matched controls (P = 0.12). Patients with sepsis had a mortality rate of 15.2% among cases and 20.8% among matched controls (P = 0.07). Similarly, patients with stroke had a mortality rate of 12.4% among unplanned transfer cases and 11.4% in the matched controls (P = 0.54).

Hospital Mortality Among Selected Primary Condition Groups
Primary Condition GroupMortality in ICU Case‐Control Cohorts, No. (%)
Within 24 hrWithin 48 hr
Delayed ICU Transfer (Case)Direct ICU Admit (Control)Delayed ICU Transfer (Case)Direct ICU Admit (Control)
  • Abbreviations: COPD, chronic obstructive pulmonary disease; ICU, intensive care unit; MI, myocardial infarction.

Respiratory infections143 (15.7)126 (13.8)493 (16.8)380 (13.0)
Angina, heart failure, or MI60 (6.6)41 (4.5)324 (7.7)152 (3.6)
Acute MI alone16 (5.7)17 (6.1)82 (5.0)61 (3.7)
Gastrointestinal bleeding96 (11.9)55 (6.8)549 (19.3)188 (6.6)
Infections including sepsis20 (9.8)52 (11.2)228 (14.8)220 (14.2)
Sepsis alone32 (18.9)31 (18.3)123 (15.2)168 (20.8)
COPD exacerbation20 (9.8)12 (5.9)74 (10.8)43 (6.3)
Stroke18 (10.2)19 (10.8)77 (12.4)71 (11.4)
Seizure21 (8.6)9 (3.7)68 (7.1)34 (3.6)

DISCUSSION

This study found that unplanned ICU transfers were common among medical patients, occurring in 5% of all hospitalizations originating in the ED. The majority of unplanned transfers occurred within 48 hours of admission; the rate of ICU transfers peaked within 24 hours after hospitalization. Compared with patients admitted directly from the ED to the ICU, those transferred early after admission had significantly increased mortality; for example, patients transferred within 24 hours were at a 44% increased odds of hospital death. The adverse outcomes associated with unplanned transfers varied considerably by admission diagnosis subgroups.

Our findings confirm previous reports of increased mortality among patients with unplanned ICU transfers. Escarce and Kelley reported that patients admitted to the ICU from non‐ED locationsincluding wards, intermediate care units, and other hospitalswere at an increased risk of hospital death.1 Multiple subsequent studies have confirmed the increased mortality among patients with unplanned transfers.24, 10, 13, 22, 23 We previously evaluated patients who required a transfer to any higher level of care and reported an observed‐to‐expected mortality ratio of 2.93.4

Fewer studies, however, have evaluated the association between the timing of unplanned transfers and inpatient outcomes; previous small reports suggest that delays in ICU transfer adversely affect mortality and length of stay.12, 13, 24 Parkhe et al. compared 99 direct ICU admit patients with 23 who experienced early unplanned transfers; mortality at 30 days was significantly higher among patients with unplanned transfers.13 The current multifacility study included considerably more patients and confirmed an in‐hospital mortality gapalbeit a smaller onebetween patients with early transfers and those directly admitted to the ICU.

We focused on unplanned transfers during the earliest phase of hospitalization to identify patients who might benefit from improved recognition of, and intervention for, impending critical illness. We found that even patients requiring transfers within 8 hours of hospital admission were at an increased risk of death. Bapoje et al. recently reported that as many as 80% of early unplanned transfers were preventable and that most resulted from inappropriate admission triage.11 Together, these findings suggest that heightened attention to identifying such patients at admission or within the first day of hospitalizationwhen the rates of unplanned transfers peakis critical.

Several important limitations should be recognized in interpreting these results. First, this study was not designed to specifically identify the reasons for unplanned transfers, limiting our ability to characterize episodes in which timely care could have prevented excess mortality. Notably, while previous work suggests that many early unplanned transfers might be prevented with appropriate triage, it is likely that some excess deaths are not preventable even if every patient could be admitted to the ICU directly.

We were able to characterize patient outcomes by admitting diagnoses. Patients admitted for pneumonia and respiratory infection, gastrointestinal bleeding, COPD exacerbation, or seizures demonstrated excess mortality compared with matched ICU controls, while those with AMI, sepsis, and stroke did not. It is possible that differences in diagnosis‐specific excess mortality resulted from increasing adherence to well‐defined practice guidelines for specific high‐risk conditions.2527 For example, international awareness campaigns for the treatment of sepsis, AMI, and strokeSurviving Sepsis, Door‐to‐Balloon, and F.A.S.T.emphasize early interventions to minimize morbidity and mortality.

Second, the data utilized in this study were based on automated variables extracted from the electronic medical record. Mortality prediction models based on automated variables have demonstrated excellent performance among ICU and non‐ICU populations14, 18, 28; however, the inclusion of additional data (eg, vital signs or neurological status) would likely improve baseline risk adjustment.5, 10, 2931 Multiple studies have demonstrated that vital signs and clinician judgment can predict patients at an increased risk of deterioration.5, 10, 2931 Such data might also provide insight into residual factors that influenced clinicians' decisions to triage patients to an ICU versus non‐ICU admissiona focus area of our ongoing research efforts. Utilizing electronically available data, however, facilitated the identification of a cohort of patients far larger than that in prior studies. Where previous work has also been limited by substantial variability in baseline characteristics among study subjects,1, 2, 12, 13 our large sample produced a high percentage of multivariable case matches.

Third, we chose to match patients with a severity of illness index based on variables available at the time of hospital admission. While this mortality prediction model has demonstrated excellent performance in internal and external populations,14, 18 it is calibrated for general inpatient, rather than critically ill, populations. It remains possible that case matching with ICU‐specific severity of illness scores might alter matching characteristics, however, previous studies suggest that severity of illness, as measured by these scores, is comparable between direct ICU admits and early ICU transfers.13 Importantly, our matching procedure avoided the potential confounding known to exist with the use of prediction models based on discharge or intra‐hospitalization data.32, 33

Finally, while we were able to evaluate unplanned transfer timing in a multifacility sample, all patient care occurred within a large integrated healthcare delivery system. The overall observed mortality in our study was lower than that reported in prior studies which considered more limited patient cohorts.1, 2, 12, 13, 22 Thus, differences in patient case‐mix or ICU structure must be considered when applying our results to other healthcare delivery systems.

This hypothesis‐generating study, based on a large, multifacility sample of hospitalizations, suggests several areas of future investigation. Future work should detail specific aspects of care among patients with unplanned transfer, including: evaluating the structures and processes involved in triage decisions, measuring the effects on mortality through implementation of interventions (eg, rapid response teams or diagnosis‐specific treatment protocols), and defining the causes and risk factors for unplanned transfers by elapsed time.

In conclusion, the risk of an unplanned ICU transfera common event among hospitalized patientsis highest within 24 hours of hospitalization. Patients with early unplanned transfers have increased mortality and length of stay compared to those admitted directly to the ICU. Even patients transferred to the ICU within 8 hours of hospital admission are at an increased risk of death when compared with those admitted directly. Substantial variability in unplanned transfer outcomes exists based on admitting diagnoses. Future research should characterize unplanned transfers in greater detail with the goal of identifying patients that would benefit from improved triage and early ICU transfer.

References
  1. Escarce JJ,Kelley MA.Admission source to the medical intensive care unit predicts hospital death independent of APACHE II score.JAMA.1990;264(18):23892394.
  2. Frost SA,Alexandrou E,Bogdanovski T,Salamonson Y,Parr MJ,Hillman KM.Unplanned admission to intensive care after emergency hospitalisation: risk factors and development of a nomogram for individualising risk.Resuscitation.2009;80(2):224230.
  3. Goldhill DR,Sumner A.Outcome of intensive care patients in a group of British intensive care units.Crit Care Med.1998;26(8):13371345.
  4. Escobar GJ,Greene JD,Gardner MN,Marelich GP,Quick B,Kipnis P.Intra‐hospital transfers to a higher level of care: contribution to total hospital and intensive care unit (ICU) mortality and length of stay (LOS).J Hosp Med.2010;6(2):7480.
  5. Sax FL,Charlson ME.Medical patients at high risk for catastrophic deterioration.Crit Care Med.1987;15(5):510515.
  6. Hillman K,Chen J,Cretikos M, et al.Introduction of the medical emergency team (MET) system: a cluster‐randomised controlled trial.Lancet.2005;365(9477):20912097.
  7. Sharek PJ,Parast LM,Leong K, et al.Effect of a rapid response team on hospital‐wide mortality and code rates outside the ICU in a children's hospital.JAMA.2007;298(19):22672274.
  8. Haller G,Myles PS,Wolfe R,Weeks AM,Stoelwinder J,McNeil J.Validity of unplanned admission to an intensive care unit as a measure of patient safety in surgical patients.Anesthesiology.2005;103(6):11211129.
  9. Berwick DM,Calkins DR,McCannon CJ,Hackbarth AD.The 100,000 lives campaign: setting a goal and a deadline for improving health care quality.JAMA.2006;295(3):324327.
  10. Hillman KM,Bristow PJ,Chey T, et al.Duration of life‐threatening antecedents prior to intensive care admission.Intensive Care Med.2002;28(11):16291634.
  11. Bapoje SR,Gaudiani JL,Narayanan V,Albert RK.Unplanned transfers to a medical intensive care unit: causes and relationship to preventable errors in care.J Hosp Med.2011;6(2):6872.
  12. Young MP,Gooder VJ,McBride K,James B,Fisher ES.Inpatient transfers to the intensive care unit: delays are associated with increased mortality and morbidity.J Gen Intern Med.2003;18(2):7783.
  13. Parkhe M,Myles PS,Leach DS,Maclean AV.Outcome of emergency department patients with delayed admission to an intensive care unit.Emerg Med (Fremantle).2002;14(1):5057.
  14. Escobar GJ,Greene JD,Scheirer P,Gardner MN,Draper D,Kipnis P.Risk‐adjusting hospital inpatient mortality using automated inpatient, outpatient, and laboratory databases.Med Care.2008;46(3):232239.
  15. Escobar GJ,Fireman BH,Palen TE, et al.Risk adjusting community‐acquired pneumonia hospital outcomes using automated databases.Am J Manag Care.2008;14(3):158166.
  16. Selby JV.Linking automated databases for research in managed care settings.Ann Intern Med.1997;127(8 pt 2):719724.
  17. Go AS,Hylek EM,Chang Y, et al.Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice?JAMA.2003;290(20):26852692.
  18. van Walraven C,Escobar GJ,Greene JD,Forster AJ.The Kaiser Permanente inpatient risk adjustment methodology was valid in an external patient population.J Clin Epidemiol.2009;63(7):798803.
  19. Ellis RP,Ash A.Refinements to the diagnostic cost group (DCG) model.Inquiry.1995;32(4):418429.
  20. Zhan C,Miller MR.Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization.JAMA.2003;290(14):18681874.
  21. Rosenbaum P.Optimal matching in observational studies.J Am Stat Assoc.1989;84:10241032.
  22. Simpson HK,Clancy M,Goldfrad C,Rowan K.Admissions to intensive care units from emergency departments: a descriptive study.Emerg Med J.2005;22(6):423428.
  23. Tam V,Frost SA,Hillman KM,Salamonson Y.Using administrative data to develop a nomogram for individualising risk of unplanned admission to intensive care.Resuscitation.2008;79(2):241248.
  24. Bapoje S,Gaudiani J,Narayanan V,Albert R.Unplanned intensive care unit transfers: a useful tool to improve quality of care [abstract]. In: Hospital Medicine 2010 abstract booklet. Society of Hospital Medicine 2010 Annual Meeting, April 9–11, 2010, Washington, DC;2010:1011.
  25. Dellinger RP,Levy MM,Carlet JM, et al.Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008.Crit Care Med.2008;36(1):296327.
  26. Kushner FG,Hand M,Smith SC, et al.2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST‐Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.Circulation.2009;120(22):22712306.
  27. Schwamm L,Fayad P,Acker JE, et al.Translating evidence into practice: a decade of efforts by the American Heart Association/American Stroke Association to reduce death and disability due to stroke: a presidential advisory from the American Heart Association/American Stroke Association.Stroke.2010;41(5):10511065.
  28. Render ML,Deddens J,Freyberg R, et al.Veterans Affairs intensive care unit risk adjustment model: validation, updating, recalibration.Crit Care Med.2008;36(4):10311042.
  29. Peberdy MA,Cretikos M,Abella BS, et al.Recommended guidelines for monitoring, reporting, and conducting research on medical emergency team, outreach, and rapid response systems: an Utstein‐style scientific statement: a scientific statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian Resuscitation Council, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, and the New Zealand Resuscitation Council); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiopulmonary, Perioperative, and Critical Care; and the Interdisciplinary Working Group on Quality of Care and Outcomes Research.Circulation.2007;116(21):24812500.
  30. Charlson ME,Hollenberg JP,Hou J,Cooper M,Pochapin M,Pecker M.Realizing the potential of clinical judgment: a real‐time strategy for predicting outcomes and cost for medical inpatients.Am J Med.2000;109(3):189195.
  31. Goldhill DR,White SA,Sumner A.Physiological values and procedures in the 24 h before ICU admission from the ward.Anaesthesia.1999;54(6):529534.
  32. Iezzoni LI,Ash AS,Shwartz M,Daley J,Hughes JS,Mackiernan YD.Predicting who dies depends on how severity is measured: implications for evaluating patient outcomes.Ann Intern Med.1995;123(10):763770.
  33. Pine M,Jordan HS,Elixhauser A, et al.Enhancement of claims data to improve risk adjustment of hospital mortality.JAMA.2007;297(1):7176.
References
  1. Escarce JJ,Kelley MA.Admission source to the medical intensive care unit predicts hospital death independent of APACHE II score.JAMA.1990;264(18):23892394.
  2. Frost SA,Alexandrou E,Bogdanovski T,Salamonson Y,Parr MJ,Hillman KM.Unplanned admission to intensive care after emergency hospitalisation: risk factors and development of a nomogram for individualising risk.Resuscitation.2009;80(2):224230.
  3. Goldhill DR,Sumner A.Outcome of intensive care patients in a group of British intensive care units.Crit Care Med.1998;26(8):13371345.
  4. Escobar GJ,Greene JD,Gardner MN,Marelich GP,Quick B,Kipnis P.Intra‐hospital transfers to a higher level of care: contribution to total hospital and intensive care unit (ICU) mortality and length of stay (LOS).J Hosp Med.2010;6(2):7480.
  5. Sax FL,Charlson ME.Medical patients at high risk for catastrophic deterioration.Crit Care Med.1987;15(5):510515.
  6. Hillman K,Chen J,Cretikos M, et al.Introduction of the medical emergency team (MET) system: a cluster‐randomised controlled trial.Lancet.2005;365(9477):20912097.
  7. Sharek PJ,Parast LM,Leong K, et al.Effect of a rapid response team on hospital‐wide mortality and code rates outside the ICU in a children's hospital.JAMA.2007;298(19):22672274.
  8. Haller G,Myles PS,Wolfe R,Weeks AM,Stoelwinder J,McNeil J.Validity of unplanned admission to an intensive care unit as a measure of patient safety in surgical patients.Anesthesiology.2005;103(6):11211129.
  9. Berwick DM,Calkins DR,McCannon CJ,Hackbarth AD.The 100,000 lives campaign: setting a goal and a deadline for improving health care quality.JAMA.2006;295(3):324327.
  10. Hillman KM,Bristow PJ,Chey T, et al.Duration of life‐threatening antecedents prior to intensive care admission.Intensive Care Med.2002;28(11):16291634.
  11. Bapoje SR,Gaudiani JL,Narayanan V,Albert RK.Unplanned transfers to a medical intensive care unit: causes and relationship to preventable errors in care.J Hosp Med.2011;6(2):6872.
  12. Young MP,Gooder VJ,McBride K,James B,Fisher ES.Inpatient transfers to the intensive care unit: delays are associated with increased mortality and morbidity.J Gen Intern Med.2003;18(2):7783.
  13. Parkhe M,Myles PS,Leach DS,Maclean AV.Outcome of emergency department patients with delayed admission to an intensive care unit.Emerg Med (Fremantle).2002;14(1):5057.
  14. Escobar GJ,Greene JD,Scheirer P,Gardner MN,Draper D,Kipnis P.Risk‐adjusting hospital inpatient mortality using automated inpatient, outpatient, and laboratory databases.Med Care.2008;46(3):232239.
  15. Escobar GJ,Fireman BH,Palen TE, et al.Risk adjusting community‐acquired pneumonia hospital outcomes using automated databases.Am J Manag Care.2008;14(3):158166.
  16. Selby JV.Linking automated databases for research in managed care settings.Ann Intern Med.1997;127(8 pt 2):719724.
  17. Go AS,Hylek EM,Chang Y, et al.Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice?JAMA.2003;290(20):26852692.
  18. van Walraven C,Escobar GJ,Greene JD,Forster AJ.The Kaiser Permanente inpatient risk adjustment methodology was valid in an external patient population.J Clin Epidemiol.2009;63(7):798803.
  19. Ellis RP,Ash A.Refinements to the diagnostic cost group (DCG) model.Inquiry.1995;32(4):418429.
  20. Zhan C,Miller MR.Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization.JAMA.2003;290(14):18681874.
  21. Rosenbaum P.Optimal matching in observational studies.J Am Stat Assoc.1989;84:10241032.
  22. Simpson HK,Clancy M,Goldfrad C,Rowan K.Admissions to intensive care units from emergency departments: a descriptive study.Emerg Med J.2005;22(6):423428.
  23. Tam V,Frost SA,Hillman KM,Salamonson Y.Using administrative data to develop a nomogram for individualising risk of unplanned admission to intensive care.Resuscitation.2008;79(2):241248.
  24. Bapoje S,Gaudiani J,Narayanan V,Albert R.Unplanned intensive care unit transfers: a useful tool to improve quality of care [abstract]. In: Hospital Medicine 2010 abstract booklet. Society of Hospital Medicine 2010 Annual Meeting, April 9–11, 2010, Washington, DC;2010:1011.
  25. Dellinger RP,Levy MM,Carlet JM, et al.Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008.Crit Care Med.2008;36(1):296327.
  26. Kushner FG,Hand M,Smith SC, et al.2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST‐Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.Circulation.2009;120(22):22712306.
  27. Schwamm L,Fayad P,Acker JE, et al.Translating evidence into practice: a decade of efforts by the American Heart Association/American Stroke Association to reduce death and disability due to stroke: a presidential advisory from the American Heart Association/American Stroke Association.Stroke.2010;41(5):10511065.
  28. Render ML,Deddens J,Freyberg R, et al.Veterans Affairs intensive care unit risk adjustment model: validation, updating, recalibration.Crit Care Med.2008;36(4):10311042.
  29. Peberdy MA,Cretikos M,Abella BS, et al.Recommended guidelines for monitoring, reporting, and conducting research on medical emergency team, outreach, and rapid response systems: an Utstein‐style scientific statement: a scientific statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian Resuscitation Council, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, and the New Zealand Resuscitation Council); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiopulmonary, Perioperative, and Critical Care; and the Interdisciplinary Working Group on Quality of Care and Outcomes Research.Circulation.2007;116(21):24812500.
  30. Charlson ME,Hollenberg JP,Hou J,Cooper M,Pochapin M,Pecker M.Realizing the potential of clinical judgment: a real‐time strategy for predicting outcomes and cost for medical inpatients.Am J Med.2000;109(3):189195.
  31. Goldhill DR,White SA,Sumner A.Physiological values and procedures in the 24 h before ICU admission from the ward.Anaesthesia.1999;54(6):529534.
  32. Iezzoni LI,Ash AS,Shwartz M,Daley J,Hughes JS,Mackiernan YD.Predicting who dies depends on how severity is measured: implications for evaluating patient outcomes.Ann Intern Med.1995;123(10):763770.
  33. Pine M,Jordan HS,Elixhauser A, et al.Enhancement of claims data to improve risk adjustment of hospital mortality.JAMA.2007;297(1):7176.
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Adverse outcomes associated with delayed intensive care unit transfers in an integrated healthcare system
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Adverse outcomes associated with delayed intensive care unit transfers in an integrated healthcare system
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Severe AH Among Inpatients From the ED

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Severe acute hypertension among inpatients admitted from the emergency department

Chronic hypertension affects 32% of adults in the United States.1 Each year, over 20 million emergency department visits involve hypertension.2 While many studies describe the epidemiology and outcomes of chronic hypertension, less is known about severe acute hypertension (AH). Often classified as either hypertensive urgency or emergency, it receives little attention in national treatment guidelines.3 There is a limited understanding of the epidemiology of, and the relationship between, this syndrome and patient outcomes among hospitalized patients. One registry study suggested that severe AH was associated with high rates of new organ damage, need for treatment in the intensive care unit, and a 90‐day readmission rate of 10%.4 This investigation, however, lacked generalizability, because it only enrolled subjects requiring therapy with an intravenous antihypertensive agent and did not provide information on the prevalence of severe AH. Qureshi et al.5 analyzed information in a more representative sample from the national hospital ambulatory care survey, however, the only outcome examined was the correlation between acute blood pressure and stroke. Studies focusing on a selected patient population may be of limited value to hospitalists, because they are commonly required to treat a range of patients presenting to the hospital.

In light of severe syndromes that may be associated with, or complicated by, severe AH presented early during acute care, hospitalists require a better understanding of the prevalence and the relationship between severe AH and attendant mortality and morbidity. In addition, an assessment of the association of severe AH on the need for intensive care unit (ICU) admission and mechanical ventilation (MV) may aid the initial treatment assessments and triage decisions required of hospitalists.

Our objective was to describe the prevalence and implications of severe AH present at the time of evaluation in the ED among patients eventually hospitalized, using clinical data collected on all consecutive admissions across a range of clinical conditions. We sought to determine the independent contribution, if any, of severe AH to hospital mortality, need for MV on admission, as well as hospital length of stay (LOS).

METHODS

Study Design and Setting

This was a retrospective analysis of adults admitted to 114 acute‐care hospitals in the United States from 2005 through 2007. The New England Institutional Review Board/Human Subjects Research Committee (Wellesley, MA) reviewed and approved this study. It was conducted in compliance with the Health Insurance Portability and Accountability Act (HIPAA).

Data

Data were obtained from one of the Clinical Research Databases from CareFusion (formerly Cardinal Health [CareFusion Clinical Research Services, Marlborough, MA]).613 The database contains electronically imported or manually extracted demographic, clinical (eg, comorbidities, vital signs, laboratory values, other clinical findings), and administrative data (eg, diagnosis, procedures, and length of hospitalization). All vital signs were manually extracted, including the highest and the lowest ED systolic blood pressure (SBP) measurements during the ED stay, but before inpatient admission. Patients admitted for childbirth or mental health reasons were not included.

Patients

Our main analysis focused on patients whose highest and lowest SBP were collected in the ED. These patients accounted for approximately 90% of all inpatients admitted through the ED. For the approximately 9% of patients who had only 1 SBP collected, we conducted a sensitivity analysis by both including and excluding them in the main analysis to determine if the absence of a second SBP measurement altered our findings. Patients were grouped into 1 of the following 8 mutually exclusive strata based on the maximum SBP (mmHg) in the ED: <100, 101‐139, 140‐180, 181‐190, 191‐200, 201‐210, 211‐220, and >220.

Measures

The primary exposure of interest was the prevalence of severe AH, defined as at least 1 SBP measurement recorded in the ED in excess of 180 mmHg. Outcome measures included in‐hospital mortality, need for MV on admission day (defined by International Classification of Diseases, 9th revision, Clinical Modification [ICD‐9‐CM] procedure codes of 96.70, 96.71, and 96.72), and LOS. We stratified these outcomes for each inpatient admission according to 1 of 112 mutually exclusive groups of principal diagnoses (see Supporting Appendix A in the online version of this article). To simplify the presentations, we pooled the groups into 9 major disease categories based on organ systems.

Primary Data Analysis

All statistical analyses were performed using Statistical Analysis Software (SAS version 9.01; SAS Institute Inc, Cary, NC). For evaluating trending, we used the Cochran‐Armitage test for dichotomous variables (mortality and MV), and linear regression for continuous variable (LOS). We employed a logistic regression model to estimate risk of mortality and need for MV on admission. We used linear regression models to estimate the LOS associated with severe AH. We modeled each outcome as a function of patient disease severity and SBP strata. Because patients with the most severe AH tended to have higher mortality early in hospitalization, our analysis of LOS was limited to patients who survived index hospitalization.

The original disease‐specific risk‐adjustment models accounting for patient‐level confounding risk factors, including demographics, physiologic presentation on admission (vital signs, altered mental status, and laboratory findings), and chronic conditions, were previously developed and validated.12, 13 We recalibrated each of the 112 models, for the current study cohort, using the logit of predicted probability of death generated from the mortality risk‐adjustment model as a propensity score of disease severity. Using this propensity score as an aggregate severity adjuster, we refit 9 logistic regression models (1 for each major disease category) to estimate the odds ratios for mortality or need for MV for each of the 7 SBP strata in the regression models with 101‐139 mmHg as the reference group. To estimate the attributable LOS (if any) of severe AH among survivors, we fit the 9 LOS models using log transformed LOS (to normalize the potentially skewed distribution of LOS) as the outcome, controlling for disease severity. The attributable LOS and 95% confidence intervals (CI) were estimated from 1000 bootstrap iterations, with the median as the parameter estimate and 2.5th and 97.5th percentile as 95% CI.14, 15

Sensitivity Analysis

To address potential bias of LOS associated with inpatient mortality, we refit 9 LOS models, including both patients who died and those who survived the index hospitalization. The models adjusted for disease severity, mortality, and the interaction of severity and mortality. Because patients with only 1 SBP recorded at ED may be different from those with more than 1 SBP recorded, we conducted analysis by adding these patients in the study cohort to examine the potential change of overall prevalence of AH and associated mortality for the study population.

To address the potential for a center‐specific effect on outcomes, we refit all the models using a mixed model approach.16 The mixed model accounts for both patient‐level risk factors and hospital‐specific effects on the observed outcomes.

RESULTS

Patient Characteristics

The study cohort was comprised of 1,290,804 adults who were admitted through the ED, from 2005 through 2007, and whose highest and lowest SBP measurements were collected in the ED. Median age was 69 years (interquartile range, 53‐81) for the overall population. Median age was 74 (interquartile range, 60‐83) for patients with severe AH (Table 1). Hospital mortality was 3.6% (n = 46,033), with 6119 (13.3%) having severe AH.

Patient Characteristics
CharacteristicPrevalence, n (Column %)Severe Acute Hypertension, n (Row %)
Total number of discharges1,290,804 (100.0)178,197 (13.8)
Mortality46,033 (3.6)6,119 (13.3)
Live discharges1,244,771 (96.4)172,078 (13.8)
Mechanical ventilation on admission39,238 (3.0)9,508 (24.2)
Demographics  
Age, median (1st, 3rd quartiles)69 (53, 81)74 (60, 83)
Male587,553 (45.5)71,085 (12.1)
Female703,244 (54.5)107,109 (15.2)
Race  
White949,869 (73.6)121,930 (12.8)
Black220,601 (17.1)39,667 (18.0)
Other120,334 (9.3)16,600 (13.8)
Insurance  
Medicare668,420 (51.8)105,078 (15.7)
Medicaid108,538 (8.4)12,259 (11.3)
Commercial163,858 (12.7)18,669 (11.4)
Other349,988 (27.1)42,191 (12.1)
Disease system by the principal diagnosis  
Nervous system76,744 (5.9)22,270 (29.0)
Respiratory system222,329 (17.2)24,678 (11.1)
Circulatory system416,847 (32.3)66,852 (16.0)
Digestive system186,282 (14.4)17,817 (9.6)
Hepatobiliary/pancreas system52,293 (4.1)5,664 (10.8)
Endocrine system45,050 (3.5)6,625 (14.7)
Kidney/urinary system81,782 (6.3)11,050 (13.5)
Infectious diseases60,353 (4.7)4,162 (6.9)
Other149,124 (11.6)19,079 (12.8)
Comorbidity by secondary diagnoses  
Hypertension729,417 (56.5)135,498 (18.6)
Fluid and electrolyte disorders306,666 (23.8)37,836 (12.3)
Diabetes without chronic complications286,912 (22.2)47,979 (16.7)
Chronic pulmonary disease283,895 (22.0)35,977 (12.7)
Congestive heart failure213,523 (16.5)33,956 (15.9)
Deficiency anemias210,230 (16.3)30,266 (14.4)
Renal failure159,409 (12.3)31,984 (20.1)
Hypothyroidism153,911 (11.9)22,441 (14.6)
Valvular disease140,820 (10.9)21,453 (15.2)
Depression137,259 (10.6)16,886 (12.3)
Other neurological disorders126,954 (9.8)19,103 (15.0)
Peripheral vascular disease88,321 (6.8)16,180 (18.3)
Obesity84,000 (6.5)12,351 (14.7)
Diabetes with chronic complications65,989 (5.1)13,093 (19.8)
Psychoses54,769 (4.2)5,555 (10.1)
Alcohol abuse51,765 (4.0)6,014 (11.6)
Pulmonary circulation disease49,248 (3.8)7,128 (14.5)
Coagulopathy43,584 (3.4)4,339 (10.0)
Paralysis42,128 (3.3)8,125 (19.3)
Drug abuse36,134 (2.8)4,779 (13.2)
Liver disease36,094 (2.8)3,218 (8.9)
Weight loss35,795 (2.8)3,726 (10.4)
Metastatic cancer33,517 (2.6)2,498 (7.5)
Rheumatoid arthritis32,545 (2.5)4,300 (13.2)
Solid tumor without metastasis30,677 (2.4)3,035 (9.9)
Chronic blood loss anemia25,416 (2.0)2,268 (8.9)
Lymphoma9,972 (0.8)871 (8.7)
Acquired immune deficiency syndrome3,048 (0.2)307 (10.1)
Peptic ulcer disease915 (0.1)131 (14.3)
Discharges by hospital characteristics  
Teaching status  
Teaching hospitals899,786 (69.7)127,512 (14.2)
Nonteaching hospitals391,018 (30.3)50,685 (13.0)
Urban status  
Urban hospitals1,164,802 (90.2)162,399 (13.9)
Rural hospitals126,002 (9.8)15,798 (12.5)
Bed size  
Beds <10036,624 (2.8)4,965 (13.6)
Beds 100‐300623,327 (48.3)80,156 (12.9)
Beds >300630,853 (48.9)93,076 (14.8)

Prevalence of Acute Hypertension

A total of 763,634 (59.2%) patients had at least 1 SBP measurement of 140 mmHg during the ED stay, including 178,197 (13.8%) with SBP >180 mmHg. Body systems associated with the highest prevalence of severe AH (SBP >180 mmHg) were nervous (29.0%), circulatory (16.0%), endocrine (14.7%), and kidney/urinary (13.5%) (Figure 1 presents the data in graphic form; Supporting Appendix B, in the online version of this article, presents corresponding data in table form).

Figure 1
Prevalence of acute hypertension at emergency department by major disease category.

Mortality

Univariable analysis revealed a graded relationship between SBP stratum and mortality risk (Figure 2a; and see Supporting Appendix C in the online version of this article). This relationship was most pronounced for nervous system diseases; mortality rates for each 10 mmHg increase in SBP from 180 to >220 mmHg were 6.5%, 8.1%, 10.0%, 12.0%, and 19.7%, respectively (trending P < 0.0001). The risk‐adjusted increase in mortality odds ratio ranged from 1.04 (95% CI: 0.89, 1.21) to 1.44 (95% CI: 1.25, 1.67) for patients in the severe AH strata compared to patients with SBP of 101 to 139 mmHg (Figure 3). Severe AH was not an independent mortality predictor in other disease categories.

Figure 2
Unadjusted mortality rate (a), mechanical ventilation rate (b), and length of stay (c) by blood pressure level and major disease category.
Figure 3
Adjusted mortality odds ratio (95% confidence interval) by major disease category with 101‐139 mmHg as the reference.

Mechanical Ventilation on Admission

Univariable analysis revealed a graded relationship between severe AH and a need for MV on admission, especially for respiratory, circulatory, and infectious conditions (trending P < 0.0001) (Figure 2b; and see Supporting Appendix C in the online version of this article). In the multivariable analysis, there was a relationship between severe AH stratum and adjusted risk for MV on admission across nearly all disease categories (Figure 4).

Figure 4
Adjusted mechanical ventilation on admission odds ratio (95% confidence interval) by major disease category with 101‐139 mmHg as the reference.

Length of Stay

Univariable analysis revealed a graded relationship between severe AH strata and LOS for nearly all disease categories in survivors (trending P < 0.0001), except for digestive, kidney, and infectious diseases (Figure 2c; and see Supporting Appendix C in the online version of this article). For patients with nervous system diseases, the unadjusted LOS for each 10 mmHg increase in SBP from 180 to >220 was 5.8, 6.1, 6.4, 6.8, and 8.0 days, respectively (trending P < 0.0001). The relationship was similar for other disease categories which showed significant trending.

In the multivariable analysis, the relationship between severe AH strata and adjusted attributable LOS was graded across most disease categories, especially nervous, circulatory, and hepatobiliary diseases (Figure 5). The total adjusted number of hospital days attributable to severe AH was 0.43 days per case for all survivors with severe AH.

Figure 5
Adjusted attributable length of stay (days) and 95% confidence intervals for survivors by major disease category with 101‐139 mmHg as the reference.

Sensitivity Analysis

Our sensitivity analysis of the LOS estimate, including those patients who died in the hospital, yielded similar findings in attributable LOS due to severe AH. In addition, when we added patients with only 1 SBP documented in the ED to the study cohort, the severe AH prevalence changed negligibly from 13.8% to 13.0%, and the associated mortality remained unchanged at 3.4%. Models using the mix model approach, which take into account hospital‐specific effects, showed similar results.

DISCUSSION

This large‐scale analysis demonstrated that severe AH was present in 13.8% of inpatients admitted through the ED. The prevalence of severe AH varied based on the primary reason for an acute care admission, ranging from 7% in infectious syndromes to nearly 30% in acute neurologic processes. Specific to patients with neurologic disease, initial severe blood pressure elevations independently correlated with mortality. Severe blood pressure elevations at ED were independently associated with an increased need for MV on admission and a prolonged LOS across a range of disease states.

Prior work on hypertension at admission has generally included single‐center analyses or only focused on patients with specific admitting diagnoses. For example, in a single ED analysis, Tilman et al.17 reported that 16% of 10,000 patients presented with elevated blood pressure (140/90 mmHg). In a multicenter review of 7000 persons, Karras et al.18, 19 described 423 patients with severe AH (180/110 mmHg) who comprised 6% of patients seen in the ED during a 1‐week period. Qureshi et al.5 noted severe AH in 13% of patients with acute stroke. While other ED‐based studies examined all ED patients, including those admitted and discharged from the ED, our study focused on those requiring hospitalization. This disparity in illness severity may, in part, explain the higher prevalence of severe AH we noted relative to others.

We further found that the prevalence of severe AH varied based on admitting diagnosis. This difference in prevalence rates by condition seems clinically plausible. Recognition of this pattern may prove valuable to hospitalists who, by the nature of their responsibilities, will encounter a broad range of patients. Because our data were derived from the largest analysis of blood pressure assessments for ED patients who were eventually hospitalized, and encompassed a multiplicity of hospitals, our findings are likely generalizable. Moreover, our large sample size enabled us to examine severe AH at each 10 mmHg increment across a variety of disease states, rather than restricting our analysis to 1 admitting diagnosis.

The independent relationship between severe blood pressure elevation and mortality was detected only in those with neurologic conditions. Incremental increases in SBP beyond 180 mmHg were associated with a stepwise escalation in the risk for death. Although recognition of the importance of blood pressure management in both ischemic and hemorrhagic stroke remains a cornerstone of therapy for these diseases, the stepwise relationship between escalating blood pressure and outcome suggests that further study is needed to determine the optimal management of severe AH among these patients. This relationship, along with the independent association between severe AH at presentation and the need for MV, underscores the importance of severe AH in critical care, representing a major challenge for intensivists and hospitalists, particularly those who practice in neurologic ICUs.

The independent association of severe AH and prolonged LOS represents a novel finding. Few reports have correlated the initial blood pressure with measures of resource use. Katz et al.4 found a median LOS of 6 days among 1000 patients who presented with severe AH and end organ dysfunction in 25 US hospitals. These investigators, however, did not explore the incremental independent contribution of initial blood pressure to LOS. Biologically, severe hypertension may exacerbate both acute and chronic conditions, thus complicating their management and resulting in longer hospitalizations.

Our analysis has limitations. While exposure misclassification is a potential concern, unlike other population‐based studies that use ICD‐9‐CM codes to identify AH cases, we relied on actual measures of blood pressure to identify subjects, thus minimizing this threat to validity. Similarly, since our end pointsmortality, MV on admission, and LOSwere also objective measures, the probability of their misclassification is minimal.

Another concerning contributor to exposure misclassification is the possibility that, in some instances, the initial elevation in BP meeting the inclusion criteria in our study cohort does not reflect the true BP. Indeed, a substantial body of research about BP measurement in the ED suggests that we may have included some persons who likely did not have AH. For example, Pitts and Adams described a regression to the mean phenomenon, with serial BP measurements in the ED, wherein the BP fell by approximately 11 mmHg over 4 hours.20 Baumann and colleagues reported a similar pattern.21 However, the findings of these 2 analyses do not necessarily apply to our study population; we focused on patients admitted to the hospital with an acute condition, while Pitts and Adams20 and Baumann et al.21 examined all ED patients. This distinction is crucial in that patients not admitted are likely less severely ill and systematically different from those who do merit hospitalization. Moreover, both Pitts and Adams20 and Cienki et al.22 observed that the regression to the mean and fall in serial BP measurements were less pronounced in those with the most extensive BP elevations. In our study, we found the strongest relationship between adverse outcomes and BP in patients with the most extreme BP elevations. Thus, misclassification is perhaps less likely to be an issue for these subjects.

In addition, misclassification may result when initially elevated BP simply represents the impact of untreated pain or anxiety in ED patients. However, Backer et al.23 and Tanabe and colleagues24 specifically explored the impact of pain and anxiety on BP in ED subjects, and neither group found a correlation between BP and either acute pain and/or anxiety scores. Our difficulties with case definitions and BP measurements for severe AH demonstrate the need for the creation and adoption of a formal, systematic approach to this syndrome, along with the need for prospective analyses to confirm our findings.

Selection bias represents a second potential threat to validity in our observational study, although this bias is mitigated by including all consecutive acute inpatient admissions to the participating hospitals. Furthermore, inclusion of the 9% of patients who had only 1 ED measurement of SBP collected did not alter the estimate of severe AH prevalence or associated outcomes.

Third, confounding may introduce the potential for false associations derived from observational data. The large sample size of our cohort allowed us to address this concern by adjusting for a large array of confounders. In addition, unlike other large‐scale population‐based studies which typically rely on administrative ICD‐9‐CM codes for risk adjustment, our analysis incorporated actual physiologic and laboratory results measured on admission, as well as a validated severity‐of‐illness scoring system for risk adjustment.12, 13

Although both SBP and diastolic blood pressure (DBP) thresholds are included in traditional definitions of hypertension, selecting SBP as the primary measure is reasonable because SBP >180 mmHg is a more important risk factor for cardiovascular disease than elevated DBP.25 Previous studies reported the relationship between the trend of SBP over time and clinical outcomes,26, 27 but we were not able to investigate the relationship of SBP trend and outcomes because the BP measurements in the our study were not collected in predefined intervals.

It would be ideal if serial blood pressure measures were to be collected at pre‐specified intervals and if more sophisticated schemas were to be used to refine the AH definition. This type of study may be possible in the future when vital signs can be collected automatically with advanced technology. Likewise, electronically captured treatment data could further help researchers to study the impact of process‐of‐care variables, including medications and other management strategies, in relation to outcomes. Finally, outpatient management of chronic hypertension is an integral part of clinical management. Unfortunately, these types of data are not available in our existing database. These limitations notwithstanding, an in‐depth understanding of the association between severe AH and potential adverse clinical and economic outcomes may direct further research in this field.

CONCLUSION

Severe AH appears common and its prevalence varies by underlying clinical condition in patients admitted from the ED. In those with acute neurologic syndromes, the degree of blood pressure elevation correlated with mortality, need for MV, and longer LOS. For many other conditions, elevation of blood pressure appeared to be linked to an increased need for MV and a prolongation in LOS. Future studies are needed to examine the potential impact of both 1) improved long‐term outpatient BP management, and 2) optimal management of severe AH upon admission on improving outcomes of patients hospitalized from the ED with severe AH.

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References
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Chronic hypertension affects 32% of adults in the United States.1 Each year, over 20 million emergency department visits involve hypertension.2 While many studies describe the epidemiology and outcomes of chronic hypertension, less is known about severe acute hypertension (AH). Often classified as either hypertensive urgency or emergency, it receives little attention in national treatment guidelines.3 There is a limited understanding of the epidemiology of, and the relationship between, this syndrome and patient outcomes among hospitalized patients. One registry study suggested that severe AH was associated with high rates of new organ damage, need for treatment in the intensive care unit, and a 90‐day readmission rate of 10%.4 This investigation, however, lacked generalizability, because it only enrolled subjects requiring therapy with an intravenous antihypertensive agent and did not provide information on the prevalence of severe AH. Qureshi et al.5 analyzed information in a more representative sample from the national hospital ambulatory care survey, however, the only outcome examined was the correlation between acute blood pressure and stroke. Studies focusing on a selected patient population may be of limited value to hospitalists, because they are commonly required to treat a range of patients presenting to the hospital.

In light of severe syndromes that may be associated with, or complicated by, severe AH presented early during acute care, hospitalists require a better understanding of the prevalence and the relationship between severe AH and attendant mortality and morbidity. In addition, an assessment of the association of severe AH on the need for intensive care unit (ICU) admission and mechanical ventilation (MV) may aid the initial treatment assessments and triage decisions required of hospitalists.

Our objective was to describe the prevalence and implications of severe AH present at the time of evaluation in the ED among patients eventually hospitalized, using clinical data collected on all consecutive admissions across a range of clinical conditions. We sought to determine the independent contribution, if any, of severe AH to hospital mortality, need for MV on admission, as well as hospital length of stay (LOS).

METHODS

Study Design and Setting

This was a retrospective analysis of adults admitted to 114 acute‐care hospitals in the United States from 2005 through 2007. The New England Institutional Review Board/Human Subjects Research Committee (Wellesley, MA) reviewed and approved this study. It was conducted in compliance with the Health Insurance Portability and Accountability Act (HIPAA).

Data

Data were obtained from one of the Clinical Research Databases from CareFusion (formerly Cardinal Health [CareFusion Clinical Research Services, Marlborough, MA]).613 The database contains electronically imported or manually extracted demographic, clinical (eg, comorbidities, vital signs, laboratory values, other clinical findings), and administrative data (eg, diagnosis, procedures, and length of hospitalization). All vital signs were manually extracted, including the highest and the lowest ED systolic blood pressure (SBP) measurements during the ED stay, but before inpatient admission. Patients admitted for childbirth or mental health reasons were not included.

Patients

Our main analysis focused on patients whose highest and lowest SBP were collected in the ED. These patients accounted for approximately 90% of all inpatients admitted through the ED. For the approximately 9% of patients who had only 1 SBP collected, we conducted a sensitivity analysis by both including and excluding them in the main analysis to determine if the absence of a second SBP measurement altered our findings. Patients were grouped into 1 of the following 8 mutually exclusive strata based on the maximum SBP (mmHg) in the ED: <100, 101‐139, 140‐180, 181‐190, 191‐200, 201‐210, 211‐220, and >220.

Measures

The primary exposure of interest was the prevalence of severe AH, defined as at least 1 SBP measurement recorded in the ED in excess of 180 mmHg. Outcome measures included in‐hospital mortality, need for MV on admission day (defined by International Classification of Diseases, 9th revision, Clinical Modification [ICD‐9‐CM] procedure codes of 96.70, 96.71, and 96.72), and LOS. We stratified these outcomes for each inpatient admission according to 1 of 112 mutually exclusive groups of principal diagnoses (see Supporting Appendix A in the online version of this article). To simplify the presentations, we pooled the groups into 9 major disease categories based on organ systems.

Primary Data Analysis

All statistical analyses were performed using Statistical Analysis Software (SAS version 9.01; SAS Institute Inc, Cary, NC). For evaluating trending, we used the Cochran‐Armitage test for dichotomous variables (mortality and MV), and linear regression for continuous variable (LOS). We employed a logistic regression model to estimate risk of mortality and need for MV on admission. We used linear regression models to estimate the LOS associated with severe AH. We modeled each outcome as a function of patient disease severity and SBP strata. Because patients with the most severe AH tended to have higher mortality early in hospitalization, our analysis of LOS was limited to patients who survived index hospitalization.

The original disease‐specific risk‐adjustment models accounting for patient‐level confounding risk factors, including demographics, physiologic presentation on admission (vital signs, altered mental status, and laboratory findings), and chronic conditions, were previously developed and validated.12, 13 We recalibrated each of the 112 models, for the current study cohort, using the logit of predicted probability of death generated from the mortality risk‐adjustment model as a propensity score of disease severity. Using this propensity score as an aggregate severity adjuster, we refit 9 logistic regression models (1 for each major disease category) to estimate the odds ratios for mortality or need for MV for each of the 7 SBP strata in the regression models with 101‐139 mmHg as the reference group. To estimate the attributable LOS (if any) of severe AH among survivors, we fit the 9 LOS models using log transformed LOS (to normalize the potentially skewed distribution of LOS) as the outcome, controlling for disease severity. The attributable LOS and 95% confidence intervals (CI) were estimated from 1000 bootstrap iterations, with the median as the parameter estimate and 2.5th and 97.5th percentile as 95% CI.14, 15

Sensitivity Analysis

To address potential bias of LOS associated with inpatient mortality, we refit 9 LOS models, including both patients who died and those who survived the index hospitalization. The models adjusted for disease severity, mortality, and the interaction of severity and mortality. Because patients with only 1 SBP recorded at ED may be different from those with more than 1 SBP recorded, we conducted analysis by adding these patients in the study cohort to examine the potential change of overall prevalence of AH and associated mortality for the study population.

To address the potential for a center‐specific effect on outcomes, we refit all the models using a mixed model approach.16 The mixed model accounts for both patient‐level risk factors and hospital‐specific effects on the observed outcomes.

RESULTS

Patient Characteristics

The study cohort was comprised of 1,290,804 adults who were admitted through the ED, from 2005 through 2007, and whose highest and lowest SBP measurements were collected in the ED. Median age was 69 years (interquartile range, 53‐81) for the overall population. Median age was 74 (interquartile range, 60‐83) for patients with severe AH (Table 1). Hospital mortality was 3.6% (n = 46,033), with 6119 (13.3%) having severe AH.

Patient Characteristics
CharacteristicPrevalence, n (Column %)Severe Acute Hypertension, n (Row %)
Total number of discharges1,290,804 (100.0)178,197 (13.8)
Mortality46,033 (3.6)6,119 (13.3)
Live discharges1,244,771 (96.4)172,078 (13.8)
Mechanical ventilation on admission39,238 (3.0)9,508 (24.2)
Demographics  
Age, median (1st, 3rd quartiles)69 (53, 81)74 (60, 83)
Male587,553 (45.5)71,085 (12.1)
Female703,244 (54.5)107,109 (15.2)
Race  
White949,869 (73.6)121,930 (12.8)
Black220,601 (17.1)39,667 (18.0)
Other120,334 (9.3)16,600 (13.8)
Insurance  
Medicare668,420 (51.8)105,078 (15.7)
Medicaid108,538 (8.4)12,259 (11.3)
Commercial163,858 (12.7)18,669 (11.4)
Other349,988 (27.1)42,191 (12.1)
Disease system by the principal diagnosis  
Nervous system76,744 (5.9)22,270 (29.0)
Respiratory system222,329 (17.2)24,678 (11.1)
Circulatory system416,847 (32.3)66,852 (16.0)
Digestive system186,282 (14.4)17,817 (9.6)
Hepatobiliary/pancreas system52,293 (4.1)5,664 (10.8)
Endocrine system45,050 (3.5)6,625 (14.7)
Kidney/urinary system81,782 (6.3)11,050 (13.5)
Infectious diseases60,353 (4.7)4,162 (6.9)
Other149,124 (11.6)19,079 (12.8)
Comorbidity by secondary diagnoses  
Hypertension729,417 (56.5)135,498 (18.6)
Fluid and electrolyte disorders306,666 (23.8)37,836 (12.3)
Diabetes without chronic complications286,912 (22.2)47,979 (16.7)
Chronic pulmonary disease283,895 (22.0)35,977 (12.7)
Congestive heart failure213,523 (16.5)33,956 (15.9)
Deficiency anemias210,230 (16.3)30,266 (14.4)
Renal failure159,409 (12.3)31,984 (20.1)
Hypothyroidism153,911 (11.9)22,441 (14.6)
Valvular disease140,820 (10.9)21,453 (15.2)
Depression137,259 (10.6)16,886 (12.3)
Other neurological disorders126,954 (9.8)19,103 (15.0)
Peripheral vascular disease88,321 (6.8)16,180 (18.3)
Obesity84,000 (6.5)12,351 (14.7)
Diabetes with chronic complications65,989 (5.1)13,093 (19.8)
Psychoses54,769 (4.2)5,555 (10.1)
Alcohol abuse51,765 (4.0)6,014 (11.6)
Pulmonary circulation disease49,248 (3.8)7,128 (14.5)
Coagulopathy43,584 (3.4)4,339 (10.0)
Paralysis42,128 (3.3)8,125 (19.3)
Drug abuse36,134 (2.8)4,779 (13.2)
Liver disease36,094 (2.8)3,218 (8.9)
Weight loss35,795 (2.8)3,726 (10.4)
Metastatic cancer33,517 (2.6)2,498 (7.5)
Rheumatoid arthritis32,545 (2.5)4,300 (13.2)
Solid tumor without metastasis30,677 (2.4)3,035 (9.9)
Chronic blood loss anemia25,416 (2.0)2,268 (8.9)
Lymphoma9,972 (0.8)871 (8.7)
Acquired immune deficiency syndrome3,048 (0.2)307 (10.1)
Peptic ulcer disease915 (0.1)131 (14.3)
Discharges by hospital characteristics  
Teaching status  
Teaching hospitals899,786 (69.7)127,512 (14.2)
Nonteaching hospitals391,018 (30.3)50,685 (13.0)
Urban status  
Urban hospitals1,164,802 (90.2)162,399 (13.9)
Rural hospitals126,002 (9.8)15,798 (12.5)
Bed size  
Beds <10036,624 (2.8)4,965 (13.6)
Beds 100‐300623,327 (48.3)80,156 (12.9)
Beds >300630,853 (48.9)93,076 (14.8)

Prevalence of Acute Hypertension

A total of 763,634 (59.2%) patients had at least 1 SBP measurement of 140 mmHg during the ED stay, including 178,197 (13.8%) with SBP >180 mmHg. Body systems associated with the highest prevalence of severe AH (SBP >180 mmHg) were nervous (29.0%), circulatory (16.0%), endocrine (14.7%), and kidney/urinary (13.5%) (Figure 1 presents the data in graphic form; Supporting Appendix B, in the online version of this article, presents corresponding data in table form).

Figure 1
Prevalence of acute hypertension at emergency department by major disease category.

Mortality

Univariable analysis revealed a graded relationship between SBP stratum and mortality risk (Figure 2a; and see Supporting Appendix C in the online version of this article). This relationship was most pronounced for nervous system diseases; mortality rates for each 10 mmHg increase in SBP from 180 to >220 mmHg were 6.5%, 8.1%, 10.0%, 12.0%, and 19.7%, respectively (trending P < 0.0001). The risk‐adjusted increase in mortality odds ratio ranged from 1.04 (95% CI: 0.89, 1.21) to 1.44 (95% CI: 1.25, 1.67) for patients in the severe AH strata compared to patients with SBP of 101 to 139 mmHg (Figure 3). Severe AH was not an independent mortality predictor in other disease categories.

Figure 2
Unadjusted mortality rate (a), mechanical ventilation rate (b), and length of stay (c) by blood pressure level and major disease category.
Figure 3
Adjusted mortality odds ratio (95% confidence interval) by major disease category with 101‐139 mmHg as the reference.

Mechanical Ventilation on Admission

Univariable analysis revealed a graded relationship between severe AH and a need for MV on admission, especially for respiratory, circulatory, and infectious conditions (trending P < 0.0001) (Figure 2b; and see Supporting Appendix C in the online version of this article). In the multivariable analysis, there was a relationship between severe AH stratum and adjusted risk for MV on admission across nearly all disease categories (Figure 4).

Figure 4
Adjusted mechanical ventilation on admission odds ratio (95% confidence interval) by major disease category with 101‐139 mmHg as the reference.

Length of Stay

Univariable analysis revealed a graded relationship between severe AH strata and LOS for nearly all disease categories in survivors (trending P < 0.0001), except for digestive, kidney, and infectious diseases (Figure 2c; and see Supporting Appendix C in the online version of this article). For patients with nervous system diseases, the unadjusted LOS for each 10 mmHg increase in SBP from 180 to >220 was 5.8, 6.1, 6.4, 6.8, and 8.0 days, respectively (trending P < 0.0001). The relationship was similar for other disease categories which showed significant trending.

In the multivariable analysis, the relationship between severe AH strata and adjusted attributable LOS was graded across most disease categories, especially nervous, circulatory, and hepatobiliary diseases (Figure 5). The total adjusted number of hospital days attributable to severe AH was 0.43 days per case for all survivors with severe AH.

Figure 5
Adjusted attributable length of stay (days) and 95% confidence intervals for survivors by major disease category with 101‐139 mmHg as the reference.

Sensitivity Analysis

Our sensitivity analysis of the LOS estimate, including those patients who died in the hospital, yielded similar findings in attributable LOS due to severe AH. In addition, when we added patients with only 1 SBP documented in the ED to the study cohort, the severe AH prevalence changed negligibly from 13.8% to 13.0%, and the associated mortality remained unchanged at 3.4%. Models using the mix model approach, which take into account hospital‐specific effects, showed similar results.

DISCUSSION

This large‐scale analysis demonstrated that severe AH was present in 13.8% of inpatients admitted through the ED. The prevalence of severe AH varied based on the primary reason for an acute care admission, ranging from 7% in infectious syndromes to nearly 30% in acute neurologic processes. Specific to patients with neurologic disease, initial severe blood pressure elevations independently correlated with mortality. Severe blood pressure elevations at ED were independently associated with an increased need for MV on admission and a prolonged LOS across a range of disease states.

Prior work on hypertension at admission has generally included single‐center analyses or only focused on patients with specific admitting diagnoses. For example, in a single ED analysis, Tilman et al.17 reported that 16% of 10,000 patients presented with elevated blood pressure (140/90 mmHg). In a multicenter review of 7000 persons, Karras et al.18, 19 described 423 patients with severe AH (180/110 mmHg) who comprised 6% of patients seen in the ED during a 1‐week period. Qureshi et al.5 noted severe AH in 13% of patients with acute stroke. While other ED‐based studies examined all ED patients, including those admitted and discharged from the ED, our study focused on those requiring hospitalization. This disparity in illness severity may, in part, explain the higher prevalence of severe AH we noted relative to others.

We further found that the prevalence of severe AH varied based on admitting diagnosis. This difference in prevalence rates by condition seems clinically plausible. Recognition of this pattern may prove valuable to hospitalists who, by the nature of their responsibilities, will encounter a broad range of patients. Because our data were derived from the largest analysis of blood pressure assessments for ED patients who were eventually hospitalized, and encompassed a multiplicity of hospitals, our findings are likely generalizable. Moreover, our large sample size enabled us to examine severe AH at each 10 mmHg increment across a variety of disease states, rather than restricting our analysis to 1 admitting diagnosis.

The independent relationship between severe blood pressure elevation and mortality was detected only in those with neurologic conditions. Incremental increases in SBP beyond 180 mmHg were associated with a stepwise escalation in the risk for death. Although recognition of the importance of blood pressure management in both ischemic and hemorrhagic stroke remains a cornerstone of therapy for these diseases, the stepwise relationship between escalating blood pressure and outcome suggests that further study is needed to determine the optimal management of severe AH among these patients. This relationship, along with the independent association between severe AH at presentation and the need for MV, underscores the importance of severe AH in critical care, representing a major challenge for intensivists and hospitalists, particularly those who practice in neurologic ICUs.

The independent association of severe AH and prolonged LOS represents a novel finding. Few reports have correlated the initial blood pressure with measures of resource use. Katz et al.4 found a median LOS of 6 days among 1000 patients who presented with severe AH and end organ dysfunction in 25 US hospitals. These investigators, however, did not explore the incremental independent contribution of initial blood pressure to LOS. Biologically, severe hypertension may exacerbate both acute and chronic conditions, thus complicating their management and resulting in longer hospitalizations.

Our analysis has limitations. While exposure misclassification is a potential concern, unlike other population‐based studies that use ICD‐9‐CM codes to identify AH cases, we relied on actual measures of blood pressure to identify subjects, thus minimizing this threat to validity. Similarly, since our end pointsmortality, MV on admission, and LOSwere also objective measures, the probability of their misclassification is minimal.

Another concerning contributor to exposure misclassification is the possibility that, in some instances, the initial elevation in BP meeting the inclusion criteria in our study cohort does not reflect the true BP. Indeed, a substantial body of research about BP measurement in the ED suggests that we may have included some persons who likely did not have AH. For example, Pitts and Adams described a regression to the mean phenomenon, with serial BP measurements in the ED, wherein the BP fell by approximately 11 mmHg over 4 hours.20 Baumann and colleagues reported a similar pattern.21 However, the findings of these 2 analyses do not necessarily apply to our study population; we focused on patients admitted to the hospital with an acute condition, while Pitts and Adams20 and Baumann et al.21 examined all ED patients. This distinction is crucial in that patients not admitted are likely less severely ill and systematically different from those who do merit hospitalization. Moreover, both Pitts and Adams20 and Cienki et al.22 observed that the regression to the mean and fall in serial BP measurements were less pronounced in those with the most extensive BP elevations. In our study, we found the strongest relationship between adverse outcomes and BP in patients with the most extreme BP elevations. Thus, misclassification is perhaps less likely to be an issue for these subjects.

In addition, misclassification may result when initially elevated BP simply represents the impact of untreated pain or anxiety in ED patients. However, Backer et al.23 and Tanabe and colleagues24 specifically explored the impact of pain and anxiety on BP in ED subjects, and neither group found a correlation between BP and either acute pain and/or anxiety scores. Our difficulties with case definitions and BP measurements for severe AH demonstrate the need for the creation and adoption of a formal, systematic approach to this syndrome, along with the need for prospective analyses to confirm our findings.

Selection bias represents a second potential threat to validity in our observational study, although this bias is mitigated by including all consecutive acute inpatient admissions to the participating hospitals. Furthermore, inclusion of the 9% of patients who had only 1 ED measurement of SBP collected did not alter the estimate of severe AH prevalence or associated outcomes.

Third, confounding may introduce the potential for false associations derived from observational data. The large sample size of our cohort allowed us to address this concern by adjusting for a large array of confounders. In addition, unlike other large‐scale population‐based studies which typically rely on administrative ICD‐9‐CM codes for risk adjustment, our analysis incorporated actual physiologic and laboratory results measured on admission, as well as a validated severity‐of‐illness scoring system for risk adjustment.12, 13

Although both SBP and diastolic blood pressure (DBP) thresholds are included in traditional definitions of hypertension, selecting SBP as the primary measure is reasonable because SBP >180 mmHg is a more important risk factor for cardiovascular disease than elevated DBP.25 Previous studies reported the relationship between the trend of SBP over time and clinical outcomes,26, 27 but we were not able to investigate the relationship of SBP trend and outcomes because the BP measurements in the our study were not collected in predefined intervals.

It would be ideal if serial blood pressure measures were to be collected at pre‐specified intervals and if more sophisticated schemas were to be used to refine the AH definition. This type of study may be possible in the future when vital signs can be collected automatically with advanced technology. Likewise, electronically captured treatment data could further help researchers to study the impact of process‐of‐care variables, including medications and other management strategies, in relation to outcomes. Finally, outpatient management of chronic hypertension is an integral part of clinical management. Unfortunately, these types of data are not available in our existing database. These limitations notwithstanding, an in‐depth understanding of the association between severe AH and potential adverse clinical and economic outcomes may direct further research in this field.

CONCLUSION

Severe AH appears common and its prevalence varies by underlying clinical condition in patients admitted from the ED. In those with acute neurologic syndromes, the degree of blood pressure elevation correlated with mortality, need for MV, and longer LOS. For many other conditions, elevation of blood pressure appeared to be linked to an increased need for MV and a prolongation in LOS. Future studies are needed to examine the potential impact of both 1) improved long‐term outpatient BP management, and 2) optimal management of severe AH upon admission on improving outcomes of patients hospitalized from the ED with severe AH.

Chronic hypertension affects 32% of adults in the United States.1 Each year, over 20 million emergency department visits involve hypertension.2 While many studies describe the epidemiology and outcomes of chronic hypertension, less is known about severe acute hypertension (AH). Often classified as either hypertensive urgency or emergency, it receives little attention in national treatment guidelines.3 There is a limited understanding of the epidemiology of, and the relationship between, this syndrome and patient outcomes among hospitalized patients. One registry study suggested that severe AH was associated with high rates of new organ damage, need for treatment in the intensive care unit, and a 90‐day readmission rate of 10%.4 This investigation, however, lacked generalizability, because it only enrolled subjects requiring therapy with an intravenous antihypertensive agent and did not provide information on the prevalence of severe AH. Qureshi et al.5 analyzed information in a more representative sample from the national hospital ambulatory care survey, however, the only outcome examined was the correlation between acute blood pressure and stroke. Studies focusing on a selected patient population may be of limited value to hospitalists, because they are commonly required to treat a range of patients presenting to the hospital.

In light of severe syndromes that may be associated with, or complicated by, severe AH presented early during acute care, hospitalists require a better understanding of the prevalence and the relationship between severe AH and attendant mortality and morbidity. In addition, an assessment of the association of severe AH on the need for intensive care unit (ICU) admission and mechanical ventilation (MV) may aid the initial treatment assessments and triage decisions required of hospitalists.

Our objective was to describe the prevalence and implications of severe AH present at the time of evaluation in the ED among patients eventually hospitalized, using clinical data collected on all consecutive admissions across a range of clinical conditions. We sought to determine the independent contribution, if any, of severe AH to hospital mortality, need for MV on admission, as well as hospital length of stay (LOS).

METHODS

Study Design and Setting

This was a retrospective analysis of adults admitted to 114 acute‐care hospitals in the United States from 2005 through 2007. The New England Institutional Review Board/Human Subjects Research Committee (Wellesley, MA) reviewed and approved this study. It was conducted in compliance with the Health Insurance Portability and Accountability Act (HIPAA).

Data

Data were obtained from one of the Clinical Research Databases from CareFusion (formerly Cardinal Health [CareFusion Clinical Research Services, Marlborough, MA]).613 The database contains electronically imported or manually extracted demographic, clinical (eg, comorbidities, vital signs, laboratory values, other clinical findings), and administrative data (eg, diagnosis, procedures, and length of hospitalization). All vital signs were manually extracted, including the highest and the lowest ED systolic blood pressure (SBP) measurements during the ED stay, but before inpatient admission. Patients admitted for childbirth or mental health reasons were not included.

Patients

Our main analysis focused on patients whose highest and lowest SBP were collected in the ED. These patients accounted for approximately 90% of all inpatients admitted through the ED. For the approximately 9% of patients who had only 1 SBP collected, we conducted a sensitivity analysis by both including and excluding them in the main analysis to determine if the absence of a second SBP measurement altered our findings. Patients were grouped into 1 of the following 8 mutually exclusive strata based on the maximum SBP (mmHg) in the ED: <100, 101‐139, 140‐180, 181‐190, 191‐200, 201‐210, 211‐220, and >220.

Measures

The primary exposure of interest was the prevalence of severe AH, defined as at least 1 SBP measurement recorded in the ED in excess of 180 mmHg. Outcome measures included in‐hospital mortality, need for MV on admission day (defined by International Classification of Diseases, 9th revision, Clinical Modification [ICD‐9‐CM] procedure codes of 96.70, 96.71, and 96.72), and LOS. We stratified these outcomes for each inpatient admission according to 1 of 112 mutually exclusive groups of principal diagnoses (see Supporting Appendix A in the online version of this article). To simplify the presentations, we pooled the groups into 9 major disease categories based on organ systems.

Primary Data Analysis

All statistical analyses were performed using Statistical Analysis Software (SAS version 9.01; SAS Institute Inc, Cary, NC). For evaluating trending, we used the Cochran‐Armitage test for dichotomous variables (mortality and MV), and linear regression for continuous variable (LOS). We employed a logistic regression model to estimate risk of mortality and need for MV on admission. We used linear regression models to estimate the LOS associated with severe AH. We modeled each outcome as a function of patient disease severity and SBP strata. Because patients with the most severe AH tended to have higher mortality early in hospitalization, our analysis of LOS was limited to patients who survived index hospitalization.

The original disease‐specific risk‐adjustment models accounting for patient‐level confounding risk factors, including demographics, physiologic presentation on admission (vital signs, altered mental status, and laboratory findings), and chronic conditions, were previously developed and validated.12, 13 We recalibrated each of the 112 models, for the current study cohort, using the logit of predicted probability of death generated from the mortality risk‐adjustment model as a propensity score of disease severity. Using this propensity score as an aggregate severity adjuster, we refit 9 logistic regression models (1 for each major disease category) to estimate the odds ratios for mortality or need for MV for each of the 7 SBP strata in the regression models with 101‐139 mmHg as the reference group. To estimate the attributable LOS (if any) of severe AH among survivors, we fit the 9 LOS models using log transformed LOS (to normalize the potentially skewed distribution of LOS) as the outcome, controlling for disease severity. The attributable LOS and 95% confidence intervals (CI) were estimated from 1000 bootstrap iterations, with the median as the parameter estimate and 2.5th and 97.5th percentile as 95% CI.14, 15

Sensitivity Analysis

To address potential bias of LOS associated with inpatient mortality, we refit 9 LOS models, including both patients who died and those who survived the index hospitalization. The models adjusted for disease severity, mortality, and the interaction of severity and mortality. Because patients with only 1 SBP recorded at ED may be different from those with more than 1 SBP recorded, we conducted analysis by adding these patients in the study cohort to examine the potential change of overall prevalence of AH and associated mortality for the study population.

To address the potential for a center‐specific effect on outcomes, we refit all the models using a mixed model approach.16 The mixed model accounts for both patient‐level risk factors and hospital‐specific effects on the observed outcomes.

RESULTS

Patient Characteristics

The study cohort was comprised of 1,290,804 adults who were admitted through the ED, from 2005 through 2007, and whose highest and lowest SBP measurements were collected in the ED. Median age was 69 years (interquartile range, 53‐81) for the overall population. Median age was 74 (interquartile range, 60‐83) for patients with severe AH (Table 1). Hospital mortality was 3.6% (n = 46,033), with 6119 (13.3%) having severe AH.

Patient Characteristics
CharacteristicPrevalence, n (Column %)Severe Acute Hypertension, n (Row %)
Total number of discharges1,290,804 (100.0)178,197 (13.8)
Mortality46,033 (3.6)6,119 (13.3)
Live discharges1,244,771 (96.4)172,078 (13.8)
Mechanical ventilation on admission39,238 (3.0)9,508 (24.2)
Demographics  
Age, median (1st, 3rd quartiles)69 (53, 81)74 (60, 83)
Male587,553 (45.5)71,085 (12.1)
Female703,244 (54.5)107,109 (15.2)
Race  
White949,869 (73.6)121,930 (12.8)
Black220,601 (17.1)39,667 (18.0)
Other120,334 (9.3)16,600 (13.8)
Insurance  
Medicare668,420 (51.8)105,078 (15.7)
Medicaid108,538 (8.4)12,259 (11.3)
Commercial163,858 (12.7)18,669 (11.4)
Other349,988 (27.1)42,191 (12.1)
Disease system by the principal diagnosis  
Nervous system76,744 (5.9)22,270 (29.0)
Respiratory system222,329 (17.2)24,678 (11.1)
Circulatory system416,847 (32.3)66,852 (16.0)
Digestive system186,282 (14.4)17,817 (9.6)
Hepatobiliary/pancreas system52,293 (4.1)5,664 (10.8)
Endocrine system45,050 (3.5)6,625 (14.7)
Kidney/urinary system81,782 (6.3)11,050 (13.5)
Infectious diseases60,353 (4.7)4,162 (6.9)
Other149,124 (11.6)19,079 (12.8)
Comorbidity by secondary diagnoses  
Hypertension729,417 (56.5)135,498 (18.6)
Fluid and electrolyte disorders306,666 (23.8)37,836 (12.3)
Diabetes without chronic complications286,912 (22.2)47,979 (16.7)
Chronic pulmonary disease283,895 (22.0)35,977 (12.7)
Congestive heart failure213,523 (16.5)33,956 (15.9)
Deficiency anemias210,230 (16.3)30,266 (14.4)
Renal failure159,409 (12.3)31,984 (20.1)
Hypothyroidism153,911 (11.9)22,441 (14.6)
Valvular disease140,820 (10.9)21,453 (15.2)
Depression137,259 (10.6)16,886 (12.3)
Other neurological disorders126,954 (9.8)19,103 (15.0)
Peripheral vascular disease88,321 (6.8)16,180 (18.3)
Obesity84,000 (6.5)12,351 (14.7)
Diabetes with chronic complications65,989 (5.1)13,093 (19.8)
Psychoses54,769 (4.2)5,555 (10.1)
Alcohol abuse51,765 (4.0)6,014 (11.6)
Pulmonary circulation disease49,248 (3.8)7,128 (14.5)
Coagulopathy43,584 (3.4)4,339 (10.0)
Paralysis42,128 (3.3)8,125 (19.3)
Drug abuse36,134 (2.8)4,779 (13.2)
Liver disease36,094 (2.8)3,218 (8.9)
Weight loss35,795 (2.8)3,726 (10.4)
Metastatic cancer33,517 (2.6)2,498 (7.5)
Rheumatoid arthritis32,545 (2.5)4,300 (13.2)
Solid tumor without metastasis30,677 (2.4)3,035 (9.9)
Chronic blood loss anemia25,416 (2.0)2,268 (8.9)
Lymphoma9,972 (0.8)871 (8.7)
Acquired immune deficiency syndrome3,048 (0.2)307 (10.1)
Peptic ulcer disease915 (0.1)131 (14.3)
Discharges by hospital characteristics  
Teaching status  
Teaching hospitals899,786 (69.7)127,512 (14.2)
Nonteaching hospitals391,018 (30.3)50,685 (13.0)
Urban status  
Urban hospitals1,164,802 (90.2)162,399 (13.9)
Rural hospitals126,002 (9.8)15,798 (12.5)
Bed size  
Beds <10036,624 (2.8)4,965 (13.6)
Beds 100‐300623,327 (48.3)80,156 (12.9)
Beds >300630,853 (48.9)93,076 (14.8)

Prevalence of Acute Hypertension

A total of 763,634 (59.2%) patients had at least 1 SBP measurement of 140 mmHg during the ED stay, including 178,197 (13.8%) with SBP >180 mmHg. Body systems associated with the highest prevalence of severe AH (SBP >180 mmHg) were nervous (29.0%), circulatory (16.0%), endocrine (14.7%), and kidney/urinary (13.5%) (Figure 1 presents the data in graphic form; Supporting Appendix B, in the online version of this article, presents corresponding data in table form).

Figure 1
Prevalence of acute hypertension at emergency department by major disease category.

Mortality

Univariable analysis revealed a graded relationship between SBP stratum and mortality risk (Figure 2a; and see Supporting Appendix C in the online version of this article). This relationship was most pronounced for nervous system diseases; mortality rates for each 10 mmHg increase in SBP from 180 to >220 mmHg were 6.5%, 8.1%, 10.0%, 12.0%, and 19.7%, respectively (trending P < 0.0001). The risk‐adjusted increase in mortality odds ratio ranged from 1.04 (95% CI: 0.89, 1.21) to 1.44 (95% CI: 1.25, 1.67) for patients in the severe AH strata compared to patients with SBP of 101 to 139 mmHg (Figure 3). Severe AH was not an independent mortality predictor in other disease categories.

Figure 2
Unadjusted mortality rate (a), mechanical ventilation rate (b), and length of stay (c) by blood pressure level and major disease category.
Figure 3
Adjusted mortality odds ratio (95% confidence interval) by major disease category with 101‐139 mmHg as the reference.

Mechanical Ventilation on Admission

Univariable analysis revealed a graded relationship between severe AH and a need for MV on admission, especially for respiratory, circulatory, and infectious conditions (trending P < 0.0001) (Figure 2b; and see Supporting Appendix C in the online version of this article). In the multivariable analysis, there was a relationship between severe AH stratum and adjusted risk for MV on admission across nearly all disease categories (Figure 4).

Figure 4
Adjusted mechanical ventilation on admission odds ratio (95% confidence interval) by major disease category with 101‐139 mmHg as the reference.

Length of Stay

Univariable analysis revealed a graded relationship between severe AH strata and LOS for nearly all disease categories in survivors (trending P < 0.0001), except for digestive, kidney, and infectious diseases (Figure 2c; and see Supporting Appendix C in the online version of this article). For patients with nervous system diseases, the unadjusted LOS for each 10 mmHg increase in SBP from 180 to >220 was 5.8, 6.1, 6.4, 6.8, and 8.0 days, respectively (trending P < 0.0001). The relationship was similar for other disease categories which showed significant trending.

In the multivariable analysis, the relationship between severe AH strata and adjusted attributable LOS was graded across most disease categories, especially nervous, circulatory, and hepatobiliary diseases (Figure 5). The total adjusted number of hospital days attributable to severe AH was 0.43 days per case for all survivors with severe AH.

Figure 5
Adjusted attributable length of stay (days) and 95% confidence intervals for survivors by major disease category with 101‐139 mmHg as the reference.

Sensitivity Analysis

Our sensitivity analysis of the LOS estimate, including those patients who died in the hospital, yielded similar findings in attributable LOS due to severe AH. In addition, when we added patients with only 1 SBP documented in the ED to the study cohort, the severe AH prevalence changed negligibly from 13.8% to 13.0%, and the associated mortality remained unchanged at 3.4%. Models using the mix model approach, which take into account hospital‐specific effects, showed similar results.

DISCUSSION

This large‐scale analysis demonstrated that severe AH was present in 13.8% of inpatients admitted through the ED. The prevalence of severe AH varied based on the primary reason for an acute care admission, ranging from 7% in infectious syndromes to nearly 30% in acute neurologic processes. Specific to patients with neurologic disease, initial severe blood pressure elevations independently correlated with mortality. Severe blood pressure elevations at ED were independently associated with an increased need for MV on admission and a prolonged LOS across a range of disease states.

Prior work on hypertension at admission has generally included single‐center analyses or only focused on patients with specific admitting diagnoses. For example, in a single ED analysis, Tilman et al.17 reported that 16% of 10,000 patients presented with elevated blood pressure (140/90 mmHg). In a multicenter review of 7000 persons, Karras et al.18, 19 described 423 patients with severe AH (180/110 mmHg) who comprised 6% of patients seen in the ED during a 1‐week period. Qureshi et al.5 noted severe AH in 13% of patients with acute stroke. While other ED‐based studies examined all ED patients, including those admitted and discharged from the ED, our study focused on those requiring hospitalization. This disparity in illness severity may, in part, explain the higher prevalence of severe AH we noted relative to others.

We further found that the prevalence of severe AH varied based on admitting diagnosis. This difference in prevalence rates by condition seems clinically plausible. Recognition of this pattern may prove valuable to hospitalists who, by the nature of their responsibilities, will encounter a broad range of patients. Because our data were derived from the largest analysis of blood pressure assessments for ED patients who were eventually hospitalized, and encompassed a multiplicity of hospitals, our findings are likely generalizable. Moreover, our large sample size enabled us to examine severe AH at each 10 mmHg increment across a variety of disease states, rather than restricting our analysis to 1 admitting diagnosis.

The independent relationship between severe blood pressure elevation and mortality was detected only in those with neurologic conditions. Incremental increases in SBP beyond 180 mmHg were associated with a stepwise escalation in the risk for death. Although recognition of the importance of blood pressure management in both ischemic and hemorrhagic stroke remains a cornerstone of therapy for these diseases, the stepwise relationship between escalating blood pressure and outcome suggests that further study is needed to determine the optimal management of severe AH among these patients. This relationship, along with the independent association between severe AH at presentation and the need for MV, underscores the importance of severe AH in critical care, representing a major challenge for intensivists and hospitalists, particularly those who practice in neurologic ICUs.

The independent association of severe AH and prolonged LOS represents a novel finding. Few reports have correlated the initial blood pressure with measures of resource use. Katz et al.4 found a median LOS of 6 days among 1000 patients who presented with severe AH and end organ dysfunction in 25 US hospitals. These investigators, however, did not explore the incremental independent contribution of initial blood pressure to LOS. Biologically, severe hypertension may exacerbate both acute and chronic conditions, thus complicating their management and resulting in longer hospitalizations.

Our analysis has limitations. While exposure misclassification is a potential concern, unlike other population‐based studies that use ICD‐9‐CM codes to identify AH cases, we relied on actual measures of blood pressure to identify subjects, thus minimizing this threat to validity. Similarly, since our end pointsmortality, MV on admission, and LOSwere also objective measures, the probability of their misclassification is minimal.

Another concerning contributor to exposure misclassification is the possibility that, in some instances, the initial elevation in BP meeting the inclusion criteria in our study cohort does not reflect the true BP. Indeed, a substantial body of research about BP measurement in the ED suggests that we may have included some persons who likely did not have AH. For example, Pitts and Adams described a regression to the mean phenomenon, with serial BP measurements in the ED, wherein the BP fell by approximately 11 mmHg over 4 hours.20 Baumann and colleagues reported a similar pattern.21 However, the findings of these 2 analyses do not necessarily apply to our study population; we focused on patients admitted to the hospital with an acute condition, while Pitts and Adams20 and Baumann et al.21 examined all ED patients. This distinction is crucial in that patients not admitted are likely less severely ill and systematically different from those who do merit hospitalization. Moreover, both Pitts and Adams20 and Cienki et al.22 observed that the regression to the mean and fall in serial BP measurements were less pronounced in those with the most extensive BP elevations. In our study, we found the strongest relationship between adverse outcomes and BP in patients with the most extreme BP elevations. Thus, misclassification is perhaps less likely to be an issue for these subjects.

In addition, misclassification may result when initially elevated BP simply represents the impact of untreated pain or anxiety in ED patients. However, Backer et al.23 and Tanabe and colleagues24 specifically explored the impact of pain and anxiety on BP in ED subjects, and neither group found a correlation between BP and either acute pain and/or anxiety scores. Our difficulties with case definitions and BP measurements for severe AH demonstrate the need for the creation and adoption of a formal, systematic approach to this syndrome, along with the need for prospective analyses to confirm our findings.

Selection bias represents a second potential threat to validity in our observational study, although this bias is mitigated by including all consecutive acute inpatient admissions to the participating hospitals. Furthermore, inclusion of the 9% of patients who had only 1 ED measurement of SBP collected did not alter the estimate of severe AH prevalence or associated outcomes.

Third, confounding may introduce the potential for false associations derived from observational data. The large sample size of our cohort allowed us to address this concern by adjusting for a large array of confounders. In addition, unlike other large‐scale population‐based studies which typically rely on administrative ICD‐9‐CM codes for risk adjustment, our analysis incorporated actual physiologic and laboratory results measured on admission, as well as a validated severity‐of‐illness scoring system for risk adjustment.12, 13

Although both SBP and diastolic blood pressure (DBP) thresholds are included in traditional definitions of hypertension, selecting SBP as the primary measure is reasonable because SBP >180 mmHg is a more important risk factor for cardiovascular disease than elevated DBP.25 Previous studies reported the relationship between the trend of SBP over time and clinical outcomes,26, 27 but we were not able to investigate the relationship of SBP trend and outcomes because the BP measurements in the our study were not collected in predefined intervals.

It would be ideal if serial blood pressure measures were to be collected at pre‐specified intervals and if more sophisticated schemas were to be used to refine the AH definition. This type of study may be possible in the future when vital signs can be collected automatically with advanced technology. Likewise, electronically captured treatment data could further help researchers to study the impact of process‐of‐care variables, including medications and other management strategies, in relation to outcomes. Finally, outpatient management of chronic hypertension is an integral part of clinical management. Unfortunately, these types of data are not available in our existing database. These limitations notwithstanding, an in‐depth understanding of the association between severe AH and potential adverse clinical and economic outcomes may direct further research in this field.

CONCLUSION

Severe AH appears common and its prevalence varies by underlying clinical condition in patients admitted from the ED. In those with acute neurologic syndromes, the degree of blood pressure elevation correlated with mortality, need for MV, and longer LOS. For many other conditions, elevation of blood pressure appeared to be linked to an increased need for MV and a prolongation in LOS. Future studies are needed to examine the potential impact of both 1) improved long‐term outpatient BP management, and 2) optimal management of severe AH upon admission on improving outcomes of patients hospitalized from the ED with severe AH.

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  21. Cienki JJ,DeLuca LA,Daniel N.The validity of emergency department triage blood pressure measurements.Acad Emerg Med.2004;11(3):237243.
  22. Backer HD,Decker L,Ackerson L.Reproducibility of increased blood pressure during an emergency department or urgent care visit.Ann Emerg Med.2003;41(4):507512.
  23. Tanabe P,Persell SD,Adams JG,McCormick JC,Martinovich Z,Baker DW.Increased blood pressure in the emergency department: pain, anxiety, or undiagnosed hypertension?Ann Emerg Med.2008;51(3):221229.
  24. Izzo JL,Levy D,Black HR.Clinical Advisory Statement. Importance of systolic blood pressure in older Americans.Hypertension.2000;35(5):10211024.
  25. Abboud H,Labreuche J,Plouin F,Amarenco P.High blood pressure in early acute stroke: a sign of a poor outcome?J Hypertens.2006;24(2):381386.
  26. Jensen MB,Yoo B,Clarke WR,Davis PH,Adams HR.Blood pressure as an independent prognostic factor in acute ischemic stroke.Can J Neurol Sci.2006;33(1):3438.
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  17. Karras DJ,Kruus LK,Cienki JJ, et al.Evaluation and treatment of patients with severely elevated blood pressure in academic emergency departments: a multicenter study.Ann Emerg Med.2006;47(3):230236.
  18. Karras DJ,Ufberg JW,Heilpern KL, et al.Elevated blood pressure in urban emergency department patients.Acad Emerg Med.2005;12(9):835843.
  19. Pitts SR,Adams RP.Emergency department hypertension and regression to the mean.Ann Emerg Med.1998;31(2):214218.
  20. Baumann BM,Abate NL,Cowan RM,Boudreaux ED.Differing prevalence estimates of elevated blood pressure in ED patients using 4 methods of categorization.Am J Emerg Med.2008;26(5):561565.
  21. Cienki JJ,DeLuca LA,Daniel N.The validity of emergency department triage blood pressure measurements.Acad Emerg Med.2004;11(3):237243.
  22. Backer HD,Decker L,Ackerson L.Reproducibility of increased blood pressure during an emergency department or urgent care visit.Ann Emerg Med.2003;41(4):507512.
  23. Tanabe P,Persell SD,Adams JG,McCormick JC,Martinovich Z,Baker DW.Increased blood pressure in the emergency department: pain, anxiety, or undiagnosed hypertension?Ann Emerg Med.2008;51(3):221229.
  24. Izzo JL,Levy D,Black HR.Clinical Advisory Statement. Importance of systolic blood pressure in older Americans.Hypertension.2000;35(5):10211024.
  25. Abboud H,Labreuche J,Plouin F,Amarenco P.High blood pressure in early acute stroke: a sign of a poor outcome?J Hypertens.2006;24(2):381386.
  26. Jensen MB,Yoo B,Clarke WR,Davis PH,Adams HR.Blood pressure as an independent prognostic factor in acute ischemic stroke.Can J Neurol Sci.2006;33(1):3438.
Issue
Journal of Hospital Medicine - 7(3)
Issue
Journal of Hospital Medicine - 7(3)
Page Number
203-210
Page Number
203-210
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Severe acute hypertension among inpatients admitted from the emergency department
Display Headline
Severe acute hypertension among inpatients admitted from the emergency department
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Pulmonary and Critical Care Medicine Service, Washington Hospital Center, Washington, DC 20010
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