This article is part of a series that illustrates strategies intended to redesign primary care education at the Veterans Health Administration (VHA), using interprofessional workplace learning. All have been implemented in the VA Centers of Excellence in Primary Care Education (CoEPCE). These models embody visionary transformation of clinical and educational environments that have potential for replication and dissemination throughout VA and other primary care clinical educational environments. For an introduction to the series see Klink K. Transforming primary care clinical learning environments to optimize education, outcomes, and satisfaction. Fed Pract. 2018;35(9):8-10.

Background

In 2011, 5 US Department of Veterans Affairs (VA) medical centers (VAMCs) were selected by the Office of Academic Affiliations (OAA) to establish CoEPCE. Part of the VA New Models of Care initiative, the 5 Centers of Excellence (CoE) in Boise, Idaho; Cleveland, Ohio; San Francisco, California; Seattle, Washington; and West Haven, Connecticut, are utilizing VA primary care settings to develop and test innovative approaches to prepare physician residents and students, advanced practice nurse residents and undergraduate nursing students, and other professions of health trainees (eg, pharmacy, social work, psychology, physician assistants [PAs]) for primary care practice in the 21st century.

The Boise CoE developed and implemented a practice-based learning model. Nurse practitioner (NP) students and residents, physician residents, pharmacy residents, psychology interns, and psychology postdoctoral fellows participate in a comprehensive curriculum and practice together for 1 to 3 years. The goal is to produce providers who are able to lead and practice health care in patient-centered primary care and rural care environments. All core curricula are interprofessionally coauthored and cotaught.¹

Methods

In 2015, OAA evaluators reviewed background documents and conducted open-ended interviews with 10 CoE staff, participating trainees, VA faculty, VA facility leadership, and affiliate faculty. In response to questions focused on their experiences, informants described lessons learned, challenges encountered, and benefits for participants, veterans, and the VA. Using a qualitative and quantitative approach, this case study draws on those interviews, surveys of PACT ICU (patient aligned care team interprofessional care update) participants, and analysis of presented patients to examine PACT ICU outcomes.

Related: Hypoglycemia Safety Initiative: Working With PACT Clinical Pharmacy Specialists to Individualize HbA1c Goals

Interprofessional Education and Care

A key CoEPCE aim is to create more clinical opportunities for CoE trainees from a variety of professions to work as a team in ways that anticipate and address the care needs of veterans. This emphasis on workplace learning is needed since most current health care professional education programs lack settings where trainees from different professions can learn and work together with their clinic partners to provide care for patients. With the emphasis on patient-centered medical homes (PCMH) and team-based care in the Affordable Care Act, there is an imperative to develop new training models that address this gap in the preparation of future health professionals. Along with this imperative, clinicians are increasingly required to optimize the health of complex patients who consequently require a multidisciplinary approach to care, particularly high-risk, high-needs patients inappropriately using services, such as frequent emergency department (ED) use.

Addressing Complex Needs

In 2010, the Boise VA Medical Center (VAMC) phased in patient aligned care teams (PACTs), the VA-mandated version of PCMH that consist of a physician or NP primary care provider (PCP), a registered nurse (RN) care manager, a licensed vocational nurse (LVN), and a medical support assistant (MSA). 

The PACT ICU also serves as a venue in which trainees and supervisors from different professions use a patient-centered framework to collaborate on these specific patient cases. The PACT ICU is easily applied to a range of health conditions, such as diabetes mellitus (DM), mental and behavioral health, lack of social support, and delivery system issues, such as ED use. The goals of PACT ICU are to improve the quality and satisfaction of patient care for high-risk patients; encourage appropriate use of health care resources by prioritizing continuity with the PACT team; and enhance interprofessional PACT team function, decreasing PCP and staff stress.

Planning and Implementation

In January 2013, Boise VAMC and the Caldwell, Idaho community-based outpatient clinic (CBOC) implemented PACT ICU. Other nonteaching clinics followed later in the year. Planning and executing PACT ICU took about 10 hours of CoE staff time and required no change in Boise VAMC policy. Program leadership approval was necessary for participation of CoE residents and postdocs. Service-line leadership support was required to protect clinic staff time (nurse care manager, social workers, chaplaincy, and ethics service). At the Caldwell CBOC, the section chief approved the program, and it took about 1 month to initiate a similar version of PACT ICU.

Curriculum

PACT ICU is a workplace clinical activity with roots in the case conference model, specifically the EFECT model (Elicit the narrative of illness, Facilitate a group meeting, Evidence-based gap analysis, Care plan, and Track changes).³ PACT ICU emphasizes a patient-centered approach to developing care plans. Staff review the 5 highest risk patients who are identified by the VA Care Assessment Need (CAN) registry. The CAN is an analytic tool that is available throughout VA and estimates patients’ risk of mortality or hospitalization in the following 90 days. Physician and NP residents choose 1 of the 5 patients to discuss in PACT ICU, while the remaining 4 serve as case-control comparisons to examine long-term patient outcomes. All trainees, faculty, and staff are provided patient data that can be discussed on a secure website.

The PACT ICU combines didactic teaching with workplace learning. For example, the patient’s medical issues may lead to a formal presentation about a topic, such as secondary stroke medication prophylaxis. The workplace learning occurs as the trainees observe and participate in the decision making toward a treatment plan. Interprofessional interactions are role-modeled by clinical faculty and staff during these discussions, and the result impact the patients care. PACT ICU embodies the core domains that shape the CoEPCE curriculum: Interprofessional collaboration (IPC), performance improvement (PI), sustained relationships (SR), and shared decision making (SDM) (Table 1). 

There have been some changes to the PACT ICU model over time. Initially, conferences took place on a weekly basis, to build momentum among the team and to normalize processes. After about 2 years, this decreased to every other week to reduce the time burden. Additionally, the CoE has strengthened the “tracking changes” component of the EFECT model—trainees now present a 5-minute update on the last patient they presented at the prior PACT ICU case conference. Most recently, psychology postdoctoral candidates have instituted preconference calls with patients to further improve the teams understanding of the patients’ perspective and narrative.

Related: Improving Team-Based Care Coordination Delivery and Documentation in the Health Record

Resources

The CoE faculty participate in an education program concerning facilitation of interprofessional meetings. All faculty are expected to role model collaborative behavior and mentor trainees on the cases they present.

The PACT ICU requires a room large enough to accommodate at least 12 people. One staff member is required to review patient cases prior to the case conferences (usually about 1 hour of preparation per case conference). Another staff person creates and shares a spreadsheet stored with VA-approved information security with data fields to include the site, PACT ICU date, patient identifier, the CAN score, and a checkbox for whether the patient was selected or part of a control group. Logistic support is required for reserving the room and sending information to presenters. A clinic-based RN with training in interprofessional care case management uses an online schedule to facilitate selection and review of patients. The RN care managers can use a secure management tool to track patient care and outreach.

The RN care manager also needs to be available to attend the PACT ICU case conferences. The Boise CoE built a website to share and standardize resources, such as a presenter schedule, PACT ICU worksheet, and provider questionnaire. (Contact Boise CoE staff for access.) For the initial evaluation of impact, PACT ICU utilized staff data support in the form of a data manager and biostatistician to identify, collect, and analyze data. While optional, this was helpful in refining the approach and demonstrating the impact of the project. Other resource-related requirements for exporting PACT ICU include:

• Staff members, usually RN care managers who coordinate meetings with participants and identify appropriate patients using a registry, such as CAN;
• Meeting facilitators who enforce use of the EFECT model and interprofessional participation to ensure that the interprofessional care plan is carried out by the presenting provider; and
• Interprofessional trainees and faculty who participate in PACT ICU and complete surveys after the first conference.

Monitoring and Assessment

The CoE staff have analyzed the evaluation of PACT ICU with participant self-evaluation, consultation referral patterns, and utilization data, combination of ED and episodic care visits along with hospitalizations).⁴ Pharmacy faculty are exploring the use polypharmacy registries, and psychology will use registries of poor psychosocial function.

Partnerships

Beyond support and engagement from VA CoEPCE and affiliate faculty, PACT ICU has greatly benefited from partnerships with VA facility department and CBOC leadership. The CoEPCE codirector and faculty are in facility committees, such as the PACT Strategic Planning Committee.

Academic affiliates are integral partners who assist with NP student and resident recruitment as well as participate in the planning and refinement of CoEPCE components. PACT ICU supports their mandate to encourage interprofessional teamwork. Faculty members from Gonzaga University (NP affiliate) were involved in the initial discussion on PACT ICU and consider it a “learning laboratory” to work through challenging problems. Gonzaga CoEPCE NP trainees are asked to talk about their PACT ICU experience—its strengths, weaknesses, and challenges—to other Gonzaga students who don’t have exposure to the team experience.

Challenges and Solutions

The demand for direct patient care puts pressure on indirect patient care approaches like PACT ICU, which is a time-intensive process with high impact on only a small number of patients. The argument for deploying strategies such as PACT ICU is that managing chronic conditions and encouraging appropriate use of services will improve outcomes for the highest risk patients and save important system resources in the long-run. However, in the short-term, a strong case must be made for the diversion of resources from usual clinic flow, particularly securing recurring blocks of provider time and clinic staff members. In addition, issues about team communication and understanding of appropriate team-based care can overflow to complex patients not presented in the PACT ICU conference.

Providing a facilitated interprofessional venue to discuss how to appropriately coordinate care improves the participation and perceived value of different team members. This approach has led to improved engagement of the team for patients discussed in the PACT ICU, as well as in general care within the participating clinic. With recent changes, the VA does see a workload benefit, and participants get encounter credit through “Non face-to-face prolonged service” codes (CPT 99358/99359), and other possibilities exist related to clinical team conference codes (CPT 99367-8) and complex chronic care management codes (CPT 99487-89). More information on documentation, scheduling and encountering/billing can be found at boisevacoe.org under Products. Other challenges include logistic challenges of finding appropriate patients and distributing sensitive patient information among the team. Additionally, PACT ICU has to wrestle with staffing shortages and episodic participation by some professions that are chronically understaffed. We have addressed many of these problems by receiving buy-in from both leadership and participants. Leadership have allowed time for participation in clinic staff schedules, and each participant has committed to recruiting a substitute in case of a schedule conflict.

Factors for Success

The commitment from the Boise VAMC facility, primary care clinic leadership and affiliated training programs to support staff and trainee participation also has been critical. Additionally, VA facility leadership commitment to ongoing improvements to PACT implementation was a key facilitating factor. Colocation of trainees and clinic staff on the academic PACT team facilitates communication between PACT ICU case conferences, while also supporting team dynamics and sustained relationships with patients. Many of these patients can and will typically seek care using the interdisciplinary trainees, and trainees were motivated to proactively coordinate warm handoffs and other models of transfer of care. PACT ICU has been successfully replicated and sustained at 4 of the 5 CoEPCE sites. The Caldwell CBOC PACT ICU has been up and running for 2 years, and 2 other nonacademic clinics have piloted PACT ICU managed care conferences thus far. Experience regarding the implementation at other academic sites has been published.⁵

Accomplishments and Benefits

There is evidence that PACT ICU is achieving its goals of improving trainee learning and patient outcomes. Trainees are using team skills to provide patient-centered care; trainees are strengthening their overall clinical skills by learning how to improve their responses to high-risk patients. There is also evidence of an increase in interprofessional warm handoffs within the clinic, in which “a clinician directly introduces a patient to another clinician at the time of the patient’s visit, and often a brief encounter between the patient and the health care professional occurs.”^4,6

Unlike a traditional didactic with classroom case conferences on interprofessional collaboration, PACT ICU is an opportunity for health care professionals to both learn and work together providing care in a clinic. Moreover, colocation of diverse trainee and faculty professions during the case conferences better prepares trainees to work with other professions and supports all participants to work and communicate as a team.

CoE staff have assessed educational outcomes before and after attendance in PACT ICU. On average, trainees (n = 30) said they found the PACT ICU case conferences to be “very helpful” in developing treatment plans. 

Interprofessional Collaboration

Team building and colocating trainees, faculty, and clinic staff from different professions are a primary focus of PACT ICU. The case conferences are designed to break down silos and foster a team approach to care. Trainees learn how the team works and the ways other professionals can help them take care of the patient. For example, trainees learn early about the contributions and expertise that the pharmacist and psychologist offer in terms of their scope of practice and referral opportunities. Additionally, the RN care manager increases the integration with the PACT clinical team by sharing pertinent information on individual patients. Based on recent trainee survey findings, the CoE has observed a positive change in the team dynamic and trainee ability to interface between professions. PACT ICU participants were more likely to make referrals to other members within the PACT team, such as a warm handoff during a clinic appointment, while they were less likely to seek a consult outside the team.⁷

Clinical Performance

The PACT ICU is an opportunity for a trainee to increase clinical expertise. It provides exposure to a variety of patientsand their care needs and serves as an opportunity to present a high-risk, challenging patient to colleagues of various professions. As of June 2018, 96 physician resident and NP residents have presented complex patient cases.

In addition, a structured forum for discussing patients and their care options strengthens team clinical performance, which supports people to work to the full scope of their practice. Trainees learn and apply team skills, such as communication and the warm handoff.

An interprofessional care plan that is delineated during the meeting supports the trainee and is carried out with help from consultants as needed. These consultants often facilitate plans for a covisit or warm handoff at the next clinic visit, a call from the RN care manager, a virtual clinic appointment, or other nontraditional visits. The clinic staff can get information from PCPs about patient’s plan of care, and PCPs get a more complete picture of a patient’s situation (eg, history, communications, and life-style factors). In addition, surveys of PACT ICU participants suggest the curriculum’s effectiveness at encouraging use of PACT principles within the clinic team and improving appropriate referrals to other members of the PACT team, such as pharmacy and behavioral health.

Patients presented at PACT ICU can be particularly challenging, so there may be a psychological benefit to working with a team to develop a new care plan. The PCPs who feel they are overwhelmed and have exhausted every option step back, get input, and look at the patient in a new light.

Related: Interprofessional Education in Patient Aligned Care Team Primary Care-Mental Health Integration

CoEPCE Function

The PACT ICU is flexible and has been adapted to different ambulatory care settings. Currently, PACT ICU case conferences take place at Boise VAMC, the Caldwell CBOCs, and more recently at a smaller CBOC in Burns, Oregon. The PACT ICU structure is slightly different in the clinic settings since the VA primary care clinic has different resources to draw upon, such as hospital and specialty services. The Caldwell CBOC was unable to protect time for PCPs, so it holds a monthly PACT ICU case conference. In addition to continuing expansion in other nonacademic PACT clinics and collaboration with other CoEPCE sites, work is underway to disseminate generalizable principles for interprofessional education, as well as exporting the model for implementation in non-VA settings.

Primary Care Services

The PACT ICU has the potential to create efficiencies in busy clinic settings. It strengthens communication between PCPs and is an opportunity to touch base on the patient, delegate care, and keep track of high-risk patients who might otherwise receive attention only when having an acute problem. Nurses gain a deeper understanding of the patients presented at PACT ICU.

PACT ICU leverages and builds on existing PACT resources in an achievable and sustainable manner benefiting primary care. CoE trainees, who are part of the Silver Team, tap in to the information that team nurses gain from checking in with these high-risk patients biweekly. Moreover, the integration with the Silver Team improves continuity, which helps enhance a patient’s level of trust. The relationship strengthened between primary care and behavioral health at the Caldwell CBOC, providing improved patient access and increased professional sharing.

Patient Outcomes

The PACT ICU provides a forum for input beyond that of the PCP. This feature results in a more robust treatment plan than might be developed by individual PCPs who might not have time to consider options that are outside their scope of practice. Formulating an enriched care plan, informed by multiple professions, has the potential to improve utilization and provide better care.

The Boise VAMC PACT ICU has presented 219 patients as of June 2018. While clinical outcomes data are difficult to collect, the CoE has data on utilization differences on all patients presented at the PACT ICU case conferences. This includes 4 control patients from the same PCP, with similarly high risk based on CAN scores at the time of selection. A single control patient is selected based on gender, closest age, and CAN score; this serves as a comparator for subsequent utilization analysis.

Data from the first 2 years of this study demonstrate that compared with the high-risk control group, there was an increase in contacts with PACT team members, including behavioral health, clinical pharmacists, and nurse care management, persisting up to 6 months following the PACT ICU presentation.⁴ However, PACT ICU participation did not increase the number of visits with the PCP, indicating better engagement with the entire team. Participation was associated with significantly decreased hospitalizations and a trend toward decreased ED visits. These findings persisted when compared with controls in the PCP’s panel with similar CAN scores, making “regression to the mean” often seen in these studies much less likely.

Analysis of patients early in the project suggests the possibility of improved glycemic control in patients with DM and improved blood pressure control in hypertensive patients presented at the PACT ICU compared with that of non-PACT ICU patients.⁸ Another potential benefit includes better team-based coordination. Because the patient now has a team focusing on care, this new dynamic results in improving outreach, identifying patients who could receive care by a telephone, and better preparing team members to establish rapport when the patient calls or comes in for a visit.

The Future

In stage 2 of the CoEPCE program, a multi-site trial of PACT ICU was completed to better understand which elements are critical to success, with the goal of facilitating broader exportability.⁵ The trial focused on 3 intertwined elements: structure, delivery, and evaluation. Using local implementation and the multisite trial, the most effective practices have been documented as part of an implementation kit, available at boisevacoe.org. The goal of the implementation kit is to facilitate step-by-step implementation of PACT ICU to other settings beyond the multisite study. Since the open-ended structure of PACT ICU enables accommodating different professions and specialties beyond the model’s Boise VAMC participants, it could be easily adapted to potentially support a variety of implementations elsewhere (Appendix).

Another opportunity for expansion is increased patient involvement. Currently, PACT ICU patients have the opportunity to review and ask questions about their multidisciplinary care plans before starting. 

This article is part of a series that illustrates strategies intended to redesign primary care education at the Veterans Health Administration (VHA), using interprofessional workplace learning. All have been implemented in the VA Centers of Excellence in Primary Care Education (CoEPCE). These models embody visionary transformation of clinical and educational environments that have potential for replication and dissemination throughout VA and other primary care clinical educational environments. For an introduction to the series see Klink K. Transforming primary care clinical learning environments to optimize education, outcomes, and satisfaction. Fed Pract. 2018;35(9):8-10.

Background

In 2011, 5 US Department of Veterans Affairs (VA) medical centers (VAMCs) were selected by the Office of Academic Affiliations (OAA) to establish CoEPCE. Part of the VA New Models of Care initiative, the 5 Centers of Excellence (CoE) in Boise, Idaho; Cleveland, Ohio; San Francisco, California; Seattle, Washington; and West Haven, Connecticut, are utilizing VA primary care settings to develop and test innovative approaches to prepare physician residents and students, advanced practice nurse residents and undergraduate nursing students, and other professions of health trainees (eg, pharmacy, social work, psychology, physician assistants [PAs]) for primary care practice in the 21st century.

The Boise CoE developed and implemented a practice-based learning model. Nurse practitioner (NP) students and residents, physician residents, pharmacy residents, psychology interns, and psychology postdoctoral fellows participate in a comprehensive curriculum and practice together for 1 to 3 years. The goal is to produce providers who are able to lead and practice health care in patient-centered primary care and rural care environments. All core curricula are interprofessionally coauthored and cotaught.¹

Methods

In 2015, OAA evaluators reviewed background documents and conducted open-ended interviews with 10 CoE staff, participating trainees, VA faculty, VA facility leadership, and affiliate faculty. In response to questions focused on their experiences, informants described lessons learned, challenges encountered, and benefits for participants, veterans, and the VA. Using a qualitative and quantitative approach, this case study draws on those interviews, surveys of PACT ICU (patient aligned care team interprofessional care update) participants, and analysis of presented patients to examine PACT ICU outcomes.

Related: Hypoglycemia Safety Initiative: Working With PACT Clinical Pharmacy Specialists to Individualize HbA1c Goals

Interprofessional Education and Care

A key CoEPCE aim is to create more clinical opportunities for CoE trainees from a variety of professions to work as a team in ways that anticipate and address the care needs of veterans. This emphasis on workplace learning is needed since most current health care professional education programs lack settings where trainees from different professions can learn and work together with their clinic partners to provide care for patients. With the emphasis on patient-centered medical homes (PCMH) and team-based care in the Affordable Care Act, there is an imperative to develop new training models that address this gap in the preparation of future health professionals. Along with this imperative, clinicians are increasingly required to optimize the health of complex patients who consequently require a multidisciplinary approach to care, particularly high-risk, high-needs patients inappropriately using services, such as frequent emergency department (ED) use.

Addressing Complex Needs

In 2010, the Boise VA Medical Center (VAMC) phased in patient aligned care teams (PACTs), the VA-mandated version of PCMH that consist of a physician or NP primary care provider (PCP), a registered nurse (RN) care manager, a licensed vocational nurse (LVN), and a medical support assistant (MSA). 

The PACT ICU also serves as a venue in which trainees and supervisors from different professions use a patient-centered framework to collaborate on these specific patient cases. The PACT ICU is easily applied to a range of health conditions, such as diabetes mellitus (DM), mental and behavioral health, lack of social support, and delivery system issues, such as ED use. The goals of PACT ICU are to improve the quality and satisfaction of patient care for high-risk patients; encourage appropriate use of health care resources by prioritizing continuity with the PACT team; and enhance interprofessional PACT team function, decreasing PCP and staff stress.

Planning and Implementation

In January 2013, Boise VAMC and the Caldwell, Idaho community-based outpatient clinic (CBOC) implemented PACT ICU. Other nonteaching clinics followed later in the year. Planning and executing PACT ICU took about 10 hours of CoE staff time and required no change in Boise VAMC policy. Program leadership approval was necessary for participation of CoE residents and postdocs. Service-line leadership support was required to protect clinic staff time (nurse care manager, social workers, chaplaincy, and ethics service). At the Caldwell CBOC, the section chief approved the program, and it took about 1 month to initiate a similar version of PACT ICU.

Curriculum

PACT ICU is a workplace clinical activity with roots in the case conference model, specifically the EFECT model (Elicit the narrative of illness, Facilitate a group meeting, Evidence-based gap analysis, Care plan, and Track changes).³ PACT ICU emphasizes a patient-centered approach to developing care plans. Staff review the 5 highest risk patients who are identified by the VA Care Assessment Need (CAN) registry. The CAN is an analytic tool that is available throughout VA and estimates patients’ risk of mortality or hospitalization in the following 90 days. Physician and NP residents choose 1 of the 5 patients to discuss in PACT ICU, while the remaining 4 serve as case-control comparisons to examine long-term patient outcomes. All trainees, faculty, and staff are provided patient data that can be discussed on a secure website.

The PACT ICU combines didactic teaching with workplace learning. For example, the patient’s medical issues may lead to a formal presentation about a topic, such as secondary stroke medication prophylaxis. The workplace learning occurs as the trainees observe and participate in the decision making toward a treatment plan. Interprofessional interactions are role-modeled by clinical faculty and staff during these discussions, and the result impact the patients care. PACT ICU embodies the core domains that shape the CoEPCE curriculum: Interprofessional collaboration (IPC), performance improvement (PI), sustained relationships (SR), and shared decision making (SDM) (Table 1). 

There have been some changes to the PACT ICU model over time. Initially, conferences took place on a weekly basis, to build momentum among the team and to normalize processes. After about 2 years, this decreased to every other week to reduce the time burden. Additionally, the CoE has strengthened the “tracking changes” component of the EFECT model—trainees now present a 5-minute update on the last patient they presented at the prior PACT ICU case conference. Most recently, psychology postdoctoral candidates have instituted preconference calls with patients to further improve the teams understanding of the patients’ perspective and narrative.

Related: Improving Team-Based Care Coordination Delivery and Documentation in the Health Record

Resources

The CoE faculty participate in an education program concerning facilitation of interprofessional meetings. All faculty are expected to role model collaborative behavior and mentor trainees on the cases they present.

The PACT ICU requires a room large enough to accommodate at least 12 people. One staff member is required to review patient cases prior to the case conferences (usually about 1 hour of preparation per case conference). Another staff person creates and shares a spreadsheet stored with VA-approved information security with data fields to include the site, PACT ICU date, patient identifier, the CAN score, and a checkbox for whether the patient was selected or part of a control group. Logistic support is required for reserving the room and sending information to presenters. A clinic-based RN with training in interprofessional care case management uses an online schedule to facilitate selection and review of patients. The RN care managers can use a secure management tool to track patient care and outreach.

The RN care manager also needs to be available to attend the PACT ICU case conferences. The Boise CoE built a website to share and standardize resources, such as a presenter schedule, PACT ICU worksheet, and provider questionnaire. (Contact Boise CoE staff for access.) For the initial evaluation of impact, PACT ICU utilized staff data support in the form of a data manager and biostatistician to identify, collect, and analyze data. While optional, this was helpful in refining the approach and demonstrating the impact of the project. Other resource-related requirements for exporting PACT ICU include:

• Staff members, usually RN care managers who coordinate meetings with participants and identify appropriate patients using a registry, such as CAN;
• Meeting facilitators who enforce use of the EFECT model and interprofessional participation to ensure that the interprofessional care plan is carried out by the presenting provider; and
• Interprofessional trainees and faculty who participate in PACT ICU and complete surveys after the first conference.

Monitoring and Assessment

The CoE staff have analyzed the evaluation of PACT ICU with participant self-evaluation, consultation referral patterns, and utilization data, combination of ED and episodic care visits along with hospitalizations).⁴ Pharmacy faculty are exploring the use polypharmacy registries, and psychology will use registries of poor psychosocial function.

Partnerships

Beyond support and engagement from VA CoEPCE and affiliate faculty, PACT ICU has greatly benefited from partnerships with VA facility department and CBOC leadership. The CoEPCE codirector and faculty are in facility committees, such as the PACT Strategic Planning Committee.

Academic affiliates are integral partners who assist with NP student and resident recruitment as well as participate in the planning and refinement of CoEPCE components. PACT ICU supports their mandate to encourage interprofessional teamwork. Faculty members from Gonzaga University (NP affiliate) were involved in the initial discussion on PACT ICU and consider it a “learning laboratory” to work through challenging problems. Gonzaga CoEPCE NP trainees are asked to talk about their PACT ICU experience—its strengths, weaknesses, and challenges—to other Gonzaga students who don’t have exposure to the team experience.

Challenges and Solutions

The demand for direct patient care puts pressure on indirect patient care approaches like PACT ICU, which is a time-intensive process with high impact on only a small number of patients. The argument for deploying strategies such as PACT ICU is that managing chronic conditions and encouraging appropriate use of services will improve outcomes for the highest risk patients and save important system resources in the long-run. However, in the short-term, a strong case must be made for the diversion of resources from usual clinic flow, particularly securing recurring blocks of provider time and clinic staff members. In addition, issues about team communication and understanding of appropriate team-based care can overflow to complex patients not presented in the PACT ICU conference.

Providing a facilitated interprofessional venue to discuss how to appropriately coordinate care improves the participation and perceived value of different team members. This approach has led to improved engagement of the team for patients discussed in the PACT ICU, as well as in general care within the participating clinic. With recent changes, the VA does see a workload benefit, and participants get encounter credit through “Non face-to-face prolonged service” codes (CPT 99358/99359), and other possibilities exist related to clinical team conference codes (CPT 99367-8) and complex chronic care management codes (CPT 99487-89). More information on documentation, scheduling and encountering/billing can be found at boisevacoe.org under Products. Other challenges include logistic challenges of finding appropriate patients and distributing sensitive patient information among the team. Additionally, PACT ICU has to wrestle with staffing shortages and episodic participation by some professions that are chronically understaffed. We have addressed many of these problems by receiving buy-in from both leadership and participants. Leadership have allowed time for participation in clinic staff schedules, and each participant has committed to recruiting a substitute in case of a schedule conflict.

Factors for Success

The commitment from the Boise VAMC facility, primary care clinic leadership and affiliated training programs to support staff and trainee participation also has been critical. Additionally, VA facility leadership commitment to ongoing improvements to PACT implementation was a key facilitating factor. Colocation of trainees and clinic staff on the academic PACT team facilitates communication between PACT ICU case conferences, while also supporting team dynamics and sustained relationships with patients. Many of these patients can and will typically seek care using the interdisciplinary trainees, and trainees were motivated to proactively coordinate warm handoffs and other models of transfer of care. PACT ICU has been successfully replicated and sustained at 4 of the 5 CoEPCE sites. The Caldwell CBOC PACT ICU has been up and running for 2 years, and 2 other nonacademic clinics have piloted PACT ICU managed care conferences thus far. Experience regarding the implementation at other academic sites has been published.⁵

Accomplishments and Benefits

There is evidence that PACT ICU is achieving its goals of improving trainee learning and patient outcomes. Trainees are using team skills to provide patient-centered care; trainees are strengthening their overall clinical skills by learning how to improve their responses to high-risk patients. There is also evidence of an increase in interprofessional warm handoffs within the clinic, in which “a clinician directly introduces a patient to another clinician at the time of the patient’s visit, and often a brief encounter between the patient and the health care professional occurs.”^4,6

Unlike a traditional didactic with classroom case conferences on interprofessional collaboration, PACT ICU is an opportunity for health care professionals to both learn and work together providing care in a clinic. Moreover, colocation of diverse trainee and faculty professions during the case conferences better prepares trainees to work with other professions and supports all participants to work and communicate as a team.

CoE staff have assessed educational outcomes before and after attendance in PACT ICU. On average, trainees (n = 30) said they found the PACT ICU case conferences to be “very helpful” in developing treatment plans. 

Interprofessional Collaboration

Team building and colocating trainees, faculty, and clinic staff from different professions are a primary focus of PACT ICU. The case conferences are designed to break down silos and foster a team approach to care. Trainees learn how the team works and the ways other professionals can help them take care of the patient. For example, trainees learn early about the contributions and expertise that the pharmacist and psychologist offer in terms of their scope of practice and referral opportunities. Additionally, the RN care manager increases the integration with the PACT clinical team by sharing pertinent information on individual patients. Based on recent trainee survey findings, the CoE has observed a positive change in the team dynamic and trainee ability to interface between professions. PACT ICU participants were more likely to make referrals to other members within the PACT team, such as a warm handoff during a clinic appointment, while they were less likely to seek a consult outside the team.⁷

Clinical Performance

The PACT ICU is an opportunity for a trainee to increase clinical expertise. It provides exposure to a variety of patientsand their care needs and serves as an opportunity to present a high-risk, challenging patient to colleagues of various professions. As of June 2018, 96 physician resident and NP residents have presented complex patient cases.

In addition, a structured forum for discussing patients and their care options strengthens team clinical performance, which supports people to work to the full scope of their practice. Trainees learn and apply team skills, such as communication and the warm handoff.

An interprofessional care plan that is delineated during the meeting supports the trainee and is carried out with help from consultants as needed. These consultants often facilitate plans for a covisit or warm handoff at the next clinic visit, a call from the RN care manager, a virtual clinic appointment, or other nontraditional visits. The clinic staff can get information from PCPs about patient’s plan of care, and PCPs get a more complete picture of a patient’s situation (eg, history, communications, and life-style factors). In addition, surveys of PACT ICU participants suggest the curriculum’s effectiveness at encouraging use of PACT principles within the clinic team and improving appropriate referrals to other members of the PACT team, such as pharmacy and behavioral health.

Patients presented at PACT ICU can be particularly challenging, so there may be a psychological benefit to working with a team to develop a new care plan. The PCPs who feel they are overwhelmed and have exhausted every option step back, get input, and look at the patient in a new light.

Related: Interprofessional Education in Patient Aligned Care Team Primary Care-Mental Health Integration

CoEPCE Function

The PACT ICU is flexible and has been adapted to different ambulatory care settings. Currently, PACT ICU case conferences take place at Boise VAMC, the Caldwell CBOCs, and more recently at a smaller CBOC in Burns, Oregon. The PACT ICU structure is slightly different in the clinic settings since the VA primary care clinic has different resources to draw upon, such as hospital and specialty services. The Caldwell CBOC was unable to protect time for PCPs, so it holds a monthly PACT ICU case conference. In addition to continuing expansion in other nonacademic PACT clinics and collaboration with other CoEPCE sites, work is underway to disseminate generalizable principles for interprofessional education, as well as exporting the model for implementation in non-VA settings.

Primary Care Services

The PACT ICU has the potential to create efficiencies in busy clinic settings. It strengthens communication between PCPs and is an opportunity to touch base on the patient, delegate care, and keep track of high-risk patients who might otherwise receive attention only when having an acute problem. Nurses gain a deeper understanding of the patients presented at PACT ICU.

PACT ICU leverages and builds on existing PACT resources in an achievable and sustainable manner benefiting primary care. CoE trainees, who are part of the Silver Team, tap in to the information that team nurses gain from checking in with these high-risk patients biweekly. Moreover, the integration with the Silver Team improves continuity, which helps enhance a patient’s level of trust. The relationship strengthened between primary care and behavioral health at the Caldwell CBOC, providing improved patient access and increased professional sharing.

Patient Outcomes

The PACT ICU provides a forum for input beyond that of the PCP. This feature results in a more robust treatment plan than might be developed by individual PCPs who might not have time to consider options that are outside their scope of practice. Formulating an enriched care plan, informed by multiple professions, has the potential to improve utilization and provide better care.

The Boise VAMC PACT ICU has presented 219 patients as of June 2018. While clinical outcomes data are difficult to collect, the CoE has data on utilization differences on all patients presented at the PACT ICU case conferences. This includes 4 control patients from the same PCP, with similarly high risk based on CAN scores at the time of selection. A single control patient is selected based on gender, closest age, and CAN score; this serves as a comparator for subsequent utilization analysis.

Data from the first 2 years of this study demonstrate that compared with the high-risk control group, there was an increase in contacts with PACT team members, including behavioral health, clinical pharmacists, and nurse care management, persisting up to 6 months following the PACT ICU presentation.⁴ However, PACT ICU participation did not increase the number of visits with the PCP, indicating better engagement with the entire team. Participation was associated with significantly decreased hospitalizations and a trend toward decreased ED visits. These findings persisted when compared with controls in the PCP’s panel with similar CAN scores, making “regression to the mean” often seen in these studies much less likely.

Analysis of patients early in the project suggests the possibility of improved glycemic control in patients with DM and improved blood pressure control in hypertensive patients presented at the PACT ICU compared with that of non-PACT ICU patients.⁸ Another potential benefit includes better team-based coordination. Because the patient now has a team focusing on care, this new dynamic results in improving outreach, identifying patients who could receive care by a telephone, and better preparing team members to establish rapport when the patient calls or comes in for a visit.

The Future

In stage 2 of the CoEPCE program, a multi-site trial of PACT ICU was completed to better understand which elements are critical to success, with the goal of facilitating broader exportability.⁵ The trial focused on 3 intertwined elements: structure, delivery, and evaluation. Using local implementation and the multisite trial, the most effective practices have been documented as part of an implementation kit, available at boisevacoe.org. The goal of the implementation kit is to facilitate step-by-step implementation of PACT ICU to other settings beyond the multisite study. Since the open-ended structure of PACT ICU enables accommodating different professions and specialties beyond the model’s Boise VAMC participants, it could be easily adapted to potentially support a variety of implementations elsewhere (Appendix).

Another opportunity for expansion is increased patient involvement. Currently, PACT ICU patients have the opportunity to review and ask questions about their multidisciplinary care plans before starting. 

This article is part of a series that illustrates strategies intended to redesign primary care education at the Veterans Health Administration (VHA), using interprofessional workplace learning. All have been implemented in the VA Centers of Excellence in Primary Care Education (CoEPCE). These models embody visionary transformation of clinical and educational environments that have potential for replication and dissemination throughout VA and other primary care clinical educational environments. For an introduction to the series see Klink K. Transforming primary care clinical learning environments to optimize education, outcomes, and satisfaction. Fed Pract. 2018;35(9):8-10.

Background

In 2011, 5 US Department of Veterans Affairs (VA) medical centers (VAMCs) were selected by the Office of Academic Affiliations (OAA) to establish CoEPCE. Part of the VA New Models of Care initiative, the 5 Centers of Excellence (CoE) in Boise, Idaho; Cleveland, Ohio; San Francisco, California; Seattle, Washington; and West Haven, Connecticut, are utilizing VA primary care settings to develop and test innovative approaches to prepare physician residents and students, advanced practice nurse residents and undergraduate nursing students, and other professions of health trainees (eg, pharmacy, social work, psychology, physician assistants [PAs]) for primary care practice in the 21st century.

The Boise CoE developed and implemented a practice-based learning model. Nurse practitioner (NP) students and residents, physician residents, pharmacy residents, psychology interns, and psychology postdoctoral fellows participate in a comprehensive curriculum and practice together for 1 to 3 years. The goal is to produce providers who are able to lead and practice health care in patient-centered primary care and rural care environments. All core curricula are interprofessionally coauthored and cotaught.¹

Methods

In 2015, OAA evaluators reviewed background documents and conducted open-ended interviews with 10 CoE staff, participating trainees, VA faculty, VA facility leadership, and affiliate faculty. In response to questions focused on their experiences, informants described lessons learned, challenges encountered, and benefits for participants, veterans, and the VA. Using a qualitative and quantitative approach, this case study draws on those interviews, surveys of PACT ICU (patient aligned care team interprofessional care update) participants, and analysis of presented patients to examine PACT ICU outcomes.

Related: Hypoglycemia Safety Initiative: Working With PACT Clinical Pharmacy Specialists to Individualize HbA1c Goals

Interprofessional Education and Care

A key CoEPCE aim is to create more clinical opportunities for CoE trainees from a variety of professions to work as a team in ways that anticipate and address the care needs of veterans. This emphasis on workplace learning is needed since most current health care professional education programs lack settings where trainees from different professions can learn and work together with their clinic partners to provide care for patients. With the emphasis on patient-centered medical homes (PCMH) and team-based care in the Affordable Care Act, there is an imperative to develop new training models that address this gap in the preparation of future health professionals. Along with this imperative, clinicians are increasingly required to optimize the health of complex patients who consequently require a multidisciplinary approach to care, particularly high-risk, high-needs patients inappropriately using services, such as frequent emergency department (ED) use.

Addressing Complex Needs

In 2010, the Boise VA Medical Center (VAMC) phased in patient aligned care teams (PACTs), the VA-mandated version of PCMH that consist of a physician or NP primary care provider (PCP), a registered nurse (RN) care manager, a licensed vocational nurse (LVN), and a medical support assistant (MSA). 

The PACT ICU also serves as a venue in which trainees and supervisors from different professions use a patient-centered framework to collaborate on these specific patient cases. The PACT ICU is easily applied to a range of health conditions, such as diabetes mellitus (DM), mental and behavioral health, lack of social support, and delivery system issues, such as ED use. The goals of PACT ICU are to improve the quality and satisfaction of patient care for high-risk patients; encourage appropriate use of health care resources by prioritizing continuity with the PACT team; and enhance interprofessional PACT team function, decreasing PCP and staff stress.

Planning and Implementation

In January 2013, Boise VAMC and the Caldwell, Idaho community-based outpatient clinic (CBOC) implemented PACT ICU. Other nonteaching clinics followed later in the year. Planning and executing PACT ICU took about 10 hours of CoE staff time and required no change in Boise VAMC policy. Program leadership approval was necessary for participation of CoE residents and postdocs. Service-line leadership support was required to protect clinic staff time (nurse care manager, social workers, chaplaincy, and ethics service). At the Caldwell CBOC, the section chief approved the program, and it took about 1 month to initiate a similar version of PACT ICU.

Curriculum

PACT ICU is a workplace clinical activity with roots in the case conference model, specifically the EFECT model (Elicit the narrative of illness, Facilitate a group meeting, Evidence-based gap analysis, Care plan, and Track changes).³ PACT ICU emphasizes a patient-centered approach to developing care plans. Staff review the 5 highest risk patients who are identified by the VA Care Assessment Need (CAN) registry. The CAN is an analytic tool that is available throughout VA and estimates patients’ risk of mortality or hospitalization in the following 90 days. Physician and NP residents choose 1 of the 5 patients to discuss in PACT ICU, while the remaining 4 serve as case-control comparisons to examine long-term patient outcomes. All trainees, faculty, and staff are provided patient data that can be discussed on a secure website.

The PACT ICU combines didactic teaching with workplace learning. For example, the patient’s medical issues may lead to a formal presentation about a topic, such as secondary stroke medication prophylaxis. The workplace learning occurs as the trainees observe and participate in the decision making toward a treatment plan. Interprofessional interactions are role-modeled by clinical faculty and staff during these discussions, and the result impact the patients care. PACT ICU embodies the core domains that shape the CoEPCE curriculum: Interprofessional collaboration (IPC), performance improvement (PI), sustained relationships (SR), and shared decision making (SDM) (Table 1). 

There have been some changes to the PACT ICU model over time. Initially, conferences took place on a weekly basis, to build momentum among the team and to normalize processes. After about 2 years, this decreased to every other week to reduce the time burden. Additionally, the CoE has strengthened the “tracking changes” component of the EFECT model—trainees now present a 5-minute update on the last patient they presented at the prior PACT ICU case conference. Most recently, psychology postdoctoral candidates have instituted preconference calls with patients to further improve the teams understanding of the patients’ perspective and narrative.

Related: Improving Team-Based Care Coordination Delivery and Documentation in the Health Record

Resources

The CoE faculty participate in an education program concerning facilitation of interprofessional meetings. All faculty are expected to role model collaborative behavior and mentor trainees on the cases they present.

The PACT ICU requires a room large enough to accommodate at least 12 people. One staff member is required to review patient cases prior to the case conferences (usually about 1 hour of preparation per case conference). Another staff person creates and shares a spreadsheet stored with VA-approved information security with data fields to include the site, PACT ICU date, patient identifier, the CAN score, and a checkbox for whether the patient was selected or part of a control group. Logistic support is required for reserving the room and sending information to presenters. A clinic-based RN with training in interprofessional care case management uses an online schedule to facilitate selection and review of patients. The RN care managers can use a secure management tool to track patient care and outreach.

The RN care manager also needs to be available to attend the PACT ICU case conferences. The Boise CoE built a website to share and standardize resources, such as a presenter schedule, PACT ICU worksheet, and provider questionnaire. (Contact Boise CoE staff for access.) For the initial evaluation of impact, PACT ICU utilized staff data support in the form of a data manager and biostatistician to identify, collect, and analyze data. While optional, this was helpful in refining the approach and demonstrating the impact of the project. Other resource-related requirements for exporting PACT ICU include:

• Staff members, usually RN care managers who coordinate meetings with participants and identify appropriate patients using a registry, such as CAN;
• Meeting facilitators who enforce use of the EFECT model and interprofessional participation to ensure that the interprofessional care plan is carried out by the presenting provider; and
• Interprofessional trainees and faculty who participate in PACT ICU and complete surveys after the first conference.

Monitoring and Assessment

The CoE staff have analyzed the evaluation of PACT ICU with participant self-evaluation, consultation referral patterns, and utilization data, combination of ED and episodic care visits along with hospitalizations).⁴ Pharmacy faculty are exploring the use polypharmacy registries, and psychology will use registries of poor psychosocial function.

Partnerships

Beyond support and engagement from VA CoEPCE and affiliate faculty, PACT ICU has greatly benefited from partnerships with VA facility department and CBOC leadership. The CoEPCE codirector and faculty are in facility committees, such as the PACT Strategic Planning Committee.

Academic affiliates are integral partners who assist with NP student and resident recruitment as well as participate in the planning and refinement of CoEPCE components. PACT ICU supports their mandate to encourage interprofessional teamwork. Faculty members from Gonzaga University (NP affiliate) were involved in the initial discussion on PACT ICU and consider it a “learning laboratory” to work through challenging problems. Gonzaga CoEPCE NP trainees are asked to talk about their PACT ICU experience—its strengths, weaknesses, and challenges—to other Gonzaga students who don’t have exposure to the team experience.

Challenges and Solutions

The demand for direct patient care puts pressure on indirect patient care approaches like PACT ICU, which is a time-intensive process with high impact on only a small number of patients. The argument for deploying strategies such as PACT ICU is that managing chronic conditions and encouraging appropriate use of services will improve outcomes for the highest risk patients and save important system resources in the long-run. However, in the short-term, a strong case must be made for the diversion of resources from usual clinic flow, particularly securing recurring blocks of provider time and clinic staff members. In addition, issues about team communication and understanding of appropriate team-based care can overflow to complex patients not presented in the PACT ICU conference.

Providing a facilitated interprofessional venue to discuss how to appropriately coordinate care improves the participation and perceived value of different team members. This approach has led to improved engagement of the team for patients discussed in the PACT ICU, as well as in general care within the participating clinic. With recent changes, the VA does see a workload benefit, and participants get encounter credit through “Non face-to-face prolonged service” codes (CPT 99358/99359), and other possibilities exist related to clinical team conference codes (CPT 99367-8) and complex chronic care management codes (CPT 99487-89). More information on documentation, scheduling and encountering/billing can be found at boisevacoe.org under Products. Other challenges include logistic challenges of finding appropriate patients and distributing sensitive patient information among the team. Additionally, PACT ICU has to wrestle with staffing shortages and episodic participation by some professions that are chronically understaffed. We have addressed many of these problems by receiving buy-in from both leadership and participants. Leadership have allowed time for participation in clinic staff schedules, and each participant has committed to recruiting a substitute in case of a schedule conflict.

Factors for Success

The commitment from the Boise VAMC facility, primary care clinic leadership and affiliated training programs to support staff and trainee participation also has been critical. Additionally, VA facility leadership commitment to ongoing improvements to PACT implementation was a key facilitating factor. Colocation of trainees and clinic staff on the academic PACT team facilitates communication between PACT ICU case conferences, while also supporting team dynamics and sustained relationships with patients. Many of these patients can and will typically seek care using the interdisciplinary trainees, and trainees were motivated to proactively coordinate warm handoffs and other models of transfer of care. PACT ICU has been successfully replicated and sustained at 4 of the 5 CoEPCE sites. The Caldwell CBOC PACT ICU has been up and running for 2 years, and 2 other nonacademic clinics have piloted PACT ICU managed care conferences thus far. Experience regarding the implementation at other academic sites has been published.⁵

Accomplishments and Benefits

There is evidence that PACT ICU is achieving its goals of improving trainee learning and patient outcomes. Trainees are using team skills to provide patient-centered care; trainees are strengthening their overall clinical skills by learning how to improve their responses to high-risk patients. There is also evidence of an increase in interprofessional warm handoffs within the clinic, in which “a clinician directly introduces a patient to another clinician at the time of the patient’s visit, and often a brief encounter between the patient and the health care professional occurs.”^4,6

Unlike a traditional didactic with classroom case conferences on interprofessional collaboration, PACT ICU is an opportunity for health care professionals to both learn and work together providing care in a clinic. Moreover, colocation of diverse trainee and faculty professions during the case conferences better prepares trainees to work with other professions and supports all participants to work and communicate as a team.

CoE staff have assessed educational outcomes before and after attendance in PACT ICU. On average, trainees (n = 30) said they found the PACT ICU case conferences to be “very helpful” in developing treatment plans. 

Interprofessional Collaboration

Team building and colocating trainees, faculty, and clinic staff from different professions are a primary focus of PACT ICU. The case conferences are designed to break down silos and foster a team approach to care. Trainees learn how the team works and the ways other professionals can help them take care of the patient. For example, trainees learn early about the contributions and expertise that the pharmacist and psychologist offer in terms of their scope of practice and referral opportunities. Additionally, the RN care manager increases the integration with the PACT clinical team by sharing pertinent information on individual patients. Based on recent trainee survey findings, the CoE has observed a positive change in the team dynamic and trainee ability to interface between professions. PACT ICU participants were more likely to make referrals to other members within the PACT team, such as a warm handoff during a clinic appointment, while they were less likely to seek a consult outside the team.⁷

Clinical Performance

The PACT ICU is an opportunity for a trainee to increase clinical expertise. It provides exposure to a variety of patientsand their care needs and serves as an opportunity to present a high-risk, challenging patient to colleagues of various professions. As of June 2018, 96 physician resident and NP residents have presented complex patient cases.

In addition, a structured forum for discussing patients and their care options strengthens team clinical performance, which supports people to work to the full scope of their practice. Trainees learn and apply team skills, such as communication and the warm handoff.

An interprofessional care plan that is delineated during the meeting supports the trainee and is carried out with help from consultants as needed. These consultants often facilitate plans for a covisit or warm handoff at the next clinic visit, a call from the RN care manager, a virtual clinic appointment, or other nontraditional visits. The clinic staff can get information from PCPs about patient’s plan of care, and PCPs get a more complete picture of a patient’s situation (eg, history, communications, and life-style factors). In addition, surveys of PACT ICU participants suggest the curriculum’s effectiveness at encouraging use of PACT principles within the clinic team and improving appropriate referrals to other members of the PACT team, such as pharmacy and behavioral health.

Patients presented at PACT ICU can be particularly challenging, so there may be a psychological benefit to working with a team to develop a new care plan. The PCPs who feel they are overwhelmed and have exhausted every option step back, get input, and look at the patient in a new light.

Related: Interprofessional Education in Patient Aligned Care Team Primary Care-Mental Health Integration

CoEPCE Function

The PACT ICU is flexible and has been adapted to different ambulatory care settings. Currently, PACT ICU case conferences take place at Boise VAMC, the Caldwell CBOCs, and more recently at a smaller CBOC in Burns, Oregon. The PACT ICU structure is slightly different in the clinic settings since the VA primary care clinic has different resources to draw upon, such as hospital and specialty services. The Caldwell CBOC was unable to protect time for PCPs, so it holds a monthly PACT ICU case conference. In addition to continuing expansion in other nonacademic PACT clinics and collaboration with other CoEPCE sites, work is underway to disseminate generalizable principles for interprofessional education, as well as exporting the model for implementation in non-VA settings.

Primary Care Services

The PACT ICU has the potential to create efficiencies in busy clinic settings. It strengthens communication between PCPs and is an opportunity to touch base on the patient, delegate care, and keep track of high-risk patients who might otherwise receive attention only when having an acute problem. Nurses gain a deeper understanding of the patients presented at PACT ICU.

PACT ICU leverages and builds on existing PACT resources in an achievable and sustainable manner benefiting primary care. CoE trainees, who are part of the Silver Team, tap in to the information that team nurses gain from checking in with these high-risk patients biweekly. Moreover, the integration with the Silver Team improves continuity, which helps enhance a patient’s level of trust. The relationship strengthened between primary care and behavioral health at the Caldwell CBOC, providing improved patient access and increased professional sharing.

Patient Outcomes

The PACT ICU provides a forum for input beyond that of the PCP. This feature results in a more robust treatment plan than might be developed by individual PCPs who might not have time to consider options that are outside their scope of practice. Formulating an enriched care plan, informed by multiple professions, has the potential to improve utilization and provide better care.

The Boise VAMC PACT ICU has presented 219 patients as of June 2018. While clinical outcomes data are difficult to collect, the CoE has data on utilization differences on all patients presented at the PACT ICU case conferences. This includes 4 control patients from the same PCP, with similarly high risk based on CAN scores at the time of selection. A single control patient is selected based on gender, closest age, and CAN score; this serves as a comparator for subsequent utilization analysis.

Data from the first 2 years of this study demonstrate that compared with the high-risk control group, there was an increase in contacts with PACT team members, including behavioral health, clinical pharmacists, and nurse care management, persisting up to 6 months following the PACT ICU presentation.⁴ However, PACT ICU participation did not increase the number of visits with the PCP, indicating better engagement with the entire team. Participation was associated with significantly decreased hospitalizations and a trend toward decreased ED visits. These findings persisted when compared with controls in the PCP’s panel with similar CAN scores, making “regression to the mean” often seen in these studies much less likely.

Analysis of patients early in the project suggests the possibility of improved glycemic control in patients with DM and improved blood pressure control in hypertensive patients presented at the PACT ICU compared with that of non-PACT ICU patients.⁸ Another potential benefit includes better team-based coordination. Because the patient now has a team focusing on care, this new dynamic results in improving outreach, identifying patients who could receive care by a telephone, and better preparing team members to establish rapport when the patient calls or comes in for a visit.

The Future

In stage 2 of the CoEPCE program, a multi-site trial of PACT ICU was completed to better understand which elements are critical to success, with the goal of facilitating broader exportability.⁵ The trial focused on 3 intertwined elements: structure, delivery, and evaluation. Using local implementation and the multisite trial, the most effective practices have been documented as part of an implementation kit, available at boisevacoe.org. The goal of the implementation kit is to facilitate step-by-step implementation of PACT ICU to other settings beyond the multisite study. Since the open-ended structure of PACT ICU enables accommodating different professions and specialties beyond the model’s Boise VAMC participants, it could be easily adapted to potentially support a variety of implementations elsewhere (Appendix).

Another opportunity for expansion is increased patient involvement. Currently, PACT ICU patients have the opportunity to review and ask questions about their multidisciplinary care plans before starting. 

The evaluation of acute kidney injury (AKI) often starts with the classic prerenal, renal, and postrenal causalities, delineating a practical workable approach in its differential diagnosis. Accordingly, the history, physical examination, urinalysis, and kidney-bladder sonography are standard resources in the initial approach to renal disease assessment. Ultrasonography has a well-established role as an important adjuvant for postrenal diagnosis of renal failure. Nevertheless, most of the causes of AKI are prerenal and renal.

Some etiologies of kidney injury are sequelae of systemic diseases in which sonography can be diagnostically analogous to the history and physical examination. Furthermore, ultrasonography may be informative in various clinical scenarios, for example, patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). In this narrative review, the contribution of point-of-care (POC) sonography to the evaluation and management of AKI, CKD, and associated diseases are explored beyond the traditional sonogram uses for kidney biopsy, central catheter placement, and/or screening of hydronephrosis.

Two important elements made possible the incorporation of POC sonography into nephrology practice.^1,2 First, the development of handheld reliable and portable ultrasound devices and, second, the derived capacity of POC sonography to obtain objective signs of physiologic and/or pathophysiologic phenomena. The latter clinical application is realized through the incorporation of POC protocols into the modified focused assessment with sonography for trauma (FAST) examination in conjunction with limited echocardiography and lung sonography (Figure 1). 

These protocols have allowed the evaluation of extracellular volume, which is important to measure for the diagnosis and management of renal diseases. For example, the evaluation of lung water by POC ultrasonography for patients with ESRD is emerging as a promising tool. In a study of patients with ESRD undergoing hemodialysis, POC ultrasonography detected moderate-to-severe lung congestion in 45% of patients, most of whom (71%) were asymptomatic. Two years of follow-up of patients was associated with 3 to 4 times greater risk of heart attack and death, respectively, compared with individuals without congestion on sonography.^4-6 Thus, ultrasound assessment of lung water in patients with ESRD may prove to be an essential tool to assure an adequate ultrafiltration and improve patient outcomes.

Related: Nephrogenic Systemic Fibrosis in a Patient With Multiple Inflammatory Disorders

Acute Kidney Injury

Prerenal

The physical examination provides evaluation of effective arterial circulatory flow (EACF) and is clinically useful in the evaluation of prerenal azotemia. The utility is more obvious in the extremes of EACF. However, in the case of blood volume losses of > 10% or the physiologic equivalent, heart rate, blood pressure, skin turgor, urinary output, and capillary refill may be within normal limits. Obvious changes in these parameters during the physical examination are considered relatively late manifestations.^7-10 Therefore, prerenal failure is frequently diagnosed retrospectively after correction of the EACF through use of crystalloids, blood products, vasopressors, inotropic agents, discontinuation of antihypertensive agents, or treatment of its prerenal causes. Certain sonographic maneuvers, performed at the bedside during acute renal injury, may be useful in many patients to evaluate a multitude of prerenal causes of AKI.

Sonographic inferior vena cava (IVC) luminal diameter and inspiratory collapsibility together serve as a surrogate marker of preload venous return and right side heart function. Such imaging results have been shown to be more accurate than jugular venous distension on physical examination but only modestly helpful as a surrogate for central venous pressure (CVP), with more accuracy in the lower values of the CVP.¹¹ However, this procedure can be repeated often after volume resuscitation to achieve a 1.5- to 2.5-cm diameter dimension of the IVC and < 25% inspiratory collapsibility as a goal.

An IVC with a diameter > 2.5 cm in the context of a suspected prerenal AKI is more likely the consequence of heart failure (HF) rather than hypovolemia. The caveat to this finding is that pulmonary hypertension may induce false-positive results.^12,13 Hepatic vein dilation is another sign of HF and/or pulmonary hypertension. Furthermore, sonographic images of the left ventricle either from the parasternal long axis or subxiphoid approach can identify supranormal left ventricular ejection fraction (LVEF) or hyperdynamic heart as an important clue of the absolute or relative decrease of EACF.¹⁴ Conversely, a decrease in EACF in patients with low LVEF can be assessed qualitatively at the bedside in patients with systolic HF. Supporting evidence of prerenal azotemia as the result of HF can be suggested by the presence of pleural effusions and bilateral comet/rockets tails or B lines in lung sonography.¹⁵

The easily recognizable hypoechoic ascitic fluid in the presence of small, hyperechoic gross changes in the echocardiographic texture of liver may indicate a hepatorenal component as the cause of prerenal failure. A small increase of > 20% in the diameter of the portal vein with deep inspiration indicates portal hypertension, with a sensitivity of 80% and a specificity of 100%.^15,16 Other clinical scenarios leading to AKI in association with systemic hypotension may be identified quickly with the aid of POC sonography. These scenarios include cardiac tamponade, tension pneumothorax, right ventricular dysfunction (as a surrogate of pulmonary embolism), or an acute coronary event.^16,17 Alternatively, identifying the presence of severe left ventricular hypertrophy through POC ultrasonography in a patient with AKI and normal or low normal blood pressures may alert clinicians to the diagnosis of normotensive renal failure in individuals with previously unrecognized severe hypertension. In this clinical context, keeping mean arterial pressures higher than usual with vasopressors may improve renal function while decreasing dialysis utilization.^18-21

Likewise, in clinical scenarios of shock with AKI, POC ultrasonography has proven to be an indispensable tool. For example, rapid exploration of the biliary tree demonstrating anterior gallbladder wall thickening, a stone or sludge, common bile duct dilation, or perigallbladder inflammation suggests acute cholecystitis and/or cholangitis as the cause. The presence of dyspnea in association with hypotension and unilateral signs of a higher proportion of comet tails and/or a lung consolidation suggests pneumonia. Rapid differentiation between acute respiratory distress syndrome (ARDS) and pulmonary edema from HF is possible with ultrasonography. When pleural line abnormalities are seen, ARDS is a common cause.

POC ultrasonography will be key in management of ARDS, as ultrasound results will help avoid the use of excessive diuretics, which can result in renal hypoperfusion and AKI.²² In trauma patients, the ultrasound examination will identify free fluid (bleeding) as the source of the prerenal failure, along with its cause (aortic dissection, hepatic hemorrhage, splenic hemorrhage, ectopic pregnancy, etc).²³ Sonographic free air observed in the abdomen can provide the clue of a perforated viscus.²⁴ The sonographic image of an inflamed pancreas can suggest pancreatitis as the cause of the systemic hypotension. Ultimately, intravascular losses in the hypoechoic edematous bowel wall in obstruction, ileus, pseudomembranous, or infectious or autoimmune enterocolitis can lead to significant decreases in the EACF and cause prerenal injury.

Related: Prevalence of Suspicious Ultrasound Features in Hot Thyroid Nodules

Intrinsic Renal Disease

In intrinsic AKI, acute tubular necrosis (ATN), glomerulonephritis, and interstitial nephritis are the typical causes. Although no signs are specific to each of the potential causes, a poor corticomedullary differentiation, kidney size < 9 cm, and cortex size < 1 cm help to distinguish CKD from AKI, especially if no previous serum creatinine values are available. The early diagnosis of ATN continues to be clinically relevant in the management of acute renal failure. Despite not being a practical tool for POC sonography currently, the use of bedside Doppler repetitive renal vasculature measures of resistive index predict occurrence and severity of ATN in the critical care setting and are an independent risk factor for poor survival in arterial hypertension and HF.^25-30

Other POC sonographic evaluations of intrinsic AKI have been helpful in the following clinical scenarios. The presence of an ultrasonographic sign of sinusitis in the context of nephritic sediment and a rapid decline of renal function suggest antineutrophil cytoplasmic antibody (ANCA)-related vasculitis. Likewise, in younger adults, nephritic sediment and bilateral sonographic lung interstitial fluid in the absence of infection and a normal POC echocardiogram without significant edema elsewhere suggest glomerulonephritis in the category of pulmonary lung syndrome caused by antiglomerular basement membrane antibodies.

In the elderly, a similar systemic presentation suggests an ANCA vasculitis. Pleural effusion, synovitis, proteinuria, and/or hematuria will suggest lupus nephritis. Another important cause of acute renal failure in the critical care setting is intra-abdominal compartment syndrome. Here, bladder pressure measurement protocols are the standard of care. A human model evaluated the predictive value of intra-abdominal compartment syndrome pressures using the IVC square surface. In this study, a normal surface area of the IVC of > 1 cm²/m² excluded the presence of intra-abdominal hypertension 87.5% of the time. However, the sensitivity of detection of the intra-abdominal hypertension was only 67.5% when the surface area of the IVC was < 1 cm²/m².³¹

CKD and Associated Diseases

The diagnostic validity of ultrasonography is well established in adult-onset polycystic kidney disease. Bedside visualization of a parathyroid adenoma may be an important clue for a patient with CKD, echogenic kidneys, or nephrolithiasis with or without hypercalcemia to diagnose primary hyperparathyroidism. The sonographic diagnosis of abnormal parathyroid gland compared with parathyroid surgical exploration had a sensitivity, specificity, and positive predictive value of 74%, 96%, and 90%, respectively.³² In the clinical presentation of severe hypertension with headaches, ultrasonography at bedside can provide valuable diagnostic and risk assessment information of endocranial hypertension from measuring the optic nerve sheath. Sensitivity and specificity of papilledema was 90% and 79%, respectively, when 3.3 mm was the cutoff of the nerve sheath with a 30-degrees sign.³³ The carotid artery intima media thickness measured on sonography correlates with the future development of atherogenesis, left ventricular hypertrophy, cognition deficits, CKD, and cardiovascular disease in asymptomatic patients. An intima media thickness of > 1.1 mm has been associated with a higher cardiovascular mortality.

Early initiation of antihypertensive medications and/or statins has been suggested to lower risk in these asymptomatic patients.³⁴ The size and contour (smooth or irregular) of kidneys may provide clues to reflux nephropathy, dysplastic kidneys, radiation nephritis, or chronic pyelonephritis. The presence of nephrotic syndrome and abnormal free light chains ratio with a bedside echocardiogram showing the typical refractile myocardial walls with a peculiar speckled pattern is strongly suggestive of amyloidosis.³⁵ Conditions associated with chronic hypercalcemia, medullary sponge kidney, milk alkali syndrome, sarcoidosis, and distal renal tubular acidosis are causes of nephrocalcinosis. Some degree of CKD is a constant feature in nephrocalcinosis. The initial imaging of choice in nephrocalcinosis and specially the medullary type is ultrasonography preferable to X-ray and perhaps to computed tomography.³⁶

End-Stage Renal Disease

In a patient undergoing peritoneal dialysis with exit-site infection, the presence of > 1 mm radiolucent rim around the subcutaneous catheter after antibiotics has a bad prognosis and prompts catheter removal. This sonographic sign has a positive and negative predictive value for a tunneled infection of 84.6% and 94.1%, respectively.^37,38 A risk factor for peritonitis in peritoneal dialysis is air in the peritoneum, which can be seen in one-third of patients. These individuals have 2.4 times more risk of peritonitis compared with patients without pneumoperitoneum. The sensitivity and specificity of sonographic detection of pneumoperitoneum is 94% and 100%, respectively, using the scissor technique.³⁹ Proper training in performing home peritoneal dialysis decreases the incidence of pneumoperitoneum. Although not formally assessed, patient education and change in procedure techniques may decrease the incidence of pneumoperitoneum and peritonitis. The use of prelaparoscopic ultrasonography before insertion of the peritoneal dialysis catheter has detected intra-abdominal adhesions (visceral slide sign) with a sensitivity of 90% to 92%.⁴⁰

History and physical examination are frequently helpful in the diagnosis of malfunctioning arteriovenous fistulas (AVF) for inflow or outflow disturbances, with sensitivity ranging from 70% to 100% and specificity ranging from 71% to 93% compared with angiography. Frequently, POC limited ultrasound can be helpful for a problematic AVF, either for cannulation or diagnosis. The congruence of duplex sonography with arteriogram is 85% to 96%. Various etiologies of a dysfunctional AVF (pseudo- or true aneurysm, poor development, stenosis, thrombi, or accessory veins) can be observed in the dialysis unit through limited sonography.^41-44

After placement of a hemodialysis catheter using real-time ultrasonography, pneumohemothorax can be diagnosed reliably and rapidly. Catheter misplacement outside of the right atrium was detected by thoracic echocardiogram with a sensitivity of 96%, a specificity of 83%, and a positive predictive value of 98%.^45,46 Ultimately, ultrasonography may replace chest X-ray in most cases after central vein dialysis catheter placement in the acute care setting.

Postrenal Failure

The sensitivity of ultrasonography to detect dilation to hydronephrosis of the pelvicaliceal system is well established. Sonography is the diagnostic examination of choice in pregnancy and the initial screening test for the nonpregnant patient. Computed tomography is the preferred imaging study in nephroureterolithiasis; however, due to ionizing radiation and cost, ultrasonography is gaining popularity for initial and/or follow-up evaluations. The ureteral jet is a relatively unexplored color and Doppler sonographic methodology that can provide insight into pelvicalyceal peristalsis, potentially yielding evidence of functional obstruction.^47-51 Postvoid bladder residual volumes and bladder wall hypertrophy may provide important clues as to the cause(s) of the obstructive uropathy.

Telenephrology

In our institution, sonography is used in the evaluation of IVC, lungs, and kidneys via telemedicine. The probe is handled by trained nurses at the distant site. 

Cardiac Arrest in ESRD

Patients with ESRD may have sudden cardiac arrest as a result of several etiologies. During the advance cardiac life support algorithm, there is a brief period of evaluation of the electrical rhythm in which echocardiography can be helpful with the diagnosis immediately after the 2 initial minutes of cardiopulmonary resuscitation. An enlarged right ventricular cavity (> 2/3 of the left ventricle) is a sonographic sign of a pulmonary embolism.

Bedside sonography has the potential to alter the current guidelines of advance cardiac life support management. For example, if the bedside echo shows a significant pericardial effusion, a pericardiocentesis could be performed faster as it would be diagnosed faster. In addition, at times the heart may appear to be beating rapidly but there is a small amount of fluid (blood) within the cardiac chambers. This may be from an extreme case of dehydration for which rapid administration of IV fluids may help manage. Therefore, a quick bedside point of care echocardiography may reveal a cardiac anomaly that may be able to be restored in a efficient manner. 

Related: General Applications of Ultrasound in Rheumatology Practice

Conclusion

Ultrasonography at the POC provides an important and continuously expanding tool to improve nephrological diagnostic accuracy in concert with history and physical examination. Extracellular fluid evaluation is paramount in all kidney disease conditions. Recent clinical studies in lung ultrasonography suggest that the learning curve for the medical provider is quicker than with other organs. Because POC sonography in association with limited bedside echocardiography may reveal discriminatory signs of pneumonia and differentiate between cardiogenic vs noncardiogenic pulmonary edema, such imaging may be important cost-effective strategies in the management of dyspnea and in the categorization/etiology of AKI. Therefore, incorporation of POC sonography into clinical practice will require that medical schools, residency programs, and nephrology fellowship programs design teaching strategies within their respective curricula. Research studies with outcomes regarding diagnosis, morbidity, and mortality are necessary in these areas.

The evaluation of acute kidney injury (AKI) often starts with the classic prerenal, renal, and postrenal causalities, delineating a practical workable approach in its differential diagnosis. Accordingly, the history, physical examination, urinalysis, and kidney-bladder sonography are standard resources in the initial approach to renal disease assessment. Ultrasonography has a well-established role as an important adjuvant for postrenal diagnosis of renal failure. Nevertheless, most of the causes of AKI are prerenal and renal.

Some etiologies of kidney injury are sequelae of systemic diseases in which sonography can be diagnostically analogous to the history and physical examination. Furthermore, ultrasonography may be informative in various clinical scenarios, for example, patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). In this narrative review, the contribution of point-of-care (POC) sonography to the evaluation and management of AKI, CKD, and associated diseases are explored beyond the traditional sonogram uses for kidney biopsy, central catheter placement, and/or screening of hydronephrosis.

Two important elements made possible the incorporation of POC sonography into nephrology practice.^1,2 First, the development of handheld reliable and portable ultrasound devices and, second, the derived capacity of POC sonography to obtain objective signs of physiologic and/or pathophysiologic phenomena. The latter clinical application is realized through the incorporation of POC protocols into the modified focused assessment with sonography for trauma (FAST) examination in conjunction with limited echocardiography and lung sonography (Figure 1). 

These protocols have allowed the evaluation of extracellular volume, which is important to measure for the diagnosis and management of renal diseases. For example, the evaluation of lung water by POC ultrasonography for patients with ESRD is emerging as a promising tool. In a study of patients with ESRD undergoing hemodialysis, POC ultrasonography detected moderate-to-severe lung congestion in 45% of patients, most of whom (71%) were asymptomatic. Two years of follow-up of patients was associated with 3 to 4 times greater risk of heart attack and death, respectively, compared with individuals without congestion on sonography.^4-6 Thus, ultrasound assessment of lung water in patients with ESRD may prove to be an essential tool to assure an adequate ultrafiltration and improve patient outcomes.

Related: Nephrogenic Systemic Fibrosis in a Patient With Multiple Inflammatory Disorders

Acute Kidney Injury

Prerenal

The physical examination provides evaluation of effective arterial circulatory flow (EACF) and is clinically useful in the evaluation of prerenal azotemia. The utility is more obvious in the extremes of EACF. However, in the case of blood volume losses of > 10% or the physiologic equivalent, heart rate, blood pressure, skin turgor, urinary output, and capillary refill may be within normal limits. Obvious changes in these parameters during the physical examination are considered relatively late manifestations.^7-10 Therefore, prerenal failure is frequently diagnosed retrospectively after correction of the EACF through use of crystalloids, blood products, vasopressors, inotropic agents, discontinuation of antihypertensive agents, or treatment of its prerenal causes. Certain sonographic maneuvers, performed at the bedside during acute renal injury, may be useful in many patients to evaluate a multitude of prerenal causes of AKI.

Sonographic inferior vena cava (IVC) luminal diameter and inspiratory collapsibility together serve as a surrogate marker of preload venous return and right side heart function. Such imaging results have been shown to be more accurate than jugular venous distension on physical examination but only modestly helpful as a surrogate for central venous pressure (CVP), with more accuracy in the lower values of the CVP.¹¹ However, this procedure can be repeated often after volume resuscitation to achieve a 1.5- to 2.5-cm diameter dimension of the IVC and < 25% inspiratory collapsibility as a goal.

An IVC with a diameter > 2.5 cm in the context of a suspected prerenal AKI is more likely the consequence of heart failure (HF) rather than hypovolemia. The caveat to this finding is that pulmonary hypertension may induce false-positive results.^12,13 Hepatic vein dilation is another sign of HF and/or pulmonary hypertension. Furthermore, sonographic images of the left ventricle either from the parasternal long axis or subxiphoid approach can identify supranormal left ventricular ejection fraction (LVEF) or hyperdynamic heart as an important clue of the absolute or relative decrease of EACF.¹⁴ Conversely, a decrease in EACF in patients with low LVEF can be assessed qualitatively at the bedside in patients with systolic HF. Supporting evidence of prerenal azotemia as the result of HF can be suggested by the presence of pleural effusions and bilateral comet/rockets tails or B lines in lung sonography.¹⁵

The easily recognizable hypoechoic ascitic fluid in the presence of small, hyperechoic gross changes in the echocardiographic texture of liver may indicate a hepatorenal component as the cause of prerenal failure. A small increase of > 20% in the diameter of the portal vein with deep inspiration indicates portal hypertension, with a sensitivity of 80% and a specificity of 100%.^15,16 Other clinical scenarios leading to AKI in association with systemic hypotension may be identified quickly with the aid of POC sonography. These scenarios include cardiac tamponade, tension pneumothorax, right ventricular dysfunction (as a surrogate of pulmonary embolism), or an acute coronary event.^16,17 Alternatively, identifying the presence of severe left ventricular hypertrophy through POC ultrasonography in a patient with AKI and normal or low normal blood pressures may alert clinicians to the diagnosis of normotensive renal failure in individuals with previously unrecognized severe hypertension. In this clinical context, keeping mean arterial pressures higher than usual with vasopressors may improve renal function while decreasing dialysis utilization.^18-21

Likewise, in clinical scenarios of shock with AKI, POC ultrasonography has proven to be an indispensable tool. For example, rapid exploration of the biliary tree demonstrating anterior gallbladder wall thickening, a stone or sludge, common bile duct dilation, or perigallbladder inflammation suggests acute cholecystitis and/or cholangitis as the cause. The presence of dyspnea in association with hypotension and unilateral signs of a higher proportion of comet tails and/or a lung consolidation suggests pneumonia. Rapid differentiation between acute respiratory distress syndrome (ARDS) and pulmonary edema from HF is possible with ultrasonography. When pleural line abnormalities are seen, ARDS is a common cause.

POC ultrasonography will be key in management of ARDS, as ultrasound results will help avoid the use of excessive diuretics, which can result in renal hypoperfusion and AKI.²² In trauma patients, the ultrasound examination will identify free fluid (bleeding) as the source of the prerenal failure, along with its cause (aortic dissection, hepatic hemorrhage, splenic hemorrhage, ectopic pregnancy, etc).²³ Sonographic free air observed in the abdomen can provide the clue of a perforated viscus.²⁴ The sonographic image of an inflamed pancreas can suggest pancreatitis as the cause of the systemic hypotension. Ultimately, intravascular losses in the hypoechoic edematous bowel wall in obstruction, ileus, pseudomembranous, or infectious or autoimmune enterocolitis can lead to significant decreases in the EACF and cause prerenal injury.

Related: Prevalence of Suspicious Ultrasound Features in Hot Thyroid Nodules

Intrinsic Renal Disease

In intrinsic AKI, acute tubular necrosis (ATN), glomerulonephritis, and interstitial nephritis are the typical causes. Although no signs are specific to each of the potential causes, a poor corticomedullary differentiation, kidney size < 9 cm, and cortex size < 1 cm help to distinguish CKD from AKI, especially if no previous serum creatinine values are available. The early diagnosis of ATN continues to be clinically relevant in the management of acute renal failure. Despite not being a practical tool for POC sonography currently, the use of bedside Doppler repetitive renal vasculature measures of resistive index predict occurrence and severity of ATN in the critical care setting and are an independent risk factor for poor survival in arterial hypertension and HF.^25-30

Other POC sonographic evaluations of intrinsic AKI have been helpful in the following clinical scenarios. The presence of an ultrasonographic sign of sinusitis in the context of nephritic sediment and a rapid decline of renal function suggest antineutrophil cytoplasmic antibody (ANCA)-related vasculitis. Likewise, in younger adults, nephritic sediment and bilateral sonographic lung interstitial fluid in the absence of infection and a normal POC echocardiogram without significant edema elsewhere suggest glomerulonephritis in the category of pulmonary lung syndrome caused by antiglomerular basement membrane antibodies.

In the elderly, a similar systemic presentation suggests an ANCA vasculitis. Pleural effusion, synovitis, proteinuria, and/or hematuria will suggest lupus nephritis. Another important cause of acute renal failure in the critical care setting is intra-abdominal compartment syndrome. Here, bladder pressure measurement protocols are the standard of care. A human model evaluated the predictive value of intra-abdominal compartment syndrome pressures using the IVC square surface. In this study, a normal surface area of the IVC of > 1 cm²/m² excluded the presence of intra-abdominal hypertension 87.5% of the time. However, the sensitivity of detection of the intra-abdominal hypertension was only 67.5% when the surface area of the IVC was < 1 cm²/m².³¹

CKD and Associated Diseases

The diagnostic validity of ultrasonography is well established in adult-onset polycystic kidney disease. Bedside visualization of a parathyroid adenoma may be an important clue for a patient with CKD, echogenic kidneys, or nephrolithiasis with or without hypercalcemia to diagnose primary hyperparathyroidism. The sonographic diagnosis of abnormal parathyroid gland compared with parathyroid surgical exploration had a sensitivity, specificity, and positive predictive value of 74%, 96%, and 90%, respectively.³² In the clinical presentation of severe hypertension with headaches, ultrasonography at bedside can provide valuable diagnostic and risk assessment information of endocranial hypertension from measuring the optic nerve sheath. Sensitivity and specificity of papilledema was 90% and 79%, respectively, when 3.3 mm was the cutoff of the nerve sheath with a 30-degrees sign.³³ The carotid artery intima media thickness measured on sonography correlates with the future development of atherogenesis, left ventricular hypertrophy, cognition deficits, CKD, and cardiovascular disease in asymptomatic patients. An intima media thickness of > 1.1 mm has been associated with a higher cardiovascular mortality.

Early initiation of antihypertensive medications and/or statins has been suggested to lower risk in these asymptomatic patients.³⁴ The size and contour (smooth or irregular) of kidneys may provide clues to reflux nephropathy, dysplastic kidneys, radiation nephritis, or chronic pyelonephritis. The presence of nephrotic syndrome and abnormal free light chains ratio with a bedside echocardiogram showing the typical refractile myocardial walls with a peculiar speckled pattern is strongly suggestive of amyloidosis.³⁵ Conditions associated with chronic hypercalcemia, medullary sponge kidney, milk alkali syndrome, sarcoidosis, and distal renal tubular acidosis are causes of nephrocalcinosis. Some degree of CKD is a constant feature in nephrocalcinosis. The initial imaging of choice in nephrocalcinosis and specially the medullary type is ultrasonography preferable to X-ray and perhaps to computed tomography.³⁶

End-Stage Renal Disease

In a patient undergoing peritoneal dialysis with exit-site infection, the presence of > 1 mm radiolucent rim around the subcutaneous catheter after antibiotics has a bad prognosis and prompts catheter removal. This sonographic sign has a positive and negative predictive value for a tunneled infection of 84.6% and 94.1%, respectively.^37,38 A risk factor for peritonitis in peritoneal dialysis is air in the peritoneum, which can be seen in one-third of patients. These individuals have 2.4 times more risk of peritonitis compared with patients without pneumoperitoneum. The sensitivity and specificity of sonographic detection of pneumoperitoneum is 94% and 100%, respectively, using the scissor technique.³⁹ Proper training in performing home peritoneal dialysis decreases the incidence of pneumoperitoneum. Although not formally assessed, patient education and change in procedure techniques may decrease the incidence of pneumoperitoneum and peritonitis. The use of prelaparoscopic ultrasonography before insertion of the peritoneal dialysis catheter has detected intra-abdominal adhesions (visceral slide sign) with a sensitivity of 90% to 92%.⁴⁰

History and physical examination are frequently helpful in the diagnosis of malfunctioning arteriovenous fistulas (AVF) for inflow or outflow disturbances, with sensitivity ranging from 70% to 100% and specificity ranging from 71% to 93% compared with angiography. Frequently, POC limited ultrasound can be helpful for a problematic AVF, either for cannulation or diagnosis. The congruence of duplex sonography with arteriogram is 85% to 96%. Various etiologies of a dysfunctional AVF (pseudo- or true aneurysm, poor development, stenosis, thrombi, or accessory veins) can be observed in the dialysis unit through limited sonography.^41-44

After placement of a hemodialysis catheter using real-time ultrasonography, pneumohemothorax can be diagnosed reliably and rapidly. Catheter misplacement outside of the right atrium was detected by thoracic echocardiogram with a sensitivity of 96%, a specificity of 83%, and a positive predictive value of 98%.^45,46 Ultimately, ultrasonography may replace chest X-ray in most cases after central vein dialysis catheter placement in the acute care setting.

Postrenal Failure

The sensitivity of ultrasonography to detect dilation to hydronephrosis of the pelvicaliceal system is well established. Sonography is the diagnostic examination of choice in pregnancy and the initial screening test for the nonpregnant patient. Computed tomography is the preferred imaging study in nephroureterolithiasis; however, due to ionizing radiation and cost, ultrasonography is gaining popularity for initial and/or follow-up evaluations. The ureteral jet is a relatively unexplored color and Doppler sonographic methodology that can provide insight into pelvicalyceal peristalsis, potentially yielding evidence of functional obstruction.^47-51 Postvoid bladder residual volumes and bladder wall hypertrophy may provide important clues as to the cause(s) of the obstructive uropathy.

Telenephrology

In our institution, sonography is used in the evaluation of IVC, lungs, and kidneys via telemedicine. The probe is handled by trained nurses at the distant site. 

Cardiac Arrest in ESRD

Patients with ESRD may have sudden cardiac arrest as a result of several etiologies. During the advance cardiac life support algorithm, there is a brief period of evaluation of the electrical rhythm in which echocardiography can be helpful with the diagnosis immediately after the 2 initial minutes of cardiopulmonary resuscitation. An enlarged right ventricular cavity (> 2/3 of the left ventricle) is a sonographic sign of a pulmonary embolism.

Bedside sonography has the potential to alter the current guidelines of advance cardiac life support management. For example, if the bedside echo shows a significant pericardial effusion, a pericardiocentesis could be performed faster as it would be diagnosed faster. In addition, at times the heart may appear to be beating rapidly but there is a small amount of fluid (blood) within the cardiac chambers. This may be from an extreme case of dehydration for which rapid administration of IV fluids may help manage. Therefore, a quick bedside point of care echocardiography may reveal a cardiac anomaly that may be able to be restored in a efficient manner. 

Related: General Applications of Ultrasound in Rheumatology Practice

Conclusion

Ultrasonography at the POC provides an important and continuously expanding tool to improve nephrological diagnostic accuracy in concert with history and physical examination. Extracellular fluid evaluation is paramount in all kidney disease conditions. Recent clinical studies in lung ultrasonography suggest that the learning curve for the medical provider is quicker than with other organs. Because POC sonography in association with limited bedside echocardiography may reveal discriminatory signs of pneumonia and differentiate between cardiogenic vs noncardiogenic pulmonary edema, such imaging may be important cost-effective strategies in the management of dyspnea and in the categorization/etiology of AKI. Therefore, incorporation of POC sonography into clinical practice will require that medical schools, residency programs, and nephrology fellowship programs design teaching strategies within their respective curricula. Research studies with outcomes regarding diagnosis, morbidity, and mortality are necessary in these areas.

The evaluation of acute kidney injury (AKI) often starts with the classic prerenal, renal, and postrenal causalities, delineating a practical workable approach in its differential diagnosis. Accordingly, the history, physical examination, urinalysis, and kidney-bladder sonography are standard resources in the initial approach to renal disease assessment. Ultrasonography has a well-established role as an important adjuvant for postrenal diagnosis of renal failure. Nevertheless, most of the causes of AKI are prerenal and renal.

Some etiologies of kidney injury are sequelae of systemic diseases in which sonography can be diagnostically analogous to the history and physical examination. Furthermore, ultrasonography may be informative in various clinical scenarios, for example, patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). In this narrative review, the contribution of point-of-care (POC) sonography to the evaluation and management of AKI, CKD, and associated diseases are explored beyond the traditional sonogram uses for kidney biopsy, central catheter placement, and/or screening of hydronephrosis.

Two important elements made possible the incorporation of POC sonography into nephrology practice.^1,2 First, the development of handheld reliable and portable ultrasound devices and, second, the derived capacity of POC sonography to obtain objective signs of physiologic and/or pathophysiologic phenomena. The latter clinical application is realized through the incorporation of POC protocols into the modified focused assessment with sonography for trauma (FAST) examination in conjunction with limited echocardiography and lung sonography (Figure 1). 

These protocols have allowed the evaluation of extracellular volume, which is important to measure for the diagnosis and management of renal diseases. For example, the evaluation of lung water by POC ultrasonography for patients with ESRD is emerging as a promising tool. In a study of patients with ESRD undergoing hemodialysis, POC ultrasonography detected moderate-to-severe lung congestion in 45% of patients, most of whom (71%) were asymptomatic. Two years of follow-up of patients was associated with 3 to 4 times greater risk of heart attack and death, respectively, compared with individuals without congestion on sonography.^4-6 Thus, ultrasound assessment of lung water in patients with ESRD may prove to be an essential tool to assure an adequate ultrafiltration and improve patient outcomes.

Related: Nephrogenic Systemic Fibrosis in a Patient With Multiple Inflammatory Disorders

Acute Kidney Injury

Prerenal

The physical examination provides evaluation of effective arterial circulatory flow (EACF) and is clinically useful in the evaluation of prerenal azotemia. The utility is more obvious in the extremes of EACF. However, in the case of blood volume losses of > 10% or the physiologic equivalent, heart rate, blood pressure, skin turgor, urinary output, and capillary refill may be within normal limits. Obvious changes in these parameters during the physical examination are considered relatively late manifestations.^7-10 Therefore, prerenal failure is frequently diagnosed retrospectively after correction of the EACF through use of crystalloids, blood products, vasopressors, inotropic agents, discontinuation of antihypertensive agents, or treatment of its prerenal causes. Certain sonographic maneuvers, performed at the bedside during acute renal injury, may be useful in many patients to evaluate a multitude of prerenal causes of AKI.

Sonographic inferior vena cava (IVC) luminal diameter and inspiratory collapsibility together serve as a surrogate marker of preload venous return and right side heart function. Such imaging results have been shown to be more accurate than jugular venous distension on physical examination but only modestly helpful as a surrogate for central venous pressure (CVP), with more accuracy in the lower values of the CVP.¹¹ However, this procedure can be repeated often after volume resuscitation to achieve a 1.5- to 2.5-cm diameter dimension of the IVC and < 25% inspiratory collapsibility as a goal.

An IVC with a diameter > 2.5 cm in the context of a suspected prerenal AKI is more likely the consequence of heart failure (HF) rather than hypovolemia. The caveat to this finding is that pulmonary hypertension may induce false-positive results.^12,13 Hepatic vein dilation is another sign of HF and/or pulmonary hypertension. Furthermore, sonographic images of the left ventricle either from the parasternal long axis or subxiphoid approach can identify supranormal left ventricular ejection fraction (LVEF) or hyperdynamic heart as an important clue of the absolute or relative decrease of EACF.¹⁴ Conversely, a decrease in EACF in patients with low LVEF can be assessed qualitatively at the bedside in patients with systolic HF. Supporting evidence of prerenal azotemia as the result of HF can be suggested by the presence of pleural effusions and bilateral comet/rockets tails or B lines in lung sonography.¹⁵

The easily recognizable hypoechoic ascitic fluid in the presence of small, hyperechoic gross changes in the echocardiographic texture of liver may indicate a hepatorenal component as the cause of prerenal failure. A small increase of > 20% in the diameter of the portal vein with deep inspiration indicates portal hypertension, with a sensitivity of 80% and a specificity of 100%.^15,16 Other clinical scenarios leading to AKI in association with systemic hypotension may be identified quickly with the aid of POC sonography. These scenarios include cardiac tamponade, tension pneumothorax, right ventricular dysfunction (as a surrogate of pulmonary embolism), or an acute coronary event.^16,17 Alternatively, identifying the presence of severe left ventricular hypertrophy through POC ultrasonography in a patient with AKI and normal or low normal blood pressures may alert clinicians to the diagnosis of normotensive renal failure in individuals with previously unrecognized severe hypertension. In this clinical context, keeping mean arterial pressures higher than usual with vasopressors may improve renal function while decreasing dialysis utilization.^18-21

Likewise, in clinical scenarios of shock with AKI, POC ultrasonography has proven to be an indispensable tool. For example, rapid exploration of the biliary tree demonstrating anterior gallbladder wall thickening, a stone or sludge, common bile duct dilation, or perigallbladder inflammation suggests acute cholecystitis and/or cholangitis as the cause. The presence of dyspnea in association with hypotension and unilateral signs of a higher proportion of comet tails and/or a lung consolidation suggests pneumonia. Rapid differentiation between acute respiratory distress syndrome (ARDS) and pulmonary edema from HF is possible with ultrasonography. When pleural line abnormalities are seen, ARDS is a common cause.

POC ultrasonography will be key in management of ARDS, as ultrasound results will help avoid the use of excessive diuretics, which can result in renal hypoperfusion and AKI.²² In trauma patients, the ultrasound examination will identify free fluid (bleeding) as the source of the prerenal failure, along with its cause (aortic dissection, hepatic hemorrhage, splenic hemorrhage, ectopic pregnancy, etc).²³ Sonographic free air observed in the abdomen can provide the clue of a perforated viscus.²⁴ The sonographic image of an inflamed pancreas can suggest pancreatitis as the cause of the systemic hypotension. Ultimately, intravascular losses in the hypoechoic edematous bowel wall in obstruction, ileus, pseudomembranous, or infectious or autoimmune enterocolitis can lead to significant decreases in the EACF and cause prerenal injury.

Related: Prevalence of Suspicious Ultrasound Features in Hot Thyroid Nodules

Intrinsic Renal Disease

In intrinsic AKI, acute tubular necrosis (ATN), glomerulonephritis, and interstitial nephritis are the typical causes. Although no signs are specific to each of the potential causes, a poor corticomedullary differentiation, kidney size < 9 cm, and cortex size < 1 cm help to distinguish CKD from AKI, especially if no previous serum creatinine values are available. The early diagnosis of ATN continues to be clinically relevant in the management of acute renal failure. Despite not being a practical tool for POC sonography currently, the use of bedside Doppler repetitive renal vasculature measures of resistive index predict occurrence and severity of ATN in the critical care setting and are an independent risk factor for poor survival in arterial hypertension and HF.^25-30

Other POC sonographic evaluations of intrinsic AKI have been helpful in the following clinical scenarios. The presence of an ultrasonographic sign of sinusitis in the context of nephritic sediment and a rapid decline of renal function suggest antineutrophil cytoplasmic antibody (ANCA)-related vasculitis. Likewise, in younger adults, nephritic sediment and bilateral sonographic lung interstitial fluid in the absence of infection and a normal POC echocardiogram without significant edema elsewhere suggest glomerulonephritis in the category of pulmonary lung syndrome caused by antiglomerular basement membrane antibodies.

In the elderly, a similar systemic presentation suggests an ANCA vasculitis. Pleural effusion, synovitis, proteinuria, and/or hematuria will suggest lupus nephritis. Another important cause of acute renal failure in the critical care setting is intra-abdominal compartment syndrome. Here, bladder pressure measurement protocols are the standard of care. A human model evaluated the predictive value of intra-abdominal compartment syndrome pressures using the IVC square surface. In this study, a normal surface area of the IVC of > 1 cm²/m² excluded the presence of intra-abdominal hypertension 87.5% of the time. However, the sensitivity of detection of the intra-abdominal hypertension was only 67.5% when the surface area of the IVC was < 1 cm²/m².³¹

CKD and Associated Diseases

The diagnostic validity of ultrasonography is well established in adult-onset polycystic kidney disease. Bedside visualization of a parathyroid adenoma may be an important clue for a patient with CKD, echogenic kidneys, or nephrolithiasis with or without hypercalcemia to diagnose primary hyperparathyroidism. The sonographic diagnosis of abnormal parathyroid gland compared with parathyroid surgical exploration had a sensitivity, specificity, and positive predictive value of 74%, 96%, and 90%, respectively.³² In the clinical presentation of severe hypertension with headaches, ultrasonography at bedside can provide valuable diagnostic and risk assessment information of endocranial hypertension from measuring the optic nerve sheath. Sensitivity and specificity of papilledema was 90% and 79%, respectively, when 3.3 mm was the cutoff of the nerve sheath with a 30-degrees sign.³³ The carotid artery intima media thickness measured on sonography correlates with the future development of atherogenesis, left ventricular hypertrophy, cognition deficits, CKD, and cardiovascular disease in asymptomatic patients. An intima media thickness of > 1.1 mm has been associated with a higher cardiovascular mortality.

Early initiation of antihypertensive medications and/or statins has been suggested to lower risk in these asymptomatic patients.³⁴ The size and contour (smooth or irregular) of kidneys may provide clues to reflux nephropathy, dysplastic kidneys, radiation nephritis, or chronic pyelonephritis. The presence of nephrotic syndrome and abnormal free light chains ratio with a bedside echocardiogram showing the typical refractile myocardial walls with a peculiar speckled pattern is strongly suggestive of amyloidosis.³⁵ Conditions associated with chronic hypercalcemia, medullary sponge kidney, milk alkali syndrome, sarcoidosis, and distal renal tubular acidosis are causes of nephrocalcinosis. Some degree of CKD is a constant feature in nephrocalcinosis. The initial imaging of choice in nephrocalcinosis and specially the medullary type is ultrasonography preferable to X-ray and perhaps to computed tomography.³⁶

End-Stage Renal Disease

In a patient undergoing peritoneal dialysis with exit-site infection, the presence of > 1 mm radiolucent rim around the subcutaneous catheter after antibiotics has a bad prognosis and prompts catheter removal. This sonographic sign has a positive and negative predictive value for a tunneled infection of 84.6% and 94.1%, respectively.^37,38 A risk factor for peritonitis in peritoneal dialysis is air in the peritoneum, which can be seen in one-third of patients. These individuals have 2.4 times more risk of peritonitis compared with patients without pneumoperitoneum. The sensitivity and specificity of sonographic detection of pneumoperitoneum is 94% and 100%, respectively, using the scissor technique.³⁹ Proper training in performing home peritoneal dialysis decreases the incidence of pneumoperitoneum. Although not formally assessed, patient education and change in procedure techniques may decrease the incidence of pneumoperitoneum and peritonitis. The use of prelaparoscopic ultrasonography before insertion of the peritoneal dialysis catheter has detected intra-abdominal adhesions (visceral slide sign) with a sensitivity of 90% to 92%.⁴⁰

History and physical examination are frequently helpful in the diagnosis of malfunctioning arteriovenous fistulas (AVF) for inflow or outflow disturbances, with sensitivity ranging from 70% to 100% and specificity ranging from 71% to 93% compared with angiography. Frequently, POC limited ultrasound can be helpful for a problematic AVF, either for cannulation or diagnosis. The congruence of duplex sonography with arteriogram is 85% to 96%. Various etiologies of a dysfunctional AVF (pseudo- or true aneurysm, poor development, stenosis, thrombi, or accessory veins) can be observed in the dialysis unit through limited sonography.^41-44

After placement of a hemodialysis catheter using real-time ultrasonography, pneumohemothorax can be diagnosed reliably and rapidly. Catheter misplacement outside of the right atrium was detected by thoracic echocardiogram with a sensitivity of 96%, a specificity of 83%, and a positive predictive value of 98%.^45,46 Ultimately, ultrasonography may replace chest X-ray in most cases after central vein dialysis catheter placement in the acute care setting.

Postrenal Failure

The sensitivity of ultrasonography to detect dilation to hydronephrosis of the pelvicaliceal system is well established. Sonography is the diagnostic examination of choice in pregnancy and the initial screening test for the nonpregnant patient. Computed tomography is the preferred imaging study in nephroureterolithiasis; however, due to ionizing radiation and cost, ultrasonography is gaining popularity for initial and/or follow-up evaluations. The ureteral jet is a relatively unexplored color and Doppler sonographic methodology that can provide insight into pelvicalyceal peristalsis, potentially yielding evidence of functional obstruction.^47-51 Postvoid bladder residual volumes and bladder wall hypertrophy may provide important clues as to the cause(s) of the obstructive uropathy.

Telenephrology

In our institution, sonography is used in the evaluation of IVC, lungs, and kidneys via telemedicine. The probe is handled by trained nurses at the distant site. 

Cardiac Arrest in ESRD

Patients with ESRD may have sudden cardiac arrest as a result of several etiologies. During the advance cardiac life support algorithm, there is a brief period of evaluation of the electrical rhythm in which echocardiography can be helpful with the diagnosis immediately after the 2 initial minutes of cardiopulmonary resuscitation. An enlarged right ventricular cavity (> 2/3 of the left ventricle) is a sonographic sign of a pulmonary embolism.

Bedside sonography has the potential to alter the current guidelines of advance cardiac life support management. For example, if the bedside echo shows a significant pericardial effusion, a pericardiocentesis could be performed faster as it would be diagnosed faster. In addition, at times the heart may appear to be beating rapidly but there is a small amount of fluid (blood) within the cardiac chambers. This may be from an extreme case of dehydration for which rapid administration of IV fluids may help manage. Therefore, a quick bedside point of care echocardiography may reveal a cardiac anomaly that may be able to be restored in a efficient manner. 

Related: General Applications of Ultrasound in Rheumatology Practice

Conclusion

Ultrasonography at the POC provides an important and continuously expanding tool to improve nephrological diagnostic accuracy in concert with history and physical examination. Extracellular fluid evaluation is paramount in all kidney disease conditions. Recent clinical studies in lung ultrasonography suggest that the learning curve for the medical provider is quicker than with other organs. Because POC sonography in association with limited bedside echocardiography may reveal discriminatory signs of pneumonia and differentiate between cardiogenic vs noncardiogenic pulmonary edema, such imaging may be important cost-effective strategies in the management of dyspnea and in the categorization/etiology of AKI. Therefore, incorporation of POC sonography into clinical practice will require that medical schools, residency programs, and nephrology fellowship programs design teaching strategies within their respective curricula. Research studies with outcomes regarding diagnosis, morbidity, and mortality are necessary in these areas.

Although patients with multiple myeloma (MM) have an increased risk of developing venous thromboembolism (VTE), no validated model exists that predicts VTE in MM. To help health care providers better assess the risks and the appropriateness of thromboprophylaxis, a team of researchers have developed the IMPEDE VTE risk assessment tool.

According to Kristen M. Sanfilippo, MD, of Washington University School of Medicine and the St. Louis Veterans Affairs Medical Center in Missouri, who presented the paper at the American Society of Hematology meeting last week in San Diego, this is the first effort to build a tool that is both internally and externally validated. The goal was to develop a model that outperformed current National Comprehensive Cancer Network (NCCN) guidelines for VTE that are based on expert opinion and were not specific to patients with multiple myeloma.

“We evaluated the performance of the current NCCN and International Myeloma Working Group guidelines with the VA data and our model outperformed these guidelines. Our recommendations is that our IMPEDE VTE should be considered to replace them,” said Sanfilippo. "I think we can improve our predictability of thrombosis in myeloma by adding novel predictors to the model, but that would have to be assessed in a prospective manner.”

Using the VA Central Cancer Registry, the researchers identified 4,448 patients diagnosed with MM between 1999 and 2014 and retrospectively followed the patients for 180 days after start of MM chemotherapy. Using beta coefficients, the researchers developed a risk score by dividing by a common divisor and rounding to the nearest integer. The risk score for each patient was the sum of all scores for each predictor variable.

The factors associated with VTE were combined to develop the IMPEDE VTE score. The factors were: Immunomodulatory drugs, 3 points; BMI > 25,  1 point; Pathologic fracture pelvis/femur 2 points; Erythropoiesis-stimulating agents, 1 point, Dexamethasone (High-dose 4 points; low-dose 2 points)/Doxorubicin 2 points; Asian Ethnicity, -3 points; history of VTE, 3 points; Tunneled line/ central venous catheter, 2 points). In addition, use of therapeutic anticoagulation (-5 points) with warfarin or low molecular weight heparin (LWMH) and use of prophylactic LMWH or aspirin (-2 points) were associated with a decreased risk of VTE. The risk score then identifies patients’ VTE risk as low (≤ 3), intermediate (4-6), or high (≥ 7).

According to Sanfilippo, the model showed satisfactory discrimination in both the derivation cohort (Harrell’s c-statistic = 0.66) and in the bootstrap validation, c-statistic = 0.66 (95% CI: 0.63 – 0.70). Within the first 6-months of starting chemotherapy, the rate of VTE was 3.5% compared to > 10% for high-risk patients.

The researchers hoped that the risk prediction model for VTE in MM would allow for use of thromboprophylaxis in MM patients at high-risk of VTE while sparing those at low risk. 

Although patients with multiple myeloma (MM) have an increased risk of developing venous thromboembolism (VTE), no validated model exists that predicts VTE in MM. To help health care providers better assess the risks and the appropriateness of thromboprophylaxis, a team of researchers have developed the IMPEDE VTE risk assessment tool.

According to Kristen M. Sanfilippo, MD, of Washington University School of Medicine and the St. Louis Veterans Affairs Medical Center in Missouri, who presented the paper at the American Society of Hematology meeting last week in San Diego, this is the first effort to build a tool that is both internally and externally validated. The goal was to develop a model that outperformed current National Comprehensive Cancer Network (NCCN) guidelines for VTE that are based on expert opinion and were not specific to patients with multiple myeloma.

“We evaluated the performance of the current NCCN and International Myeloma Working Group guidelines with the VA data and our model outperformed these guidelines. Our recommendations is that our IMPEDE VTE should be considered to replace them,” said Sanfilippo. "I think we can improve our predictability of thrombosis in myeloma by adding novel predictors to the model, but that would have to be assessed in a prospective manner.”

Using the VA Central Cancer Registry, the researchers identified 4,448 patients diagnosed with MM between 1999 and 2014 and retrospectively followed the patients for 180 days after start of MM chemotherapy. Using beta coefficients, the researchers developed a risk score by dividing by a common divisor and rounding to the nearest integer. The risk score for each patient was the sum of all scores for each predictor variable.

The factors associated with VTE were combined to develop the IMPEDE VTE score. The factors were: Immunomodulatory drugs, 3 points; BMI > 25,  1 point; Pathologic fracture pelvis/femur 2 points; Erythropoiesis-stimulating agents, 1 point, Dexamethasone (High-dose 4 points; low-dose 2 points)/Doxorubicin 2 points; Asian Ethnicity, -3 points; history of VTE, 3 points; Tunneled line/ central venous catheter, 2 points). In addition, use of therapeutic anticoagulation (-5 points) with warfarin or low molecular weight heparin (LWMH) and use of prophylactic LMWH or aspirin (-2 points) were associated with a decreased risk of VTE. The risk score then identifies patients’ VTE risk as low (≤ 3), intermediate (4-6), or high (≥ 7).

According to Sanfilippo, the model showed satisfactory discrimination in both the derivation cohort (Harrell’s c-statistic = 0.66) and in the bootstrap validation, c-statistic = 0.66 (95% CI: 0.63 – 0.70). Within the first 6-months of starting chemotherapy, the rate of VTE was 3.5% compared to > 10% for high-risk patients.

The researchers hoped that the risk prediction model for VTE in MM would allow for use of thromboprophylaxis in MM patients at high-risk of VTE while sparing those at low risk. 

Although patients with multiple myeloma (MM) have an increased risk of developing venous thromboembolism (VTE), no validated model exists that predicts VTE in MM. To help health care providers better assess the risks and the appropriateness of thromboprophylaxis, a team of researchers have developed the IMPEDE VTE risk assessment tool.

According to Kristen M. Sanfilippo, MD, of Washington University School of Medicine and the St. Louis Veterans Affairs Medical Center in Missouri, who presented the paper at the American Society of Hematology meeting last week in San Diego, this is the first effort to build a tool that is both internally and externally validated. The goal was to develop a model that outperformed current National Comprehensive Cancer Network (NCCN) guidelines for VTE that are based on expert opinion and were not specific to patients with multiple myeloma.

“We evaluated the performance of the current NCCN and International Myeloma Working Group guidelines with the VA data and our model outperformed these guidelines. Our recommendations is that our IMPEDE VTE should be considered to replace them,” said Sanfilippo. "I think we can improve our predictability of thrombosis in myeloma by adding novel predictors to the model, but that would have to be assessed in a prospective manner.”

Using the VA Central Cancer Registry, the researchers identified 4,448 patients diagnosed with MM between 1999 and 2014 and retrospectively followed the patients for 180 days after start of MM chemotherapy. Using beta coefficients, the researchers developed a risk score by dividing by a common divisor and rounding to the nearest integer. The risk score for each patient was the sum of all scores for each predictor variable.

The factors associated with VTE were combined to develop the IMPEDE VTE score. The factors were: Immunomodulatory drugs, 3 points; BMI > 25,  1 point; Pathologic fracture pelvis/femur 2 points; Erythropoiesis-stimulating agents, 1 point, Dexamethasone (High-dose 4 points; low-dose 2 points)/Doxorubicin 2 points; Asian Ethnicity, -3 points; history of VTE, 3 points; Tunneled line/ central venous catheter, 2 points). In addition, use of therapeutic anticoagulation (-5 points) with warfarin or low molecular weight heparin (LWMH) and use of prophylactic LMWH or aspirin (-2 points) were associated with a decreased risk of VTE. The risk score then identifies patients’ VTE risk as low (≤ 3), intermediate (4-6), or high (≥ 7).

According to Sanfilippo, the model showed satisfactory discrimination in both the derivation cohort (Harrell’s c-statistic = 0.66) and in the bootstrap validation, c-statistic = 0.66 (95% CI: 0.63 – 0.70). Within the first 6-months of starting chemotherapy, the rate of VTE was 3.5% compared to > 10% for high-risk patients.

The researchers hoped that the risk prediction model for VTE in MM would allow for use of thromboprophylaxis in MM patients at high-risk of VTE while sparing those at low risk. 

Activity during week 5 of open enrollment on HealthCare.gov was up by more than 50% over the previous week, but the total number of plans selected for the 2019 coverage year remains lower than it was last year, according to the Centers for Medicare & Medicaid Services.

The 773,000 plans selected during week 5 (Nov. 25 – Dec. 1) of the 2019 open enrollment season were an increase of 54% over week 4, CMS data show for the 39 states that use the HealthCare.gov platform, with the cumulative total now at 3.2 million. By comparison, week-5 selections in last year’s open enrollment totaled 823,000, and the cumulative figure was 3.6 million.

The deadline for applying for 2019 coverage on HealthCare.gov is Dec. 15.

[email protected]

Activity during week 5 of open enrollment on HealthCare.gov was up by more than 50% over the previous week, but the total number of plans selected for the 2019 coverage year remains lower than it was last year, according to the Centers for Medicare & Medicaid Services.

The 773,000 plans selected during week 5 (Nov. 25 – Dec. 1) of the 2019 open enrollment season were an increase of 54% over week 4, CMS data show for the 39 states that use the HealthCare.gov platform, with the cumulative total now at 3.2 million. By comparison, week-5 selections in last year’s open enrollment totaled 823,000, and the cumulative figure was 3.6 million.

The deadline for applying for 2019 coverage on HealthCare.gov is Dec. 15.

[email protected]

Activity during week 5 of open enrollment on HealthCare.gov was up by more than 50% over the previous week, but the total number of plans selected for the 2019 coverage year remains lower than it was last year, according to the Centers for Medicare & Medicaid Services.

The 773,000 plans selected during week 5 (Nov. 25 – Dec. 1) of the 2019 open enrollment season were an increase of 54% over week 4, CMS data show for the 39 states that use the HealthCare.gov platform, with the cumulative total now at 3.2 million. By comparison, week-5 selections in last year’s open enrollment totaled 823,000, and the cumulative figure was 3.6 million.

The deadline for applying for 2019 coverage on HealthCare.gov is Dec. 15.

[email protected]

This week, apixaban edges out other DOACs for octogenarians, methotrexate fails to cut cardiovascular events in a large trial, withdrawing heart failure medications after recovery leads to relapse, and showing patients their own atherosclerosis may reduce their cardiovascular event risk.

Subscribe to Cardiocast wherever you get your podcasts.
Amazon Alexa
Apple Podcasts






 

This week, apixaban edges out other DOACs for octogenarians, methotrexate fails to cut cardiovascular events in a large trial, withdrawing heart failure medications after recovery leads to relapse, and showing patients their own atherosclerosis may reduce their cardiovascular event risk.

Subscribe to Cardiocast wherever you get your podcasts.
Amazon Alexa
Apple Podcasts






 

This week, apixaban edges out other DOACs for octogenarians, methotrexate fails to cut cardiovascular events in a large trial, withdrawing heart failure medications after recovery leads to relapse, and showing patients their own atherosclerosis may reduce their cardiovascular event risk.

Subscribe to Cardiocast wherever you get your podcasts.
Amazon Alexa
Apple Podcasts






 

SAN DIEGO – Prophylaxis with rivaroxaban significantly reduced the rate of venous thromboembolism and associated death in high-risk ambulatory cancer patients receiving systemic therapy, results of a randomized trial show.

The reduction in venous thromboembolism (VTE) or VTE-related death was not statistically significant in the primary analysis, in part because a large proportion of patients stopped taking the direct oral anticoagulant, according to investigator Alok A. Khorana, MD, of the Cleveland Clinic.

However, the reduction in events was significant in a prespecified secondary analysis limited to the on-treatment period, Dr. Khorana reported at the annual meeting of the American Society of Hematology, adding that rates of major and nonmajor bleeding were low.

Results are “eagerly awaited” from a different prophylaxis trial – the AVERT study – looking at another direct oral anticoagulant in high-risk cancer patients, Dr. Khorana said in a late-breaking abstracts session.

“If the findings of that trial are consistent with ours, then we certainly hope that these findings should inform future recommendations regarding thromboprophylaxis for high-risk ambulatory cancer patients, and then the landscape of anticoagulation in the cancer population should start to shift from management of events to primary prevention,” he said.

In the study by Dr. Khorana and his colleagues, known as CASSINI, 841 patients with various solid tumors and lymphomas were randomized to either rivaroxaban 10 mg or placebo once daily. The patients, enrolled at 143 study centers in 11 countries, all had a Khorana risk score of 2 or greater.

In the primary analysis period of 180 days, the composite endpoint of VTE or VTE-related death occurred in 5.95% of the rivaroxaban-treated group and 8.79% of the placebo group (hazard ratio, 0.66; 95% confidence interval, 0.40-1.09; P = .101). However, a total of 177 patients (43.7%) stopped rivaroxaban earlier than 180 days, and likewise, 203 patients (50.2%) stopped placebo early.

In a prespecified secondary analysis looking just at the period of time when patients were actually taking rivaroxaban or placebo, rivaroxaban did significantly reduce risk of VTE or VTE-related death, Dr. Khorana said. The composite endpoint occurred in 2.62% of the rivaroxaban patients and 6.41% of placebo patients in that on-treatment analysis (HR, 0.40; 95% CI, 0.20-0.80; P = .007).

Rates of major bleeding and clinically relevant nonmajor bleeding were not significantly different between groups, according to results of a safety analysis. Major bleeding occurred in eight rivaroxaban patients and four placebo patients, or 1.98% and 0.99%, respectively (P = .265).

CASSINI was sponsored by Bayer and Janssen. Dr. Khorana reported disclosures related to Janssen, Bayer, PAREXEL, Sanofi, Pfizer, TriSalus Life Sciences, Halozyme, Seattle Genetics, AngioDynamics, and others.

SAN DIEGO – Prophylaxis with rivaroxaban significantly reduced the rate of venous thromboembolism and associated death in high-risk ambulatory cancer patients receiving systemic therapy, results of a randomized trial show.

The reduction in venous thromboembolism (VTE) or VTE-related death was not statistically significant in the primary analysis, in part because a large proportion of patients stopped taking the direct oral anticoagulant, according to investigator Alok A. Khorana, MD, of the Cleveland Clinic.

However, the reduction in events was significant in a prespecified secondary analysis limited to the on-treatment period, Dr. Khorana reported at the annual meeting of the American Society of Hematology, adding that rates of major and nonmajor bleeding were low.

Results are “eagerly awaited” from a different prophylaxis trial – the AVERT study – looking at another direct oral anticoagulant in high-risk cancer patients, Dr. Khorana said in a late-breaking abstracts session.

“If the findings of that trial are consistent with ours, then we certainly hope that these findings should inform future recommendations regarding thromboprophylaxis for high-risk ambulatory cancer patients, and then the landscape of anticoagulation in the cancer population should start to shift from management of events to primary prevention,” he said.

In the study by Dr. Khorana and his colleagues, known as CASSINI, 841 patients with various solid tumors and lymphomas were randomized to either rivaroxaban 10 mg or placebo once daily. The patients, enrolled at 143 study centers in 11 countries, all had a Khorana risk score of 2 or greater.

In the primary analysis period of 180 days, the composite endpoint of VTE or VTE-related death occurred in 5.95% of the rivaroxaban-treated group and 8.79% of the placebo group (hazard ratio, 0.66; 95% confidence interval, 0.40-1.09; P = .101). However, a total of 177 patients (43.7%) stopped rivaroxaban earlier than 180 days, and likewise, 203 patients (50.2%) stopped placebo early.

In a prespecified secondary analysis looking just at the period of time when patients were actually taking rivaroxaban or placebo, rivaroxaban did significantly reduce risk of VTE or VTE-related death, Dr. Khorana said. The composite endpoint occurred in 2.62% of the rivaroxaban patients and 6.41% of placebo patients in that on-treatment analysis (HR, 0.40; 95% CI, 0.20-0.80; P = .007).

Rates of major bleeding and clinically relevant nonmajor bleeding were not significantly different between groups, according to results of a safety analysis. Major bleeding occurred in eight rivaroxaban patients and four placebo patients, or 1.98% and 0.99%, respectively (P = .265).

CASSINI was sponsored by Bayer and Janssen. Dr. Khorana reported disclosures related to Janssen, Bayer, PAREXEL, Sanofi, Pfizer, TriSalus Life Sciences, Halozyme, Seattle Genetics, AngioDynamics, and others.

SAN DIEGO – Prophylaxis with rivaroxaban significantly reduced the rate of venous thromboembolism and associated death in high-risk ambulatory cancer patients receiving systemic therapy, results of a randomized trial show.

The reduction in venous thromboembolism (VTE) or VTE-related death was not statistically significant in the primary analysis, in part because a large proportion of patients stopped taking the direct oral anticoagulant, according to investigator Alok A. Khorana, MD, of the Cleveland Clinic.

However, the reduction in events was significant in a prespecified secondary analysis limited to the on-treatment period, Dr. Khorana reported at the annual meeting of the American Society of Hematology, adding that rates of major and nonmajor bleeding were low.

Results are “eagerly awaited” from a different prophylaxis trial – the AVERT study – looking at another direct oral anticoagulant in high-risk cancer patients, Dr. Khorana said in a late-breaking abstracts session.

“If the findings of that trial are consistent with ours, then we certainly hope that these findings should inform future recommendations regarding thromboprophylaxis for high-risk ambulatory cancer patients, and then the landscape of anticoagulation in the cancer population should start to shift from management of events to primary prevention,” he said.

In the study by Dr. Khorana and his colleagues, known as CASSINI, 841 patients with various solid tumors and lymphomas were randomized to either rivaroxaban 10 mg or placebo once daily. The patients, enrolled at 143 study centers in 11 countries, all had a Khorana risk score of 2 or greater.

In the primary analysis period of 180 days, the composite endpoint of VTE or VTE-related death occurred in 5.95% of the rivaroxaban-treated group and 8.79% of the placebo group (hazard ratio, 0.66; 95% confidence interval, 0.40-1.09; P = .101). However, a total of 177 patients (43.7%) stopped rivaroxaban earlier than 180 days, and likewise, 203 patients (50.2%) stopped placebo early.

In a prespecified secondary analysis looking just at the period of time when patients were actually taking rivaroxaban or placebo, rivaroxaban did significantly reduce risk of VTE or VTE-related death, Dr. Khorana said. The composite endpoint occurred in 2.62% of the rivaroxaban patients and 6.41% of placebo patients in that on-treatment analysis (HR, 0.40; 95% CI, 0.20-0.80; P = .007).

Rates of major bleeding and clinically relevant nonmajor bleeding were not significantly different between groups, according to results of a safety analysis. Major bleeding occurred in eight rivaroxaban patients and four placebo patients, or 1.98% and 0.99%, respectively (P = .265).

CASSINI was sponsored by Bayer and Janssen. Dr. Khorana reported disclosures related to Janssen, Bayer, PAREXEL, Sanofi, Pfizer, TriSalus Life Sciences, Halozyme, Seattle Genetics, AngioDynamics, and others.

Anesthesia care is provided by physician anesthesiologists, certified registered nurse anesthetists (CRNAs), anesthesiology residents, and anesthesiologist assistants. These providers may practice alone (anesthesiologists or CRNAs) or in various combinations of supervised roles and teams. Previous studies reveal mixed findings regarding whether patient outcomes differ by anesthesia practice models.^1-7However, little is known about the prevalence of various anesthesia models in the US.

Background

In recent years, anesthesiology has undergone substantial expansion in its scope of services provided, the settings in which it is provided, and the diversity of its workforce.⁸As the field continues to evolve, especially within the context of value-based health care reform, it is imperative to evaluate how anesthesia care models are used in health systems and how these models may optimize care delivery.

The Veterans Health Administration (VHA) is the largest integrated health care system in the US, providing surgical care in 110 inpatient medical centers and 27 ambulatory surgery centers. Despite national integration, anesthesia practices vary widely among facilities. The question of which model of anesthesia care is associated with the best outcomes and offers the most value is widely debated.^1,5,7,9 As an important first step in understanding anesthesia care delivery, a baseline assessment of the practice patterns of anesthesia providers is necessary and may benefit future studies of the impact of these care models on outcomes. Thus, the aim of this work was to understand and describe the previously unassessed landscape of anesthesia care delivery within the VHA.

Methods

As part of a larger evaluation of anesthesia care delivery in the VHA, an observational assessment of anesthesia provider practice patterns was conducted using retrospective surgical data. This project complies with VHA policy pertaining to nonresearch operational activities and did not require institutional review board approval and adheres to the EQUATOR Network guidelines described in Strengthening the Reporting of Observational Studies in Epidemiology (STROBE).¹⁰

Data were obtained from the VHA Managerial Cost Accounting National Data Extract for Surgery package for all surgical procedures (n = 726,706) between October 1, 2013 and March 31, 2015. There were 420 facilities represented in these surgical data. The VHA facility records were used to specifically identify inpatient and ambulatory surgery facilities for inclusion. Additionally, to ensure facilities were valid surgical sites with sufficient surgical volume, those with 100 or fewer cases during the period were excluded. In total, 288 facilities with 9,434 surgical cases (representing 1% of cases) were excluded. These excluded facilities included nursing homes (38%), domiciliaries (26%), outpatient clinics (11%), rehabilitation programs (9%), other nonsurgical facilities (8%), and medical centers (8%). The majority (80%) of excluded medical centers had 30 or fewer surgical cases.

In 6 instances, data from subfacilities were combined with their organizationally affiliated main facilities. The final sample included 125 facilities. The VHA assigns a complexity level designation to facilities, defined as follows: 1a (most complex), 1b, 1c, 2, and 3 (least complex).¹¹ Facilities with 1a designation perform the most complex surgical cases, such as cardiovascular surgery or neurosurgery and have more staff and resource support, whereas levels 2 and 3 facilities perform fewer and less complex cases.

Surgical records were excluded when the primary Current Procedural Terminology (CPT) code was missing (n = 85,748, or 12% of cases). This resulted in 631,524 remaining cases. The surgical CPT codes were mapped to anesthesia CPT codes to obtain the associated base unit (BU) values via a published crosswalk by the American Society of Anesthesiologists (ASA).¹² A higher number of associated BUs indicates a more complex procedure. For example, procedures such as biopsies, arthroscopies, and laparoscopies receive 3 to 4 BUs, whereas a venous thrombectomy of the leg and a transurethral resection of the prostate are both 5 BUs, a total knee arthroplasty is 7 BUs, a craniotomy is 10 BUs, and a coronary artery bypass receives 18 BUs. Surgical case complexity was defined as low (3 or 4 BUs), medium (5 BUs), and high (≥ 6 BUs). Although the VHA has an existing case complexity assignment process based on CPT codes, it defines complexity differently for inpatient facilities and ambulatory surgery centers. Thus, the BU-defined complexity permitted a standardized complexity categorization across all facilities. Categorization of BUs similar to this has previously been used in the literature as a proxy for case complexity.^13,14

Patient-level information included the ASA physical status classification, a measure of overall health status determined by an anesthesia provider preoperatively.¹⁵ These classifications included ASA I (healthy), ASA II (mild systemic disease), ASA III (severe systemic disease), ASA IV (severe systemic disease that is a constant threat to life), and ASA V (moribund patient who is not expected to survive without surgery). The last classification, ASA VI: brain-dead with planned organ donation, was excluded. The “E” subcategory denoting “emergency” was subsumed within the corresponding ASA category (eg, ASA V-E was combined with ASA V).

Provider data identified the principal and supervising (if present) anesthetists involved in the case. The provision of anesthesia care was categorized into 3 models: Model 1—a physician anesthesiologist supervising a CRNA; Model 2—a physician anesthesiologist practicing independently or supervising an anesthesiology resident; and Model 3—a CRNA without supervision. Surgical cases were excluded when there was no anesthesia provider (n = 95,795, or 15% of remaining cases), or a nonanesthesia provider (n = 51,647, or 8% of remaining cases) on record. The final sample was 484,082 surgical cases conducted at 125 facilities.

Related: Improving Care and Reducing Length of Stay in Patients Undergoing Total Knee Replacement

Statistical Analysis

The percentage of surgical cases in each anesthesia care model was calculated overall and by the following characteristics: surgical case complexity, ASA classification, and facility complexity. The anesthesia model was determined for each case and summed at the facility level, yielding a total number of cases attributed to each model for each facility, thus identifying the predominant anesthesia model for each facility. The facilities were geographically displayed by their predominant anesthesia model and total number of surgical cases during the period. Because the aim was to present a descriptive representation of anesthesia care models, rather than infer significance, statistical testing was not included.

Results

A total of 484,082 surgical cases met inclusion criteria (Table). These cases were from 109 inpatient facilities and 16 ambulatory surgery facilities. 

The percentage of cases in Model 1 was similar across the levels of surgical case complexity. However, a higher proportion of highly complex cases had a physician anesthesiologist (Model 2, 38.8%) than a CRNA (Model 3, 6.4%) as the primary anesthesia provider. Patients in each ASA classification were most likely to receive anesthesia care via Model 1. As ASA level increased, fewer patients had their anesthesia managed by a CRNA without supervision (Model 3: 18.4% of ASA 1 patients vs 8.3% of ASA 4 patients).

Facility complexity demonstrated notable differences in the proportions of surgical cases within each model. More than half of surgical cases in the largest, most complex facilities used Model 1 (64.9%, 58.2%, and 57.7% of cases in 1a, 1b, and 1c facilities, respectively). In comparison, Model 3 was found almost exclusively among surgical cases in smaller facilities with lower complexity (52% and 74% of cases in level 2 and 3 facilities, respectively).

The Figure displays the 125 facilities by their predominant model of anesthesia care. The diameter of the dots is relative to the facility’s total number of surgical cases. For each facility, the predominant model accounted for about half or more of cases but was not necessarily the only model of care used at a particular facility. 

Related: Initiative to Minimize Pharmaceutical Risk in Older Veterans (IMPROVE) Polypharmacy Clinic

Discussion

Anesthesia care in more than half of surgical cases in VHA facilities was delivered by physician anesthesiologists supervising CRNAs. This model of anesthesia care was the dominant model in 54% of the facilities included in the sample. Consistent with a study of non-VHA facilities, this assessment found that the type of facility may influence the model of anesthesia care, with smaller, less complex facilities more often using a CRNA without supervision model.⁴ In these data, it was noted that among the 28 facilities that predominantly used Model 3, half had 12% or fewer cases that indicated a physician anesthesiologist model of care, and 6 had no cases with physician anesthesiologist involvement. These findings may reflect the limited scope of surgical services offered at lower complexity facilities and/or the reduced availability and/or utilization of physician anesthesiologists in these facilities.

Limitations

We recognize limitations in our assessment of anesthesia care. The documented presence or absence of a supervising anesthesia provider on the surgical record may not adequately characterize the model of anesthesia care in use at a facility, thus limiting an understanding of care delivery relationships among anesthesia providers. In addition, the patterns of anesthesia care delivery are likely influenced by factors not accounted for in this assessment, including the labor market share and economic forces.^16,17 The veteran population tends to be older, male, and with substantial chronic disease burden, thus may have differing surgical needs and experiences than that of the general public.^18,19 The surgical services offered in VHA facilities as well as the policies and practice environment surrounding anesthesia care also may vary from those found in nongovernmental facilities. However, as the largest health care system in the US, the VHA provides a diverse and robust surgical program. Many VHA facilities are large teaching hospitals with academic affiliations that would parallel some in the public sector. For example, studies have demonstrated similar surgical outcomes for patients in VHA vs non-VHA facilities.²⁰ Therefore, the findings regarding anesthesia care models in VHA are likely relevant to non-VHA surgical sites.

Related: Improving Team-Based Care Coordination Delivery and Documentation in the Health Record

Conclusion

This preliminary assessment of the different models of anesthesia care demonstrates that although primarily relying on teams of anesthesiologists and CRNAs, the VA also uses unsupervised CRNAs to meet veterans’ surgical care needs. Although CRNA practice without supervision represented only 12% of surgical cases in our data, we identified 28 facilities (22%) that predominantly used CRNAs without supervision. Thus, CRNAs with and without supervision deliver a substantial portion of anesthesia care in the VA. The prevalence of CRNAs in documented VA surgical records and among surgical facilities nationwide highlights the importance of further examining their supervised and unsupervised roles in anesthesia care delivery.²¹ As the practice of anesthesiology continues to evolve, it is imperative that research efforts further investigate ways anesthesia care models may optimize care delivery, benefit anesthesia providers, and improve health outcomes for patients.

Anesthesia care is provided by physician anesthesiologists, certified registered nurse anesthetists (CRNAs), anesthesiology residents, and anesthesiologist assistants. These providers may practice alone (anesthesiologists or CRNAs) or in various combinations of supervised roles and teams. Previous studies reveal mixed findings regarding whether patient outcomes differ by anesthesia practice models.^1-7However, little is known about the prevalence of various anesthesia models in the US.

Background

In recent years, anesthesiology has undergone substantial expansion in its scope of services provided, the settings in which it is provided, and the diversity of its workforce.⁸As the field continues to evolve, especially within the context of value-based health care reform, it is imperative to evaluate how anesthesia care models are used in health systems and how these models may optimize care delivery.

The Veterans Health Administration (VHA) is the largest integrated health care system in the US, providing surgical care in 110 inpatient medical centers and 27 ambulatory surgery centers. Despite national integration, anesthesia practices vary widely among facilities. The question of which model of anesthesia care is associated with the best outcomes and offers the most value is widely debated.^1,5,7,9 As an important first step in understanding anesthesia care delivery, a baseline assessment of the practice patterns of anesthesia providers is necessary and may benefit future studies of the impact of these care models on outcomes. Thus, the aim of this work was to understand and describe the previously unassessed landscape of anesthesia care delivery within the VHA.

Methods

As part of a larger evaluation of anesthesia care delivery in the VHA, an observational assessment of anesthesia provider practice patterns was conducted using retrospective surgical data. This project complies with VHA policy pertaining to nonresearch operational activities and did not require institutional review board approval and adheres to the EQUATOR Network guidelines described in Strengthening the Reporting of Observational Studies in Epidemiology (STROBE).¹⁰

Data were obtained from the VHA Managerial Cost Accounting National Data Extract for Surgery package for all surgical procedures (n = 726,706) between October 1, 2013 and March 31, 2015. There were 420 facilities represented in these surgical data. The VHA facility records were used to specifically identify inpatient and ambulatory surgery facilities for inclusion. Additionally, to ensure facilities were valid surgical sites with sufficient surgical volume, those with 100 or fewer cases during the period were excluded. In total, 288 facilities with 9,434 surgical cases (representing 1% of cases) were excluded. These excluded facilities included nursing homes (38%), domiciliaries (26%), outpatient clinics (11%), rehabilitation programs (9%), other nonsurgical facilities (8%), and medical centers (8%). The majority (80%) of excluded medical centers had 30 or fewer surgical cases.

In 6 instances, data from subfacilities were combined with their organizationally affiliated main facilities. The final sample included 125 facilities. The VHA assigns a complexity level designation to facilities, defined as follows: 1a (most complex), 1b, 1c, 2, and 3 (least complex).¹¹ Facilities with 1a designation perform the most complex surgical cases, such as cardiovascular surgery or neurosurgery and have more staff and resource support, whereas levels 2 and 3 facilities perform fewer and less complex cases.

Surgical records were excluded when the primary Current Procedural Terminology (CPT) code was missing (n = 85,748, or 12% of cases). This resulted in 631,524 remaining cases. The surgical CPT codes were mapped to anesthesia CPT codes to obtain the associated base unit (BU) values via a published crosswalk by the American Society of Anesthesiologists (ASA).¹² A higher number of associated BUs indicates a more complex procedure. For example, procedures such as biopsies, arthroscopies, and laparoscopies receive 3 to 4 BUs, whereas a venous thrombectomy of the leg and a transurethral resection of the prostate are both 5 BUs, a total knee arthroplasty is 7 BUs, a craniotomy is 10 BUs, and a coronary artery bypass receives 18 BUs. Surgical case complexity was defined as low (3 or 4 BUs), medium (5 BUs), and high (≥ 6 BUs). Although the VHA has an existing case complexity assignment process based on CPT codes, it defines complexity differently for inpatient facilities and ambulatory surgery centers. Thus, the BU-defined complexity permitted a standardized complexity categorization across all facilities. Categorization of BUs similar to this has previously been used in the literature as a proxy for case complexity.^13,14

Patient-level information included the ASA physical status classification, a measure of overall health status determined by an anesthesia provider preoperatively.¹⁵ These classifications included ASA I (healthy), ASA II (mild systemic disease), ASA III (severe systemic disease), ASA IV (severe systemic disease that is a constant threat to life), and ASA V (moribund patient who is not expected to survive without surgery). The last classification, ASA VI: brain-dead with planned organ donation, was excluded. The “E” subcategory denoting “emergency” was subsumed within the corresponding ASA category (eg, ASA V-E was combined with ASA V).

Provider data identified the principal and supervising (if present) anesthetists involved in the case. The provision of anesthesia care was categorized into 3 models: Model 1—a physician anesthesiologist supervising a CRNA; Model 2—a physician anesthesiologist practicing independently or supervising an anesthesiology resident; and Model 3—a CRNA without supervision. Surgical cases were excluded when there was no anesthesia provider (n = 95,795, or 15% of remaining cases), or a nonanesthesia provider (n = 51,647, or 8% of remaining cases) on record. The final sample was 484,082 surgical cases conducted at 125 facilities.

Related: Improving Care and Reducing Length of Stay in Patients Undergoing Total Knee Replacement

Statistical Analysis

The percentage of surgical cases in each anesthesia care model was calculated overall and by the following characteristics: surgical case complexity, ASA classification, and facility complexity. The anesthesia model was determined for each case and summed at the facility level, yielding a total number of cases attributed to each model for each facility, thus identifying the predominant anesthesia model for each facility. The facilities were geographically displayed by their predominant anesthesia model and total number of surgical cases during the period. Because the aim was to present a descriptive representation of anesthesia care models, rather than infer significance, statistical testing was not included.

Results

A total of 484,082 surgical cases met inclusion criteria (Table). These cases were from 109 inpatient facilities and 16 ambulatory surgery facilities. 

The percentage of cases in Model 1 was similar across the levels of surgical case complexity. However, a higher proportion of highly complex cases had a physician anesthesiologist (Model 2, 38.8%) than a CRNA (Model 3, 6.4%) as the primary anesthesia provider. Patients in each ASA classification were most likely to receive anesthesia care via Model 1. As ASA level increased, fewer patients had their anesthesia managed by a CRNA without supervision (Model 3: 18.4% of ASA 1 patients vs 8.3% of ASA 4 patients).

Facility complexity demonstrated notable differences in the proportions of surgical cases within each model. More than half of surgical cases in the largest, most complex facilities used Model 1 (64.9%, 58.2%, and 57.7% of cases in 1a, 1b, and 1c facilities, respectively). In comparison, Model 3 was found almost exclusively among surgical cases in smaller facilities with lower complexity (52% and 74% of cases in level 2 and 3 facilities, respectively).

The Figure displays the 125 facilities by their predominant model of anesthesia care. The diameter of the dots is relative to the facility’s total number of surgical cases. For each facility, the predominant model accounted for about half or more of cases but was not necessarily the only model of care used at a particular facility. 

Related: Initiative to Minimize Pharmaceutical Risk in Older Veterans (IMPROVE) Polypharmacy Clinic

Discussion

Anesthesia care in more than half of surgical cases in VHA facilities was delivered by physician anesthesiologists supervising CRNAs. This model of anesthesia care was the dominant model in 54% of the facilities included in the sample. Consistent with a study of non-VHA facilities, this assessment found that the type of facility may influence the model of anesthesia care, with smaller, less complex facilities more often using a CRNA without supervision model.⁴ In these data, it was noted that among the 28 facilities that predominantly used Model 3, half had 12% or fewer cases that indicated a physician anesthesiologist model of care, and 6 had no cases with physician anesthesiologist involvement. These findings may reflect the limited scope of surgical services offered at lower complexity facilities and/or the reduced availability and/or utilization of physician anesthesiologists in these facilities.

Limitations

We recognize limitations in our assessment of anesthesia care. The documented presence or absence of a supervising anesthesia provider on the surgical record may not adequately characterize the model of anesthesia care in use at a facility, thus limiting an understanding of care delivery relationships among anesthesia providers. In addition, the patterns of anesthesia care delivery are likely influenced by factors not accounted for in this assessment, including the labor market share and economic forces.^16,17 The veteran population tends to be older, male, and with substantial chronic disease burden, thus may have differing surgical needs and experiences than that of the general public.^18,19 The surgical services offered in VHA facilities as well as the policies and practice environment surrounding anesthesia care also may vary from those found in nongovernmental facilities. However, as the largest health care system in the US, the VHA provides a diverse and robust surgical program. Many VHA facilities are large teaching hospitals with academic affiliations that would parallel some in the public sector. For example, studies have demonstrated similar surgical outcomes for patients in VHA vs non-VHA facilities.²⁰ Therefore, the findings regarding anesthesia care models in VHA are likely relevant to non-VHA surgical sites.

Related: Improving Team-Based Care Coordination Delivery and Documentation in the Health Record

Conclusion

This preliminary assessment of the different models of anesthesia care demonstrates that although primarily relying on teams of anesthesiologists and CRNAs, the VA also uses unsupervised CRNAs to meet veterans’ surgical care needs. Although CRNA practice without supervision represented only 12% of surgical cases in our data, we identified 28 facilities (22%) that predominantly used CRNAs without supervision. Thus, CRNAs with and without supervision deliver a substantial portion of anesthesia care in the VA. The prevalence of CRNAs in documented VA surgical records and among surgical facilities nationwide highlights the importance of further examining their supervised and unsupervised roles in anesthesia care delivery.²¹ As the practice of anesthesiology continues to evolve, it is imperative that research efforts further investigate ways anesthesia care models may optimize care delivery, benefit anesthesia providers, and improve health outcomes for patients.

Anesthesia care is provided by physician anesthesiologists, certified registered nurse anesthetists (CRNAs), anesthesiology residents, and anesthesiologist assistants. These providers may practice alone (anesthesiologists or CRNAs) or in various combinations of supervised roles and teams. Previous studies reveal mixed findings regarding whether patient outcomes differ by anesthesia practice models.^1-7However, little is known about the prevalence of various anesthesia models in the US.

Background

In recent years, anesthesiology has undergone substantial expansion in its scope of services provided, the settings in which it is provided, and the diversity of its workforce.⁸As the field continues to evolve, especially within the context of value-based health care reform, it is imperative to evaluate how anesthesia care models are used in health systems and how these models may optimize care delivery.

The Veterans Health Administration (VHA) is the largest integrated health care system in the US, providing surgical care in 110 inpatient medical centers and 27 ambulatory surgery centers. Despite national integration, anesthesia practices vary widely among facilities. The question of which model of anesthesia care is associated with the best outcomes and offers the most value is widely debated.^1,5,7,9 As an important first step in understanding anesthesia care delivery, a baseline assessment of the practice patterns of anesthesia providers is necessary and may benefit future studies of the impact of these care models on outcomes. Thus, the aim of this work was to understand and describe the previously unassessed landscape of anesthesia care delivery within the VHA.

Methods

As part of a larger evaluation of anesthesia care delivery in the VHA, an observational assessment of anesthesia provider practice patterns was conducted using retrospective surgical data. This project complies with VHA policy pertaining to nonresearch operational activities and did not require institutional review board approval and adheres to the EQUATOR Network guidelines described in Strengthening the Reporting of Observational Studies in Epidemiology (STROBE).¹⁰

Data were obtained from the VHA Managerial Cost Accounting National Data Extract for Surgery package for all surgical procedures (n = 726,706) between October 1, 2013 and March 31, 2015. There were 420 facilities represented in these surgical data. The VHA facility records were used to specifically identify inpatient and ambulatory surgery facilities for inclusion. Additionally, to ensure facilities were valid surgical sites with sufficient surgical volume, those with 100 or fewer cases during the period were excluded. In total, 288 facilities with 9,434 surgical cases (representing 1% of cases) were excluded. These excluded facilities included nursing homes (38%), domiciliaries (26%), outpatient clinics (11%), rehabilitation programs (9%), other nonsurgical facilities (8%), and medical centers (8%). The majority (80%) of excluded medical centers had 30 or fewer surgical cases.

In 6 instances, data from subfacilities were combined with their organizationally affiliated main facilities. The final sample included 125 facilities. The VHA assigns a complexity level designation to facilities, defined as follows: 1a (most complex), 1b, 1c, 2, and 3 (least complex).¹¹ Facilities with 1a designation perform the most complex surgical cases, such as cardiovascular surgery or neurosurgery and have more staff and resource support, whereas levels 2 and 3 facilities perform fewer and less complex cases.

Surgical records were excluded when the primary Current Procedural Terminology (CPT) code was missing (n = 85,748, or 12% of cases). This resulted in 631,524 remaining cases. The surgical CPT codes were mapped to anesthesia CPT codes to obtain the associated base unit (BU) values via a published crosswalk by the American Society of Anesthesiologists (ASA).¹² A higher number of associated BUs indicates a more complex procedure. For example, procedures such as biopsies, arthroscopies, and laparoscopies receive 3 to 4 BUs, whereas a venous thrombectomy of the leg and a transurethral resection of the prostate are both 5 BUs, a total knee arthroplasty is 7 BUs, a craniotomy is 10 BUs, and a coronary artery bypass receives 18 BUs. Surgical case complexity was defined as low (3 or 4 BUs), medium (5 BUs), and high (≥ 6 BUs). Although the VHA has an existing case complexity assignment process based on CPT codes, it defines complexity differently for inpatient facilities and ambulatory surgery centers. Thus, the BU-defined complexity permitted a standardized complexity categorization across all facilities. Categorization of BUs similar to this has previously been used in the literature as a proxy for case complexity.^13,14

Patient-level information included the ASA physical status classification, a measure of overall health status determined by an anesthesia provider preoperatively.¹⁵ These classifications included ASA I (healthy), ASA II (mild systemic disease), ASA III (severe systemic disease), ASA IV (severe systemic disease that is a constant threat to life), and ASA V (moribund patient who is not expected to survive without surgery). The last classification, ASA VI: brain-dead with planned organ donation, was excluded. The “E” subcategory denoting “emergency” was subsumed within the corresponding ASA category (eg, ASA V-E was combined with ASA V).

Provider data identified the principal and supervising (if present) anesthetists involved in the case. The provision of anesthesia care was categorized into 3 models: Model 1—a physician anesthesiologist supervising a CRNA; Model 2—a physician anesthesiologist practicing independently or supervising an anesthesiology resident; and Model 3—a CRNA without supervision. Surgical cases were excluded when there was no anesthesia provider (n = 95,795, or 15% of remaining cases), or a nonanesthesia provider (n = 51,647, or 8% of remaining cases) on record. The final sample was 484,082 surgical cases conducted at 125 facilities.

Related: Improving Care and Reducing Length of Stay in Patients Undergoing Total Knee Replacement

Statistical Analysis

The percentage of surgical cases in each anesthesia care model was calculated overall and by the following characteristics: surgical case complexity, ASA classification, and facility complexity. The anesthesia model was determined for each case and summed at the facility level, yielding a total number of cases attributed to each model for each facility, thus identifying the predominant anesthesia model for each facility. The facilities were geographically displayed by their predominant anesthesia model and total number of surgical cases during the period. Because the aim was to present a descriptive representation of anesthesia care models, rather than infer significance, statistical testing was not included.

Results

A total of 484,082 surgical cases met inclusion criteria (Table). These cases were from 109 inpatient facilities and 16 ambulatory surgery facilities. 

The percentage of cases in Model 1 was similar across the levels of surgical case complexity. However, a higher proportion of highly complex cases had a physician anesthesiologist (Model 2, 38.8%) than a CRNA (Model 3, 6.4%) as the primary anesthesia provider. Patients in each ASA classification were most likely to receive anesthesia care via Model 1. As ASA level increased, fewer patients had their anesthesia managed by a CRNA without supervision (Model 3: 18.4% of ASA 1 patients vs 8.3% of ASA 4 patients).

Facility complexity demonstrated notable differences in the proportions of surgical cases within each model. More than half of surgical cases in the largest, most complex facilities used Model 1 (64.9%, 58.2%, and 57.7% of cases in 1a, 1b, and 1c facilities, respectively). In comparison, Model 3 was found almost exclusively among surgical cases in smaller facilities with lower complexity (52% and 74% of cases in level 2 and 3 facilities, respectively).

The Figure displays the 125 facilities by their predominant model of anesthesia care. The diameter of the dots is relative to the facility’s total number of surgical cases. For each facility, the predominant model accounted for about half or more of cases but was not necessarily the only model of care used at a particular facility. 

Related: Initiative to Minimize Pharmaceutical Risk in Older Veterans (IMPROVE) Polypharmacy Clinic

Discussion

Anesthesia care in more than half of surgical cases in VHA facilities was delivered by physician anesthesiologists supervising CRNAs. This model of anesthesia care was the dominant model in 54% of the facilities included in the sample. Consistent with a study of non-VHA facilities, this assessment found that the type of facility may influence the model of anesthesia care, with smaller, less complex facilities more often using a CRNA without supervision model.⁴ In these data, it was noted that among the 28 facilities that predominantly used Model 3, half had 12% or fewer cases that indicated a physician anesthesiologist model of care, and 6 had no cases with physician anesthesiologist involvement. These findings may reflect the limited scope of surgical services offered at lower complexity facilities and/or the reduced availability and/or utilization of physician anesthesiologists in these facilities.

Limitations

We recognize limitations in our assessment of anesthesia care. The documented presence or absence of a supervising anesthesia provider on the surgical record may not adequately characterize the model of anesthesia care in use at a facility, thus limiting an understanding of care delivery relationships among anesthesia providers. In addition, the patterns of anesthesia care delivery are likely influenced by factors not accounted for in this assessment, including the labor market share and economic forces.^16,17 The veteran population tends to be older, male, and with substantial chronic disease burden, thus may have differing surgical needs and experiences than that of the general public.^18,19 The surgical services offered in VHA facilities as well as the policies and practice environment surrounding anesthesia care also may vary from those found in nongovernmental facilities. However, as the largest health care system in the US, the VHA provides a diverse and robust surgical program. Many VHA facilities are large teaching hospitals with academic affiliations that would parallel some in the public sector. For example, studies have demonstrated similar surgical outcomes for patients in VHA vs non-VHA facilities.²⁰ Therefore, the findings regarding anesthesia care models in VHA are likely relevant to non-VHA surgical sites.

Related: Improving Team-Based Care Coordination Delivery and Documentation in the Health Record

Conclusion

This preliminary assessment of the different models of anesthesia care demonstrates that although primarily relying on teams of anesthesiologists and CRNAs, the VA also uses unsupervised CRNAs to meet veterans’ surgical care needs. Although CRNA practice without supervision represented only 12% of surgical cases in our data, we identified 28 facilities (22%) that predominantly used CRNAs without supervision. Thus, CRNAs with and without supervision deliver a substantial portion of anesthesia care in the VA. The prevalence of CRNAs in documented VA surgical records and among surgical facilities nationwide highlights the importance of further examining their supervised and unsupervised roles in anesthesia care delivery.²¹ As the practice of anesthesiology continues to evolve, it is imperative that research efforts further investigate ways anesthesia care models may optimize care delivery, benefit anesthesia providers, and improve health outcomes for patients.

NEW ORLEANS – For patients with Dravet syndrome, a 44% or greater reduction in seizure frequency can be considered a clinically meaningful response, according to a study described at the annual meeting of the American Epilepsy Society. A reduction in seizure frequency of between 60% and 68% is associated with Clinical Global Impression of Improvement (CGI-I) ratings of “very much improved,” as assessed by caregivers and investigators.

“Further analyses from other phase III studies in Dravet syndrome and other patient populations should be performed to confirm these findings and explore other potential factors that contribute to caregiver and investigator CGI-I ratings, such as nonseizure outcomes and tolerability,” said Arnold Gammaitoni, PharmD, vice president of medical and scientific affairs at Zogenix in San Diego, and his colleagues.

A 50% reduction in seizure frequency is conventionally considered to be the cutoff for a clinically meaningful change. To develop an evidence-based definition of clinically meaningful seizure reduction, Dr. Gammaitoni and colleagues examined data from a phase III, randomized, double-blind, placebo-controlled trial of fenfluramine HCl oral solution for the adjunctive treatment of seizures associated with Dravet syndrome. The investigators took an anchor-based approach and examined the percentage change in seizure frequency, along with caregiver and investigator CGI-I ratings.

A total of 119 patients with Dravet syndrome were enrolled and randomized in equal groups to placebo, 0.2 mg/kg per day of fenfluramine HCl, or 0.8 mg/kg per day of fenfluramine HCl. After a 2-week titration period, patients entered a 12-week maintenance period. Patients in the 0.8-mg/kg per day group had a 63.9% greater reduction in seizure frequency than controls did.

After the 14-week titration and maintenance period, caregivers and investigators rated the change in participants’ clinical status from baseline, using the CGI-I scale, on which responses range from 1 (very much improved) to 7 (very much worse). The investigators considered patients with CGI-I scores of 1 or 2 (much improved) to have achieved a clinically meaningful response. A score of 3 (minimally improved) was not considered meaningful. The researchers pooled the results of the three treatment groups for this analysis. They estimated the clinically meaningful percentage change in seizure frequency using receiver operating characteristic analysis of binary CGI-I score, compared with percentage change in seizure frequency, and defined it as the cut-point for which specificity and sensitivity were equal or most similar.

Caregivers and investigators provided CGI-I assessments for 112 patients and 114 patients, respectively. The receiver operating characteristic analysis identified a 44% reduction in seizure frequency as a clinically meaningful cutoff point for caregiver and investigator assessments. Using this threshold, 75%, 46%, and 12.5% of patients in the 0.8-mg/kg per day, 0.2-mg/kg per day, and placebo groups, respectively, achieved a clinically meaningful reduction from baseline in seizure frequency in the phase III study.

“The use of external anchors is one method to define a clinically meaningful change in seizure frequency,” said Dr. Gammaitoni. “Having a defined minimum clinically important difference like this allows clinicians to assess impacts of treatments on an individual patient basis.... This is a chance for others to do similar types of analyses to confirm the findings that we have had in this first study with bigger data sets, in terms of using external anchors and data to define what a clinically meaningful change is.”

Zogenix, which is developing the fenfluramine formulation examined in this study, provided funding for this research.
 

[email protected]

SOURCE: Nabbout R et al. AES 2018, Abstract 3.202.

NEW ORLEANS – For patients with Dravet syndrome, a 44% or greater reduction in seizure frequency can be considered a clinically meaningful response, according to a study described at the annual meeting of the American Epilepsy Society. A reduction in seizure frequency of between 60% and 68% is associated with Clinical Global Impression of Improvement (CGI-I) ratings of “very much improved,” as assessed by caregivers and investigators.

“Further analyses from other phase III studies in Dravet syndrome and other patient populations should be performed to confirm these findings and explore other potential factors that contribute to caregiver and investigator CGI-I ratings, such as nonseizure outcomes and tolerability,” said Arnold Gammaitoni, PharmD, vice president of medical and scientific affairs at Zogenix in San Diego, and his colleagues.

A 50% reduction in seizure frequency is conventionally considered to be the cutoff for a clinically meaningful change. To develop an evidence-based definition of clinically meaningful seizure reduction, Dr. Gammaitoni and colleagues examined data from a phase III, randomized, double-blind, placebo-controlled trial of fenfluramine HCl oral solution for the adjunctive treatment of seizures associated with Dravet syndrome. The investigators took an anchor-based approach and examined the percentage change in seizure frequency, along with caregiver and investigator CGI-I ratings.

A total of 119 patients with Dravet syndrome were enrolled and randomized in equal groups to placebo, 0.2 mg/kg per day of fenfluramine HCl, or 0.8 mg/kg per day of fenfluramine HCl. After a 2-week titration period, patients entered a 12-week maintenance period. Patients in the 0.8-mg/kg per day group had a 63.9% greater reduction in seizure frequency than controls did.

After the 14-week titration and maintenance period, caregivers and investigators rated the change in participants’ clinical status from baseline, using the CGI-I scale, on which responses range from 1 (very much improved) to 7 (very much worse). The investigators considered patients with CGI-I scores of 1 or 2 (much improved) to have achieved a clinically meaningful response. A score of 3 (minimally improved) was not considered meaningful. The researchers pooled the results of the three treatment groups for this analysis. They estimated the clinically meaningful percentage change in seizure frequency using receiver operating characteristic analysis of binary CGI-I score, compared with percentage change in seizure frequency, and defined it as the cut-point for which specificity and sensitivity were equal or most similar.

Caregivers and investigators provided CGI-I assessments for 112 patients and 114 patients, respectively. The receiver operating characteristic analysis identified a 44% reduction in seizure frequency as a clinically meaningful cutoff point for caregiver and investigator assessments. Using this threshold, 75%, 46%, and 12.5% of patients in the 0.8-mg/kg per day, 0.2-mg/kg per day, and placebo groups, respectively, achieved a clinically meaningful reduction from baseline in seizure frequency in the phase III study.

“The use of external anchors is one method to define a clinically meaningful change in seizure frequency,” said Dr. Gammaitoni. “Having a defined minimum clinically important difference like this allows clinicians to assess impacts of treatments on an individual patient basis.... This is a chance for others to do similar types of analyses to confirm the findings that we have had in this first study with bigger data sets, in terms of using external anchors and data to define what a clinically meaningful change is.”

Zogenix, which is developing the fenfluramine formulation examined in this study, provided funding for this research.
 

[email protected]

SOURCE: Nabbout R et al. AES 2018, Abstract 3.202.

NEW ORLEANS – For patients with Dravet syndrome, a 44% or greater reduction in seizure frequency can be considered a clinically meaningful response, according to a study described at the annual meeting of the American Epilepsy Society. A reduction in seizure frequency of between 60% and 68% is associated with Clinical Global Impression of Improvement (CGI-I) ratings of “very much improved,” as assessed by caregivers and investigators.

“Further analyses from other phase III studies in Dravet syndrome and other patient populations should be performed to confirm these findings and explore other potential factors that contribute to caregiver and investigator CGI-I ratings, such as nonseizure outcomes and tolerability,” said Arnold Gammaitoni, PharmD, vice president of medical and scientific affairs at Zogenix in San Diego, and his colleagues.

A 50% reduction in seizure frequency is conventionally considered to be the cutoff for a clinically meaningful change. To develop an evidence-based definition of clinically meaningful seizure reduction, Dr. Gammaitoni and colleagues examined data from a phase III, randomized, double-blind, placebo-controlled trial of fenfluramine HCl oral solution for the adjunctive treatment of seizures associated with Dravet syndrome. The investigators took an anchor-based approach and examined the percentage change in seizure frequency, along with caregiver and investigator CGI-I ratings.

A total of 119 patients with Dravet syndrome were enrolled and randomized in equal groups to placebo, 0.2 mg/kg per day of fenfluramine HCl, or 0.8 mg/kg per day of fenfluramine HCl. After a 2-week titration period, patients entered a 12-week maintenance period. Patients in the 0.8-mg/kg per day group had a 63.9% greater reduction in seizure frequency than controls did.

After the 14-week titration and maintenance period, caregivers and investigators rated the change in participants’ clinical status from baseline, using the CGI-I scale, on which responses range from 1 (very much improved) to 7 (very much worse). The investigators considered patients with CGI-I scores of 1 or 2 (much improved) to have achieved a clinically meaningful response. A score of 3 (minimally improved) was not considered meaningful. The researchers pooled the results of the three treatment groups for this analysis. They estimated the clinically meaningful percentage change in seizure frequency using receiver operating characteristic analysis of binary CGI-I score, compared with percentage change in seizure frequency, and defined it as the cut-point for which specificity and sensitivity were equal or most similar.

Caregivers and investigators provided CGI-I assessments for 112 patients and 114 patients, respectively. The receiver operating characteristic analysis identified a 44% reduction in seizure frequency as a clinically meaningful cutoff point for caregiver and investigator assessments. Using this threshold, 75%, 46%, and 12.5% of patients in the 0.8-mg/kg per day, 0.2-mg/kg per day, and placebo groups, respectively, achieved a clinically meaningful reduction from baseline in seizure frequency in the phase III study.

“The use of external anchors is one method to define a clinically meaningful change in seizure frequency,” said Dr. Gammaitoni. “Having a defined minimum clinically important difference like this allows clinicians to assess impacts of treatments on an individual patient basis.... This is a chance for others to do similar types of analyses to confirm the findings that we have had in this first study with bigger data sets, in terms of using external anchors and data to define what a clinically meaningful change is.”

Zogenix, which is developing the fenfluramine formulation examined in this study, provided funding for this research.
 

[email protected]

SOURCE: Nabbout R et al. AES 2018, Abstract 3.202.

SAN DIEGO – In the phase 3 Alliance A041202 trial of older patients with previously untreated chronic lymphocytic leukemia (CLL), ibrutinib showed superior progression-free survival (PFS). Results of the trial were reported by Jennifer A. Woyach, MD, of the Ohio State University in Columbus during a press briefing at the recently concluded American Society of Hematology 2018 meeting. The briefing was based on an abstract from the meeting.

“There was no difference in progression-free survival between ibrutinib and ibrutinib plus rituximab,” said Dr. Woyach. “We undertook this study to determine the most effective therapy for older patients with CLL.” She noted that the findings justify the use of ibrutinib as a standard-of-care treatment for CLL patients aged 65 years and older.

Median age of patients in the study was 71 years and 67% of the patient were men, a profile that is similar, to those of patients with CLL seen at the US Department of Veterans Affairs. 

The 2-year PFS was 74% in 183 patients randomized to receive standard chemoimmunotherapy with bendamustine and rituximab (BR), compared with 87% in 182 patients randomized to receive ibrutinib alone (hazard ratio, 0.39 vs. BR), and 88% in 182 patients who received ibrutinib and rituximab (IR; HR, 0.38 vs. BR). Median PFS in this study was 43 months in the BR arm, and was not reached in either of the ibrutinib-containing arms, she said. No significant differences in overall survival (OS) were seen among the treatment arms, which may have been because of short follow-up and the fact that patients in the BR arm were allowed to cross over to ibrutinib if they progressed on treatment.

The results suggest that the additional of rituximab provided little benefit to the patients though it does add to both the costs and the chair time in an infusion center, according to former Association of VA Hematology/Oncology Mary Thomas, MS, CNS, AOCN.  

“I think this really does indicate that ibrutinib as front-line therapy, which many clinicians have been doing, is a very reasonable practice,” said David P. Steensma, MD, of Dana-Farber Cancer Institute in Boston, who moderated the press briefing.

Dr. Woyach added, however, that while ibrutinib represents a major therapeutic advance, its cost and its toxicities in older patients are a concern that warrant close monitoring and development of strategies to reduce the need for long-term continuous treatment.

Thomas agreed noting that health care providers needs to be aware of the risk of  atrial fib and bleeding when using ibrutinib and to ensure that patient will be able to adhere to daily dosing.

Additional phase 3 studies set to open soon will compare ibrutinib in combination with venetoclax and obinutuzumab with standard ibrutinib.

Dr. Woyach and Ms. Thomas reported having no disclosures. Dr. Steensma reported receiving research funding from, and/or serving as a consultant, board member, or adviser for Takeda Pharmaceutical, Syros Pharmaceuticals, Otsuka Pharmaceutical, Onconova Therapeutics, Novartis, Kura Oncology, Janssen, H3 Biosciences, Celgene, Amphivena Therapeutics, and Acceleron Pharma.

SAN DIEGO – In the phase 3 Alliance A041202 trial of older patients with previously untreated chronic lymphocytic leukemia (CLL), ibrutinib showed superior progression-free survival (PFS). Results of the trial were reported by Jennifer A. Woyach, MD, of the Ohio State University in Columbus during a press briefing at the recently concluded American Society of Hematology 2018 meeting. The briefing was based on an abstract from the meeting.

“There was no difference in progression-free survival between ibrutinib and ibrutinib plus rituximab,” said Dr. Woyach. “We undertook this study to determine the most effective therapy for older patients with CLL.” She noted that the findings justify the use of ibrutinib as a standard-of-care treatment for CLL patients aged 65 years and older.

Median age of patients in the study was 71 years and 67% of the patient were men, a profile that is similar, to those of patients with CLL seen at the US Department of Veterans Affairs. 

The 2-year PFS was 74% in 183 patients randomized to receive standard chemoimmunotherapy with bendamustine and rituximab (BR), compared with 87% in 182 patients randomized to receive ibrutinib alone (hazard ratio, 0.39 vs. BR), and 88% in 182 patients who received ibrutinib and rituximab (IR; HR, 0.38 vs. BR). Median PFS in this study was 43 months in the BR arm, and was not reached in either of the ibrutinib-containing arms, she said. No significant differences in overall survival (OS) were seen among the treatment arms, which may have been because of short follow-up and the fact that patients in the BR arm were allowed to cross over to ibrutinib if they progressed on treatment.

The results suggest that the additional of rituximab provided little benefit to the patients though it does add to both the costs and the chair time in an infusion center, according to former Association of VA Hematology/Oncology Mary Thomas, MS, CNS, AOCN.  

“I think this really does indicate that ibrutinib as front-line therapy, which many clinicians have been doing, is a very reasonable practice,” said David P. Steensma, MD, of Dana-Farber Cancer Institute in Boston, who moderated the press briefing.

Dr. Woyach added, however, that while ibrutinib represents a major therapeutic advance, its cost and its toxicities in older patients are a concern that warrant close monitoring and development of strategies to reduce the need for long-term continuous treatment.

Thomas agreed noting that health care providers needs to be aware of the risk of  atrial fib and bleeding when using ibrutinib and to ensure that patient will be able to adhere to daily dosing.

Additional phase 3 studies set to open soon will compare ibrutinib in combination with venetoclax and obinutuzumab with standard ibrutinib.

Dr. Woyach and Ms. Thomas reported having no disclosures. Dr. Steensma reported receiving research funding from, and/or serving as a consultant, board member, or adviser for Takeda Pharmaceutical, Syros Pharmaceuticals, Otsuka Pharmaceutical, Onconova Therapeutics, Novartis, Kura Oncology, Janssen, H3 Biosciences, Celgene, Amphivena Therapeutics, and Acceleron Pharma.

SAN DIEGO – In the phase 3 Alliance A041202 trial of older patients with previously untreated chronic lymphocytic leukemia (CLL), ibrutinib showed superior progression-free survival (PFS). Results of the trial were reported by Jennifer A. Woyach, MD, of the Ohio State University in Columbus during a press briefing at the recently concluded American Society of Hematology 2018 meeting. The briefing was based on an abstract from the meeting.

“There was no difference in progression-free survival between ibrutinib and ibrutinib plus rituximab,” said Dr. Woyach. “We undertook this study to determine the most effective therapy for older patients with CLL.” She noted that the findings justify the use of ibrutinib as a standard-of-care treatment for CLL patients aged 65 years and older.

Median age of patients in the study was 71 years and 67% of the patient were men, a profile that is similar, to those of patients with CLL seen at the US Department of Veterans Affairs. 

The 2-year PFS was 74% in 183 patients randomized to receive standard chemoimmunotherapy with bendamustine and rituximab (BR), compared with 87% in 182 patients randomized to receive ibrutinib alone (hazard ratio, 0.39 vs. BR), and 88% in 182 patients who received ibrutinib and rituximab (IR; HR, 0.38 vs. BR). Median PFS in this study was 43 months in the BR arm, and was not reached in either of the ibrutinib-containing arms, she said. No significant differences in overall survival (OS) were seen among the treatment arms, which may have been because of short follow-up and the fact that patients in the BR arm were allowed to cross over to ibrutinib if they progressed on treatment.

The results suggest that the additional of rituximab provided little benefit to the patients though it does add to both the costs and the chair time in an infusion center, according to former Association of VA Hematology/Oncology Mary Thomas, MS, CNS, AOCN.  

“I think this really does indicate that ibrutinib as front-line therapy, which many clinicians have been doing, is a very reasonable practice,” said David P. Steensma, MD, of Dana-Farber Cancer Institute in Boston, who moderated the press briefing.

Dr. Woyach added, however, that while ibrutinib represents a major therapeutic advance, its cost and its toxicities in older patients are a concern that warrant close monitoring and development of strategies to reduce the need for long-term continuous treatment.

Thomas agreed noting that health care providers needs to be aware of the risk of  atrial fib and bleeding when using ibrutinib and to ensure that patient will be able to adhere to daily dosing.

Additional phase 3 studies set to open soon will compare ibrutinib in combination with venetoclax and obinutuzumab with standard ibrutinib.

Dr. Woyach and Ms. Thomas reported having no disclosures. Dr. Steensma reported receiving research funding from, and/or serving as a consultant, board member, or adviser for Takeda Pharmaceutical, Syros Pharmaceuticals, Otsuka Pharmaceutical, Onconova Therapeutics, Novartis, Kura Oncology, Janssen, H3 Biosciences, Celgene, Amphivena Therapeutics, and Acceleron Pharma.

SAN ANTONIO – The longer the delay in initiating adjuvant chemotherapy, the worse the survival in patients with triple-negative breast cancer (TNBC), findings from a review of nearly 700 cases suggest.

Delays of more than 30 days between surgery and initiation of chemotherapy were associated with lower disease-free survival (DFS), distant recurrence–free survival (DRFS), and overall survival (OS), Zaida Morante, MD, reported at the San Antonio Breast Cancer Symposium.

In 687 women with clinical stage I, II, or III TNBC who were diagnosed at the Instituto Nacional de Enfermedades Neoplasicas in Lima, Peru, during 2000-2014 and followed for a median of 8.5 years, time to chemotherapy was less than 30 days in 189 patients (27.5%), 31-60 days in 329 patients (47.9%), 61-90 days in 115 patients (16.7%), and more than 91 days in 54 patients (7.9%), said Dr. Morante, a medical oncologist at the institute.

Overall survival at 10 years was 82% in those who received chemotherapy within 30 days of surgery, compared with 67.4%, 67.1%, and 65.1% in those treated at 31-60, 61-90, and more than 91 days after surgery, respectively, she said.

“The difference was consistent across the different periods of the evaluation,” she said during a press briefing at the symposium. “Additionally, the benefit of receiving chemotherapy within 30 days exists and is statistically significant for [nodal status] N0 and N1 (hazard ratios, 1.701 and 2.498).”

In those with N2 and N3 nodal status, there was a numerical difference, but it didn’t reach statistical significance.

DFS was also significantly worse if treated later than 30 days after surgery; those treated within 30 days had 10-year DFS of 81.4%, compared with 68.8%, 70.8%, and 68.1% in the other groups, respectively. The difference was even more pronounced for 10-year DRFS, which was 80.2%, 64.9%, 67.5%, and 58.6% in the groups, respectively.

Multivariate analyses confirmed that time to adjuvant chemotherapy was an independent prognostic factor for survival, she said, noting that compared with patients treated within 30 days of surgery, those treated at 31-60 days had 1.9-fold increased risk of death, and those treated at 61-90 days had a 2.4-fold increased risk of death.

“The difference in 10-year overall survival rates between receiving chemotherapy within 30 days after surgery and after 30 days was more than 10%,” she said. “These results represent a feasible opportunity for improving outcomes in triple-negative breast cancer patients.”

Although only 28% of patients in this review received adjuvant chemotherapy within 30 days, most patients in the United States “will fall within the 30 days and under” category, said press briefing moderator Carlos Arteaga, MD, professor and director of the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern Medical Center in Dallas.

However, the findings might suggest a greater role for neoadjuvant chemotherapy in these patients.

“Because this is systemic therapy ... it’s treating the systemic disease. I wonder if this is arguing ... that we need to have an impetus to deliver the systemic therapy as soon as we can – early, even before the operation,” he said.

Indeed, while timing isn’t everything, Dr. Morante’s findings and others presented at the meeting “highlight the possibility that perhaps it is more important than we previously suspected,” discussant Joseph A. Sparano, MD, said at the meeting, adding that the findings raise questions about current paradigms for management of breast cancer.

“We now have substantial data suggesting that the timing of adjuvant chemotherapy matters in triple-negative breast cancer, and that 30 days may be optimal,” said Dr. Sparano, professor at the Albert Einstein College of Medicine, New York.

“This doesn’t mean that patients who may not be ready for the chemotherapy because of complications related to the surgery should be forced into a situation where they are at higher risk from receiving the chemotherapy, but nevertheless, the results are important,” he said.

Dr. Morante and Dr. Arteaga each reported having no relevant conflicts of interest to declare. Dr. Sparano has received consulting fees from Roche, Eli Lilly, Novartis, Celldex, AstraZeneca, Pfizer, and Adgero. He also has ownership interests with MetaStat.

SOURCE: Morante Z et al. SABCS 2018, Abstract GS2-05.

SAN ANTONIO – The longer the delay in initiating adjuvant chemotherapy, the worse the survival in patients with triple-negative breast cancer (TNBC), findings from a review of nearly 700 cases suggest.

Delays of more than 30 days between surgery and initiation of chemotherapy were associated with lower disease-free survival (DFS), distant recurrence–free survival (DRFS), and overall survival (OS), Zaida Morante, MD, reported at the San Antonio Breast Cancer Symposium.

In 687 women with clinical stage I, II, or III TNBC who were diagnosed at the Instituto Nacional de Enfermedades Neoplasicas in Lima, Peru, during 2000-2014 and followed for a median of 8.5 years, time to chemotherapy was less than 30 days in 189 patients (27.5%), 31-60 days in 329 patients (47.9%), 61-90 days in 115 patients (16.7%), and more than 91 days in 54 patients (7.9%), said Dr. Morante, a medical oncologist at the institute.

Overall survival at 10 years was 82% in those who received chemotherapy within 30 days of surgery, compared with 67.4%, 67.1%, and 65.1% in those treated at 31-60, 61-90, and more than 91 days after surgery, respectively, she said.

“The difference was consistent across the different periods of the evaluation,” she said during a press briefing at the symposium. “Additionally, the benefit of receiving chemotherapy within 30 days exists and is statistically significant for [nodal status] N0 and N1 (hazard ratios, 1.701 and 2.498).”

In those with N2 and N3 nodal status, there was a numerical difference, but it didn’t reach statistical significance.

DFS was also significantly worse if treated later than 30 days after surgery; those treated within 30 days had 10-year DFS of 81.4%, compared with 68.8%, 70.8%, and 68.1% in the other groups, respectively. The difference was even more pronounced for 10-year DRFS, which was 80.2%, 64.9%, 67.5%, and 58.6% in the groups, respectively.

Multivariate analyses confirmed that time to adjuvant chemotherapy was an independent prognostic factor for survival, she said, noting that compared with patients treated within 30 days of surgery, those treated at 31-60 days had 1.9-fold increased risk of death, and those treated at 61-90 days had a 2.4-fold increased risk of death.

“The difference in 10-year overall survival rates between receiving chemotherapy within 30 days after surgery and after 30 days was more than 10%,” she said. “These results represent a feasible opportunity for improving outcomes in triple-negative breast cancer patients.”

Although only 28% of patients in this review received adjuvant chemotherapy within 30 days, most patients in the United States “will fall within the 30 days and under” category, said press briefing moderator Carlos Arteaga, MD, professor and director of the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern Medical Center in Dallas.

However, the findings might suggest a greater role for neoadjuvant chemotherapy in these patients.

“Because this is systemic therapy ... it’s treating the systemic disease. I wonder if this is arguing ... that we need to have an impetus to deliver the systemic therapy as soon as we can – early, even before the operation,” he said.

Indeed, while timing isn’t everything, Dr. Morante’s findings and others presented at the meeting “highlight the possibility that perhaps it is more important than we previously suspected,” discussant Joseph A. Sparano, MD, said at the meeting, adding that the findings raise questions about current paradigms for management of breast cancer.

“We now have substantial data suggesting that the timing of adjuvant chemotherapy matters in triple-negative breast cancer, and that 30 days may be optimal,” said Dr. Sparano, professor at the Albert Einstein College of Medicine, New York.

“This doesn’t mean that patients who may not be ready for the chemotherapy because of complications related to the surgery should be forced into a situation where they are at higher risk from receiving the chemotherapy, but nevertheless, the results are important,” he said.

Dr. Morante and Dr. Arteaga each reported having no relevant conflicts of interest to declare. Dr. Sparano has received consulting fees from Roche, Eli Lilly, Novartis, Celldex, AstraZeneca, Pfizer, and Adgero. He also has ownership interests with MetaStat.

SOURCE: Morante Z et al. SABCS 2018, Abstract GS2-05.

SAN ANTONIO – The longer the delay in initiating adjuvant chemotherapy, the worse the survival in patients with triple-negative breast cancer (TNBC), findings from a review of nearly 700 cases suggest.

Delays of more than 30 days between surgery and initiation of chemotherapy were associated with lower disease-free survival (DFS), distant recurrence–free survival (DRFS), and overall survival (OS), Zaida Morante, MD, reported at the San Antonio Breast Cancer Symposium.

In 687 women with clinical stage I, II, or III TNBC who were diagnosed at the Instituto Nacional de Enfermedades Neoplasicas in Lima, Peru, during 2000-2014 and followed for a median of 8.5 years, time to chemotherapy was less than 30 days in 189 patients (27.5%), 31-60 days in 329 patients (47.9%), 61-90 days in 115 patients (16.7%), and more than 91 days in 54 patients (7.9%), said Dr. Morante, a medical oncologist at the institute.

Overall survival at 10 years was 82% in those who received chemotherapy within 30 days of surgery, compared with 67.4%, 67.1%, and 65.1% in those treated at 31-60, 61-90, and more than 91 days after surgery, respectively, she said.

“The difference was consistent across the different periods of the evaluation,” she said during a press briefing at the symposium. “Additionally, the benefit of receiving chemotherapy within 30 days exists and is statistically significant for [nodal status] N0 and N1 (hazard ratios, 1.701 and 2.498).”

In those with N2 and N3 nodal status, there was a numerical difference, but it didn’t reach statistical significance.

DFS was also significantly worse if treated later than 30 days after surgery; those treated within 30 days had 10-year DFS of 81.4%, compared with 68.8%, 70.8%, and 68.1% in the other groups, respectively. The difference was even more pronounced for 10-year DRFS, which was 80.2%, 64.9%, 67.5%, and 58.6% in the groups, respectively.

Multivariate analyses confirmed that time to adjuvant chemotherapy was an independent prognostic factor for survival, she said, noting that compared with patients treated within 30 days of surgery, those treated at 31-60 days had 1.9-fold increased risk of death, and those treated at 61-90 days had a 2.4-fold increased risk of death.

“The difference in 10-year overall survival rates between receiving chemotherapy within 30 days after surgery and after 30 days was more than 10%,” she said. “These results represent a feasible opportunity for improving outcomes in triple-negative breast cancer patients.”

Although only 28% of patients in this review received adjuvant chemotherapy within 30 days, most patients in the United States “will fall within the 30 days and under” category, said press briefing moderator Carlos Arteaga, MD, professor and director of the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern Medical Center in Dallas.

However, the findings might suggest a greater role for neoadjuvant chemotherapy in these patients.

“Because this is systemic therapy ... it’s treating the systemic disease. I wonder if this is arguing ... that we need to have an impetus to deliver the systemic therapy as soon as we can – early, even before the operation,” he said.

Indeed, while timing isn’t everything, Dr. Morante’s findings and others presented at the meeting “highlight the possibility that perhaps it is more important than we previously suspected,” discussant Joseph A. Sparano, MD, said at the meeting, adding that the findings raise questions about current paradigms for management of breast cancer.

“We now have substantial data suggesting that the timing of adjuvant chemotherapy matters in triple-negative breast cancer, and that 30 days may be optimal,” said Dr. Sparano, professor at the Albert Einstein College of Medicine, New York.

“This doesn’t mean that patients who may not be ready for the chemotherapy because of complications related to the surgery should be forced into a situation where they are at higher risk from receiving the chemotherapy, but nevertheless, the results are important,” he said.

Dr. Morante and Dr. Arteaga each reported having no relevant conflicts of interest to declare. Dr. Sparano has received consulting fees from Roche, Eli Lilly, Novartis, Celldex, AstraZeneca, Pfizer, and Adgero. He also has ownership interests with MetaStat.

SOURCE: Morante Z et al. SABCS 2018, Abstract GS2-05.