High-dose oral vitamin D supplements taken for 1 year significantly improved cardiac structure and function in patients with chronic heart failure secondary to left ventricular systolic dysfunction, according to results from a new study.

However, the same study. led by Dr. Klaus Witte of the University of Leeds (England), found that 6-minute walk distance – the study’s primary outcome measure – was not improved after a year’s supplementation with vitamin D.

©Joss/Fotolia.com

It is unclear why vitamin D deficiency co-occurs in a majority of people with chronic heart failure (CHF) due to left ventricular systolic dysfunction (LVSD) or to what degree reversing it can improve outcomes. However, vitamin D deficiency is thought to interfere with calcium transport in cardiac cells, and may contribute to cardiac fibrosis and inflammation, leading to faster progression to heart failure following damage to cardiac muscle.

The new VINDICATE study randomized 223 patients with CHF due to LVSD and vitamin D deficiency to 1 year’s treatment with 4,000 IU of 25(OH) vitamin D3 daily, or placebo, Dr. Witte and associates concluded at the annual meeting of the American College of Cardiology. The results were published online April 4 in JACC (doi: 10.1016/j.jacc.2016.03.508).

Of these patients, 163 completed follow-up at 12 months, and 6-minute walk distance (MWT) and echocardiography findings were recorded at baseline and follow-up.

Dr. Witte and colleagues found significant evidence of improved function in the vitamin D–treated patients as measured by left ventricular ejection fraction +6.07% (95% confidence interval 3.20, 8.95; P less than .0001); and a reversal of left ventricular remodeling (left ventricular end diastolic diameter –2.49 mm (95% CI –4.09, –0.90; P equal to .002) and left ventricular end systolic diameter –2.09 mm (95% CI –4.11; –0.06; P equal to .043).

The researchers also drew blood at 3-month intervals to check for serum calcium concentration, renal function, and vitamin D levels. Treatment was well tolerated, and no patients suffered hypervitaminosis or required a dose adjustment.

“There was no effect of vitamin D supplementation on the primary endpoint of 6 MWT distance but there were statistically significant, and prognostically and clinically relevant improvements in the secondary outcomes of left ventricular ejection fraction, dimensions, and volumes, suggesting that vitamin D is leading to beneficial reverse remodeling,” the investigators wrote in their analysis.

The study’s failure to meet its primary endpoint despite significant results from its secondary endpoints led Dr. Witte and colleagues to say that its design led to underpowering.

“Variability in the walk distance measure at baseline was much greater than predicted from our pilot study such that our sample size only had 7% post hoc power to detect a difference between the groups,” meaning it was underpowered to detect a clinically relevant change in walk distance. The findings “have implications for future studies using 6-minute walk distance as an outcome measure,” they wrote.

The investigators championed the addition of vitamin D₃ to CHF treatment regimens.

As new therapies for CHF are “often expensive, increasingly technical, and frequently fail to meet the rigorous demands of large phase III clinical trials,” Dr. Witte and colleagues wrote, vitamin D “might be a cheap and safe additional option for CHF patients and may have beneficial effects on multiple features of the syndrome.”

The U.K.’s National Institute for Health Research supported the study, and none of its authors declared conflicts of interest.

High-dose oral vitamin D supplements taken for 1 year significantly improved cardiac structure and function in patients with chronic heart failure secondary to left ventricular systolic dysfunction, according to results from a new study.

However, the same study. led by Dr. Klaus Witte of the University of Leeds (England), found that 6-minute walk distance – the study’s primary outcome measure – was not improved after a year’s supplementation with vitamin D.

©Joss/Fotolia.com

It is unclear why vitamin D deficiency co-occurs in a majority of people with chronic heart failure (CHF) due to left ventricular systolic dysfunction (LVSD) or to what degree reversing it can improve outcomes. However, vitamin D deficiency is thought to interfere with calcium transport in cardiac cells, and may contribute to cardiac fibrosis and inflammation, leading to faster progression to heart failure following damage to cardiac muscle.

The new VINDICATE study randomized 223 patients with CHF due to LVSD and vitamin D deficiency to 1 year’s treatment with 4,000 IU of 25(OH) vitamin D3 daily, or placebo, Dr. Witte and associates concluded at the annual meeting of the American College of Cardiology. The results were published online April 4 in JACC (doi: 10.1016/j.jacc.2016.03.508).

Of these patients, 163 completed follow-up at 12 months, and 6-minute walk distance (MWT) and echocardiography findings were recorded at baseline and follow-up.

Dr. Witte and colleagues found significant evidence of improved function in the vitamin D–treated patients as measured by left ventricular ejection fraction +6.07% (95% confidence interval 3.20, 8.95; P less than .0001); and a reversal of left ventricular remodeling (left ventricular end diastolic diameter –2.49 mm (95% CI –4.09, –0.90; P equal to .002) and left ventricular end systolic diameter –2.09 mm (95% CI –4.11; –0.06; P equal to .043).

The researchers also drew blood at 3-month intervals to check for serum calcium concentration, renal function, and vitamin D levels. Treatment was well tolerated, and no patients suffered hypervitaminosis or required a dose adjustment.

“There was no effect of vitamin D supplementation on the primary endpoint of 6 MWT distance but there were statistically significant, and prognostically and clinically relevant improvements in the secondary outcomes of left ventricular ejection fraction, dimensions, and volumes, suggesting that vitamin D is leading to beneficial reverse remodeling,” the investigators wrote in their analysis.

The study’s failure to meet its primary endpoint despite significant results from its secondary endpoints led Dr. Witte and colleagues to say that its design led to underpowering.

“Variability in the walk distance measure at baseline was much greater than predicted from our pilot study such that our sample size only had 7% post hoc power to detect a difference between the groups,” meaning it was underpowered to detect a clinically relevant change in walk distance. The findings “have implications for future studies using 6-minute walk distance as an outcome measure,” they wrote.

The investigators championed the addition of vitamin D₃ to CHF treatment regimens.

As new therapies for CHF are “often expensive, increasingly technical, and frequently fail to meet the rigorous demands of large phase III clinical trials,” Dr. Witte and colleagues wrote, vitamin D “might be a cheap and safe additional option for CHF patients and may have beneficial effects on multiple features of the syndrome.”

The U.K.’s National Institute for Health Research supported the study, and none of its authors declared conflicts of interest.

High-dose oral vitamin D supplements taken for 1 year significantly improved cardiac structure and function in patients with chronic heart failure secondary to left ventricular systolic dysfunction, according to results from a new study.

However, the same study. led by Dr. Klaus Witte of the University of Leeds (England), found that 6-minute walk distance – the study’s primary outcome measure – was not improved after a year’s supplementation with vitamin D.

©Joss/Fotolia.com

It is unclear why vitamin D deficiency co-occurs in a majority of people with chronic heart failure (CHF) due to left ventricular systolic dysfunction (LVSD) or to what degree reversing it can improve outcomes. However, vitamin D deficiency is thought to interfere with calcium transport in cardiac cells, and may contribute to cardiac fibrosis and inflammation, leading to faster progression to heart failure following damage to cardiac muscle.

The new VINDICATE study randomized 223 patients with CHF due to LVSD and vitamin D deficiency to 1 year’s treatment with 4,000 IU of 25(OH) vitamin D3 daily, or placebo, Dr. Witte and associates concluded at the annual meeting of the American College of Cardiology. The results were published online April 4 in JACC (doi: 10.1016/j.jacc.2016.03.508).

Of these patients, 163 completed follow-up at 12 months, and 6-minute walk distance (MWT) and echocardiography findings were recorded at baseline and follow-up.

Dr. Witte and colleagues found significant evidence of improved function in the vitamin D–treated patients as measured by left ventricular ejection fraction +6.07% (95% confidence interval 3.20, 8.95; P less than .0001); and a reversal of left ventricular remodeling (left ventricular end diastolic diameter –2.49 mm (95% CI –4.09, –0.90; P equal to .002) and left ventricular end systolic diameter –2.09 mm (95% CI –4.11; –0.06; P equal to .043).

The researchers also drew blood at 3-month intervals to check for serum calcium concentration, renal function, and vitamin D levels. Treatment was well tolerated, and no patients suffered hypervitaminosis or required a dose adjustment.

“There was no effect of vitamin D supplementation on the primary endpoint of 6 MWT distance but there were statistically significant, and prognostically and clinically relevant improvements in the secondary outcomes of left ventricular ejection fraction, dimensions, and volumes, suggesting that vitamin D is leading to beneficial reverse remodeling,” the investigators wrote in their analysis.

The study’s failure to meet its primary endpoint despite significant results from its secondary endpoints led Dr. Witte and colleagues to say that its design led to underpowering.

“Variability in the walk distance measure at baseline was much greater than predicted from our pilot study such that our sample size only had 7% post hoc power to detect a difference between the groups,” meaning it was underpowered to detect a clinically relevant change in walk distance. The findings “have implications for future studies using 6-minute walk distance as an outcome measure,” they wrote.

The investigators championed the addition of vitamin D₃ to CHF treatment regimens.

As new therapies for CHF are “often expensive, increasingly technical, and frequently fail to meet the rigorous demands of large phase III clinical trials,” Dr. Witte and colleagues wrote, vitamin D “might be a cheap and safe additional option for CHF patients and may have beneficial effects on multiple features of the syndrome.”

The U.K.’s National Institute for Health Research supported the study, and none of its authors declared conflicts of interest.

[WpProQuiz 6]

[WpProQuiz_toplist 6]

[WpProQuiz 6]

[WpProQuiz_toplist 6]

[WpProQuiz 6]

[WpProQuiz_toplist 6]

The Journal of Vascular Surgery: Venous and Lymphatic Disorders is now indexed on PubMed, from Issue 1 Volume 1. PubMed is often the first stop for researchers because it comprises more than 25 million citations for biomedical literature from MEDLINE, life science journals and online books.

Not only does this accomplishment increase the visibility of the Journal, it confirms the Journal of Vascular Surgery: Venous and Lymphatic Disorders as the premier international journal of medical, endovascular and surgical care of venous and lymphatic disorders.

Only 12 to 15 percent of the journals reviewed are recommended for inclusion in MEDLINE, so it is clear that this accomplishment is due in great part to the fact that every issues of JVSVL includes high-quality and rigorously peer-reviewed articles.

The Journal of Vascular Surgery: Venous and Lymphatic Disorders is now indexed on PubMed, from Issue 1 Volume 1. PubMed is often the first stop for researchers because it comprises more than 25 million citations for biomedical literature from MEDLINE, life science journals and online books.

Not only does this accomplishment increase the visibility of the Journal, it confirms the Journal of Vascular Surgery: Venous and Lymphatic Disorders as the premier international journal of medical, endovascular and surgical care of venous and lymphatic disorders.

Only 12 to 15 percent of the journals reviewed are recommended for inclusion in MEDLINE, so it is clear that this accomplishment is due in great part to the fact that every issues of JVSVL includes high-quality and rigorously peer-reviewed articles.

The Journal of Vascular Surgery: Venous and Lymphatic Disorders is now indexed on PubMed, from Issue 1 Volume 1. PubMed is often the first stop for researchers because it comprises more than 25 million citations for biomedical literature from MEDLINE, life science journals and online books.

Not only does this accomplishment increase the visibility of the Journal, it confirms the Journal of Vascular Surgery: Venous and Lymphatic Disorders as the premier international journal of medical, endovascular and surgical care of venous and lymphatic disorders.

Only 12 to 15 percent of the journals reviewed are recommended for inclusion in MEDLINE, so it is clear that this accomplishment is due in great part to the fact that every issues of JVSVL includes high-quality and rigorously peer-reviewed articles.

From the Department of Pediatrics, George Washington University and Children’s National Medical Center, Washington, DC (Dr. Kern), the Department of Pediatrics, Children’s Hospital Los Angeles and University of Southern California Keck School of Medicine, Los Angeles, CA (Dr. Gay), and the Department of Pediatrics, University of Texas Southwestern Medical Center and Children’s Health System, Dallas, TX (Dr. Mittal).

Abstract

• Objective: To present a model for operationalizing successful family-centered rounds (FCRs).
• Methods: Literature review and experience with leading FCR workshops at national meetings.
• Results: FCRs are multidisciplinary rounds that involve patients and families in decision-making. The model has gained substantial momentum nationally and is widely practiced in US pediatric hospitals. Many quality improvement–related FCR benefits have been identified, including improved parental satisfaction, communication, team-based practice, incorporation of practice guidelines, prevention of medication errors, and improved trainee and staff education and satisfaction. Physical and time constraints, variability in attending FCR style and teaching style, lack of FCR structure and process, specific and sensitive patient conditions, and language barriers are key challenges to implementing FCRs. Operationalizing a successful FCR program requires key stakeholders developing and defining a FCR process and structure, including developing a strong faculty development program.
• Conclusion: FCR benefits for a health care system are many. Key stakeholders involvement, developing FCR "ground rules," troubleshooting FCR barriers, and developing a strong faculty development program are key to managing successful FCRs.

The practice of medicine is a team sport and no team is complete without the patient and family being an integral part of it. Over the past 15 years, health care and the practice of medicine has slowly moved away from physician-centered care to patient- and family-centered care (FCC). This change has been a gradual shift in our culture and FCC has become a widely adopted philosophy within the US health care system [1]. FCC has been recognized and embraced by numerous medical and professional societies, including the Institute of Medicine (IOM), the American Academy of Pediatrics (AAP), and family advocacy organizations such as Family Voices and the Institute for Patient- and Family-Centered Care [1,2]. At its most basic, “family-centered care” occurs when patients/families and medical providers partner together to formulate medical plans that are built upon the sharing of open and unbiased information and that account for the diversity and individual strengths and needs of each patient and family unit [3]. FCC in the inpatient setting for hospitalized patients is most exemplified by the practice of family-centered (bedside) rounds, or FCRs [1].

Interestingly, FCC as a philosophy of care developed during a time when bedside rounds, and by extension clinical teaching, moved away from the bedside. Rounds are an integral part of how work is done in the inpatient setting. They come in many different flavors, from “pre-rounds” to “card-flip rounds” to “attending rounds,” “table/conference room rounds,” “hallway rounds,” “bedside rounds,” and the aforementioned family-centered rounds. In the first half of the 20th century,the majority of teaching rounds took place at the patient’s bedside, in the model advocated by Sir William Osler [4]. Indeed, as Dr. Osler wrote in 1903, “there should be no teaching without a patient for a text, and the best teaching is that taught by the patient himself” [5]. By the late 1970s through the mid-1990s, however, the proportion of clinical teaching occurring at the bedside had decreased to as low as 16% [6–8]. Many reasons behind the change have been speculated, including faculty comfort with lecture-based teaching and desire to control the content of teaching discussions, as well as technological advancement necessitating access to computers during case review.

In contrast, the patient-and family-centered movement began in the mid-20th century as a response to the separation trauma experienced by hospitalized children and their families [9]. Hospitals responded by liberalizing their visiting policies and encouraging direct care-giving by parents. FCC was further bolstered by consumer-led movements in the 1960s and 1970s, and by federal legislation in the 1980s targeting children with special health care needs. FCC gained national recognition in 2001 when the Institute of Medicine emphasized that involving patients and families in health care decisions increased the quality of their care [2]. Subsequently, the AAP endorsed FCC as a guiding approach to pediatric care in their 2003 report “Family-centered care and the pediatrician’s role” [1]. As part of this report, the AAP recommended that bedside presentations with active engagement of families become the standard of care. FCRs developed at several children’s hospitals in the US in the following years, with the first conceptual model of FCR published by Muething et al in 2007 [10].

Definition of Family-Centered Rounds

While no consensus definition of FCR exists, the most frequently cited description comes from Sisterhen et al who describe FCR as “interdisciplinary work rounds at the bedside in which the patient and family share in the control of the management plan as well as in the evaluation of the process itself” [11]. Three key features should be noted in this definition. First, FCR requires the active participation of family members, not merely their presence. In this way, patient and family voices are heard and their preferences solicited with respect to clinical decision-making. Second, FCR take place at the bedside, in alignment with the 2003 AAP policy statement that standard practice should be to conduct attending rounds with full case presentations in patient rooms in the presence of family. Third, FCR are typically interdisciplinary, involving patients and their families, physicians and trainees, nurses, and other ancillary staff (such as interpreters, case managers, and pharmacists) [1,10,11,12].

Since the IOM report, FCRs have gained substantial national momentum. A PRIS (Pediatric Research in Inpatient Setting) network study in 2010 published the first survey of pediatric hospitalist rounding practices in the US and Canada [12]. The study reported that 44% of pediatric hospitalists conducted FCRs, and about a quarter conducted rounds as hallway rounds or sit down rounds. Academic hospitalists were significantly more likely to conduct FCRs compared with non-academic (48% vs. 31%; P < 0.05) hospitalists. In accordance with Muething et al’s experience with FCRs in the Cincinnati model, the survey respondents did not associate FCR with prolonged rounding duration [10,12]. FCRs were also associated with greater bedside nurse participation [12]. Given the momentum behind FCC and the oft-cited benefits of FCR, it can only be presumed that the number of pediatric hospitals conducting FCR has significantly increased since the PRIS study was published in 2010.

FCRs Can Improve Quality of Care for Hospitalized Children

FCRs bring together multiple stakeholders involved in the patient’s care in the same place at the same time everyday. This allows for shared-decision making, identification of medical teams by families, and allows for direct and open communication between parents and medical teams [1,10–12]. The key stakeholders on a FCR team include the patient and family members and the medical team. The medical team includes attending physician, fellow, resident, and students, bedside nurse, care coordinator/case manager and other ancillary services. Although not enough data is available on who should attend rounds, case mangers and bedside nurse along with medical team and patients and families were found to be crucial in the general inpatient setting [12].

Integrating FCRs into the daily workflow in the inpatient setting provides several benefits for patients and families and the medical team, including trainees. Improvements in family-centered care principles, parental satisfaction, interdisciplinary team communication, efficiency, patient safety, and resident and medical student education have been reported consistently [9–23].

FCR Benefits for Patients and Families    

Muething et al described increased patient-family satis-faction with higher levels of family participation in rounds and earlier discharge times [10]. On FCRs, families report having the opportunity to communicate directly with the entire care team, clarify misinformation and better understand care plans including discharge goals, leading to higher levels family satisfaction [10,14,24]. Both English and limited-English-proficient families report positive experiences with FCRs [21–23]. Families express appreciation with learning opportunities on FCRs, as well as the opportunity to serve as teachers to the medical team [14,16,21]. Families reported comfort with trainees being on rounds and appreciated seeing the medical personnel working as team [21]. They also report trust, comfort, and accountability towards the system and providers as they saw them working together as teams. They felt respected and involved as the medical teams involved them during rounds. Parents also report comfort with diversity of providers and feel that having multidisciplinary and diverse teams help with cultural competencies. Parents appreciated trainees being led by attending physician and felt that attending FCRs made them understand the medical process and the steps involved in caring for their child. They also reported that attending FCRs helps trainees learn about answering the kind of questions that parents usually ask. Contrary to the popular belief, parental participation has not increased the duration of FCRs and parental presence during rounds decreases time spent discussing each patient [14,25].

FCRs and Staff Satisfaction

Staff satisfaction with FCRs has been consistently high [13,14,18–23]. Nursing and medical staffs report valuing FCRs as they foster a sense of teamwork, improve understanding of the patient’s care plan and enhance communication between the care team and families [14]. FCRs significantly increase bedside nurse participation during rounds [12]. Presence of nursing and ancillary staff on FCRs improves efficiency by providing valuable information and helping address discharge goal [10]. Anecdotal data suggests that FCRs reduces number of pages trainees receive from nurses.

FCRs and Outcomes

FCRs have been perceived to improve in patient safety including errors in history taking and miscommunication, and incorrect information; and promote medication reconciliation, safety and adherence [17,20,21]. FCRs have shown to improve patient satisfaction, communication, and coordination of care and trainee education [10,14,21].

Educational Benefits of FCRs

FCR Benefits for Hospitals and Health Care Systems

As health care prepares to fully adopt reforms and shift from volume-based to value-based payment systems, creating value in every patient encounter is vital. Conducting daily FCRs provide an dynamic venue for hospitals where daily rounds can incorporate evidence-based practice guidelines, prevent medication errors, ensure safety, reduce unnecessary tests and treatments, and improve transparency and accountability in care. This model can help hospital financially by meeting key quality and safety metrics and also help provide cost effective care through use and reinforcement of clinical pathways during rounds.

FCR Barriers

While many hospitals have adopted FCRs, many barriers to FCR implementation exist [10–14,18–23] (Table 1). Understanding these barriers and overcoming them are crucial for successful implementation. Conducting FCRs involve many aspects of care that happen during rounds. These include discussions about history, physical examinations, labs, and other tests; clinical decision-making and communication between parents and providers; team communication; teaching of trainees; discharge planning; and coordination of care [20]. Given all these aspects of care involved during rounds, being able to conduct multidisciplinary rounds in a timely and efficient way can be a challenge in a busy and dynamic inpatient setting.

Key identified FCR barriers have included physical constraints such as small patient rooms, large team size, patients being on multiple floors or units, infection control precautions leading to increased time involved with teams gowning and gloving; lack of training on FCRs for trainees and faculty; language and cultural barriers; family/patient concerns of privacy/disclosure of sensitive information; trainee’s fears of not appearing knowledgeable in front of families; and variability in attending physicians’ teaching style and approach to FCR [10–15,21].

Operationalizing Successful FCRs

Forming FCR Steering Committee: Developing Ground Rules

While there are many barriers to conducting efficient FCRs there are some that are unique to each institution. Therefore, for those institutions planning to initiate FCRs, the first step might be to form a FCR steering committee of key stakeholders who could review the current state, do a needs assessment for initiating FCRs, develop a structured and standardized FCR process and revise the FCR process periodically to meet the needs of the dynamic inpatient setting [10,12,14].

Defining and Identifying the FCR Process: Who, Where, and When of FCRs

The steering committee should clearly define FCRs and identify what FCRs would involve. For example, should FCRs involve complete case presentations and discussion in front of the parent or focused relevent H&P in a language that the parent understands? The steering committee should identify key elements/aspects of FCRs that would happen on daily rounds. For example: how should each patient receive information about FCRs? Should FCRs be offered to all patients? Do patients have options to opt-in or opt-out of FCRs on a daily basis or a one-time basis? Who should attend FCRs? For example, other than medical team, the bedside nurse and case manager should attend FCRs on a general pediatric service. Should the team round based on nursing assignments or resident assignments or in the order of room numbers? What should a typical rounding encounter involve? For example, each encounter should begin with the intern knocking on the door, asking parental permission for FCR team to enter the room, who should present, who should lead the rounds (the senior resident or the attending), who should stand where in the room? What should each encounter involve—for example, case presentation and discussion, parental involvement in decision-making, clarification of any parental questions, plan for that day, criteria for discharge and discharge needs assessment, teaching of resident and students, use of lay language etc. How should each rounding encounter end? Should the intern ask if parents have additional questions? It is important that the steering committee clearly identify these minute rounding details. Additionally, the committee should identify the rounding wards/area, the timing and duration of FCRs, how information about FCRs will be shared with patients and families, how trainees and attendees will be educated about FCRs and when are FCRs appropriate and when not. Defining the process early through stakeholder identification can reduce variability and create some standardization yet allow for individual style variations within the constraints of standardization. This will help reduced attending variability, which was cited as the most common FCR barrier by trainees.

As Seltz et al described, Latino families reported positive experiences with FCRs when a Spanish-speaking provider was involved. However, they report less satisfaction with telephone interpreters and did not feel empowered at times on FCRs due to language differences [23]. Addressing the language needs based on demographics and cultural needs will promote greater acceptance of FCRs [23].

Identifying and Defining Trainee Role 

Participating in the FCR can create anxiety for medical students and residents. Therefore, educating them about the FCR process and structure beforehand and clearly defining roles can help them conceptualize their roles and expectation and ease their anxiety with FCRs. This will require the steering committee to collaboratively discuss how each encounter would look during FCR from a trainee’s perspective. Who will present the case? The third- year medical student versus the fourth-year medical student or the intern or based on case allocations? How should the case be presented? Should it be short and pointed presentation versus complete history and physical examination on each patient? How long should an encounter last on a new patient and on a follow-up patient? Who will examine the patient? The student who is presenting the case, the attending, the intern who overlooks the student, or the senior resident? Who will answer the follow-up questions from a parent initially? Should the senior resident lead the team under the attending guidance? How will the senior resident be prepared for morning rounds? Using lay language when talking to parents should be encouraged and taught to trainees routinely during FCRs.

Identifying and Defining Clinical Teaching Styles

Faculty Development Program and Importance of “Safe Environment”

Developing an educational program to train faculty, trainee and staff about FCRs can help streamline FCRs. Conducting FCRs is a cultural change and focusing on early adopters is crucial. Muething et al’s model showed better acceptance of FCRs by interns than by senior residents. Being patient during change management is key to successful implementation. Anecdotal discussions during PAS workshops suggests that on an average programs have required 3 years to get significant buy-in and streamlining of FCRs [10,12].

Suboptimal attending behavior such as attending variability in the FCRs process and teaching strategies have been reported as FCR barriers [14,21]. Residents report attending physician as an important factor determining success of FCRs. As attending physicians typically are the leaders of the FCRs team, training faculty about conducting effective and efficient FCRs is crucial to successful FCRs. [12,21]. Key aspects of faculty development should include: (1) education about the FCR standard process for the institution, (2) importance of time management during rounds, including tips and strategies to be efficient, (3) teaching styles during FCRs, including demonstrating role modeling, and (4) direct observation of trainees and individual and team feedback to streamline FCRs. Role-plays or simulated FCRs might be a venue to explore for faculty development on FCRs [14,21].

Creating a “safe environment” during FCRs where each person feels comfortable and secure is vital to team work [7,12,21]. Often trainees are apprehensive or afraid due to medical hierarchy and this might prevent developing a teaching and learning environment. Trainees fear not appearing knowledgeable in front of families and student rotate too often to adapt to different attending styles [21]. Therefore, reassuring trainees that the goal of FCRs is to conduct daily inpatient rounding to ensure key aspects of FCRs are met without disrespecting and insulting any person on rounds and clarifying and reassuring trainees that their fear of not appearing knowledgeable is real and it will be respected, might help create a safe environment where FCR teams are not only conducting the daily ritual of inpatient rounding, and teaching but also ensuring that trainees are enjoying being the clinician and physicians that they want to be. Therefore, attending role modeling is crucial and it is no surprise that in multiple studies variability in attending rounding and teaching style was identified consistently as a FCR barrier.

Preparing for Daily FCRS: Team Work, Efficiency, and Time Management

Conducting daily timely and efficient rounds require daily preparation by teams. Prior to FCRs, teams should know about all of the patients on whom FCRs will be conducted including those who refused FCRs, if any. This can be done via a pre-round or card-flip rounding method where the teams discuss key diagnoses, indication for admission, and identify any outliers to conducting FCRs such as sensitive patient condition, patients refused FCRs, etc. Some institutions have incorporated these at “morning check out” or at morning “huddles.” These help faculty avoid any last minute surprises during rounds and helps with time management during FCRs [12]. Faculty can then plan on some anticipated “teaching moments” before rounds to keep the rounds flowing, for example, a physical exam finding, a clarifying history that can clinch a diagnoses, a clinical pearl, a complex medical case where the parent might share their story and knowledge, an interesting interpretation of a lab, an x-ray or MRI finding. Faculties are multitasking during FCRs by diagnosing and managing patient and learners and leading effective efficient and timely rounds where parental questions are answered, orders are written, to-do work is identified, discharge planning and care coordination is done and trainees stay focused and attend noon conference on time. This requires thoughtful planning before starting FCRs. Time management and managing priorities is key to positive team experiences of FCRs. Both starting and ending FCRs on time should be emphasized and reinforced continually.

Nurse Preparation for FCRs

Nurses are the frontline providers and educating them about FCRs process can help them better explain FCRs to patients and families. Nurses often know the minute details such as timing of an MRI, if the patient has vomited in the morning, or when the parents are coming, etc. This important information sharing during FCRs can help team prepare for the day and provide patients and families’ expectations for the day. Nursing participation can also enhance their knowledge about the thought process behind decisions and care plans and avoid additional time paging house staff to obtain clarification [12–15,21].

Trainee Preparation for FCRs

While pediatric residents do report that FCRs leads to fewer requests for clarifications from families and nurses after FCRs, many still harbor concerns about the time required for FCRs and the overall efficiency of rounds [14]. Educating trainees about the FCR process and explaining why FCRs are beneficial can help alleviate trainee anxiety around FCRs. Involving trainees in the FCR communication and creating a safe and nurturing environment during FCRs can further reduce trainee anxiety [21]. Parents who have attended FCRs with trainees report understanding that trainees are in training and that they have felt comfortable to see attending physician lead the trainees.

FCRs and Technology

Use of technology during FCRs can be helpful to write orders in real time, follow-up and share lab values and or imaging study with parents or teach students. The increasing use of technology on FCRs, such as computers and handheld devices, can help with rounding and teaching; however, it also has the potential to be a distractor and requires that the medical team remain vigilant that the patient and family are the focus of FCRs [26].

Efficiency Pearls

Certain strategies can be utilized to keep FCRs efficient:

1. Orient the FCR team about FCR process
2. Identify rounding sequence for the day so team can move efficiently between rooms. Identifying potential discharges for the following morning and discharging those patients before rounds can reduce rounding census and provide additional rounding time. Teams can identify approximate time spent in each room based on census, as rounding time is constant.
3. Starting and ending FCRs at the allocated time is key to success of FCRs. Sometimes this might require the attending and senior resident splitting the last 1–2 patients to finish rounds on time.
4. Prepare students and interns for effective and efficient yet complete presentations during rounds that reflect their knowledge and thought process rather than presenting the entire H&P.
5. Keep teaching during rounds focused. As a resident reported, “attendings should keep it short and not go off on a half hour lecture during FCRs. On FCRs I want to hear bam…bam…bam! tidbits, little hints, clinical pearls. Things that you would not know and only see and know when you were there in the room [21].”
6. Encourage and teach senior residents’ role as a leader and teacher [21].
7. With a situation requiring more time talking to families, request to go back later in the afternoon so as to stay on track on FCR time.
8. Faculty can review lab results and history and physical findings on new admissions before rounds to avoid surprises during FCRs and to save time. This can be done during pre-round/card flip/or morning huddle.

Limitations

This article is based on the authors’ review of literature, experience in conducting FCRs, and experience from leading and attending FCR-related workshops at annual pediatric academic societies’ meetings and annual pediatric hospital medicine meetings between 2010 and 2015. There are several limitations to this work. Firstly, the majority of FCR literature is based on perceptions and are not measured outcomes. In addition, how FCRs will apply on services with complex patients needs more study. Different institutions have different physical constraints as well as sociodemographic and cultural factors that might affect FCRs. Daily census among hospitals varies and rounding duration may vary for them.

Conclusion

Family-centered rounds are widely accepted among pediatric hospitalists in the US. Reported benefits of FCRs include improved parent satisfaction, communication, better team communication, improved patient safety and better education for trainees. Many barriers to efficient FCRs exist, and for programs planning to incorporate FCRs in their daily rounds it is crucial to understand FCR benefits and barriers and assess their current state, including physical environment, when planning FCRs. Having a period to plan for FCR implementation through key stakeholder involvement helps define FCR process and lay down a conceptual model suited to individual organization. Educating the team members including families about FCRs and developing a strong faculty development program can further strengthen FCR implementation. Special focus should be given to time management, teaching styles during FCRs, and creating a safe and nurturing environment for FCRs to succeed.

Corresponding author: Vineeta Mittal, MD, MBA, 1935 Medical District Dr., Dallas, TX 75235, [email protected].

From the Department of Pediatrics, George Washington University and Children’s National Medical Center, Washington, DC (Dr. Kern), the Department of Pediatrics, Children’s Hospital Los Angeles and University of Southern California Keck School of Medicine, Los Angeles, CA (Dr. Gay), and the Department of Pediatrics, University of Texas Southwestern Medical Center and Children’s Health System, Dallas, TX (Dr. Mittal).

Abstract

• Objective: To present a model for operationalizing successful family-centered rounds (FCRs).
• Methods: Literature review and experience with leading FCR workshops at national meetings.
• Results: FCRs are multidisciplinary rounds that involve patients and families in decision-making. The model has gained substantial momentum nationally and is widely practiced in US pediatric hospitals. Many quality improvement–related FCR benefits have been identified, including improved parental satisfaction, communication, team-based practice, incorporation of practice guidelines, prevention of medication errors, and improved trainee and staff education and satisfaction. Physical and time constraints, variability in attending FCR style and teaching style, lack of FCR structure and process, specific and sensitive patient conditions, and language barriers are key challenges to implementing FCRs. Operationalizing a successful FCR program requires key stakeholders developing and defining a FCR process and structure, including developing a strong faculty development program.
• Conclusion: FCR benefits for a health care system are many. Key stakeholders involvement, developing FCR "ground rules," troubleshooting FCR barriers, and developing a strong faculty development program are key to managing successful FCRs.

The practice of medicine is a team sport and no team is complete without the patient and family being an integral part of it. Over the past 15 years, health care and the practice of medicine has slowly moved away from physician-centered care to patient- and family-centered care (FCC). This change has been a gradual shift in our culture and FCC has become a widely adopted philosophy within the US health care system [1]. FCC has been recognized and embraced by numerous medical and professional societies, including the Institute of Medicine (IOM), the American Academy of Pediatrics (AAP), and family advocacy organizations such as Family Voices and the Institute for Patient- and Family-Centered Care [1,2]. At its most basic, “family-centered care” occurs when patients/families and medical providers partner together to formulate medical plans that are built upon the sharing of open and unbiased information and that account for the diversity and individual strengths and needs of each patient and family unit [3]. FCC in the inpatient setting for hospitalized patients is most exemplified by the practice of family-centered (bedside) rounds, or FCRs [1].

Interestingly, FCC as a philosophy of care developed during a time when bedside rounds, and by extension clinical teaching, moved away from the bedside. Rounds are an integral part of how work is done in the inpatient setting. They come in many different flavors, from “pre-rounds” to “card-flip rounds” to “attending rounds,” “table/conference room rounds,” “hallway rounds,” “bedside rounds,” and the aforementioned family-centered rounds. In the first half of the 20th century,the majority of teaching rounds took place at the patient’s bedside, in the model advocated by Sir William Osler [4]. Indeed, as Dr. Osler wrote in 1903, “there should be no teaching without a patient for a text, and the best teaching is that taught by the patient himself” [5]. By the late 1970s through the mid-1990s, however, the proportion of clinical teaching occurring at the bedside had decreased to as low as 16% [6–8]. Many reasons behind the change have been speculated, including faculty comfort with lecture-based teaching and desire to control the content of teaching discussions, as well as technological advancement necessitating access to computers during case review.

In contrast, the patient-and family-centered movement began in the mid-20th century as a response to the separation trauma experienced by hospitalized children and their families [9]. Hospitals responded by liberalizing their visiting policies and encouraging direct care-giving by parents. FCC was further bolstered by consumer-led movements in the 1960s and 1970s, and by federal legislation in the 1980s targeting children with special health care needs. FCC gained national recognition in 2001 when the Institute of Medicine emphasized that involving patients and families in health care decisions increased the quality of their care [2]. Subsequently, the AAP endorsed FCC as a guiding approach to pediatric care in their 2003 report “Family-centered care and the pediatrician’s role” [1]. As part of this report, the AAP recommended that bedside presentations with active engagement of families become the standard of care. FCRs developed at several children’s hospitals in the US in the following years, with the first conceptual model of FCR published by Muething et al in 2007 [10].

Definition of Family-Centered Rounds

While no consensus definition of FCR exists, the most frequently cited description comes from Sisterhen et al who describe FCR as “interdisciplinary work rounds at the bedside in which the patient and family share in the control of the management plan as well as in the evaluation of the process itself” [11]. Three key features should be noted in this definition. First, FCR requires the active participation of family members, not merely their presence. In this way, patient and family voices are heard and their preferences solicited with respect to clinical decision-making. Second, FCR take place at the bedside, in alignment with the 2003 AAP policy statement that standard practice should be to conduct attending rounds with full case presentations in patient rooms in the presence of family. Third, FCR are typically interdisciplinary, involving patients and their families, physicians and trainees, nurses, and other ancillary staff (such as interpreters, case managers, and pharmacists) [1,10,11,12].

Since the IOM report, FCRs have gained substantial national momentum. A PRIS (Pediatric Research in Inpatient Setting) network study in 2010 published the first survey of pediatric hospitalist rounding practices in the US and Canada [12]. The study reported that 44% of pediatric hospitalists conducted FCRs, and about a quarter conducted rounds as hallway rounds or sit down rounds. Academic hospitalists were significantly more likely to conduct FCRs compared with non-academic (48% vs. 31%; P < 0.05) hospitalists. In accordance with Muething et al’s experience with FCRs in the Cincinnati model, the survey respondents did not associate FCR with prolonged rounding duration [10,12]. FCRs were also associated with greater bedside nurse participation [12]. Given the momentum behind FCC and the oft-cited benefits of FCR, it can only be presumed that the number of pediatric hospitals conducting FCR has significantly increased since the PRIS study was published in 2010.

FCRs Can Improve Quality of Care for Hospitalized Children

FCRs bring together multiple stakeholders involved in the patient’s care in the same place at the same time everyday. This allows for shared-decision making, identification of medical teams by families, and allows for direct and open communication between parents and medical teams [1,10–12]. The key stakeholders on a FCR team include the patient and family members and the medical team. The medical team includes attending physician, fellow, resident, and students, bedside nurse, care coordinator/case manager and other ancillary services. Although not enough data is available on who should attend rounds, case mangers and bedside nurse along with medical team and patients and families were found to be crucial in the general inpatient setting [12].

Integrating FCRs into the daily workflow in the inpatient setting provides several benefits for patients and families and the medical team, including trainees. Improvements in family-centered care principles, parental satisfaction, interdisciplinary team communication, efficiency, patient safety, and resident and medical student education have been reported consistently [9–23].

FCR Benefits for Patients and Families    

Muething et al described increased patient-family satis-faction with higher levels of family participation in rounds and earlier discharge times [10]. On FCRs, families report having the opportunity to communicate directly with the entire care team, clarify misinformation and better understand care plans including discharge goals, leading to higher levels family satisfaction [10,14,24]. Both English and limited-English-proficient families report positive experiences with FCRs [21–23]. Families express appreciation with learning opportunities on FCRs, as well as the opportunity to serve as teachers to the medical team [14,16,21]. Families reported comfort with trainees being on rounds and appreciated seeing the medical personnel working as team [21]. They also report trust, comfort, and accountability towards the system and providers as they saw them working together as teams. They felt respected and involved as the medical teams involved them during rounds. Parents also report comfort with diversity of providers and feel that having multidisciplinary and diverse teams help with cultural competencies. Parents appreciated trainees being led by attending physician and felt that attending FCRs made them understand the medical process and the steps involved in caring for their child. They also reported that attending FCRs helps trainees learn about answering the kind of questions that parents usually ask. Contrary to the popular belief, parental participation has not increased the duration of FCRs and parental presence during rounds decreases time spent discussing each patient [14,25].

FCRs and Staff Satisfaction

Staff satisfaction with FCRs has been consistently high [13,14,18–23]. Nursing and medical staffs report valuing FCRs as they foster a sense of teamwork, improve understanding of the patient’s care plan and enhance communication between the care team and families [14]. FCRs significantly increase bedside nurse participation during rounds [12]. Presence of nursing and ancillary staff on FCRs improves efficiency by providing valuable information and helping address discharge goal [10]. Anecdotal data suggests that FCRs reduces number of pages trainees receive from nurses.

FCRs and Outcomes

FCRs have been perceived to improve in patient safety including errors in history taking and miscommunication, and incorrect information; and promote medication reconciliation, safety and adherence [17,20,21]. FCRs have shown to improve patient satisfaction, communication, and coordination of care and trainee education [10,14,21].

Educational Benefits of FCRs

FCR Benefits for Hospitals and Health Care Systems

As health care prepares to fully adopt reforms and shift from volume-based to value-based payment systems, creating value in every patient encounter is vital. Conducting daily FCRs provide an dynamic venue for hospitals where daily rounds can incorporate evidence-based practice guidelines, prevent medication errors, ensure safety, reduce unnecessary tests and treatments, and improve transparency and accountability in care. This model can help hospital financially by meeting key quality and safety metrics and also help provide cost effective care through use and reinforcement of clinical pathways during rounds.

FCR Barriers

While many hospitals have adopted FCRs, many barriers to FCR implementation exist [10–14,18–23] (Table 1). Understanding these barriers and overcoming them are crucial for successful implementation. Conducting FCRs involve many aspects of care that happen during rounds. These include discussions about history, physical examinations, labs, and other tests; clinical decision-making and communication between parents and providers; team communication; teaching of trainees; discharge planning; and coordination of care [20]. Given all these aspects of care involved during rounds, being able to conduct multidisciplinary rounds in a timely and efficient way can be a challenge in a busy and dynamic inpatient setting.

Key identified FCR barriers have included physical constraints such as small patient rooms, large team size, patients being on multiple floors or units, infection control precautions leading to increased time involved with teams gowning and gloving; lack of training on FCRs for trainees and faculty; language and cultural barriers; family/patient concerns of privacy/disclosure of sensitive information; trainee’s fears of not appearing knowledgeable in front of families; and variability in attending physicians’ teaching style and approach to FCR [10–15,21].

Operationalizing Successful FCRs

Forming FCR Steering Committee: Developing Ground Rules

While there are many barriers to conducting efficient FCRs there are some that are unique to each institution. Therefore, for those institutions planning to initiate FCRs, the first step might be to form a FCR steering committee of key stakeholders who could review the current state, do a needs assessment for initiating FCRs, develop a structured and standardized FCR process and revise the FCR process periodically to meet the needs of the dynamic inpatient setting [10,12,14].

Defining and Identifying the FCR Process: Who, Where, and When of FCRs

The steering committee should clearly define FCRs and identify what FCRs would involve. For example, should FCRs involve complete case presentations and discussion in front of the parent or focused relevent H&P in a language that the parent understands? The steering committee should identify key elements/aspects of FCRs that would happen on daily rounds. For example: how should each patient receive information about FCRs? Should FCRs be offered to all patients? Do patients have options to opt-in or opt-out of FCRs on a daily basis or a one-time basis? Who should attend FCRs? For example, other than medical team, the bedside nurse and case manager should attend FCRs on a general pediatric service. Should the team round based on nursing assignments or resident assignments or in the order of room numbers? What should a typical rounding encounter involve? For example, each encounter should begin with the intern knocking on the door, asking parental permission for FCR team to enter the room, who should present, who should lead the rounds (the senior resident or the attending), who should stand where in the room? What should each encounter involve—for example, case presentation and discussion, parental involvement in decision-making, clarification of any parental questions, plan for that day, criteria for discharge and discharge needs assessment, teaching of resident and students, use of lay language etc. How should each rounding encounter end? Should the intern ask if parents have additional questions? It is important that the steering committee clearly identify these minute rounding details. Additionally, the committee should identify the rounding wards/area, the timing and duration of FCRs, how information about FCRs will be shared with patients and families, how trainees and attendees will be educated about FCRs and when are FCRs appropriate and when not. Defining the process early through stakeholder identification can reduce variability and create some standardization yet allow for individual style variations within the constraints of standardization. This will help reduced attending variability, which was cited as the most common FCR barrier by trainees.

As Seltz et al described, Latino families reported positive experiences with FCRs when a Spanish-speaking provider was involved. However, they report less satisfaction with telephone interpreters and did not feel empowered at times on FCRs due to language differences [23]. Addressing the language needs based on demographics and cultural needs will promote greater acceptance of FCRs [23].

Identifying and Defining Trainee Role 

Participating in the FCR can create anxiety for medical students and residents. Therefore, educating them about the FCR process and structure beforehand and clearly defining roles can help them conceptualize their roles and expectation and ease their anxiety with FCRs. This will require the steering committee to collaboratively discuss how each encounter would look during FCR from a trainee’s perspective. Who will present the case? The third- year medical student versus the fourth-year medical student or the intern or based on case allocations? How should the case be presented? Should it be short and pointed presentation versus complete history and physical examination on each patient? How long should an encounter last on a new patient and on a follow-up patient? Who will examine the patient? The student who is presenting the case, the attending, the intern who overlooks the student, or the senior resident? Who will answer the follow-up questions from a parent initially? Should the senior resident lead the team under the attending guidance? How will the senior resident be prepared for morning rounds? Using lay language when talking to parents should be encouraged and taught to trainees routinely during FCRs.

Identifying and Defining Clinical Teaching Styles

Faculty Development Program and Importance of “Safe Environment”

Developing an educational program to train faculty, trainee and staff about FCRs can help streamline FCRs. Conducting FCRs is a cultural change and focusing on early adopters is crucial. Muething et al’s model showed better acceptance of FCRs by interns than by senior residents. Being patient during change management is key to successful implementation. Anecdotal discussions during PAS workshops suggests that on an average programs have required 3 years to get significant buy-in and streamlining of FCRs [10,12].

Suboptimal attending behavior such as attending variability in the FCRs process and teaching strategies have been reported as FCR barriers [14,21]. Residents report attending physician as an important factor determining success of FCRs. As attending physicians typically are the leaders of the FCRs team, training faculty about conducting effective and efficient FCRs is crucial to successful FCRs. [12,21]. Key aspects of faculty development should include: (1) education about the FCR standard process for the institution, (2) importance of time management during rounds, including tips and strategies to be efficient, (3) teaching styles during FCRs, including demonstrating role modeling, and (4) direct observation of trainees and individual and team feedback to streamline FCRs. Role-plays or simulated FCRs might be a venue to explore for faculty development on FCRs [14,21].

Creating a “safe environment” during FCRs where each person feels comfortable and secure is vital to team work [7,12,21]. Often trainees are apprehensive or afraid due to medical hierarchy and this might prevent developing a teaching and learning environment. Trainees fear not appearing knowledgeable in front of families and student rotate too often to adapt to different attending styles [21]. Therefore, reassuring trainees that the goal of FCRs is to conduct daily inpatient rounding to ensure key aspects of FCRs are met without disrespecting and insulting any person on rounds and clarifying and reassuring trainees that their fear of not appearing knowledgeable is real and it will be respected, might help create a safe environment where FCR teams are not only conducting the daily ritual of inpatient rounding, and teaching but also ensuring that trainees are enjoying being the clinician and physicians that they want to be. Therefore, attending role modeling is crucial and it is no surprise that in multiple studies variability in attending rounding and teaching style was identified consistently as a FCR barrier.

Preparing for Daily FCRS: Team Work, Efficiency, and Time Management

Conducting daily timely and efficient rounds require daily preparation by teams. Prior to FCRs, teams should know about all of the patients on whom FCRs will be conducted including those who refused FCRs, if any. This can be done via a pre-round or card-flip rounding method where the teams discuss key diagnoses, indication for admission, and identify any outliers to conducting FCRs such as sensitive patient condition, patients refused FCRs, etc. Some institutions have incorporated these at “morning check out” or at morning “huddles.” These help faculty avoid any last minute surprises during rounds and helps with time management during FCRs [12]. Faculty can then plan on some anticipated “teaching moments” before rounds to keep the rounds flowing, for example, a physical exam finding, a clarifying history that can clinch a diagnoses, a clinical pearl, a complex medical case where the parent might share their story and knowledge, an interesting interpretation of a lab, an x-ray or MRI finding. Faculties are multitasking during FCRs by diagnosing and managing patient and learners and leading effective efficient and timely rounds where parental questions are answered, orders are written, to-do work is identified, discharge planning and care coordination is done and trainees stay focused and attend noon conference on time. This requires thoughtful planning before starting FCRs. Time management and managing priorities is key to positive team experiences of FCRs. Both starting and ending FCRs on time should be emphasized and reinforced continually.

Nurse Preparation for FCRs

Nurses are the frontline providers and educating them about FCRs process can help them better explain FCRs to patients and families. Nurses often know the minute details such as timing of an MRI, if the patient has vomited in the morning, or when the parents are coming, etc. This important information sharing during FCRs can help team prepare for the day and provide patients and families’ expectations for the day. Nursing participation can also enhance their knowledge about the thought process behind decisions and care plans and avoid additional time paging house staff to obtain clarification [12–15,21].

Trainee Preparation for FCRs

While pediatric residents do report that FCRs leads to fewer requests for clarifications from families and nurses after FCRs, many still harbor concerns about the time required for FCRs and the overall efficiency of rounds [14]. Educating trainees about the FCR process and explaining why FCRs are beneficial can help alleviate trainee anxiety around FCRs. Involving trainees in the FCR communication and creating a safe and nurturing environment during FCRs can further reduce trainee anxiety [21]. Parents who have attended FCRs with trainees report understanding that trainees are in training and that they have felt comfortable to see attending physician lead the trainees.

FCRs and Technology

Use of technology during FCRs can be helpful to write orders in real time, follow-up and share lab values and or imaging study with parents or teach students. The increasing use of technology on FCRs, such as computers and handheld devices, can help with rounding and teaching; however, it also has the potential to be a distractor and requires that the medical team remain vigilant that the patient and family are the focus of FCRs [26].

Efficiency Pearls

Certain strategies can be utilized to keep FCRs efficient:

1. Orient the FCR team about FCR process
2. Identify rounding sequence for the day so team can move efficiently between rooms. Identifying potential discharges for the following morning and discharging those patients before rounds can reduce rounding census and provide additional rounding time. Teams can identify approximate time spent in each room based on census, as rounding time is constant.
3. Starting and ending FCRs at the allocated time is key to success of FCRs. Sometimes this might require the attending and senior resident splitting the last 1–2 patients to finish rounds on time.
4. Prepare students and interns for effective and efficient yet complete presentations during rounds that reflect their knowledge and thought process rather than presenting the entire H&P.
5. Keep teaching during rounds focused. As a resident reported, “attendings should keep it short and not go off on a half hour lecture during FCRs. On FCRs I want to hear bam…bam…bam! tidbits, little hints, clinical pearls. Things that you would not know and only see and know when you were there in the room [21].”
6. Encourage and teach senior residents’ role as a leader and teacher [21].
7. With a situation requiring more time talking to families, request to go back later in the afternoon so as to stay on track on FCR time.
8. Faculty can review lab results and history and physical findings on new admissions before rounds to avoid surprises during FCRs and to save time. This can be done during pre-round/card flip/or morning huddle.

Limitations

This article is based on the authors’ review of literature, experience in conducting FCRs, and experience from leading and attending FCR-related workshops at annual pediatric academic societies’ meetings and annual pediatric hospital medicine meetings between 2010 and 2015. There are several limitations to this work. Firstly, the majority of FCR literature is based on perceptions and are not measured outcomes. In addition, how FCRs will apply on services with complex patients needs more study. Different institutions have different physical constraints as well as sociodemographic and cultural factors that might affect FCRs. Daily census among hospitals varies and rounding duration may vary for them.

Conclusion

Family-centered rounds are widely accepted among pediatric hospitalists in the US. Reported benefits of FCRs include improved parent satisfaction, communication, better team communication, improved patient safety and better education for trainees. Many barriers to efficient FCRs exist, and for programs planning to incorporate FCRs in their daily rounds it is crucial to understand FCR benefits and barriers and assess their current state, including physical environment, when planning FCRs. Having a period to plan for FCR implementation through key stakeholder involvement helps define FCR process and lay down a conceptual model suited to individual organization. Educating the team members including families about FCRs and developing a strong faculty development program can further strengthen FCR implementation. Special focus should be given to time management, teaching styles during FCRs, and creating a safe and nurturing environment for FCRs to succeed.

Corresponding author: Vineeta Mittal, MD, MBA, 1935 Medical District Dr., Dallas, TX 75235, [email protected].

From the Department of Pediatrics, George Washington University and Children’s National Medical Center, Washington, DC (Dr. Kern), the Department of Pediatrics, Children’s Hospital Los Angeles and University of Southern California Keck School of Medicine, Los Angeles, CA (Dr. Gay), and the Department of Pediatrics, University of Texas Southwestern Medical Center and Children’s Health System, Dallas, TX (Dr. Mittal).

Abstract

• Objective: To present a model for operationalizing successful family-centered rounds (FCRs).
• Methods: Literature review and experience with leading FCR workshops at national meetings.
• Results: FCRs are multidisciplinary rounds that involve patients and families in decision-making. The model has gained substantial momentum nationally and is widely practiced in US pediatric hospitals. Many quality improvement–related FCR benefits have been identified, including improved parental satisfaction, communication, team-based practice, incorporation of practice guidelines, prevention of medication errors, and improved trainee and staff education and satisfaction. Physical and time constraints, variability in attending FCR style and teaching style, lack of FCR structure and process, specific and sensitive patient conditions, and language barriers are key challenges to implementing FCRs. Operationalizing a successful FCR program requires key stakeholders developing and defining a FCR process and structure, including developing a strong faculty development program.
• Conclusion: FCR benefits for a health care system are many. Key stakeholders involvement, developing FCR "ground rules," troubleshooting FCR barriers, and developing a strong faculty development program are key to managing successful FCRs.

The practice of medicine is a team sport and no team is complete without the patient and family being an integral part of it. Over the past 15 years, health care and the practice of medicine has slowly moved away from physician-centered care to patient- and family-centered care (FCC). This change has been a gradual shift in our culture and FCC has become a widely adopted philosophy within the US health care system [1]. FCC has been recognized and embraced by numerous medical and professional societies, including the Institute of Medicine (IOM), the American Academy of Pediatrics (AAP), and family advocacy organizations such as Family Voices and the Institute for Patient- and Family-Centered Care [1,2]. At its most basic, “family-centered care” occurs when patients/families and medical providers partner together to formulate medical plans that are built upon the sharing of open and unbiased information and that account for the diversity and individual strengths and needs of each patient and family unit [3]. FCC in the inpatient setting for hospitalized patients is most exemplified by the practice of family-centered (bedside) rounds, or FCRs [1].

Interestingly, FCC as a philosophy of care developed during a time when bedside rounds, and by extension clinical teaching, moved away from the bedside. Rounds are an integral part of how work is done in the inpatient setting. They come in many different flavors, from “pre-rounds” to “card-flip rounds” to “attending rounds,” “table/conference room rounds,” “hallway rounds,” “bedside rounds,” and the aforementioned family-centered rounds. In the first half of the 20th century,the majority of teaching rounds took place at the patient’s bedside, in the model advocated by Sir William Osler [4]. Indeed, as Dr. Osler wrote in 1903, “there should be no teaching without a patient for a text, and the best teaching is that taught by the patient himself” [5]. By the late 1970s through the mid-1990s, however, the proportion of clinical teaching occurring at the bedside had decreased to as low as 16% [6–8]. Many reasons behind the change have been speculated, including faculty comfort with lecture-based teaching and desire to control the content of teaching discussions, as well as technological advancement necessitating access to computers during case review.

In contrast, the patient-and family-centered movement began in the mid-20th century as a response to the separation trauma experienced by hospitalized children and their families [9]. Hospitals responded by liberalizing their visiting policies and encouraging direct care-giving by parents. FCC was further bolstered by consumer-led movements in the 1960s and 1970s, and by federal legislation in the 1980s targeting children with special health care needs. FCC gained national recognition in 2001 when the Institute of Medicine emphasized that involving patients and families in health care decisions increased the quality of their care [2]. Subsequently, the AAP endorsed FCC as a guiding approach to pediatric care in their 2003 report “Family-centered care and the pediatrician’s role” [1]. As part of this report, the AAP recommended that bedside presentations with active engagement of families become the standard of care. FCRs developed at several children’s hospitals in the US in the following years, with the first conceptual model of FCR published by Muething et al in 2007 [10].

Definition of Family-Centered Rounds

While no consensus definition of FCR exists, the most frequently cited description comes from Sisterhen et al who describe FCR as “interdisciplinary work rounds at the bedside in which the patient and family share in the control of the management plan as well as in the evaluation of the process itself” [11]. Three key features should be noted in this definition. First, FCR requires the active participation of family members, not merely their presence. In this way, patient and family voices are heard and their preferences solicited with respect to clinical decision-making. Second, FCR take place at the bedside, in alignment with the 2003 AAP policy statement that standard practice should be to conduct attending rounds with full case presentations in patient rooms in the presence of family. Third, FCR are typically interdisciplinary, involving patients and their families, physicians and trainees, nurses, and other ancillary staff (such as interpreters, case managers, and pharmacists) [1,10,11,12].

Since the IOM report, FCRs have gained substantial national momentum. A PRIS (Pediatric Research in Inpatient Setting) network study in 2010 published the first survey of pediatric hospitalist rounding practices in the US and Canada [12]. The study reported that 44% of pediatric hospitalists conducted FCRs, and about a quarter conducted rounds as hallway rounds or sit down rounds. Academic hospitalists were significantly more likely to conduct FCRs compared with non-academic (48% vs. 31%; P < 0.05) hospitalists. In accordance with Muething et al’s experience with FCRs in the Cincinnati model, the survey respondents did not associate FCR with prolonged rounding duration [10,12]. FCRs were also associated with greater bedside nurse participation [12]. Given the momentum behind FCC and the oft-cited benefits of FCR, it can only be presumed that the number of pediatric hospitals conducting FCR has significantly increased since the PRIS study was published in 2010.

FCRs Can Improve Quality of Care for Hospitalized Children

FCRs bring together multiple stakeholders involved in the patient’s care in the same place at the same time everyday. This allows for shared-decision making, identification of medical teams by families, and allows for direct and open communication between parents and medical teams [1,10–12]. The key stakeholders on a FCR team include the patient and family members and the medical team. The medical team includes attending physician, fellow, resident, and students, bedside nurse, care coordinator/case manager and other ancillary services. Although not enough data is available on who should attend rounds, case mangers and bedside nurse along with medical team and patients and families were found to be crucial in the general inpatient setting [12].

Integrating FCRs into the daily workflow in the inpatient setting provides several benefits for patients and families and the medical team, including trainees. Improvements in family-centered care principles, parental satisfaction, interdisciplinary team communication, efficiency, patient safety, and resident and medical student education have been reported consistently [9–23].

FCR Benefits for Patients and Families    

Muething et al described increased patient-family satis-faction with higher levels of family participation in rounds and earlier discharge times [10]. On FCRs, families report having the opportunity to communicate directly with the entire care team, clarify misinformation and better understand care plans including discharge goals, leading to higher levels family satisfaction [10,14,24]. Both English and limited-English-proficient families report positive experiences with FCRs [21–23]. Families express appreciation with learning opportunities on FCRs, as well as the opportunity to serve as teachers to the medical team [14,16,21]. Families reported comfort with trainees being on rounds and appreciated seeing the medical personnel working as team [21]. They also report trust, comfort, and accountability towards the system and providers as they saw them working together as teams. They felt respected and involved as the medical teams involved them during rounds. Parents also report comfort with diversity of providers and feel that having multidisciplinary and diverse teams help with cultural competencies. Parents appreciated trainees being led by attending physician and felt that attending FCRs made them understand the medical process and the steps involved in caring for their child. They also reported that attending FCRs helps trainees learn about answering the kind of questions that parents usually ask. Contrary to the popular belief, parental participation has not increased the duration of FCRs and parental presence during rounds decreases time spent discussing each patient [14,25].

FCRs and Staff Satisfaction

Staff satisfaction with FCRs has been consistently high [13,14,18–23]. Nursing and medical staffs report valuing FCRs as they foster a sense of teamwork, improve understanding of the patient’s care plan and enhance communication between the care team and families [14]. FCRs significantly increase bedside nurse participation during rounds [12]. Presence of nursing and ancillary staff on FCRs improves efficiency by providing valuable information and helping address discharge goal [10]. Anecdotal data suggests that FCRs reduces number of pages trainees receive from nurses.

FCRs and Outcomes

FCRs have been perceived to improve in patient safety including errors in history taking and miscommunication, and incorrect information; and promote medication reconciliation, safety and adherence [17,20,21]. FCRs have shown to improve patient satisfaction, communication, and coordination of care and trainee education [10,14,21].

Educational Benefits of FCRs

FCR Benefits for Hospitals and Health Care Systems

As health care prepares to fully adopt reforms and shift from volume-based to value-based payment systems, creating value in every patient encounter is vital. Conducting daily FCRs provide an dynamic venue for hospitals where daily rounds can incorporate evidence-based practice guidelines, prevent medication errors, ensure safety, reduce unnecessary tests and treatments, and improve transparency and accountability in care. This model can help hospital financially by meeting key quality and safety metrics and also help provide cost effective care through use and reinforcement of clinical pathways during rounds.

FCR Barriers

While many hospitals have adopted FCRs, many barriers to FCR implementation exist [10–14,18–23] (Table 1). Understanding these barriers and overcoming them are crucial for successful implementation. Conducting FCRs involve many aspects of care that happen during rounds. These include discussions about history, physical examinations, labs, and other tests; clinical decision-making and communication between parents and providers; team communication; teaching of trainees; discharge planning; and coordination of care [20]. Given all these aspects of care involved during rounds, being able to conduct multidisciplinary rounds in a timely and efficient way can be a challenge in a busy and dynamic inpatient setting.

Key identified FCR barriers have included physical constraints such as small patient rooms, large team size, patients being on multiple floors or units, infection control precautions leading to increased time involved with teams gowning and gloving; lack of training on FCRs for trainees and faculty; language and cultural barriers; family/patient concerns of privacy/disclosure of sensitive information; trainee’s fears of not appearing knowledgeable in front of families; and variability in attending physicians’ teaching style and approach to FCR [10–15,21].

Operationalizing Successful FCRs

Forming FCR Steering Committee: Developing Ground Rules

While there are many barriers to conducting efficient FCRs there are some that are unique to each institution. Therefore, for those institutions planning to initiate FCRs, the first step might be to form a FCR steering committee of key stakeholders who could review the current state, do a needs assessment for initiating FCRs, develop a structured and standardized FCR process and revise the FCR process periodically to meet the needs of the dynamic inpatient setting [10,12,14].

Defining and Identifying the FCR Process: Who, Where, and When of FCRs

The steering committee should clearly define FCRs and identify what FCRs would involve. For example, should FCRs involve complete case presentations and discussion in front of the parent or focused relevent H&P in a language that the parent understands? The steering committee should identify key elements/aspects of FCRs that would happen on daily rounds. For example: how should each patient receive information about FCRs? Should FCRs be offered to all patients? Do patients have options to opt-in or opt-out of FCRs on a daily basis or a one-time basis? Who should attend FCRs? For example, other than medical team, the bedside nurse and case manager should attend FCRs on a general pediatric service. Should the team round based on nursing assignments or resident assignments or in the order of room numbers? What should a typical rounding encounter involve? For example, each encounter should begin with the intern knocking on the door, asking parental permission for FCR team to enter the room, who should present, who should lead the rounds (the senior resident or the attending), who should stand where in the room? What should each encounter involve—for example, case presentation and discussion, parental involvement in decision-making, clarification of any parental questions, plan for that day, criteria for discharge and discharge needs assessment, teaching of resident and students, use of lay language etc. How should each rounding encounter end? Should the intern ask if parents have additional questions? It is important that the steering committee clearly identify these minute rounding details. Additionally, the committee should identify the rounding wards/area, the timing and duration of FCRs, how information about FCRs will be shared with patients and families, how trainees and attendees will be educated about FCRs and when are FCRs appropriate and when not. Defining the process early through stakeholder identification can reduce variability and create some standardization yet allow for individual style variations within the constraints of standardization. This will help reduced attending variability, which was cited as the most common FCR barrier by trainees.

As Seltz et al described, Latino families reported positive experiences with FCRs when a Spanish-speaking provider was involved. However, they report less satisfaction with telephone interpreters and did not feel empowered at times on FCRs due to language differences [23]. Addressing the language needs based on demographics and cultural needs will promote greater acceptance of FCRs [23].

Identifying and Defining Trainee Role 

Participating in the FCR can create anxiety for medical students and residents. Therefore, educating them about the FCR process and structure beforehand and clearly defining roles can help them conceptualize their roles and expectation and ease their anxiety with FCRs. This will require the steering committee to collaboratively discuss how each encounter would look during FCR from a trainee’s perspective. Who will present the case? The third- year medical student versus the fourth-year medical student or the intern or based on case allocations? How should the case be presented? Should it be short and pointed presentation versus complete history and physical examination on each patient? How long should an encounter last on a new patient and on a follow-up patient? Who will examine the patient? The student who is presenting the case, the attending, the intern who overlooks the student, or the senior resident? Who will answer the follow-up questions from a parent initially? Should the senior resident lead the team under the attending guidance? How will the senior resident be prepared for morning rounds? Using lay language when talking to parents should be encouraged and taught to trainees routinely during FCRs.

Identifying and Defining Clinical Teaching Styles

Faculty Development Program and Importance of “Safe Environment”

Developing an educational program to train faculty, trainee and staff about FCRs can help streamline FCRs. Conducting FCRs is a cultural change and focusing on early adopters is crucial. Muething et al’s model showed better acceptance of FCRs by interns than by senior residents. Being patient during change management is key to successful implementation. Anecdotal discussions during PAS workshops suggests that on an average programs have required 3 years to get significant buy-in and streamlining of FCRs [10,12].

Suboptimal attending behavior such as attending variability in the FCRs process and teaching strategies have been reported as FCR barriers [14,21]. Residents report attending physician as an important factor determining success of FCRs. As attending physicians typically are the leaders of the FCRs team, training faculty about conducting effective and efficient FCRs is crucial to successful FCRs. [12,21]. Key aspects of faculty development should include: (1) education about the FCR standard process for the institution, (2) importance of time management during rounds, including tips and strategies to be efficient, (3) teaching styles during FCRs, including demonstrating role modeling, and (4) direct observation of trainees and individual and team feedback to streamline FCRs. Role-plays or simulated FCRs might be a venue to explore for faculty development on FCRs [14,21].

Creating a “safe environment” during FCRs where each person feels comfortable and secure is vital to team work [7,12,21]. Often trainees are apprehensive or afraid due to medical hierarchy and this might prevent developing a teaching and learning environment. Trainees fear not appearing knowledgeable in front of families and student rotate too often to adapt to different attending styles [21]. Therefore, reassuring trainees that the goal of FCRs is to conduct daily inpatient rounding to ensure key aspects of FCRs are met without disrespecting and insulting any person on rounds and clarifying and reassuring trainees that their fear of not appearing knowledgeable is real and it will be respected, might help create a safe environment where FCR teams are not only conducting the daily ritual of inpatient rounding, and teaching but also ensuring that trainees are enjoying being the clinician and physicians that they want to be. Therefore, attending role modeling is crucial and it is no surprise that in multiple studies variability in attending rounding and teaching style was identified consistently as a FCR barrier.

Preparing for Daily FCRS: Team Work, Efficiency, and Time Management

Conducting daily timely and efficient rounds require daily preparation by teams. Prior to FCRs, teams should know about all of the patients on whom FCRs will be conducted including those who refused FCRs, if any. This can be done via a pre-round or card-flip rounding method where the teams discuss key diagnoses, indication for admission, and identify any outliers to conducting FCRs such as sensitive patient condition, patients refused FCRs, etc. Some institutions have incorporated these at “morning check out” or at morning “huddles.” These help faculty avoid any last minute surprises during rounds and helps with time management during FCRs [12]. Faculty can then plan on some anticipated “teaching moments” before rounds to keep the rounds flowing, for example, a physical exam finding, a clarifying history that can clinch a diagnoses, a clinical pearl, a complex medical case where the parent might share their story and knowledge, an interesting interpretation of a lab, an x-ray or MRI finding. Faculties are multitasking during FCRs by diagnosing and managing patient and learners and leading effective efficient and timely rounds where parental questions are answered, orders are written, to-do work is identified, discharge planning and care coordination is done and trainees stay focused and attend noon conference on time. This requires thoughtful planning before starting FCRs. Time management and managing priorities is key to positive team experiences of FCRs. Both starting and ending FCRs on time should be emphasized and reinforced continually.

Nurse Preparation for FCRs

Nurses are the frontline providers and educating them about FCRs process can help them better explain FCRs to patients and families. Nurses often know the minute details such as timing of an MRI, if the patient has vomited in the morning, or when the parents are coming, etc. This important information sharing during FCRs can help team prepare for the day and provide patients and families’ expectations for the day. Nursing participation can also enhance their knowledge about the thought process behind decisions and care plans and avoid additional time paging house staff to obtain clarification [12–15,21].

Trainee Preparation for FCRs

While pediatric residents do report that FCRs leads to fewer requests for clarifications from families and nurses after FCRs, many still harbor concerns about the time required for FCRs and the overall efficiency of rounds [14]. Educating trainees about the FCR process and explaining why FCRs are beneficial can help alleviate trainee anxiety around FCRs. Involving trainees in the FCR communication and creating a safe and nurturing environment during FCRs can further reduce trainee anxiety [21]. Parents who have attended FCRs with trainees report understanding that trainees are in training and that they have felt comfortable to see attending physician lead the trainees.

FCRs and Technology

Use of technology during FCRs can be helpful to write orders in real time, follow-up and share lab values and or imaging study with parents or teach students. The increasing use of technology on FCRs, such as computers and handheld devices, can help with rounding and teaching; however, it also has the potential to be a distractor and requires that the medical team remain vigilant that the patient and family are the focus of FCRs [26].

Efficiency Pearls

Certain strategies can be utilized to keep FCRs efficient:

1. Orient the FCR team about FCR process
2. Identify rounding sequence for the day so team can move efficiently between rooms. Identifying potential discharges for the following morning and discharging those patients before rounds can reduce rounding census and provide additional rounding time. Teams can identify approximate time spent in each room based on census, as rounding time is constant.
3. Starting and ending FCRs at the allocated time is key to success of FCRs. Sometimes this might require the attending and senior resident splitting the last 1–2 patients to finish rounds on time.
4. Prepare students and interns for effective and efficient yet complete presentations during rounds that reflect their knowledge and thought process rather than presenting the entire H&P.
5. Keep teaching during rounds focused. As a resident reported, “attendings should keep it short and not go off on a half hour lecture during FCRs. On FCRs I want to hear bam…bam…bam! tidbits, little hints, clinical pearls. Things that you would not know and only see and know when you were there in the room [21].”
6. Encourage and teach senior residents’ role as a leader and teacher [21].
7. With a situation requiring more time talking to families, request to go back later in the afternoon so as to stay on track on FCR time.
8. Faculty can review lab results and history and physical findings on new admissions before rounds to avoid surprises during FCRs and to save time. This can be done during pre-round/card flip/or morning huddle.

Limitations

This article is based on the authors’ review of literature, experience in conducting FCRs, and experience from leading and attending FCR-related workshops at annual pediatric academic societies’ meetings and annual pediatric hospital medicine meetings between 2010 and 2015. There are several limitations to this work. Firstly, the majority of FCR literature is based on perceptions and are not measured outcomes. In addition, how FCRs will apply on services with complex patients needs more study. Different institutions have different physical constraints as well as sociodemographic and cultural factors that might affect FCRs. Daily census among hospitals varies and rounding duration may vary for them.

Conclusion

Family-centered rounds are widely accepted among pediatric hospitalists in the US. Reported benefits of FCRs include improved parent satisfaction, communication, better team communication, improved patient safety and better education for trainees. Many barriers to efficient FCRs exist, and for programs planning to incorporate FCRs in their daily rounds it is crucial to understand FCR benefits and barriers and assess their current state, including physical environment, when planning FCRs. Having a period to plan for FCR implementation through key stakeholder involvement helps define FCR process and lay down a conceptual model suited to individual organization. Educating the team members including families about FCRs and developing a strong faculty development program can further strengthen FCR implementation. Special focus should be given to time management, teaching styles during FCRs, and creating a safe and nurturing environment for FCRs to succeed.

Corresponding author: Vineeta Mittal, MD, MBA, 1935 Medical District Dr., Dallas, TX 75235, [email protected].

From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, [email protected].


Funding/support: RB Salter Chair in Paediatric Surgical Research.

From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, [email protected].


Funding/support: RB Salter Chair in Paediatric Surgical Research.

From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, [email protected].


Funding/support: RB Salter Chair in Paediatric Surgical Research.

Study Overview

Objective. To assess the effectiveness of an intervention that focused on the home environment to reduce energy intake and increase physical activity among overweight and obese women.

Design. Randomized controlled trial.

Setting and participants. Study participants were overweight and obese females recruited via their providers from 3 community health centers (9 clinical sites) in southwest Georgia. Only women were recruited because of their potential role as gatekeepers of the home environment. Inclusion criteria included being aged 35 to 65 years at baseline, living with at least one other person, and living no further than 30 miles from the referring clinic. Exclusion criteria included patients with conditions that could impact their ability to be physically active and pregnant women.

Intervention. Participants in the intervention arm received 3 home visits and 4 coaching calls over 16 weeks. Core elements of the intervention were informed by social-cognitive theory and included a tailored home environment profile, goal setting, behavioral contracting for 6 healthy actions, and supportive materials delivered via mail. Home visits and coaching calls were completed by health coaches with at least high-school education and experience in social or customer service who had completed 2 days of formal training by university staff. Control condition patients received 3 mailings of educational booklets at 6-week intervals that included government documents encouraging adoption of US dietary and physical activity guidelines. All participants completed baseline, 6- and 12-month follow-up telephone interviews and wore an accelerometer at baseline and 6-month follow-up. Intervention patients also received follow-up surveys assessing satisfaction with the coach, home visits, telephone calls, and support materials.

Main outcome measures. The main outcomes were energy intake (average daily kilocalories from two 24-hour dietary recalls) and physical activity (hours per week spent in moderate or vigorous physical activity using the 7-day physical activity recall). Self-reported height and weight was used to calculate body mass index (BMI). Secondary outcome measures included self-reported weight loss and aspects of the home environment. Home food environment was assessed by asking participants about the presence of 3 unhealthy drinks and 8 unhealthy foods and snacks in the home in the past week, if fruits and vegetables and high-calorie snack foods were kept in easy to see and reach places in the home, how often the family ate meals and snacks in front of the TV, how often participants served healthier food or prepared foods using healthy cooking methods, and asking the number of days family meals were purchased from outside the home. Home activity environment was assessed by asking about rules regarding limits on time spent watching TV, using a computer, playing video games, and using other hand-held devices. The authors adapted a 14-item inventory to assess personal exercise equipment accessibility and availability in the home. Community facility use was assessed with 9 survey items that assessed frequency of use and spaces for exercise in the participants’ neighborhoods.

Main results. A total of 948 patients were referred, of which 751 were reached by phone and assessed for eligibility. 81 did not meet inclusion criteria, 203 declined to participate, and 118 did not complete baseline data collection, leaving 349 participants. Of these, 177 were randomized to the control group, 172 to the intervention, and 21 dropped out. The majority of participants were African-American women (84.8%) with an average age of 50.2 years (SD = 8.1) and average BMI of 38.3kg/m² (SD = 8.4). Most were low income, with 68.7% reporting an annual household income under $25,000, and nearly 50% reported fair or poor general health. Roughly 45% were employed and 49% lived in a rural area. At 6 months, 82.5% of participants completed data collection (n = 288); at 12 months, 76.8% completed data collection (n = 268). Participants who did not complete follow-up through 12 months were either non-responders (6 months: n = 36, 12 months: n = 44), refused (6 months: n = 3, 12 months: n = 7), or died (6 months: n = 0, 12 months: n = 1).

Daily energy consumption significantly decreased in the intervention group compared to the control group at 6 months (–274 vs. –69 kcal/day, P = 0.003), however there was no meaningful change in self-reported moderate to vigorous physical activity nor was there significant change in physical activity measured by accelerometers at 6 months compared to baseline. For secondary outcomes, self-reported weight loss at 6 months was significantly higher among intervention patients (mean, –9.1 lb) compared to control patients (mean, –5.0 pounds) (SD = 13.7 pounds; P = 0.03). In addition, at 12 months, 82.6% of intervention patients had not gained weight compared with 71.4% of control patients (P = 0.03). Intervention patients made several changes to their home food environments compared to control patients. Intervention patients had reduced the number of unhealthy drink and snacks, increased purchasing of fruits and vegetables, and reduced the frequency of watching TV while eating. In addition, they also improved meal preparation and service and reduced the number of non-home meals eaten. For home activity environment, having exercise equipment in a visible location changed significantly more in the intervention group compared to the control group. Intervention patients also incorporated more physical activity into their daily lives compared to control patients, and created more exercise space in their homes and yards. There were no significant differences in screen time rules, use of community facilities and spaces, and family social support for physical activity.

Conclusion. A moderate-intensity, coach-delivered weight gain prevention intervention targeting the home environment led to reduced energy intake and improved home environments to better facilitate healthy living and weight loss.

Commentary

More than half of all US adults are considered overweight or obese [1].Changing health behaviors has the best potential for decreasing morbidity and mortality and for improving quality of life and this has been supported by the literature in a wide variety of behaviors including smoking cessation and weight loss [2–4]. Currently, most overweight and obese patients are treated through primary care provider–based (PCP) counseling or referral to clinic-based weight management interventions. However, barriers to PCP weight management counseling include physicians’ negative attitudes towards the personal attributes of individuals with weight management issues, lack of time, and poor nutrition counseling competency [5–7]. In addition, there are notable differences between providers’ and patients’ beliefs about weight and weight loss; providers tend to believe patients lack self-control, while patients largely feel they should manage their weight problems on their own and that counseling from a provider is unhelpful [8]. Many patients report feeling judged by their doctor because of their weight, and very few of those who feel judged and discuss weight loss options actually lose a clinically significant amount of weight [9]. Considering the many barriers to providing/receiving weight management counseling in the clinic setting, weight management techniques provided outside the doctor’s office may be a more effective and feasible alternative.

The most common causes of death are related to lifestyle behaviors such as poor dietary habits and inactivity [10]. Since most calories are consumed within the home [11] and the average person spends the majority of their time in the home [12], interventions that target home-life behaviors are needed to combat weight gain. The Kegler et al study suggests that a moderate-intensity intervention targeted at changing home eating and exercise behaviors will be effective in changing home environments and reducing energy intake. While the authors had a fairly specific population, these findings suggest that interventions that specifically target health behaviors at home may have more potential for success than merely educating patients on the benefits of a healthy lifestyle.

This study has several strengths including the randomized controlled trial design, the intention-to-treat analysis, and low attrition rates. In addition, the intervention achieved reduced energy intake and improved health behaviors in the home, supporting significant weight loss among intervention participants, especially compared to control patients. Both of these suggest high adherence to the intervention, which is a complex but crucial component of successful weight loss and weight management [13]. Finally, the inclusion of a wide variety of secondary outcomes helped to distinguish between specific home environment changes to discern which aspects of the intervention were most successful. A limitation of the study was that the population was nearly entirely African American and from clinics in rural Georgia, which limits generalizability. However, the success of the intervention in this population is critical, as African American adults are nearly 1.5 times more likely to be obese compared to white adults, and greater than 75% of African Americans are overweight or obese [14]. Additionally, while the study did have significant success with energy intake and eating habits, the intervention was less successful with changing physical activity habits, and physical activity and exercise training can significantly impact weight loss and maintenance [15]. A final limitation is the use of self-reported weight and behaviors, which can reduce reliability of these results.

Applications for Clinical Practice

This study suggests that interventions that target health behaviors in the home may achieve better energy intake and physical activity outcomes and improve weight loss compared to traditional educational counseling. Providers may want to consider brief counseling around improving the home environment as opposed to or in addition to counseling around improving nutrition or physical activity. More research is necessary to understand whether this type of intervention is feasible and acceptable in other populations (eg, urban, other races). In addition, further research is necessary to improve the physical activity component of the intervention. The use of non-clinical providers has been shown to be effective in improving health outcomes [16] and this study provides further evidence on the impactful role that trained community residents can have on changing behaviors. These initiatives are vital to supplement weight loss and management efforts occurring in the clinical setting.

—Natalie L. Ricci, Columbia University Mailman School of Public Health, and Katrina F. Mateo, MPH

Study Overview

Objective. To assess the effectiveness of an intervention that focused on the home environment to reduce energy intake and increase physical activity among overweight and obese women.

Design. Randomized controlled trial.

Setting and participants. Study participants were overweight and obese females recruited via their providers from 3 community health centers (9 clinical sites) in southwest Georgia. Only women were recruited because of their potential role as gatekeepers of the home environment. Inclusion criteria included being aged 35 to 65 years at baseline, living with at least one other person, and living no further than 30 miles from the referring clinic. Exclusion criteria included patients with conditions that could impact their ability to be physically active and pregnant women.

Intervention. Participants in the intervention arm received 3 home visits and 4 coaching calls over 16 weeks. Core elements of the intervention were informed by social-cognitive theory and included a tailored home environment profile, goal setting, behavioral contracting for 6 healthy actions, and supportive materials delivered via mail. Home visits and coaching calls were completed by health coaches with at least high-school education and experience in social or customer service who had completed 2 days of formal training by university staff. Control condition patients received 3 mailings of educational booklets at 6-week intervals that included government documents encouraging adoption of US dietary and physical activity guidelines. All participants completed baseline, 6- and 12-month follow-up telephone interviews and wore an accelerometer at baseline and 6-month follow-up. Intervention patients also received follow-up surveys assessing satisfaction with the coach, home visits, telephone calls, and support materials.

Main outcome measures. The main outcomes were energy intake (average daily kilocalories from two 24-hour dietary recalls) and physical activity (hours per week spent in moderate or vigorous physical activity using the 7-day physical activity recall). Self-reported height and weight was used to calculate body mass index (BMI). Secondary outcome measures included self-reported weight loss and aspects of the home environment. Home food environment was assessed by asking participants about the presence of 3 unhealthy drinks and 8 unhealthy foods and snacks in the home in the past week, if fruits and vegetables and high-calorie snack foods were kept in easy to see and reach places in the home, how often the family ate meals and snacks in front of the TV, how often participants served healthier food or prepared foods using healthy cooking methods, and asking the number of days family meals were purchased from outside the home. Home activity environment was assessed by asking about rules regarding limits on time spent watching TV, using a computer, playing video games, and using other hand-held devices. The authors adapted a 14-item inventory to assess personal exercise equipment accessibility and availability in the home. Community facility use was assessed with 9 survey items that assessed frequency of use and spaces for exercise in the participants’ neighborhoods.

Main results. A total of 948 patients were referred, of which 751 were reached by phone and assessed for eligibility. 81 did not meet inclusion criteria, 203 declined to participate, and 118 did not complete baseline data collection, leaving 349 participants. Of these, 177 were randomized to the control group, 172 to the intervention, and 21 dropped out. The majority of participants were African-American women (84.8%) with an average age of 50.2 years (SD = 8.1) and average BMI of 38.3kg/m² (SD = 8.4). Most were low income, with 68.7% reporting an annual household income under $25,000, and nearly 50% reported fair or poor general health. Roughly 45% were employed and 49% lived in a rural area. At 6 months, 82.5% of participants completed data collection (n = 288); at 12 months, 76.8% completed data collection (n = 268). Participants who did not complete follow-up through 12 months were either non-responders (6 months: n = 36, 12 months: n = 44), refused (6 months: n = 3, 12 months: n = 7), or died (6 months: n = 0, 12 months: n = 1).

Daily energy consumption significantly decreased in the intervention group compared to the control group at 6 months (–274 vs. –69 kcal/day, P = 0.003), however there was no meaningful change in self-reported moderate to vigorous physical activity nor was there significant change in physical activity measured by accelerometers at 6 months compared to baseline. For secondary outcomes, self-reported weight loss at 6 months was significantly higher among intervention patients (mean, –9.1 lb) compared to control patients (mean, –5.0 pounds) (SD = 13.7 pounds; P = 0.03). In addition, at 12 months, 82.6% of intervention patients had not gained weight compared with 71.4% of control patients (P = 0.03). Intervention patients made several changes to their home food environments compared to control patients. Intervention patients had reduced the number of unhealthy drink and snacks, increased purchasing of fruits and vegetables, and reduced the frequency of watching TV while eating. In addition, they also improved meal preparation and service and reduced the number of non-home meals eaten. For home activity environment, having exercise equipment in a visible location changed significantly more in the intervention group compared to the control group. Intervention patients also incorporated more physical activity into their daily lives compared to control patients, and created more exercise space in their homes and yards. There were no significant differences in screen time rules, use of community facilities and spaces, and family social support for physical activity.

Conclusion. A moderate-intensity, coach-delivered weight gain prevention intervention targeting the home environment led to reduced energy intake and improved home environments to better facilitate healthy living and weight loss.

Commentary

More than half of all US adults are considered overweight or obese [1].Changing health behaviors has the best potential for decreasing morbidity and mortality and for improving quality of life and this has been supported by the literature in a wide variety of behaviors including smoking cessation and weight loss [2–4]. Currently, most overweight and obese patients are treated through primary care provider–based (PCP) counseling or referral to clinic-based weight management interventions. However, barriers to PCP weight management counseling include physicians’ negative attitudes towards the personal attributes of individuals with weight management issues, lack of time, and poor nutrition counseling competency [5–7]. In addition, there are notable differences between providers’ and patients’ beliefs about weight and weight loss; providers tend to believe patients lack self-control, while patients largely feel they should manage their weight problems on their own and that counseling from a provider is unhelpful [8]. Many patients report feeling judged by their doctor because of their weight, and very few of those who feel judged and discuss weight loss options actually lose a clinically significant amount of weight [9]. Considering the many barriers to providing/receiving weight management counseling in the clinic setting, weight management techniques provided outside the doctor’s office may be a more effective and feasible alternative.

The most common causes of death are related to lifestyle behaviors such as poor dietary habits and inactivity [10]. Since most calories are consumed within the home [11] and the average person spends the majority of their time in the home [12], interventions that target home-life behaviors are needed to combat weight gain. The Kegler et al study suggests that a moderate-intensity intervention targeted at changing home eating and exercise behaviors will be effective in changing home environments and reducing energy intake. While the authors had a fairly specific population, these findings suggest that interventions that specifically target health behaviors at home may have more potential for success than merely educating patients on the benefits of a healthy lifestyle.

This study has several strengths including the randomized controlled trial design, the intention-to-treat analysis, and low attrition rates. In addition, the intervention achieved reduced energy intake and improved health behaviors in the home, supporting significant weight loss among intervention participants, especially compared to control patients. Both of these suggest high adherence to the intervention, which is a complex but crucial component of successful weight loss and weight management [13]. Finally, the inclusion of a wide variety of secondary outcomes helped to distinguish between specific home environment changes to discern which aspects of the intervention were most successful. A limitation of the study was that the population was nearly entirely African American and from clinics in rural Georgia, which limits generalizability. However, the success of the intervention in this population is critical, as African American adults are nearly 1.5 times more likely to be obese compared to white adults, and greater than 75% of African Americans are overweight or obese [14]. Additionally, while the study did have significant success with energy intake and eating habits, the intervention was less successful with changing physical activity habits, and physical activity and exercise training can significantly impact weight loss and maintenance [15]. A final limitation is the use of self-reported weight and behaviors, which can reduce reliability of these results.

Applications for Clinical Practice

This study suggests that interventions that target health behaviors in the home may achieve better energy intake and physical activity outcomes and improve weight loss compared to traditional educational counseling. Providers may want to consider brief counseling around improving the home environment as opposed to or in addition to counseling around improving nutrition or physical activity. More research is necessary to understand whether this type of intervention is feasible and acceptable in other populations (eg, urban, other races). In addition, further research is necessary to improve the physical activity component of the intervention. The use of non-clinical providers has been shown to be effective in improving health outcomes [16] and this study provides further evidence on the impactful role that trained community residents can have on changing behaviors. These initiatives are vital to supplement weight loss and management efforts occurring in the clinical setting.

—Natalie L. Ricci, Columbia University Mailman School of Public Health, and Katrina F. Mateo, MPH

Study Overview

Objective. To assess the effectiveness of an intervention that focused on the home environment to reduce energy intake and increase physical activity among overweight and obese women.

Design. Randomized controlled trial.

Setting and participants. Study participants were overweight and obese females recruited via their providers from 3 community health centers (9 clinical sites) in southwest Georgia. Only women were recruited because of their potential role as gatekeepers of the home environment. Inclusion criteria included being aged 35 to 65 years at baseline, living with at least one other person, and living no further than 30 miles from the referring clinic. Exclusion criteria included patients with conditions that could impact their ability to be physically active and pregnant women.

Intervention. Participants in the intervention arm received 3 home visits and 4 coaching calls over 16 weeks. Core elements of the intervention were informed by social-cognitive theory and included a tailored home environment profile, goal setting, behavioral contracting for 6 healthy actions, and supportive materials delivered via mail. Home visits and coaching calls were completed by health coaches with at least high-school education and experience in social or customer service who had completed 2 days of formal training by university staff. Control condition patients received 3 mailings of educational booklets at 6-week intervals that included government documents encouraging adoption of US dietary and physical activity guidelines. All participants completed baseline, 6- and 12-month follow-up telephone interviews and wore an accelerometer at baseline and 6-month follow-up. Intervention patients also received follow-up surveys assessing satisfaction with the coach, home visits, telephone calls, and support materials.

Main outcome measures. The main outcomes were energy intake (average daily kilocalories from two 24-hour dietary recalls) and physical activity (hours per week spent in moderate or vigorous physical activity using the 7-day physical activity recall). Self-reported height and weight was used to calculate body mass index (BMI). Secondary outcome measures included self-reported weight loss and aspects of the home environment. Home food environment was assessed by asking participants about the presence of 3 unhealthy drinks and 8 unhealthy foods and snacks in the home in the past week, if fruits and vegetables and high-calorie snack foods were kept in easy to see and reach places in the home, how often the family ate meals and snacks in front of the TV, how often participants served healthier food or prepared foods using healthy cooking methods, and asking the number of days family meals were purchased from outside the home. Home activity environment was assessed by asking about rules regarding limits on time spent watching TV, using a computer, playing video games, and using other hand-held devices. The authors adapted a 14-item inventory to assess personal exercise equipment accessibility and availability in the home. Community facility use was assessed with 9 survey items that assessed frequency of use and spaces for exercise in the participants’ neighborhoods.

Main results. A total of 948 patients were referred, of which 751 were reached by phone and assessed for eligibility. 81 did not meet inclusion criteria, 203 declined to participate, and 118 did not complete baseline data collection, leaving 349 participants. Of these, 177 were randomized to the control group, 172 to the intervention, and 21 dropped out. The majority of participants were African-American women (84.8%) with an average age of 50.2 years (SD = 8.1) and average BMI of 38.3kg/m² (SD = 8.4). Most were low income, with 68.7% reporting an annual household income under $25,000, and nearly 50% reported fair or poor general health. Roughly 45% were employed and 49% lived in a rural area. At 6 months, 82.5% of participants completed data collection (n = 288); at 12 months, 76.8% completed data collection (n = 268). Participants who did not complete follow-up through 12 months were either non-responders (6 months: n = 36, 12 months: n = 44), refused (6 months: n = 3, 12 months: n = 7), or died (6 months: n = 0, 12 months: n = 1).

Daily energy consumption significantly decreased in the intervention group compared to the control group at 6 months (–274 vs. –69 kcal/day, P = 0.003), however there was no meaningful change in self-reported moderate to vigorous physical activity nor was there significant change in physical activity measured by accelerometers at 6 months compared to baseline. For secondary outcomes, self-reported weight loss at 6 months was significantly higher among intervention patients (mean, –9.1 lb) compared to control patients (mean, –5.0 pounds) (SD = 13.7 pounds; P = 0.03). In addition, at 12 months, 82.6% of intervention patients had not gained weight compared with 71.4% of control patients (P = 0.03). Intervention patients made several changes to their home food environments compared to control patients. Intervention patients had reduced the number of unhealthy drink and snacks, increased purchasing of fruits and vegetables, and reduced the frequency of watching TV while eating. In addition, they also improved meal preparation and service and reduced the number of non-home meals eaten. For home activity environment, having exercise equipment in a visible location changed significantly more in the intervention group compared to the control group. Intervention patients also incorporated more physical activity into their daily lives compared to control patients, and created more exercise space in their homes and yards. There were no significant differences in screen time rules, use of community facilities and spaces, and family social support for physical activity.

Conclusion. A moderate-intensity, coach-delivered weight gain prevention intervention targeting the home environment led to reduced energy intake and improved home environments to better facilitate healthy living and weight loss.

Commentary

More than half of all US adults are considered overweight or obese [1].Changing health behaviors has the best potential for decreasing morbidity and mortality and for improving quality of life and this has been supported by the literature in a wide variety of behaviors including smoking cessation and weight loss [2–4]. Currently, most overweight and obese patients are treated through primary care provider–based (PCP) counseling or referral to clinic-based weight management interventions. However, barriers to PCP weight management counseling include physicians’ negative attitudes towards the personal attributes of individuals with weight management issues, lack of time, and poor nutrition counseling competency [5–7]. In addition, there are notable differences between providers’ and patients’ beliefs about weight and weight loss; providers tend to believe patients lack self-control, while patients largely feel they should manage their weight problems on their own and that counseling from a provider is unhelpful [8]. Many patients report feeling judged by their doctor because of their weight, and very few of those who feel judged and discuss weight loss options actually lose a clinically significant amount of weight [9]. Considering the many barriers to providing/receiving weight management counseling in the clinic setting, weight management techniques provided outside the doctor’s office may be a more effective and feasible alternative.

The most common causes of death are related to lifestyle behaviors such as poor dietary habits and inactivity [10]. Since most calories are consumed within the home [11] and the average person spends the majority of their time in the home [12], interventions that target home-life behaviors are needed to combat weight gain. The Kegler et al study suggests that a moderate-intensity intervention targeted at changing home eating and exercise behaviors will be effective in changing home environments and reducing energy intake. While the authors had a fairly specific population, these findings suggest that interventions that specifically target health behaviors at home may have more potential for success than merely educating patients on the benefits of a healthy lifestyle.

This study has several strengths including the randomized controlled trial design, the intention-to-treat analysis, and low attrition rates. In addition, the intervention achieved reduced energy intake and improved health behaviors in the home, supporting significant weight loss among intervention participants, especially compared to control patients. Both of these suggest high adherence to the intervention, which is a complex but crucial component of successful weight loss and weight management [13]. Finally, the inclusion of a wide variety of secondary outcomes helped to distinguish between specific home environment changes to discern which aspects of the intervention were most successful. A limitation of the study was that the population was nearly entirely African American and from clinics in rural Georgia, which limits generalizability. However, the success of the intervention in this population is critical, as African American adults are nearly 1.5 times more likely to be obese compared to white adults, and greater than 75% of African Americans are overweight or obese [14]. Additionally, while the study did have significant success with energy intake and eating habits, the intervention was less successful with changing physical activity habits, and physical activity and exercise training can significantly impact weight loss and maintenance [15]. A final limitation is the use of self-reported weight and behaviors, which can reduce reliability of these results.

Applications for Clinical Practice

This study suggests that interventions that target health behaviors in the home may achieve better energy intake and physical activity outcomes and improve weight loss compared to traditional educational counseling. Providers may want to consider brief counseling around improving the home environment as opposed to or in addition to counseling around improving nutrition or physical activity. More research is necessary to understand whether this type of intervention is feasible and acceptable in other populations (eg, urban, other races). In addition, further research is necessary to improve the physical activity component of the intervention. The use of non-clinical providers has been shown to be effective in improving health outcomes [16] and this study provides further evidence on the impactful role that trained community residents can have on changing behaviors. These initiatives are vital to supplement weight loss and management efforts occurring in the clinical setting.

—Natalie L. Ricci, Columbia University Mailman School of Public Health, and Katrina F. Mateo, MPH

MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.

Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).

However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.

When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.

“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.

Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.

New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.

Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.

The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.

“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”

The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.

Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.

They reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.

Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).

However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.

When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.

“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.

Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.

New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.

Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.

The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.

“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”

The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.

Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.

They reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.

Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).

However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.

When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.

“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.

Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.

New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.

Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.

The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.

“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”

The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.

Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.

They reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

Twelve weeks of treatment with the anti-inflammatory drug losmapimod did not prevent cardiovascular death, myocardial infarction, or severe recurrent ischemia in patients hospitalized with acute MI, based on the results of LATITUDE-TIMI 60, a multicenter placebo-controlled phase 3 trial.

Losmapimod also did not significantly affect secondary outcomes such as all-cause mortality, said Dr. Michelle O’Donoghue at Brigham and Women’s Hospital in Boston and her associates.

“The results of this exploratory efficacy study did not justify proceeding to a larger efficacy trial in the existing patient population,” they concluded at the annual meeting of the American College of Cardiology and in a report published online April 4 in JAMA.

Losmapimod selectively inhibits pro-inflammatory p38 mitogen-activated protein kinase, which contributes to atherosclerosis and plaque destabilization and is activated by stressors such as oxidized low-density lipoprotein cholesterol, hypertension, ischemia, and volume overload. In a prior 12-week phase 2 study, losmapimod failed to reduce inflammatory biomarker levels or myonecrosis, but showed a trend toward lower rates of mortality, MI, recurrent ischemia, stroke, and heart failure, as well as improved left ventricular function.

Based on those observations, Dr. O’Donoghue and her associates randomly assigned 3,503 hospitalized patients with acute MI and at least one other cardiovascular risk factor to receive either losmapimod (7.5 mg twice daily) or placebo, along with guideline-recommended therapy for 12 weeks. Patients averaged 66 years old, about 90% were white, and about 30% were women. The primary endpoint was a composite of cardiovascular death, MI, or severe recurrent ischemia requiring urgent coronary revascularization (JAMA 2016 April 4 doi: 10.1001/jama.2016.3609).

The endpoint was met for 139 (8.1%) losmapimod patients and 123 (7%) placebo patients, for a non-significant hazard ratio of 1.16, said the researchers. Losmapimod was, however, associated with significant decreases in levels of high-sensitivity C-reactive protein and N-terminal pro-brain natriuretic peptide as compared with placebo, with durable effects at 12 weeks. Serious adverse events affected 16% of losmapimod patients and 14% of placebo patients, and rates of premature treatment discontinuation were 15.5% with losmapimod and nearly 14% with placebo. Losmapimod did not appear to increase the risk of infections compared with placebo at week 12, but did show a non-significant trend toward mildly increased hepatic transaminases.

“Because inflammation is believed to play a key role in atherogenesis, there remains intense interest to identify an anti-inflammatory therapeutic that will reduce the risk of cardiovascular events,” the researchers noted. “However, because inflammation acts along multiple redundant and interconnected pathways, the identification of an appropriate target may be difficult, and it is challenging to predict clinical efficacy prior to phase 3 testing. Ongoing clinical trials are currently evaluating additional anti-inflammatory therapeutics in patients with atherosclerosis, and will provide further insight into pathways that contribute to vascular disease.”

Pharmacodynamic data on losmapimod do not suggest that its anti-inflammatory effects increase at higher doses, the researchers also noted.

GlaxoSmithKline developed losmapimod and funded the study. Dr. O’Donoghue reported grant funding from Eisai, Merck, and AstraZeneca. The senior author and several coinvestigators disclosed relationships with numerous pharmaceutical companies.

Twelve weeks of treatment with the anti-inflammatory drug losmapimod did not prevent cardiovascular death, myocardial infarction, or severe recurrent ischemia in patients hospitalized with acute MI, based on the results of LATITUDE-TIMI 60, a multicenter placebo-controlled phase 3 trial.

Losmapimod also did not significantly affect secondary outcomes such as all-cause mortality, said Dr. Michelle O’Donoghue at Brigham and Women’s Hospital in Boston and her associates.

“The results of this exploratory efficacy study did not justify proceeding to a larger efficacy trial in the existing patient population,” they concluded at the annual meeting of the American College of Cardiology and in a report published online April 4 in JAMA.

Losmapimod selectively inhibits pro-inflammatory p38 mitogen-activated protein kinase, which contributes to atherosclerosis and plaque destabilization and is activated by stressors such as oxidized low-density lipoprotein cholesterol, hypertension, ischemia, and volume overload. In a prior 12-week phase 2 study, losmapimod failed to reduce inflammatory biomarker levels or myonecrosis, but showed a trend toward lower rates of mortality, MI, recurrent ischemia, stroke, and heart failure, as well as improved left ventricular function.

Based on those observations, Dr. O’Donoghue and her associates randomly assigned 3,503 hospitalized patients with acute MI and at least one other cardiovascular risk factor to receive either losmapimod (7.5 mg twice daily) or placebo, along with guideline-recommended therapy for 12 weeks. Patients averaged 66 years old, about 90% were white, and about 30% were women. The primary endpoint was a composite of cardiovascular death, MI, or severe recurrent ischemia requiring urgent coronary revascularization (JAMA 2016 April 4 doi: 10.1001/jama.2016.3609).

The endpoint was met for 139 (8.1%) losmapimod patients and 123 (7%) placebo patients, for a non-significant hazard ratio of 1.16, said the researchers. Losmapimod was, however, associated with significant decreases in levels of high-sensitivity C-reactive protein and N-terminal pro-brain natriuretic peptide as compared with placebo, with durable effects at 12 weeks. Serious adverse events affected 16% of losmapimod patients and 14% of placebo patients, and rates of premature treatment discontinuation were 15.5% with losmapimod and nearly 14% with placebo. Losmapimod did not appear to increase the risk of infections compared with placebo at week 12, but did show a non-significant trend toward mildly increased hepatic transaminases.

“Because inflammation is believed to play a key role in atherogenesis, there remains intense interest to identify an anti-inflammatory therapeutic that will reduce the risk of cardiovascular events,” the researchers noted. “However, because inflammation acts along multiple redundant and interconnected pathways, the identification of an appropriate target may be difficult, and it is challenging to predict clinical efficacy prior to phase 3 testing. Ongoing clinical trials are currently evaluating additional anti-inflammatory therapeutics in patients with atherosclerosis, and will provide further insight into pathways that contribute to vascular disease.”

Pharmacodynamic data on losmapimod do not suggest that its anti-inflammatory effects increase at higher doses, the researchers also noted.

GlaxoSmithKline developed losmapimod and funded the study. Dr. O’Donoghue reported grant funding from Eisai, Merck, and AstraZeneca. The senior author and several coinvestigators disclosed relationships with numerous pharmaceutical companies.

Twelve weeks of treatment with the anti-inflammatory drug losmapimod did not prevent cardiovascular death, myocardial infarction, or severe recurrent ischemia in patients hospitalized with acute MI, based on the results of LATITUDE-TIMI 60, a multicenter placebo-controlled phase 3 trial.

Losmapimod also did not significantly affect secondary outcomes such as all-cause mortality, said Dr. Michelle O’Donoghue at Brigham and Women’s Hospital in Boston and her associates.

“The results of this exploratory efficacy study did not justify proceeding to a larger efficacy trial in the existing patient population,” they concluded at the annual meeting of the American College of Cardiology and in a report published online April 4 in JAMA.

Losmapimod selectively inhibits pro-inflammatory p38 mitogen-activated protein kinase, which contributes to atherosclerosis and plaque destabilization and is activated by stressors such as oxidized low-density lipoprotein cholesterol, hypertension, ischemia, and volume overload. In a prior 12-week phase 2 study, losmapimod failed to reduce inflammatory biomarker levels or myonecrosis, but showed a trend toward lower rates of mortality, MI, recurrent ischemia, stroke, and heart failure, as well as improved left ventricular function.

Based on those observations, Dr. O’Donoghue and her associates randomly assigned 3,503 hospitalized patients with acute MI and at least one other cardiovascular risk factor to receive either losmapimod (7.5 mg twice daily) or placebo, along with guideline-recommended therapy for 12 weeks. Patients averaged 66 years old, about 90% were white, and about 30% were women. The primary endpoint was a composite of cardiovascular death, MI, or severe recurrent ischemia requiring urgent coronary revascularization (JAMA 2016 April 4 doi: 10.1001/jama.2016.3609).

The endpoint was met for 139 (8.1%) losmapimod patients and 123 (7%) placebo patients, for a non-significant hazard ratio of 1.16, said the researchers. Losmapimod was, however, associated with significant decreases in levels of high-sensitivity C-reactive protein and N-terminal pro-brain natriuretic peptide as compared with placebo, with durable effects at 12 weeks. Serious adverse events affected 16% of losmapimod patients and 14% of placebo patients, and rates of premature treatment discontinuation were 15.5% with losmapimod and nearly 14% with placebo. Losmapimod did not appear to increase the risk of infections compared with placebo at week 12, but did show a non-significant trend toward mildly increased hepatic transaminases.

“Because inflammation is believed to play a key role in atherogenesis, there remains intense interest to identify an anti-inflammatory therapeutic that will reduce the risk of cardiovascular events,” the researchers noted. “However, because inflammation acts along multiple redundant and interconnected pathways, the identification of an appropriate target may be difficult, and it is challenging to predict clinical efficacy prior to phase 3 testing. Ongoing clinical trials are currently evaluating additional anti-inflammatory therapeutics in patients with atherosclerosis, and will provide further insight into pathways that contribute to vascular disease.”

Pharmacodynamic data on losmapimod do not suggest that its anti-inflammatory effects increase at higher doses, the researchers also noted.

GlaxoSmithKline developed losmapimod and funded the study. Dr. O’Donoghue reported grant funding from Eisai, Merck, and AstraZeneca. The senior author and several coinvestigators disclosed relationships with numerous pharmaceutical companies.

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes