Development of an Enhanced Recovery After Surgery ...

ORIGINAL ARTICLE

Development of an Enhanced Recovery After Surgery Guideline and Implementation Strategy Based on the Knowledge-to-action Cycle Robin S. McLeod, MD,∗ † Mary-Anne Aarts, MD,‡∗ Frances Chung, MD,§†† Cagla Eskicioglu, MD,|| Shawn S. Forbes, MD,|| Lesley Gotlib Conn, PhD,∗∗ Stuart McCluskey, MD,§†† Marg McKenzie, RN,∗ Beverly Morningstar, MD,†† Ashley Nadler, MD,∗ Allan Okrainec, MD,∗ ¶ Emily A. Pearsall, MSc,∗ Jason Sawyer, RN,‡‡ Naveed Siddiqui, MD,∗ †† and Trevor Wood, MD∗ Objective: To develop and implement an ERAS clinical practice guideline (CPG) at multiple hospitals. Background: Enhanced Recovery After Surgery (ERAS) protocols have been shown to increase recovery, decrease complications, and reduce length of stay. However, they are difficult to implement. Methods: A tailored strategy based on the Knowledge to Action (KTA) cycle was used to develop and implement an ERAS CPG at 15 academic hospitals in Canada. This included an initial audit to identify gaps and interviews to assess barriers and enablers to implementation. Implementation included development of an ERAS guideline by a multidisciplinary group, communities of practice led by multidiscipline champions (surgeons, anesthesiologists, and nurses) both provincially and locally, educational tools, and clinical pathways as well as audit and feedback. Results: The initial audit revealed there was greater than 75% compliance in only 2 of 18 CPG recommendations. Main themes identified by stakeholders were that the CPG must be based on best evidence, there must be increased communication and collaboration among perioperative team members, and patient education is essential. ERAS and Pain Management CPGs were developed by a multidisciplinary team and have been adopted at all hospitals. Preliminary data from more than 1000 patients show that the uptake of recommended interventions varies but despite this, mean length of stay has decreased with low readmission rates and adverse events. Conclusions: On the basis of short-term findings, our results suggest that a tailored implementation strategy based on the KTA cycle can be used to successfully implement an ERAS program at multiple sites. Keywords: enhanced recovery, implementation, general surgery, knowledge translation, quality improvement (Ann Surg 2015;00:1–10)

E

nhanced Recovery After Surgery (ERAS) pathways have been shown to decrease the amount of stress and gut dysfunction in individuals undergoing elective colorectal surgery, which leads to enhanced recovery and decreased morbidity and length of stay.1,2

From the ∗ Department of Surgery, Mount Sinai Hospital; †Institute of Health Policy, Management and Evaluation, University of Toronto; ‡Department of Surgery, Toronto East General Hospital; §Department of Anaesthesia and Pain Management; ¶Department of Surgery, University Health Network; ||Department of Surgery, McMaster University, Hamilton; and Departments of ∗∗ Surgery, ††Anesthesia, and ‡‡Nursing, Sunnybrook Health Sciences Center, Toronto, Ontario, Canada. Disclosure: Dr McLeod holds the Angelo and Alfredo De Gasperis Families Chair in Colorectal Cancer and IBD Research. Funded in part by Council of Academic Hospitals of Ontario, Canadian Institutes of Health Research, and Colon Cancer Canada. The authors declare no conflicts of interest. C 2015 Wolters Kluwer Health, Inc. All rights reserved. Copyright ISSN: 0003-4932/15/00000-0001 DOI: 10.1097/SLA.0000000000001067

Annals of Surgery r Volume 00, Number 00, 2015

Numerous reports have documented the effectiveness of ERAS guidelines.1,2 However, the published trials and guidelines often differ in the components included within the ERAS guidelines and the evidence supporting each intervention. Furthermore, in some cases, the components included in the guidelines may be contradictory (eg, inclusion or exclusion of mechanical bowel preparation).3–7 There is also increasing evidence that ERAS guidelines are difficult to adopt, largely because they require a commitment from all members of the perioperative team.8–12 The most often sited barriers to adoption are related to time and personnel restrictions required to develop the protocol, limited hospital resources (financial, staffing, space restrictions, and education), active or passive resistance from members of the perioperative team, lack of data and/or education, social and cultural settings, and the organizational environment.8–12 Because of the relatively high number of interventions that must be adopted simultaneously by a multidisciplinary team, ERAS guidelines require a tailored implementation strategy to increase adherence. Best Practice in General Surgery (BPIGS) is a University of Toronto quality initiative led by general surgeons. The goal of BPIGS is to optimize patient care at the adult teaching hospitals affiliated with the University of Toronto by developing and implementing guidelines based on best evidence on topics pertinent to general surgery. In 2008, the BPIGS group undertook the development and implementation of a University of Toronto ERAS guideline using the Knowledge to Action (KTA) framework described by Graham et al.13 The KTA process is an iterative process that involves both the creation and application of knowledge (Fig. 1). The creation and synthesis of knowledge in the KTA cycle often occurs simultaneously with the implementation or application of the knowledge. The process of knowledge creation includes locating the knowledge, synthesizing it, and creating knowledge tools or products (eg, guidelines). The action cycle involves multiple stages that may occur sequentially or simultaneously and may also overlap with different stages of the knowledge creation process. These include (1) identification of the problem, (2) adaptation of knowledge to local context, (3) assessment of barriers and enablers to knowledge use, (4) selection, tailoring, and implementation of interventions, (5) monitoring knowledge use, (6) evaluating outcomes, and (7) sustaining knowledge use. The phases in both knowledge creation and the action cycle are dynamic and therefore can influence or be influenced by other phases within or between each of these elements at any time.13,14 This report describes the development of an ERAS guideline and an implementation strategy using this multidimensional process consisting of several distinct, yet interconnected phases. The first 4 stages of problem identification, knowledge adaptation, barrier assessment, and intervention implementation are outlined here. It does not include the last 3 phases of monitoring knowledge use, evaluating outcomes, and sustaining knowledge use. www.annalsofsurgery.com | 1

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McLeod et al

Monitor knowledge use Select, tailor, implement intervenons

KNOWLEDGE CREATION

TABLE 1. List of Potential ERAS Interventions and Compliance With These Interventions at Initial Audit of 7 University of Toronto Hospitals Pre-implementation Evaluate Outcomes

Knowledge Inquiry

Assess barriers to knowledge use

Knowledge Synthesis Knowledge Tools/ Products

Adapt knowledge to local context

Sustain knowledge use

Idenfy problem Idenfy, review, select knowledge

ACTION CYCLE

FIGURE 1. Knowledge-to-action cycle.

Knowledge Creation Knowledge Inquiry and Synthesis Before development of our guideline, a systematic review and meta-analysis was performed by our group to synthesize the evidence and determine the utility of ERAS programs for patients undergoing elective colorectal surgery.3–7 A search of MEDLINE, EMBASE, and the Cochrane Central Registry of Controlled Trials as well as reference lists of identified articles were searched up until May 2008. Four randomized controlled trials that randomized patients having colorectal surgery to ERAS or traditional care were identified.4–7 The interventions included in the 4 trials varied. All included preoperative counseling, early feeding and ambulation, and no nasogastric tubes but varied in pain recommendations.4–7 Only 3 guidelines recommended the use of thoracic epidural analgesia.5–7 5–6 Two guidelines recommended use of transverse incisions. Interestingly, 2 guidelines recommended no bowel preparation,5,6 1 did not make any recommendation,4 whereas 1 recommended it should be used.7 Three of the trials showed significantly shorter lengths of stay for patients enrolled in ERAS programs compared to traditional care.5–7 When combined, there was no significant difference in postoperative mortality (relative risk = 0.53, 95% confidence interval: 0.12–2.38) but there were fewer postoperative complications observed in patients in the ERAS group (relative risk = 0.61, 95% confidence interval: 0.42–0.88).3 On the basis of this meta-analysis, the BPIGS group felt there was strong evidence that supported implementation of an ERAS program at the University of Toronto. Subsequently other meta-analysis including as many as 16 trials and more than 2000 patients have been published and have found similar conclusions as our metaanalysis.2,15–17

Action Cycle Identification of the Problem A retrospective audit of patients having colorectal surgery at 7 of the University of Toronto–affiliated hospitals was performed to assess current management and to determine whether care was provided in compliance with ERAS guidelines and protocols.18 Interventions included in the audit were identified by reviewing interventions included in previously published randomized controlled trials, guidelines, and protocols. In total, 18 interventions were included (Table 1). 2 | www.annalsofsurgery.com

Preoperative counseling Preoperative evaluation by anesthesia Probiotics given Mechanical oral bowel preparation Yes No Undetermined Carbohydrate loading Preoperative fasting protocol ≤ 3 h Intraoperative fluid restriction Perioperative hyperoxia O2 > 80% Type of incision Transverse Midline No nasogastric tube Received epidural analgesia Standing NSAIDs Clear fluids day of surgery Ambulation encouraged day of surgery Early D/C of Foley catheter Routine prescription of domperidone Routine prescription of magnesium hydroxide Liquid calorie supplements

N = 336

%

139 260 0

41.4 77.4 0%

109 129 98 0 7 24 8

32.4 38.4 29.2 0% 2.1 7.1 2.4

128 208 311 71 117 140 33 174 0 4 4

38.1 61.9 92.6 21.1 34.8 41.7 9.8 51.8 0 1.2 1.2

Data related to 3 of the interventions (preoperative counseling regarding early discharge, use of probiotics, and carbohydrate loading before surgery) were not recorded in the charts so surgeons were asked directly if they routinely prescribed or discussed these issues. Data regarding use of a bowel preparation were obtained from the charts but were available in less than 25% of patients. In total, 336 charts (45–50 charts/hospital) of consecutive patients who had colorectal surgery between July 1, 2008, and June 30, 2009, were reviewed. The median length of stay was 6.8 days (range: 5.0–10.2 across hospitals), whereas the mean was 8.6 days. Of the 18 ERAS interventions that were audited, only 2 (omission of nasogastric tubes and preoperative assessment by an anesthesiologist) were performed more than 75% of the time. Counseling regarding expected length of stay, early removal of urinary catheters, avoidance of oral bowel preparation, and clear liquids on the evening of surgery were employed approximately half of the time whereas other interventions were used sparingly. In particular, probiotics, carbohydrate loading, shortened preoperative fasting, ambulation on the day of surgery, and prescription of motility drugs and liquid supplements postoperatively were rarely ordered.18 This audit was limited by its retrospective nature. In some instances, information about specific interventions was not available and data were attained by asking surgeons of their “usual” practice. There was also significant variability in surgical procedures and technique even though multivisceral resections and ileoanal pouch procedures were excluded. The cohort, however, is representative of patients undergoing colorectal surgery and the audit clearly showed that practice was variable and that the majority of known ERAS interventions, which are supported by strong level I evidence, were not being used routinely.18 This knowledge-to-practice gap was even more revealing in that many of the hospitals stated that they had already adopted all or parts of ERAS protocols. In addition to identifying a gap in care, these data also highlight the need for auditing performance to assess compliance when a new guideline is implemented. C 2015 Wolters Kluwer Health, Inc. All rights reserved.



Development of Knowledge Tools and Adapting Knowledge to the Local Context The BPIGS group, in collaboration with anesthesiologists and nurses from 8 University of Toronto–affiliated teaching hospitals developed an ERAS guideline and a companion guideline, Management of Perioperative Pain. The target was patients undergoing small bowel and colorectal surgical procedures. A decision was made that our group should develop our own tailored guideline based on a few considerations. First, published ERAS guidelines and protocols were quite variable in what interventions were included and there seemed to be no established standard. Second, some interventions that were included in some ERAS protocols and guidelines were not supported by strong evidence (eg, probiotics, carbohydrate loading drinks and motility drugs). Third, the process of developing our own guideline uniquely tailored to our context would engage all stakeholders and would be an important part of the knowledge translation strategy used to implement the guideline. Initially, a systematic review was performed to identify all published ERAS guidelines, protocols, and trials by searching MEDLINE and EMBASE databases using the keywords “fast-track,” “accelerated care,” “enhanced recovery,” “ERAS,” and “multimodal recovery.” Using these articles, we compiled a list of 18 potential interventions, which had been included in 1 or more ERAS protocols (Table 1). Chewing gum was also included as there was emerging evidence that it decreases the time to recovery of bowel function.19 We then performed a systematic review of each individual intervention using the Cochrane Collaboration, MEDLINE, and EMBASE databases. Each intervention was searched using keywords that were specific to the intervention of interest. In addition, each intervention was searched as both a component of an enhanced recovery strategy and an independent intervention. Each search was limited to randomized controlled trials, systematic reviews, and meta-analysis and guidelines to retrieve the highest quality of evidence. If randomized controlled trials were not available, the search was expanded to included case studies and cohort trials. Additional articles were identified by searching through the reference lists of the relevant articles retrieved from the electronic databases and from group member’s personal collections.

Development of an ERAS KT Strategy

A round table meeting was held in May 2011, with general surgeons, anesthesiologists, nurses, a registered pain nurse, nurse administrators, and surgery residents representing all 8 hospitals. An overview of each ERAS intervention, as well as some key evidence, was sent to all invitees before the meeting, so consensus could be reached at the meeting as to which interventions should be included in the guideline. At the meeting, the evidence for each intervention was presented. The group reviewed the available evidence, as well as the current practice (from the completed audit), and deliberated as to which interventions should be included in the guideline. After the discussion, each individual voted on whether the intervention should be included, not included, or was uncertain whether to include or exclude the intervention by completing a form that listed all of the interventions. The participants were asked to make their decision on the basis of the strength of the evidence as well as the feasibility of adopting it taking into consideration local practices and resources. Scores for each intervention were tallied and there was agreement that 13 interventions would be included in the guideline (see Table 2). After this meeting, 3 subcommittees were formed: surgical interventions, anesthesia interventions, patient education and nursing. The surgical group included surgeons and surgical residents, and the anesthesia group included anesthesiologists, a registered pain nurse, and surgeons. The patient education and nursing subcommittee included nurses, general surgeons, dieticians, physiotherapists, and surgical residents. Each group was given the task of developing specific recommendations for each intervention and if necessary perform further review of the literature. The surgical subcommittee made recommendations on 8 interventions including early ambulation, early enteral nutrition, reduced fasting duration, use of chewing gum and prophylactic nasogastric tubes and abdominal drains, early removal of urinary catheters, and provided input on the use of nonsteroidal anti-inflammatory drugs (NSAIDs) pre- and postoperatively. The anesthesia subcommittee made recommendations on intra- and postoperative fluid management and pre-, intra-, and postoperative pain management as well as providing input on preoperative fasting. The patient education and nursing subcommittee made recommendations on patient education and provided input on early ambulation and early enteral nutrition, use of chewing gum, and early removal of

TABLE 2. Results∗ of the Consensus Workshop on Which Recommendations to Include Intervention

Include n (%)

Do Not Include n (%)

Indifferent/ Do Not Know n (%)

16 (100) 0 (0) 1 (6) 12 (75) 11 (69) 7 (44) 5 (31) 5 (31) 13 (81) 12 (75) 13 (81) 0 (0) 1 (6) 15 (94) 15 (94) 16 (100) 1 (6) 14 (88)

0 (0) 14 (88) 13 (81) 1 (6) 3 (19) 3 (19) 5 (31) 4 (25) 2 (13) 3 (19) 0 (0) 13 (81) 11 (69) 0 (0) 0 (0) 0 (0) 10 (63) 0 (0)

0 (0) 2 (13) 2 (13) 3 (19) 2 (13) 6 (38) 6 (38) 7 (44) 1 (6) 1 (6) 3 (19) 3 (19) 4 (25) 1 (6) 1 (6) 0 (0) 5 (31) 2 (13)

Preoperative counseling Probiotics Carb loading Shortened fast Preoperative NSAIDs Intraoperative fluid management Epidural Lidocane No nasogastric tubes No drains Postoperative NSAIDs Promotilities Laxatives Clear fluids/early feeding Ambulation Foley catheter Liquid calorie supplements Gum chewing ∗

Highlighted interventions were included in the guideline.

C 2015 Wolters Kluwer Health, Inc. All rights reserved.

www.annalsofsurgery.com | 3



McLeod et al

urinary catheters. In addition, this subcommittee developed a patient education handbook in consultation with patients and the patient education network at the University Health Network and a subgroup made specific recommendations regarding postoperative diet. All recommendations were subsequently reviewed by all members of the 3 subgroups. Then, the guidelines and the supporting evidence were circulated to all general surgeons and anesthesiologists at all hospitals. Feedback was reviewed and changes were incorporated or explanations given if they were not included. In February 2012, 85 individuals representing surgery, anesthesia, nursing, allied health professionals, and administration from all hospitals gathered for a workshop. At the workshop, the specific guideline recommendations were reviewed and finalized. Only 1 recommendation was contentious. Our initial recommendation regarding NSAID use was that celecoxib 400 mg should be prescribed to all patients (except those with renal insufficiency) preoperatively and continued postoperatively. During development of the guideline, surgeons raised concerns about the use of NSAIDs because there was conflicting evidence about whether NSAID usage in the perioperative period is associated with an increased risk of anastomotic leaks.20–22 After discussion at the February 2012 workshop, the guideline recommendation was modified to “Prescription of celecoxib 400 mg as a loading dose should be considered in all open and laparoscopic colorectal procedures only after discussion between the surgeon and anaesthetist regarding the potential risks and benefits.” Subsequently, it was further revised to “Pre-operative celecoxib 400 mg followed by 200 mg bid for 5 days is recommended in patients having a colorectal resection where NO anastomosis is performed (for example, abdominal perineal resection) and where no contraindications to its use are present” after there was further published evidence showing an association between NSAID usage and anastomotic leaks.23–25 The guideline recommendations are available in Appendix 1 and 2. The complete guideline recommendations and supporting evidence can be found on the BPIGS Web site (www.bpigs.ca).

Assessment of Barriers and Facilitators Potential barriers and facilitators to implementation of the ERAS guideline were assessed by interviewing a purposive sample of nurses, anesthesiologists, and general surgeons from each of the 7 University of Toronto–affiliated adult hospitals.12 Semi-structured interviews were conducted using the grounded theory approach.26 The interview guide consisted of questions related to the implementation of the proposed ERAS guideline, specific recommendations, and potential barriers and enablers to the implementation. In total, 19 general surgeons, 18 anesthesiologists, and 18 nurses participated in the interviews. Overall, interviewees were supportive of the implementation of a standardized ERAS protocol and agreed that hospital and discipline champions, a standardized ERAS protocol based on best evidence, preprinted pre- and postoperative order sets and education of the perioperative team were essential. Engagement of patients and families and patient education were also felt to be essential. Lack of manpower, hospital resources, and buy-in; poor communication among perioperative team members; and physician preferences and patient factors were sited by most as barriers. Discipline specific issues were identified; most nurses felt that early feeding was not important and that manpower issues were barriers to early ambulation. Conversely, most surgeons felt both were important and easily implementable. Many surgeons were against shortened preoperative fasting because cases might be cancelled. Most anesthesiologists and surgeons felt a change in nursing culture would be required. Sites with ERAS programs in existence felt ongoing reeducation and audit and feedback were essential.12 4 | www.annalsofsurgery.com

In summary, although there was agreement that a standardized ERAS protocol should be adopted, identified barriers included lack of understanding of other disciplines and lack of communication among members of the perioperative team. Identification of respected champions or opinion leaders who would provide peer education and encourage interprofessional communication and collaboration was cited as an enabler to increase the likelihood of adoption of an ERAS protocol. In addition, the results of this study emphasized the need for patient education and involvement of both the patient and his or her family. Surgical residents also play a major role in the care of patients postoperatively, so all general surgery residents were surveyed to assess their current management of patients and perceived barriers and enablers to early discharge of patients.27 Seventy-seven general surgery residents representing all levels of training completed the survey. Approximately three quarters of the residents agreed with the adoption of an ERAS program. Residents felt that patient expectations must be set before surgery and postoperatively, and early ambulation and feeding and good pain control were essential. However, they stated that patient and family expectations, staff surgeon preferences, and beliefs of the local health care teams were barriers to compliance with an ERAS program.

Development and Implementation of Tailored Knowledge Translation Interventions It is recognized that the “surgical journey” of patients is quite complex and involves contact with a range of individuals from a variety of disciplines in various clinical settings. The patient’s pathway starts in the surgeon’s office and then continues through the preadmission unit, admission to a surgical holding area on the day of surgery, care in the operating room followed by recovery in the post anesthetic care unit, and finally, care and discharge planning on a surgical ward. Successful implementation of the ERAS program requires agreement on the care of the patient as well as good communication and collaboration among caregivers throughout the pathway. On the basis of the perceived barriers and facilitators identified during our interviews and survey, as well as the available literature on the effectiveness of implementation strategies, a multipronged implementation strategy spanning across all disciplines and all hospitals was developed. The main components of the implementation strategy included the following.

Identification of Nurse, Surgeon, and Anesthesiologist Champions at Each Site. A key component of the implementation strategy was to develop a cohesive perioperative team including all disciplines who are involved in the care of the patient as they transition along the surgical pathway. This was facilitated by identification of a nurse, surgeon, and anesthesiologist champion who communicate with all members of the team, share audit results, and lead changes in practices at their individual centers. These individuals meet regularly with members of the perioperative team at their hospital and facilitate education and communication by presenting multidisciplinary educational rounds, in-services, and teaching sessions at their hospitals to increase awareness and acceptance of the guideline recommendations.

Strategies to Facilitate Communication and Share Best Practices Among All Disciplines and Centers. In addition to communication among members of the perioperative team at individual hospitals, various strategies have been implemented to facilitate communication and sharing of best practices among teams at different hospitals. These include regular electronic updates to share best practices; visits by the implementation steering committee to individual centers to meet with the multidisciplinary teams and make presentations; and regular conference calls including biweekly calls C 2015 Wolters Kluwer Health, Inc. All rights reserved.



with the nurse champions and monthly calls with the surgeon and anesthesia champions. In addition, annual workshops have been held where all champions from all participating hospitals meet to discuss the progress with implementation, review audit results, and share best practices. Two unique initiatives are listserv discussions and webinars. A listserv allows individuals to post an e-mail, which is automatically distributed to all participants. The iERAS listserv has facilitated ongoing sharing of best practices by allowing champions to post questions related to the implementation of the guidelines and others on the listserv to respond and share their own experiences. Webinars have been held to provide teaching to site coordinators and nurse champions on issues related to data entry and classification of surgical procedures. Surgical residents are important members of the surgical team and play an important role in managing patients postoperatively. They rotate on and off services frequently. Thus, resident education, given as seminars as well as printed material, is an important aspect of the program. As well, all of our BPIGS guidelines are available on an app in iTunes because smart phones are the usual tool used by residents to find information. Support From Hospital Administration. The implementation of the ERAS guidelines was supported in part by a grant from the Council of Academic Hospitals of Ontario. A requirement of the grant was that hospital administration had to agree to provide certain hospital resources. Presentations were made to senior members of hospital administration by the local project teams outlining the project. As well, administrators attended educational rounds where the concept of ERAS was discussed, preliminary data were presented, and the evidence supporting ERAS and its effect on outcomes were discussed. The contract between the Council of Academic Hospitals of Ontario and each hospital stipulated that the hospital would provide funding for a nurse champion and that ERAS implementation was part of her/his job description. As well, it provided support for the champions to implement the necessary changes to anesthetic and surgical protocols.

Development of Printed and Electronic Standardized Materials. The patient education and nursing subcommittee developed a standardized patient education booklet, which is handed out to all patients who are undergoing elective colorectal surgery so they are aware of the care pathway, what is expected of them as active participants in their recovery and the proposed milestones. While in hospital, patients are asked to complete a daily “Patient Activity Log” where information on their activity, oral intake, chewing gum, pain control, and elimination is recorded. This has been strongly embraced by patients and nurses as it provides information to health care workers while also reinforcing expectations of patients. As well, patients have felt it empowers them in their recovery. Standardized preoperative and postoperative order sets, which reflect the guideline recommendations, have been developed. Posters, reminder cards, and slide decks have also been created to promote similar messaging as well as for use as teaching tools and reminders for the Champions. Many of the products produced by the central team have been adapted for use at local hospitals. In addition, other educational tools have been developed locally and posted on the BPIGS Web site so they can be shared with all sites. These include care pathways and maps which have been developed to assist different disciplines with implementation. Examples are clinical pathways for the management of urinary retention, anesthesia checklists, and flowcharts for nurses (available at www.bpigs.ca). Audit and Feedback. Audit and feedback is an important part of our KT strategy. As shown by the low compliance with guideline recommendations in our baseline audit, assessment of performance is important as compliance with guideline recommendations cannot be assumed.18 A database which captures demographic information, past C 2015 Wolters Kluwer Health, Inc. All rights reserved.


medical history, surgical procedure, intraoperative and postoperative management, compliance with the guideline recommendations, and clinical outcomes was developed. Our goal is to capture data on all patients having colorectal or small bowel procedures. Reports on a variety of process and outcome measures are produced at 3 monthly intervals so individual hospitals can benchmark their own performance against the other hospitals as well as use the data to implement specific strategies to improve performance at their own hospital. Although data on each of the indicators have been presented anonymously, there is a spirit of collaboration among all hospitals so champions have requested that data be shared openly so they can discuss results and learn from other sites, which are performing better on an individual indicator.

DISCUSSION In summary, our team developed an ERAS guideline and implementation strategy based on the KTA cycle.13,14 We chose to undertake this process rather than simply adopt an existing published guideline because our initial work suggested that adoption of an ERAS guideline may be limited by contextual knowledge and practice barriers. In addition to developing the guideline, our key implementation strategies were the development of communities of practice led by local champions to foster multidisciplinary communication and collaboration; patient education materials and development of standardized tools; and audit and feedback. In addition, support of hospital administration was important. Although it is too early to determine whether our strategy has been successful, preliminary evidence suggests that there have already been several positive outcomes as a result of this process. First, our ERAS program has expanded outside of the University of Toronto hospitals, so there are now 15 academic hospitals in Ontario that are participating. During this transition, we rebranded our initiative as the implementation of an ERAS (iERAS) program. Second, all institutions have successfully adopted the iERAS protocol and compliance with individual guidelines is being monitored and seems to be increasing. Third, increased collaboration and communication among members of the perioperative teams at each hospital has occurred. Fourth, there has been strong engagement of health care providers in the program with attendance of champions at our regular conference calls and workshops. Fifth, we have been able to capture clinical data on more than 1000 patients and reports have been shared with participating hospital teams. Furthermore, our preliminary data suggest that there has been increased compliance with various process measures as well as clinical outcomes. Overall, 81% of patients received the iERAS patient education booklet and 92% were instructed on length of stay preoperatively. On the day of surgery, 89% of patients received clear liquids and 99% walked or dangled on the side of the bed. Beginning on postoperative day one, 56% received regular diet, 82% chewed gum, and 67% reported having a pain score of 4 or less. The median length of stay decreased to 5 days with 30-day readmission rates of 7%. The anastomotic leak rate was 5% and 4% developed urinary retention (unpublished data). The early success of the iERAS program can be attributed in large part to the process, which was undertaken to develop and implement the guideline. First, development of an ERAS guideline was identified as a high priority by members of the Division of General Surgery at a retreat in 2006. Thus, the “problem” was initially identified by clinicians working at ground level and using a “ground up” and inclusive approach not only validated the concerns of the clinicians but also motivated them to be involved in the project. In addition, the working group included anesthesiologists and nurses as well as surgeons so all disciplines were included in the development and implementation of the guidelines right from the start. www.annalsofsurgery.com | 5



McLeod et al

Second, although the guidelines are based on best evidence, they were tailored to local practice. Thus, some interventions such as postoperative laxatives and high carbohydrate drinks, which are part of other ERAS guidelines, were not included in our guideline. As well, we recommended a range of options for pain management so pain management can be tailored to the needs of the patient taking in to consideration the surgical technique as well as the procedure. Intraoperative intravenous lidocaine had not been used at any centers before developing the guideline but there was enthusiasm to include it in the guideline recommendations and has been widely adopted subsequently. To practice guided fluid management, it was agreed that cardiac monitors should be used to monitor cardiac output to avoid the potential complications associated with excess fluid administration. Finally, once the guidelines were completed by the working group, they were widely circulated for review by all stakeholders and many suggestions were incorporated. Thus, the development of the guidelines with wide involvement of stakeholders was also part of the implementation strategy. Understanding stakeholder views on ERAS and potential barriers and enablers was extremely helpful in developing a knowledge translation strategy and the findings were similar to those found by Lyon et al.28 The need for communication and collaboration was a recurring theme. As well, patient education was identified as an important element. On the basis of this feedback, we identified champions or opinion leaders in each discipline at all hospitals. In a review of the impact of NICE guidelines, Sheldon et al29 concluded that guideline uptake was more likely when there was strong professional support. A Cochrane review included 12 studies which evaluated the effect of opinion leaders on compliance with guideline recommendations.30 They found a 10% increase in compliance in the intervention group, which is comparable to other implementation strategies such as educational outreach and audit and feedback.31 In our program, the champions have also played a pivotal role in developing communities of practice in their hospitals. Communities of practice have been described as “groups of people who share a concern, a set of problems or a passion for a topic and who deepen their knowledge and expertise in this area by interacting on an ongoing basis.”32 Communities of practice tend to encourage a systems viewpoint, integrating different perspectives. The perioperative teams can be considered a community of practice. The positive effect of this collaboration and communication is substantiated by a report from Polle and colleagues33 who found that at their center, there was approximately 50% compliance with guideline recommendations. Interestingly, though, they observed a significant reduction in length of stay and they suggest that the protocolized way of management was more important than the combined effect of each intervention in achieving this decrease. They also attributed the improved outcomes to clearly defined goals for patients and the health care team working together to achieve these. In other words, positive change occurred with increased collaboration and communication of the same message to patients. The results of our initial audit led us to develop a database to collect information prospectively to monitor compliance with guideline recommendations and clinical outcomes. Previous studies have suggested that audit and feedback can lead to increased compliance with guideline recommendations.31,34 We developed a set of key indicators and are providing reports at 3 monthly intervals so individual hospitals can assess their performance against the other institutions. As well, because of the strong collaboration that has been fostered, sharing of best practices is part of the quality improvement process. Furthermore, modification of the indicators will occur as performance in some areas is optimized and other areas become a focus for improvement. Although we believe that this systematic process has led to improved care, there were costs both in terms of time and money. 6 | www.annalsofsurgery.com

The process was labor intensive and it took almost 4 years from the initial meta-analysis to completion and implementation of the guideline. Multiple stakeholders were involved in the process. In addition, financial support has been provided by hospitals to support the nurse champion role. Funding for site coordinators who have done the data collection and entry has been provided by a grant from the Council of Academic Hospitals of Ontario. As well, funding was provided by many of the hospitals to purchase cardiac monitors to assist with guided fluid management. Although ERAS programs have been shown to be cost-effective, there may be reluctance by hospital administration to provide up front funds to realize future cost savings.35 This process is also not over, as the guideline recommendations will require ongoing reevaluation and modification as new evidence emerges. There are also concerns about the sustainability of the program, as there is limited available information on the sustainability of these types of programs.36,37 As well, Massen et al9 reported on the outcome of 425 patients who had surgery at 5 institutions in Europe. They observed that cultural factors impacted on compliance and outcome. In particular, hospitals with previous exposure to fast track concepts were more likely to have reduced length of stay than at those where the ERAS protocol was being introduced suggesting that active strategies are required to sustain the program. Currently, there is support for our site coordinators who assist in administrative aspects of the practice and collect data for another year. However, there are concerns whether ongoing financial support will be available to continue data collection. For various reasons, we chose to develop a database to collect data. Audit and feedback has been an essential part of the program. However, development of the database required significant resources and ongoing resources will be required to support data entry, which may impact on sustainability. Initially, we made the database very comprehensive and have subsequently modified it to decrease the amount of data being collected to decrease data entry time as well as the realization that all data were not being used. There are now other options available such as the European ERAS Society database and recently National Surgical Quality Improvement Program has added ERAS fields to its database.38,39 The advantage of our database is that it has been tailored to our needs and we can make changes to what data are collected and what indicators are reported. As an example, as we have developed other guidelines through BPIGS, we have added fields to the database. As well, all sites have access to their own data.

CONCLUSIONS In summary, guidelines on ERAS and Pain Management have been developed by members of the Best Practice in General Surgery group as well as nurses and anesthesiologists. The framework of the KTA cycle was followed to assess the baseline rate of adoption of ERAS interventions and assess the views of members of the perioperative teams regarding enablers and barriers. Subsequently, a tailored knowledge translation strategy was used to implement the guideline recommendations. The early results suggest that this strategy has led to successful adoption at the multiple participating hospital sites and could potentially be used by other hospitals wishing to implement an ERAS program.

ACKNOWLEDGMENTS Hanna Tuszynska, Linda Onorato, Jana Macdonald, Daniel Broomfield (Hamilton Health Sciences Centre); Tony Hick, Paula Varney, Monique Kvaltin, Steve Blakely, Antonio Caycedo (Health Sciences North); Janet Van Vlymen, Julia Fournier, Ellie Scott, Hugh MacDonald, Natalie Lefrancois-Gauvin (Kingston General Hospital); Chris Harle, Debbie Wawryszyn, Amy Chambers, Chris Schlachta (London Health Sciences); Shohreh Abrouie, Anisa C 2015 Wolters Kluwer Health, Inc. All rights reserved.



Memon, Anand Govindarajan (Mount Sinai Hospital); Darryl Irwin, Michelle Wong, Lucia Vanta, Peter Stotland (North York General Hospital); Elaine Avila, Anna Speke, Steve MacLellan (Sunnybrook Health Sciences Centre); Ahmed Hamdy, Joan Park, Jacinta Reddigan, Ori Rotstein, Darlene Fenech (St. Michael’s Hospital); Cyndie Horner, Mary Dunn, Tobi Adeyemo, Margherita Cadeddu (St. Josephs Heathcare); John Agellon, Maureen Savoie, Laura Tomat, David Lindsay (St. Josephs Health Centre); Scott Bonneville, Deboura Olson, Erin Woodbeck, Gabriel Mapeso (Thunder Bay Regional Health Centre); Michael Hiscox, Chris Saby, Elissa Downey (Toronto East General Hospital); Anna Kacikanis, Catherine O’Brien (Toronto General Hospital); Michael Szeto, Maureen McGrath, Julie Sinclair, Rebecca Auer (The Ottawa Hospital); Carol Lopez, Afshin Mosavi Mirkolaei (Toronto Western Hospital). This work was supported in part by the Council of Academic of Ontario, Canadian Institutes of Health Research and Colon Cancer Canada.


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REFERENCES 1. Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008;248:189–198. 2. Greco M, Capretti G, Beretta L, et al. Enhanced recovery program in colorectal surgery: a meta-analysis of randomized controlled trials. World J Surg. 2014;38:1531–1541. 3. Eskicioglu C, Forbes SS, Aarts MA, et al. Enhanced recovery after surgery (ERAS) programs for patients having colorectal surgery: a meta-analysis of randomized trials. J Gastrointest Surg. 2009;13:2321–2329. 4. Delaney CP, Zutshi M, Senagore AJ, et al. Prospective, randomised, controlled trial between a pathway of controlled rehabilitation with early ambulation and diet and traditional postoperative care after laparotomy and intestinal resection. Dis Colon Rectum. 2003;46:851–859. 5. Anderson ADG, McNaught CE, MacFie J, et al. Randomized clinical trial of multimodal optimization and standard perioperative surgical care. Br J Surg. 2003;90:1497–1504. 6. Gatt M, Anderson ADG, Reddy BS, et al. Randomized clinical trial of multimodal optimization of surgical care in patients undergoing major colonic resection. Br J Surg. 2005;92:1354–1362. 7. Khoo CK, Vickery CJ, Forsyth N, et al. A prospective randomised controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Ann Surg. 2007;245:867–872. 8. Donohoe CL, Nguyen M, Cook J, et al. Fast-track protocols in colorectal surgery. Surgeon. 2011;9:95–103. 9. Maessen J, Dejong CH, Hausel J, et al. A protocol is not enough to implement an enhanced recovery programme for colorectal resection. Br J Surg. 2007;94:224–231. 10. Gustafsson UO, Hausel J, Thorell A, et al. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011;146:571–577. 11. Kahokehr A, Sammour T, Zargar-Shoshtari K, et al. Implementation of ERAS and how to overcome the barriers. Int J Surg. 2009;7:16–19. 12. Pearsall EA, Meghji Z, Pitzul KB, et al. A qualitative study to understand the barriers and enablers in implementing an enhanced recovery after surgery program. Ann Surg. 2015;261:92–96. 13. Graham ID, Logan J, Harrison MB, et al. Lost in knowledge translation: time for a map? J Contin Educ Health Prof. 2006;26:13–24. 14. Straus S, Tetroe J, Graham I, eds. Knowledge Translation in Health Care: Moving from Evidence to Practice. 2nd ed. West Sussex, UK: BMJ Books; 2013. 15. Zhuang CL, Ye XZ, Zhang XD, et al. Enhanced recovery after surgery programs versus traditional care for colorectal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2013;56:667–678. 16. Lv L, Shao YF, Zhou YB. The enhanced recovery after surgery (ERAS) pathway for patients undergoing colorectal surgery: an update of meta-analysis of randomized controlled trials. Int J Colorectal Dis. 2012;27:1549–1554. 17. Adamina M, Kehlet H, Tomlinson GA, et al. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis


24.

25.

26.

27.

28.

29.

30.

31.

32.

33. 34.

35.

36.

37.

38. 39.

of randomized controlled trials in colorectal surgery. Surgery. 2011; 149:830–840. Aarts MA, Okrainec A, Glicksman A, et al. Adoption of enhanced recovery after surgery (ERAS) strategies for colorectal surgery at academic teaching hospitals and impact on total length of hospital stay. Surg Endosc. 2012;26:442– 450. Fitzgerald JE, Ahmed I. Systematic review and meta-analysis of chewing-gum therapy in the reduction of postoperative paralytic ileus following gastrointestinal surgery. World J Surg. 2009;33:2557–2566. Schlachta CM, Burpee SE, Fernandez C, et al. Optimizing recovery after laparoscopic colon surgery (ORAL-CS): effect of intravenous ketorolac on length of hospital stay. Surg Endosc. 2007;21:2212–2219. Holte K, Andersen J, Jakobsen DH, et al. Cyclo-oxygenase 2 inhibitors and the risk of anastomotic leakage after fast-track colonic surgery. Br J Surg. 2009;96:650–654. Sim R, Cheong DM, Wong KS, et al. Prospective randomized, double-blind, placebo-controlled study of pre- and postoperative administration of a COX2-specific inhibitor as opioid-sparing analgesia in major colorectal surgery. Colorectal Dis. 2007;9:52–60. Klein M, G¨ogenur I, Rosenberg J. Postoperative use of non-steroidal antiinflammatory drugs in patients with anastomotic leakage requiring reoperation after colorectal resection: cohort study based on prospective data. BMJ. 2012;345:e6166. Klein M, Andersen LP, Harvald T, et al. Increased risk of anastomotic leakage with diclofenac treatment after laparoscopic colorectal surgery. Dig Surg. 2009;26:27–30. Gorissen KJ, Benning D, Berghmans T, et al. Risk of anastomotic leakage with non-steroidal anti-inflammatory drugs in colorectal surgery. Br J Surg. 2012;99:721–727. Strauss A, Corbin J, eds. Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory. 2nd ed. Thousand Oaks, CA: Sage Publications; 1998. Nadler A, Pearsall EA, Victor JC, et al. Understanding surgical residents’ postoperative practices and barriers and enablers to the implementation of an enhanced recovery after surgery (ERAS) guideline. J Surg Educ. 2014;71:632– 638. Lyon A, Solomon MJ, Harrison JD. A qualitative study assessing the barriers to implementation of enhanced recovery after surgery. World J Surg. 2014;38:1374–1380. Sheldon TA, Cullum N, Dawson D, et al. What’s the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients’ notes, and interviews. BMJ. 2004;329:999. Flodgren G, Parmelli E, Doumit G, et al. Local opinion leaders: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2011;8:CD000125. Grimshaw J, Eccles M, Tetroe J. Implementing clinical guidelines: current evidence and future implications. J Contin Educ Health Prof. 2004;24:S31– S37. Fung-Kee-Fung M, Watters J, Crossley C, et al. Regional collaborations as a tool for quality improvements in surgery: a systematic review of the literature. Ann Surg. 2009;249:565–572. Polle SW, Wind J, Fuhring JW, et al. Implementation of a fast-track perioperative care program: what are the difficulties? Dig Surg. 2007;24:441–449. Jamtvedt G, Young JM, Kristoffersen DT, et al. Audit and feedback: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2006;2:CD000259. Lemanu DP, Singh PP, Stowers MD, et al. A systematic review to assess cost effectiveness of enhanced recovery after surgery programmes in colorectal surgery. Colorectal Dis. 2014;16:338–346. Wiltsey Stirman S, Kimberly J, Cook N, et al. The sustainability of new programs and innovations: a review of the empirical literature and recommendations for future research. Implement Sci. 2012;7:17. Tricco AC, Cogo E, Ashoor H, et al. Sustainability of knowledge translation interventions in healthcare decision-making: protocol for a scoping review. BMJ Open. 2013;3:5. ERAS Society. ERAS Interactive Audit System: Available at: http://www .erassociety.org/. Accessed January 15, 2015. American college of Surgeons National Surgical Quality Improvement Program. Available at: http://site.acsnsqip.org/. Accessed January 15, 2015.

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APPENDIX 1. Summary of ERAS Guideline Recommendations 1. Preoperative Care 1.1 Preoperative Information and Counseling 1.1.1 For patients who do not have postoperative complications and have no other comorbidities or issues which would affect length of stay, the target for the duration of stay for those having colon operations is 3 days and for rectal operations (anastomosis below the peritoneal reflection) is 4 days 1.1.2 Patients should receive information on approximate length of stay; preoperative fasting and carbohydrate loading; pain control; early ambulation; postoperative feeding/ileus; time of catheter removal; and gum chewing 1.1.3 Patients should also receive information on smoking cessation 1.1.4 Patients and their families should receive oral information, as well as the patient education booklet 1.1.5 The booklet should be given to patients in the surgeon’s office. The surgeon should inform the patient to bring the booklet with them every time they come to the hospital, including their preoperative appointment and the day of their surgery 1.1.6 Nurses in the Pre-Admission Unit as well as on the Surgical Floor should be familiar with the booklet to assist the patients in answering any questions 1.1.7 Patients should be instructed to bring 2 packages of gum to the hospital 1.2 Reduced Fasting Duration For patients who are undergoing elective colorectal surgery and a significant delay in gastric emptying is not suspected 1.2.1 Patients should be allowed to eat solid foods until 12 midnight and clear liquids until 2 to 3 hours before surgery or until they leave for the hospital (Level of evidence: High) 1.2.2 Patients should be encouraged to drink a suitable carbohydrate rich drink, up to 800 mL at bedtime the night before surgery and 400 mL until 2 to 3 hours before surgery or until they leave for the hospital (Level of evidence: Moderate-Low) 1.3 Mechanical Bowel Preparation (refer to BPIGS Guideline 2 at www.bpigs.ca) 1.3.1 All open and laparoscopic procedures including segmental resections, abdominoperineal resection, total proctocolectomy, ileo pouch anal anastomosis, etc, but excluding low anterior resections (LAR) with/without diverting stoma • No dietary restrictions • No MBP • Fleet enema for patients having a left sided anastomosis where a stapler will be passed per anus 1.3.2 Open and laparoscopic LAR with/without diverting stoma LAR is defined as a rectal resection where the anastomosis is at or below the peritoneal reflection • No dietary restrictions before MBP; clear fluids after MBP completed • MBP 2. Intraoperative Care 2.1 Surgical Site Infection Prevention (refer to BPIGS Guideline 1 at www.bpigs.ca) 2.1.1 Antibiotics Prophylaxis • Antibiotics should be given within 1 hour before incision (infusion of vancomycin should be started more than 1 hour before incision because it requires infusion over 60 minutes) • For operative procedures >3 hours, antibiotics should be re-dosed (see Table) • Antibiotics should not be given postoperatively Regimen (No β-lactam Allergy) Cefazolin† and metronidazole Dose: metronidazole: 500 mg IV cefazolin†: 2 g IV gentamicin: 1.5–2 mg/kg IV Intraoperative Antimicrobial Re-Administration Guidelines for Operations Lasting > 3 hours Indication Colon, rectum, small bowel and nonperforated appendicitis∗

Antimicrobial cefazolin 1 g IV gentamicin dosed at 2 mg/kg metronidazole vancomycin

Regimen (β -lactam Allergy) Metronidazole and gentamicin Dose: metronidazole: 500 mg IV gentamicin: 1.5–2 mg/kg IV

Recommended Dosing Interval q3h q6h q8h q12h

2.1.2 Choice of Skin Preparation • Patients undergoing general surgical procedures should be prepped with chlorhexidine gluconate (2% chlorhexidine gluconate and 70% isopropyl alcohol) • Prevent pooling of chlorhexidine gluconate on drapes and patient and allow the antiseptic solution time to dry completely (∼3 minutes) 2.1.3 Perioperative Normothermia • Patients undergoing surgery where the abdominal cavity is entered should have active measures such as warmed intravenous fluids, inspired gases, as well as forced air warming undertaken to maintain core temperature between 36.0 and 38.0◦ C 2.2 Thromboprophylaxis (refer to BPIGS Guideline 3 at www.bpigs.ca) 2.2.1 For patients having surgery, administer thromboprophylaxis at the ‘time out’, and between 10:00-12:00 daily thereafter. For all patients, continue thromboprophylaxis until discharge 2.2.2 Low risk patients Includes: patients who are having outpatient surgery, minor procedures (elective laparoscopic cholecystectomy) and who have no additional thromboembolic risk factors • No thromboprophylaxis is required 2.2.3 All other patients having elective or emergency abdominal surgery Includes: patients having open or laparoscopic abdominal procedures for benign or malignant disease, irrespective of their age or other risk factors for VTE • Lovenox (enoxaparin) 40 mg subcu q 24 hour OR Fragmin (dalteparin) 5000 units subcu q 24 hour∗ (Continues)

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(Continued) • For patients at high risk for bleeding, where anticoagulation prophylaxis is contraindicated, bilateral well measured below knee support stockings or surgical compression devices should be used. • Patients should be reassessed daily and converted to low molecular weight heparin (LMWH) when the risk of bleeding is decreased 2.2.4 Special Circumstances: 2.2.4.a Patients having elective or emergency abdominal surgery after 6 PM • Give half of the regular dose of LMWH preoperatively: • Lovenox (enoxaparin) 20 mg OR Fragmin (dalteparin) 2500 units∗ • Administer full dose next day between 10:00–12:00 2.2.4.b Adjustment of thromboprophylaxis according to weight∗ Wt (kg)