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Multicenter Implementation of a ConsensusDeveloped, Evidence-Based, Spontaneous Breathing Trial Protocol

T. Elizabeth Robertson, MD; Henry J. Mann, PharmD; Robert Hyzy, MD; Angela Rogers, MD; Ivor Douglas, MD; Aaron B. Waxman, MD, PhD; Craig Weinert, MD, MPH; Philip Alapat, MD; Kalpalatha K. Guntupalli, MD; Timothy G. Buchman, PhD, MD; Partnership for Excellence in Critical Care

Posted: 10/27/2008; Crit Care Med. 2008;36(10):2753-2762. 2008 Lippincott Williams & Wilkins

Abstract and Introduction

Abstract

Objective: Evidence-based practice recommendations abound, but implementation is often unstructured and poorly audited. We assessed the ability of a peer network to implement an evidence-based best practice protocol and to measure patient outcomes. Design: Consensus definition of spontaneous breathing trial followed by implementation in eight academic medical centers. Setting: Six medical, two surgical, and two combined medical/surgical adult intensive care units among eight academic medical centers. Study Population: Patients initiating mechanical ventilation through an endotracheal tube during a 12-wk interval formed the study population. Interventions: Adoption and implementation of a common spontaneous breathing trial protocol across multiple intensive care units. Measurements and Main Results: Seven hundred five patients had 3,486 safety screens for conducting a spontaneous breathing trial; 2072 (59%) patients failed the safety screen. Another 379 (11%) patients failed a 2-min tolerance screen and 1,122 (34%) patients had a full 30-120 min spontaneous breathing trial performed. Seventy percent of eligible patients were enrolled. Only 55% of passing spontaneous breathing trials resulted in liberation from mechanical ventilatory support before another spontaneous breathing trial was performed. Conclusions: Peer networks can be effective in promoting and implementing evidence-based best practices. Implementation of a best practice (spontaneous breathing trial) may be necessary for, but by itself insufficient to achieve, consistent and timely liberation from ventilator support.
Introduction

The final step in translating a scientific advance into clinical practice is implementation of evidence-based recommended actions. In comparison with the effort spent generating recommendations, less has been done describing and optimizing their implementation. The few studies of implementation of care protocols show significant barriers that prevent realization of maximal benefit.[1] In preventive and wellness medicine, adults in the United States receive only about 55% of recommended healthcare services.[2] This limited implementation is surprisingly consistent across socioeconomic levels, insurance characteristics, and education levels, suggesting that core processes used to translate recommendations into best practices are ineffective. Implementation failure has been shown in many medical fields, including primary care of pneumonia,[3,4] preventive healthcare in high and low income countries,[5] screening for cancer in family practice clinics,[6,7] providing smoking cessation advice in general health clinics,[8] and ventilation support for acute respiratory distress syndrome in critical care.[9] Professional organizations such as the Society of Critical Care Medicine acknowledge that implementation gaps exist in intensive care. Society of Critical Care Medicine's current campaign (Right Care, Right Now)[10] instructs its members to deliver evidence-based medicine in a timely fashion. However, with the exception of single- institution studies,[11-13] there is little information on the success of implementation in critical care and less on optimizing strategies for such implementation. A recent single-institution review of its fidelity to recommended best practices in critical care suggested an overall compliance rate of 56%.[14]

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Peer networks have previously been shown to facilitate patient care,[15] implementation of clinical pathways,[16] management of parenteral nutrition in the home setting,[17] standardization of laboratory measurements,[18] and management of rare chronic conditions.[19] Factors cited for success of peer networks include agreement on standards of care, identification of education needs, shared protocols, voluntary agreement to perform to meet a standard or risk losing membership in the network, equity of access to standard of care for patients in member organizations, and production of scientific data with combined patient numbers from the centers. In 2002, a voluntary association of 18 academic intensive care units (ICUs) constituted itself as the Partnership for Excellence in Critical Care (PECC).[20] PECC surmised that a peer network would facilitate implementation of best practices in critical care. This report describes the selection, implementation process, and outcome of adopting a single consensus-developed, evidence-based, best practice for a daily spontaneous breathing trial (SBT) of mechanically ventilated patients across eight PECC member institutions. Daily SBTs have ample support in the literature as a best practice, including a consensus statement from the American College of Chest Physicians.[21] Protocols have also been shown to improve outcomes in critical care.[22-25] The aim of this initial project was to demonstrate the ability of the PECC members to synchronously implement a mutually agreed upon best practice; to assess heterogeneity in the implementation of the best practice across PECC sites; and to identify opportunities for further improvement.

Methods
Formation of the PECC and Best Practice Protocol

PECC is a voluntary association of ICUs whose primary mission is translation of critical care research into practice. The partnership is diverse in terms of geography, administrative model (open vs. closed ICUs), hospital type (public vs. private), and patient population (surgical vs. medical). Representatives to PECC are equally diverse and include ICU physicians, respiratory therapists, nurses, and pharmacists. PECC chose to implement an SBT as its first mutually agreed upon best practice based on strength of evidence, ease of implementation, and its inclusion in several best-practice measures such as the Institute for Heathcare Improvement ventilator bundle.[26] Individual site SBT protocols in place at members' ICUs were analyzed for common characteristics. Three institutions did not have any SBT protocol in place before the study, two institutions had physician-ordered (optional) SBT protocols in place before initiation of the study protocol, three institutions had daily SBTs protocols as standard care before initiation of the study protocol, but only two reported >50% application. Publications on SBTs and SBT guidelines were reviewed for consistency with site protocols. Members then met in May 2005 to design an initial consensus protocol and data collection mechanism. Partnership members piloted the protocol and then met again in December 2005 to refine and establish the final consensus protocol and collection method. Synchronous data collection began in February 2006 and continued for 12 wks. Heterogeneity of implementation was reviewed in June 2006 after data collection completion. Further optimization strategies were identified.
SBT Protocol

Each intubated patient was evaluated by both a respiratory therapist and nurse each day. The cliniciandriven consensus SBT protocol included three steps: a safety screen to determine the patient's readiness to undergo an SBT, a 2-min tolerance screen of intensive monitoring to assess whether the SBT should continue, and a 30-120 min SBT. The patient passed or failed based on agreed upon criteria for each step (Figs. 1 and 2). The tolerance screen was conducted for 2 mins on 0 cm H2O pressure support at each patient's prior positive end-expiratory pressure level. During the full SBT, duration and specific level of positive end-expiratory pressure (0-8 cm H2O) and pressure support (0-8 cm H2O) varied by local practice. Vital signs were recorded at the end of each trial. If the patient failed to complete the full SBT, reasons for early exit were recorded. At each step of the protocol, ICU physicians retained override authority and could either move the patient on to the next step or stop the SBT. Physicians could also order additional SBTs

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each day.

Figure 1. Common protocol for daily spontaneous breathing trials (SBT) agreed upon by the Partnership for Excellence in Critical Care in Miami, November, 2005. ICP, intracranial pressure; ECMO, extracorporeal membrane oxygenation; ETT, endotracheal tube; PSV, pressure support ventilation; ID, internal diameter; bpm, breaths per minute; CPAP, continuous positive airway pressure; RR, respiratory rate; HR, heart rate; BP, blood pressure; SOB, shortness of breath.

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Figure 2. Daily spontaneous breathing trial form template used by the Partnership for Excellence in Critical Care. This form was distributed to participating institutions in modifiable format. For example, different sedation scores were used by institutions and the form was altered for local use. Similar to other protocols, extubation after a successful SBT was not mandated.[24] Rather, the protocol ended with the collection of data to be used by clinicians in deciding whether a patient was a candidate for extubation. The time of extubation (and subsequent reintubation, if necessary) was recorded as part of the data collection process. The reintubation rate included only those patients who required reinstitution of

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mechanical ventilation <48 hrs since extubation. Patient status after each trial was recorded, including pass vs. fail for each step of the SBT, and extubation or continued mechanical ventilation. A glossary clarifying the terms used in the protocols is included ( Table 1 ).
Table 1. Glossary

Data Collection

Eight PECC members agreed to implement the SBT protocol and collect data from February 12, 2006 to May 9, 2006. These eight institutions were Baylor College of Medicine, Massachusetts General and Harvard Medical School, University of Colorado, University of Maryland, University of Miami, University of Michigan, University of Minnesota, and Washington University in Saint Louis. All patients for whom mechanical ventilation via endotracheal tube was initiated during the interval were included. The SBT protocol was ordered automatically upon initiation of mechanical ventilation although physicians could opt out at their discretion. The main outcome variable was percentage of eligible patients screened for a daily SBT. Each institution received Institutional Review Board (IRB) approval. In each case, informed consent was waived as implementation of the uniform SBT protocol was judge to be a quality improvement initiative rather than a clinical trial. Data were de-identified locally before transmission to the central data analysis site. Participating institutions were surveyed to determine prior performance of daily SBTs and, post hoc, how the partnership aided implementation.
Analysis

Outcome measures established before data collection included percentage of patient's extubated after a passed SBT, percentage of patients not extubated after a passed SBT with associated reasoning, and patients re-intubated within 48 hrs of extubation. Data were collected using Microsoft Access and statistically analyzed by GraphPad Prism software. Descriptive statistics, Spearman's correlation coefficient, and Pearson's correlation coefficient were calculated with significance taken at p < 0.05. To assess the network's ability to capture relevant data, we compared the protocol data submitted at each site with independent billing data from respiratory care databases. The ratio of protocol data to billing data defined the capture rate. Validation checks were also performed to detect logical inconsistencies and these were referred back to sites for clarification. For all trials that passed the final SBT, end vital signs were

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evaluated by the data center to assess if pass and fail criteria for each step were applied correctly by the site. An error was defined as any vital sign outside the variables of the protocol's passing criteria in a passing SBT (Fig. 1). Validation and error checking could be performed only on those breathing trials with complete end vital signs. Missing data were interpreted as neither valid nor invalid, but simply as missing.

Results
Table 2 lists the characteristics of study institutions and participants. The collective capture rate (the total number of patients with documentation of a safety screen completion compared with the total number of patients with billing data) from all sites was 70% (interquartile range, 53%-78%). Thus, 30% of patients who were eligible for safety screening did not have this documentation completed. At least 65% of these missed patients were intubated <24 hrs. One institution's daily SBT protocol captured a greater number of patients than their billing database did, yielding a local capture rate of 119%. This excess demonstrates one hazard of using administrative databases to investigate clinical questions. Billing and other nonclinical databases may omit episodes and thereby color analyses. All participating institutions reported that inception of the SBT protocol improved the capture rate, in five of nine cases more than doubling the capture rate. In aggregate, a total of 705 mechanically ventilated patients with 747 ventilation episodes were recorded among the eight institutions. Seventy-eight (10% of 747 ventilation episodes) patients underwent subsequent tracheostomy. The duration of mechanical ventilation ranged from extubation on arrival to the unit to 65 days with a median of 2.8 days (interquartile range 1-6 days).
Table 2. Demographic and Clinical Characteristics of Study Institutions and Participants Undergoing Mechanical Ventilation From February 12, 2006 to May 9, 2006

The outcomes of the three-step SBT for the patients are shown in Figure 3. Of 3,486 safety screens, 2,072 (59%) patients met at least one fail criterion. Another 379 (11%) patients failed the 2-min tolerance screen, leaving 1,122 (34%) patients to continue on to a full 30-120 min SBT. Distribution of the levels of positive end-expiratory pressure and pressure support ventilation used during the SBT are shown in Figures 4A and B. The average crude completion rate (percentage of safety screen evaluations that proceeded to the full SBT by passing steps 1 and 2) was 32% (interquartile range, 20%-40%). Thus, on an average day, fewer than half of intubated patients reached the threshold for an extubation decision. There was a seven-fold range of crude completion rates (9%-55%) among the PECC sites (Fig. 5) which was, in part, due to differing clinician perception of what constituted a safe airway. The majority of institutions interpreted the unsafe airway in the safety screen as only anatomical airway instability (i.e., injury or edema). However, Site 9 determined patients with oversedation and depressed or altered mental status to have an unsafe

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airway. This led to Site 9 having a lower crude completion rate and consequently higher extubation rate than the other sites. This demonstrates the need for unambiguous consensus on objective criteria in safety evaluations.

Figure 3. Outcomes of daily spontaneous breathing trials (SBTs) for endotracheally intubated patients.

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Figure 4. (A and B) Distribution of levels of positive end-expiratory pressure and pressure support ventilation (PSV) used during the spontaneous breathing trial (SBT) of patients who passed the safety screen. N = 1380. ATC, automatic tube compensation; a level of PSV determined by some models of ventilators to compensate for the resistance of the endotracheal tube and ventilator circuitry.

Figure 5. Crude completion rates (percentage of safety screen evaluations that proceeded to a full 30-120 min trial by passing steps 1 and 2). Institutions were assigned numbers for anonymization. (N = number of safety screens performed). SBT, spontaneous breathing trial.

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Some patients continued on to an SBT despite failing the safety or 2-min tolerance screen, resulting in crossover for the outcomes of subsequent steps in the protocol. Crossover resulted from either deliberate (physician override) or inadvertent decisions to proceed in the face of stopping (fail) criteria. Sixty-one SBTs were continued after failing step 1 and 96 SBTs were continued after failing step 2. Twenty-one SBTs were stopped after passing step 1 and 43 were stopped after passing the step 2 tolerance screen. Overall 55% of patients who successfully completed a SBT were extubated before another SBT was performed. Extubation rates by site are shown in Figure 6. Protocol violations were noted in 4% of safety screens and 13% of SBTs.

Figure 6. Rates of extubation after a passed spontaneous breathing trials (SBT) before another trial was performed. Institutions were assigned numbers for anonymization. (N = number of passed SBTs). Each on-site data collector was charged with querying the bedside physician for specific nonextubation reasons. Some patients had more than one reason identified and each reason was counted individually (Fig. 7). When other was designated, physicians were asked to provide the alternative reason. This was not done for 30 of 59 (51%) other designations. Reasons listed included: shortness of breath orincreased minute ventilation (6 of 59, 10%), cardiovascular instability (5 of 59, 8%), and findings on chest x-ray (3 of 59, 5%). Reasons listed once or twice included: patient awaiting tracheostomy, just reintubated, patient needs rest, the physician thought the patient failed the SBT, post-SBT apnea, do-not-resuscitate status, high end tidal CO2, low hematocrit, abdominal distention, metabolic acidosis, and concern for hypothyroidism. No documentation was provided for continuing mechanical ventilation (and other was not marked) in 20% of passing trials.

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Figure 7. Reasons for continuing mechanical ventilation after passing a spontaneous breathing trial. There were 734 passing trials that resulted in continued mechanical ventilation. N = 434 total reasons given for continued mechanical ventilation. The study was not powered to assess reintubation rates. The following data and analysis are included solely for descriptive purposes. The reintubation rate within 48 hrs for patients who were extubated after successfully completing the SBT was 5.3% (interquartile range, 1%-10%) (Fig. 8). There was no apparent correlation between the extubation rate and reintubation rate (Spearman's r = -.28, p = 0.46, Pearson's r = .46, p = 0.22, n = 9). Centers with the highest extubation rates did not necessarily have higher reintubation rates (Fig. 9).

Figure 8. Reintubation rates between centers from February 12 through May 9, 2006 (N = total number of extubations). Only reintubations <48 hrs after extubation were included. The standard deviation of the reintubation rates is 6.7%. There are 34 more extubations included in the total than in the passed and failed spontaneous breathing trials (SBT) columns as some SBTs had no result

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recorded.

Figure 9. Reintubation rate vs. extubation rate by center. r = -.34, p = 0.38. Site 3 had a high rate of reintubations (21%), despite a low pass rate for completed trials (39%). Site 9 interpreted the safety screen conservatively, counting most intubated patients as unsafe to trial for inability to support their airway because of physiologic airway instability (i.e., severe illness or depressed mental status) instead of anatomic instability (i.e., injury). This yielded a low crude completion rate (8%), a high extubation rate of passed trials (98%) and no reintubations. The post hoc survey revealed that representatives from each institution agreed that PECC aided implementation. Specific local barriers overcome were identified for 75% of institutions. For example, mention of PECC motivated team members and timeline achievement was encouraged with regular PECC meetings. Three institutions stated that their IRBs were more willing to approve the project with mention of PECC.

Discussion
Implementation Process

Evidence-based protocols using the results of prospective studies have been widely advocated as a means to improve patient outcomes. Reports usually describe single institution experiences that require additional resources (e.g., study personnel) to collect and process data. Translation of guidelines for multiple institutions is less widely reported and may be less effective. When implementation is widespread and successful it is often at the behest of regulatory agencies. Pronovost et al.[27] demonstrated the success of implementing procedures to reduce the incidence of catheter-related bloodstream infections using a statewide safety initiative funded by the Agency for Healthcare Research and Quality. We have described key steps and outcomes in synchronous implementation of a single best practice-a daily SBT-across a voluntary association of diverse ICUs. A peer network aimed at implementing best practices across institutions was perceived by its members to be an effective strategy for collaboration, analysis, and commitment to specific goals. Many of the participating institutions found that local barriers were more easily overcome when reference to the multicentered partnership was made. For example, description of the partnership and enumeration of its goals strengthened support for implementation of the new protocol at many institutions. For healthcare providers who would assume additional workload, personal participation in the partnership was more motivating than scientific references for evidence of best practice. Several IRBs cited the partnership in

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their approval to implement unit-wide change as best practice with concurrent data collection. Timeline and process fulfillment was enhanced with scheduled interinstitutional meetings where participants were mutually accountable for results. Such a partnership across institutions differs from partnerships within institutions (that can be mandated by local administrations) and partnerships founded on prospective clinical research (that are often externally funded to develop the evidence used in forming best practice recommendations). Voluntary peer networks that create mutual opportunity and accountability for implementing best practices seem well suited for ICUs and their healthcare organizations. Implementation of evidence-based practice cannot occur without direct leadership from the involved professions. Here, nursing and respiratory therapy took collective responsibility for executing and recording outcomes for the SBTs. Nursing- and respiratory therapy-driven protocols have previously been shown to be effective and safe.[25,28,29] We suggest that implementation of other best practices should include all relevant professions from the design phase onward and physicians must be enthusiastic about granting authority and responsibility to those professionals. Reports on successful adoption of an evidence-based SBT as best practice are conspicuously absent. During the initial meetings of the PECC, participants were asked whether they routinely performed SBTs and, if so, to describe their unit-standard SBT. This process of describing, refining, and ultimately converging upon a common protocol illuminated wide variations of application and execution. In the past, it has been asserted that evidence-based recommendations made by professional organizations and other authoritative bodies must be refined to accommodate local practice and needs.[30-32] Although this assertion is reasonable, we suggest that an intermediate step explicitly defining the intent of the recommendation and operationalizing the concept into a generally executable protocol (that can later be slightly modified to accommodate local practice) may be essential if such recommendations are ever to be consistently implemented and to achieve expected benefits. Implementation strategies aimed at increasing acceptance of and adherence to this and other evidencedriven protocols are key to obtaining optimal outcomes. The factors that affect clinical guideline adoption are complex, as are the social norms, administrative processes, and local systems that must be aligned to execute such protocols.[33] The emerging field of implementation science aims to make the uptake of research findings into routine healthcare efficient and predictable. Accordingly, this field is rapidly developing new theory and practice.[34,35] The intensive care environment-high-risk, high-cost, and problem prone-would seem to be an early and appropriate target for this new science.
Low Extubation Rate

Implementation exposed substantial physician ambivalence about the use of SBT data. Despite evidence that unnecessary prolongation of mechanical ventilation is costly with respect to access to ICU services and patient-specific complications (e.g., ventilator-associated pneumonia), there was a surprisingly low rate of extubation after a patient passed a SBT as compared with previously published reports[36,37] and each unit's own physician staff expectations. An appropriate extubation rate is unknown. We do not mean to suggest that a passing SBT should be the sole or even major criterion driving a physician decision to liberate the patient from mechanical ventilation. Nevertheless, fully 45% of passing trials did not result in a physician decision to extubate before another SBT was performed, suggesting that either patient-specific, unit-specific, or physician-specific processes are responsible for considerable delay in separating the patient from the ventilator. As nearly 30% of patients who had a successful SBT were not extubated because of concerns regarding mental status, efforts aimed at improving mental status before performing an SBT, such as daily wake-up sedation holidays[38] might result in an increased rate of extubation after SBT. This initial study did not attempt to assess, control for, or implement sedation holidays. Concerns regarding increasing reintubation rates with increasing extubation rates were not borne out in this study (Fig. 9). This may suggest that some clinicians are overly cautious regarding the decision to extubate. However, with only eight institutions participating, the correlation analysis is underpowered, and the differences inpatient types at each institution could also account for the lack of association.
Heterogeneity in Implementation

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Despite formal agreement on interpretation of the final three step protocol among a highly motivated group of intensive careproviders, implementation differed among institutions. As an example, one institution (site 9) interpreted the safety screen conservatively, counting most intubated patients as unsafe to conduct an SBT for having an unstable airway if they were deemed to have depressed or altered mentation. This yielded a low crude completion rate (9%) (Fig. 5), a high extubation rate of passed trials (98%) (Fig. 6), and no reintubations (Fig. 8). This disparity in implementation emphasizes the importance of clarity in and fidelity to multi-step protocols in achieving consistent outcomes across multiple institutions. Different patients, providers, and belief systems resulted in a difference in outcomes in crude completion rates, extubation rates, and reintubation rates. Variation inpatient populations seemed to contribute to heterogeneous protocol performance. Institution 3 had a low extubation rate (47%), one of the lowest crude completion rates (11%), the highest reintubation rate (21%), and a high tracheostomy rate (21%). Internal review found that all extubated patients had passed their SBT, but this particular patient population had a high rate of severe obstructive pulmonary disease. This was thought to result in SBT passing with subsequent respiratory failure. Further research into the applicability of SBTs in this and other selected patient populations, and variation in implementation by highly trained critical care professionals is warranted.
IRB Issues

We found a range of expectations among human studies committees regarding the collection, sharing, and reporting of fully de-identified and aggregated data containing only clinical information obtained and used in routine care. Some human studies committees considered the process of establishing and implementing best practice to be quality improvement and, therefore, exempt from human studies oversight. Other IRBs opined that the intent to compare and publish outcomes constituted human studies research and required complete committee review. Ultimately, no IRB required informed consent that would have introduced a selection bias and rendered an institution's contribution meaningless for multicentered outcome assessment.
Limitations

There are several important limitations to this study. First, participation was voluntary. Of 18 members in the partnership, only eight participated. Reasons for nonparticipation included preexisting commitments to SBT protocols or ventilator studies, delay in IRB approval, delay in institutional acceptance, and loss of contact with PECC. Although the reasons are valid and understandable, the nonparticipation rate illustrates the difficulty of embedding a single evidence-based recommendation into the complex operation of a busy ICU. The environmental impact of such implementations extends beyond patients into local practice patterns. There is a need to understand why nonparticipation occurs and to design practical strategies favoring adoption. Reporting was not audited as a necessary consequence of study design. Our goal was to test widespread implementation in the natural environment of the ICU, without the additional resources brought to bear by classic prospective trials. We chose a balance between participation, data reporting, and audit access that favored simplicity of data collection over more complex processes that would have required written consent and thereby discouraged participation. As a result, validation checks of the data were limited to simple retrospective assessment for compliance with the protocol and logical impossibilities. High compliance rates (89% of passing SBTs were error-free) coupled with the consistency of findings across disparate ICUs are reassuring but cannot guarantee validity. The capture rate of 70% (leaving 30% of eligible patients unrecorded) could have biased the results, depending on the population missed. In review at several institutions, the majority of patients missed by the protocol were those intubated <24 hrs, possibly skewing the extubation rate lower and the reintubation rates higher than reality. Generalizability to nonacademic institutions without a history of evidence-based practice is unknown. Additional steps of knowledge transfer and provider education may have to be added to the concepts of peer networks, protocol development, and joint implementation. PECC is a model that addresses relevant issues and offers protocols and data collection strategies with proven success in an academic setting.

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Conclusion
Implementation of evidence-based recommendations at the patient level remains a formidable challenge that can be partially addressed through a peer network of committed ICUs that includes all related professions. Mutual commitments to simultaneously measure and subsequently report performance across care sites can be an effective stimulus to examine local practice, compare with evidence-based recommendations, operationalize those recommendations, and improve care processes.
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Acknowledgments In addition to the members of the Writing Committee, the members of the Partnership for Excellence in Critical Care who contributed to conception, design and execution of this study are: Baystate Medical Center/Tufts University-Jay Steingrub, Patrick Mailloux, Thomas Higgins; Baylor College of Medicine-Kalpalatha Guntupalli, Philip Alapat, Caryn Pope, Antara Mallampalli, Diane McCabe, Narenda Wickramatunge, Thomas Wilson; Cedars Sinai Medical Center-Scott Cuneen; Denver Health Medical Center-Ivor Douglas, Mark Devereux, James Fisher, Debbie Lathrop, Jan Smith, Bob Wolken; Massachusetts General Hospital-Aaron B. Waxman, Ernie Chou, Kevin Foley, Margaret Hegarty, Dean Hess, Ann Koontz, Angela Rogers, Debra Sloboth, Taylor Thompson; Stanford University-Ronald Pearl, Ann Weinacker; University of Maryland-Stephen B. Johnson, Marlin Martin, Kristin Seidl; University of Miami/Miami Veteran's Administration HospitalRoland Schein, Andrew Quartin; University of Michigan-Robert Hyzy, Linda Folk, Carl Haas, Philip Lenart; University of Minnesota-Henry Mann, Craig Weinert, Paula Aherns, Julie Koplitz, Patty Lawrence, Monica Lupei; University of Pittsburgh-Scott Gunn; and Washington University/Barnes Jewish Hospital-Timothy Buchman, Marcy Buckles, Lisa Cracchiolo, T. Elizabeth Robertson, Carrie Sona, Fine Song. Funding Information Supported in part by a grant from the James S. McDonnell Foundation and NIGMS postdoctoral fellowship, GM008795 (to TER). Reprint Address For information regarding this article, E-mail: robertsont@wudosis.wustl.edu

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