implementation of a spontantaneous breathing trial protocol friendly)

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www.medscape.com 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] Multicenter Implementation of a Consensus- Developed, 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 Implementation of a Spontantaneous Breathing Trial Protocol (printer-f... http://www.medscape.com/viewarticle/581831_print 1 of 16 12/2/11 3:44 PM

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Page 1: Implementation of a Spontantaneous Breathing Trial Protocol Friendly)

www.medscape.com

Abstract and Introduction

Abstract

Objective: Evidence-based practice recommendations abound, but implementation is often unstructuredand poorly audited. We assessed the ability of a peer network to implement an evidence-based bestpractice protocol and to measure patient outcomes.Design: Consensus definition of spontaneous breathing trial followed by implementation in eight academicmedical centers.Setting: Six medical, two surgical, and two combined medical/surgical adult intensive care units amongeight academic medical centers.Study Population: Patients initiating mechanical ventilation through an endotracheal tube during a 12-wkinterval formed the study population.Interventions: Adoption and implementation of a common spontaneous breathing trial protocol acrossmultiple intensive care units.Measurements and Main Results: Seven hundred five patients had 3,486 safety screens for conducting aspontaneous breathing trial; 2072 (59%) patients failed the safety screen. Another 379 (11%) patients faileda 2-min tolerance screen and 1,122 (34%) patients had a full 30-120 min spontaneous breathing trialperformed. Seventy percent of eligible patients were enrolled. Only 55% of passing spontaneous breathingtrials resulted in liberation from mechanical ventilatory support before another spontaneous breathing trialwas performed.Conclusions: Peer networks can be effective in promoting and implementing evidence-based bestpractices. Implementation of a best practice (spontaneous breathing trial) may be necessary for, but byitself 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-basedrecommended actions. In comparison with the effort spent generating recommendations, less has beendone describing and optimizing their implementation. The few studies of implementation of care protocolsshow 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 limitedimplementation is surprisingly consistent across socioeconomic levels, insurance characteristics, andeducation levels, suggesting that core processes used to translate recommendations into best practicesare ineffective. Implementation failure has been shown in many medical fields, including primary care ofpneumonia,[3,4] preventive healthcare in high and low income countries,[5] screening for cancer in familypractice clinics,[6,7] providing smoking cessation advice in general health clinics,[8] and ventilation supportfor acute respiratory distress syndrome in critical care.[9]

Professional organizations such as the Society of Critical Care Medicine acknowledge that implementationgaps exist in intensive care. Society of Critical Care Medicine's current campaign (Right Care, RightNow™)[10] instructs its members to deliver evidence-based medicine in a timely fashion. However, with theexception of single- institution studies,[11-13] there is little information on the success of implementation incritical care and less on optimizing strategies for such implementation. A recent single-institution review ofits fidelity to recommended best practices in critical care suggested an overall compliance rate of 56%.[14]

Multicenter Implementation of a Consensus-Developed, Evidence-Based, SpontaneousBreathing Trial ProtocolT. Elizabeth Robertson, MD; Henry J. Mann, PharmD; Robert Hyzy, MD; AngelaRogers, 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

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Peer networks have previously been shown to facilitate patient care,[15] implementation of clinicalpathways,[16] management of parenteral nutrition in the home setting,[17] standardization of laboratorymeasurements,[18] and management of rare chronic conditions.[19] Factors cited for success of peernetworks 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 ofaccess to standard of care for patients in member organizations, and production of scientific data withcombined patient numbers from the centers.

In 2002, a voluntary association of 18 academic intensive care units (ICUs) constituted itself as thePartnership for Excellence in Critical Care (PECC).[20] PECC surmised that a peer network would facilitateimplementation of best practices in critical care. This report describes the selection, implementationprocess, and outcome of adopting a single consensus-developed, evidence-based, best practice for a dailyspontaneous breathing trial (SBT) of mechanically ventilated patients across eight PECC memberinstitutions.

Daily SBTs have ample support in the literature as a best practice, including a consensus statement fromthe American College of Chest Physicians.[21] Protocols have also been shown to improve outcomes incritical care.[22-25] The aim of this initial project was to demonstrate the ability of the PECC members tosynchronously implement a mutually agreed upon best practice; to assess heterogeneity in theimplementation of the best practice across PECC sites; and to identify opportunities for furtherimprovement.

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 intopractice. 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 PECCare 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 ofevidence, ease of implementation, and its inclusion in several best-practice measures such as the Institutefor Heathcare Improvement ventilator bundle.[26] Individual site SBT protocols in place at members' ICUswere analyzed for common characteristics. Three institutions did not have any SBT protocol in place beforethe study, two institutions had physician-ordered (optional) SBT protocols in place before initiation of thestudy protocol, three institutions had daily SBTs protocols as standard care before initiation of the studyprotocol, but only two reported >50% application.

Publications on SBTs and SBT guidelines were reviewed for consistency with site protocols. Members thenmet in May 2005 to design an initial consensus protocol and data collection mechanism. Partnershipmembers piloted the protocol and then met again in December 2005 to refine and establish the finalconsensus protocol and collection method. Synchronous data collection began in February 2006 andcontinued for 12 wks. Heterogeneity of implementation was reviewed in June 2006 after data collectioncompletion. Further optimization strategies were identified.

SBT Protocol

Each intubated patient was evaluated by both a respiratory therapist and nurse each day. The clinician-driven consensus SBT protocol included three steps: a safety screen to determine the patient's readinessto undergo an SBT, a 2-min tolerance screen of intensive monitoring to assess whether the SBT shouldcontinue, 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 eachpatient's prior positive end-expiratory pressure level. During the full SBT, duration and specific level ofpositive 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 forearly exit were recorded. At each step of the protocol, ICU physicians retained override authority and couldeither 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 thePartnership for Excellence in Critical Care in Miami, November, 2005. ICP, intracranial pressure;ECMO, extracorporeal membrane oxygenation; ETT, endotracheal tube; PSV, pressure supportventilation; 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 inCritical 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 protocolended with the collection of data to be used by clinicians in deciding whether a patient was a candidate forextubation. The time of extubation (and subsequent reintubation, if necessary) was recorded as part of thedata 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 passvs. fail for each step of the SBT, and extubation or continued mechanical ventilation. A glossary clarifyingthe terms used in the protocols is included ( Table 1 ).

Data Collection

Eight PECC members agreed to implement the SBT protocol and collect data from February 12, 2006 toMay 9, 2006. These eight institutions were Baylor College of Medicine, Massachusetts General andHarvard Medical School, University of Colorado, University of Maryland, University of Miami, University ofMichigan, University of Minnesota, and Washington University in Saint Louis. All patients for whommechanical ventilation via endotracheal tube was initiated during the interval were included. The SBTprotocol was ordered automatically upon initiation of mechanical ventilation although physicians could optout at their discretion. The main outcome variable was percentage of eligible patients screened for a dailySBT.

Each institution received Institutional Review Board (IRB) approval. In each case, informed consent waswaived as implementation of the uniform SBT protocol was judge to be a quality improvement initiativerather than a clinical trial. Data were de-identified locally before transmission to the central data analysissite.

Participating institutions were surveyed to determine prior performance of daily SBTs and, post hoc, howthe partnership aided implementation.

Analysis

Outcome measures established before data collection included percentage of patient's extubated after apassed SBT, percentage of patients not extubated after a passed SBT with associated reasoning, andpatients re-intubated within 48 hrs of extubation. Data were collected using Microsoft Access andstatistically analyzed by GraphPad Prism software. Descriptive statistics, Spearman's correlationcoefficient, 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 eachsite with independent billing data from respiratory care databases. The ratio of protocol data to billing datadefined the capture rate. Validation checks were also performed to detect logical inconsistencies and thesewere referred back to sites for clarification. For all trials that passed the final SBT, end vital signs were

Table 1. Glossary

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evaluated by the data center to assess if pass and fail criteria for each step were applied correctly by thesite. An error was defined as any vital sign outside the variables of the protocol's passing criteria in apassing SBT (Fig. 1). Validation and error checking could be performed only on those breathing trials withcomplete 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 totalnumber of patients with documentation of a safety screen completion compared with the total number ofpatients with billing data) from all sites was 70% (interquartile range, 53%-78%). Thus, 30% of patients whowere eligible for safety screening did not have this documentation completed. At least 65% of these missedpatients were intubated <24 hrs. One institution's daily SBT protocol captured a greater number of patientsthan their billing database did, yielding a local capture rate of 119%. This excess demonstrates one hazardof using administrative databases to investigate clinical questions. Billing and other nonclinical databasesmay omit episodes and thereby color analyses. All participating institutions reported that inception of theSBT protocol improved the capture rate, in five of nine cases more than doubling the capture rate. Inaggregate, a total of 705 mechanically ventilated patients with 747 ventilation episodes were recordedamong the eight institutions. Seventy-eight (10% of 747 ventilation episodes) patients underwentsubsequent tracheostomy. The duration of mechanical ventilation ranged from extubation on arrival to theunit to 65 days with a median of 2.8 days (interquartile range 1-6 days).

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 positiveend-expiratory pressure and pressure support ventilation used during the SBT are shown in Figures 4A andB. The average crude completion rate (percentage of safety screen evaluations that proceeded to the fullSBT by passing steps 1 and 2) was 32% (interquartile range, 20%-40%). Thus, on an average day, fewerthan half of intubated patients reached the threshold for an extubation decision. There was a seven-foldrange of crude completion rates (9%-55%) among the PECC sites (Fig. 5) which was, in part, due todiffering clinician perception of what constituted a safe airway. The majority of institutions interpreted theunsafe 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

Table 2. Demographic and Clinical Characteristics of Study Institutions and ParticipantsUndergoing Mechanical Ventilation From February 12, 2006 to May 9, 2006

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

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

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Figure 4. (A and B) Distribution of levels of positive end-expiratory pressure and pressure supportventilation (PSV) used during the spontaneous breathing trial (SBT) of patients who passed the safetyscreen. N = 1380. ATC, automatic tube compensation; a level of PSV determined by some models ofventilators 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 full30-120 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 incrossover 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-oneSBTs were continued after failing step 1 and 96 SBTs were continued after failing step 2. Twenty-one SBTswere stopped after passing step 1 and 43 were stopped after passing the step 2 tolerance screen. Overall55% 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 and13% of SBTs.

Figure 6. Rates of extubation after a passed spontaneous breathing trials (SBT) before another trialwas 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 nonextubationreasons. 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 wasnot done for 30 of 59 (51%) other designations. Reasons listed included: shortness of breath orincreasedminute ventilation (6 of 59, 10%), cardiovascular instability (5 of 59, 8%), and findings on chest x-ray (3 of59, 5%). Reasons listed once or twice included: patient awaiting tracheostomy, just reintubated, patientneeds 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 forhypothyroidism. No documentation was provided for continuing mechanical ventilation (and other was notmarked) 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 reasonsgiven for continued mechanical ventilation.

The study was not powered to assess reintubation rates. The following data and analysis are includedsolely for descriptive purposes. The reintubation rate within 48 hrs for patients who were extubated aftersuccessfully completing the SBT was 5.3% (interquartile range, 1%-10%) (Fig. 8). There was no apparentcorrelation 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 reintubationrates (Fig. 9).

Figure 8. Reintubation rates between centers from February 12 through May 9, 2006 (N = totalnumber of extubations). Only reintubations <48 hrs after extubation were included. The standarddeviation of the reintubation rates is 6.7%. There are 34 more extubations included in the total than inthe 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 ofreintubations (21%), despite a low pass rate for completed trials (39%). Site 9 interpreted the safetyscreen conservatively, counting most intubated patients as unsafe to trial for inability to support theirairway 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 highextubation rate of passed trials (98%) and no reintubations.

The post hoc survey revealed that representatives from each institution agreed that PECC aidedimplementation. 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 PECCmeetings. Three institutions stated that their IRBs were more willing to approve the project with mention ofPECC.

Discussion

Implementation Process

Evidence-based protocols using the results of prospective studies have been widely advocated as a meansto improve patient outcomes. Reports usually describe single institution experiences that require additionalresources (e.g., study personnel) to collect and process data. Translation of guidelines for multipleinstitutions is less widely reported and may be less effective. When implementation is widespread andsuccessful it is often at the behest of regulatory agencies. Pronovost et al.[27] demonstrated the success ofimplementing procedures to reduce the incidence of catheter-related bloodstream infections using astatewide safety initiative funded by the Agency for Healthcare Research and Quality. We have describedkey steps and outcomes in synchronous implementation of a single best practice-a daily SBT-across avoluntary association of diverse ICUs.

A peer network aimed at implementing best practices across institutions was perceived by its members tobe an effective strategy for collaboration, analysis, and commitment to specific goals. Many of theparticipating institutions found that local barriers were more easily overcome when reference to themulticentered partnership was made. For example, description of the partnership and enumeration of itsgoals strengthened support for implementation of the new protocol at many institutions. For healthcareproviders who would assume additional workload, personal participation in the partnership was moremotivating 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 andprocess fulfillment was enhanced with scheduled interinstitutional meetings where participants weremutually accountable for results.

Such a partnership across institutions differs from partnerships within institutions (that can be mandated bylocal administrations) and partnerships founded on prospective clinical research (that are often externallyfunded to develop the evidence used in forming best practice recommendations). Voluntary peer networksthat create mutual opportunity and accountability for implementing best practices seem well suited for ICUsand their healthcare organizations.

Implementation of evidence-based practice cannot occur without direct leadership from the involvedprofessions. Here, nursing and respiratory therapy took collective responsibility for executing and recordingoutcomes for the SBTs. Nursing- and respiratory therapy-driven protocols have previously been shown tobe effective and safe.[25,28,29] We suggest that implementation of other best practices should include allrelevant professions from the design phase onward and physicians must be enthusiastic about grantingauthority 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 SBTsand, if so, to describe their unit-standard SBT. This process of describing, refining, and ultimatelyconverging upon a common protocol illuminated wide variations of application and execution. In the past, ithas been asserted that evidence-based recommendations made by professional organizations and otherauthoritative bodies must be refined to accommodate local practice and needs.[30-32] Although thisassertion is reasonable, we suggest that an intermediate step explicitly defining the intent of therecommendation and operationalizing the concept into a generally executable protocol (that can later beslightly modified to accommodate local practice) may be essential if such recommendations are ever to beconsistently implemented and to achieve expected benefits.

Implementation strategies aimed at increasing acceptance of and adherence to this and other evidence-driven protocols are key to obtaining optimal outcomes. The factors that affect clinical guideline adoptionare complex, as are the social norms, administrative processes, and local systems that must be aligned toexecute such protocols.[33] The emerging field of implementation science aims to make the uptake ofresearch findings into routine healthcare efficient and predictable. Accordingly, this field is rapidlydeveloping new theory and practice.[34,35] The intensive care environment-high-risk, high-cost, andproblem 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 evidencethat unnecessary prolongation of mechanical ventilation is costly with respect to access to ICU servicesand patient-specific complications (e.g., ventilator-associated pneumonia), there was a surprisingly low rateof extubation after a patient passed a SBT as compared with previously published reports[36,37] and eachunit's own physician staff expectations. An appropriate extubation rate is unknown. We do not mean tosuggest that a passing SBT should be the sole or even major criterion driving a physician decision toliberate the patient from mechanical ventilation. Nevertheless, fully 45% of passing trials did not result in aphysician 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 thepatient from the ventilator. As nearly 30% of patients who had a successful SBT were not extubatedbecause of concerns regarding mental status, efforts aimed at improving mental status before performingan SBT, such as daily wake-up sedation holidays[38] might result in an increased rate of extubation afterSBT. 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 thisstudy (Fig. 9). This may suggest that some clinicians are overly cautious regarding the decision toextubate. However, with only eight institutions participating, the correlation analysis is underpowered, andthe 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 groupof intensive careproviders, implementation differed among institutions. As an example, one institution (site9) interpreted the safety screen conservatively, counting most intubated patients as unsafe to conduct anSBT for having an unstable airway if they were deemed to have depressed or altered mentation. Thisyielded a low crude completion rate (9%) (Fig. 5), a high extubation rate of passed trials (98%) (Fig. 6), andno reintubations (Fig. 8). This disparity in implementation emphasizes the importance of clarity in andfidelity to multi-step protocols in achieving consistent outcomes across multiple institutions. Differentpatients, 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 3had a low extubation rate (47%), one of the lowest crude completion rates (11%), the highest reintubationrate (21%), and a high tracheostomy rate (21%). Internal review found that all extubated patients hadpassed their SBT, but this particular patient population had a high rate of severe obstructive pulmonarydisease. This was thought to result in SBT passing with subsequent respiratory failure. Further researchinto the applicability of SBTs in this and other selected patient populations, and variation in implementationby highly trained critical care professionals is warranted.

IRB Issues

We found a range of expectations among human studies committees regarding the collection, sharing, andreporting of fully de-identified and aggregated data containing only clinical information obtained and used inroutine care. Some human studies committees considered the process of establishing and implementingbest practice to be quality improvement and, therefore, exempt from human studies oversight. Other IRBsopined that the intent to compare and publish outcomes constituted human studies research and requiredcomplete committee review. Ultimately, no IRB required informed consent that would have introduced aselection bias and rendered an institution's contribution meaningless for multicentered outcomeassessment.

Limitations

There are several important limitations to this study. First, participation was voluntary. Of 18 members inthe partnership, only eight participated. Reasons for nonparticipation included preexisting commitments toSBT protocols or ventilator studies, delay in IRB approval, delay in institutional acceptance, and loss ofcontact with PECC. Although the reasons are valid and understandable, the nonparticipation rate illustratesthe difficulty of embedding a single evidence-based recommendation into the complex operation of a busyICU. The environmental impact of such implementations extends beyond patients into local practicepatterns. There is a need to understand why nonparticipation occurs and to design practical strategiesfavoring adoption.

Reporting was not audited as a necessary consequence of study design. Our goal was to test widespreadimplementation in the natural environment of the ICU, without the additional resources brought to bear byclassic prospective trials. We chose a balance between participation, data reporting, and audit access thatfavored simplicity of data collection over more complex processes that would have required written consentand thereby discouraged participation. As a result, validation checks of the data were limited to simpleretrospective assessment for compliance with the protocol and logical impossibilities. High compliancerates (89% of passing SBTs were error-free) coupled with the consistency of findings across disparateICUs 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 theprotocol were those intubated <24 hrs, possibly skewing the extubation rate lower and the reintubationrates 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 ofpeer networks, protocol development, and joint implementation. PECC is a model that addresses relevantissues 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 challengethat can be partially addressed through a peer network of committed ICUs that includes all relatedprofessions. Mutual commitments to simultaneously measure and subsequently report performance acrosscare sites can be an effective stimulus to examine local practice, compare with evidence-basedrecommendations, operationalize those recommendations, and improve care processes.

References

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AcknowledgmentsIn addition to the members of the Writing Committee, the members of the Partnership for Excellence in Critical Care whocontributed 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, AntaraMallampalli, Diane McCabe, Narenda Wickramatunge, Thomas Wilson; Cedars Sinai Medical Center-Scott Cuneen; DenverHealth 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 ofMaryland-Stephen B. Johnson, Marlin Martin, Kristin Seidl; University of Miami/Miami Veteran's Administration Hospital-Roland Schein, Andrew Quartin; University of Michigan-Robert Hyzy, Linda Folk, Carl Haas, Philip Lenart; University ofMinnesota-Henry Mann, Craig Weinert, Paula Aherns, Julie Koplitz, Patty Lawrence, Monica Lupei; University ofPittsburgh-Scott Gunn; and Washington University/Barnes Jewish Hospital-Timothy Buchman, Marcy Buckles, LisaCracchiolo, T. Elizabeth Robertson, Carrie Sona, Fine Song.

Funding InformationSupported in part by a grant from the James S. McDonnell Foundation and NIGMS postdoctoral fellowship, GM008795 (toTER).

Reprint AddressFor information regarding this article, E-mail: [email protected]

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

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