Understanding and Changing the Practice of Mechanical Ventilation in the Community

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of Mechanical Ventilation in the Community

G. D. Rubenfeld

Introduction

There is a considerable body of evidence that patients frequently do not receive optimal medical care. Failure to employ thrombolytics, beta-blockers, aspirin, and angiotensin-converting enzyme inhibitors where appropriate in patients with acute myocardial infarction may cause as many as 18,000 deaths per year in the United States [1, 2]. Twenty-two to 45 percent of asthma patients in 4 European countries were treated with inappropriate beta-agonist monotherapy and 9–24%

of asthma patients were on inadequate doses of inhaled corticosteroids [3]. Outpa- tients frequently have hypertension inadequately managed, preventive services neglected, and diagnoses such as depression missed [4, 5]. Inadequacies are not limited to failure to provide necessary treatments. Antibiotics, hysterectomies, cardiac pacemakers, and coronary angiography have all been shown to be over- used in inappropriate cases [2].

These observations have led to strong responses from the academic, medical, consumer, and health care payer communities. In November 1998, the American Association of Medical Colleges and the American Medical Association convened a Clinical Research Summit devoted to establishing broad, national goals in clinical research. One of the principal recommendations of this commission was to develop a “broadened agenda of clinical research [that is], related more specifically to health outcomes and [is] designed to assess the effectiveness of methods for incorporating evidence-based practice into clinical care” [6]. Additional recommendations were to place an increased emphasis on understanding the delivery of care and the epidemiology of disease particularly as it occurs in the community outside of selected academic medical centers. A recent publication by the Institute of Medi- cine, “Crossing the quality chasm : a new health system for the 21st century”, outlined the case that modern health care frequently fails to deliver optimal medical care even in the absence of access and financial barriers to care. This widely cited document charges the United States Department of Health and Human Services to

“establish and maintain a comprehensive program aimed at making scientific evidence more useful and accessible to clinicians and patients” [7]. This chapter will review the issue of translating clinical research into clinical practice with specific emphasis on studies related to mechanical ventilation and critical care.

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Table1.Approachestoimplementingbehavioralchange? ApproachTheoriesFocusInterventionstrategiesExample Focuson internalprocesses Educational[65]AdultlearningIntrinsicmotivationProblembasedlearningMechanicalventilationcourseusing theoriesofprofessionalshands-ondemonstrations Epidemiological[66]CognitivetheoriesRationalinformationseekingEvidencebasedguidelineConsensusconferenceonmechanical anddecisionmakingdevelopmentanddisseminationventilation Marketing[67]Healthpromotion,AttractiveproductadaptedNeedsassessment,adaptingTargetedinterventiontoincreaseuse innovationandsocialtoneedsoftargetaudiencechangeproposalstolocalneedsofsemi-recumbentpositioningbased marketingtheoriesonfocusgroupsofclinicians Focusonexternal influences Behavioral[68]LearningtheoryControllingperformanceAuditandfeedback,reminders,Physicianpromptthatpatientshave byexternalstimulieconomicincentivespassedatrialofspontaneousbreathing SocialinteractionSociallearningandSocialinfluenceofsignificantPeerreviewinlocalnetworks,Regionallyprominentphysician, [69,70]innovationtheories,peers/rolemodelsopinionleaders,academicnurse,andrespiratorytherapistwho socialinfluence/detailingmeetwithlocalcliniciansinsmall powertheoriesgroupstoconvincethemtouse weaningprotocol Organizational[71]Managementtheories,CreatingstructuralandRe-engineeringcareprocess,Developmentofaweaningteamthat systemtheoriesorganizationalconditionstotalqualitymanagement,teamconsultsonallpatientsmechanically toimprovecarebuilding,changestosystemsventilatedformorethan72hours. Coercive[72]Economic,power,Controlandpressure,Regulations,laws,budgeting,Hospitalremovesinhalednitricoxide andlearningtheoriesexternalmotivationlegalproceduresfromformulary.

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Models of Changing Clinical Practice

There are a number of conceptual models describing the processes that individuals and organizations go through as they change behavior. Not surprisingly, these models come from fields that are intimately familiar with trying to change knowledge and behavior: psychology, education, health promotion, and marketing.

Understanding how to get people to write better, eat differently, stop smoking, or buy a brand of milk is not conceptually different than getting clinicians to treat myocardial infarctions or asthma correctly. Models for understanding behavioral change are important because they lead to strategies for changing behavior (Table 1). Although there is some overlap, it is useful to think of these models as falling into broad categories: educational, epidemiological, and marketing strategies (targeting an individual’s internal factors) and behavioral, social, organizational, and coercive (targeting factors external to the individual).

Educational models are the ones physicians are most familiar with. Adult learning theory stresses the importance of interactive educational experiences over passive learning in lectures. Examples include Advanced Cardiac Life Support or Advance Trauma Life Support courses taught with individual skill stations [8].

Epidemiological models focus on synthesizing and presenting the evidence on optimal practice. Examples include published meta-analyses, the Cochrane reviews, and formal guideline developing activities. Large data warehouses of these resources are available on the internet [9, 10]. Marketing strategies rely on research to understand the values, concerns, aspirations, needs, and knowledge of their target audience [11]. Marketers realize that selling a product often does not rely on informing their audience about its benefits, but in convincing the target that they will be more popular if they buy it or ‘left out’ if they don’t. Similarly, social marketers, trying to ‘sell smoking cessation or appropriate antibiotic use must provide the audience with a reason to act that may have little to do with the evidence about benefits of the action.

A number of models try to influence behavior by using external factors to influence behavior. Behavioral theory uses feedback and stimulus-response to affect behavior such as automatic reminders or clinician audit and feedback re- ports. Social theory takes advantage of information about how individuals behave in groups. A model developed by Everett M. Rogers called the Diffusion-Adoption model has been used to study changes in use of hybrid seeds, computer technology, and magnetic resonance imaging [12]. Individuals fit into broad categories of:

Innovators, Early Adopters, Early Majority, Late Majority, and Laggards based on their willingness to adopt new practices. Understanding which group a clinician fits into will let you understand the barriers to changing their practice. Organiza- tional approaches are adapted from the Total Quality Management and other quality improvement methods used by corporations. The Institute of Healthcare Improvement (IHI) has championed these practices in healthcare [13]. Finally, coercive techniques rely on regulations, fiscal, or legal constraints or incentives to change practice.

There have been four recent extensive meta-reviews (reviews of reviews and meta-analyses) evaluating which techniques are most effective at changing clinical

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practice [14–17]. The authors of these reviews cite common problems with the literature: publication bias, lack of repeat studies to validate methods, and weak study designs. However, the reviews reach remarkably similar conclusions. They rank interventions to change behavior in health professionals into three categories based on the evidence of their effectiveness (Table 2). It is noteworthy that academic clinicians spend a great deal of time engaged in activities known to be only marginally effective at changing clinical practice: lectures and passive dissemina- tion of written materials.

Implementation Research in Critical Care

Many medical specialties have responded to the observations that clinicians fail to incorporate research into their practice by creating a research program directed specifically at this issue. With the notable exception of cardiology, which has devoted extensive resources to understanding the care of patients with ischemic heart disease, most other aspects of care for critically ill patients have not been studied extensively with regard to these issues [18–20].

For example, a recent study by Cabana and colleagues systematically reviewed the extensive body of literature studying barriers to implementation of effective treatments and guidelines [21]. The authors developed a conceptual model for categorizing barriers to changing clinical behavior. A wide range of clinical topics were reviewed based on the existing literature including barriers to appropriate preventive care, obstetric care, pain control, and use of thrombolytic therapy.

Similarly, studies evaluating the knowledge, attitudes, and behavior of a broad range of clinicians including general practitioners, cardiologists, radiologists, and surgeons, were reviewed. However, this extensive review did not identify a single study of the barriers to implementation of effective therapy in critical care. There is no mention of common critical illness syndromes such as sepsis, acute respiratory distress syndrome (ARDS), or acute respiratory failure. Finally, no studies of intensivists, intensive care nurses, or respiratory therapists were reported in this review. In a series of review articles published as a supplement to Chest titled Table 2. Evidence base for various behavior change strategies

Weak Moderately Relatively strong

or variably effective or Consistently effective

Passive education by Economic incentives Multifaceted interventions distribution of guidelines Audit and feedback combining 2 or more of or continuing medical Local opinion leaders (feedback, reminders, education,

education lectures or marketing)

unsolicited written Academic detailing

material Reminders or prompting

adapted from [14–17]

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“Translating Guidelines Into Practice: Implementation and Physician Behavior Change”, only two examples from critical care are discussed: antimicrobial pre- scribing in the ICU and treatment of myocardial infarction [22, 23].

There may be a perfectly acceptable reason why critical care has not produced a body of research about changing clinical practice in the ICU. Intensivists have grown used to making clinical decisions based on physiologic rationale in the absence of evidence demonstrating an improvement in outcome. Unlike our colleagues in cardiology and oncology, intensivists do not enjoy the luxury of a rich evidence base of positive clinical trials. As typical examples, consider the conclusions of recent reviews on two perennial questions in critical care: “Is colloid better than crystalloid for fluid resuscitation?” and “Is total parenteral nutrition (TPN) beneficial to critically ill patients?”

• “There is no evidence from randomized controlled trials that resuscitation with colloids reduces the risk of death compared to crystalloids in patients with trauma, burns and following surgery” [24].

• “While TPN may have a positive effect on nutritional end points and on even minor complications, the overall results of our meta-analysis fail to support a benefit of TPN on mortality or major complication rates, particularly in critically ill patients” [25].

Statements of evidence such as these allow intensivists to justify a range of thera- peutic decisions. In the absence of compelling evidence of harm or benefit, physicians will base decisions on biologic rationale, experience, and personal values about cost-effectiveness [26]. If, in fact, there are very few practices in critical care of demonstrable benefit, then the question of implementing practice is moot.

Lack of compelling evidence of benefit is not the only factor that distinguishes critical care from other areas of medicine where implementation research has been studied. Although not unique in this respect, critical care relies on multiple disci- plines. The intensive care unit (ICU) is essentially an organizational innovation that focuses technology and experienced clinicians into a specific location in the hospital. Intensivists rely on and work closely with primary care physicians, con- sulting specialists, ICU nurses, respiratory therapists, pharmacists, nutritionists, and other clinicians in the ICU. The knowledge, attitudes, and behaviors of all of these clinicians must be considered in interventions designed to implement effective ICU care. The multi-disciplinary nature of critical care must be considered in designing interventions to change behavior [27]. The SUPPORT study, a large multicenter trial designed to change clinical practice has been criticized because its intervention failed to consider the organizational structure of the ICU and interactions between clinicians [28].

Investigators studying the translation of research findings into practice in the ICU must consider the differences in barriers and facilitators likely to be encountered when evaluating interventions targeted at the system level (intensivist cover- age, computerized orders, rounding pharmacist, step-down unit) versus the patient level (lung protective ventilation, activated protein C, tight glucose control). For example, identifying factors affecting structure of the ICU may require surveying the hospital chief executive officer (CEO), non-intensivist physicians who admit to

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the ICU, and hospital financial staff. Large capital investments, hospital-wide policy changes, and legal issues may be involved. Patient-level changes in practice may involve system factors, particularly system solutions.

Evidence and Consensus

Since evidence of benefit is the first step in translating research into practice, it is important to ask which aspects of mechanical ventilation are known to be beneficial. The amount of evidence it takes to convince individual clinicians may vary and will certainly vary with the plausibility, cost, risks, and benefits of the proposed treatment [26]. We need more compelling evidence to convince us to use inhaled nitric oxide or prone positioning in patients with ARDS than to provide oxygen supplementation to patients with acute hypoxemic respiratory failure and a PaO2

of 40 mmHg. In fact, the purpose of this chapter is to present the current evidence for various aspects of mechanical ventilation. A number of consensus conferences on mechanical ventilation have been published over the years [29–35]. This chapter is not focused on the evidence base or consensus on the practice of mechanical ventilation but on research directed at understanding its translation into practice in the community. Research in this area includes: studies that evaluate current practice in the community, studies that explore the barriers and facilitators to changing practice, and studies that evaluate specific interventions to change the practice of mechanical ventilation.

To identify articles that address these topics the following MEDLINE search strategy was used: Artificial respiration was combined with each of the following:

Guideline adherence, physician’s practice patterns; questionnaires; medical audit;

and surveys. This list was screened for articles that covered one of the three topics:

understanding current practice, barriers to changing practice, effective strategies to change practice. It is important to note that some implementation research occurs without publication in mainstream academic research journals. For example, the Institute for Healthcare Improvement is a non-profit organization that sponsors workshops to help clinicians improve the quality of care they provide [13]. Many of these quality improvement projects have focused on critical care interventions. The projects are usually single institution, before-after studies and the results are not peer reviewed. Nevertheless, this is an important source of information about projects designed to change clinical practice at single sites or within collaborative of hospitals.

Understanding Current Practice

There are probably more data on current mechanical ventilation practice in the ICU than any other aspect of critical care. There are several techniques for meas- uring process of care. Clinicians can be surveyed about their attitudes about using different treatments or their practice in hypothetical case vignettes. Charts can be abstracted retrospectively by protocol by research staff. Clinicians can report on their practice prospectively. Administrative databases collected for billing or ad-

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ministrative purposes can be analyzed. As with all research methods each approach has specific benefits, limitations, and costs. Surveys of clinicians’ behavior to measure their practice is notoriously unreliable at capturing their actual practice.

Analysis of administrative data has been used to understand the outcomes of mechanical ventilation in large patient populations, but does not provide detailed data on patient management or diagnosis [36–40].

Several recent studies have explored practice in broad populations of mechanically ventilated patients or patients with acute lung injury (ALI) [41–44]. These studies used a combination of self report of practice by clinicians and survey of attitudes to describe clinical practice. The studies did not specifically compare patients’ care with current practice recommendations. Despite recommendations and clinical experience that mechanical ventilation should be customized for individual diseases, patients received remarkably similar average tidal volume (VT), positive end-expiratory pressure (PEEP), and FiO2regardless of whether they were diagnosed with ALI, ARDS, acute hypoxemic respiratory failure, or chronic obstructive pulmonary disease (COPD) (Fig. 1). In one study, 63% of patients managed on assisted mechanical ventilation received VT< 10 ml/kg, but patients diagnosed by their physicians with ALI were no more likely to receive low VTthan other patients [41]. Two studies have evaluated the use of long-term mechanical ventilation in the community, documenting the resources used by this population of patients with primarily neuromuscular disease and a shift from home-based care to institutional care [45, 46]. Considerable variability in the process of performing weaning parameters and in documentation of patient-ventilator system checks have been noted [47]. There is surprisingly little research documenting the pene- tration of non-invasive ventilation (NIV) into current practice. Doherty and Green- stone surveyed 268 hospitals in the United Kingdom and found considerable regional variation in the availability of NIV [48]. Barriers to implementation of NIV included lack of staff training, inconsistent funding to purchase equipment, and lack of training [48]. In a single site audit at a teaching hospital, Sinuff and colleagues found that NIV was used by physicians of different training levels in various settings within the hospital and found important areas for improving the quality of documentation, monitoring, and implementation of non-invasive ventilation [49].

Fig. 1. Comparison of FiO2tidal volume, and PEEP, in large cohorts of mechanically ventilated patients. ARF=acute respiratory failure. COPD = chronic obsctructive pulmonary disease. Scan- dinavia, Australia, and International are from [44, 43, 41], respectively.

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Respondents to a physician questionnaire indicated a broad range of approaches to weaning and tracheostomy with inter-country variability [41]. Although physicians’ attitudes to various weaning regimens were assessed, there was no attempt to identify how many patients received a standardized approach to weaning readi- ness assessment. In a study of patients with traumatic brain injury, investigators found that guideline recommendations to avoid hyperventilation were frequently violated at community hospitals and during transport to a treatment center [50].

A survey of critical care physician members of the American Thoracic Society reported a wide range of VTused to treat patients with ARDS [51]. Wong and colleagues surveyed Canadian intensivists about their attitudes toward using oxygen in patients in the ICU. Although the study found that all responding physicians believed that oxygen contributed to complications in the ICU, there was wide variability in the tradeoffs between inspired oxygen and hemoglobin saturation [26, 52]. Finally, survey data from 1994 on withdrawal of mechanical ventilation showed significant variability in practice in withdrawing mechanical ventilation and, at least at the time of the survey, that 15% of respondents almost never withdrew mechanical ventilation when limiting life sustaining treatment in the ICU [53].

Two important Franco-Canadian studies based on a survey of ventilator circuit and secretion management practices have been performed. These showed considerable inter-country variability in physicians’ stated practice regarding intubation route, ventilator circuit change frequency, humidification system, endotracheal suction system, subglottic secretion drainage, kinetic therapy beds, and body position [54, 55]. This study validated the finding that guidelines and consensus recommendations have little impact on practice even when practice is assessed by survey. Many centers reported practice that deviated from recommended evidence based standards. In a study that combined patient level data and survey data from physicians, Heyland et al. identified NIV, subglottic secretion drainage endotracheal tubes, kinetic bed therapy, small bowel feedings, and elevation of the head of the bed as effective preventive treatments for ventilator associated pneumonia (VAP) that were not being used in a set of Canadian ICUs [56].

Barriers to Changing Practice

A considerable body of literature exists evaluating why clinicians do not follow evidence based clinical practice guidelines [21]. The model proposed by Cabana and colleagues after reviewing the literature in this area identified seven categories of barriers: lack of awareness or lack of familiarity with the guidelines; lack of agreement, lack of self-efficacy, lack of outcome expectancy, or the inertia of previous practice; and external barriers (usually factors associated with the structure of the guideline or local systems of care). Relatively few studies have specifically focused on the research question about why certain ventilator practices are implemented or not. The surveys of French and Canadian intensivists asked about barriers to using the various ventilator circuit and secretion management practices across 6 domains: adverse effects, cost, patient discomfort, nurse inconvenience, not available, and other. They found that the barriers to use varied across the different treatments and noted that there were important differences between

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France and Canada regarding who had decisional responsibility. In Canada, many decisions were made by respiratory therapists who have no equivalent in the French ICUs [54, 55]. Several barriers to implementing a protocol based weaning program were identified including failure to have consistent staffing of respiratory therapists in the same ICU, failure of respiratory therapists to report patient status at shift change, and individual physician reasons to exclude patients from the protocolized spontaneous breathing trial [57]. Qualitative research techniques are particularly useful to explore barriers to implementing practice. Focus groups and surveys have been used to explore barriers to implementing semi-recumbent positioning in ALI [58]. This study showed that nurses and physicians had very different perceptions of the major barriers. Nurses believed that physician failure to specify the patient’s position and physicians identified nursing preference as the major barrier to using semi-recumbent positioning. It is interesting to note that most respondents identified education as the most important technique to change body positioning practice although this is known to be only marginally effective.

Effective Strategies to Change Practice

It is important to distinguish studies that demonstrate benefit of a particular approach to mechanical ventilation from studies that are primarily interested in implementing this approach. Two studies by Ely clarify this distinction. In the first, a randomized controlled trial, the value of a daily weaning screen followed by a protocolized spontaneous breathing trial and a physician prompt was shown to reduce duration of mechanical ventilation by 1.5 days [59]. In the second study, the investigators studied the effect of “graded, staged educational interventions” directed at respiratory therapists to implement the protocol found to be effective in the clinical trial [57]. Implementation research is not designed to identify effective treatment strategies. The research question is not whether a specific ventilator technique improves outcome this is presumed to be known. The question is whether this technique can be deployed in a larger community. The effect of the intervention on patient outcome is important, but is a secondary research question.

There have been no large scale, multicenter, community based programs to improve the quality of care to mechanically ventilated patients. A computerized decision support tool to direct mechanical ventilation in patients with ARDS was implemented in a randomized clinical trial at 10 academic sites, however, this study was directed as much at evaluating the efficacy of the ventilator strategy as the feasibility of using a computer to effect practice change [60]. Other models have been explored for changing ventilator practice. Pronovost and colleagues used a

‘quality improvement’ model to reduce failed extubations in a single ICU study [61]. Structural approaches including a nurse-practitioner run ICU for chronically critically ill patients and a ventilator team consult model have been explored to improve ventilator outcomes [62–64]. The evidence from other fields suggests that effective implementation studies of ventilator practices will require a multi-faceted approach that incorporates: local ‘buy-in’ of the treatment, local opinion leaders, staff education, audit and feedback, and timely prompts.

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Conclusion

As the evidence base for clinical decisions in mechanical ventilation increases, investigators must devote attention to seeing that innovations in mechanical ventilation are translated into community practice. Evidence from other fields suggests that this will not be easy, particularly if the innovations involve protocols that use existing technology rather than new devices which will be promoted by a corporate developer. Unique barriers to implementing effective practice in mechanical ventilation are likely to be encountered. For example, differences in ICU organization mean that different clinicians have responsibility for ventilator management in each hospital. Implementing protocols for management, as opposed to simply convincing clinicians to prescribe a drug, may require more complex ongoing interventions.

An aggressive research program directed at understanding how current ventilator decisions are made, who makes them, and why effective strategies are or are not used should be started. Although several studies exist describing mechanical ventilation in broad populations, data have not been provided specifically oriented toward estimating the proportion of patients receiving care that deviates from published guidelines. Information about the use of NIV is particularly lacking.

Future research directed at these questions can save lives while reducing costs and morbidity.

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