Clinical Decision-Making · ing efficient, safe, and quality health care. Hence, this external...

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CHAPTER

6Clinical Decision-MakingGuy Meyer and Pierre Durieux

CHAPTER

8Quality Assurance, Safety, Outcomes, and External ComplianceASAD LATiF, MiCHAeL C. GrANT, and PeTer J. PrONOVOST

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7How to Read a Medical Journal and Understand Basic StatisticsCHriSTOPHer Lee SiSTrOM and CyNTHiA WiLSON GArVAN

IntRODUCtIOn

In response to the 1999 landmark report, To Err is Human (1), health care professionals have become increasingly atten-tive to improving the quality of care provided while mitigating any unintended harm. In the ensuing period, we have seen the evolution of global initiatives like the World Health Organiza-tion Patient Safety Programme, the strengthening of standards by international accreditation bodies like the Joint Commis-sion, and even reimbursement becoming linked to quality with entities like the Centers for Medicare and Medicaid Service

(CMS) progressively linking payments to health care outcomes rather than individual services. Yet, despite substantial prog-ress made by the efforts of a wide variety of stakeholders to reduce harm in focused areas, quality gaps continue to rise in other areas, suggesting little comprehensive progress (2,3).

Quality gaps occur when clinicians fail to deliver care to qualifying patients commensurate with best practices or the available scientific evidence. These quality gaps result in less optimal care, and may lead to adverse events that cause direct patient harm. The individual concepts of health care quality and patient safety are naturally interwoven in this manner and, thus, can be considered almost interchangeable. High-quality

This chapter can be accessed in the accompanying eBook (see inside front cover for access instructions).

This chapter can be accessed in the accompanying eBook (see inside front cover for access instructions).

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42 SECTion 1 iNTrODuCTiON AND GeNerAL CONCePTS

care inherently leads to improved patient safety. Derived from the Institute of Medicine (IOM) (4), quality in health care is achieved when health services for patients result in the best possible outcome, no harm results from the care provided, and every aspect of care is consistent with current evidence-based knowledge given the patient’s medical condition, comorbidities, and contraindications.

Although preventing quality gaps by providing care appro-priate to the patient and condition appears a simple endeavor, proper adherence to these principles requires extensive review and improvement of existing health care delivery systems. The IOM considers health care quality a direct correlate of the level of improved health services and the desired health outcomes of individuals and populations (5). Therefore, quality improve-ment (QI) initiatives utilize systematic and continuous data-driven activities to exact measurable improvement in both the delivery of health care services and resultant patient outcomes. Given the direct link between health care delivery system qual-ity and subsequent reduction in quality gaps, meaningful improvement in performance and quality often requires sys-tematic change. In order to prevent quality gaps consistently, QI interventions adhere to basic principles that include evalu-ation of patient-centered outcomes through interpretation of measurable endpoints, multidisciplinary team-based collabo-ration, and evaluation of processes at the systems level, rather than at the individual provider level. By employing effective QI and forming predictable and reliable systems of care, organiza-tions not only benefit directly, through improvements in health and process outcomes, but also indirectly, through heightened efficiency, more robust communication, more adaptive local culture, and potentially substantial cost savings.

No consensus exists regarding the best way to assess the current state of health care quality and patient safety (6–8). A recent panel of experts convened by the Agency for Health Care Research and Quality (AHRQ) reviewed the available literature (9), finding that most initiatives were based only on causal inferences to prove effectiveness. It is remarkable that health care still uses a limited range of approaches and models compared to the comprehensive intervention programs associ-ated with other safety-focused industries. In this chapter, we will discuss the evaluation of compliance regarding quality in patient care, offer a framework for developing QI initiatives, discuss some implementation strategies, and examine several current tools and future directions for improving quality and safety in the intensive care unit (ICU) setting.

ASSESSIng QUAlIty Of PAtIEnt CARE

External Compliance Organizations

To Err Is Human served as a solemn reminder to all involved in the delivery of health care that further safeguards are criti-cal for realizing much needed improvements in patient safety (1). An increased public awareness further fortified the impe-tus toward establishment of a systems-based approach and independent external evaluation to address this need through multiple mechanisms, at both local and national levels. The Joint Commission (JC), AHRQ, CMS, the Institute for Health-care Improvement (IHI), VHA, Inc., and Leapfrog Group are just a few of the many organizations that have been focused on improving the quality of patient care over the years (10–18).

Evolution of External Performance Improvement Organizations

As a result of the 1999 IOM report, it was recommended to make the establishment of a center for patient safety a national priority. It further justified the development of mandatory and voluntary reporting systems as essential components in the evolution of a culture of safety and QI (1). In parallel, prior to that, the not-for-profit National Quality Forum was estab-lished at the behest of the President’s Advisory Commission on Consumer Protection and Quality in the Health Care Indus-try (19). The mission of this entity was to lead national col-laboration to promote the improvement of health and health care quality by establishing national consensus standards for measuring and publicly reporting on performance. In keeping with this, they helped formulate 30 novel standards directed at preventing adverse events and improving patient safety which were published in 2003, many of which were applicable to the ICU setting as well (20).

The JC has, as well, been an active contributor in the dis-semination of improvements in patient safety and quality. Driven solely by health care professionals, JC was created to assist hospitals in improving quality of care and staff recruit-ment, and to offer accreditation of graduate medical education programs (12). Through the establishment of Medicare, and with the Social Security Amendments of 1965, any hospital accredited by JC was also eligible to participate in the Medi-care Program. This was representative of the broader changes occurring in the health care sector, with the use of accredita-tion as an external QI evaluation mechanism. This introduced a governmental influence, which was soon followed by the public’s use of accreditation as a proxy to evaluate the quality and safety of health care.

Today, other organizations and agencies are involved in the external evaluation of health care institutions. This list includes the National Committee for Quality Assurance, the American Medical Accreditation Program, the American Accreditation Health Care Commission/Utilization Review Accreditation Commission, and the Accreditation Association for Ambula-tory Health Care; other agencies, such as the Foundation for Accountability, National Coalition on Health Care (NCHC), AHRQ, IHI, and Leapfrog Group also carry out unique roles in the assurance of safe, quality health care delivery (18). Each of these entities has differing missions and structures, making some better positioned to affect specialized environments like the ICU. However, most of the accrediting agencies share com-mon tenets, similar to those established by JC at its inception as an accrediting body (8):• Accreditation is a voluntary process.• The evaluation of quality represents a cross-sectional

analysis of the institution at the time of evaluation.• The accreditation is based on previously defined standards

and indicators of quality.• The process of accreditation must occur periodically based

on a fixed number of years.

The Joint Commission

The JC, previously known as the Joint Commission on Accred-itation of Health Care Organizations (JCAHO), is the oldest accrediting body for health care worldwide and currently the largest hospital regulator in the United States. It has evolved

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CHAPTER 8 Quality Assurance, Safety, Outcomes, and external Compliance 43

significantly since it was first conceived as a standing commit-tee of the American College of Surgeons in 1917, becoming an independent group in 1951 (12,15). This organization’s role in the external accreditation process broadened in response to the dynamic changes that the health care environment experi-enced in the 1970s and 1980s. The escalating costs of health insurance threatened businesses in the globally competitive marketplace, resulting in the drive for cost containment and the eventual implementation of managed care and capitation payments. Concomitantly, rising costs of health insurance were continually passed on to employees, who were then respon-sible for copayments for health care services in addition to a rising proportion of employer-subsidized health insurance. In parallel, health care institutions were financially pressured to restructure and reorganize to meet the challenge of provid-ing efficient, safe, and quality health care. Hence, this external accrediting agency took a national direction when, through the accreditation process, it began assisting the purchasers of health care services to make informed decisions regarding choice of health plans and providers. Finally, in response to public demand for representation in the development of poli-cies and standards, JC added public members to its board and to its advisory committees in 1982 (12). This change was fol-lowed by the development of an Office of Quality Monitor-ing, which provides a mechanism to address public complaints pertaining to an institution’s alleged noncompliance with standards, and discloses performance reports that detail the accreditation status of an institution and its performance in each of the standards on the JC website.

The accreditation process is still voluntary, as it was when this organization was first conceptualized in the early 1900s. It is noteworthy that approximately 50% of the JC standards have direct relevance to patient safety, and the remain-ing standards all have some indirect relationship (21–23). Therefore, the public, employers, insurers, and governmen-tal agencies all tend to share the common belief that those institutions with accreditation provide a higher quality of professional care.

Institute for Health Care Improvement

The not-for-profit, Boston-based IHI was founded in 1991 as a by-product of the National Demonstration Project on Quality Improvement in Healthcare. Its website provides guidelines and tools for tracking both change in practice and outcomes (17). This organization has published a report in conjunction with the NCHC directly relevant to the ICU envi-ronment, entitled Care in the ICU: Teaming Up to Improve Quality. The basic premise is that improvements in ICU care that promote safety and quality are achievable now, based on evidence-based literature. IHI is a strong proponent for using care “bundles”—e.g., for patients on ventilators, or those with central lines – “rapid response teams,” employing mul-tidisciplinary rounds with daily goals assessment, and imple-menting the “intensivist-led model” of ICU care. They define a “bundle” as a “structured way of improving the processes of care and patient outcomes: a small, straightforward set of practices—generally three to five—that, when performed col-lectively and reliably, have been proven to improve patient outcomes” (17,24). The initiatives of the IHI are frequently closely aligned with JC, particularly in regards to their core measures.

The Leapfrog Group

This agency was founded in 2000, after a group of employers began the process of determining how best to approach the challenge of purchasing affordable, quality health care for their employees. Notably, this came on the heels of the IOM’s report To Err Is Human: Building a Safer Health System, which rec-ommended that large employers provide reinforcement for the provision of safe, quality health care through market pressure. The Leapfrog Group comprises a number of Fortune 500 cor-porations and spans a broad range of health care purchasers that represent more than 34 million individuals (10,15). CMS supports this group by propagating information-identifying facilities that achieve established standards. The Leapfrog Group proposes a tripartite approach to address the patient safety initiative, and estimated that it could save up to 58,300 lives and prevent more than 500,000 medication errors annu-ally. The three recommendations included use of computerized physician order entry, increased evidence-based hospital refer-rals, and improved ICU physician staffing.

In common with proposals put forth by other organiza-tions and agencies vested in patient safety and quality care in the ICU environment, the Leapfrog Group has conducted its own surveys to determine the degree to which institutions have been able to implement their recommendations. Significantly, some insurers have established incentives for health care facili-ties that integrate Leapfrog Group initiatives into their pro-grams. The results have been promising, but not without its detractors from certain communities within the health care system. The American Hospital Association has questioned whether hospital should embrace standards promulgated by outside, or external, agencies, and challenged the costs needed to implement and sustain programs for computerized order entry and to employ qualified intensivists, who are already in short supply.

Evaluating Quality Improvement Initiatives

Though we are quick to compare current approaches and models of health care to other industrial surrogates, the nature of health care can differ significantly from other industries. It remains an unpredictable, dynamic environment with patient and provider behaviors that can be difficult to control. Health care does not enjoy a virtually fault-free operation as a start-ing point, which may preclude us from directly importing safety models from industries such as aviation and automobile manufacturing, which can easily pinpoint problems and have safe baselines. Health care’s perspective also remains reactive, with an over-reliance on voluntary incident reporting and root cause analysis, rather than the more proactive approach of adjusting the process to prevent the adverse event from happening in the first place.

The greatest initial impediment to reforming health care quality and safety is the adoption of a universal framework to evaluate and monitor safety. Given the lack of rigorous appraisal of methodology and analysis employed by prior QI initiatives, the generalized research community has often labeled individual interventions as pseudo-science. The lack of rigor may be in part due to paucity of funding and research capacity, but also to a failure to develop pragmatic and scal-able QI evaluation methods. Potentially novel and effective

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quality and safety initiatives garner less publicity than care-fully controlled counterparts, leading to lost opportunity for advancement in the field. To begin to meet the lofty standards set by other areas of health research, we must set establish a framework for proper scientific discovery.

The ideal safety initiative would not only learn from past mistakes, but adapt to any unexpected present or future demands. Much like any formal research design, quality initiatives must:• Review the theoretical basis for a proposed intervention and

establish a hypothesis• Employ valid and objective metrics• Apply and describe consistent methodology and compre-

hensive process development, and• Assess outcomes systematically

We will discuss these key elements to provide a simple framework that will help structure the approach to QI inter-vention (25).

Theoretical Basis

Most clinical research draws from extensive amounts of pre-defined molecular and physiologic data and principles that provide assumptions about how and why the single interven-tion should work even before it is demonstrated. Though one would expect similar standards to apply to improvement ini-tiatives, this can prove most difficult given the wide-ranging diversity of foundational sciences including clinical medicine, human factors engineering, organizational psychology, and systems factors frameworks. As a result, a combination of qualitative and quantitative approaches is often needed to pro-vide a meaningful understanding of safety and QI initiatives (26–28). For example, public attention attributed decreased central line–associated bloodstream infection (CLABSI) rates to the use of a checklist. However, the intervention also included and integrated a model for translating research evi-dence into practice with a comprehensive unit-based safety program (CUSP) to improve local safety and teamwork culture (29). Such a multifaceted approach was necessary to overcome local barriers, including social, emotional, cultural, and politi-cal ones, to affect a lasting change in provider behavior (30). Given that QI success can rarely (if ever) be attributed to a single intervention and is, rather, the result of a comprehen-sive multisystem endeavor, attempting to control for individ-ual confounding and apply traditional research design would prove exceedingly challenging. Certainly, advancements can be made to current QI project design, but the answer may ulti-mately lie somewhere in between current less-exacting practice and excessive basic science standards.

Appropriate Measures

The challenge in monitoring patient safety stems from the fact that a patient can be harmed in innumerable ways, but only a limited number of measures exist for evaluating performance. The few publically reported performance measures that cur-rently exist have done little to effectively evaluate safety (31). Even if organizations have scientifically sound measures in place, they often have an underdeveloped infrastructure for appropriately monitoring those endpoints. This problem is made all the more challenging as organizations are increas-ingly tasked with providing evidence that patients are safer.

Ultimately, health care organizations are charged not only with establishing safety performance metrics, but also with creating information systems that recognize the dynamic nature of health care.

Good safety measures should have several qualities, such as importance, validity, and applicability to the local environ-ment (32). Rather than conceptualize safety as a dichotomous variable—safe or unsafe—measures should be considered continuous—is it more safe than before? Ideally, measures should be quantifiable as rates or proportions to readily iden-tify improvement in outcomes and processes, or they should be nonrate-based to enable evaluation of structure and context of care (33). Upon initial selection of a measure, its strategic importance should be assessed, both in the context of impor-tance to the people responsible for improvement, and its impor-tance given available effort, time, and resources. The measure should also maintain validity as upheld by existing supporting evidence, to ensure proper uptake and utilization. In that light, it must also be reliable and reproducible to minimize the poten-tial for bias. Finally, any high-quality safety measure needs to be feasible and useful in its local environment to justify the commitment of potentially scarce resources. Data collection and analysis represents a significant organizational burden, and if any measure does not meet the standards of being an important, valid, and pragmatic way to guide improvement, efforts should be reconsidered. These qualities maintain the independent validity and objectivity of the individual measures, molding the overall initiative within the scientific methods framework instead of a less rigorous enterprise.

Detailing of Processes

Traditional clinical research relies on specific conserved meth-odology, but only limited guidance is available for successful implementation and evaluation of safety and QI initiatives in health care (34). This fact is underlined by management chal-lenges that make it difficult to even report methods and results, such as the use of evolving multifaceted interventions and minimal dedicated data collection resources (35). Regardless, describing these practices in sufficient detail to allow replica-tion should be a key requirement. The International Commit-tee of Medical Journal Editors advises authors to “Describe statistical methods with enough detail to enable a knowledge-able reader with access to the original data to judge its appro-priateness for the study and verify the reported results” (36). A recent review noted that several studies of prominent patient safety practices limited their descriptions to just a few sen-tences (9). While unique impediments to adequate reporting may exist in the QI infrastructure, several authors and guide-lines have nonetheless recommended the practice (9,37,38).

Ironically, trials of complex multifaceted interventions, such as those used to improve safety and quality, would find detailing their processes of particular benefit. Given the evolv-ing nature of most safety initiatives, detailing the encountered barriers and how they were addressed is of critical importance. The core intervention may be difficult to separate from the culture-based efforts to implement it, with the two often blend-ing together over the course of the intervention. For example, the Keystone ICU project recognized the importance of lead-ership support and safety culture when is asked providers to change their practices to help reduce bloodstream infections, and therefore packaged them together as a safety practice (27,39).

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Though some experts might believe that disentangling the co-interventions may not be meaningful, detailing then is crucial for any future replication and dissemination.

Assessment of Initiatives

Health care organizations are continuously adapting to address the dynamic nature of risks to patient safety. Dynamic systems theory suggests that all of the factors that influence safety and quality in the future cannot be completely defined today. Successful initiatives need to be able to incorporate multiple components, including anticipation of harm, sensitiv-ity to local context and provider feedback, and the tracking of various outcomes.

Anticipation and Preparedness

In much the same way that clinical care delivery has preemp-tively adjusted treatment to satisfy predicted patient condi-tions, safety science is increasingly adopting a more proactive perspective as opposed to a reactive one. This approach relies on anticipation and foresight to predict potential problems. Unfortunately, as we have alluded to, there is usually no spe-cific set of data that is explicitly relevant to anticipated harm. Instead, it remains a matter of fostering discussion and con-tinually self-appraising, even in times of relative success and stability.

While the science of safety is ever evolving, some surrogate measures have proven promising. Hospitals that score higher on safety climate assessments are less likely to have patient safety events, a fact that serves to emphasize the importance of safety culture (40,41). What’s more, programs like the Safer Clinical Systems curriculum run by the Health Foundation and Warwick Medical School have begun to develop the use of “safety cases,” which provide an overall quantitative assessment of the likeli-hood that a variety of possible failures will occur based upon reported narratives of regular use. These cases stem from system-atically examining processes of care to identify potential failures. Although these methods have not been widely adopted in health care, they provide reasonable starting points for further explora-tion of health care systems research.

Environmental Sensitivity and Feedback

Early identification of potential risk before a patient sustains direct harm is the hallmark of any well-constituted safety intervention program. To make this goal a reality, interven-tions must enable regular monitoring and response to appro-priate information. The monitoring must also have sensitivity to variables within the local system and environment to allow researchers to develop, refine, and update interventions based on changes in the situation, including those outside normal operational activities (42). Examples of mechanisms that sup-port sensitivity in health care organizations include safety walk-rounds, briefings and debriefings, operational rounds, the use of dedicated patient safety officers, and patient safety assessments (43,44).

Effective safety initiatives are tasked with identifying devia-tions from best practices and recognizing near-misses in an attempt to inform future operations. Health care organizations use a variety of formal and informal approaches to obtain information about safety in the context of care delivery. And

while relevant information in this context can be gathered in a variety of ways, effective response is perhaps most impor-tant. The response must be prompt to mitigate the potential for growing patient risk, appropriate to the specific cultural environment, and discussed and integrated on multiple levels within the organization to obtain a comprehensive solution. Ultimately, the key is to ensure that the response to safety information engages frontline staff, because it will reassure them that their reports are being taken seriously.

Outcomes

Every clinical outcome relies on a formal assessment of associ-ated outcomes. However, this assessment is often ignored when safety initiatives are evaluated, especially when the benefits are marginal, difficult to quantify, or may be outweighed by other effects (45,46). And though changes in the outcome of inter-est are often measured, tracking of the indirect consequences and costs is often ignored. It is important to note that certain practices, while not directly harmful, can undermine the origi-nal intent of the intervention and cause changes in practices or behaviors that lead to unintended consequences (47). An example is the regulation of resident work hours intended to decrease fatigue and thereby improve patient safety. This change was based on studies demonstrating decreased cogni-tive functioning in sleep-deprived individuals and the focused assessment of errors when physicians performed specific cog-nitive tasks in a simulated environment (47–49). When further analyzed, there were no definitive improvements in patient mortality, but there were some increases in complications (50–52). Another example is the use of computerized pro-vider order entry systems. Even though these systems decrease medication errors, they might not reduce actual harm from adverse drug events (53). So it must be remembered that the outcome that we are measuring is often a surrogate marker, and changes in it do not necessarily affect the actual outcome of interest. Also, when operating within a complicated inter-woven health care system, individual component changes can lead to unexpected collateral effects that need constant pos-tintervention monitoring. These interactions can provide use-ful feedback to optimize system architecture and strengthen iterative processes.

Assessment of Contextual Factors

In much the same way, researchers evaluate the heterogeneity of treatment effects in clinical trials, one must appreciate the varied contextual factors to successfully implement a multifac-eted safety intervention. Failure to adopt conceptually similar interventions in differing settings is likely associated with an inability to account for the influence of context (53,54). At least one published framework proposes the grouping of high-prior-ity contexts into four domains (9): (a) structural characteristics of the organization; (b) leadership, culture, and teamwork; (c) patient safety tools and technologies; and (d) external factors.

Structural characteristics of organizations include geographic and demographic characteristics of hospital patrons and pro-viders, organizational complexity, and financial status. These elements tend to be fixed and are unlikely to change. In con-trast, local leadership, culture, and teamwork are all integrated concepts that can be altered appreciably with focused efforts (28). As previously reported, they can represent the backbone

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to the relative success or failure of safety initiatives, determin-ing how an intervention is implemented and sustained. The use of specific tools for patient safety interventions can have a significant impact on deploying and managing culture-based components, and can be influenced relatively easily at the organizational level. These tools will be discussed in further detail later in this chapter. And finally, external factors consist of the overall environment in which the organization resides. While not under the direct influence of the organization, they often have a profound effect on patient safety and quality, often influencing crucial issues such as allocation of resources. Although the applications of the proposed high-priority con-texts might vary based on the specifics of the initiative in question, evaluations should consider all of these contextual influences to be broadly applicable.

SPECIfIC IMPlEMEntAtIOn MEtHODOlOgIES

After establishing the fundamental framework for a safety inter-vention program and considering the complexities of research design within the health care system format, successful QI requires a comprehensive strategy for implementation. It is imperative to use a systematic and multidisciplinary approach that involves relevant stakeholders in the pursuit of a common safety-based enterprise. In strategizing such an approach, it will help if a conceptual framework of safety issues and solutions is created to guide team efforts and ensure common points of dialogue. Some authors have described a consensus classification for patient safety practices in an effort to provide a common language for interpreting patient safety literature, whereas others have categorized patient safety efforts into general themes, which can be useful in focusing efforts to improve the culture of safety within a particular ICU (55,56). Here we provide examples of useful project frameworks for unit-based safety programs.

Translating Evidence into Practice (TRiP)

Although most available research funding has been devoted to understanding disease mechanisms and identifying therapy, lit-tle evidence describes how to effectively, efficiently, and safely deliver these therapies to patients. This omission only serves to further underline the ongoing issues with quality gap. Multiple methods seek to increase the reliable delivery of evidence-based therapies to patients. These methods include evidence-based medicine and clinical practice guidelines, professional educa-tion and development, assessment and accountability, patient-centered care, and quality management.

To better operationalize safety intervention “therapies,” a four-step process has been developed and successfully used to translate research evidence into practice within the ICU (29,57). This model involves an interdisciplinary team taking ownership of the improvement project, is based on evidence and performance measurement, and encourages creation of a collaborative culture that is essential for sustaining results (Figure 8.1). The steps are described below:

1. Summarize the evidence: Rather than rely on the tra-ditional practice of medicine wherein external consor-tiums provide impractical practice guidelines in the form

of nonprioritized lists with ambiguous language, guide-lines should be concisely summarized into individual key interventions based on the best evidence available. This practice serves to target interventions and aid in practical decision-making. For example, evidence sup-ports the use of lung protective ventilation (LPV) for patients with acute respiratory distress syndrome, which can be concisely defined as providing a tidal volume <6 mL/kg of predicted body weight and a plateau pres-sure of <30 cm H2O (58,59).

2. Identify local barriers to practice compliance: After establishing the key elements of the intervention, the next step is to identify and alleviate local barriers to effective implementation. Thus, researchers formally and systematically walk through the process, observe others performing key duties therein, and investigate the impediments to appropriate care. This exercise serves to reveal system defects or aspects of the process that prevent compliance with evidence-based practice. For example, intensivists may be aware of and agree with LPV use, but they may (a) find it difficult to know if they are actually compliant, or (b) fail to have access to ele-ments vital to compliance. Although height is necessary in calculating predicted body weight, frequently it may be missing from the patient chart, resulting in uninten-tional noncompliance (60–67).

3. Measure performance: After choosing an intervention and developing specific practice behaviors, process measures (how frequently patients receive intended therapy) and outcome measures (how patient outcomes have improved) should be thoughtfully evaluated in the appropriate context. Each of these performance mea-sures has its own relative strengths and weaknesses. Compliance with LPV strategy can vary considerably with each individual ventilator setting alteration dur-ing the course of a patient’s ICU stay. Researchers must, therefore, structure the timing and frequency of measuring LPV compliance around certain clinical care parameters to ensure accuracy without becoming overly burdensome. Although potentially more burden-some, obtaining more frequent measures provides a bet-ter understanding of performance over the course of a patient’s treatment course.

4. Ensure all patients receive the therapy: Ultimately, com-pliance of a unit or an organization with established practices requires similar adherence of QI teams with each element of the implementation model. Embedded into the final step of the TRiP model are the four E’s of practice change:a. Engage clinicians, front-line staff, and organizational

decision-makers alike by using local estimates of patient harm so that clinicians recognize the impact of noncompliance with evidence-based practices in their clinical area. For acute lung injury, this could be estimating the number of preventable deaths based on prevalence of LPV nonuse in such patients in an ICU.

b. Educate involved parties to ensure that they know the evidence, agree with it, and understand the ac-tions and resources needed to ensure compliance.

c. Execute the intervention through a variety of indi-vidual tools (see below). This step should take the

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form of some standardized process intervention to ensure that all patients meeting certain criteria re-ceive the intervention(s).

d. Evaluate the intervention with timely, accurate, appropriate, and consistent measures and serially report findings back to clinicians, staff, and leaders.

Comprehensive Unit-Based Safety Program

Although measuring harm and implementing effective thera-pies are important for patient safety, they are insufficient without teamwork and creation of a concomitant culture that embraces these directives (68). Repeated examples have shown that the pertinent elements of culture, such as failures in com-munication, lead to sentinel events in health care (69).

The CUSP is a comprehensive and longitudinal program designed to improve local culture and safety (70). Supported by a web-based project management tool, the CUSP has evolved significantly since its inception from an eight-step (70) to a five-step (71) program (Table 8.1). CUSP is designed to be adopted by individual work units or care areas, and to involve every individual who provides care within a given

unit, from physicians to nurses, pharmacists, administrative clerks, and other support staff. The program also leverages support from senior leaders in the health care organiza-tion to provide financial, administrative, and other resource assistance.

TABLE 8.1 Comprehensive Unit-Based Safety Program

Pre-CuSP Conduct a culture assessment as baseline to evaluate various domains (e.g., safety, team-work, job satisfaction, unit- and hospital-level management).

Should be repeated annually.

Step 1 educate staff about the science of patient safety

Step 2 engage frontline staff to identify locally relevant safety concerns.

Provide mechanism for implementation and follow-up.

Step 3 Partner with senior executive.Set up monthly meetings to discuss safety issues

and potential/existing initiatives

Step 4 use defect investigation tool on regular basis (e.g., monthly or quarterly)

Step 5 implement tool for improvement (e.g., teamwork, communication, culture).

Identify local barriers to implementation

Overall concepts

Place the problem within context of larger health care system

Use collaborative multidisciplinary teams both centrally and locally

Ensure all patients receive interventions

Measure performance Select measures (both processes and outcomes) Develop and pilot feasibility of measures Measure baseline performance

Summarize the evidence Identify interventions associated with improved outcomes Select interventions with most benefit and least barriers to use Convert the interventions to behaviors

Observe frontline staff performing the interventions “Walk the process” to identify defects in implementationAsk all stakeholders to share concerns and identify potential

risks and benefits associated with implementation

EngageExplain importance

of interventions

Educate Share evidence supporting the interventions

Execute Develop tools targeting

standardization, independent checks, barriers, reminders,

and feedback for intervention

Evaluate Regularly assess

measures and for unintended

consequences

fIgURE 8.1 A model for translating research evidence into practice. (Adapted from Pronovost PJ, et. al. Translating evidence into practice: a model for large-scale knowledge translation. BMJ 2008;337:963–965, with permission from BMJ Publishing Group Ltd.)

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The CUSP model, which was originally implemented in 2001 at two surgical ICUs at the Johns Hopkins Hospital, resulted in significant reductions in ICU length of stay, and medication errors, and even improvements in nursing turnover (72–74). This success was derived from emphasizing practical tools to investigate and learn from defects, improve teamwork and communication, and organize transitions of care within and between patient care areas. These elements empowered frontline staff with a strong baseline knowledge about the sci-ence of safety to recognize potential safety hazards and design interventions to eliminate them.

An intended byproduct of the CUSP initiative is gradual improvement in an individual unit’s safety culture. Embedding patient quality and safety tasks into daily practice—for physi-cians, nurses, and staff alike—shifts workflow focus away from risk-provoking behavior and automatically prioritizes those same quality and safety tenets. The staff is provided a plat-form to share experiences with everyone in the unit, and the group is empowered to solve local problems in care delivery. For example, the creation of interdisciplinary rounds created a setting wherein nurses can voice concerns, seek clarification regarding a patient’s management, and gain autonomy as the bedside caregiver. Interdisciplinary rounds lessen the hierarchy that usually occurs between physicians and nurses, a hierarchy that causes ineffective collaboration among clinical disciplines and prevents individuals from acting upon safety concerns.

The culture-based CUSP initiative was put into place before the CLABSI intervention to provide a foundation for safety awareness, to establish interdisciplinary teamwork, and to encourage the widespread use of evidence-based practices. This was instrumental in the long-term sustainability of the results (75). In the Keystone project and subsequent nationwide pro-grams, the following occurred:

Step 1: Staff were educated about the patient safety as a sci-ence using a standard presentation and a series of inter-active discussions.

Step 2: Staff were asked to identify how the next patient would be harmed on their unit, and what they would do to prevent this harm from occurring; a CUSP improve-ment team was formed to interpret the results and imple-ment the work.

Step 3: Partnership with a senior hospital administrator was strongly encouraged. Their roles included reviewing the safety hazards identified by the unit staff with the improvement team, provide the institutional support and resources needed to implement appropriate risk reduc-tion interventions, and hold staff accountable for miti-gating hazards.

Step 4: Teams were trained to use a novel defect investi-gation tool, and asked to use it to address at least one defect each month.

Step 5: Teams were provided a variety of tools to improve communication and teamwork, and instructed to mod-ify the tools to fit the local context and ensure ease of implementation.

Specific Tools for Quality Improvement

Briefings and Debriefings

Briefing and debriefing tools are designed to promote effective interdisciplinary communication and teamwork. A briefing

is a structured review of the case at hand among all team members before any task is undertaken with the patient. A debriefing occurs after a procedure or situation in which the team reviews what worked well, what failed, and what can be done better in the future. Both have been used in the operating rooms (ORs), in hand-offs among the ICU nursing staff and intensivists, and between OR nursing and anesthesia coordi-nators (76–78).

A typical OR briefing will first introduce the relevant par-ties and establish anticipated roles of various team members. Next comes confirmation of the correct patient, site/side, and procedure, which coincides directly with the established JC “time-out” procedure, and assurance that all team members understand the important aspects of the intended procedure. A check of all necessary equipment (e.g., electrocautery) and medications (e.g., appropriate antibiotic) is then performed. Finally, to mitigate potential hazard, a concise discussion should take place regarding what plans are in place if pro-cedure variables fall outside of intended practice parameters. A briefing will typically focus on a critical procedure, but it can also focus on unit management of a patient. Briefings may occur in an ICU setting, where attendings and nurse man-agement meet to discuss (a) events that happened overnight, (b) admissions and discharges for the day, and (c) potential hazards that may occur during the day. This morning briefing organizes the ICU team, prioritizes the workflow for the unit, allocates resources, and mitigates potential hazards (78).

Debriefings occur after a formative event, regardless of the result. Often these are considered sessions for review of key elements of the procedure and discussion of relative merits and opportunities for improvement. Although constructive, this practice is often overlooked in the daily clinical care set-ting unless an unintended harm occurs or the consequence of a procedure is in question. Regular use of the debriefing strategy can serve not only to help establish root cause, but also to further educate providers for future similar patient encounters.

Learning from Defects

Most medical errors require the alignment of multiple failures within a system to occur. Reason’s “Swiss cheese” model (Fig-ure 8.2) illustrates how multiple failures, though insufficient by themselves to cause harm to the patient, can align to cause and adverse event in aggregate. The Learning from Defects tool is a less intensive version of a root cause analysis, allowing it to be implemented more frequently and with fewer resources to look at near-misses that would not necessarily trigger a hospital-level investigation. It provides a structured approach to help caregiv-ers and administrators investigate a case and identify elements of a given system that contributed to the defect, while also pro-viding a follow-up mechanism to ensure safety improvements are achieved. It does so by asking four basic questions: (a) what happened; (b) why did it happen; (c) how will you reduce the likelihood of this happening again; and (d) how will you know the risk has been reduced (79). Use of such a tool allows staff to investigate more incidents closer to the time of occurrence and to identify and mitigate a larger number of contributory fac-tors. The learning-from-defects process can be implemented as part of the CUSP framework or as a key element in educational programs that focus on QI (80).

This form of retrospective identification, which shares over-lap with key elements of debriefing, can be used to identify

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medical errors and analyze contributing factors, thereby providing a learning opportunity, rather than just a way to recover from harm. The lessons will provide defense against recurrence of the same or similar harm and are essential to promoting a comprehensive culture of safety. The IOM has targeted incident reporting systems as a method to not only collect defect information, but also to investigate the causes, thereby improving safety (1,81). To make incident data use-ful, health care organizations can utilize a variety of formal (root cause analysis) or informal (Learning from Defects, case review) methods.

Checklists

As outlined, the care of any one patient may require any num-ber of health care providers across multiple disciplines and levels of training. Hundreds of tasks, designed to implement dozens of therapies, may represent the balance of a single intensive care day. Given the natural limitations of human memory and attention, appreciation for and successful imple-mentation of the associated choreography can prove nearly impossible.

These realities can lead to decreased compliance with proper protocols, increased error rates, and reduced efficiency (82,83). Using checklists to standardize processes ensures that all steps and activities are addressed, thereby reducing the risk of costly oversights or mistakes and improving outcomes. Checklists represent an organized list of essential elements or steps that need to be considered or performed for a given task. Lying somewhere between an informal cognitive aid and a protocol, checklists provide real-time guidance to users and serve as verification after task completion (84). Checklists are thus multifunctional as memory aids, evaluation frameworks, and tools to standardize and regulate processes. Ultimately, checklists facilitate care delivery by decreasing variability, and thus improving performance.

In large part, our understanding of checklist use in the workplace comes from industries outside of medicine. In avia-tion, checklists are now a mandatory part of routine opera-tions and are highly regulated. They are used both in the course of normal practice and during emergency situations, providing a systematic approach to situation recovery. In product manufacturing, the smallest error during development can affect the quality of the final product, increase costs, and potentially harm the consumer. Checklists play a central role in ensuring that proper operating procedures are followed and quality standards are maintained. Quality assurance personnel use them routinely at multiple stages of the production process to evaluate whether required regulatory standards are being met. Checklists are an important component of standard oper-ating procedures for manufacturing and distribution processes because they help to maintain product quality standards. A central theme among these exemplars is the reliance on precise execution to provide consistent quality and minimize error.

Although similar in enterprise, health care has been slow to adopt the use of checklists. Operationally, it can be challeng-ing to standardize processes for the wide variability that exists between and even within patients. Nuanced patient comorbidi-ties, individual physiology, and unforeseen events can continu-ously influence the approach to diagnosis, treatment, and even recovery, making the design and implementation of a standard-ized approach difficult. Socioculturally, health care providers, particularly physicians, are frequently resistant to standardized tools and approaches, viewing them as a restriction of their autonomy. Certainly, similar restraints have been overcome suc-cessfully in other industry, but universal adoption within health care will require a concerted effort focused on improving effi-ciency and outcome rather than catering to resistance.

Daily Goals Sheet

Since July 2001, the daily goals sheet has been used during multidisciplinary rounds in the ICUs at Johns Hopkins to improve communication (85). This tool is a one-page check-list that is completed every morning to document establish-ment of the care plan, set goals, and review potential safety risks for each patient. Posted at the bedside of the patient, the goals sheet is updated as needed based on the dynamic nature of patient care and used as an information sheet for all staff involved in the patient’s care. This checklist can be modified for use on regular floor units and during OR sign-out.

The ICU version of a daily goals sheet can include the following questions:• What needs to be done to move the patient closer to transfer

or discharge?• What is the patient’s greatest safety risk?• What are the plans for pain management, cardiovascular

management, and respiratory management?• Is it appropriate to evaluate the patient’s rapid shallow

breathing index?• Is there any planned diuresis and nutritional support?• Are any antibiotic levels needed?• Can any lines, tubes, or drains be discontinued?• Are any tests or procedures planned? Have consents and

orders been completed?• Consider key local safety initiatives, including family

updates, or implementation of local protocols.To evaluate the impact of the daily goals sheet, all care team

members should answer two simple questions after rounding

A Medication Error Story

Nurse “borrows”medication fromanother patient

Fax system for orderingmedications is broken

Tube systemfor obtainingmedications

is broken

Nurse gives the patienta medication to which

he is allergic

Patientarrests

Inadequate ICU nursestaffing due to call-out

fIgURE 8.2 The “Swiss cheese” model of a medical error. The events leading up to an adverse event involving a medication error are illus-trated. The Swiss cheese model is a concept that originates from the work of James reason, in which he proposes that the alignment of multiple system failures allows harm to reach a patient. His premise is that system failures occur often, but that health care professionals and other systems are built in to catch a failure (e.g., final safety check at the pharmacy to catch medication allergies). Couched in this way, it takes the alignment of several failures or defects to pass by and harm a patient. (Adapted from reason J. understanding adverse events: human factors. in: Vincent C, ed. Clinical Risk Management. London: BMJ Publications; 1995.)

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at each patient’s bedside: (a) Do you understand the patient’s goals for the day?; and, (b) Do you understand what work needs to be accomplished on this patient today? These ques-tions were the impetus behind the development of this check-list. When asked initially, fewer than 10% of the residents and nurses time actually knew the care plan for the day. Traditional bedside rounds tended to focus as much or more on teaching staff about the disease than what work needed to occur to treat the patient. Approximately 4 weeks after Johns Hopkins implemented the daily goals sheet, 95% of the residents and nurses understood the goals for each patient (85). Moreover, length of stay in a surgical ICU at Johns Hopkins decreased from a mean of 2.2 days to just 1.1 days (85). Implementation of a daily goals sheet can also help improve communication and collaboration among nurses and physicians for individual patients, and lead to more effective coordination of daily care plans, and efficient movement of patients to ICU and even hospital discharge.

fUtURE DIRECtIOnS

Simulation

Simulation is a powerful tool/technique that has been used in high-risk industries to improve safety and reduce errors (86,87). The potential benefits of simulation in health care include (88):• Frequent training for emergencies (crisis resource

management)• Teamwork training (which is a weak link in the whole

process of patient safety)• Skills training and evaluation of competency before a trainee

touches a patient• Testing of new procedures and usability of new devices.

Health care takes place in a complex, high-stress environment that can affect human performance and patient outcomes. High-fidelity simulation allows us to not only examine human perfor-mance, but also analyze system-based problems. Although most medical simulation is still relatively new, it provides an opportu-nity to reorganize our “see one, do one, teach one” method of clinical training and better prepare trainees before they practice medicine. Education of health care staff is a vital part of any strategy to prevent errors. The benefits of simulation-based edu-cation include a pragmatic approach involving greater degree of interaction than traditional didactic sessions. It allows for the development of nontechnical skills along with assessment of technical skills. It facilitates real-time evaluation and feedback, assessment of practical and clinical judgment, as well as devel-opment of psychomotor and communication skills to optimize understanding of material and improve task execution (89–91).

Although a more thorough evaluation of the effect of simulation on patient safety might be necessary, just like in other industries, the face validity of this tool is likely to drive change and impact outcome. This impact will be especially apparent in the training domain, for both technical and non-technical, or behavioral, skills (communication skills, leader-ship, task management, teamwork, situational awareness, and decision- making) (92,93). These behavioral skills are common contributors to critical events in health care (94). Simulation allows trainees to practice in an environment that is safe for the trainee and the patient. In addition, trainees are exposed to

common, rare, and crisis situations, and can practice learned competencies and receive immediate feedback about their performance (95,96). A simulation-based approach has the potential to not only prevent similar errors from recurring, but to improve health care provider awareness to improve detec-tion of error and quality gaps in the first place.

Systems Engineering

The fields of patient safety and QI must look beyond indi-vidual interventions and instead appreciate the ultimate goal— ensuring universal delivery of evidence-based therapies to eliminate harm. Health care quality and patient safety initia-tives succeed only when collaborative teams account for the aspects specific to the system in which they live and operate. However, no individual system exists in a vacuum. While an individual checklist or learning-from-defects discussion may serve a function at the time of its use, it is a static tool that may become irrelevant over the dynamic course of a patient’s care. The current siloed approach of targeting harms individu-ally demonstrates a lack of understanding regarding when and where these synergies and discordances may be occurring, potentially leading to unintended, and sometimes harmful, consequences. Seemingly small personnel, resource, or architec-tural modifications can lead to domino effects at the individual and health system level given the interrelated nature of vari-ous systems. What’s more, with the rapidly growing nature of health care technologies, providers are expected to deliver care that remains efficient and cost-conscious, yet robust enough to cover a range of disease and therapeutic complexities. Indus-tries such as aerospace, defense, and information technologies have managed to thrive under similar conditions by integrating highly complex systems to function optimally without sacrific-ing principles of safety and quality. In them, harm is not per-ceived as being inevitable, but rather as a problem that can be overcome through a systems engineering approach (97).

Systems engineering is the practice of using core principles – termed systems methodology – to design systems architecture, language, and integration to satisfy a pre-determined goal. This approach contrasts with current health care strategy, wherein providers often address newly evolving problems by trying to retrofit current systems through “patches” or “work-arounds” because they are constrained by time and/or resources. By adopting systems engineering practices used ubiquitously in other surrogate industries, health care may more comprehen-sively alleviate systems defects by simply preventing them from occurring in the first place. All systems engineering initiatives follow a set of phases to either improve upon an existing system or develop a new system to solve a problem:

1. System Concept Development: To establish scope, the first phase in developing a new system is to define the problem, identify stakeholders and determine the goal. This step requires clear, concise language to adequately stage the overall initiative. Example: Surgeons, intensiv-ists, and administrators (stakeholders) believe nursing and provider workflow is significantly impeded in the ICU by redundant tasking (problem). They believe vital sign monitors should automatically input vital signs into the electronic medical record (EMR) and reduce time burden to bedside personnel (concise goal).

2. Requirements Analysis: Individual stakeholders, with the aid of systems engineers, establish the necessary

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requirements to successfully implement the system. They will make a rational appraisal of necessary finan-cial, personnel, raw material and regulatory resources in order to provide a meaningful end product. Example: Collaborators create a requirements list that includes raw elements (monitors, cables, hardware elements), personnel (programmers, engineers, software develop-ers, construction), and so on to properly address the necessary systems architecture.

3. Functional Definition: Define the system through a vari-ety of diagrams geared toward simulating or prototyping the anticipated system. Here you establish the input, the intermediate steps and the final output product as well as all relevant components and interrelated subsystems. Example: Numerous flow diagrams, object- oriented models, computer simulations, and even graphical user interfaces (GUIs) are prototyped to theoretically pro-pose an optimal solution to the original problem.

4. Implementation: Construct the system and properly integrate it among any pre-existing systems or subsys-tems in place. In the end, it should produce the expected output. Example: All makes and models of individual existing monitors must work seamlessly in the new sys-tem, which must also be modified to current workflow (establish appropriate timing and ranges of vital signs).

5. Verification and Validation: Over the life cycle of the new system, researchers must verify that the system meets the stated goals and validate the system under constraints of real-world operation. Predefined metrics are employed to ensure both endpoints. Example: Intensivists review vital sign data to ensure accuracy, stakeholders observe work-flow to comment on efficiency, and each provided feedback to systems architects to direct necessary modifications.

6. Iteration: Through numerous cycles of the system, stake-holders may modify elements and improve upon them to optimize efficiency and integrate new goals. Example: After vital signs are automatically input into the EMR, system checks may be set on subsequent cycles to notify providers if they fall outside of a preset range. This addi-tion satisfies the original stated goal and improves upon the system through iteration.

Application of such a systems engineering approach in health care has already begun in the ICUs in several settings. Project Emerge is an example of an active prototype devel-oped at the Johns Hopkins Medical System and the University of California San Francisco to implement and track success-ful application of evidence-based practices to improve seven common harms in ICU patients. These include ICU-acquired delirium, venous thromboembolic events, CLABSI, ventilator-associated events, ICU-acquired weakness, provision of care inconsistent with patient goals, and loss of respect and dignity. Creating a model to address the chosen harms involved cata-loging all the stakeholders, resources, and workflows associ-ated with the evidence-based practices that contribute to the prevention of each harm. This detailed appraisal was neces-sary to gain insight regarding the interdependencies within the existing system. Based on this understanding, a generalizable, scalable framework was then developed, explicitly detailing the steps needed for harm reduction. A novel interface sys-tem was developed to allow providers to quickly visualize and assess successful application of known bundled elements of care to prevent the defined harms.

Similarly, researchers at the Mayo Clinic recognized issues surrounding burdensome interpretation of traditional elec-tronic medical records; therefore, researchers created the Patient-centered Cloud-based Electronic System: Ambient Warning and Response Evaluation. This multicenter trial uses cloud-based technology to redesign the acute care interface system with built-in tools for prevention of provider error and practice surveillance.

Systems engineering principles can be applied within health care not only to establish new systems, but also to repair defects associated with existing ones. This practice has been successful across numerous industries with emphasis on safety amidst similarly complex infrastructure. Early returns in health care have been promising, and in an era of increasing emphasis on performance-based outcome, widespread utiliza-tion of systems methodology may be the link to engineering health care toward zero harm.

SUMMARy

Approaching QI and patient safety as a science is a relatively new concept and broad area of health care research that draws upon many disciplines. Many health care organizations have made concerted efforts to address the hazards that plague safety. Over the past several years, most of our efforts have been aimed at investigating causes and executing interventions to improve patient safety. Only now are researchers beginning to discuss how to evaluate these interventions and determine if patients are indeed safer. Evaluating our programs—and reli-ably answering whether patients are safer—will require valid measures and the ability to know whether we mitigated haz-ards, an area that is currently underdeveloped. Yet, the mea-surement model we describe in this chapter should move us in the right direction in developing new measures of safety.

To begin to improve patient safety and quality, we can implement collaborative projects that utilize proven models such as Translating Evidence into Practice (TRiP) and the Comprehensive Unit-based Safety Program (CUSP). Such ini-tiatives foster a culture of safety where staff learns the inter-dependence between patient safety and quality, and why they are important, identify system failures in their workplace, and turn their efforts into safety and QI. Indeed, staff feels valued for their opinions and recognized when senior leaders listen. Once a more solid safety culture is established, interventions can be implemented more effectively through collaborative projects. The CUSP also provides feasible and reliable tools for collaboration to implement improvements in communica-tion, teamwork, and adverse-event investigations. Collabora-tive projects are important because multiple sites that share the same goal can network to communicate successes and correct failures. The shared momentum increases sustainability.

Any QI program should provide a practical, goal-oriented toolset that will improve culture and lead to measurable improvements, using the principles described in this chapter as a guide. Additional research is necessary to identify other effec-tive safety interventions. Links must be developed between the structural elements of health care delivery and patient safety outcomes. Given the evidence to date, it seems reasonable that all ICUs should be routinely assessing their culture of safety.

Although work is necessary at the organizational level, the question of whether our patients are safer and receiving the

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best quality of care possible can be meaningfully answered. Significant and very exciting improvements are beginning to be implemented throughout the United States and around the world. The critical care community must continue to develop the science of safety, but many of the foundations have clearly already been laid.

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• While providing care appropriate to the patient and their condition seems simple, doing so consistently requires proper adherence to QI principles including review and improvement of health delivery systems.

• Independent external evaluation and reporting systems are essential components in the evolution of a culture of safety and QI.

• Adoption of a common framework to evaluate and monitor safety is one of the greatest impediments to reforming health care quality and safety. The ideal ini-tiative be designed to not only learn from past mistakes, but adapt to any unexpected present or future demands by being based on sound theory, using valid and objec-tive metrics, application of a consistent methodology, and a systematic assessment of outcomes.

• A multidisciplinary approach involving all relevant stakeholders is necessary for successful QI initiatives. A conceptual framework of pertinent issues and solu-tions helps guide team efforts and ensure common point of dialogue. Examples of useful project frame-works include TRiP to operationalize safety interven-tion therapies, and CUSP to involve multiple levels of care providers in a work area while leveraging support from senior leaders.

• Using systems engineering to design system architec-ture, language, and integration with the existing health care environment to satisfy pre-determined QI and patient safety goals might help comprehensively allevi-ate systems defects by potentially preventing them from occurring in the first place.

Key Points

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