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D National Guidelines and Local Action: Priority-Setting for the Development of Research-Based Protocols at Intermountain Health Care Susan D. Horror, Ph.D. INTRODUCTION This paper describes how Intermountain Health Care (IHC) selects areas in which to develop research-based protocols to improve outcomes of care for lower cost. It also describes the fundamental concept of research-based protocols, explains how they are developed through clinical practice improvement studies, and gives an example of their implementation. PRIORITY SETTING FOR RESEARCH-BASED PROTOCOLS AT IHC At the corporate level, IHC uses the following process to decide which clinical areas to focus on across its hospitals or ambulatory care sites. The pnonty-setting methodology examines four overall factors, each with several components: 1. Quality a. Clinical impact (ability to improve or probability of success). b. Problem proneness (areas with high variation in cost, length of stay, or clinical outcomes). Paper prepared by Susan D. Horn, Ph.D., senior scientist at Intermountain Health Care, Salt Lake City, Utah. Portions of this paper have been adapted from Clinical Practice Improvement: A New Technology for Delivering Cost-E~ective Quality Health Care, Susan D. Horn and David S. P. Hopkins, eds. Washington, D.C.: Faulkner & Gray, Inc., 1994. 111

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112 compatibility. SE17Il1G PRIORITIES FOR CLINICAL PRACTICE GUIDELINES c. Total volume ~igh-volume areas). 2. Finance a. Fixed-payer payments (not fee-for-service, so IHC is at risk). 3. External Customers a. Community cost and health needs. b. Purchaser interest. 4. Operational Feasibility a. Joint Commission on Accreditation of Healthcare Organizations b. Clinical champion (clinician with special interest in the area). c. Availability of measures to assess the area. For each factor, the components are scored from 1 (low) to 3 (high) on its importance to IHC and the average of the scores is computed to give a factor score. Subsequently, the average of the four factor scores is computed to give an overall score for a clinical area. The higher the overall score, the higher the priority of that clinical area for study. (See Tables D. 1 and D.2 for examples.) However, any clinician who wishes to produce a protocol in an area and has the resources to do so is encouraged to proceed. IHC divides its hospital-associated functions into three major classes to help identify key areas to study. Support services include operational and administrative systems, such as admit/discharge, scheduling, billing, and purchasing. Clinical infrastructure contains non-condition-specific clinical processes, such as prevention of adverse drug events, prevention of hospital- acquired infections, ventilator management, operation of clinical laboratories, and major medical support departments (e.g., radiology or anesthesiology). Clinical conditions include clinical processes aimed at specific presenting diagnoses (e.g., management of symptomatic benign prostatic hypertrophy or management of acute myocardial infarction). Since 35-40 clinical conditions often account for more than 70 percent of total inpatient volume, these high-volume clinical conditions are an appropriate focus for research-based protocol development efforts. After an area is selected for study, a version of the following clinical practice improvement methodology can be used to acquire the data necessary to develop or validate a research-based protocol.

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APPENDLY D CLINICAL PRACTICE IMPROVEMENT: THE FUNDAMENTAL CONCEPT BEHIND RESEARCH-BASED PROTOCOLS 115 Quality improvement in the American medical community is open called continuous quality improvement (CQI) or total qualify management MOM). Properly implemented, CQI embodies the principles of the scientific method that American medical practitioners have always avowed, but have rarely been able to practice fully (James, 1991; Horn and Hopkins, 1994~. Those principles remain the foundation of American medical practice: Clinicians commit to continually assessing the treatments they apply to patients' diseases and the medical outcomes they achieve, with an aim to improving treatments and outcomes for future patients. Clinicians also understand the importance of objective evidence when evaluating treatments and outcomes, and the use ofthe scientific method to systematically improve them. As it is applied to clinical medicine, we will refer to TQMlCQI's methodological component as Clinical Practice Improvement (CPI) (Horn and Hopkins, 1994~. Clinical Practice Improvement Many American health care facilities have come to understand that quality controls cost (James, 1989~. But clinical practice improvement provides amajor additional benefit: it creates a clinical laboratory, built into the everyday practice setting, to find and test best practices. Under a fully functional clinical practice improvement program, every patient automatically enters a clinical trial. Clinical practice improvement is a system designed to generate valid statistical inferences about the operational, day-to-day elements of the process of clinical care. Clinical practice improvement combines major elements of both practice guidelines and outcomes management. It uses consensus, combined with measurement and feedback, to eliminate inappropriate treatment variation for well-defined groups of comparable patients. Clinical practice improvement carefully tracks medical care process steps and outcomes and feeds the resulting information back to clinicians so that they can evaluate objectively the effects of the treatments they apply. To minimize overhead, clinical practice improvement integrates all of these elements into the routine process of care. A clinical practice improvement study is act analysis of the content and tinning ofthe individual steps of a medical care process to produce better medical outcomes for the least necessary cost over the continuum of a patient's care. Statistical measures are used to determine whether and how much a particular step actually improves medical outcomes. Systematic determination of the individual medical process steps that actually cause improvement in medical outcomes is of critical importance. This determination permits clinical practice

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116 SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES improvement studies to develop medical processes that constitute demonstrably better care and practice. Comparison of Clinical Practice Improvement with Randomized Controlled Trials The gold standard to determine optimal medical practice is the randomized controlled clinical trial (RCT). However, RCTs are difficult to conduct and costly to carry out, so relatively few are undertaken, and published results of completed trials fall far short ofthe medical profession's need for valid scientific information. As a remedy, several investigators have proposed alternative structures that allow practitioners to draw valid statistical inferences about patient care from routine practice, while avoiding the bureaucracy and overhead so often encountered in traditional RCTs. Clinical practice improvement is one such structure. Each step of a properly conducted clinical practice improvement study has a parallel step in an RCT. However, clinical practice improvement requires fewer resources than traditional RCTs and so can examine detailed operational factors, including the cost of care, that resource-intensive RCTs usually fail to explore. While RCTs may be the best approach for evaluating new clinical treatments (particularly drugs), clinical practice improvement methods can be used to optimize established treatments. Both methods RCTs and clinical practice improvement-describe a homogenous patient population, balance known and unknown patient factors, eliminate inappropriate variation in care delivery, and statistically evaluate predefined outcomes. However, RCTs accomplish these steps as an add-on effort of limited duration, while clinical practice improvement methods integrate the steps into the routine practice of medicine. Because clinical practice improvement methods allow a wide range of study designs, they can be useful when the rigor of a full RCT is not practical. In an RCT, patient eligibility criteria are critical, since one does not want the outcome ofthe study to be influenced by extraneous factors. Therefore, patients with secondary problems or more severe disease, which might adversely affect or bias the outcome of the comparison between the treatment and the control arm, are often rejected from the trial. Only a small percentage of patients with the condition under study, usually 10 to 15 percent, are eligible. But not all criteria can be thought of in advance. Therefore, at the end of the trial one may have to adjust for several variables in an analysis of covariance. In clinical practice improvement, every patient is allowed to enter a study. The patient's severity of illness, detailed process steps, and outcomes are assessed, and statistically valid inferences of their interrelationships are determined by multiple regression analyses (see Figure D.1~. Clinical practice

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APPENDLY D Contro' for: Patient Factors Disease Severity of Disease - Physiologic signs and symptoms - Complexity/Psychosocial factors Multiple points in time I m prove/Stan d ard ize: Process Factors Medications Interventions Develop protocols _ lilGURE D.l Study design clinical practice improvement model. 117 Measure: Outcomes End Results - Cost/Length of stay - Clinical - Health status improvement integrates a clinical quality monitor a data system that follows important patient, process, and outcome information into the care delivery infrastructure. Quality monitors may be employed in circumstances in which traditional RCTs are not practical to track and improve common process of care factors, which may not warrant the expense and effort of a traditional clinical trial. But as the Japanese (and later the Americans) have shown in manufacturing, a series of manly small advances may result in a greater total improvement than a few large breakthroughs (Imai, 1986~. RCTs use a protocol document to create act artificial practice environment that allows valid statistical inference. While that structure eliminates practice variation, it usually covers a very limited subset of patients and practices. Clinical practice improvement addresses the same issues-practice variation and

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118 SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES valid statistical inference- from another point of view. It measures process variation, then eliminates it through a combination of consensus, measurement, and feedback. Under a quality monitor, large groups of similar patients receive the same treatment, and valid statistical inference is possible. RCTs also tend to be limited in time in most circumstances, they explicitly modify clinician behavior only for the duration of a study and only for the individuals directly involved in the trial. In contrast, clinical practice improvement establishes a permanent measurement and feedback loop aimed at all clinicians in an Institution, providing the information necessary to understand and modify their own activities at a detailed, operational level. Specific Components of Clinical Practice Improvement A clinical practice improvement study includes four major components: quality planning, quality monitor, process stabilization, and systematic improvement Quality Planning (select key processes to monitor) A health care delivery system contains tens of thousands of interlocking processes. The first step is to prioritize-to find and focus on the most important processes. Quality Monitor Guild an integrated measurement system) A clinical quality monitor works best when built into the infrastructure of the health care delivery system, where it can function inexpensively and unobtrusively as part of routine operations. It captures data items that are crucial to the delivery of care items that must be collected in the medical record in any circumstance, as they are often essential to a patient's description, treatment, and recovery. Clinical quality monitors are most efficient as part of an electronic medical record, although they can arid do work in traditional manually operated record systems as well. If a monitor is in simultaneous operation at several facilities, it can act as a multicenter clinical practice improvement data system. A clinical quality monitor collects three major classes of information: patient eligibility and patient attributes (severity of illness), major process of care factors, and outcomes.

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APPENDIX D 119 For a particular clinical condition, a team of clinical experts identifies the data elements In each class during the quality planning phase. The team typically uses the medical literature, practice guidelines, critical paths, other organizations' quality monitors, and its own expertise. Patient Factors. Patient eligibility factors (severity of illness measurement and specific indications for treatments define a group of patients who should receive the same process of care, except for small, random variations as clinicians respond to minor patient differences. Within a well-defined patient group, one would expect to observe the same outcomes of care, except for random, patient-based differences. Clinical practice improvement requires disease-specific physiologic data such as those contained in the Computerized Severity Index and the Ambulatory Patient Severity systems (Horn and Hopkins, 1994~. This part of a quality monitor is analogous to the eligibility and stratification factors used in RCTs. If a detailed physiologic severity system is not available, then the clinical practice improvement team determines what data are needed to define patients with similar levels of illness so that a decidable and executable treatment protocol can be developed, based on the patient's derangements. Major Process Factors. A process of care consists of a series of linked, usually sequential steps designed to cause a set of desired patient outcomes to occur. The aim is to find a measurable factor that describes each major process step. The quality monitor usually does not specify thresholds for a process step, unless there is a scientifically defensible "best practice" that should be applied to all cases in the patient cohort. Outcome Factors. In theory, processes of care do not just happen they are designed to achieve specific medical outcomes. Among the outcomes commonly encountered in clinical quality monitors are patient functional status, diagnosis- specific complications, diagnosis-specific long-tern medical outcomes (which may be assessed by both clinicians and patients), patient satisfaction, and cost. Outcome factors parallel the assessment endpoints included in an RCT. Because a quality monitor is an ongoing, long-term measurement system (as opposed to a one-time RCT), quality improvement principles may be applied to iteratively improve the measurement system itself. It is therefore possible to start a quality monitor even when some details necessary for a full study are unknown. With a quality monitor, the chief principle is to start-initiate measurement and feedback and then iteratively improve both patient care and the measurement system.

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120 SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES Process Stabilization (identify and eliminate inappropriate variation in process steps) Once a clinical quality monitor is designed and implemented, and is actively collecting data, the next objective is to eliminate inappropriate variation within me process of care. Process stabilization is the act of identifying and eliminating inappropriate variation. Not all variation is inappropriate. Some clinical practice improvement programs use statistical process control to separate random variation (clinicians' adaptation to random patient factors at such a fine level of detail that they escape control through the eligibility or severity criteria, or other random variations associated with environmental factors or the measurement system itself) from attributable variation (consistent inappropriate variation in major delivery steps, environmental factors, or measurement) (Berwick, 19911. There are at least three methods to stabilize process performance across ~ . groups or clinicians. Method 1: Measure pe~forr,~ance without setting explicit process thresholds. The resulting comparative data are presented to the clinical group, usually in subspecialty medical section meetings or clinical practice improvement team meetings. Over time, attributable variation declines as clinicians discuss, consider, and compare their own techniques to those of their peers. When more than three or four patient and process variables have to be taken into account, multiple regression analyses can be used to model the effects of these factors on the outcome-dependent variables. The coefficients of the independent variables in the regression equations tell which process steps, controlling for patient factors, lead to better outcomes. For example, the analysis can help answer the question "What is the best prophylactic antibiotic to use in a coronary bypass artery graph surgery?" Method 2: Bring all practitioners treating a particular clinical condition together for a series of meetings at which they agree upon clear statements detailing the process steps that should be performed, taking into account the severity of the patient's signs and symptoms. A quality monitor then measures performance against the agreed-upon specifications. Ongoing meetings allow the clinicians to reassess the specifications in light of compliance data and their own experience. The structure of the protocol improvement process requires that, if a clinician fails to follow a step in the protocol at some point, she or he gives substantive, nonstylistic reasons for doing so, and the corresponding protocol element is automatically placed on the agenda for the next clinical practice improvement train meeting. The team always starts from the assumption that the protocol is incorrect or incomplete with regard to the clinical point under discussion. The reasoning is that, if the protocol were correct, then all clinicians in the group would follow it. The clinician who disagrees with the protocol step

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APPENDLY D 121 has an opportunity to present his or her reasoning to the team, in the context of a real patient, so that the group can modify the protocol step or reach consensus that the protocol, as written, does represent best practice. Even after much refinement, usually 5 to 10 percent of the protocol steps are not followed, due to patient differences not accounted for by the protocol. Method 3: Use a set of process specifications generated by an external group (e.g., a national consensus panel) or a subset of local clinicians working in isolation from their local peers. Even when external guidelines and parameters are developed by well-respected groups, distributed widely, and supported by respected clinical leaders and professional specialty societies, it may still be necessary to establish a measurement and feedback system to achieve guideline and parameter compliance. The goal of the clinician group is to generate a decidable and executable research-based protocol over time through measurement, feedback, and stabilization. A protocol is decidable if it tells precisely under what circumstances to do something; it is executable if it tells exactly what to do under these circumstances. External information, such as medical literature synthesis, other practice guidelines, or results from other external clinical practice improvement groups, may be employed. But, regardless of the source of information, the clinicians in the group choose their own collective "best practice" based on data associating patient severity characteristics and process steps with outcomes. A stabilized process corresponds to the treatment protocols that describe the control and test arms of an RCT. RCTs achieve stable processes by explicitly specifying every important element of the process of care, for both the test and control arms. RCT protocol violations occur when a treatment step deviates from the RCT protocol's specification. Such violations can seriously damage an RCT: if treatment on one or more of the arms of a trial is not applied consistently, it is impossible to tell whether differences in outcomes between the trial's control and test arms are due to the specified treatments or to the variations that occurred. Within clinical practice improvement, process stabilization involves the same principle: it is impossible to assess the outcomes of a process unless that process is stable. Systematic Improvement (generate valid information and document continuous improvement in patient outcomes) Once study results are available, the clinical practice improvement team evaluates them and makes fact-based decisions about the proposed process change. The team can change the standard process of care to follow the newly tested process step, modify the clinical quality monitor and repeat a modified

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122 SEWING PRIORITIES FOR CLINICALPRACTICE GUIDELINES trial, or reject the proposed process change and go on to test others. In such a setting, changes to the process of care rest on experimental results rather than . ~ c 1nlca opmlon. While formal patient randomization (e.g., an RCT) is the safest approach, the alternative study designs used in clinical practice improvement may provide a more pragmatic balance of study overhead, clinician participation, rapid patient accrual, and need for timely information, versus potential bias. This is particularly true when permanent quality monitors routinely track patient and process factors, so that invalid inferences are likely to be found and corrected over time and when examining operational process of care factors as opposed to major new treatments. Clinical Practice Improvement and Outcomes Research The foregoing discussion illustrates the fact that clinical practice improvement is a superset of outcomes research. Clinical quality monitors track a full set of outcomes as well as patient factors (severity data) and process factors. They permit care delivery teams to understand and stabilize process steps, so that outcomes can be compared accurately and understood. They also provide the means to relate outcomes to process steps that are under an individual clinician's control. Through that mechanism, clinical practice improvement provides a means to unite effectiveness research (the study of medicine as it is really practiced in the community) with efficacy research (the study oftightly deigned treatments in carefully controlled patient groups) (Palmer, 1976~. Clinical Practice Improvement and Practice Guidelines and Parameters Clinical practice improvement and practice guideline and parameters are complementary. Well-designed practice guidelines and parameters can form the core of a clinical quality monitor. On the other hand, clinical quality monitors can be used to generate research-based protocols, implement them, measure their impact, and improve them over time. Appropriate use of quality monitors provides clinicians with the necessary tools to build, use, and systematically improve research-based protocols.

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APPENDIX D DEVELOPMENT OF RESEARCH-BASED PROTOCOLS THROUGH CLINICAL PRACTICE IMPROVEMENT STUDIES 123 A research-based protocol is a detailed process of care based on a clinical practice improvement study showing that the process has achieved better care and practice for the least necessary cost over the continuum of a patient's care. Research-based protocols significantly narrow the otherwise wide variation normally observed in the medical care process because they are very precise and comprehensive in defining the process of care steps (i.e., they are decidable and executable). Research-based protocols are much more detailed than general checklists or traditional practice guidelines and parameters. Research-based protocols typically are developed in two stages, using clinical practice improvement methodology: In the first stage, called stabilization, detailed steps of a diagnostic or therapeutic process for similarly sick patients (controlling for severity) are determined through discussion of the medical literature and the clinical experience and judgment of the clinicians, resulting in consensus on the detailed steps that the clinicians will follow. If this process does not result in consensus, the detailed steps of each clinician's existing practice patterns for similarly sick patients, along with their common medical outcomes, are measured and fed back to the clinicians, resulting in increased communication among the clinicians and consensus on the detailed steps that the clinicians agree to follow and then implement. In the second stage, called validation, there is measurement and feedback of the detailed steps of the diagnostic or therapeutic process of similarly sick patients, and analysis to statistically associate each process step with medical outcomets) to more clearly determine the degree of effectiveness of each step in a protocol to achieve better outco~nefs). The second stage is done initially and then repeatedly thereafter to continuously attain better research-based protocols. Inherent in the methodology of research-based protocol development is: 1. An ongoing process to improve the protocol by continuous measurement and feedback of selected changes (adding, subtracting, and/or modifying) in the detailed steps of the medical process, and analysis to statistically associate the changes with better medical outcomes. 2. The essential part played by clinicians in research-based protocol development. Research-based protocols must reflect clinicians' actual practice. In contrast, traditional guidelines and parameters developed through synthesis of medical literature and expert consensus by third-party developers, are typically not, without additional material incentivets), accepted and followed by clinicians.

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124 SEITING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES 3. Formal measurement ofthe degree of clinician compliance with research- based protocols, including the usual requirement that the clinician state and record the specific reasonfs) (substantive and not stylistic) for his or her noncompliance with the research-based protocol. AN EXAMPLE OF THE DEVELOPMENT OF A RESEARCH-BASED PROTOCOL: PREVENTION AND TREATMENT OF PRESSURE ULCERS Conservative estimates indicate that well over one million hospital and nursing home patients suffer frown pressure ulcers each year (NPUAP, 1989~. Estimates of costs to heal one ulcer range from $5,000 to $50,000 with annual costs for pressure ulcer treatment thought to exceed $5 billion ~Iaklebust, Mondoux, and Sieggreen, 1986; Frantz, 1989~. Few precise data are available on ulcer treatment by stage of lesion or by concomitant health problems and their influence on cost of treatment; hospital costs are not typically broken down to identify multiple services involved in treating patients with pressure ulcers. Definition Problems There are several methodologic limitations to assessing the incidence and prevalence of pressure ulcers in various health care settings. Differences about such basic matters as definition of act ulcer and its stage make it difficult to analyze and interpret many of the published studies (NPUAP, 19891. Variation in Process of Care to Prevent and Treat Pressure Ulcers There is great variation in the treatment of pressure ulcer patients. In a pressure ulcer quality of care assessment carried out at IHC-affiliated hospitals, we found that guidelines differed between facilities and between neighboring nursing units within a facility. In a small study of six patients, two skilled nurses agreed on the level of risk (low, medium, and high) only twice. The great variation among clinicians in determining risk makes it very difficult to identify correctly high-risk patients and to use preventive measures appropriately. In addition, great variation in treatment methods was fouled from nurse to nurse in treating the same ulcer. One impediment to wound healing is the combination of many different methods and products used in pressure ulcer management (Lidowski, 1988~. Great variation occurs because there is little scientific evidence to indicate which process or therapy is best; even available scientific evidence has not been translated into a protocol or plan (Wennberg, 1987~.

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APPENDLY D 125 The single most important aspect of pressure ulcer care is prevention (Ameis, Chiarcossi, and Jimenez, 1980~. Many clinicians have indicated that pressure ulcers are entirely preventable (Dyson, 1978; Fugill, 1980; Kosiak, 1991~. Since nurses can devote 1,000 extra hours of care to heal a major ulcer in one patient, an effective program to prevent pressure ulcers could have a major impact on lowering nursing costs (Makelbust, 19873. Methods The two main questions we consider here are: 1. Are pressure ulcers related to the severity of illness of the patient beyond risk factors contained in the Braden Scale? 2. Does implementation of a research-based protocol to stabilize the process of care for prevention of pressure ulcers reduce the incidence of pressure ulcers? The Clinical Practice Improvement Team The first step was to form a multidisciplinary clinical practice improvement team composed of physicians, nursing skin care specialists, staff nurses, nurse educators, nursing information systems experts, physical therapists, nutritionists, and health services researchers. The team created two research-based protocols: one for prevention of pressure ulcers in high-risk patients and another for treatment of pressure ulcers. AHCPR's Guideline In May, 1992, the Agency for Health Care Policy and Research (AHCPR) published Pressure Ulcers in Adults. Prediction and Prevention, Clinical Practice Guideline No. 3 (AHCPR, 1992~. This publication was the first major attempt to synthesize available research on pressure ulcer risk assessment, prevention, and early intervention. The guideline provided recommendations to relevant care providers physicians, nurses, physical therapists, patients, and families risk assessment tools and risk factors, skin care and early treatment, mechanical support surfaces, and education. Our clinical practice improvement team used the AHCPR Clinical Practice Guideline as a starting point for its own research- based protocol. Since most hospital providers who manage skin assessment are nurses, this research-based protocol was developed as a nursing department policy-procedure.

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126 SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES To assess the risk of a patient developing a pressure ulcer, we used the Braden Scale for Predicting Pressure Ulcer Risk, which was used in the AHCPR Guideline (Bergstrom and Braden, 19874. The six subscales ofthe Braden Scale are derived from a conceptual schema identifying two major factors responsible for pressure ulcer development: the amount and duration of pressure, and the tolerance of the tissue for pressure. Development of a Research-based Prevention Protocol For each level of each of the six subscales in the Braden Scale, the clinical practice improvement team determined which interventions should be performed to stabilize the process of care with the intent of achieving better outcomes at lower cost. For example, if the patient is completely immobile (does not make even slight changes in body or extremity position without assistance), the protocol treatment specifies that the nurse is to turn and position the patient every 2 hours, observe skin when positioning, and perform a daily skin assessment between 0600 and 1200 hours. If the patient is constantly moist (skin is kept moist almost constantly by perspiration, urine, etc.), the nurse is to bathe with soap and water and pat dry, use moisture barrier ointment and cream, contain incontinence (condom, foley catheter, pouch), and perform daily skin assessment between 0600 and 1200 hours. If the patient has very poor nutrition (never eats a complete meal, rarely eats more than one-third of any food offered, etc.), then the nurse is to contact the dietician to evaluate nutritional status, assist and encourage oral intake to increase protein, increase calorie diet, and use frequent small feedings, tube feedings, or total parenteral nutrition. Neither of our research-based protocols recommended the use of low air-loss specialty beds or other special mattresses for either prevention or treatment of pressure ulcers. After extensive discussion, the clinical practice improvement team did not think there was sufficient evidence in the literature or in their own experience to warrant their use. The prevention protocol represented the clinical practice improvement team's best assessment of optimal prevention treatment. Development of a Research-Based Treatment Protocol Using the medical literature, the team developed a uniform staging system for ulcers and developed standardized treatments for each stage, including appropriate care to reduce and relieve pressure, reduce and relieve friction/shear, reduce and relieve excess skin/surface moisture, maintain good nutrition, and the like.

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APPENDLY D 127 Controlling for Severity of Illness The Computerized Severity Index (ASIA, a disease-specific, physiologic- based severity system, was employed to stratify patients for analysis on the basis of the severity of their underlying illnesses on admission, maximum severity throughout the hospital stay, and severity at discharge (Horn and Hopkins, 1994~. Education A one-hour inservice training program was developed to train nurses to use both protocols. It involved a knowledge pretest about measurement of risk assessment and pressure ulcer formation, instruction about using the Braden Scale and pressure ulcer staging (NPUAP, 1989), and a presentation on appropriate nursing interventions. The education inservice was designed to ensure that all nurses would have adequate information about risk assessment and about staging of ulcers, if present. The education intervention also included a paper clinical quality monitor to help determine the patient's risk of developing a pressure ulcer, or the stage of the pressure ulcer, and the treatment that should be followed in each case. To facilitate documentation, special Morons were developed for nurses to use during the study period. Since these forms could be used elsewhere, our study is generalizable to other institutions. Data Collection We studded three different time periods. The time period 7/92-12192 was the pre-intervention time period (time period 1~; the protocols were being developed but no floor nurses had yet been trained. The time period 1/93- 6/93 was the training time period (time period 2~; the nurses were trained and, hence, knew about the protocols, but were not required to follow them until 7/93. The time period 7193-12193 was the post-intervention time period (time period 3~; by 7/93 the nurses were trained and were expected to follow the protocols and use the Braden Scale to collect information about immobile patients. During time periods 1 and 2 (when Braden Scale data were not being collected by the nurses), we considered a patient to be at risk for developing a pressure ulcer if at least one risk indicator in Table D.3 was present in the HELP system (IHC's computerized clinical data system). Results The preliminary results we discuss here refer primarily to time periods 1 and 2. Patients at risk for pressure ulcers were divided into three groups:

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128 SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES Group 1: Patients at risk who were admitted without a pressure ulcer and did not develop a pressure ulcer during the admission. Group 2: Patients at risk who were admitted without a pressure ulcer but developed a pressure ulcer after admission. Group 3: Patients who were admitted with a pressure ulcer. The mean admission CSI continuous severity scores for the patients in Groups 1 through 3 for time periods 1 and 2 show clearly that patients who developed a pressure ulcer (average admission CSI = 39) or patients who entered the hospital with a pressure ulcer (average admission CSI = 42) had higher admission CSI scores on average than patients at risk who did not develop pressure ulcers (average admission CSI = 22~. Similarly, higher maximum and discharge CSI scores were found for patients admitted with or who developed pressure ulcers than at-risk patients without ulcers. Thus, it appears that at-risk patients who develop pressure ulcers are sicker on average than those who do not. All the differences in average admission, maximum, and discharge severity levels for the three groups were significant by the analysis of variance test, p < .0001. Figure D.2 shows the pressure ulcer rate by admission CSI discrete levels, O through 4, for time periods 1 and 2; within each admission CSI level and for all the at-risk patients at that level, the rate plotted is the number of patients who developed pressure ulcers during their hospitalization divided by the total number of patients. Although use of the pressure ulcer protocols was not required during time period 2, the data show that knowing about them (as a result of the trainings was associated with a large decrease in the rate of pressure ulcers by admission severity level. For each severity level 2, 3, and 4, the decreases in rates of pressure ulcers Mom time period 1 to time period 2 are significant, p < .002. We are considering how to use admission CSI level as an additional prospective risk factor to identify patients who are at highest risk of developing a pressure ulcer. The portion of at-risk patients who used low air-loss specialty beds declined hom 6.2% to 5.8% to 3.5% during the three time periods, respectively. Discussion of Pressure Ulcer Protocol Study The goal of this clinical practice improvement study was to improve the outcomes of patients with, or at risk of developing, pressure ulcers by stabilizing the process of care. We developed one research-based protocol for prevention and one for treatment of pressure ulcers by consensus of the clinical practice improvement team. A one-hour formal inservice training program was used to educate the nursing staff on the use of the protocols. Compared with the 6- month pre-protocol time period, the 6-n~onth interim time period when the protocols were being taught showed a significant decrease in the incidence of

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APPENDLY D TABLE DO Risk Indicators for Developing Pressure Ulcers 129 Glascow Coma Score < 7 Unable to detect pressure Unable to detect pain Numbness Paralyzed induced 2 3 days Paralyzed Presence of coma findings ICD-9 codes 806: Fracture of vertebral column with spinal cord injury 808: Fracture of pelvis 820: Fracture of femur 821: Fracture of other and unspecified parts of femur 823: Fracture of tibia and fibula 827: Other, multiple, and ill-defined fractures of lower limbs 953.9: Injury to nerve roots and spinal plexus 437.8: Other and ill-defined cerebrovascular disease 344.1: Quadriplegia 728.3: Other specific muscle disorders ignobility syndrome pressure ulcers and the use of specialty beds. These preliminary results indicate that stabilizing the process of care has all effect on improving outcomes and decreasing costs. The clinical practice improvement study team is now training the remaining nursing units in the hospital with the research-based protocols and is implementing them on the HELP system for more consistent practice. Full results of this study, including the financial ramifications, will be presented in detail in future reports. The estimated cost savings per year, based on ulcers prevented, was about $500,000. The study cost about $50,000 to conduct, including the costs of the hourly salaries of the 500 nurses while they were trained, the person hours to develop the protocol, the person hours to collect the CSI data, and the cost to analyze the data.

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130 SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES 40 30 10 326% 297% 194/' it, 1 O-' ~.~5% 1 0 1 2 3 4 Admission CSI Level 7/92 - 12/92 1/93 - 6/93 time period 1 time period 2 ~+ FIGURE D.2 Pressure ulcer rate by admission CSI level. LESS PRIORITY SETTING NEEDED WITH CLINICAL PRACTICE IMPROVEMENT The clinical practice improvement framework to improve quality of care requires much less prioritization thank do RCTs or traditional national guideline and parameter development. This is because clinical practice improvement studies are usually much less costly to conduct than RCTs and traditional national guidelines and parameters development. RCTs require an add-on effort to select eligible patients, maintain study design, and collect required data. The traditional national guideline arid parameter development methodology requires performing thorough literature synthesis arid obtaining multiple clinicians' opinions and judgments in order to base the guidelines arid parameters on expert national consensus. This methodology leads not only to high cost but also to less

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APPENDLY D 131 detail in the guidelines and parameters than in the typical, locally produced decidable and executable research-based protocol. If many research-based protocols are produced by different groups of clinicians for a particular medical problem, they can be shared, perhaps through a national data bank. Researchers and practitioners could use than as a starting point to develop even better research-based protocols in the future. Why do clinicians change their behavior as a result of a clinical practice improvement study? We believe they change because: they help develop the criteria used to determine better processes and outcomes, results. they are involved in the analyses and hence are vested in the study and its they can violate protocols when they think they are not right, and they are not profiled arid need not feel threatened. Although clinical practice improvement studies focus on improving clinical outcomes, they often decrease the cost of care as well by preventing complications or using more efficient processes of care. In this way an environment is created in wluch clinicians continually seek better methods of treatment based on scientifically sound data. REFERENCES Agency for Health Care Policy and Research (AHCPR) Pressure Ulcers in Adults: Prediction arid Prevention. Clinical Practice Guideline No. 3. USDHHS, AHCPR Pub. No. 92-0047, May 1992. Ameis, A., Chiarcossi, A., and Jimenez, J. Management of Pressure Sores: Comparative Study in Medical and Surgical Patients. Postgraduate Medicine 67~2~:177-84, 1980. Bergstrom, N., and Braden, B. A Conceptual Schema for the Study of the Etiology of Pressure Sores. Rehabilitation Nursing 12:81, 1987. Berwick, D.M. Controlling Variation in Health Care: A Consultation Tom Walter Shewhart. Medical Care 29~12~:1212-25, 1991. Dyson, R. Bedsores: The Injuries Hospital Staff Inflict on Patients. Nursing Mirror June 15:30-32, 1978. Frantz, R.A. Pressure Ulcer Costs in Long Term Care. Decubitus 2~3~:5~57, 1989. Fugill, G.C. Pressure Sores. Pl~ysiot1`erapy 66~21:46~7, 1980. Horn, S.D., and Hopkins, D.S.P. Clinical Practice Improvement: A New Technology for Developing Cost-Effective Quality Health Care. Volume 1,

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132 SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES Medical Outcomes and Practice Guidelines Library. Washington, D.C.: Faulkner & Gray, 1994. Imai. M. Kaizen: The Key to Japan 's Competitive Success. New York: Random House Business Division, 1986. James, B.C. TOM and Clinical Medicine. Frontiers of Health Services Management 7~4~:42~6, 1991. James, B.C. Quality Management for Health Care Delivery. Hospital Research and Educational Trust (American Hospital Association), Chicago, 1989. Kosiak, M. Prevention and Rehabilitation of Pressure Ulcers. Decubitus 4~2~:60~8, 1991. Lidowski, H. NAMP: A System for Preventing arid Managing Pressure Ulcers. Decubitus 1~2~:28-37, 1988. Maklebust, J. Pressure Ulcers: Etiology arid Prevention. Nursing Clinics of North America 22~2~:359-377, 1987. Maklebust, J., Mondoux, L., Sieggreen, M. Pressure Relief Characteristics of Various Support Surfaces Used in Prevention and Treatment of Pressure Ulcers. Journal of Enterostomal Therapy 13~3~:85, 1986. National Pressure Ulcer Advisory Panel (NPUAP). Pressure Ulcers Prevalence, Cost and Risk Assessment: Consensus Development Conference Statement. Decubitus 2~2~:2~28, 1989. Palmer H. Definitions aIld Data. In Assuring Quality in Medical Care. Richard Green, ed. Cambridge, MA.: Ballinger Publishing Co., 1976. Wennberg, J.E. The Paradox of Appropriate Care. Journal of the American Medical Association 258:2568-9, 1987.