11
Needs for Future Research and Capacity Building

Throughout this report we have identified issues that we cannot presently resolve because the knowledge base is weak or inconclusive. These topics include, but are not limited to, how to measure quality of care reliably and validly, how to apply such measures efficiently, how to address deficiencies in quality of care when they are discovered, and how to evaluate systematic approaches and innovations in quality assurance. The knowledge base is also inadequate about the efficacy and effectiveness of health care services and technologies, that is, about what works in the practice of medicine (Roper et al., 1988).

In debating a redirected quality assurance program for Medicare, we concluded that the nation’s capacity to undertake such an effort is weak. The numbers of practitioners and clinicians trained in appropriate research methods are inadequate. Too few caregivers and administrators are trained in quality assessment and assurance methods. In short, the need for capacity building, especially education and training, in the quality-of-care field is appreciable.

These deficits in our present state of knowledge and quality assurance manpower mean that the credibility of quality measurement and improvement can be questioned. Addressing these problems through a coherent research strategy, expanded training, and other quality assurance activities should be seen as fundamental prerequisites for improving our ability to measure and change the performance of providers of health care for the elderly.

This chapter examines research needs and capacity building. Most of our attention is given to outlining a research agenda for quality review and assurance, in keeping with the congressional charge to evaluate current research on methodologies for measuring quality of care and to suggest



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I 11 Needs for Future Research and Capacity Building Throughout this report we have identified issues that we cannot presently resolve because the knowledge base is weak or inconclusive. These topics include, but are not limited to, how to measure quality of care reliably and validly, how to apply such measures efficiently, how to address deficiencies in quality of care when they are discovered, and how to evaluate systematic approaches and innovations in quality assurance. The knowledge base is also inadequate about the efficacy and effectiveness of health care services and technologies, that is, about what works in the practice of medicine (Roper et al., 1988). In debating a redirected quality assurance program for Medicare, we concluded that the nation’s capacity to undertake such an effort is weak. The numbers of practitioners and clinicians trained in appropriate research methods are inadequate. Too few caregivers and administrators are trained in quality assessment and assurance methods. In short, the need for capacity building, especially education and training, in the quality-of-care field is appreciable. These deficits in our present state of knowledge and quality assurance manpower mean that the credibility of quality measurement and improvement can be questioned. Addressing these problems through a coherent research strategy, expanded training, and other quality assurance activities should be seen as fundamental prerequisites for improving our ability to measure and change the performance of providers of health care for the elderly. This chapter examines research needs and capacity building. Most of our attention is given to outlining a research agenda for quality review and assurance, in keeping with the congressional charge to evaluate current research on methodologies for measuring quality of care and to suggest

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I areas of research needed for further progress. First, we advance a framework for setting priorities for research topics; we also review past and current research efforts in the quality-of-care area. Second, we discuss in more detail the research efforts we believe should be pursued. Third, because we are not persuaded that research by itself will stimulate and support the progress that is needed (at least not in the timeframe contemplated), we discuss aspects of capacity building that we believe deserve high priority attention. RESEARCH NEEDS Overview Research in quality-of-care measurement and quality assurance is our main concern. We do not address fields such as biomedical research or technology assessment, both of which have an indirect role in the information base for quality assurance, or research into the organization and financing of health care, access to care, or continuity of care. These aspects of health care delivery can strongly influence the quality of health care, but solutions to access and continuity problems are likely to lie outside the purview of quality measurement and assurance programs. A federal quality assurance program and its national, population-based databanks offer an unparalleled opportunity to track and document problems of access to care, fragmentation of care, and underuse of services. We also do not survey the field of health services research, which is closely related to research in quality assurance. Two important links between these fields should be noted. First, the formal research methods and approaches for health services research are those most likely to be used in much of the research that will be called for later in this chapter. Second, much of the existing theory, tools and methods, and investigators in the quality assurance field come out of the health services research community. A decade ago an Institute of Medicine (IOM) study committee stated that the “need for more knowledge about health services in the United States is becoming increasingly apparent to health care professionals, government officials, and the public” (IOM, 1979, p. 1). More recently Reinhardt (1989, p. 5) noted that “the development and implementation of a sustained, multidisciplinary research agenda is the only way that we will attract the best minds to this field [of health services research] and build a knowledge base over the next decade that will be useful for health professionals, consumers, payers, and policy makers.” Substituting “quality of care” for “health services” yields equally true observations. Berwick (1989) has proposed a broad conceptual framework on which a quality-related research agenda for the next decade might be built. One

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I pillar is that of efficacy, or knowing what works, and includes an emphasis on technology assessment.1 The second pillar is appropriateness, or using what works, and includes practice guidelines and standards. Execution of care, or doing well what works is the third pillar, and purpose of care, or clarifying the values and objectives of health care, is the fourth. According to Eddy (1984, p.75), “uncertainty, biases, errors, and differences of opinions, motives, and values weaken every link in the chain…” of efficacy, appropriateness, and execution. Brook and Lohr (1985) argued that greater returns from health services research would be realized when work on efficacy, effectiveness, variations in population-based rates of use, and quality of care were integrated into an operational model for policy, planning, and evaluation. Our view of a research agenda for quality review and assurance reflects this integrative or boundary-crossing approach; although we identify key topics, we believe that efforts along a broad, multidimensional, and multidisciplinary front will be required. The research community must have orderly ideas about how to set research priorities. For broad quality-of-care issues, Lohr et al. (1988) advanced the following criteria for priority setting in research: (1) the history and persistence of the problem; (2) the likely utility, persuasiveness, and generalizability of the research; (3) the probability of obtaining data and results in a timely way; (4) the ease and cost of acquiring clinically valid data; and (5) the tradeoffs with other appealing allocations of research dollars. Within the dozen or so broad topics discussed later in this chapter, which we conclude deserve significant attention and investigation, are many competing subjects and problems. Congress and public- and private-sector funding agencies could apply such criteria in selecting topics of highest priority. Current Knowledge Base on Quality of Care The literature on quality of care and quality measurement is immense. Since World War II in particular, much work has been done on assessing quality of care, rather less on assuring quality of care.2 For instance, a bibliography by Williamson (1977) listed about 3,500 publications in this field. In the subsequent decade, that body of work has grown exponentially. At least one peer-reviewed journal, Quality Review Bulletin (QRB), is oriented exclusively to quality measurement and assurance. Also, the first issue of Quality Assurance in Health Care, the official journal of the International Society for Quality Assurance in Health Care (based in Stockholm, Sweden) has just appeared (Jessee et al., 1989). The nursing literature on quality assurance is also very extensive (Lang and Kraegel, 1989). Several publications, such as the Journal of Quality Assurance and the Journal of

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I Nursing Quality Assurance, are devoted to operational and management aspects of quality of care. Despite these targeted publications, this quality assurance work tends to be scattered over a wide array of clinical, management, evaluation, and health services research publications. Thus, tracking the knowledge base is a very difficult task. In the spring of 1988, two leading journals published special issues on quality of care (Health Affairs, 1988; Inquiry, 1988). Several subjects have become especially topical: (1) measurement of patient outcomes and health status; (2) the impact of Medicare’s Prospective Payment System (PPS) and other financing schemes on quality of care (Heinen et al., 1988; ProPAC, 1989; PPRC, 1989); (3) the extraordinary and unexplained variations in population-based rates of use of services across like geographic areas (Chassin et al., 1986; Schroeder, 1987; Brook et al., 1989); and (4) appropriateness of diagnostic and therapeutic procedures and ways to feed information on utilization back to clinicians in those geographic areas.3 Several federal agencies support work in quality assessment and assurance. The National Center for Health Services Research (NCHSR) has funded quality assessment studies for two decades (Brook and Lohr, 1985; Komaroff, 1985). NCHSR has also supported work in many related areas, such as patient and provider relations (Becker, 1985; Inui and Carter, 1985), health information systems (Pryor et al., 1985; Steinwachs, 1985), and clinical decision making (Doubilet and McNeil, 1985). With the new Agency for Health Care Policy and Research (AHCPR), especially its Medical Treatment Effectiveness Program, these efforts can be expected to grow. The Health Care Financing Administration (HCFA) Office of Research and Demonstrations (ORD) supports nearly 300 research, evaluation, and demonstration projects on many health services and health policy topics relating to Medicare and Medicaid (ORD, 1988). The major focus is the relationship of Medicare program expenditures to reimbursement, coverage, eligibility, and management, but some studies examine the impact of the Medicare program on beneficiary health status, access to services, and use of services. As of 1988, for instance, HCFA was sponsoring about two dozen projects related directly or indirectly to quality of care (ORD, 1988), and the agency had proposed an “effectiveness initiative” to study and document the effectiveness of medical interventions of particular concern to the Medicare program (Roper and Hackbarth, 1988; Roper et al., 1988; IOM, 1989). HCFA’s Health Standards and Quality Bureau (HSQB) and the Peer Review Organizations (PROs) are embarking on pilot projects related to assessing quality of care delivered to Medicare enrollees. HSQB also oversees the development of a Uniform Needs Assessment Instrument for evaluating the needs of Medicare patients for posthospital care. Finally, the American Medical Review Research Center (AMRRC, a PRO membership organization) is conducting a small area variations study that will compare

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I utilization and outcomes across geographic areas and feed practice-pattern information back to physicians in those areas. The private sector also supports work related to quality assessment, quality assurance, and patient health status. One case in point is the Robert Wood Johnson Foundation (1989), which is initiating a large-scale effort in hospital quality assurance. Other foundations, such as The John A.Hartford Foundation and the Pew Memorial Trust, support studies relating to utilization management and appropriateness of invasive procedures. The Henry J.Kaiser Family Foundation has funded work on functional health outcomes and health status measurement (Tarlov et al., 1989). In addition, major business coalitions are beginning to devote considerable attention to quality assessment and quality improvement; one instance is the work of the Midwest Business Group on Health (MGBH, 1989). Gaps in the Current Research Base This array of work and investment in quality-of-care studies is useful, but many gaps and deficiencies remain. Most quality assessment research has been narrowly focused on evaluating the level of quality of care for specific diagnoses, groups of patients, or types of institutions. Although perhaps only a small number of diagnoses or procedures may make up most of the issues in quality of care, past work tends not to be easily generalizable to other diagnoses, patient populations, or institutions. Research into quality assurance and improvement is sparse. Very little is known about how to change the habits, practice styles, and standard operating procedures of physicians, nurses, and other caregivers, of institutions such as hospitals or prepaid group practices, or of health care organizations such as home health agencies. This gap is particularly significant for the quality assurance and continuous improvement models described in Chapter 2. Little is known about the links between the process of care and the outcomes of care. In the absence of reliable and valid information about these relationships, reliable and valid measurements of quality of care are more difficult to construct; hence, changes in medical, nursing, and institutional practices are even more difficult to bring about. The “art of care” deserves more attention. Little information is available on important aspects of the patient-provider relationship, on the role of patient values and expectations in achieving good outcomes, or on effective communication styles. Similarly, although the literature on patient satisfaction is growing (Cleary and McNeil, 1988), our understanding of how best to gather and to use information from patients, family members, and consumers in quality measurement and assurance efforts is only at a formative stage (Davies and Ware, 1988; Kaplan and Ware, 1989). A related void in the knowledge base concerns data and data bases,

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I although investigators are becoming more proficient at using some administrative data banks for research purposes (Roos, 1989). Among the questions deserving further study are the following: how best to gather quality-related information; how to validate the accuracy of data elements in patient management or insurance claims systems; and how to transmit, store, share, and link data and data files, yet protect patient and provider confidentiality and privacy. Finally, we know relatively little about how most effectively to feed back quality-related information to practitioners and institutional providers. These lacunae in the knowledge base for quality measurement and assurance might be characterized as falling into one of three stages. They are (1) basic research (e.g., on measuring patient outcomes and on efficacy and effectiveness of health care interventions), (2) applied research (e.g., on translating the results of basic research into information and tools that can be employed in quality assurance programs), and (3) diffusion (e.g., the actual incorporation of such information and tools into real-life programs and the evaluation of those programs). The remainder of this section discusses key topics identified (somewhat arbitrarily) in these stages (Table 11.1), which we believe deserve high priority attention and funding. Priorities for Basic Research Table 11.1 illustrates the three basic stages of the research process into which we have categorized topics or areas of need for additional research. This table does not give an exhaustive account of research subjects, and some topics are discussed more fully than others in the following sections. Variations, Effectiveness, and Appropriateness of Medical Care Interventions The quality of care for Medicare beneficiaries can differ considerably from one area to area, beneficiary to beneficiary, doctor to doctor, and hospital to hospital. The appreciable variation in the use of services across areas or organizations is worrisome; nevertheless, we do not know from the literature on variations in care whether some people are getting too little care and others too much, because appropriateness cannot be inferred from low or high rates of use. Thus, it will be necessary to continue to study population-based variations in use of services and to document whether and how differences in rates correspond to differences in appropriateness. The research community recognizes that many medical services are of little or no benefit to patients; some pose a substantial risk to patients (PPRC, 1989). Bunker (1988) contended that perhaps only 20 percent of what physicians do every day has been shown to be of clear value by well-designed clinical studies.

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I TABLE 11.1 Topics and Stages of Research in Quality Assessment and Assurance Basic Research Applied Research Diffusion Variations, effectiveness and appropriateness Process of care measures Technical measures Art of care measures Outcomes, health status, and quality of life Continuous improvement models       Linking process and outcome Practice guidelines Effectiveness of quality assurance interventions Setting-specific issues hospitals ambulatory care home health care health maintenance organizations Effect of organization and financing on quality assurance Rural health care       Data systems and hardware Data sharing Data feedback and disclosure Program evaluation Decisions to provide services are influenced by many factors including the organization of practice, reimbursement incentives, and availability of resources. Physicians often do not have enough information to predict whether a particular service or procedure will benefit the patient. Wennberg (1984), for instance, attributed much of the variation in the use of services to physician uncertainty. Part of the reason for poor understanding of variations and appropriateness is the lack of broadly accepted information on effectiveness of serv-

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I ices. Effectiveness, defined by PPRC (1989) as the probability of benefit to a given individual from a medical procedure applied to a given medical problem, relates to the value of resource use—that is, the combination of quality and cost. According to Roper and Hackbarth (1988), the goal of effectiveness research is to assure that any given patient receives the maximum benefit in improved health for any given level of health care expenditure. Appropriateness relates the procedures recommended for a given patient to the current knowledge of effectiveness. Knowledge about effective and appropriate medical care can be increased through clinical and health services research, including clinical trials, epidemiological studies, analysis of cost effectiveness, and assessment of techniques to influence clinical decision making. Process-of-Care Measures Technical aspects of care. Process-of-care measures have long been the yardsticks against which to measure quality of care. Properly evaluating the technical process of care requires the use of explicit criteria. Much needs to be done in the area of developing adequate process measures. This topic may be more an issue of application than of basic research; for instance, ways need to be found to make good criteria sets, which may be developed for research or program evaluation purposes, more easily accessible to quality assurance professionals. Process criteria typically contain statements about diagnosis- or problem-specific elements of care that practitioners agree are relevant, important, and measurable. For instance, criteria sets may ask whether the right problems were identified and diagnosed, whether the correct diagnostic steps were taken, whether the appropriate treatments were recommended or delivered, and whether those treatments were correctly administered in a timely fashion. Developing criteria sets that are reliable, valid, and parsimonious with respect to data-collection requirements is a very difficult task, and existing criteria sets vary widely in these respects. Very few meet the standards of clarity, validity, reliability, flexibility, and clinical adaptability discussed in Chapter 10. Art-of-care measures. The art of care is both extremely important and difficult to measure. This interpersonal dimension includes the practitioners’ responsiveness to patient needs, ability to elicit information about patient preferences for treatment alternatives and generally their caring attitude. These aspects resist quantification, but they influence outcomes of care, often in the form of patient satisfaction. A substantial research effort is needed to establish the reliability, validity, and generalizability of the

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I concepts and methods for measuring the art of care. These include the use of videotapes, written transcripts, and audiotapes in research settings and interviews, questionnaires, and self-report measures in ordinary practice settings. A better understanding of the interpersonal and communication aspects of the care process implies a need to appreciate which factors can erode the sense of trust implied by the phrase the “doctor-patient relationship.” Some attention should be given to the pressures on physicians that may undermine their relationship with patients. These include malpractice concerns and intrusive utilization management. Also important is the extent to which patients and their families appreciate the effect of such forces and pressures on practitioners. Outcomes, Health Status, and Quality of Life The importance of using patient outcomes in quality-of-care measurement is unquestioned. Measuring outcomes is a very complex task, and the need continues for research into the development of valid, reliable, and practical outcome measures. Research in this area should be viewed more broadly than merely the assessment of clinical or physiologic end results. It should include assessments of several dimensions of health and health-related quality of life as well as patient satisfaction. Four basic facets of outcomes research warrant further examination (Lohr, 1988). The first is the link between process of care and outcomes, which is discussed below with respect to applied research. Second is the assessment of medical technologies in ways that will provide useful information about process of care; it underscores the need to strengthen the relationship between technology assessment and quality assessment (Brook, 1988; Greenfield, 1988; Mosteller and Falotico-Taylor, 1989). A third facet of outcomes research calls for better ways to adjust outcome measures for severity of illness. Although HCFA has sponsored a large body of work in this area (ORD, 1988), severity adjustment remains a major area of contention; without agreed-on adjusters for severity (or risk), outcome measurement in quality assurance will always be open to criticism. Related to this is the need to improve the reliability and validity of outcomes as ways to screen for potentially poor quality care. Mortality statistics in which severity or expected patient outcomes are not well controlled, for example, can be very misleading. Fourth and most critical is the need to expand and improve measures of health status and functional outcomes measures. Several good instruments exist. More are needed, for different settings of care for the elderly generally and for particular subgroups such as the very old or very frail. Al-

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I though consensus about the appropriate domains of health status and quality of life to measure is considerable, this field is constantly evolving, and new concepts and measures (e.g., social and role functioning, and vitality) are continually being proposed, developed, and tested. Other conceptual problems center on how health status scales should be scored to yield summary information for quality assessment and assurance uses and whether health status scales can and should be aggregated into more global indexes. Steady support for research in this area is critical if the field is to avoid a confusing proliferation of measures whose similarities or differences are not apparent to or understandable by clinicians or quality assurance professionals. The practical strengths and limitations of existing health status measures should be studied. Important problems involve length and complexity of questionnaires and obstacles to administration such as illiteracy, blindness, deafness, and language barriers. Methodologic studies should answer questions such as: What are the best ways to collect information directly from patients? How can medical record or insurance claims data be linked with those outcomes? How much information can be obtained from self-reports, especially by telephone? How can information be obtained from frail geriatric patients, especially those in long-term-care institutions? Is it possible to use “representative” patients (akin to Nielsen raters for television)? Continuous Improvement Models Research funding for continuous improvement should be directed to several different questions. First is to understand better the ways in which health care organizations can most effectively undertake the shift to the continuous improvement model. The move to implement this model is complex and time-consuming; knowing what strategies make it more feasible throughout an organization would be an important question to answer. A second issue concerns how to demonstrate to external customers (i.e., to patients, payers, and the community) the “value added” by fully implementing the continuous improvement approach. Third is the need to explore how health care is different from other industries (manufacturing, utilities, or other service industries such as education) and what that implies for the application of the continuous improvement model. Fourth, health care gives licenses for people to do things to other people (for good or for harm), which is not the same as a license to manufacture a car or to produce electricity. Therefore, there will always be a need for regulatory procedures, but how to achieve a blending of regulatory approaches with the internal, organization-based continuous improvement approaches is a difficult question warranting direct study.

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I Priorities in Applied Research Linking Process and Outcomes We have emphasized the need for basic research to develop and document good process and outcome measures because quality assessment and assurance will always need both types of measures. Establishing a causal link between process and outcome is also crucial. To understand the links (or lack thereof) between process of care and outcome requires that one develop complex models that encompass a full range of health outcomes, take into account different clinical approaches to the same clinical problems, and permit comparisons of process and outcome across different organizational settings and payment structures. The link between process and outcome must embody principles of patient values and preferences. Although these issues might be thought to be a matter of basic research, we discuss them here because well documented process-outcomes links are crucial to applied quality assurance. Two major points for operational programs should be underscored. First, in quality assessment, making the appropriate choice of quality measures (e.g., process measures for physician office-based care or outcomes for long-term care) is critical. This task is facilitated when the relationships between processes of care and expected results for patients are reasonably well understood. Second, in quality assurance, the aim is to understand enough about problems in performance to know what to fix; outcome measures lacking a strong tie to process do not provide adequate guides to an operational quality assurance program. Quality-of-care measures must encompass patient values and preferences. We know little about patient attitudes toward, expectations for, and preferences about health and health care or about how they might differ according to the patient’s sociodemographic characteristics or health status. We know less about how to build such concepts into measures of quality of care, and whether they should be reflected in measures of technical or interpersonal care, in outcome measures, or both. Practice Guidelines Practice guidelines give recommendations about the appropriateness of medical interventions and are thought to contribute to better patient management.4 As discussed above, relevant basic research in the realms of efficacy, effectiveness, and appropriateness will provide the intellectual and clinical base for clinical standards and guidelines. AHCPR, which has a

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I contract reimbursement have to meet certain federal conditions, which typically concern structural aspects of the plans more than process or outcomes of care. Research into the links between those structural components and process and outcome measures would be useful for external regulatory programs. Hornbrook and Berki (1985) identified research priorities within the HMO industry. They included (1) the extent to which variations between prepaid group practices and fee-for-service settings arise from differences in resource availability, practice patterns, or management approaches; (2) the effect of duration of enrollment on the use and cost of health services and health status; and (3) the impact of membership in HMOs for special populations such as the elderly, the disabled, or the terminally ill. These questions, although only tangentially related to quality measurement and assurance, continue to warrant further investigation. Rural Health Care Several organizations (such as HCFA, the Robert Wood Johnson Foundation, the American Hospital Association, and the W.K.Kellogg Foundation) currently support research on the delivery of health care in rural areas, but additional work on assessing and improving the quality of care delivered to one of the nation’s most vulnerable populations is justified. Congress has emphasized the need for studies on (1) the future of rural hospitals, (2) long-term health care for the rural elderly, (3) hospital care for the rural poor and uninsured, and (4) alternative delivery systems and managed care in rural areas. Among the questions that might be addressed are the following: What socioeconomic and demographic factors most affect access to health care services, use of services, and quality of care received by residents of rural areas, especially the elderly? What is the impact of a sole provider rural hospital on pricing, costs, and quality of health care services in rural areas? In addition, we believe that research support should be directed at developing and testing specialized external quality review and assurance programs for small rural hospitals (or networks) that cannot undertake their own internal programs. We also endorse the development, testing, and dissemination of methods to extend the resources of rural health-care providers through such mechanisms as telecommunication for consultation, continuing medical education, and remedial education. Effect of Organization and Financing on Quality Assurance Activities Understanding the generalizability (or external validity) of quality assessment and assurance methods is important because such approaches are generally intended to be universal in their application. Organizational and

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I financing arrangements influence the quality of care provided and limit the generalizability of quality assessment and assurance methods (Donabedian, 1989). These arrangements and their effects should be studied for the lessons to be learned about applying various assessment and assurance techniques to different settings and payment arrangements. As discussed in Chapters 8 and 9, controls over recruitment and staffing, equipment and material resources, and direct supervision of professional work may well be correlated with higher quality (Donabedian, 1989). One important topic for investigation, therefore, is the effects of structural characteristics, incentives (financial or other), and leadership styles on quality. Priorities for Diffusion Data Systems and Hardware Efforts to improve the Medicare data bases will continue; one objective is to enhance their usefulness for quality measurement and quality assurance. Several problems should be addressed, including: (1) their content (e.g., only crude outcome measures are available); (2) the extensiveness and detail of information on diagnosis and services rendered; and (3) the reliability and validity of coded data (especially on diagnosis and procedures). Related to these problems are issues of key quality-related data missing because the services are not covered (e.g., prescription medications). A recent IOM project has identified limitations to the use of the Medicare files for effectiveness research (IOM, 1989; IOM, forthcoming), and the same drawbacks apply for quality assurance. The steps needed to overcome these problems do not, strictly speaking, lie in the realm of research; rather they need to be taken to enhance the possibility of doing quality-related research, and quality measurement and assurance, with insurance claims and administrative data. Mechanisms are needed by which ambulatory claims data from the Medicare/Medicaid Decision Support Systems (see Appendix B of Chapter 4) can be used to screen for potential quality-of-care problems warranting more in-depth review or monitoring. Use of the Uniform Clinical Data Set in quality-of-care review (Chapter 6) should be evaluated further. Also, the addition of any health status measure to the Medicare insurance claims or other billing forms must be rigorously evaluated. Outside the realm of the Medicare claims data files lie medical records and clinical information systems. Health care data systems are evolving: from informal (often idiosyncratic), manual systems for recording patient information, to personal computers for storing or analyzing small amounts of information, to mainframe systems for manipulating large files of clinical, administrative, and billing information. Further development and re-

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I finement of these systems and better empirical work in how to use them in quality review and assurance programs are needed. Among the questions to be addressed is how to promote greater uniformity and standardization among systems maintained by different providers and programs. Using mainframe systems, personal and laptop computers (such as computer-assisted telephone interviewing and computer-assisted personal interviewing), and electronic record technologies should be studied in all facets of the quality assurance loop—data collection and analysis, provider feedback, and education. Another topic is how to build more patient-reported information, for example, on health status, into such systems. The final question is how to develop personal-computer-based algorithms for quality review. Data Sharing The multiplicity of external review activities we have observed throughout this study results in unacceptable duplication of effort, appreciable waste of resources, and considerable frustration on the part of providers. To minimize this duplication, some research funds should be devoted to developing ways that quality-related data can be shared in a timely manner among review entities. This would explicitly include examining the extent to which data collected by practitioners or institutional providers for an external agency or group (such as a state-mandated data commission or the Joint Commission) might substitute for data that the Medicare quality assurance program would otherwise require or collect. Interested parties will have to agree on specifications for standard clinical data sets for all settings in which Medicare beneficiaries receive care. Requirements concerning psychosocial and other health status profiles should be a part of those specifications. Data Feedback and Disclosure Two major issues arise with respect to the diffusion of quality-related information: feedback to practitioners and providers, and disclosure of information to the public. At the core of quality assurance is the need to make data available to providers in a steady stream to support their own activities and to serve as benchmarks for more detailed data analysis, while balancing the needs of privacy, confidentiality, and due process. The quality assurance field has little in the way of a conceptual framework and theory of feedback at present, and even less in terms of effective feedback mechanisms in place. Considerable attention should be given to this gap. Some research funds should be invested in understanding how best to make quality-related information useful to, and available to, patient and consumer groups and the public at large. Although the release of hospital-

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I specific mortality rate data has established the principle of the public’s right to such information, it is not clear that the approach taken has been of particular use to either the provider or the patient community. Care must be taken to present data in ways that are useful to the intended audiences, rather than in ways that may anger, intimidate, or frighten them. The release of provider-specific quality-related data also raises difficult problems concerning privacy, confidentiality, and due process issues. Individual rights and protection must be balanced with society’s need for more and better aggregate information about medical practice and patient outcomes. The IOM examined these questions with respect to the Professional Standards Review Organization program some years ago (IOM, 1981) and they warrant reviewing in the context of our proposed Medicare quality assurance program. Evaluation Program evaluation and evaluation research are major disciplines in their own right. The principles and tools developed in those fields have not been systematically applied to the evaluation of quality assurance programs. We believe that research efforts relating to evaluation should be directed at three major questions. First, how should the government evaluate the impact of the Medicare quality assurance programs on quality of care for the elderly? Evaluation criteria grounded in cost containment and cost savings do not seem appropriate for a quality assurance emphasis; criteria are needed that will reflect an effect (or lack of it) on quality of care. Second, what techniques could be used by a federal program (especially one that moves away from strict contracting toward grants, cooperative agreements, or other hybrid financing mechanisms) to evaluate its local agents? Third, what techniques would best let external quality assurance evaluators reduce intrusive external review for providers and practitioner groups when that is warranted by good performance and increase review for poor performance? Related to this is how to identify exemplary performers who might warrant special recognition or additional relief from external review. CAPACITY BUILDING We are not convinced that research by itself can accomplish improvements in quality measurement and assurance techniques needed for progress in this field. The capacity for conducting successful quality assurance programs calls for more than methods; it requires well-motivated and well-trained personnel. Thus we emphasize the need for investments in the

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I training and development of professionals in the field of quality assurance and assessment. Because ultimately quality assurance cannot proceed without an appreciation of its purposes, methods, strengths, and limitations by the patient population, we also comment briefly on issues relating to patient education. Professional Education Capacity building can be viewed as having both short- and long-term components. In the short run, concepts and methods of quality assurance must be introduced to health care professionals already practicing in the health care field, and technical assistance must be provided to them. The aim is to train established professionals to assume responsibility for and to take leadership roles in quality assurance. Methods to achieve these goals can take several forms. CME courses and in-service training programs can be used to introduce the need for, and the concepts and methods of, quality assessment and assurance. Curricula may be developed and implemented by quality assurance associations, such as the National Association for Quality Assurance Professionals (NAQAP) or the Joint Commission and by professional associations such as the Association of American Medical Colleges, the Association of Schools of Public Health, the Council of Medical Specialty Societies, the American Nurses Association and National League for Nursing, and similar organizations. Quality assurance should be seen as a viable career path for physicians and other clinical professionals in much the same way as clinical administration has become a career path for some practitioners. For instance, NAQAP offers certification for professionals in quality assurance based on a written examination. However, practicing physicians must always be involved in quality assurance. Thus, the notion of developing career opportunities for practitioners does not imply that quality assurance can or should be delegated to a cadre of “specialists” in quality assurance. Longer-range capacity building involves education and training in the concepts and tools of quality assurance as part of undergraduate and graduate professional training. Although we recognize that medical, nursing, and other training programs are already heavily burdened with teaching basic subject matters and skills as well as staying abreast of new areas of knowledge, we believe that the professionalism of health professionals requires a greater investment in the quality-of-care field. Closely allied to the need for more health professionals trained in and committed to quality assurance is the need for better-trained researchers, especially those who will be in the forefront of research into quality measurement and assurance like that advocated in this chapter. Health professionals and researchers must gain proficiency in areas such as study design

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I and statistics, clinical epidemiology, decision analysis, health law, information processing, and the like. Patient Education Informed consumers capable of asking questions and evaluating information about quality of care and quality assurance programs must be an integral part of the quality assurance process. By emphasizing desired patient outcomes in our quality-of-care definition, we are also emphasizing that informed patients who can participate effectively in decision making about their care are critical to good quality care. The federal government should fund, sponsor, or produce printed and audio-visual materials for distribution to Medicare beneficiaries. These could take the form of newsletters, brochures, television programs, tapes, and the like. Such products should explain the Medicare program’s interest in quality of care and how the program seeks to review and assure the quality of the care that it covers. These materials should also stress the importance of responsible, knowledgeable beneficiaries. These communications should be geared to a range of educational, income, and cultural backgrounds. They should be simply written and include a steady stream of findings from research about the effectiveness of medical treatments. They should be augmented by an 800 number telephone line, by which Medicare beneficiaries or their representatives could gain leads to appropriate sources of information about the risks and benefits of care and about qualified providers of care. Because such information must be presented in a useable manner, the identification of practical dissemination techniques that will reach and be responsive to the public is crucial. Continuous Improvement Capacity building and training for continuous improvement have these same needs, particularly to develop the relevant curricula for graduate medical, nursing, and administrative education. Continuous improvement has three special foci as well: customer knowledge, the focus on processes, and statistical thinking. First, we know very little about what patients, employees, health care professionals, payers, and others need and want to know about quality of care, and even less about how the continuous improvement models (or indeed any quality assurance program) can satisfy those needs and wants. What might be called market research on these topics would be useful. Second, the process focus calls for attention to many repeated actions over time; in health care this can include repetitive steps in taking histories and physicals, ordering, processing, or reporting laboratory tests;

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I prescribing and dispensing medications; maintaining adequate medical records; and producing and sending bills. We need to develop better ways to help people understand the repetitive content of what they do so that they can recognize and correct inefficient aspects of these processes. Third, actions that continue over time are measurable and testable with statistical tools, but people are often apprehensive of learning and applying methods or instruments with even a simple mathematical basis. The issue is tied to problems of “enumeracy” in the society as a whole, but for implementing the continuous improvement model it means that some attention has to be given to training all members of the health care organization in the use of the basic tools of quality control. FUNDING ISSUES This chapter has focused on research priorities and capacity building. Meeting these needs would not be carried out solely by our proposed Medicare quality assurance program. Indeed, in some cases this would clearly be neither desirable nor practical. Rather we expect that, of the work to be funded by the federal government, several agencies must be involved. Within HCFA, ORD would probably have a major role, although funding for pilot projects (like those now being conducted by the PROs) might continue to come through HSQB. The field of health services research has the most direct links to research on quality assessment and assurance, so we would expect AHCPR to have the major role in funding extramural research projects of the type recommended earlier in this chapter. The efforts of major private sector groups will contribute greatly to these goals. Major foundations and groups within the business community have begun to invest in important projects. We hope that our research agenda will prove helpful to these parties as well. With respect to capacity building, we note that elements of the DHHS Public Health Service other than AHCPR, most particularly those concerned with education and training of health professionals, will be significant. Again, the role of the private sector, including especially the major professional and educational associations, will be critical to the future success of these efforts. SUMMARY This chapter has discussed research needs and capacity building. We categorized research priorities, somewhat arbitrarily, into one of three stages: basic research, applied research, and diffusion. Priorities for basic research included the following topics: (1) variations, effectiveness, and appropriate-

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I ness of medical care interventions; (2) process-of-care measures for both the technical aspects of care and the art of care; (3) outcomes, health status, and quality of life; and (4) continuous improvement models. Priorities in applied research included: (1) linking process and outcomes; (2) practice guidelines; (3) effectiveness of quality assurance interventions; (4) various setting-specific issues (relating to hospitals, ambulatory care, home health care, and HMOs); (5) rural health care; and (6) the effects of organizational and financing arrangements on quality of care and quality assurance. Finally, with respect to diffusion, we identified the following areas as warranting continued work and investigation: (1) data systems and hardware; (2) data sharing; (3) data feedback and disclosure; and (4) program evaluation. Improvements in quality assurance and assessment call for much greater investment in the training of professionals in these fields. Capacity building must also include the patient, because informed patients are an integral part of successful quality assurance. NOTES 1.   Berwick does not explicitly distinguish efficacy (what works in ideal or controlled trial settings) from effectiveness (what works in the day-to-day practice of medicine) (OTA, 1978; Brook and Lohr, 1985), but his conceptualization can be understood to accommodate that distinction. 2.   Chapters 8 and 9 of this volume discuss issues relating to quality-of-care measurement and quality assurance. Chapter 6 of Volume II describes different approaches to preventing, detecting, and correcting quality of care problems; it includes an extensive bibliography on these topics and a number of exhibits. 3.   These types of issues are often subsumed under rubrics such as outcomes research and effectiveness research, both of which were receiving considerable support at the federal level and in the Congress as this study was being conducted. Several bills were introduced into the House of Representatives and the Senate during 1989 to strengthen the role of the Department of Health and Human Services (DHHS), and more particularly the Public Health Service, in research of this sort. The titles of the bills (e.g., “The Medical Care Quality Research and Improvement Act”; “The Patient Outcomes Research Act”) make clear their intent. Among the steps contemplated was the creation of a new agency on health care research and policy. In addition, agency budgets would be increased for research into patient outcomes and the effectiveness of health care technologies and practices, the development of practice guidelines, and the appointment of various national advisory councils. These initiatives were still being debated as this report was being prepared. In December 1989, Title IX of the Omnibus Budget Reconciliation Act of 1989 (P.L. 101–239) terminated the National Center for Health Services Research and replaced it with the Agency for Health Care Policy and Research, a larger research organization in the Public Health Service. This move is seen as a significant expansion of the relevant research capacity of the DHHS.

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I 4.   Chapter 10 discussed the important characteristics of technology- and procedure-specific appropriateness guidelines and their uses both as an educational tool for clinicians and as a mechanism for controlling the use of inappropriate and unnecessary services. 5.   As explained earlier in this report, we did not include nursing home care in this study, but defining quality of care for the elderly broadly means that nursing home care cannot be overlooked. The nursing home setting provides unique opportunities for research into the quality and continuity of care for a relatively stable population and for particular groups of patients, such as the very old or those with chronic, disabling diseases. The IOM made a series of recommendations to Congress about necessary changes within the industry to improve quality of care (IOM, 1986). We concur with research recommendations advanced by that commission. First were factors that affect demand for nursing home care: the rate and direction of change in health status at advanced ages (which affects survival and the risk of institutionalization), increases in the availability of alternative long-term care services, and the influence of PPS or other cost containment measures on the supply of, demand for, and availability of nursing home beds. Second, that IOM committee argued that more work was needed to develop minimum nursing staff requirements (with respect to qualification and training) based on case-mix and to compare the effectiveness of different staffing patterns, types of staff, and training requirements. Finally, that IOM report recommended a study on the costs and benefits of single-occupancy versus multiple-occupancy rooms on the quality of life of nursing home residents. We would supplement these efforts with work on outcomes of care, particularly measures that relate actual to expected outcomes. REFERENCES Becker, M.H. Patient Adherence to Prescribed Therapies. Medical Care 23:539–555, 1985. Berwick, D.M. Health Services Research and Quality of Care: Assignments for the 1990s. Medical Care 27:763–771, 1989. Brook, R.H. Quality Assessment and Technology Assessment: Critical Linkages. Pp. 21–28 in Quality of Care and Technology Assessment. Lohr, K.N. and Rettig, R.A., eds. Report of a Forum of the Council on Health Care Technology. Washington, D.C.: National Academy Press, 1988. Brook, R.H. and Lohr, K.N. Efficacy, Effectiveness, Variations, and Quality: Boundary-Crossing Research. Medical Care 23:710–722, 1985. Brook, R.H., Kamberg, C.J., Mayer-Oakes, A., et al. Appropriateness of Acute Medical Care for the Elderly. R-3717-AARP. Santa Monica, Calif.: The RAND Corporation, 1989. Bunker, J.P. Is Efficacy the Gold Standard for Quality Assessment? Inquiry 25:51–58, 1988. Chassin, M.R., Brook, R.H., Park, R.E., et al. Variations in the Use of Medical and Surgical Services by the Medicare Population. New England Journal of Medicine 314:285–290, 1986.

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I Cleary, P.D. and McNeil, B.J. Patient Satisfaction as an Indicator of Quality Care. Inquiry 25:25–36, 1988. Davies, A.R. and Ware, J.E. Involving Consumers in Quality Assessment. Health Affairs 7:33–48, Spring 1988. Donabedian, A. Reflections on the Effectiveness of Quality Assurance. Paper prepared for the Institute of Medicine Study to Design a Strategy for Quality Review and Assurance in Medicare, 1989. Doubilet, P. and McNeil, B.J. Clinical Decisionmaking. Medical Care 23:648–662, 1985. Eddy, D. Variations in Physician Practice: The Role of Uncertainty. Health Affairs 3:74–89, Summer 1984. Greenfield, S. The Challenges and Opportunities that Quality Assurance Raises for Technology Assessment. Pp. 134–141 in Quality of Care and Technology Assessment. Lohr, K.N. and Rettig, R.A., eds. Report of a Forum of the Council on Health Care Technology. Washington, D.C.: National Academy Press, 1988. Health Affairs 7:1–113, Spring 1988. (Special Issue. The Pursuit of Quality.) Heinen, L., Gorski, J.A., and Roe, W. Quality of Care Research and Projects in Progress. Health Affairs 7:145–150, Spring 1988. Hornbrook, M.C. and Berki, S.E. Practice Mode and Payment Method: Effects on Use, Costs, Quality, and Access. Medical Care 23:484–511, 1985. Inquiry 25:1–192, Spring 1988. (Special Issue. The Challenge of Quality.) Inui, T.S. and Carter, W.B. Problems and Projects for Health Services Research on Provider-Patient Communication. Medical Care 23:521–538, 1985. IOM (Institute of Medicine). Health Services Research. A Report of a Study. Washington, D.C.: National Academy Press, 1979. IOM. Access to Medical Review Data. A Report of a Study. Washington, D.C.: National Academy Press, 1981. IOM. Improving the Quality of Nursing Homes. Washington, D.C.: National Academy Press, 1986. IOM. Effectiveness Initiative: Setting Priorities for Clinical Conditions. A Report of a Study. Washington, D.C.: National Academy Press, 1989. IOM. Effectiveness and Outcomes of Health Care. Report of a Conference. Washington, D.C.: National Academy Press (forthcoming), Jessee, W.F., Reerink, E., Reizenstein, P., et al. Quality Assurance in Health Care. Editorial. Quality Assurance in Health Care 1:1, 1989. Kaplan, S.H. and Ware, J.E. The Patient’s Role in Health Care and Quality Assessment. Pp. 25–68 in Providing Quality Care: The Challenge to Clinicians. Goldfield, N. and Nash, D., eds. Philadelphia, Pa.: American College of Physicians, 1989. Komaroff, A.L. Quality Assurance in 1984. Medical Care 23:723–734, 1985. Lang, N. and Kraegel, J. Quality of Health Care for Older People in America. Paper prepared for the Institute of Medicine Study to Design a Strategy for Quality Review and Assurance in Medicare, 1989. Lohr, K.N. Outcome Measurement: Concepts and Questions. Inquiry 25:37–50, 1988. Lohr, K.N., Yordy, K.D., and Thier, S.O. Current Issues in Quality of Care. Health Affairs 7:5–18, Spring 1988.

OCR for page 343
Medicare: A Strategy for Quality Assurance - Volume I MBGH (Midwest Business Group on Health). Value-Managed Health Care Purchasing: An Employers Guidebook Series. Volume I: Project Conclusions; Volume II: Health Care Quality Assessment; Volume III: Purchasing System Evaluations; Volume IV: Site Specific Results on Health Care Purchasing. Chicago, Ill.: MBGH, 1989. Mosteller, F. and Falotico-Taylor, J., eds. Quality of Life and Technology Assessment. Monograph of the Council on Health Care Technology. Washington, D.C.: National Academy Press, 1989. ORD (Office of Research and Demonstrations). Status Report, Research and Demonstrations in Health Care Financing. Baltimore, Md.: Health Care Financing Administration, January 1988. OTA (Office of Technology Assessment). Assessing the Efficacy and Safety of Medical Technologies. OTA-H-75. Washington, D.C.: U.S. Government Printing Office, 1978. PPRC (Physician Payment Review Commission). Annual Report to Congress. Washington, D.C.: Physician Payment Review Commission, 1989. ProPAC (Prospective Payment Assessment Commission). Medicare Prospective Payment and the American Health Care System: Report to the Congress . Washington, D.C.: Prospective Payment Assessment Commission, 1989. Pryor, D.B., Califf, R.M., Harrell, F.E., et al. Clinical Data Bases: Accomplishments and Unrealized Potential. Medical Care 23:623–647, 1985. Reinhardt, U. Statement of the Association for Health Services Research on the Medical Care Quality Research and Improvement Act (H.R. 1692). May 1989. The Robert Wood Johnson Foundation. Call For Proposals: Improving the Quality of Hospital Care. Princeton, N.J.: The Foundation, May 1989. Roos, L.L. Nonexperimental Data Systems in Surgery. International Journal of Technology Assessment in Health Care 5:341–356, 1989. Roper, W.L. and Hackbarth, G.M. HCFA’s Agenda for Promoting High-Quality Care. Health Affairs 7:91–98, Spring 1988. Roper, W.L., Winkenwerder, W., Hackbarth, G.M., et al. Effectiveness in Health Care. An Initiative to Evaluate and Improve Medical Practice. New England Journal of Medicine 319:1197–1202, 1988. Schroeder, S.A. Strategies for Reducing Medical Costs by Changing Physician Behavior: Efficacy and Impact on Quality of Care. International Journal of Technology Assessment in Health Care 3:39–50, 1987. Steinwachs, D.M. Management Information Systems: New Challenges to Meet Changing Needs. Medical Care 23:607–622, 1985. Tarlov, A.R., Ware, J.E., Greenfield, S., et al. The Medical Outcomes Study: An Application of Methods for Monitoring the Results of Medical Care. Journal of the American Medical Association 262:928–943, 1989. Wennberg, J.E. Dealing with Medical Practice Variations: A Proposal for Action. Health Affairs 3:7–32, Summer 1984. Williamson, J.W. Improving Medical Practice and Health Care: A Bibliographic Guide to Information Management in Quality Assurance and Continuing Education. Cambridge, Mass.: Ballinger Publishing Co., 1977.