- Email: [email protected]
Clinical Research in the Managed Care Environment
Clinical Research in the Managed Care Environment Barry D. Lebowit%, Ph.D. Gary L. Gottlieb, M.D., M.B.A. The authors present the conclusions of a workshop devoted to the challenges to clinical research in the changing environment of managed care and health care reform. They identify problems and concerns with current conditions and discuss promising opportunities/or new approaches to research. (American Journal of Geriatric Psychiatry 1995; 3:21-25)
H
ealth care in the United States is undergoing profound change. Beginning with cost-containment, moving through managed care, and, ultimately, concluding in health care reform, the nature and characteristics of the system are in flux. Whatever the final shape of the system, it will be characterized by vertical integration of community facilities, private practice physicians, and tertiary care with an increased emphasis on primary care. Other systemic characteristics will include proliferation of ambulatory care, geographic coverage, broader price reductions, and redesign of incentives encouraging cost-control rather than enhancement of financial reserves. Clinical research in the mental disorders of late life is carried out, in large part, in specialized tertiary care academic health centers that may also be affiliated with other facilities, such as the Department of Veterans Affairs Medical Centers, nursing homes, and chronic care facilities. The future of the structure, function, and viability of these institutions is precarious
in the emerging health care system. 1 A workshop of clinical investigators met in April 1994, under the auspices of the Mental Disorders of the Aging Research Branch of the National Institute of Mental Health, to consider approaches to the nurturing and continued development of research in these new circumstances. Three general areas were discussed: sources of funding for clinical research, challenges to current methodologies, and opportunities emerging for new ap.. proaches.
SOURCES OF FUNDING Clinical research must build on the clinical care of patients. The direct cost for most of this care is usually derived from health insurance or out-of-pocket payments by consumers. Research funding usually supports only procedures or treatments that are considered experimental or incremental to standard care. Greater outside control of
ReceivedJune 21,1994; revisedJuly 13,1994; accepted July 20,1994. From the National Institute of Mental Health, Rockville, MD. Address correspondence to Dr. Lebowitz, Mental Disorders of the Aging Research Branch, National Institute of Mental Health, Room 18-105, 5600 Fishers Lane, Rockville, MD 20815. THE AMERICAN JOURNAL OF GERIATIUC PSYCHIATRY
21
Clinical Research in Managed Care
resources and of the process of patient care may limit access to patient populations and funding for aspects of the care that they consume. For example, expensive diagnostic procedures like neuropsychological testing and magnetic resonance imaging that are necessary clinically and can provide key research data are more likely to be disallowed by managed health systems. The funding for research in the mental disorders of late life is overwhelmingly based on individual grants from funding agencies of the federal governnlent, particularly the National Institute of Mental Health and other units of the National Institutes of Health. The cOJnpetition for project-specific funds has grown particularly intense in this time of budgetary restraint, and budget reductions are invariably required even for that relatively small proportion of applications that are funded. Average grant size, yearly growth, and project expansion are all tightly controlled. Research personnel salaries usually account for the bulk of a project grant award, and the workshop participants considered it unlikely that patient care costs could be included as a greater part of a project budget. Private sources, including foundation awards and individual gifts, are usually targeted to large-capital campaigns or are restricted to capital investments or general program operations. Many foundations use most of their research funding to support new investigators in helping launch their research careers. New investigators are also supported through the increasingly frequent use of the creation of "term chair endownlents-modest annual gifts for a fixed period of time supporting the appointlnent of a new faculty member and providing salary support to reduce requirements for clinical responsibilities. Pharmaceutical-company-supported clinical trials have proven useful in the development of a research infrastructure and in the retention of technical staff in nU111erous acadelnic health centers. Clinical trials are llseful in the recruitment of paU
22
tients for other types of studies as well. Treatment, whether experimental or established, was identified as a critical inducement to participation for subjects for all clinical research. Commercial clinical trial organizations, for reasons of efficiency and limited focus, have displaced acacleluic centers as the predominant sites for new drug studies, however. Drug studies in non-academic settings rarely support the adjunctive studies of basic mechanisms or clinical response differentials that have no direct Inarketing implications. This fact is eroding the capacity of academic investigators to develop clinical research. State-funded mental health research institutes have nlade itnportant contributions to the clinical research infrastructure by supporting bed costs, laboratories, and other services. Only a few of these institutes relnaio, and limitations on mental health budgets have severely restricted their activities. Participants underscored the importance of continued state support for these institutes. The Medical Centers of the Department of Veterans Affairs (the VA) also provide an important foundation for acaden1ic clinical research. The VA, with its tradition of acting as an academic liaison, has developed an important capacity for clinical research supported within its own funding system and used as a resource for other sources of research funding. Investigators are increasingly concerned, however, that the VA population is limited in diversity, represented by a predominantly male, socioeconomically disadvantaged population suffering a disproportionately high prevalence of substance abuse. The General Clinical Research Centers (GCRC) program of the National Center for Research Resources of the NIH is another key resource for clinical research. Gene's facilities are available at Jnany academic medical centers and provide bed costs, laboratories, biostatistical consultation, and other components of the clinical research infrastructure. Investigators who are able to VOl.UME 3 • NUlvlBER 1 • \VINTEH 1995
Lebolvi/z and Gottlieb
gain access to these resources have found the GeRe to be particularly valuable in undelWriting S0111e research costs, especially those associated with nornlal control subjects.
CHALLENGES AND CONCERNS REGARDING CURRENT METHODOLOGIES \Vorkshop participants endorsed the need to reconsider the full range of research questions, methods, and approaches used in clinical research. For exanlple, the traditional use of inpatient hospital settings to support research is likely to be replaced by the use of ambulatory and other less intense care sites. Most observers acknowledge that health care delivery is currently flawed: too ll1any people cannot gain access to appropriate care in the current patchwork of private insurance and public entitlements; routine care is often provided in emergency and urgent care sites; the specialty and subspecialty sectors dwarf primary care resources; and rehabilitative and long-term care is often provided in the acute setting. A fortuitous outcome of this disorganization is that clinical investigators in the academic health setting have had access to large, diverse, and clinically heterogeneous populations. This sample base has provided sufficient variability to allow for further refinement and testing of hypotheses regarding etiology and pathophysiology, clinical course, response to treatment, and long-term outcome of numerous mental disorders. As the health care system is changed and vertical integration becomes more common, tertiary care facilities are becoming one component of complex systems that include community hospitals and primary care practices. As part of the creation of health care systems, workshop participants predicted pressure toward standardization THE AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
of care through the use of clinical practice guidelines 2 in prin1ary care and cOlnn1unity settings. These guidelines were predicted to result in the diversion of insured patients away froll1 Clcademic health center facilities. Outcomes derived from these changes in the process of care will require evaluation of effectiveness and other parameters of quality. This redistribution of patients will substantially affect clinical research because it will constrict the nature and range of severity of disorders that will be accessible to investigators based solely in traditional acadell1ic settings. These constraints will necessarily reduce the breadth of research questions that can be addressed. Questions that require the full range of variability and heterogeneity of a particular disorder would be more difficult to address in the academic environment. Workshop participants noted that the most immediate solution to this, the pooling of patient populations from different settings, introduces site variance that may be confounded with severity and other variables. This phenomenon could significantly compromise the integrity of the study design. Vertical integration of health service delivery olay increase difficulty in problems of access to ethnic minority populations. Consolidation of hospitals and creation of primary care networks are largely based on economic considerations of potential efficiencies in care. Participants were concerned that clinicians with practices that are not considered cost-effective by a central corporate entity would be excluded from networks. Patients who require extensive care, close monitoring for compliance, and frequent follow-up are not attractive to payors with fixed budgets. Certain kinds of patients (poor, traditionally medically underserved, seriously mentally ill substance abusers) and the clinicians who serve them may not be invited to participate. This limitation could severely restrict the diversity and variability of patient populations available for clinical investigation in an academic health center that is part of a managed care 23
Clinical Research in Managed Care
system. The historically black medical schools and other health care institutions that serve predominantly minority populations constitute a potentially significant resource for clinical research with ethnic minority patients and populations. These institutions may be particularly disadvantaged with regard to the development of research because they have not had the support to develop the scientific infrastructure and private sources of funds that are essential to a major research program. Workshop participants identified a number of other barriers to clinical research emerging in the transition toward health care reform. A number of investigators noted that inpatient psychiatric units have become less useful research resources: length of stay has been significantly shortened, and many procedures and conditions once carried out or managed in the inpatient setting have been moved to the outpatient setting. This change has already resulted in a number of modifications to established scientific procedures. For example) a fundamental tenet of design is that the symptoms of disease must be differentiated from the effects of treatment. The result has been development of a number of procedures such as drug washout) placebo mnin, and other approaches to isolate the true disease state. Particularly for patients with severe mental disorders, all of these approaches are best conducted in a more controlled environment such as an inpatient setting, with expenses that are increasingly impossible to reimburse. Much clinical research in psychopharmacology involves the theory-driven search for new indications for use of marketed compounds (the 50-called off-label indications). Examples include the use of anticonvulsants to manage bipolar illness and the use of stimulants to treat depression associated with chronic disease. Health insurance plans that have prescription benefits generally provide reimbursement for only particular medications in a listing referred to as a formulary. For a treatment not listed in the 24
formula!)', co-payments or total out-ofpocket payment by the patient or investigator are required. Clinical trials in nursing homes are further constrained by regulations derived from the nursing home reform provisions of OBRA '87 restricting the type) use, indication, dose, and duration of psychotropic medication.
EMERGING OPPORTUNITIES FOR NEW APPROACHES Workshop participants concurred that the future organization of health care services will create significant opportunities for research in the mental disorders of late life. Mental health services research will gain even greater prominence as these new arrangements are developed, and studies of access, cost, cost-offset, and outcome are emphasized. Outcomes of interest extend far beyond the traditional focus on symp.. toms of psychopathology, to incorporate measures of function, disability, and quality of life. A number of interesting clinical research opportunities will also evolve. For example, studies of treatment-refractory illness have been compromised by concerns regarding the adequacy of prior treatment trials. Managed care and compulsory treatment guidelines will increase the likelihood of full trials of specific treatments. Following such guidelines may improve the homogeneity of patient samples with truly refractol)' illness who are seen in academic settings. Clinical research frequently involves intensive study of individual differences by examining rich and varied databases on very small) non-representative populations. In the new health care system, we may have exactly the opposite situation. Health care management requires thinner databases, on larger samples, from populations with known parameters. This may provide greater opportunity for generalization and for generating and testing new hypotheses. VOLUME
3 • NUMBER 1 • WINTER 1995
Lebowitz and Gottlieb
Participants agreed that exciting possibilities for longitudinal studies will be created by the development of advanced information systems describing populations and their health care. Health care management databases will represent the characteristics of a more heterogeneous population than available in most clinical research. Workshop participants saw this as an opportunity for further study of the impact of medical burden on the course and outcome of mental disorder in late life, and, conversely, on the impact of mental illness on the course and outcome of physical disorders. Finally, the emphasis of managed health care systems on the continuity of care and the coordination of multiple service sites was seen as validating the need for diversification of research sites that has become a tradition in geriatrics.
CONCLUSION The development of systems of managed health care and the processes leading to health care reform put great pressure on clinical research in the late-life mental disorders. Established practices of clinical care, and of the research associated with it) are being reformulated. The basic questions of clinical research-studies of phenomenology, etiology, and pathogenesis; diagnosis; and clinical course, treatment response, outcome, and prevention--can no longer be addressed with research designs and methods that were developed on the academic
health system of the last generation. However, exciting opportunities are emerging to study broad, heterogeneous populations and to focus on a diversity of outcomes. Geriatrics, with its history of longitudinal research, attention to comorbidity, breadth of interest in function and disability, and access to nonpsychiatric settings, such as nursing homes, is in an ideal position to capitalize on these opportunities and to lead the mental health field into this new era.
This report is the result ofa workshop, ItClinicalResearch in the Managed Care Environment," held on April 25, 1994, and sponsored by the Mental Disorders of the Aging Research Branch of the National In-
stitute of Mental Health (NIMH). Gary L. Gottlieb, M.D., M.B.A., and Barry D. Lebowitz, Ph.D., chaired the workshop. The workshop included the following participants from the field.· Nathan Billig, M.D.,.
WalterP. Bland, M.D.; GeneD. Cohen, M.D., Ph.D.,' jiska Cohen-Mansfield, Ph.D.,' Davangere P. Devanand, M.D.; Ira R. Katz, M.D., Ph.D.; Alan G. Kraut, Ph.D.,· William B. Lawson, M.D., Ph.D.,' Harold A. Pincus, M.D.; Peter v: Rabins, M.D.,· Jules Rosen, M.D.; and Steven S. Shaifstein, M.D.; and the
following participantsfrom the National Institutes of Health: Rex w: Cowdry, M.D.; HarrietL.G. Gordon, M.D.; RickA.Martinez, M.D.; George Niederehe, Ph.D.;Jean K. Paddock, Ph.D.; Jane L. Pearson, Ph.D.,. and janeA. Steinberg, Ph.D. Staffsupportforthe workshop was provided by Barbara Taylor, ofCircle Solution, Inc., and Faye K. Vlahos, afNIMH.
References 1. Marshall E: Academic medicine's stake in health care reform. Science 1994; 263: 1081 2. Depression Guidelines Panel: Depression in Primary Care, Vol. 2: Treatment of Major Depression. Clinical Practice Guideline Number 5. Rockville,
THE AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
MD. U.S. Department of Health and Human Services t Public Health Service, Agency for Health Care Policy and Research. AHCPR Publication No.
93-0551, April 1993
25
H
ealth care in the United States is undergoing profound change. Beginning with cost-containment, moving through managed care, and, ultimately, concluding in health care reform, the nature and characteristics of the system are in flux. Whatever the final shape of the system, it will be characterized by vertical integration of community facilities, private practice physicians, and tertiary care with an increased emphasis on primary care. Other systemic characteristics will include proliferation of ambulatory care, geographic coverage, broader price reductions, and redesign of incentives encouraging cost-control rather than enhancement of financial reserves. Clinical research in the mental disorders of late life is carried out, in large part, in specialized tertiary care academic health centers that may also be affiliated with other facilities, such as the Department of Veterans Affairs Medical Centers, nursing homes, and chronic care facilities. The future of the structure, function, and viability of these institutions is precarious
in the emerging health care system. 1 A workshop of clinical investigators met in April 1994, under the auspices of the Mental Disorders of the Aging Research Branch of the National Institute of Mental Health, to consider approaches to the nurturing and continued development of research in these new circumstances. Three general areas were discussed: sources of funding for clinical research, challenges to current methodologies, and opportunities emerging for new ap.. proaches.
SOURCES OF FUNDING Clinical research must build on the clinical care of patients. The direct cost for most of this care is usually derived from health insurance or out-of-pocket payments by consumers. Research funding usually supports only procedures or treatments that are considered experimental or incremental to standard care. Greater outside control of
ReceivedJune 21,1994; revisedJuly 13,1994; accepted July 20,1994. From the National Institute of Mental Health, Rockville, MD. Address correspondence to Dr. Lebowitz, Mental Disorders of the Aging Research Branch, National Institute of Mental Health, Room 18-105, 5600 Fishers Lane, Rockville, MD 20815. THE AMERICAN JOURNAL OF GERIATIUC PSYCHIATRY
21
Clinical Research in Managed Care
resources and of the process of patient care may limit access to patient populations and funding for aspects of the care that they consume. For example, expensive diagnostic procedures like neuropsychological testing and magnetic resonance imaging that are necessary clinically and can provide key research data are more likely to be disallowed by managed health systems. The funding for research in the mental disorders of late life is overwhelmingly based on individual grants from funding agencies of the federal governnlent, particularly the National Institute of Mental Health and other units of the National Institutes of Health. The cOJnpetition for project-specific funds has grown particularly intense in this time of budgetary restraint, and budget reductions are invariably required even for that relatively small proportion of applications that are funded. Average grant size, yearly growth, and project expansion are all tightly controlled. Research personnel salaries usually account for the bulk of a project grant award, and the workshop participants considered it unlikely that patient care costs could be included as a greater part of a project budget. Private sources, including foundation awards and individual gifts, are usually targeted to large-capital campaigns or are restricted to capital investments or general program operations. Many foundations use most of their research funding to support new investigators in helping launch their research careers. New investigators are also supported through the increasingly frequent use of the creation of "term chair endownlents-modest annual gifts for a fixed period of time supporting the appointlnent of a new faculty member and providing salary support to reduce requirements for clinical responsibilities. Pharmaceutical-company-supported clinical trials have proven useful in the development of a research infrastructure and in the retention of technical staff in nU111erous acadelnic health centers. Clinical trials are llseful in the recruitment of paU
22
tients for other types of studies as well. Treatment, whether experimental or established, was identified as a critical inducement to participation for subjects for all clinical research. Commercial clinical trial organizations, for reasons of efficiency and limited focus, have displaced acacleluic centers as the predominant sites for new drug studies, however. Drug studies in non-academic settings rarely support the adjunctive studies of basic mechanisms or clinical response differentials that have no direct Inarketing implications. This fact is eroding the capacity of academic investigators to develop clinical research. State-funded mental health research institutes have nlade itnportant contributions to the clinical research infrastructure by supporting bed costs, laboratories, and other services. Only a few of these institutes relnaio, and limitations on mental health budgets have severely restricted their activities. Participants underscored the importance of continued state support for these institutes. The Medical Centers of the Department of Veterans Affairs (the VA) also provide an important foundation for acaden1ic clinical research. The VA, with its tradition of acting as an academic liaison, has developed an important capacity for clinical research supported within its own funding system and used as a resource for other sources of research funding. Investigators are increasingly concerned, however, that the VA population is limited in diversity, represented by a predominantly male, socioeconomically disadvantaged population suffering a disproportionately high prevalence of substance abuse. The General Clinical Research Centers (GCRC) program of the National Center for Research Resources of the NIH is another key resource for clinical research. Gene's facilities are available at Jnany academic medical centers and provide bed costs, laboratories, biostatistical consultation, and other components of the clinical research infrastructure. Investigators who are able to VOl.UME 3 • NUlvlBER 1 • \VINTEH 1995
Lebolvi/z and Gottlieb
gain access to these resources have found the GeRe to be particularly valuable in undelWriting S0111e research costs, especially those associated with nornlal control subjects.
CHALLENGES AND CONCERNS REGARDING CURRENT METHODOLOGIES \Vorkshop participants endorsed the need to reconsider the full range of research questions, methods, and approaches used in clinical research. For exanlple, the traditional use of inpatient hospital settings to support research is likely to be replaced by the use of ambulatory and other less intense care sites. Most observers acknowledge that health care delivery is currently flawed: too ll1any people cannot gain access to appropriate care in the current patchwork of private insurance and public entitlements; routine care is often provided in emergency and urgent care sites; the specialty and subspecialty sectors dwarf primary care resources; and rehabilitative and long-term care is often provided in the acute setting. A fortuitous outcome of this disorganization is that clinical investigators in the academic health setting have had access to large, diverse, and clinically heterogeneous populations. This sample base has provided sufficient variability to allow for further refinement and testing of hypotheses regarding etiology and pathophysiology, clinical course, response to treatment, and long-term outcome of numerous mental disorders. As the health care system is changed and vertical integration becomes more common, tertiary care facilities are becoming one component of complex systems that include community hospitals and primary care practices. As part of the creation of health care systems, workshop participants predicted pressure toward standardization THE AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
of care through the use of clinical practice guidelines 2 in prin1ary care and cOlnn1unity settings. These guidelines were predicted to result in the diversion of insured patients away froll1 Clcademic health center facilities. Outcomes derived from these changes in the process of care will require evaluation of effectiveness and other parameters of quality. This redistribution of patients will substantially affect clinical research because it will constrict the nature and range of severity of disorders that will be accessible to investigators based solely in traditional acadell1ic settings. These constraints will necessarily reduce the breadth of research questions that can be addressed. Questions that require the full range of variability and heterogeneity of a particular disorder would be more difficult to address in the academic environment. Workshop participants noted that the most immediate solution to this, the pooling of patient populations from different settings, introduces site variance that may be confounded with severity and other variables. This phenomenon could significantly compromise the integrity of the study design. Vertical integration of health service delivery olay increase difficulty in problems of access to ethnic minority populations. Consolidation of hospitals and creation of primary care networks are largely based on economic considerations of potential efficiencies in care. Participants were concerned that clinicians with practices that are not considered cost-effective by a central corporate entity would be excluded from networks. Patients who require extensive care, close monitoring for compliance, and frequent follow-up are not attractive to payors with fixed budgets. Certain kinds of patients (poor, traditionally medically underserved, seriously mentally ill substance abusers) and the clinicians who serve them may not be invited to participate. This limitation could severely restrict the diversity and variability of patient populations available for clinical investigation in an academic health center that is part of a managed care 23
Clinical Research in Managed Care
system. The historically black medical schools and other health care institutions that serve predominantly minority populations constitute a potentially significant resource for clinical research with ethnic minority patients and populations. These institutions may be particularly disadvantaged with regard to the development of research because they have not had the support to develop the scientific infrastructure and private sources of funds that are essential to a major research program. Workshop participants identified a number of other barriers to clinical research emerging in the transition toward health care reform. A number of investigators noted that inpatient psychiatric units have become less useful research resources: length of stay has been significantly shortened, and many procedures and conditions once carried out or managed in the inpatient setting have been moved to the outpatient setting. This change has already resulted in a number of modifications to established scientific procedures. For example) a fundamental tenet of design is that the symptoms of disease must be differentiated from the effects of treatment. The result has been development of a number of procedures such as drug washout) placebo mnin, and other approaches to isolate the true disease state. Particularly for patients with severe mental disorders, all of these approaches are best conducted in a more controlled environment such as an inpatient setting, with expenses that are increasingly impossible to reimburse. Much clinical research in psychopharmacology involves the theory-driven search for new indications for use of marketed compounds (the 50-called off-label indications). Examples include the use of anticonvulsants to manage bipolar illness and the use of stimulants to treat depression associated with chronic disease. Health insurance plans that have prescription benefits generally provide reimbursement for only particular medications in a listing referred to as a formulary. For a treatment not listed in the 24
formula!)', co-payments or total out-ofpocket payment by the patient or investigator are required. Clinical trials in nursing homes are further constrained by regulations derived from the nursing home reform provisions of OBRA '87 restricting the type) use, indication, dose, and duration of psychotropic medication.
EMERGING OPPORTUNITIES FOR NEW APPROACHES Workshop participants concurred that the future organization of health care services will create significant opportunities for research in the mental disorders of late life. Mental health services research will gain even greater prominence as these new arrangements are developed, and studies of access, cost, cost-offset, and outcome are emphasized. Outcomes of interest extend far beyond the traditional focus on symp.. toms of psychopathology, to incorporate measures of function, disability, and quality of life. A number of interesting clinical research opportunities will also evolve. For example, studies of treatment-refractory illness have been compromised by concerns regarding the adequacy of prior treatment trials. Managed care and compulsory treatment guidelines will increase the likelihood of full trials of specific treatments. Following such guidelines may improve the homogeneity of patient samples with truly refractol)' illness who are seen in academic settings. Clinical research frequently involves intensive study of individual differences by examining rich and varied databases on very small) non-representative populations. In the new health care system, we may have exactly the opposite situation. Health care management requires thinner databases, on larger samples, from populations with known parameters. This may provide greater opportunity for generalization and for generating and testing new hypotheses. VOLUME
3 • NUMBER 1 • WINTER 1995
Lebowitz and Gottlieb
Participants agreed that exciting possibilities for longitudinal studies will be created by the development of advanced information systems describing populations and their health care. Health care management databases will represent the characteristics of a more heterogeneous population than available in most clinical research. Workshop participants saw this as an opportunity for further study of the impact of medical burden on the course and outcome of mental disorder in late life, and, conversely, on the impact of mental illness on the course and outcome of physical disorders. Finally, the emphasis of managed health care systems on the continuity of care and the coordination of multiple service sites was seen as validating the need for diversification of research sites that has become a tradition in geriatrics.
CONCLUSION The development of systems of managed health care and the processes leading to health care reform put great pressure on clinical research in the late-life mental disorders. Established practices of clinical care, and of the research associated with it) are being reformulated. The basic questions of clinical research-studies of phenomenology, etiology, and pathogenesis; diagnosis; and clinical course, treatment response, outcome, and prevention--can no longer be addressed with research designs and methods that were developed on the academic
health system of the last generation. However, exciting opportunities are emerging to study broad, heterogeneous populations and to focus on a diversity of outcomes. Geriatrics, with its history of longitudinal research, attention to comorbidity, breadth of interest in function and disability, and access to nonpsychiatric settings, such as nursing homes, is in an ideal position to capitalize on these opportunities and to lead the mental health field into this new era.
This report is the result ofa workshop, ItClinicalResearch in the Managed Care Environment," held on April 25, 1994, and sponsored by the Mental Disorders of the Aging Research Branch of the National In-
stitute of Mental Health (NIMH). Gary L. Gottlieb, M.D., M.B.A., and Barry D. Lebowitz, Ph.D., chaired the workshop. The workshop included the following participants from the field.· Nathan Billig, M.D.,.
WalterP. Bland, M.D.; GeneD. Cohen, M.D., Ph.D.,' jiska Cohen-Mansfield, Ph.D.,' Davangere P. Devanand, M.D.; Ira R. Katz, M.D., Ph.D.; Alan G. Kraut, Ph.D.,· William B. Lawson, M.D., Ph.D.,' Harold A. Pincus, M.D.; Peter v: Rabins, M.D.,· Jules Rosen, M.D.; and Steven S. Shaifstein, M.D.; and the
following participantsfrom the National Institutes of Health: Rex w: Cowdry, M.D.; HarrietL.G. Gordon, M.D.; RickA.Martinez, M.D.; George Niederehe, Ph.D.;Jean K. Paddock, Ph.D.; Jane L. Pearson, Ph.D.,. and janeA. Steinberg, Ph.D. Staffsupportforthe workshop was provided by Barbara Taylor, ofCircle Solution, Inc., and Faye K. Vlahos, afNIMH.
References 1. Marshall E: Academic medicine's stake in health care reform. Science 1994; 263: 1081 2. Depression Guidelines Panel: Depression in Primary Care, Vol. 2: Treatment of Major Depression. Clinical Practice Guideline Number 5. Rockville,
THE AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
MD. U.S. Department of Health and Human Services t Public Health Service, Agency for Health Care Policy and Research. AHCPR Publication No.
93-0551, April 1993
25