COST RESEARCH ON ALCOHOL TREATMENT AND PREVENTION SERVICES Release Date: September 16, 1998 PA NUMBER: PA-98-104 P.T. National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks health services research grant applications that are aimed at increasing knowledge about the cost of services for the treatment and prevention of alcoholism and alcohol- related problems. This knowledge can be increased through cost analysis studies, cost effectiveness studies, cost benefit studies, cost offset studies, and cost modeling studies. It can also be increased through advances in the methods used to measure costs of treatment and prevention interventions. This program announcement (PA) invites applications to study the costs of services to treat and prevent alcoholism and alcohol-related problems, either by themselves or in conjunction with the outcomes of these services. The research objectives include, but are not limited to, the broad goal of advancing scientific understanding of treatment and prevention costs and outcomes as they relate to costs. Studies of costs and outcomes of specific interventions are encouraged, as are studies of the costs and outcomes of classes of interventions (e.g., inpatient versus outpatient). Studies to improve the methodologies of estimating costs and comparing costs to outcomes are also encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Cost Research on Alcohol Treatment and Prevention Services, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No.017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, (Telephone: 202-512-1800). ELIGIBILITY Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01) or Small Grant (R03). Applications are also encouraged for Exploratory/Developmental Grants (R21), which are limited to up to 2 years for up to $100,000 for direct costs per year. Applicants for an Exploratory/Developmental Grant must cite the program announcement for Secondary Analysis of Existing Health Services Data Sets PA-97-066 in addition to this program announcement in their application. Applicants may also submit Investigator-Initiated Interactive Research Project Grants (IRPG) under this program announcement. IRPGs require the coordinated submission of related regular research project grant applications from investigators who wish to collaborate on research. Potential applicants for an Exploratory/Developmental Grant may obtain copies of the PA-97-066 from the NIAAA Home Page at http://www.niaaa.nih.gov or from the Office of Scientific Affairs, NIAAA, 6000 Executive Boulevard, Suite 409, MSC 7003, Bethesda, MD 20892-7003, telephone: 301-443-4375 or fax 301-443-6077. Further information on grant mechanisms and areas of research interest may be obtained from program staff listed under INQUIRIES. RESEARCH OBJECTIVES An important goal of research is to evaluate both the costs and outcomes of alcoholism treatment and prevention interventions. The importance of this goal is established by two considerations. First, it is prudent to avoid wasting resources available for the treatment of alcoholism. The amount of resources available to treat alcoholism typically falls short of need. Hence, any dollars spent for unnecessary or ineffective treatment reduce the amount that could be used effectively. Second, effective treatments need to be preserved against the pressures of cost containment. In an era that gives close scrutiny to all medical care costs, cheaper therapies will displace more expensive ones unless there is evidence that the higher costs of some therapies are justified by better outcomes. Economists recognize several varieties of cost research. All of these are pertinent to the study of alcohol treatment and prevention. All of them are encouraged under the terms of this announcement. Cost analysis is the most basic. It concerns the accurate measurement of costs. Given that most studies rely on charges for services rather than on true costs, there is clearly room for improvement in this area. In addition, the measurement of cost is least well developed for publicly-funded treatment, despite the growing importance of the publicly-funded treatment sector. Cost effectiveness studies compare the costs of treatments to their outcomes, using non-monetary units to measure outcomes. For example, for two treatment interventions one might want to know the cost of each per treated client and the proportion of clients who remained abstinent (or alternatively were free of drinking-related problems) at six months after treatment. A noteworthy subset of cost effectiveness studies are those that measure outcomes in terms of quality adjusted life years (QALYS; Patrick and Erickson 1993; Spilker 1990). These are also encouraged under the terms of this announcement. Cost benefit studies measure both costs and outcomes in monetary units. This is achieved by estimating monetary values for mortality, morbidity, and such outcome variables as improved productivity and reduced criminality. Cost offset analyses are, in fact, partial cost benefit analyses in which future medical care costs are the only outcomes measured. Historically, cost offset research has formed the largest part of the cost research undertaken in the alcohol field (Holder and Blose 1986, 1992; Holder and Shachtman 1987; Jones and Vischi 1979). Cost modeling analyses develop and test formal models of the relationship between treatment inputs and outcomes, with attention to prices and costs. It is not expected than any one study will provide a full answer to the question of which treatments provide the best outcomes for the costs incurred. Answering this question is a general goal that will be approached through the accretion of many studies over time. These individual studies will most likely take one of two approaches. Some studies will focus on particular treatment interventions of interest, conducting cost studies (cost effectiveness, cost offset, cost benefit, etc.) of those specific programs. Usually the intent is to establish that the interventions analyzed provide a good enough balance between outcomes and costs that their more widespread application would be justified. Accordingly, future work should be directed at: Analyses of the costs, cost effectiveness, cost benefits, and cost offsets of specific, interventions. Other studies draw conclusions about a class of interventions or about a dimension of the treatment process. A familiar example is the comparison of inpatient to outpatient treatment. Results have generally shown that outpatient treatment achieves comparable outcomes for lower costs (Institute of Medicine 1990; Miller and Hester 1986; Office of Technology Assessment 1983; Note, however, that for some types of patients, inpatient treatment is still more appropriate.). In part because of such findings, various forms of outpatient treatment have been replacing inpatient treatment. Current need is shifting to questions about the relative costs and outcomes of other dimensions of patient care. An example of this type of cost study would be the following: Comparisons of more intensive versus less intensive versions of outpatient treatment, longer versus shorter treatment interventions, stronger versus weaker links to an aftercare system, and other critical variables in the treatment process, focusing on their outcomes and their costs. Studies of both types are encouraged under the terms of this announcement. As the case of inpatient care for the most severely dependent alcoholics indicates, the balance between costs and outcomes will vary by patient characteristics. Studies of these variations are also encouraged such as: Assessments of how the balance between outcomes and costs varies for different population subgroups and by patient characteristics. The advance of scientific understanding in this area can be enhanced significantly by improvements in methodology. For example, two general methodological developments in cost research have unfolded over recent years, but neither has been applied specifically to the study of alcoholism treatment. Hence the field could benefit from studies that address: Cost effectiveness analyses conducted by applying the guidelines of the Public Health Service Panel on Cost Effectiveness in Health and Medicine (Gold et al. 1996). Such a study could provide important information by showing how these guidelines can be applied to the study of alcohol treatment and could identify areas where the recommended methods for measuring costs and/or outcomes are problematic in this particular application. Also encouraged are studies that utilize: Applications of the Drug Abuse Treatment Cost Analysis Program (French 1995; French et al. 1997), or similar "user friendly" systems for monitoring treatment costs to the provision of alcohol treatment services. Additional methodological developments are also sought such as: Development and testing of alternative approaches to case mix adjustment. This would facilitate comparisons between interventions that have differing client profiles. Improved methods of gathering data on health care utilization and cost records. This would facilitate the study of pools of subjects who may change health plans or insurers several times over the period of study and who may furthermore combine plan-financed with out-of-plan services use in unknown proportions. Improvements in techniques for using administrative data sets for research purposes. Development and use of improved techniques for estimating the true costs of treatment services as distinct from the charges for those services. Two additional topics, aimed at substantive rather than methodological goals, also stand out as specific research priorities at this time. They are: Development and improvement of estimates of the cost of providing parity between insurance coverage for substance abuse treatment and the coverage of other health conditions. While a very thorough study of this issue has recently been released by the Center for Substance Abuse Treatment (Sing et al. 1997), that analysis is based only on the experience of States that had adopted parity at the time of the study and represents only one of several possible methodological approaches to the subject. A compelling but neglected question within this area of research is whether the phenomenon of "moral hazard" can be asserted for a disease typified by denial of the need for treatment. Assessments of the impact of interventions to prevent alcohol-related problems on subsequent demand for health services. While most of the text in this section addresses the need for cost studies of alcoholism treatment, there is a parallel need to begin work on cost studies of prevention. This need was identified as a priority for future research by the Subcommittee on Health Services Research, National Advisory Council on Alcohol Abuse and Alcoholism (1997), but has not yet captured the attention of the research community. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (e.g., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available a the following URL address: http://www.nih.gov./grants/guide/notice-files/not98-024.html APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7710, Bethesda, MD 20892-7910, telephone 301-710-0267, email, grantsinfo@nih.gov. The title and number of the program announcement must be typed in section 2 on the face page of the application. The completed original application and five legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Investigator: Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Budget: Is the requested budget and estimation of time to completion of the project appropriate for the proposed research? The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment as well as the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, programmatic needs and balance, and the availability of funds. INQUIRIES Inquiries concerning this program announcement are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Mike Hilton, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8753 FAX: (301) 443-8774 Email: mhilton@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Edward Ellis Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4706 FAX: (301) 443-3891 Email: eellis@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52 and 45 CFR Part 74 or 45 CFR Part 95, as applicable. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References French MT. "Economic evaluation of drug abuse treatment programs: Methodology and findings." American Journal of Drug and Alcohol Abuse 21:111-135, 1995. French MT, Dunlap LJ, Zarkin GA, McGeary KA, and McLellan AT. "A structured instrument for estimating the economic cost of drug abuse treatment: The Drug Abuse Treatment Cost Analysis Program (DATCAP)." Journal of Substance Abuse Treatment, 14: 1-11, 1997. Gold ME, Siegel JE, Russell LB, and Weinstein MC. Cost-Effectiveness in Health and Medicine. New York: Oxford University Press, 1996. Holder, HD and Blose, JO. "Alcoholism treatment and total health care utilization costs: A four-year longitudinal analysis of Federal employees." Journal of the American Medical Association, 256: 1456-1460, 1986. Holder, HD and Blose, JO. "The reduction of health care costs associated with alcoholism treatment: A 14-year longitudinal study." Journal of Studies on Alcohol, 53:293-302, 1992. Holder, HD and Shachtman, RH. "Estimating health care savings associated with alcoholism treatment." Alcoholism: Clinical and Experimental Research, 11: 66-73, 1987. Institute of Medicine. Broadening the Base of Treatment for Alcohol Problems. Washington, D.C.: National Academy Press, 1990. Jones KR and Vischi TR. "Impact of alcohol, drug abuse and mental health treatment on medical care utilization: A review of research literature." Medical Care, 17: 1-82, 1979. Miller WR and Hester RK. "The effectiveness of alcoholism treatment methods: What research reveals." In: Miller WR and Heather N (eds.). Treating Addictive Behaviors: Processes of Change. New York: Plenum Press, 1986, pp. 121-174. Office of Technology Assessment, U.S. Congress. The Effectiveness and Costs of Alcoholism Treatment. Washington, D.C.: U.S. Government Printing Office, 1983. Patrick DL and Erickson P. Health Status and Health Policy: Quality of Life in Health Care Evaluation and Resource Evaluation. New York: Oxford University Press, 1990. Spilker B. Quality of Life Assessment in Clinical Trials. New York: Raven Press, 1990. Subcommittee on Health Services Research, National Advisory Council on Alcohol Abuse and Alcoholism. Improving the Delivery of Alcohol Treatment and Prevention Services: A National Plan for Alcohol Health Services Research. Bethesda, MD: National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Department of Health and Human Services, 1997.
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