Full Text PA-96-021 HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA NUMBER: PA-96-021 P.T. 34 Keywords: Alcohol/Alcoholism Health Services Delivery Health Care Economics 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 developing a knowledge base to improve the efficiency and effectiveness of services for alcohol-related problems. This program announcement invites research applications related to improving the availability, accessibility, delivery, quality, cost effectiveness, impact, and outcomes of alcohol-related treatment and prevention services. The research objectives include, but are not limited to, four major areas: (1) determining impacts of financing and reimbursement mechanisms on alcohol-related health care program availability, accessibility, delivery, organization, content, quality, and outcomes; (2) assessing sources of variation in the utilization and cost of treatment services for alcohol-related problems; (3) identifying and assessing the effectiveness and outcomes of alcohol-related treatment and preventive services; and (4) identifying factors that influence the organization, management, and delivery services for alcohol-related problems across regions, populations, and settings. 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 program announcement, Health Services Research on Alcohol-Related Problems, 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, D.C. 20402-9325 (Telephone: 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, 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. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). Regular research grant applications (R01) from foreign institutions are limited to three years. MECHANISM OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01) or First Independent Research Support and Transition (FIRST) Award (R29). Applicants may also submit Investigator-Initiated Interactive Research Project Grants (IRPG) under this program announcement. Interactive Research Project Grants require the coordinated submission of related regular research project grant applications and, to a limited extent, FIRST Award applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. Further information on the IRPG mechanism is available in program announcement PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995. Program Project Grants applications (P01) will not be accepted under this program announcement. The NIAAA also seeks to increase the pool of health services researchers who have expertise in the alcohol field. NIAAA encourages interested institutions to undertake programs of research training and career development in the area of alcohol-related health services research. FUNDS AVAILABLE The NIAAA estimates that the average research grant (R01) award size will be approximately $250,000 in total costs for the first year. Outyear budgets should conform to NIH cost-containment policies. Investigators who wish to submit an application that request more than $500,000 in direct costs in any one year must contact program staff before submitting an application. Although the financial plans of NIAAA provide for the support of this program, the award of grants pursuant to this program announcement is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES In June 1992, "The ADAMHA Reorganization Act" (Public Law 101-321) directed NIAAA to expand its program of health services research. Health services research is defined in the legislation as "research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care" (Section 409). Health services research also is concerned with identifying factors that influence the effectiveness of health services in "real world" settings. This program announcement invites research applications related to understanding and improving the financing, utilization, effectiveness, and organization of health services for the prevention and treatment of alcohol-related problems. For the purposes of this program announcement, health services research includes: (a) the assessment of the impact of health services and the effects of organizational and financing arrangements in "real world" clinical settings on the quality and outcomes of care provided to patients with alcohol abuse and alcoholism or with medical problems consequent to alcoholism, and (b) the assessment of the effectiveness of prevention services as well as their financing, organization, management, implementation, cost, and utilization. As directed by subsequent legislation (P.L. 103-43), for the purposes of this announcement health services research does not include studies of the efficacy of specific preventive, diagnostic, and treatment services where the analysis is directed at the individual as distinct from the service system. Applications whose main objective is to establish and support treatment or prevention services are not eligible for funding under this program announcement. Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for those particular costs and for that period of time required by the research. These costs must be justified in terms of research objectives, methods, and designs that promise to yield important generalizable knowledge and/or to make a significant contribution to theoretical concepts. Applicants should adopt the most carefully controlled and rigorous research designs feasible in conducting treatment and prevention services research and studies (see Lettieri 1992; Sechrest, Persin, and Bunker 1990; Cook and Campbell 1979). As elaborated in the "Review Criteria" section of this program announcement, applications will judged on the basis of the scientific and technical merit of the proposed research as well as on the adequacy and appropriateness of the proposed methodology. Applicants may wish to consult generic publications in health services research as well as alcohol-specific examples of prevention and treatment research. The following list of research topics is for illustrative purposes. Topics not mentioned below that fall within the research objectives of this program announcement will also be accepted. Financing and Reimbursement of Services o Investigating the impact of innovative financing and reimbursement approaches on the quality, cost effectiveness, and supply of alcohol treatment and/or prevention services, as well as demand for and barriers to those services. o Assessing how alternative managed care systems affect availability, quality, cost, and outcomes of treatment and prevention services. o Developing uniform ways to measure insurance benefits and payments for treatment of alcohol-related problems in order to compare performance of alternative health plans. Alcohol-related problems include medical consequences of alcohol abuse and alcoholism; such as, alcohol poisoning, or cardiovascular, gastrointestinal and/or neurological disorders. o Identifying the impact of changes in compensation incentives on the behavior of consumers, clinicians, and institutions, and on treatment appropriateness and outcomes. o Modeling and assessing the impact of health care reform legislation and other policy changes on the organization, management, financing, availability, appropriateness, and cost of alternative alcohol-related health policies and treatment services. Utilization and Cost of Services o Identifying health service factors and individual characteristics influencing access to, or compliance with, treatment interventions for alcohol-related problems (including symptomatic medical problems), particularly among underserved, uninsured, and HIV-infected populations. o Identifying care-seeking behavior of people with alcohol problems, including utilization of informal resources (e.g., self-help groups) and alternative (e.g., acupuncture) health resources, as well as general medical and specialty alcohol services. o Developing standardized criteria for identifying episodes of alcohol treatment to apply in longitudinal analyses of cost and utilization data. o Determining whether or not prevention programs have significant effects on the utilization and cost of treatment services. o Determining the extent to which costs of treatment or prevention services are offset by subsequent reductions in health care costs. For example, evaluating characteristics of individuals, programs, service systems, and insurance benefits associated with greater cost offsets and cost effectiveness. Effectiveness and Outcomes of Services o Developing and assessing criteria to classify and measure objectives, components, and processes involved in delivering major types of services for alcohol-related problems, and examining linkages between treatment content, quality of care, and functional as well as alcohol-specific outcomes. o Assessing the effectiveness of brief interventions to treat problem drinking and its medical and social consequences. Research may assess brief interventions in inpatient or outpatient acute and specialty as well as primary care settings. o Assessing adequacy and appropriateness of treatment services to meet needs and demands of different groups such as women, youth, minorities, rural residents, and the elderly. o Determining the impact of organization, financing, and management on the effectiveness of treatment interventions when they are delivered to heterogeneous populations in natural rather than experimental settings. o Developing classification or measurement systems for use by clinicians to better assign patients to treatment modalities or to improve outcomes, particularly management of post-treatment relapse. o Assessing the potential of prevention activities, programs, or policies to reduce the need for, demand for, or utilization of health care, for either chronic or acute conditions related to the use of alcohol. o Applying cost effectiveness research to estimate the costs and effectiveness of particular alcohol-related health services (including treatment and prevention) from the perspective of consumers or their families as well as from the perspectives of payers, providers, or employers. o Assessing the effects of participation in Alcoholics Anonymous on treatment utilization, outcome, and cost. Service System Delivery, Organization, and Management o Examining organization and management of alcohol treatment services, including social, economic, demographic, geographic, legal or health policy, and other factors that may facilitate or impede effective and efficient linkage and delivery of those services. o Determining the impact of system-level, service integration initiatives on the coordination, comprehensiveness and continuity of alcohol treatment services. o Identifying different organizational models needed for delivery of alcohol treatment services to different subpopulations such as the elderly, youth, women, minorities, rural residents, or HIV-positive individuals. o Developing and testing innovative management approaches to improve productivity and efficiency in implementing treatment services. o Examining organizational, provider, and consumer responses to changes in the following areas: (a) financing and reimbursement policies, (b) structural aspects of managed-care systems, (c) insurance coverage characteristics of populations in the service area, (d) number and characteristics of other organizations and providers in the area, and (e) demographic factors such as population density, and/or other factors that may lead to changes in organizational and provider behavior with ultimate consequences for access to and outcomes of treatment services. 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 new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. 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 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 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. 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. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extamural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0715, email: girg@drgpo.drg.nih.gov. The title and number of the program announcement must be typed in section 2 on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS 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 Criteria to be used in the scientific and technical merit review of alcohol-related health services research grant applications will include the following: 1. The scientific, technical, health or medical significance, and originality of the proposed research 2. The appropriateness and adequacy of the research design and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. This includes the feasibility of implementing the project (including recruitment of subjects, implementation of the intervention or innovation, cooperation of relevant organizations, and/or availability and quality of necessary data). 5. The appropriateness of budget estimates and duration in relation to the proposed research. 6. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. The review criteria for FIRST Awards (R29), IRPGs, career development awards, and institutional training grants are contained in the relevant program announcements. AWARD CRITERIA Applications recommended for approval 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. The NIAAA is interested in maintaining a portfolio of research activities that is balanced among the four major issues described in the "Research Objectives" section of this program announcement. In order to expedite the achievement of such balance, special consideration will be given to applications that focus on: (a) Financing and Reimbursement of Services or (b) Service System Delivery, Organization, and Management. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. A copy of the NIH program announcement for National Research Service Awards for Institutional Research Training Grants as published in the June 3, 1994, issue of the NIH Guide for Grants and Contracts may be obtained from the program staff listed under INQUIRIES. Potential applicants may obtain copies of specific announcements from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, Maryland, 20852, telephone: 301-468-2600 or 1-800-729- 6686. Further information on grant mechanisms and areas of research interest may be obtained from the program staff listed in the Inquiries section of this program announcement. Direct general inquiries regarding health services research to: Robert B. Huebner, 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) 443-0786 FAX: (301) 443-8774 Email: bhuebner@willco.niaaa.nih.gov Direct inquiries regarding health services treatment research to: Harold I. Perl, 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) 443-0788 FAX: (301) 443-8774 Email: hperl@willco.niaaa.nih.gov Direct inquiries regarding health services prevention research to: Michael 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 health services epidemiologic research to: Harold Yahr, Ph.D. Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 594-6230 FAX: (301) 443-8614 Email: hyahr@willco.niaaa.nih.gov Direct inquiries regarding research training and career development opportunities to: Frances Cotter, M.P.H. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8774 Email: fcotter@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (301) 443-3891 Email: lhilley@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. 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 Cook, T.D. and Campbell, D.T. Quasi-Experimentation: Design and Analysis Issues for Field Settings. Boston: Houghton Mifflin, 1979. Lettieri, D.J. A Primer of Research Strategies in Alcoholism Treatment Assessment. DHHS Pub. No. (ADM) 92-1882. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism, 1992. Sechrest, L.; Persin, E.; and Bunker, J., eds. Methodology: Strengthening Causal Interpretations of Nonexperimental Data. DHHS Pub. No. (PHS) 90-3454. Rockville, MD: Agency for Health Care Policy and Research, 1990. .
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