Full Text DA-93-002 SERVICES RESEARCH IN DRUG ABUSE TREATMENT NIH GUIDE, Volume 22, Number 3, January 22, 1993 RFA: DA-93-002 (previously DA-93-02) P.T. 34 Keywords: Drugs/Drug Abuse Health Services Delivery Health Care Economics National Institute on Drug Abuse Letter of Intent Receipt Date: March 1, 1993 Application Receipt Date: April 16, 1993 PURPOSE This Request for Applications (RFA) will support a program of health services research in the field of drug abuse treatment. Research should be directed toward any of the following: (1) understanding the impact of organization, structure, financing, management, and staffing on the availability and accessibility of treatment service resources, upon program content and function, and upon treatment effectiveness; (2) understanding the role of treatment program environment, organization, structure, and operation on mechanisms of service delivery as these are related to access to treatment, retention in treatment, or compliance with treatment; and (3) improving the ability of treatment programs to match clients with appropriate levels of treatment and appropriate treatment services, to measure the cost-effectiveness of treatment, and to deal with special populations. 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 RFA, Services Research in Drug Abuse Treatment, is related to the priority area of alcohol and other drugs. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, 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. Women and minority investigators are encouraged to apply. Applications are especially encouraged from State and municipal governments with research units and/or State and municipal governments collaborating with university-based research units. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Support will be provided for a period of up to five years (renewable for subsequent periods) subject to continued availability of funds and progress achieved. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will also vary. FUNDS AVAILABLE It is anticipated that approximately $3.0 million will be available to support the first year of the services research program. However, it is anticipated that approximately 8 to 10 new awards will be made under this announcement. If required in support of research objectives, funds may be expended on drug abuse treatment costs, rental and operation of facilities, approved renovation and modification of facilities (subject to limits and conditions specified in Public Health Service grant policy), and other costs normally allowable under existing Public Health Service grants policy. Funds may not be used for new construction or to replace existing treatment funding. RESEARCH OBJECTIVES Background Section 4640(d)(2) of the ADAMHA Reorganization Act of 1992 directs NIDA to develop a program of health services research, and defines health services research 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." Estimates of treatment services and funding sources are available from the National Drug and Alcoholism Treatment Unit Survey (NIDA/NIAAA, 1990), the State Alcohol and Drug Abuse Profile study (NIDA/NIAAA, 1992). However, these studies are deficient in describing treatment service delivery systems, factors influencing availability and accessibility of services, the influence of financing and health care coverage, and the impact of these factors upon treatment effectiveness and cost-effectiveness. Compared with publicly-funded treatment, clients with private funding pay more per visit on average ($2,450 vs. $1,240) and stay in treatment for shorter durations (Gerstein and Harwood, 1990:203). Anecdotal reports on the impact of private funding for treatment suggest that the accessibility of drug abuse treatment services may often be more dependent upon availability of funding than upon need. Whether this is true or not, research indicates that treatment services vary widely from program to program in quality and effectiveness (Ball and Ross, 1991:243; D'Aunno and Vaughn, 1992). There is evidence that retention, which has been linked to positive treatment outcomes, is influenced by the availability and quality of services. Dennis et al. (1992) reports higher retention among eligible methadone maintenance clients who received augmented vocational and educational services than among those who received the standard levels of service. Joe, Simpson, and Hubbard (1991) found that treatment tenure was related to professional diagnosis of problems, to more structured treatment, and to the type and frequency of services provided. Recently, research has focused on improving treatment by providing more and better treatment services in order to improve retention and treatment outcomes (Simpson, Chatham, and Joe, 1993). McLellan and others (1982) have stated that drug abuse treatment is most effective when treatment services are matched to individual needs. However, augmented treatment services may not always be cost effective. In the context of limited treatment resources, there is also a need to determine the relative costs and benefits of individual treatment services. In a study conducted by McLellan et al. (1983), improvement was related both to client characteristics (the severity of the patient's psychopathology) and to the services received. Regardless of additional treatment services received, patients with the most severe psychopathology improved the least, while patients with little psychopathology improved the most. An additional treatment service, psychotherapy, significantly affected the outcomes only of the middle group, those with mild to moderate psychopathology in addition to their substance abuse problem. The assessment of potential benefit for treatment services is important for problem areas other than psychopathology. Dennis et al. (1992) reports that methadone maintenance clients who have a moderate level of marketable skills but who lack training, a high school diploma, appropriate work tools or clothes, or entre into the job market benefit to a greater extent from vocational and employment services than clients with severely impaired employability. Although a clear need exists to maximize the effectiveness of limited treatment resources, little research has been carried out to determine the relative costs and benefits of providing augmented treatment services. These and other studies suggest that treatment effectiveness may depend on the availability, accessibility, cost, and quality of treatment services as much as on the particular treatment model employed. However, there is relatively little knowledge regarding what service delivery systems exist or how these may be improved to increase the effective delivery of treatment. Program Description Applicants are advised to review existing information relevant to drug abuse treatment health services research and to design studies using the most rigorous methodological and analytic designs feasible to investigate the impact of treatment service structure and organization, staffing, standards, financing, and management upon the content, suitability, quality, cost, availability and accessibility, and effectiveness of drug abuse treatment services. A variety of research strategies are appropriate, including those involving primary data collection at the clinic, local area, or system level, studies that make use of existing data bases, such as provider/payor data bases (e.g., Medicaid or HMO), treatment outcome studies (e.g., Treatment Outcome Prospective Study), or clinic data archives, and conceptual and methodological work. A range of approaches is appropriate, including individual and multi-disciplinary approaches from fields including, but not limited to, economics, sociology, criminal justice, psychology, public health, and other relevant social sciences. It is intended that this program of research encourage innovation in research strategies, use of existing data in ways that maximize its usefulness, and studies that have both scientific and public policy relevance. This program of research emphasizes timely transfer of results. Awardees will be encouraged to participate in research coordination activities to maximize the utility of the research, including review and dissemination activities. Areas of particular research interest include the following: Treatment Services Structure, Organization, and Delivery o Studies to define and characterize the organization, financing, management, and quality of treatment services, in relation to treatment content and the client populations and subgroups served. o Development and testing of models to improve the availability, accessibility, and delivery of appropriate treatment services within typical treatment contexts and environments. o Investigation of treatment program environment, organization, structure, staffing, and operation on mechanisms of service delivery as these are related to access to treatment, retention in treatment, compliance with treatment, quality and comprehensiveness of services received, and treatment outcomes. For example, are outcomes better for drug treatment combined with comprehensive services, and is it more effective to deliver comprehensive services in the treatment program than to provide referral to outside sources for such services? Financing of Services o Investigation of the effects of different models/mechanisms of funding and financing on treatment service resources, on the organization, structure, management, staffing and function of treatment programs, on treatment content, on treatment service utilization, on the populations and subgroups served, on the assessment of client/patient need for services, and on treatment effectiveness and cost-effectiveness. o Investigation of minimally necessary services. What is the incremental value of increased levels of care and different combinations of services, how do these differ among the populations and subgroups served, and how may this be optimized with regard to client characteristics? Quality and Effectiveness of Services o Studies to describe the relationship between client/patient characteristics and treatment program structure, organization, and operation with regard to delivery of appropriate treatment services. Development and testing of models to improve the appropriateness of the services delivered and to increase the effectiveness of matching and referral processes. o Investigation of availability, accessibility, suitability, content, quality, cost, and effectiveness of drug abuse treatment services and delivery systems for special populations, including women, adolescents, and minorities. o Effectiveness of the structure and organization of outreach services on entry into treatment. o Effectiveness of outreach service delivery systems explicitly directed to reducing HIV risk behaviors of drug abusers. o Development and testing of measures of cost, effectiveness, cost-benefits and cost-effectiveness of treatment services, including standardized models which could be incorporated in a range of research activities. The importance of a sound research plan and qualified research staff cannot be over-emphasized. It is recommended that investigators use the most rigorous methodology consistent with the purposes of the research. Where controlled trials are not feasible, other types of controls may be used, including case controls, equivalent comparison groups, regression-discontinuity, or other designs. Where appropriate, investigators are encouraged to offer HIV testing and counseling in accordance with current guidelines to subjects identified during the course of the research as being at risk for HIV acquisition or transmission. In high risk populations, investigators are encouraged to assess the effects of new interventions on the acquisition and transmission of infectious diseases, including HIV. STUDY POPULATIONS NIH POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN RESEARCH Applications for clinical research grants and cooperative agreements that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., American Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified. The NIH funding components will not make awards of grants, cooperative agreements or contracts that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects. LETTER OF INTENT Prospective applicants are asked to submit, by March 1, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIDA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room l0-42 Rockville, MD 20857 Telephone: 301-443-2755 APPLICATION PROCEDURES Applications received after April 16, 1993, will be returned to the applicant without review. The RFA label in the PHS form 398 application kit must be affixed to the bottom of the original face page. Failure to use the RFA label and to follow instructions could result in delayed processing of the application such that it may not reach the review committee in time for review. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grant Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone (301) 496-7441. The title and number of this announcement, "Services Research in Drug Abuse Treatment, DA-93-02" must be typed in item 2a on the face page of the application, and the "YES" box must be marked. Submit a signed, typewritten original of the application and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room l0-42 Rockville, MD 20857 REVIEW PROCEDURES Applications received under this announcement will be assigned to an NIDA initial review group (IRG) in accordance with established PHS referral guidelines. The IRGs, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate Advisory Council, whose review may be based on policy considerations as well as scientific merit. Only applications recommended for further consideration by the Council may be considered for funding. AWARD CRITERIA Applications recommended for further consideration by an appropriate Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the proposal as determined by peer review, appropriateness of budget estimates, program needs and balance, policy considerations, adequacy of provisions for the protection of human subjects, and availability of funds. The anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Frank M. Tims, Ph.D. National Institute on Drug Abuse 5600 Fishers Lane, Room l0A-30 Rockville, MD 20857 Telephone: (301) 443-4060 Direct inquiries regarding fiscal matters to: Ms. Shirley Ann Denney Chief, Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Schedule Applications will be reviewed according to the following review schedule: Application Receipt Date: April 16, 1993 Initial Review: June 1993 Advisory Council: September 1993 Earliest Date of Award: September 1993 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects", Title 45 CFR Part 74 & 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects". Title 42 CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient Records" may also be applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. References Ball, J.C., and A. Ross. The effectiveness of methadone maintenance treatment. New York: Springer-Verlag, 1991. D'Aunno, T., and T.E. Vaughn. Variations in methadone treatment practices: Results from a national study. Journal of the American Medical Association, 1992, 267, 253-258. Dennis, M.L., G.T. Karuntzos, and J.V. Rachal. Accessing additional community resources through case management to meet the needs of methadone clients. In R.S. Ashery (Ed.), Progress and issues in case management. National Institute on Drug Abuse Research Monograph 127. DHHS Pub. No. (ADM) 92-1946. Washington, DC: U.S. Government Printing Office, 1992, pp. 54-78. Gerstein, D.R., and H.J. Harwood (Eds). Treating drug problems. Vol. 1. Washington, DC: National Academy Press, 1990. Joe, G.W., D.D. Simpson, and R.L. Hubbard. Treatment predictors of tenure in methadone maintenance. Journal of Substance Abuse, 1991, 3, 73-84. McLellan, A.T., L. Luborsky, C.P. O'Brien, G.E. Woody, and K.A. Druley. Is treatment for substance abuse effective? Journal of the American Medical Association, 1982, 247, 1423-1428. McLellan, A.T., G.E. Woody, L. Luborsky, C.P. O'Brien, and K.A. Druley. Increased effectiveness of substance abuse treatment: A prospective study of patient-treatment "matching." J Nervous and Mental Disease, 1983, 171, 597-605. NIDA/NIAAA. State resources and services related to alcohol and other drug abuse problems, fiscal year 1990: An analysis of state alcohol and drug abuse profile data. DHHS Pub. No. (ADM) 92-1905. Washington, DC: U.S. Government Printing Office, 1992. NIDA/NIAAA. National Drug and Alcoholism Treatment Unit Survey (NDATUS): 1989 Main Findings Report. DHHS Pub. No. (ADM) 91-1729. Washington, DC: U.S. Government Printing Office, 1990. Simpson, D.D., L.R. Chatham, and G.W. Joe. Cognitive enhancements to treatment in DATAR: Drug abuse treatment for AIDS risk reduction. In J. Inciardi, F. Tims, and B. Fletcher (Eds.), Innovative approaches to the treatment of drug abuse: Program models and strategies. Westport, CT: Greenwood Press, 1993. .
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