BRINGING DRUG ABUSE TREATMENT FROM RESEARCH TO PRACTICE Release Date: December 22, 1998 RFA: DA-99-007 P.T. National Institute on Drug Abuse Letter of Intent Receipt Date: March 29, 1999 Application Receipt Date: April 29, 1999 PURPOSE This Request for Applications (RFA) will support research to improve our knowledge of how to move research-based drug abuse treatment interventions into clinical practice. Despite research on the effectiveness of a variety of psychosocial, behavioral, and pharmacological treatment interventions, many of these interventions are still not in widespread clinical use. Not enough is known about how drug abuse treatment providers decide which clinical interventions to adopt or the nature of organizational adaptation needed to integrate new treatments with existing clinical practice. Practice research is conceptualized as having three significant aspects: Effective transfer of knowledge, changing organizational behavior, and financing new treatments. 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, Bringing Drug Abuse Treatment From Research to Practice, 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) 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. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is September 1999. 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. FUNDS AVAILABLE It is anticipated that approximately $2.0 million will be available to support research grants under this RFA. This level of support is dependent upon the receipt of a sufficient number and diversity of applications of high scientific merit. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will also vary. However, it is anticipated that up to eight new awards will be made under this announcement. RESEARCH OBJECTIVES Background Two powerful influences, a transition to managed health care and a rapidly developing base of scientific knowledge, have the potential to transform the quality of drug abuse treatment in the United States. The National Institute on Drug Abuse (NIDA) has significant ongoing research programs to develop efficacious and effective drug abuse treatment interventions. However, interventions tested in well-controlled experimental settings are not always readily adopted and used by non-scientist practitioners. There is a comparative lack of research on the processes through which science-based interventions enter clinical practice. Traditional technology transfer approaches, including education, training, and dissemination of information through journal articles, newsletters, technical reports, monographs, conferences, and workshops, produce only limited change in drug treatment programs and systems (Backer, 1995; Becker, 1970; Brown 1998). One study of the effectiveness of technology transfer randomized treatment programs into four strategies in which only receiving journal publications was one. This strategy produced no change in the programs (Sorensen et al., 1988), but other strategies involving more expensive interventions of face-to-face communication were more successful. Even among strategies that worked, up to 70% of the programs showed no significant change. Underutilized Treatment Interventions The gap between research knowledge and treatment practice was identified as leading to an underutilization of effective drug abuse interventions in the recent Institute of Medicine Report, Bridging the Gap Between Practice and Research (Lamb et al., 1998). Underutilized or imperfectly used pharmacotherapies include methadone, LAAM (levo-alpha-acetylmethadol), and naltrexone. Low methadone dosing levels have been reported (Ball & Ross, 1991; D'Aunno et al., in press). Naltrexone, a pure opioid antagonist, has had limited use (Brahen et al., 1978). LAAM, an effective long lasting agonist treatment for opioid dependence, has not been widely adopted. Nor have research-based behavioral interventions, including community reinforcement with vouchers (Higgins et al., 1994; Silverman et al., 1996), other contingency management strategies, or many cognitive behavioral approaches. Shorter treatment episodes have resulted from managed care, but little is known about the effectiveness of brief behavioral interventions in drug abuse treatment, primary care, or other settings. Reductions in the number and frequency of comprehensive or "wrap around" services such as employment, psychological, legal, or family/social services have been reported (Etheridge et al., 1995; D'Aunno et al., 1995) despite the need of drug abuse patients for such services (Ball & Ross, 1991; McLellan et al., 1994; Widman et al., 1997; Simpson et al., 1997). Injecting drug abusers are at high risk for contracting HIV, and those with HIV/AIDS have significant medical needs that often cannot be managed in drug treatment programs (Selwyn, 1996). The integration of primary care services with drug abuse services requires systematic evaluation and study of how to transfer such integrated models into delivery systems (Lamb et al., 1998). Organizational barriers may prevent the integration of services, especially where there are co- occurring mental health problems (Lamb et al., 1998). Developing research-based strategies to facilitate integrated service delivery is important for all drug abuse patients, but especially for adolescents in treatment and for drug abusing women and their children (Grella, 1996; Rahdert, 1996). Objectives and Scope Translating interventions into clinical practice is conceptualized as having three significant aspects: Effective transfer of knowledge about drug abuse treatment interventions, changing treatment organizations, and financing new treatments. How drug abuse treatment adapts to cost containment pressures and to evolving technology depends upon how new treatment approaches are learned, how treatment programs and systems are organized and managed in a rapidly changing environment, the internal and external incentives to adopt new practices, and how decisions are made to reimburse particular services or interventions in drug abuse treatment. This Request for Applications is intended to stimulate research on how clinical treatment technology is adopted by treatment providers, on how interventions are adapted to various treatment settings so that their effectiveness is maintained or improved, and on the economics of introducing treatments into new drug abuse treatment settings. Studies to further our understanding of how to translate new research-based interventions into clinical practice may include, but are not limited to research on: Transmission of knowledge o Research on technology transfer, knowledge dissemination, and education approaches, including technical assistance models, intervention marketing strategies, transportability of efficacious behavioral therapies to community- based settings. o Research on training treatment providers, including identification of needs, skills, and competencies for different providers, development of new clinical skills, adherence to manualized therapies, adult learning models, and processes for re-training needed to implement new interventions in the drug abuse treatment program environment. Organizational adaptation and change o Factors such as level of support, supervision, and communication within and outside the treatment organization needed to effectively implement, integrate, and maintain new interventions. o The role of oversight and monitoring (for example, Joint Commission on Accreditation of Healthcare Organizations, National Committee for Quality Assurance, or other organizational accreditation; performance monitoring by managed care organizations or health maintenance organizations) in changing treatment practices or affecting adoption of research-based interventions. o Attributes of effective health care staff and leadership (including professional skills, training, and experience) and approaches to improve the effectiveness of staff to deliver treatment interventions and services or to implement new research-based interventions. o Alternative models for systematic organizational change (including integration of drug abuse and other health or social service models or development and maintenance of linkages with other resources); effective clinical or organizational decision-making processes or models; or processes for defining, monitoring, and evaluating program performance; or systematic efforts to improve treatment quality. o Treatment process, including integrating drug abuse treatment interventions into existing treatment practices or into new settings (for example, primary care), addressing patient motivation and needs, or matching interventions to a staged recovery model. o Practice guidelines for drug abuse treatment and "wrap-around" services. Research on organizational roles such as assessment of need and establishment and maintenance of linkages with other service providers. o Organizational models to improve the treatment of drug dependence as a chronic disorder (for example, continuity of care models, expectation of recurring need for care, application of management of care practices from treatment of other chronic diseases). Financing o Decision-making processes to approve new treatment services, approaches, or interventions for reimbursement by various payers. o The impact of managed care and other financing mechanisms on availability, access, and utilization of research-based treatment interventions. Applications submitted under this request for applications may focus on specialty or non-specialty (e.g., health and mental health care, correctional, social, and welfare programs) settings that provide drug abuse treatment services. Research may also focus on factors that facilitate or impede effective and efficient translation of research-based treatment interventions into clinical across service settings and organizations. Research projects that examine innovative organizational and management models are of particular interest. Investigators are encouraged to utilize the most rigorous methodology consistent with the purposes of the research study. It is expected that applications may use quantitative or qualitative approaches, or both, to examine these systems. Projects that solely propose case studies or other forms of qualitative evaluative research will not be considered responsive to this RFA. Timely reporting of findings is emphasized with specific attention to the development of dissemination plans that facilitate access to current findings among researchers and practitioners. 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 were published in the Federal Register on March 28, 1994 (FR 59 14508-14513) and 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. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., 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 at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations before submitting an application that involves the administration of compounds to human subjects. The guidelines are available on the NIDA Home Page at http://www.nida.nih.gov/ or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants are asked to submit, by March 29, 1999, 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 a subsequent application, the information that it contains is helpful in planning for the review of the applications. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158 MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98). 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 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, E-mail: GrantsInfo@nih.gov. The title and number of this RFA must be typed in Item 2 on the face page of the application. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package, to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse Room 3158 MSC 9547 6001 Executive Boulevard Bethesda, Maryland 20892-9547 Applications must be received by April 29, 1999. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Applications that are incomplete and/or nonresponsive will be returned to the applicant without review. Applications that are complete will be evaluated for scientific and technical merit by a peer review group convened by NIDA 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 applications under review, will be discussed, assigned a priority score and receive a second level review by the National Advisory Drug Abuse 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. In the written comments, reviewers will be asked to discuss the following aspects of the application 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 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 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. (1) Significance: The extent the goals and objectives of this application are relevant to the RFA? 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? (2) 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? (3) Innovation: Does the project employ novel concepts, approaches, or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) 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)? (5) 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o 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. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: March 29, 1999 Application Receipt Date: April 29, 1999 Scientific Review Date: July 1999 Council Meeting Date: September 1999 Earliest Award Date: September 1999 AWARD CRITERIA Award criteria that will be used to make award decisions include: scientific and technical merit of the proposal as determined by peer review, availability of funds, program needs and balance, and adequacy of provisions for the protection of subjects. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues to: Bennett W. Fletcher, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4222, MSC 9565 Bethesda, MD 20892-9565 Telephone: (301) 443-4060 FAX: (301) 443-6815 Email: Bennett_Fletcher@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.S. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov 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, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and are administered under PHS grants policies and Federal Regulations 42 CFR 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 Public Health Service (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 Backer, T.E., David, S.L., Soucy, G. (eds.) (1995). Reviewing the Behavioral Science Knowledge Base on Technology Transfer. NIDA Monograph Series 155, Rockville, MD. Ball, J.C. & Ross, A. (1991). The effectiveness of methadone maintenance treatment. New York: Springer Verlag. Becker, M.H. (1970a, February). Factors affecting diffusion of innovations among health professional. American Journal of Public Health, 60(2), 294-304. Brahen, L.S., Capone, T., Bloom, S., et al. (1978). An alternative to methadone for probationer addicts: Narcotic agonist treatment. Contemporary Drug Issues, 13, 117-132. Brown, B.S. (1998). Making a difference: Is journal publication enough? Journal of Substance Abuse Treatment, 15(2), 87-88. D'Aunno, T., Foltz-Murphy, N., & Lin, X. (in press). Changes in methadone treatment practices, 1988-1995. American Journal of Drug and Alcohol Abuse. D'Aunno, T. & Vaughn, T.E. (1995). The organizational analysis of service patterns in outpatient drug abuse treatment units. Journal of Substance Abuse Treatment, 7, 27-42. Etheridge, R.M., Craddock, S.G., Dunteman, G.H., & Hubbard, R.L. (1995). Treatment services in two national studies of community-based drug treatment programs. Journal of Substance Abuse Treatment, 7, 9-26. Grella, C.E. (1996). Background and overview of mental health and substance abuse treatment systems: Meeting the needs of women who are pregnant or parenting. Journal of Psychoactive Drugs, 28(4), 319-343. Higgins, S.T., Budney, A.J., Bickel, W.K., et al. (1994). Incentives improve outcome in patient behavioral treatment of cocaine dependence. Archives of General Psychiatry, 51(7), 568-576. Lamb, S., Greenlick, M., McCarty, D. (1998). Bridging the Gap Between Practice and Research: Forging Partnerships with Community-Based Drug and Alcohol Treatment. Washington, D.C.: National Academy Press. McLellan, A.T., Alterman, A.I., Metzger, D.S., et al. (1994). Similarity of outcome predictors across opiate, cocaine, and alcohol treatments: Role of treatment services. Journal of Consulting and Clinical Psychology, 62(6), 1141-1158. Rahdert, E.R. (ed.) (1996). Treatment for Drug-Exposed Women and Their Children: Advances in Research Methodology. NIDA Research Monograph 165. Rockville, MD: National Institute on Drug Abuse. Selwyn, P.A. (1996). The impact of HIV infection on medical services in drug abuse treatment programs. Journal of Substance Abuse Treatment, 13(5), 397-410. Silverman, K., Higgins, S.T., Brooner, R.K. et al. (1996). Sustained cocaine abstinence in methadone maintenance patients through voucher based reinforcement therapy. Archives of General Psychiatry, 53(5),409-415. Simpson, D.D., Joe, G.W., & Brown, B.S. (1997). Treatment retention and follow- up outcomes in the drug abuse treatment outcome study (DATOS). Psychology of Addictive Behaviors, 11(4), 294-307. Sorensen, J.L., Hall, S.M., Loeb, P., et al. (1988). Dissemination of a job seekers' workshop to drug treatment programs. Behavior Therapy, 19, 143-155. Widman, M., Platt, J.J., Lidz, V., et al. (1997). Patterns of service use and treatment involvement of methadone maintenance patients. Journal of Substance Abuse Treatment, 14(1), 29-35.
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