PA-01-137: COST RESEARCH ON ALCOHOL TREATMENT AND PREVENTION SERVICES

Department of Health
and Human Services (HHS)

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This Program Announcement expires on October 5, 2004 unless reissued. COST RESEARCH ON ALCOHOL TREATMENT AND PREVENTION SERVICES Release Date: September 6, 2001 PA NUMBER: PA-01-137 National Institute on Alcohol Abuse and Alcoholism THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks applications for research projects that will advance knowledge about the cost of treating and preventing alcohol problems. Applications are sought for cost analysis studies, cost effectiveness studies, cost benefit studies, and cost offset studies. The announcement also invites studies that improve the methods used to measure the costs of treatment and prevention interventions. Studies of costs and outcomes of specific interventions are encouraged, as are studies of the costs and outcomes of categories of interventions (e.g., inpatient versus outpatient). Studies to improve the methodologies of estimating costs and of comparing costs to outcomes are also encouraged. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This Program Announcement (PA), Adoption of Alcohol Research Findings in Clinical Practice, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. 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 PA will use the National Institutes of Health (NIH) research project grant (R01) and exploratory/developmental grant (R21) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applications for R01s may request support for up to 5 years. Facilities and Administrative (F&A) costs will be awarded based on the negotiated rate at the time of the award. More detailed information on the R21 mechanism can be found at http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html. Exploratory/developmental grants cannot be renewed: however, a no-cost extension of up to one year may be granted prior to expiration of the project period. Investigators are encouraged to seek continued support after completing an exploratory/developmental grant project through a research project grant (R01). Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. RESEARCH OBJECTIVES Two considerations establish the importance of evaluating both costs and outcomes of alcoholism treatment and prevention interventions. First, resources available for the treatment of alcohol problems are typically in short supply. Hence, any money spent for unnecessary or ineffective treatment reduces the amount that could be used more 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 research provides evidence that the higher costs of some therapies are justified by better outcomes. Several varieties of cost research are described in the paragraphs below. All of these, as well as other types of cost research, are encouraged under the terms of this announcement. Cost analysis is the most basic form of cost research. It concerns the accurate measurement of costs. Given that most studies rely on charges for services rather than on true costs (opportunity costs) of services, there is room for improvement. In addition, the measurement of cost is not well developed for publicly-funded treatment, despite the significant size of this treatment sector. Cost effectiveness studies compare the costs of treatments to their outcomes. For example, one might compare the costs of obtaining a successfully-treated client across two treatment interventions. Noteworthy varieties of cost effectiveness studies are those that measure outcomes in terms of quality adjusted life years (QUALYS, Patrick and Erickson 1993, Spilker 1990) and disability adjusted life years (DALYS, Murray 1996). Such studies 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 other outcomes such as improved productivity. 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, Goodman et al. 1997, Jones and Vischi 1979). No one study can be expected to provide a complete answer to the question: Which treatments provide the best outcomes for the costs incurred? Progress will more likely be made through the accretion of results from many individual studies, each analyzing some specific treatment program. Accordingly, this announcement invites analyses of the costs, cost effectiveness, cost benefits, and cost offsets of specific treatment programs. Some studies might be more ambitious and attempt to draw conclusions about a class or a category of treatment programs. For example, past studies have compared the relative costs and outcomes of inpatient versus outpatient treatment (see Finney et al. 1996, Institute of Medicine 1990, Miller and Hester 1986, and Office of Technology Assessment 1983). Other comparisons of interest are those between more intensive versus less intensive programs, longer versus shorter programs, and programs with stronger versus weaker ties to ancillary services, primary medical care, or aftercare services. As the case of inpatient care for more severely dependent alcoholics indicates, the balance between cost and outcome can vary by patient characteristics. Studies of these variations are encouraged. Such studies could focus on population subgroups (defined by ethnicity, gender, or age) or on patient characteristics (such as severity of dependence, presence of psychiatric comorbidities, and level of social support). Scientific progress is also furthered by improvements in methodology. Two important methodological contributions to cost research have been made in recent years, but neither has been widely applied to the study of alcohol treatment. The first is a set of standardized guidelines for conducting cost effectiveness studies. These guidelines (Gold et al. 1996) were developed for the PHS for use across its constituent agencies, including the NIH. This announcement encourages research that applies these guidelines to the study of alcohol treatment or identifies areas where the recommended general approaches to measuring costs and outcomes are problematic in this specific application. The second development is the Drug Abuse Treatment Cost Analysis Program (French 1995, French et al. 1997). Though originally developed to measure treatment costs for drug abuse, this system could easily and profitably be applied to alcohol treatment as well. A number of other methodological developments could also help improve the field. These include improvements in using administrative data sets for research purposes, the development of methods to study of persons who change health plans or insurers frequently, and methods to study those who combine plan-financed with out-of-plan services. Studies of the cost of providing parity in insurance benefits between substance abuse treatment and treatment for other health conditions are also encouraged (Sing et al. 1997). Some states, such as Vermont, have enacted legislation requiring such parity, and the Federal Government has established parity for all persons insured by the Federal Employees Health Benefits (FEHB) program. However, the cost consequences of these policy initiatives are unknown. Although the research examples described in this announcement have concentrated on the cost and outcomes of alcohol treatment, there is a parallel need for cost studies of prevention activities. Such research was identified as a priority by the Subcommittee on Health Services Research, National Advisory Council on Alcohol Abuse and Alcoholism, which recommended that the Institute encourage studies to measure the effectiveness and cost- effectiveness of alcohol prevention in reducing the utilization of health care services. (NIAAA 1997, p. 49). Unfortunately, this objective has not yet captured the attention of the research community. Accordingly, such studies are expressly invited here. Summary The research encouraged by this PA is expected to increase scientific knowledge about the cost of treating and preventing alcohol abuse and alcohol dependence. It will also increase knowledge of the effectiveness and benefits of alcohol treatment and prevention in comparison to cost so that the cost effectiveness and cost benefits of treatment and prevention can be better estimated and understood. 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of the original application as well as any subsequent revisions. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and five 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific 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 applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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: 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 or the environment, to the extent they may be adversely affected by the project proposed in the application. Additional consideration pertinent to the review of Exploratory/Developmental Grant (R21) applications: Pilot feasibility studies may contain little or no preliminary data. Review should focus on whether the rationale for the study is well developed and whether the proposed research is likely to generate data that will lead to a regular research project grant or full-scale clinical trial. Adequate justification for the proposed work may be provided through literature citations, data from other sources, or investigator-generated data. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Mike Hilton, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 Executive Blvd., 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: Judy Simons Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Blvd., MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2434 FAX: (301) 443-0788 Email: jsimons@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 authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 and contract 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, and 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 TE. Drug Abuse Technology Transfer. DHHS Publication No. (ADM) 91- 1764, Rockville, MD: National Institute on Drug Abuse, 1991. Backer TE. Research utilization and managing innovation in rehabilitation organizations. Journal of Rehabilitation, 54:18-22, 1988. Brown BS. From research to practice: The bridge is out and the water’s rising. Pp. 345-365 in Levy JA, Stephens RC, and McBride DC, Advances in Medical Sociology, Volume 7. Greenwich, CT: JAI Press, 2000. Center for Substance Abuse Treatment. Improving Substance Abuse Treatment: The National Treatment Plan Initiative. DHHS Publication No. (SMA) 00-3479, Rockville, MD: Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, 2000. Dunn WN and Holzner B. Anatomy of an emergent field. Knowledge in Society 1:3-26, 1988. Finney, L.W., Hahn, A.C., and Moos, R.H. The effectiveness of inpatient and outpatient treatment for alcohol abuse: The need to focus on mediators and moderators of setting effects. Addiction 91(12):1773-1796, 1996. Glaser EM, Ableson H, and Garrison KN. Putting Knowledge to Use. San Francisco, CA: Jossey-Bass, 1983. Goodman, A.D., Nishiura, E., and Humphreys, R.S. Cost and usage impacts of treatment initiation: A comparison of alcoholism and drug abuse treatments. Alcoholism: Clinical and Experimental Research 21(5):931-938, 1997. Green LW, Gottleib NH, and Parcel GS. Diffusion Theory Extended and Applied. Pp. 91-117 in Ward WB (ed.) Advances in Health Education and Promotion. Greenwich, CT: JAI Press, 1987. Lamb S, Greenlick MR, and McCarty, D. (eds.). Bridging the Gap Between Practice and Research: Forging Partnerships with Community-Based Drug and Alcohol Treatment. Institute of Medicine. Washington, DC: National Academy Press, 1998. Christopher J.L. Murray. Rethinking DALYs. Pp. 1-98 in Christopher J. L. Murray and Alan D. Lopez. The Global burden of Disease: A Comprehensive Assessment of Mortality and Disability from Diseases, Injuries, and Risk Factors in 1990 and Projected to 2020. Cambridge: MA, Harvard University Press, 1996 National Institute on Drug Abuse. Reviewing the Behavioral Science Knowledge Base on Technology Transfer. NIH Publication No. 95-4035. Rockville, MD: National Institute on Drug Abuse, National Institutes of Health, Public Health Service, 1995. National Institute on Alcohol Abuse and Alcoholism. Improving the Delivery of Alcohol Treatment and Prevention Services: A National Plan for Alcohol Health Services Research. NIH Publication No. 97-4223. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Public Health Service, 1997. Oldenburg B, Hardcastle DM, and Kok G. Diffusion of Innovations. Pp. 270- 286 in Glantz K and Lewis FM (eds.). Health Behavior and Health Education. San Francisco, CA: Jossey-Bass, 1997. Rogers EM. Diffusion of Innovations. New York: Free Press, 1983. Weisner C, Mertens J, Parthasarathy S, Moore C, Hu TW, Hunkeler E, and Selby J. Outcome and cost of alcohol and drug treatment in an HMO: Day hospital versus traditional outpatient. Health Services Research, 35:791-810, 2000. Zaltman G, Duncan R, and Holbek J. Innovations and Organizations. New York: Wiley, 1973.

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