PA-01-142: HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS

Department of Health
and Human Services (HHS)

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This Program Announcement expires on October 5, 2004, unless reissued. HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS Release Date: September 27, 2001 PA NUMBER: PA-01-142 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 research grant applications on the delivery of treatment and prevention services for alcohol-related problems, including alcohol dependence and alcohol abuse. Expanding the knowledge base about these services will help improve the delivery of treatment and prevention services. This program announcement (PA) invites research applications to test strategies for improving the availability, accessibility, delivery, quality, effectiveness, cost- effectiveness, and outcomes of alcohol-telated treatment and prevention services. The research objectives include, but are not limited to, the effects of the organization, financing, and management of health services on the quality, cost, access to, and outcomes of care. Objectives also include studying the effectiveness and cost-effectiveness of alcohol prevention services in reducing the demand for health care services. Also of key importance is improving the methodological tools and analysis techniques useful for conducting health services research. This program announcement replaces the announcement Health Services Research on Alcohol-Related Problems (PA-98-037) issued March 6, 1998. 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. Faith-based organizations are eligible to apply for these grants. 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),Exploratory/Developmental Grant (R21), and Small Grant (R03) 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. More detailed information on the R03 mechanism can be found at http://grants.nih.gov/grants/guide/pa-files/PAR-99-098.html. Exploratory/Developmental Grants and Small 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 or a Small Grant project through a Research Project Grant (R01). RESEARCH OBJECTIVES The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is committed to supporting a strong program of health services research. As delineated by the Congressional definition -- 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 (PL 101-321, Section 409) -- health services research at NIAAA includes research on both treatment and prevention services especially as these are delivered in applied settings. However, health services research does not include studies that establish the efficacy of specific preventive, diagnostic, or treatment modalities under carefully controlled research conditions (PL 103-43). The following list of research topics is for illustrative purposes. Applications on topics not explicitly listed below, but which fall within the objectives described above, are also welcome. 1) Managed care. A variety of practices are used to control costs of care, access to care, utilization of care, and quality of care. NIAAA is interested in how these practices, either singly or in combination, affect the outcome, quality, access, utilization, and cost of care for alcohol- related problems. Comparisons between more and less integrated systems of care and between more and less tightly managed systems of care are also encouraged. 2) Cost of treatment. Economic analyses of several kinds are encouraged, including studies of the cost effectiveness of care, the cost offsets of care, and the cost benefits of care. Also included are studies to improve and standardize the techniques for measuring costs, cost effectiveness, cost offsets, and cost benefits. 3) Finance. This includes studies of financial access to care, studies of the consequences of being uninsured, and studies of the effects of insurance parity between alcoholism treatment and other medical treatment. 4) Improved methods for conducting services research. This includes new techniques for conducting secondary analyses of administrative data and improved measurement techniques for outcomes, quality, cost, and patient satisfaction. Research that analyses selection bias and examines how the differences between participants sampled in clinical trials and patients sampled in real-world distributions may affect the generalizability of clinical trials results is also encouraged. 5) Brief interventions and other forms of care directed at drinkers who may be at risk for developing, but who are not yet diagnosable with, alcohol abuse or dependence. NIAAA encourages studies of the effectiveness of such interventions, their costs, and how they might best be implemented in applied practice. Also needed are studies of instruments designed to screen and identify individuals appropriate for such interventions. 6) Coordination of specialty alcohol treatment with other medical services. Linkages to medical settings that treat many persons with alcohol use disorders, such as primary care, emergency care, obstetric care, and mental health care systems, are of particular interest. Research is needed to develop more effective methods for screening, identifying and referring patients to specialty alcoholism treatment. Also of interest are studies of interventions such as extended case monitoring of treated patients that facilitate the return to treatment in case of relapse. 7) Alcohol treatment delivered within institutions not primarily concerned with health care. Significant amounts of alcohol treatment are delivered through workplace programs, employee assistance programs, and programs located within the criminal justice, child protective services, and welfare systems. The utilization, outcome, quality, cost, and coordination of such services are all areas of interest. 8) Pathways to entering alcohol treatment. Studies of the processes that lead individuals to seek treatment, including individual decision-making, informal social influences from family and friends, and institutional pressures from employers or the legal system are encouraged. A principal interest in this line of research should be the identification of barriers toward seeking treatment and approaches to reducing those barriers. 9) Enrollment, retention, and completion. Research is encouraged to examine the characteristics of service systems that promote: (a) actual enrollment in treatment by individuals who have been referred to it, (b) retention in treatment, and (c) completion of treatment. 10) Long-term treatment careers of alcohol dependent and abusing individuals. Little is known about the sequencing, timing, interactions, or collective impact of separate episodes of treatment that an individual may receive over a lifetime. Studies that establish cohorts for long-term longitudinal study would be especially valuable. 11) Barriers to treatment faced by specific population groups. Research is needed to identify barriers that may be faced by some population subgroups and steps that can be taken to reduce these barriers. Groups of interest include women, ethnic minorities, residents of rural areas, residents of Indian reservations, adolescents, the elderly, persons with concurrent mental health illnesses, the uninsured, the homeless, and the handicapped. Also of interest are evaluations of programs designed to reduce barriers and facilitate treatment access for members of any of these groups. 12) Status of the counseling workforce. Studies could investigate trends in the training, accreditation, remuneration, and stability of employment of those who provide alcohol treatment. Key studies here include how the advent of managed care and other organizational and financing developments has affected these trends. 13) Adoption of research findings in applied practice. The Institute is specifically interested in studies that might facilitate wider use of pharmacotherapy, manualized behavioral treatments, screening and diagnostic instruments, and behavioral couples therapy in applied practice. Studies that focus on the identification of barriers to adoption (both individual and institutional) and on the reduction of those barriers are especially encouraged. 14) Prevention. This announcement invites studies of the potential of prevention activities to reduce the demand for health care services, including both alcohol treatment services and general medical services. Studies of both the effectiveness and the cost effectiveness of prevention activities in achieving these ends are sought. 15) Quality of care indicators and placement criteria. Studies are needed to develop and evaluate indices of quality of care and patient placement criteria. Applicants should adopt research designs appropriate to the research goals proposed (see Lettieri 1992, Sechrest et al. 1990, Cook and Campbell 1979, Gold et al. 1996, and Perl et al. 2000). Research designs should contain a judicious mixture of scientific rigor and thoughtful response to the exigencies of conducting research in real world settings. Applications whose main objective is to establish and support treatment or prevention service programs are not eligible for funding under this Request for Applications. Support for the costs of research-related treatment, rehabilitation, or prevention services and programs may be requested only for those particular costs related to the implementation of the research project and for that period of time required by the research project. These costs must be justified by research objectives, methods, and designs that promise to yield important, generalizable knowledge. Summary Studies are sought on a number of topics that promise to expand knowledge about alcohol treatment delivered in applied settings. These include studies of treatment access, utilization, quality, cost and outcome. Of special interest are studies of improved models of care, studies of underlying principles that promise such improvement, studies of barriers to improved treatment, and studies that assess new approaches to delivering treatment in applied settings. 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. 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: 1) 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. 2) The reasonableness of the proposed budget and duration in relation to the proposed research. 3) 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. Additional consideration pertinent to the review of Exploratory/Developmental Grant (R21) and Small Grant (R03) 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. 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. 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 REFERENCES Cook, T.D. and Campbell, D.T. Quasi-Experimentation: Design and Analysis Issues for Field Settings. Boston: Houghton Mifflin, 1979. Gold, M.J., Siegel, J.E., Russell, L.B., and Weinstein, M.C. Cost- Effectiveness in Health and Medicine. New York: Oxford University Press, 1996. 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. Perl, H.I., Dennis, M., and Huebner, R.B. State-of-the-art methodologies in alcohol-related health services research. Addiction, #95 (Supplement 3), pp. S275-S280, 2000. Sechrest, L., Persin, E., and Bunker, J., eds. Research 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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