This Program Announcement expires on March 31, 2004, unless reissued. ADOPTION OF ALCOHOL RESEARCH FINDINGS IN CLINICAL PRACTICE Release Date: February 27, 2001 PA NUMBER: PA-01-058 National Institute on Alcohol Abuse and Alcoholism THIS PA USES THE MODULAR GRANT AND JUST-IN-TIME CONCEPTS, IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites applications to support studies of the adoption in clinical practice of scientific advances in the treatment of alcohol dependence and abuse. It is hoped that a better understanding of these adoption processes will strengthen effective communication between researchers and providers, thereby facilitating the adoption of emergent research-based advances. Specific areas of research encouraged herein include: studies that prepare findings from efficacy trials for real-world clinical adoption, studies of communication channels between the scientific community and the provider community, studies of adoption trials, naturalistic studies of knowledge adoption, contributions toward the theory of the adoption process, studies of organizational change, and studies of the resources required for the adoption of treatment improvements. 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 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 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 RESEARCH OBJECTIVES BACKGROUND A gap in communication between alcoholism treatment providers and alcoholism treatment researchers has become a significant concern. On the one hand, research advances have not been transmitted to practitioners in such a way that routine adoption into clinical practice can be assumed. On the other hand, research projects are designed and conducted without the participation of non-academically based providers, who consequently have little influence on the research agenda. This gap was the subject of an influential Institute of Medicine Report (Lamb et al. 1998) and has prompted constructive responses from several Federal agencies. For example, the recently released National Treatment Plan of the Center for Substance Abuse Treatment (CSAT) devotes a major section to Connecting Services and Research, in which a new mechanism for improved coordination among CSAT, NIAAA, the National Institute on Drug Abuse (NIDA), and relevant State and local partners is proposed (CSAT 2000). Such programs as CSAT’s Addiction Technology Transfer Centers and its Practice Research Collaboratives, NIAAA’s Research to Practice Forums and its Researcher in Residence Program, and NIDA’s Clinical Trials Network all have been established to address one or another aspect of the overall problem. Yet an understanding of a key piece of this problem, the process by which research advances become adopted in clinical practice, has a weak scientific base, being little studied within the context of alcoholism and drug abuse treatment. In more general contexts, studies of research dissemination, knowledge adoption, and technology transfer have an established history. Readers can trace this history in Backer (1988 and 1991), Dunn and Holzner (1988), Glaser et al. (1983), NIDA (1995), Rogers (1983), and Zaltman (1973). Two basic lessons have emerged from this work. First, it has become recognized that a focus on organizational change was an important complement to a focus on change at the individual level (change in the behavior of targeted individual clinicians). Second, it has been recognized that research dissemination strategies that relied on the spread of written materials alone might not be effective and that other personal contact might be needed in addition. Despite these advances, validated models of the research adoption process in the alcoholism and drug abuse fields have yet to emerge. Brown’s recent review of the topic (2000) suggests six factors (relevance, timeliness, clarity, credibility, replicability, and reduction of staff concerns) that should be related to effective knowledge transfer, but empirical tests of this nascent theory have not yet been conducted. The purpose of this announcement is to stimulate a program of research on the process of adopting research findings in treatment practice, which should provide essential guidance to efforts to improve the delivery of alcohol treatment services. AREAS OF RESEARCH INTEREST Studies are encouraged in seven areas under the terms of this announcement: o Studies that prepare the findings from efficacy trials for real-world clinical adoption. Moving knowledge from efficacy studies into effectiveness studies is a principal goal of health services research (NIAAA 1997). Clinical trials often exclude subjects seeking repeated episodes of treatment or having compounding drug abuse or mental health comorbidities. In consequence, clinical subject populations are often not representative of typical client populations. Similarly, clinical trials subjects typically must agree to random assignment to treatment condition; whereas, clinic patients typically self-select among treatment options. These differences can have implications for the generalizability of research findings (see Weisner et al. 2000). Similar differences emerge because clinical trials tend to be conducted in academic treatment clinics and because treatment protocols may focus on individual rather than group delivery of therapy. o Studies of communication channels between the scientific community and the provider community. Publishing findings in scientific journals alone has not proven an effective way to communicate those results to treatment providers. Processes by which knowledge is transmitted between the scientific and the provider community require further study. It is important to note, in this regard, that communications ideally should flow between these communities in both directions (Lamb et al. 1998). Researchers need to hear from clinicians about clinical problems and emerging trends in care delivery that require examination. Studies are needed to assess how effectively these channels of communication operate, whether there are significant barriers to communication, and whether effective means to reduce these barriers can be identified. o Studies of adoption trials. A significant need is the need for evaluations of specific efforts to stimulate clinical adoption of improved treatment practices. Ultimately, progress in this field will be built through a case-by-case accretion of successes and failures as different approaches are tried and their outcomes are observed, over both the short and long term. Studies of this sort might include such things as: horse race comparisons between specific approaches; comparisons between literature only and personal instruction approaches; comparisons between consultant approaches and workshop approaches (Brown 2000); studies of the effectiveness of specific manuals, videotapes, or other tools; and studies of the relative effectiveness of instruction provided by clinicians versus instruction provided by researchers. o Naturalistic studies of knowledge adoption. While experimental or quasi- experimental trials to conduct studies described in the above section hold the greatest promise for moving this field forward, the paucity of current knowledge makes it likely that naturalistic studies could also make important contributions. These might include descriptive studies of natural variation in treatment innovativeness as well as the networks and processes of diffusion, adoption, and communication. Also important would be comparisons between early adopters and late adopters. o Contributions toward the theory of the adoption process. Ultimately, the field hopes to build a theory of the adoption process. This theory will, in turn, help us design more effective adoption strategies. Studies might test the adequacy of general theories of the adoption process. For example, they might test the implicit theory suggested by Brown (2000), which identifies six factors as key influences on adoption: relevance, timeliness, clarity, credibility, replicability, and reduction of staff concerns. Other models can be found in Green et al. (1987) and Oldenburg et al. (1997). The field could also benefit from more modest studies that focus on one or two factors thought to either facilitate or impede adoption. o Studies of organizational change. Most successful practice improvements go beyond the level of changing the knowledge or skill of individual clinicians and also require changes in the operation of the treatment organization. Studies here could address how organizational change to facilitate practice improvement is best accomplished and managed. Included would be studies that identify which organizational forms or management approaches do the best job of facilitating innovativeness. o Resources and treatment finance. We can not expect that improvements in treatment will be free. Significant time and resource expenditures will be needed. Studies are needed of the availability and adequacy of resources to support practice improvement. Also relevant are studies of the role and functioning of incentives to improve practice, studies that estimate the financial arrangements most facilitative of practice improvement, studies estimating the size of resource barriers to treatment improvement, and studies of how innovation can be secured for the least cost (cost effectiveness studies). Similarly, studies estimating the potential cost savings or increased cost effectiveness (or cost offsets) of treatment due to the adoption of particular treatment improvements are encouraged. 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 (; a complete copy of the updated Guidelines are available at 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: 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. 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. 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, email: 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 both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at 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 Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: - Complete the educational block at the top of the form page: - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations; o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. 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, 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) 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: Direct inquiries regarding fiscal matters to: Edward Ellis Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Blvd., MSC 7003 Bethesda, MD 20892-7003 Telephone: 301-443-4703 FAX: 301- 443-0788 Email: 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. Glaser EM, Ableson H, and Garrison KN. Putting Knowledge to Use. San Francisco, CA: Jossey-Bass, 1983. 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. National Institute on Drug Abuse. Reviewing the Behavioral Science Knowledge Base on Technology Transfer. NIH Publicatoin 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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