STATE IMPLEMENTATION OF EVIDENCE-BASED PRACTICES – BRIDGING SCIENCE AND SERVICE RELEASE DATE: August 16, 2002 RFA: MH-03-007 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) Substance Abuse and Mental Health Services Administration (SAMHSA) (http://www.samhsa.gov/) LETTER OF INTENT RECEIPT DATE: September 29, 2002 APPLICATION RECEIPT DATE: October 29, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Mental Health (NIMH) and the Substance Abuse and Mental Health Services Administration (SAMHSA) have entered into a partnership to promote and support implementation of evidence-based mental health treatment practices into state mental health systems. NIMH seeks to enhance the research agenda of state mental health systems by focusing on activities that yield knowledge about the most effective and feasible methods for implementing evidence-based practices into state clinical practice settings. SAMHSA seeks to provide direct support to states and localities that are ready and committed to adopting evidence-based practices. This Request for Applications (RFA) is designed to accomplish both objectives. This RFA is to provide funding to states for planning grants to bridge science and service focusing on the implementation of Evidence-based Practices (EBPs). Some states are actively implementing EBPs despite limited information about what factors contribute to successful adoption. There is substantial variation in states" readiness to implement EBPs, and this RFA is intended to allow states at various levels of implementation readiness to participate in bridging science to service activities that will further their specific agendas. In order to ensure that the funding goes directly to the state, state offices (e.g., Departments of Mental Health, Medicare/Medicaid offices) will be required to be the applying organization, and a state officer will be required to be the Principal Investigator. Examples of activities may include: 1) meetings to convene state and local stakeholders to learn about implementation and plan EBP implementation strategies, 2) small pilot studies on research areas such as fidelity measurement assessment, and innovative cost analyses, 3) establishment networks of administrators and key leaders to share information about implementation or plan for alternative models of information management and process and outcome measurement, and 4) planning of training, financing, and policy initiatives that will advance implementation of EBPs. It is expected that the one-year planning grant will lead to the submission of a research application for an R01, R21, or R03 grant and/or applications for SAMHSA Targeted Capacity Development, Community Action and other Best Practice Development Grants. RESEARCH OBJECTIVES In response to key recommendations from the NIMH "Bridging Science and Service" report, and SAMHSA"s Science to Service goals, the Services Research and Clinical Epidemiology Branch (SRCEB) of NIMH and SAMHSA are issuing this RFA to offer awards through the P20 mechanism to stimulate science to service development activities within state mental health agencies. Applications will be solicited from individual state offices to plan activities leading toward the development of a unique science to service agenda around the implementation of evidence-based mental health services into local practice settings. The purpose of this RFA is to enable states in varying stages of readiness to perform research and/or build research capacity to undertake studies that will add to the evidence base on implementation of EBPs and improve their service delivery. Bridging science to service activities may include methods of convening state and local stakeholders to learn about implementation and plan their efforts, efforts to enhance collection and aggregation of data, creation of mechanisms to facilitate the implementation of research findings by clinicians and practices, and creation of partnership networks of administrators, key leaders and researchers to share information and plan implementation. It is anticipated that after completion of these exploratory science to service planning grants, recipient organizations will be in a position to compete for a variety of research and service enhancement mechanisms to assist states in carrying out their individualized plans. Evidence-based practice remains a central focus of mental health research and policy. Within the last few years, research has demonstrated the effectiveness of a number of mental health treatments within clinical trials and other valuable studies. However, difficulties remain in transporting and translating these treatments to fit into real-world settings (Frist, W.H., 2002, "Federal Funding for Biomedical Research," JAMA, 287(13): 1722-24). While the language of evidence-based practice is so often used in research publications and strategic plans, the knowledge base about how to disseminate evidence and implement EBPs is still vastly underdeveloped. State mental health officials have demonstrated an interest in implementing EBPs within their systems, but have been constrained by limited resources in their ability to develop the knowledge base of how EBPs can fit within their system. Given the great difficulty of determining how EBPs can fit within real-world settings, state research efforts toward implementation of EBPs can provide a wealth of information about the factors that affect implementation. These efforts can build a foundation for the next generation of interventions that more effectively accommodate the complexities of everyday practice settings. While learning more about the factors that contribute to successful implementation of evidence-based practices, these grants also simultaneously provide states with opportunities to begin planning concrete service improvement strategies. To this bridging science to service end, states may choose from numerous service improvement objectives, including (but not limited to): o Assessing, adapting, and evaluating the impact of practical forms of evidence such as practice guidelines o Assessing and planning long-term sustainability from the inception of service improvement change o Implementing accountability mechanisms in linking EBP implementation with achievable client outcomes We envision that state efforts facilitated by these science to service planning grants will contribute to our understanding of what factors affect the implementation of Evidence-based Practices. Responses to the RFA will be referred to the NIMH Dissemination and Implementation Research or Outcomes and Quality of Care Programs within the Services Research and Clinical Epidemiology Branch of Division of Services and Intervention Research. NIMH and SAMHSA will provide oversight of science to services grants jointly. OVERVIEW OF THE FIELD OF RESEARCH A large body of evidence across relevant disciplines forms the basis for addressing the need of this RFA. Over the past several decades, mental health services and intervention research has seen tremendous growth in the number of empirically-supported treatments, as defined by successful patient outcomes in scientifically-rigorous randomized controlled trials (RCTs). Further, research studies have established, to a lesser degree, the generalizability of some treatment and prevention programs through effectiveness studies. However, state systems continue to implement far fewer "evidence-based" treatments than expected by the research community. State mental health departments have demonstrated tremendous interest in the implementation of these treatments, but hesitate about whether the treatments are suitable for their public mental health services. Questions remain about the appropriate fit between the state systems and the treatments, as defined within the RCT. Evidence is lacking about the implementation of evidence-based mental health treatments within state care settings, and this is making decision-making difficult about whether to implement treatment programs within state systems. Some have argued that the lack of evidence stems from the small role that state departments have played in research. As a result, many important implementation questions are not being asked (and need to be) within research studies. However, some important field approaches to implementing evidence-based practices are emerging, supported by efforts from large state and local networks of researchers, providers, consumers, family members, policy makers, and program officials (e.g., the National EBP project supported by SAMHSA and others). These approaches bring unique opportunities to add scope and different dimensions to their promised knowledge through this RFA. In addition to supporting development of EBP capacity, this RFA gives an opportunity for additional questions to emerge, for partnerships with researchers to be cultivated, and important implementation studies to be planned for future grant submissions. KNOWLEDGE TO BE GAINED THROUGH THIS INITIATIVE As indicated above, many of the research questions about implementing evidence- based mental health treatments into public care settings have been slow to emerge. Several recent NIMH and SAMHSA reports and related grant initiatives have signaled the importance of involving more practitioners and important stakeholders in research, as a method of making the resulting studies more relevant to the real world. This RFA enables monies to be used by state agencies for the specific activities of developing these questions into viable research studies and service enhancement projects. The resulting knowledge will build on the existing efficacy and effectiveness data for a variety of interventions, and will improve the capacity for state agencies to inform and conduct research, and raise the awareness of researchers and policymakers about real-world implementation importance. Activities appropriate to this RFA include, but are not limited to: o Use of sophisticated survey methodologies to solicit research questions from key target audiences, specifically targeting the implementation of evidence- based practices in state mental health care settings o Development of innovative and sustainable partnerships with researchers from multiple disciplines, including organizational change and development, knowledge management, marketing, technology transfer, information technology, etc o Use of existing and emerging technology transfer mechanisms to plan and sponsor enhanced EBP service capacity o Development of rigorous and effective dissemination strategies (e.g., training, technical assistance) that support and sustain adoption of evidence- based practices o Innovative, highly-focused meetings reaching out to target adopter groups (e.g., providers, policymakers, administrators), in preparation for the bridging science and service agenda development. Use of multiple methods (e.g., virtual meetings, online discussion groups, conference calls, research seminars) to discuss implementation issues and obtain input on research questions from these stakeholders o Development of a highly-focused science to service agenda, including short- term and long-term goals for researching evidence-based mental health practice implementation in state settings, based on a theoretical or conceptual framework of state-wide implementation. It is expected that the planning activities will lead to one or more R01, R03, or R21 grant application submissions to NIH and to SAMHSA grant submissions o Development of initial pilot studies to gather data on evidence-based implementation-related issues which will lead to the submission of R01s MECHANISM OF SUPPORT This RFA will use the NIH P20 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 2003. FUNDS AVAILABLE NIMH and SAMHSA intend to commit approximately $1 million in FY 2003 to fund 10 to 15 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 1 year and a budget for direct costs of up to $100,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIMH and SAMHSA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o Units of State governments INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS/PROGRAM DIRECTORS Any state mental health department, Medicare/Medicaid office, or state health department full-time employee with the skills, knowledge, and resources necessary to carry out the proposed science to service development is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: science to service development, peer review, and financial or grants management issues: Direct your questions about science to service planning issues to: David A. Chambers, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7133, MSC-9631 Bethesda, MD 20892-9631 Telephone: (301) 443-3747 FAX: (301) 443-4045 Email: dchamber@mail.nih.gov Crystal R. Blyler, Ph.D. Division of Service and Systems Improvement Center for Mental Health Services Substance Abuse and Mental Health Services Administration 5600 Fishers Lane, Room 11C-22 Rockville, MD 20857 Telephone: (301) 443-3653 FAX: (301) 443-0541 Email: cblyler@samhsa.gov Direct inquiries regarding peer review issues to: Michael Kozak, Ph.D. Chief, Extramural Review Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC-9608 Bethesda, MD 20892-9608 Telephone: (301) 443-1340 FAX: (301) 594-0702 Email: mkozak@mail.nih.gov Direct inquiries regarding fiscal matters to: Joy R. Knipple Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC-9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: jk173@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed science to service planning activity o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 allows NIMH and SAMHSA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: David A. Chambers, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7133 MSC-9631 Bethesda, MD 20892-9631 Telephone: (301) 443-3747 FAX: (301) 443-4045 Email: dchamber@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Where the application asks for a "Research Plan," describe the science to service planning activity for your proposed project. The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892 Rockville, MD 20852 (For express/courier service) Telephone: (301) 443-3367 FAX: (301) 443-4720 Email: jnoronha@mail.nih.gov APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIMH and SAMHSA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH and SAMHSA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Mental Health 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. The goals of SAMHSA-supported projects are to increase the availability and quality of mental health services. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Do your science to service planning activities address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge and application of scientific knowledge? What will be the effect of these planning activities on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses underlying the science to service planning activities adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Do your science to service planning activities employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or employ innovative methodologies or technologies? (4) INVESTIGATOR/PROGRAM DIRECTOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator/program director and to that of other key personnel (if any)? (5) ENVIRONMENT: Does the environment in which your work will be done contribute to the probability of success? Do the proposed science to service planning activities take advantage of unique features of the environment or employ useful collaborative arrangements? Is there clear and unwavering evidence of State support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: 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. o INCLUSION: The adequacy of plans to include participants from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific and programmatic goals of the grant. Plans for the recruitment and retention of research subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed project. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: September 29, 2002 Application Receipt Date: October 29, 2002 Peer Review Date: February 2003 Council Review: May 2003 Earliest Anticipated Start Date: July 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific and technical merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at https://grants.nih.gov/grants/funding/children/children.htm. 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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 RFA 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.242 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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.

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