PA-00-082: RESEARCH ON MENTAL DISORDERS IN RURAL AND FRONTIER POPULATIONS

Department of Health
and Human Services (HHS)

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RESEARCH ON MENTAL DISORDERS IN RURAL AND FRONTIER POPULATIONS Release Date: March 28, 2000 PA NUMBER: PA-00-082 (see replacement PA-04-061) National Institute of Mental Health THIS PA USES MODULAR GRANT AND JUST IN TIME CONCEPTS. THIS PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA PURPOSE This is a revision of program announcement PA 91-52B, entitled Research on Mental Disorders in Rural Populations, which was issued in 1991. The National Institute of Mental Health invites grant applications from interested investigators for research on populations located in diverse rural and frontier areas of the United States. The purpose of this announcement is to stimulate research on mental health problems and risks associated with rural and frontier communities and to undertake studies that will: (1) improve our understanding of barriers that place limits on the provision of care in these areas, and (2) provide information that will improve the organization, financing, delivery, quality, effectiveness, and outcomes of care for persons with mental disorders living in these diverse communities. 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, Research on Mental Disorders in Rural and Frontier Populations, is related to the priority areas of Mental Health and Mental Disorders. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/ ELIGIBILITY REQUIREMENTS Applications may be submitted by any domestic public or private nonprofit organization and by for-profit organizations, including universities, colleges, hospitals, laboratories, units of State or 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. Foreign institutions are not eligible for an R03 award. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (RO1) and small grant (R03) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this PA may not exceed five years for the R01 award and two years for the R03 award. For all R03 applications and for competing R01 applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being undertaken at NIH. More detailed information about modular grant applications, including a sample budget narrative justification page and a sample biographical sketch, is available via the Internet at: http://grants.nih.gov/grants/funding/modular/modular.htm. Because small grants have special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain the appropriate additional announcements for those grant mechanisms. Special instructions and information for the small grants program is found at: http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html RESEARCH OBJECTIVES Background The impact of mental health problems upon the lives of people and nations long has been profoundly underestimated. A recent landmark study (the Global Burden of Disease study, conducted by the World Health Organization, the World Bank, and Harvard University in 1996) provided a new perspective on this impact. Major depression alone ranked second only to ischemic heart disease in magnitude of disease burden in established market economies, such as the United States. Other kinds of mental illnesses also contributed to the burden represented by mental illness. Mental Health: A Report of the Surgeon General, published in 1999, documents the enormous public health burden of mental disorders in the United States, reviews the scientific progress in understanding, treating, and preventing these disorders, and points out the barriers to further progress in reducing the toll of mental disorders. A clear message of this report is that a variety of well-established treatments are available for the range of mental and behavioral disorders that occur across all ages and that everyone should be encouraged to seek help for mental health problems just as for other health problems. Much of the personal and societal burden of mental disorders could be alleviated if people experiencing these disorders sought and received appropriate treatments. However, the Surgeon General’s report acknowledged the existence of major barriers that deter people from accessing treatment. For the United States as a whole, these barriers are primarily insurance, availability and stigma. More than 44 million Americans are without any health care insurance, and even those who have insurance coverage find that mental health benefits are much more restrictive than those for other types of illnesses. For example, current mental health outpatient visits provide only about 50 percent co-payment (compared to 85 to 90 percent for all other illnesses), and in most private insurance plans, the annual number of outpatient visits allowed for mental health treatment is often restricted. For many years, Americans viewed mental illness as a stigmatized condition. While this attitude is slowly being replaced by a more scientific understanding, stigma is still a powerful barrier to people seeking help for mental disorders and is reflected in the public’s reluctance to pay for mental health treatments, particularly through insurance premiums or taxes. Nearly 60 million Americans living in rural and frontier America have the same kinds of mental and general health problems and needs for services as individuals who live in urban and suburban areas. However, in addition to the access barriers discussed above that affect all Americans, individuals living in underserved rural and frontier areas encounter numerous additional barriers to the receipt of effective services. Access to and availability of mental health specialists, such as psychiatrists and psychologists is seriously lacking. Poverty, geographic isolation and cultural differences further hinder the amount and quality of mental health care available to people in rural areas. More than 800 rural counties have high poverty rates, but only 25 percent of people living in rural areas qualify for Medicaid, compared to 43 percent in urban areas. Women head 46 percent of rural households, and, of these families, 27 percent are below the poverty level, compared to 9% of male- headed rural families. The elderly are represented disproportionately in rural areas. As Mentioned above, most rural counties have no practicing psychiatrists, psychologists or social workers, and providers with formal mental health training prescribe only 20 percent of psychotrophic medications. In sum, availability of, and access to, mental health specialists (and often any kind of provider) remains a serious problem. Geographic location creates problems in delivering services in less densely populated rural and even more sparsely populated frontier areas. Questions have been raised about whether providers who are available are also adequately trained to deliver culturally sensitive care to different groups residing in these communities. Cultural barriers may exist to the extent that rural America still reflects different values and lifestyles than urban America. These and many other inequities in rural and frontier populations, as well as the lack of mental health and health care services, have led members of Congress to urge both parity in mental health insurance coverage and greater parity in providing mental health services to rural and frontier populations. Recent changes in the health care system (including managed care) that emphasizes cost containment could further imperil access to mental health services for people in rural and frontier areas. There is concern that, in the effort to trim the health care costs, rural mental health services could continue to suffer disproportionately. There is a continuing need for studies that will assess and monitor the availability and quality of mental health services for people in rural and frontier areas. Listed below are examples of important research topics that need to be addressed in order to provide new knowledge on rural and frontier mental health problems and how to deliver cost effective care. This list is illustrative, but not exhaustive. It is expected that researchers who respond to this announcement will identify additional research questions that will assess how to intervene to enhance the delivery of mental health care to a variety of rural and frontier populations. o Studies of the incidence and prevalence of mental disorders for children and adults (including co-occurring substance disorders) and associated disability in diverse rural and frontier settings with special attention to underserved populations (e.g., American Indians, Alaska Natives, African- Americans, Hispanics, the elderly, and those living in poverty). What are the salient program characteristics that are most likely to ensure successful provision of preventive interventions and treatment for persons with mental illness in diverse rural and frontier settings? o Research on barriers to care (community/structural, geographic, cultural, and financial) with special emphasis on studies of specific interventions designed to overcome such barriers. What are specific program characteristics (including community based outreach efforts) that are crucial to overcoming access barriers and enhancing delivery of mental health services? Can mental health care be delivered at least as effectively through telecommunications as it is delivered face-to-face? Does effectiveness of long distance care vary by disorder or severity of disorder? How significant is cultural competency in the delivery of effective care through telecommunications? What can be done to minimize stigma in underserved populations? o Studies of preventive interventions in rural and frontier communities. How effective are community outreach programs in overcoming stigma and encouraging individuals to seek mental health care? o Studies of the availability and effectiveness of psychosocial rehabilitation services particularly for persons with severe mental disorders. What are the characteristics of successful models that have been adapted to rural and frontier areas? o Studies of the organization and financing (including private and public sectors) of care and how they affect access to and outcomes of care. o Studies of mental health care delivery by primary care providers, social workers, psychiatric nurses and primary care providers to improve access to care and enhance the quality of care? How can communities integrate the work of mental health specialists, primary care providers and other types of providers in order to enhance access and the effectiveness of outcomes of care? o Research on the effect of cost-containment strategies and managed care on the mental health care available in rural and frontier areas. o Research on social and environmental crises in rural communities and the mental health consequences. How can we intervene to assist families in crisis and prevent violence in diverse family groups in rural areas? o Research on the reliability and validity of current diagnostic instruments used with diverse cultural groups in rural and frontier areas. o Research on the design, measurement, and statistical challenges inherent in conducting research in rural and frontier communities, including how the concept of rural should be defined and operationalized in order to provide a context within which investigators can determine meaningful rural/urban comparisons. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-42). All investigators proposing research involving human subjects should read the NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research, which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html 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. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding their proposed project and the goals of this PA. 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 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: GrantsInfo@nih.gov. Applications are also available on the World Wide Web at: http://grants.nih.gov/grants/forms.htm. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS 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 grants application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. 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 this application. o NARRATIVE BUDGET JUSTIFICATION Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm 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 key 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 key 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 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: http://grants.nih.gov/grants/funding/modular/modular.htm -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. Applicants planning to submit an investigator-initiator 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 program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the Institute staff that the Institute 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 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 http://grants.nih.gov/grants/guide/notice-files/not98-030.html Any application subject to this policy that does not contain the required information in a cover letter sent with the application will be returned to the applicant without 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 MENTAL 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-sponsored 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 deserves 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 methods? 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 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. 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: Anthony Pollitt, Ph.D. Office of Rural Mental Health Research National Institute of Mental Health 6001 Executive Boulevard, Room 7130 MSC 9631 Bethesda, MD 20892-9631 Telephone: (301) 443-4525 FAX: (301) 443-4045 Email: apollitt@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115 MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The 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, a 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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