RESEARCH ON MENTAL HEALTH SERVICES IN GENERAL HEALTH CARE NIH GUIDE, Volume 21, Number 32, September 4, 1992 PA NUMBER: PA-92-103 P.T. 34 Keywords: Mental Disorders Health Services Delivery National Institute of Mental Health PURPOSE The goal of this Program Announcement (PA) is to encourage research on mental disorders in primary care and other general medical settings, particularly research that focuses on the nature, recognition, classification, treatment, and outcomes of people with mental disorders in these service settings. This announcement may encourage the development of needed research that seeks to improve understanding of how best to assess mental disorders and provide mental health services in general health care settings. Among people with current mental disorders who use health services, about half are not treated in the specialty mental health care sector and receive health services only in general medical settings. While investigator-initiated research in this area has grown substantially, there is still a tremendous dearth of accurate information on the kinds of patients with mental disorders in the general health care sector, the nature and severity of their disorders, and the relationship of these mental disorders to medical conditions, as well as on the mental health services--- types, quality, effectiveness---delivered in primary care and other general health care sectors (e.g., emergency rooms, nursing homes, general hospital medical and surgical units, rehabilitation hospitals). The Primary Care Research Program at the National Institute of Mental Health (NIMH) was established in response to research findings indicating the relative gap in use of specialty mental health services compared to primary care service use by people with mental disorders, and as an attempt to understand the low recognition rates of mental disorders in general medical settings and to contribute to health care policy. While major research issues at the outset included epidemiological (prevalence and types of disorders), nosologic (validity and reliability of diagnoses), clinical practice and services, systems/organizational, and economic questions, existing research data are still scant in most of these areas, despite a growth in the field's scientific inquiries and related activities sponsored by the program. Furthermore, this research is called for by the mental health objectives in the recent report "Healthy People 2000"---two of which directly address the provision of mental health services by primary care providers (6.13, 6.14) [footnote 1]. Other recent activities---the Agency for Health Care Policy and Research of guidelines for the treatment of depression in primary care (with which the NIMH has been involved) [footnote 2] active work with new classification of mental disorders in primary care [footnote 3]--- support this effort. These and other activities [footnote 4], aligned with scientific data on the impact of mental health on overall functioning and disability in people seen in the general health care sector [footnote 5] make a strong call for more scientific inquiry to inform the gaps between the mental health needs seen in these general sector settings and the services provided in these settings. These gaps are even more evident in special populations seen mainly in the general health care sector and the special issues of access, assessment, and utilization that are unique to them: rural groups, minority populations, inner city groups, and HIV-infected people. Attention should also be given to unique issues related to women, children, adolescents, and the elderly. Last, research is strongly needed on those people with mental disorders who may need more services in the general health sector, particularly the severely mentally ill [footnote 6] and the homeless. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This effort is in accordance with specific objectives 6.13 and 6.14. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, public and private, non-profit and for-profit organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. Foreign institutions are only eligible for traditional research grants. MECHANISMS OF SUPPORT Research support may be requested through applications for traditional research grant (RO1), a small grant (R03), and First Independent Research Support and Transition (FIRST) Award (R29). Since the latter programs have special requirements, applicants are advised to refer to specialized announcements for the small grant and FIRST award programs, available from: National Institute of Mental Health Division of Extramural Activities Office of Extramural Policy and Analysis 5600 Fishers Lane, Room 9-97 Rockville, MD 20857 Telephone: (301) 443-4673 Terms and Conditions of Support Grant funds may be used for expenses clearly related and necessary to conduct the proposed research, including direct costs and allowable indirect costs. Period of Support Applications for traditional research projects may request support for up to five years. Small grants are limited to two years and may not be renewed. FIRST awards are made for five years, but are not renewable. Annual awards will be made, subject to continued availability of funds and progress achieved. A competing continuation (renewal) application for a traditional research award (RO1) may be submitted before the end of an approved period of support in order to request funds for the continuation of the project. RESEARCH OBJECTIVES The following list of research objectives is meant to be exemplary and not exhaustive---it serves to identify key topics in which further rigorous scientific research is needed to delineate mental health needs and to assess the mental health services provided in the general health care sector: (1) Methodological Issues o Studies of classification systems for mental disorders and treatments delivered in the general health care sector, with special emphasis on validity, comparative diagnostic assessments, and clinical problems not addressed by available nosologic systems (e.g., childhood behavioral disorders, subsyndromal disorders like minor depression or mixed anxiety-depression) o Research on the development, applicability, and utility of instruments or analytic techniques that may be used to assess multi-dimensional outcomes for people with both mental and medical disorders seen in the general health care sector. Such outcomes might include severity of illness, disability, costs, and community and family burden o Research on the applicability and utility of existing mental health screening, diagnostic and management instruments in primary care settings, particularly among patients from different socio-economic, ethnic, and cultural backgrounds o Studies using innovative methodologies (e.g., decision analysis, meta-analysis) to examine the clinical management of people with mental disorders in the general health care sector (2) Recognition and Diagnosis o Studies examining the presentation and nature of mental disorders in primary care and other general health care settings (especially for children and the elderly), especially duration, remission, and recurrence of these disorders, with special consideration to the longitudinal evaluation of treated and untreated subsyndromal conditions that impair health status o Studies of the impact of co-occurring general medical illnesses on the accurate assessment of mental disorders, and impact on mental health services delivered in the general health sector for these populations (e.g., the "accurate" assessment of depression in the medically ill and service implications) o Studies of the relationship between co-occurring alcohol or drug problems and mental disorders, and the impact of these conditions on accurate recognition of mental problems by general health care providers o Studies of the barriers to the accurate recognition and diagnosis of mental disorders, especially in primary care, with special attention to (a) patient variables such as population specific beliefs (e.g., rural, cultural) and (b) provider variables, such as knowledge and attitudes about mental disorders, which may impact on recognition and management of people with mental disorders (3) Clinical Services and Practices o Research on the types, quality and effectiveness of mental health services provided by general health care providers, differences of these services in relation to type of patient (e.g., understudied groups like the elderly and women in various life cycle stages who seek general health care), provider (e.g., physician, nurse, social worker) and setting, and impact on patient outcomes o Studies of referral patterns from the general health care sector to the mental health care sector and barriers to referral (e.g., access, attitudes, training, reimbursement)---rates, processes, and effect on patient outcomes, as well as strategies to overcome those barriers o Studies addressing improvement of current clinical practice to ensure adequate mental health services in the general health care sector---application of clinical trials, analysis of provider-patient interactions, feasibility of transferring specialist mental health services to general health care settings, and consultation-liaison models o Studies of innovative educational/teaching models to improve the recognition and care of patients with mental disorders by their general health care service providers (e.g., utility of clinical practice guidelines) (4) Service System and Financing Issues o Studies of the organization, delivery, and cost-effectiveness of services for mental conditions in primary care settings, with focus on variations in practice (e.g., managed care systems) and setting (e.g., rural, community health centers) o Research on the impact of different reimbursement approaches on the use of general health vs. mental health services (e.g., prepaid health plans) and implications for services, quality of care, and patient outcomes o Research on existing or innovative models linking or integrating mental health services with the general health care sector, particularly for people with severe mental disorders and/or who are homeless, whose needs crosscut different systems of care (e.g., state consolidated funding for continuous, coordinated health and social services) o Studies examining the nature and effectiveness of relationships between the general health care sector and other systems (e.g., educational, legal, community) in providing mental health services STUDY POPULATIONS Protection of Human Subjects The Department of Health and Human Services has regulations for the protection of human subjects and has developed additional regulations for the protection of children. A copy of these regulations (45 CFR 46, Protection of Human Subjects) and those pertaining specifically to children are available from the Office for Protection from Research Risks, National Institutes of Health, Bethesda, MD 20892, telephone (301) 496-7041. Specific questions concerning protection of human subjects in research may be directed to NIMH staff members listed under INQUIRIES. NIH POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN RESEARCH Applications for grants and cooperative agreements that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., American Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research, because of the health of the subjects, or other reasons, or if in the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified. The NIH funding components will not make awards of grants and cooperative agreements that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects. APPLICATION PROCEDURES Applicants are to use the Public Health Service research grant application form PHS 398 (rev. 9/91). The number and title of this announcement, PA-92-103, Research on Mental Health Services in the General Health Care Sector, must be typed in item number 2a on the face page of the PHS 398 application form. Application kits containing the necessary forms may be obtained from business offices and offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the following office may be contacted for the necessary application material: Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-05 Rockville, MD 20857 Telephone: (301) 443-4414 The signed original and five legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be reviewed for scientific and technical merit by the assigned review group in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Review criteria include: o Scientific, technical, or medical significance and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively in the area of the proposed research; o Availability of resources necessary to perform the research, and o Appropriateness of the proposed budget and duration in relation to the proposed research. Applications will be reviewed in accordance with the following review schedule: Receipt Dates Initial Advisory Council Earliest New/Renewal Review Review Start Date Feb 1/Mar 1* May/Jun Sep/Oct Dec 1 Jun 1/Jul 1* Oct/Nov Jan/Feb Apr 1 Oct 1/Nov 1* Feb/Mar May/Jun Jul 1 *Competing continuations, supplemental, and revised applications are to be submitted on these dates. Applications received after a given receipt date will be held for the next scheduled receipt date or returned to the applicant, if so requested by the applicant, without review. AWARD CRITERIA Applications will compete for available funds with all other approved 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 balance among research areas of the announcement. INQUIRIES NIMH staff are available for consultation concerning application development before or during the process of preparing an application. Potential applicants are advised to contact NIMH staff as early as possible for information and assistance in initiating the application process and developing an application. Direct inquiries regarding programmatic issues to: Junius J. Gonzales, M.D. Chief, Primary Care Research Program Services Research Branch Division of Applied and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 18C-14 Rockville, MD 20857 Telephone: (301) 443-1330 Direct inquiries regarding fiscal matters to: Stephen J. Hudak Chief, Grants Management Section National Institute of Mental Health 5600 Fishers Lane, Room 7C-23 Rockville, MD 20857 Telephone: (301) 443-4456 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 52 and 45 CFR Part 74. Applications submitted in response to this announcement are not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. FOOTNOTES 1. Healthy People 2000, DHHS Publication No. (PHS) 91- 50212. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: (202) 783-3238). 2. AHCPR Panel on Guidelines for the Treatment of Depression in Primary Care. 3. NIMH Workshops on the Classification of Mental Disorders in Primary Care, 1989-90. 4. Primary Care Research: Theory and Practice, Conference Proceedings, Agency for Health Care Policy and Research Publication No. 91-011. 5. Wells KB et al. The functioning and well-being of depressed patients: Results from the medical outcomes study. Jour. Amer. Med. Assoc. 262: 914-919, 1989. 6. Caring for People With Severe Mental Disorders: A National Plan of Research to Improve Services, DHHS Publication No. (ADM) 91-1762. .
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