Full Text PA-96-037 HEALTH RISK REDUCTION: COMMUNITY-BASED STRATEGIES NIH GUIDE, Volume 25, Number 11, April 5, 1996 PA NUMBER: PA-96-037 P.T. 34 Keywords: Health Promotion Risk Factors/Analysis Community/Outreach Programs National Institute of Nursing Research PURPOSE The National Institute of Nursing Research (NINR) is interested in facilitating investigator-initiated research into the clinical application of intervention strategies designed to reduce health risks at the community level. Community-based strategies targeting health problems of rural residents and of underserved minority groups are of particular interest to NINR. 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 Program Announcement (PA), Health Risk Reduction: Community-Based Strategies, is related to all of the special populations targets. 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 202-512-1800). ELIGIBILITY REQUIREMENTS Research 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanisms of support will be the National Institutes of Health (NIH) research project grant (R01) and FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. RESEARCH OBJECTIVES Background Major relocations and transitions are occurring in health care. New forms of health care delivery and financing are creating the need to review the efficacy and effectiveness of wellness and risk reduction protocols, clinical treatments and intervention strategies, and rehabilitation efforts, many of which were previously tested through carefully controlled studies in hospitals. The major emphasis today is on providing health care in the community, frequently to groups of patients rather than to individuals. There is little indication that this change will reverse itself. There is also little evidence that community-based health care strategies have been tested in a systematic and ongoing manner. The NINR convened a panel of scientific experts to examine the status of research on community-based health care models, with a particular focus on those that involve nursing strategies. The report of the panel is available from NINR (See Inquiries section below). The panel reviewed a variety of community-based models and intervention strategies, many of which have not been fully evaluated, nor tested for appropriateness. In general, however, the panel determined that community-based intervention strategies which directly involve community participation are more likely to be successful and to continue overtime than those relying solely on practitioner-patient relationships. Such an approach should enhance the chances that the risk reduction and health restoration activities will be maintained and their effect seen in the long term. The panel recommended that the perspective of primary health care be used as an organizing framework for community-based models. In the public health/community health context, primary health care includes primary, secondary, and tertiary prevention of health risks and disease onset and extension. Primary prevention includes health promotion and protection (such as immunizations of children and elders, nutrition counseling, and life style alterations) aimed at risky behaviors and at intervening before disease arises. Secondary prevention measures aim to prevent disease and disability through screening, early detection of risks, and prompt treatment of pre- symptomatic or early clinical disease (such as obesity, hypercholesterolemia education, and cardiac risk reduction strategies) of populations thought to be at-risk. Tertiary prevention measures seek to limit disease progression and the onset or extension of disabilities in persons in various stages of disease and rehabilitation (such as those with obstructive pulmonary disease, hypertension, coronary artery disease or diabetes mellitus). The lack of cultural specificity in the design of community-based programs is thought to be a potential major factor in the less frequent participation of certain groups, especially ethnic minorities. Several current studies indicate that identifying and incorporating unique cultural factors into intervention strategies may result in increased acceptability, use, and adherence. Other studies have identified intervention strategies that were efficacious but which had only limited continued use after the controlled circumstances of a specific study were withdrawn. Rural residents usually have more intimate knowledge of each other than is possible in more densely populated areas resulting in the potential for some residents avoiding care from fear of neighbors finding out they have a health problem even when the health problem may be unknowingly shared by a number of their neighbors. Community member participation in planning and designing intervention strategies may assist in resolving this phenomenon. There is evidence that certain population groups use health care services only in crises and may choose not to use preventative, restorative, or rehabilitative measures even when strongly advised to do so. For example, those with known HIV risk factors are strongly urged to use condoms or other safety measures, but many do not follow this advice. Those with chronic conditions frequently have medications prescribed to control their disease or its related symptoms, such as those taking medication for seizures or for hypertension, and who may or may not take the medication as instructed. After several types of surgery or after stroke, rehabilitative protocols such as exercises are prescribed to assist in restoring function or to increase various physiological capacities; however, there is great variation in patient adherence to these exercise protocols. There are indications that the explanation for this lack of use of prescribed or advised treatments and safety measures may be less the characteristics of the population groups themselves than the approaches and design of health care systems available to them. Our understanding is further clouded by a tendency to uniformly stereotype the health-related behaviors of all population groups when indeed they relate to only one or some part of the groups. An example is the over-generalization that all minority groups have poor pregnancy outcomes, when this is true for many African-Americans, but not for most Hispanic-Americans. Another example is the prescriptive telling to do treatments rather than a collaborative planning approach to treatment choices. It is not known to what extent the limited inclusion of cultural factors represents a barrier to health care participation in general or to the use of prevention strategies in particular. The inter- relationship of cultural factors and economic factors on the use and acceptability of health care among rural minority groups is also unclear. Some investigators have found that certain ethnic minority groups and rural residents use health care services differently than others, have illnesses diagnosed at a later stage than other groups, and seek care later in a disease process than others. Intervention studies with subsets of minority groups, such as certain rural Native Americans, migrant Hispanics, southern Black churchgoers, and rural pregnant women indicate that use of prevention strategies increases, involvement in prenatal care starts earlier, and chronic illness risk factors are modified when the clinical care is modified according to cultural expectations. Research Objectives and Scope Interest is in research targeted on identifying and reducing risk factors and disease occurrence at the community level. Individuals, families and other community groups as well as clinical practitioners and other providers may be included as foci of research questions. If questions are included about practitioners/providers in a study design, they should be secondary rather than the primary questions in the study. Contextual and system issues, such as environmental factors, specific aspects of community participation or ethnic group involvement, non-health care cultural, social and economic issues may be addressed as components of studies. The major purpose of this program announcement is to stimulate studies that directly test community-based intervention strategies and models. However, preliminary studies that will lead to such research are encouraged, if such work is necessary to achieve the central purpose. These studies may take the form of epidemiological inquiries, qualitative investigations such as ethnographies, or initial testing of intervention strategies on a smaller scale. Preliminary studies examining aspects of cultural sensitivity of intervention strategies or measures are also encouraged, if needed. Other methodological studies crucial to the successful conduct and analysis of community-level studies are also encouraged. Testing of strategies that may be unique in providing community level care, such as computer linkages and interactive television, may be tested if they are targeted to health problems or clinical conditions. The focus of research questions that could be addressed under this initiative include the examples noted in the narrative above and the questions noted here, but are not limited to these: o Do community-based health care models result in improved health of, or in health-related behavioral changes among community members? Do targeted, culturally relevant health care strategies change participation, timeliness of health seeking behaviors, frequency of crisis-oriented care seeking behaviors, appropriateness and acceptability of care, and o costs? o Are there unique requirements for community-based interventions or models in rural areas? How are they met? How can primary prevention as well as the restorative and rehabilitative interventions be implemented at the community level in rural areas? o What are the effects of health care strategies targeted to particular age groups of populations, such as pre-school and school- age children or middle age adults? Are they different when family and community participation are included in the planning, design, and implementation? Are differences seen when such strategies are targeted to those of different socioeconomic levels? Are they different when targeted to rural or minority populations? o Are there differences in health status, risk factors, clinical and cost outcomes between community-based programs and the more traditional individual patient-focused, episodic health care programs? Note: NINR is not interested in studies that propose cost analyses alone. 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 new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. 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 reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The complete original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS 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 reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH in accordance with the standard NIH review procedures. Following scientific and technical review, the applications will receive second-level review by the appropriate national advisory council. Review Criteria o Scientific, technical, or clinical significance and originality of proposed research; o Appropriateness and adequacy of the experimental, quasi-experimental or qualitative 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 the resources necessary to perform the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that institute or center. 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. For general scientific questions and those related to secondary and tertiary prevention and/or chronic conditions, and for copies of the expert panel report on Community-Based Health Strategies contact: Dr. Patricia Moritz Email: pmoritz@ep.ninr.nih.gov For questions related to primary prevention and other health behavior strategies contact: Dr. J. Taylor Harden Email: tharden@ep.ninr.nih.gov For questions related to reproductive and infant health contact: Dr. Laura James Email: ljames@ep.ninr.nih.gov For questions related to cancer, HIV and other infectious diseases contact: Dr. June Lunney Email: jlunney@ep.ninr.nih.gov For questions related to cardiopulmonary health and trauma contact: Dr. Hilary Sigmon Email: hsigmon@ep.ninr.nih.gov For questions related to neurological conditions contact: Dr. Mary Leveck Email: mleveck@ep.ninr.nih.gov All of the above may be contacted at: Division of Extramural Programs National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 FAX: (301) 480-8260 Direct inquiries regarding fiscal matters to: Jeff Carow Grants Management Office National Institute of Nursing Research Building 45, Room 3AN-32 6300 Center Drive MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 FAX: (301) 480-8256 Email: jcarow@ep.ninr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research. 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. 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, 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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