HEALTH SERVICES RESEARCH ON CLINICAL PREVENTIVE SERVICES NIH GUIDE, Volume 23, Number 24, June 24, 1994 PA NUMBER: PA-94-076 P.T. 34 Keywords: Health Services Delivery Alcohol/Alcoholism Disease Prevention+ Oral Diseases Agency for Health Care Policy and Research National Institute on Alcohol Abuse and Alcoholism National Institute on Dental Research PURPOSE The Agency for Health Care Policy and Research (AHCPR), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Institute of Dental Research (NIDR) invite health services research applications that will examine methods to improve the cost effectiveness and/or quality of clinical preventive services, or that will improve access to clinical preventive services. 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 Services Research on Clinical Preventive Services, is related to the priority areas of clinical preventive services as well as related objectives from other priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-004374-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, including universities, clinics, units of State or local governments, firms, and foundations. The AHCPR can support only non-profit organizations. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This PA uses the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. RESEARCH OBJECTIVES Background The AHCPR's purpose is to enhance the quality, appropriateness, and effectiveness of health care services through the establishment of a broad base of scientific research and through the promotion of improvements in clinical practice and in the organization, financing and delivery of health care services. This PA encourages research that furthers this purpose by helping translate disease-prevention knowledge into improved clinical preventive services. Preventive services are interventions intended to prevent disease or disability, or prevent specific sequelae from diseases. When initiated or delivered to individuals in a personal health care setting, these services are considered clinical preventive services. Examples are counseling for disease risk factors including advice to reduce health risks, screening for early detection of disease, chemoprophylaxis for individuals exposed to infections, and immunizations. The NIAAA and NIDR join AHCPR in interest in these areas when the study outcomes are related to alcohol use or oral health, respectively. Most national health care reform proposals include preventive services as a necessary component of the health care system. Effective prevention programs have the potential to reduce diseases and associated use of medical services; this, in turn, may contribute to slowing the rate of increase in health care costs. The cost-effectiveness of specific methods and procedures for providing individual clinical preventive services must be determined by science-based research, and ways to improve cost-effectiveness must be sought. At the same time, there must be assurance that these services are of high quality and are readily accessible. Research Goals For this PA, "efficacy" refers to the probability of benefit under ideal conditions, while "effectiveness" refers to benefit that can be expected in typical situations. Factors that can change the probability of benefit of interventions, and thus also their effectiveness, include provider behaviors, skills, and techniques; and patient adherence/compliance and other characteristics. For preventive service programs, management and institutional characteristics may also affect benefit by increasing the proportion of targeted people receiving the intervention. Recommendations for clinical preventive services are presented in the U.S. Preventive Services Task Force's Guide to Clinical Preventive Services. While efficacy of these clinical preventive services is generally accepted, the community benefit of many prevention programs has been disappointing. Research under this PA should lead to improved effectiveness of clinical preventive services in the community. This PA seeks health services research on efficacy-proven clinical preventive services, not research on preventive services for which efficacy has not yet been established. Research is sought in the following three areas. These areas are interrelated, and applications may address one, two, or all three areas. 1. Cost-effectiveness Cost constraints and movement towards competitive contracting for clinical services will increase the need for reliable and acceptable cost-effectiveness data. Coverage for services, bundled services, and exclusions of services may be determined on the basis of cost-effectiveness and outcomes analyses. Cost-effectiveness studies examine the cost of alternatives to achieve a desired goal. Costs include direct medical costs, indirect costs, and psychological costs. Effectiveness relates to patient outcomes, and may include outcomes other than morbidity or mortality, such as functional status and quality of life. Examples of research topics include: o Cost-effectiveness of specific preventive services; o Comparison of practice standards, protocols, recommendations, and methods for the delivery of preventive services currently suggested by various organizations; o Effects of different practice management patterns on cost-effectiveness of clinical preventive services: o Cost-effectiveness of different approaches to health maintenance intended to preserve health and improve an individual's functional capacity, such as counseling and health education services, including approaches using certified non-physician providers; o Cost-effectiveness of clinical strategies for prevention of disease and disabilities that would otherwise lead to long-term care; o Evaluation of "bundling" preventive services, including cost-effectiveness of various preventive service "packages;" and o Advantages/disadvantages of innovative approaches for the delivery of infant, child, and adolescent clinical preventive services, particularly to underserved/vulnerable populations. Methods Development. In addition to dollar costs, preventive services should be evaluated in other dimensions as well. It is important to develop and apply methods for assessing outcomes of clinical preventive services including: incorporation of quality-of-life measures and patient preferences into standardized methods of comparison; risk adjustment methods that allow for accurate comparisons of outcomes of clinical preventive services; and development of outcomes measures that incorporate functional assessment. This list is illustrative only and is not meant to be restrictive. Important elements of original investigations in this area include the structure and concept of the analysis, the comparisons used, the use of appropriate descriptive and evaluative ratios such as relative risk, and the bases for sensitivity analyses. 2. Quality Quality issues include timeliness, appropriateness of technique or procedure, avoidance of harm from the service, and relevance of the technique/procedure to the recipient. Many organizations are working to refine and formalize reliable and accurate quality measures. Often ambulatory care quality assessments are based on analysis of administrative data or claims and some measure of patient satisfaction. The feedback of comparative information is used as a stimulus for quality improvement. Although the administrative data- or claims-based analyses of preventive services can be broad in scope, there are limitations to the depth of analysis. Provision of services may be reported on claims, but such data provide no indication of the service's quality. Assessment of service quality has been difficult. Research is needed to develop more meaningful and efficient methods for measuring and improving the quality of clinical preventive services. Examples of research include, but are not limited to, the following: o What are the best measures of the quality of clinical preventive services? What is the comparative validity of patient reports, chart review, facility report card, or claims data? How can quality-of-service measures be standardized for fair comparison? o What are the best methods to ensure that follow-up of abnormal screening test results is timely; for example, how can the follow-up process be improved for patients with abnormal Papanicolaou tests? 3. Access Improved availability of health care services for all citizens is a fundamental principle of most health care reform proposals. While availability may improve under health care reform, access may not necessarily improve for all people. Many factors affect access. Reducing preventive service access barriers may require a comprehensive preventive health systems management approach. In this sense, a preventive health system can be viewed as the sum of available resources for preventive services, and the organization, prioritization, and implementation of those resources. Systems management research may help determine the appropriate infrastructure and personnel needs for delivering clinical preventive services. If health care reform removes financial barriers for individuals not presently covered, there may be more demand for both acute care and preventive health services. Preventive services that must be provided by physicians may not receive as much attention by either patients or physicians as treatment services. Competing demand for treatment services from physician providers may cause provision of preventive services to decline. New strategies to use nonphysician providers for clinical preventive services may increase capacity, and preserve or increase access to preventive services. For example, the feasibility of nurses performing sigmoidoscopy, as part of a team in a controlled system, has recently been demonstrated. Technologic support also may increase access to clinical preventive health services. Computer-assisted information management may be useful. Health systems management research can define methods for integrating computer techniques into a comprehensive health plan for delivering preventive services. Examples of research include, but are not limited to, the following: o Comparisons of technological support in different managed care systems and identification of characteristics that improve the delivery of preventive services; o Evaluation of the effect of new management systems/approaches on workforce needs; Implications, quality determinants, and feasibility of nursing and allied health professionals providing clinical preventive services in a logical, documented, and coordinated fashion; o Effectiveness of computer-based information systems in improving clinical preventive services access, and enhancement of such systems; o Advantages of different strategies to promote the use of available clinical preventive health services; and o Comparison of methods to increase the delivery of recommended clinical preventive services for those who come in for other health care and fail to get preventive services (missed opportunities), and for those who do not come in for health care (outreach). Research Interests of NIAAA Under the general framework of this PA, NIAAA has special interest in research related to alcohol use. Advice about alcohol use and brief interventions to reduce problem drinking have consistently been shown to be effective in reducing alcohol consumption and associated harmful consequences (Bein, Miller, Tonigan, Addictions 88:315-336, 1993). These interventions have been implemented in a variety of health care settings and the cost-effectiveness of these procedures needs to be directly evaluated. Prevention of alcohol misuse may also serve as a co-factor in use of other medical services. Of particular interest is the primary care setting, in which cost-effectiveness, quality of care, and accessibility of preventive medical services may be affected by type of intervention. Examples of research may include, but are not limited to: o Modeling of current patterns of preventive services that address alcohol use. This includes attention to characteristics of different health care settings and special populations in order to identify optimal interventions and alcohol use or abuse on service usage. Settings could include office-based practices, emergency rooms, health maintenance organizations, or public health clinics. Special at-risk groups of interest could include adolescents, women of childbearing age, minority individuals or inner-city or rural populations. o Cost-effectiveness of these interventions in improving other health-care utilization patterns. Related to the implementation of cost-effective preventive interventions is the study of methods to change attitudes of service providers to improve their acceptance of preventive alcohol interventions. Research Interest of NIDR Under the general framework of this PA, NIDR invites applications for research in which the dependent variable of interest is a component of oral health. STUDY POPULATIONS 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 new 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 were published in the Federal Register of March 20 1994 (FR 59 14508-14513), and printed in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the NIAAA or NIDR program contact listed under INQUIRIES. The NIAAA or NIDR program contact may also provide additional relevant information concerning the policy. AHCPR supports this NIH policy, which supersedes and strengthens NIH's previous policies that the AHCPR had adopted. The AHCPR plans to publish guidelines on women and minorities specific to the AHCPR. In the interim, the AHCPR will follow the NIH guidelines, as applicable. The AHCPR program contact listed under INQUIRIES may also provide additional relevant information concerning AHCPR's policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91), and will be accepted at the standard application deadlines as indicated in the application kit. State and local government agencies may use form PHS 5161 and follow those requirements for copy submission. Application kits are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-710-0267; and for AHCPR applications from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone 301-656-3100 (FAX 301-652-5264). The title and number of the PA must be typed in Section 2a on the face page of the application. The completed, signed, original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete applications will be returned to applicants without further consideration. Review criteria for are: o scientific and technical significance of proposed research; o appropriateness and adequacy of the research 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 data or a well designed plan for gathering data necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research. Applications will be reviewed for scientific and technical merit in accordance with the criteria stated above by an appropriate peer review group. Applications recommended for funding consideration by the peer review group will be reviewed by an appropriate National Advisory Council; review by Council may be based on policy considerations as well as scientific merit. There is interest in prevention-related research among other components of the National Institutes of Health. Applications may be referred to appropriate Institutes for consideration of funding or co-funding. AWARD CRITERIA Applications will compete for available funds with all other 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. The earliest anticipated date of award is 10 months from the date of submission. INQUIRIES Those considering applying in response to this PA are strongly encouraged to discuss the project with program administrators in advance of formal submission. The AHCPR, NIAAA, and NIDR welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues, including information on the policy of inclusion of women and minorities in study populations, to: James K. Cooper, M.D. Center for General Health Services Extramural Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852 Telephone: (301) 594-1354, ext. 141 Kendall J. Bryant, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 Rockville, MD 20892-7003 Telephone: (301) 443-8820 Patricia S. Bryant, Ph.D. Behavior, Pain, Oral Function and Epidemiology Program National Institute of Dental Research Westwood Building, Room 509 Bethesda, MD 20892 Telephone: (301) 496-7784 Direct inquiries regarding fiscal matters to: Ralph Sloat Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1447 Edward B. Ellis Grants Management Specialist National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504 Rockville, MD 20892-7003 Telephone: (301) 443-4706 Teresa Ringler Chief, Grants Management Office National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 AUTHORITY AND REGULATIONS These programs are described in the Catalog of Federal Domestic Assistance Nos. 93.226, 93.273, and 93.121. Awards are made under authorization of Titles IX and IV, and Section 301 of the Public Health Service Act. Awards are administered under the PHS Grants Policy Statement; and Federal Regulations 42 CFR Part 67 Subpart A, 42 CFR Part 52, 45 CFR Part 46, and 45 CFR Part 74 (45 CFR Part 92 for State and local governments). These programs are not subject to the intergovernmental review requirements of Executive Order 12372. .
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