Path: utzoo!utgpu!watserv1!watmath!uunet!shelby!agate!bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 7, pt. 4, 15 February 1991 Message-ID: Date: 21 Feb 91 18:09:38 GMT Sender: kristoff@genbank.bio.net Lines: 1196 EFFECTIVE DISSEMINATION OF HEALTH SERVICES RESEARCH FINDINGS AND MEDICAL PRACTICE GUIDELINES RFA AVAILABLE: AHCPR-91-01 P.T. 16; K.W. 0730050, 0730000, 0403004 Agency for Health Care Policy and Research Application Receipt Dates: April 26, June 1, October 1, 1991, and February 1, 1992 BACKGROUND The Agency for Health Care Policy and Research (AHCPR) invites applications to conduct applied research on effective dissemination of clinical knowledge and medical practice guidelines to effect changes in practitioner and consumer behavior, improve patient outcomes and, thereby, improve the effectiveness, quality, and appropriateness of health care. The term "effective dissemination" encompasses the broader concept of diffusion as well as the actual distribution of knowledge and new information. Additionally, the process through which target groups become aware of, receive, accept, and utilize disseminated information and knowledge is reflected in this term. AHCPR has lead responsibility for the Medical Treatment Effectiveness Program (MEDTEP), a program of the Department of Health and Human Services. Under MEDTEP, projects are supported that systematically study the relationships between medical treatments and procedures and its outcomes. Research findings will be an important part of the knowledge base that will be used by non-Federal experts to develop medical practice guidelines, as mandated by Sections 903 and 914(c) of the Omnibus Reconciliation Act of 1989 (P.L. 101-239). Research conducted under the MEDTEP program addresses fundamental questions about what difference medical care makes: Do patients benefit? What treatments work best? Are health care resources well spent? MEDTEP research projects build on work that documents numerous and substantial variations in patterns of care that can neither be attributed to patient need nor clearly linked to patient outcomes (Wennberg, 1987; Connell, 1981). MEDTEP is concerned with those practice variations that result from uncertainty or controversy about the relative effectiveness or appropriateness of alternative interventions, and those that result from differences in the knowledge, skill, or "practice styles" of health care providers. When practice variations are associated with disparate patient outcomes, or equivalent outcomes but significant differences in resource use, serious questions arise about the quality, appropriateness, and cost effectiveness of health care. A critical assumption is that inappropriate practice patterns can be changed if relevant scientific evidence is effectively disseminated to health care providers and patients. There is growing evidence that health care providers will voluntarily change their practice patterns if they are made aware that the patterns deviate markedly from local or national norms (Wennberg, 1977; Wennberg, 1984; McCormick, 1990). For example, recent reports from hospitals in all parts of the country indicate that educational forums to disseminate research findings on quality and costs of care have led to voluntary reductions in practice patterns (McCormick, 1990). A recent article that summarized the literature on educational interventions to modify physician drug prescribing behavior concluded that sustained change in physician prescribing occurs, but only when information is provided to physicians by physicians (Soumerai, 1990). Although some health services research has occurred in the area of dissemination of new knowledge, it has focused primarily on the introduction of medical technology or the flow of new information into practice. A substantial amount of research has examined the role of continuing medical education (CME) in providing physicians with new information and knowledge. Research findings suggest that traditional CME programs tend to be ineffective in changing physician behavior over time (Haynes, et.al., 1984). Research has begun to accumulate in the area of physician behavior change resulting from the diffusion of new information or medical practice guidelines. This literature has highlighted the following: o Studies examining the flow and utility of information to physicians have emphasized: the inability to keep abreast of the volume of literature; the uncertainty associated with applying particular clinical research findings to medical practice; and the uncertainty associated with continually changing clinical findings of new studies. Peer review, journal articles, interaction at professional meetings, and opinion leaders emerge as key aspects of knowledge transfer and use and as potential channels for dissemination (Backer, et. al., 1986; Backer and Ohara, 1989; Greer, 1988; Lomas and Haynes, 1988). o Issues related to the adoption of innovations by physicians in hospital settings have been studied, focusing on the use of computerized medical records in quality assurance programs to provide feedback to physicians and other hospital staff (Lomas and Haynes, 1988; McDonald, 1990). However, research is needed on structural and process variables within a wide variety of provider settings and how these variables can facilitate or hinder the dissemination of new information and knowledge. These variables include: multifaceted organizational relationships within provider organizations; administrative governance; medical direction; type of medical equipment available within an institution; degree of compliance with recommended guidelines; and level of internal communication. These variables are often important considerations when examining outcomes of care, and they can be critical factors affecting the capacity to disseminate clinical information and medical practice guidelines. o More recent literature has focused on changes in physician behavior as a result of dissemination of medical guidelines and diffusion of new medical information and related research findings. An assessment of the Consensus Development Program conducted by the National Institutes of Health found that despite relative success in disseminating information from that program, physician practice often remained unaffected. The evidence suggests that either simply disseminating clinical recommendations or offering them in a didactic manner has not demonstrated substantial impact in changing physician behavior. Thus, there is a need for innovative strategies that utilize multiple mechanisms in conjunction with one another (Backer, 1988; Kanouse and Jacoby, 1988; Lomas and Haynes, 1988; Lomas, et. al., 1989). Patients' expectations regarding their health and their health care can also be influenced by salient information that is effectively presented. Clearly, desired changes in practice are not automatic, and more empirical evidence is needed on ways to bring changes about. MEDTEP generates and evaluates scientific information to expand and strengthen the information base for decisions by health care providers and patients regarding choice of health care services and procedures. To accomplish this, information must be delivered in a form and manner that encourages its acceptance and use by providers and its comprehension by patients and other members of the public. Health care providers need methods to explain treatment options to patients and then, to incorporate patients' preferences and values into their professional judgments. Policymakers and planners need good science to make more informed decisions about incentives and the use of health care resources under public and private programs. PURPOSE AND OBJECTIVES This Request for Applications (RFA) describes the range of studies that AHCPR encourages and intends to support at this time in the field of dissemination research. The objective is to stimulate new grant applications on issues dealing with the ways in which scientific information can be presented and disseminated to foster its assimilation and use by health care providers and patients and, ultimately, to improve the effectiveness, quality, and appropriateness of medical care. The process and structural factors influencing dissemination and assimilation need to be examined. This RFA encourages studies that evaluate the dissemination of, and outcomes associated with, clinical practice guidelines or parameters assisted by AHCPR and other public and private entities. It also encourages the assessment and use of particular models and techniques that effectively disseminate clinical information and clinical practice guidelines. Broad and timely dissemination of MEDTEP research findings is critical. Research, however, is needed to identify the relative effectiveness of various ways to disseminate findings to diverse audiences and to evaluate the effect of alternative dissemination strategies. Research is required to explore innovative methods to assess audience needs and to translate the findings of patient outcomes research into formats that will be most useful to different target groups. The effectiveness of dissemination is a measure of the speed and completeness with which information is assimilated and adopted, and the degree to which dissemination activities motivate and sustain voluntary changes in provider or patient behavior. The following questions are illustrative examples of the research issues and questions concerning dissemination of research findings that merit investigation at this time. How do factors such as timeliness of dissemination, acceptability and retention of information, and appropriateness of the format affect its assimilation and use by health care providers? How can communication and computer technologies be designed to affect assimilation and retention of information by health care providers? What is the comparative effectiveness of existing or new models and techniques in disseminating clinical information and clinical practice guidelines to providers? What is the profile of the characteristics of successful dissemination efforts in the health care sector or in other industries that can serve as models or strategies for use in the dissemination of clinical practice guidelines or other research- related knowledge? How do cultural, socioeconomic, and access factors affect the assimilation of clinical information by providers and patients within special population or target groups and geographic areas (e.g., rural and minority)? What is the effect of process and structural variables (e.g., organizational, personnel mix, work environment, and roles and incentives) on the relationship between the assimilation of practice guidelines by the health care provider and patient outcomes? How does type of provider organization (e.g., HMO, fee-for- service sector) affect assimilation and retention of new information and what is the effect of this on patient outcomes? How do economic and regulatory incentives affect the timing and nature of decisions to adopt and utilize medical practice guidelines? How do the socioeconomic, demographic, and professional characteristics of providers affect the assimilation and retention of new scientific information about health care practices? What are the barriers to the assimilation and adoption of medical practice guidelines and how can these be overcome? ELIGIBILITY Applicants must be public entities or nonprofit organizations and institutions. Proposed Principal Investigators must have demonstrated expertise in dissemination of health services research findings, clinical research findings, or medical practice guidelines. Applicants must also have demonstrated (1) capability to conduct and manage applied research or demonstration and evaluation projects in the area(s) that will be the subject of the dissemination project; and (2) expertise in communications. Eligibility is restricted to U.S. institutions. Project staff will need a combination of clinical, research, and administrative expertise. LENGTH OF SUPPORT It is anticipated that projects will vary from one to three years in length. Project lengths could be up to five years in rare cases in which the complexity or breadth of the subject area so mandated, or in areas proposing to research the longer term effects of particular forms of dissemination. MECHANISM OF SUPPORT All projects will be funded as research grants (RO1). The start date for funded projects with under $250,000 total direct costs will be September 30, 1991. The start date for funded projects with total direct costs greater than $250,000 will be December 1, 1991. Approximately four to ten grant awards will be issued during FY 1991 and FY 1992 depending upon the number and cost of approved applications. It is expected that $4 million will be spent. Applications for dissemination research grants in subsequent years will compete equally for funding with other applications to AHCPR. PREPARATION OF APPLICATIONS Each application will be submitted in accordance with the instructions of form PHS 398 (rev. 10/88). State and local governments using form DHHS 5161 must submit an original and two copies of the application. The following requirements must be discussed in the Project narrative in addition to the requirements specified in the application kit: Specific Aims o Where appropriate, the long-term objectives of the project must specify the product(s) to be disseminated and the audiences to be targeted. o The dissemination methods and questions to be addressed should be discussed in terms of ascertaining the effects of dissemination on behavior change, characteristics or effectiveness of dissemination techniques, or the development of an innovative dissemination model. Progress Report/Preliminary Studies o Prior studies conducted by the Principal Investigator pertaining to dissemination, health services research (especially in the areas where AHCPR has ongoing work) or communications research that will contribute to the proposed project should be described. Experimental Design and Methods o The specific dissemination model that will be used or developed in the project should be explicitly addressed in terms of: audiences; type of product or the knowledge to be disseminated; technique of dissemination; characteristics or variables of dissemination to be used and/or examined; and the relationship of the project to the structure of the health care system, clinical management, health care outcomes, and health status. REVIEW PROCEDURES AND CRITERIA Applications must be submitted to: Application Receipt Office Division of Research Grants Westwood Building, Room 240 Bethesda, MD 20892** Applications will be referred to an AHCPR study section for initial review. Applications requesting total direct costs in excess of $250,000 will also be reviewed by the National Advisory Council for Health Care Policy, Research, and Evaluation. Applications will be reviewed in accordance with the standard AHCPR peer review procedures. The review criteria for these applications are the considerations of scientific and technical excellence, which include: adequacy of the method to carry out the project; availability of data or the proposed plan to collect data required for the project; qualifications and experience of the Principal Investigator and proposed staff; adequacy of the plan for organizing and carrying out the project; reasonableness of the proposed budget; and adequacy of the facilities and resources available to the grantee. In addition, the following criteria will be considered: ability of the project's results to be applied to the dissemination of AHCPR products now and in the future; adherence of the project approach to accepted principles of communication and dissemination; and ability to analyze the effects of dissemination on behavior change among practitioners and consumers. APPLICATION PROCEDURES Those considering an application to this RFA are strongly encouraged to discuss their project with AHCPR program administrators in advance of formal submission. Applications must address all requirements as presented in this RFA. Use application form PHS 398 (rev. 10/88). State and local governments may use form DHHS 5161. These forms may be secured from the Office of Scientific Review, Agency for Health Care Policy and Research, Room 18A-20, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857 (telephone 301-443-3091) and from most institutional business offices. Type in line 2 of the face page of the application the words "RFA AHCPR-91-01: AHCPR Dissemination Effectiveness" and use the RFA label in the application package. The original and 6 copies of the application should be submitted to DRG as directed in the application instructions. State and local governments using form DHHS 5161 must submit an original and two copies of the application. Applications must be received at DRG by the close of business April 26, June 1, October 1, 1991, and February 1, 1992. Applications submitted after the deadline date will be considered in the next review cycle. INQUIRIES For further assistance and consultation on program requirements, contact: Margaret VanAmringe Director, Center for Research Dissemination and Liaison Parklawn Building, Room 18A-10 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2904 For information regarding budgetary/administrative issues contact: Ralph Sloat Grants Management Officer Agency for Health Care Policy and Research Parklawn Building, Room 18A-27 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4033 This program is described in the Catalog of Federal Domestic Assistance No. 93.180 and 93.226. Executive Order 12372 does not apply to AHCPR grant programs. REFERENCES Backer, TE, "Research Utilization and Managing Utilization in Rehabilitative Organizations," Journal of Rehabilitation, Vol. 54, No. 2, pp 18-22, 1988. Backer, TE, Liberman, RP, and Kuehnel, TG, "Dissemination and Adoption of Innovative Psychosocial Interventions," Journal of Consulting and Clinical Psychology, Vol. 54, No. 1, pp 111-118, 1986. Backer, TE, and Ohara, KB, Knowledge Transfer and Utilization in Health Care: A Review for the National Emergency Medical Services for Children Program, Human Interaction Research Institute, December, 1989. Connell, FA, Day, RW, and Logerfo, JP, "Hospitalization of Medicaid Children: Analysis of Small Area Variations in Admission Rates," American Journal of Public Health, Vol. 71, No. 6, pp 606-613. Greer, AL, "The State of the Art Versus the State of the Science -- the Diffusion of New Medical Technologies into Practice," International Journal of Technology Assessment in Health Care, Vol. 4, pp 5-26, 1988. Haynes, RB, Davis, DA, McKibbon, DA, and Tugwell, P, "A Critical Appraisal of the Efficacy of Continuing Medical Education," Journal of the American Medical Association, Vol. 251, pp 61-64, 1984. Kanouse, DE and Jacoby, I, "When Does Information Change Behavior?" International Journal of Technology Assessment in Health Care, Vol. 4, pp 27-33, 1988. Lomas, J, "Holding Back the Tide of Cesareans -- Publishing Recommendations is Not Enough," British Medical Journal, Vol 297, pp 569-570, 1988 (editorial). Lomas, J, Anderson, GM, Domnick-Pierre, K, Vayda, E, Enkin, MW, and Hannah, WJ, "Do Practice Guidelines Guide Practice? The Effect of a Consensus Statement on the Practice of Physicians," New England Journal of Medicine, Vol. 321, No. 19, pp 1306-1311, 1989. Lomas, J and Haynes, RB, "A Taxonomy and Critical Review of Tested Strategies for the Application of Clinical Practice Recommendations: From "Official" to "Individual" Clinical Policy," American Journal of Preventive Medicine, Vol 4 (Suppl), pp 77-84, 1988. McCormick, B, "Can Research Change the Way MDs Practice Medicine?" Hospitals, October 5, pp 32-38, 1990. McDonald, C, "Effect of Computer Feedback on Physician Test- Ordering," New England Journal of Medicine, Vol. 322, pp 1499- 1504, 1990. Soumerai, SB, and Avorn, J, "Principles of Educational Outreach ('Academic Detailing') to Improve Clinical Decision Making," Journal of the American Medical Association, Vol. 263, No. 4, pp 549-556, 1990, Wennberg, JE, Blowers, L, Parker, R, and Gittelsohn, A, "Changes in Tonsillectomy Rates Associated with Feedback and Review," Pediatrics, Vol. 59, pp 821-826, 1977. Wennberg, JE, "Dealing With Medical Practice Variations: A Proposal for Action," Health Affairs, Vol. 3, pp 6-32, 1984. Wennberg, JR, Freeman, JL, and Culp, WJ, "Are Hospital Services Rationed in New Haven or Over-Utilized in Boston?" Lancet, pp 1185-1189, 1987. CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS RFA: AG-91-05 P.T. 04; K.W. 0710010, 0745027, 0414005 National Institute on Aging Letter of Intent Receipt Date: April 15, 1991 Application Receipt Date: May 17, 1991 INTRODUCTION The National Institute on Aging (NIA) invites applications for the support of Claude D. Pepper Older Americans Independence Centers (OAICs). These centers will provide support for research to develop and test clinical interventions that promote the independence of older Americans. OAICs will also train individuals in research approaches to develop and test methods of maintaining and increasing independence, and will conduct demonstration projects and information dissemination concerning the applications of such research. Applications for these center grants (P60) must include one or more clinical intervention research projects. First year budgets may not exceed $1,500,000 (direct plus indirect costs). Future year budgets are limited to cost-of-living increases. BACKGROUND Millions of older Americans suffer from loss of abilities needed to live a fully independent life. Loss of independence imposes enormous personal and financial burdens on older persons and their families. The annual cost to the Nation for care of dependent older persons totals billions of dollars. Dependence is not inevitable in old age. It results from disabling conditions that are potentially, if not currently, preventible or reversible. The development and testing of interventions to reduce disability and increase independence thus offer immense benefits and potential savings in health care costs. To date, efforts to develop such interventions and test their efficacy in maintaining and increasing independence have been modest, and the number of researchers with the abilities to conduct such research has been small. There is a need for more researchers and research teams with the ability to: 1) Conduct controlled clinical trials of promising interventions against disabling conditions of older persons. 2) Fill gaps in knowledge of the pathophysiology of disabling conditions and of the mechanisms affecting their responses to treatment, and develop and test improved treatments based on this knowledge. 3) Develop and test ways of applying independence-enhancing advances in treatment within the American health care system. The combination of these three abilities would allow the conduct of concerted research programs to continually improve opportunities for increased independence for older Americans. The Claude D. Pepper OAIC program is designed to expand this research and the number of researchers capable of conducting it. Specifically, as authorized under amendments to Section 445A of the Public Health Service Act, each OAIC will conduct: "research into the aging processes and into the diagnosis and treatment of diseases, disorders and complications related to aging, including menopause, which research includes research on such treatments, and on medical devices and other medical interventions regarding such diseases, disorders and complications, that can assist individuals in avoiding institutionalization and prolonged hospitalization and in otherwise increasing the independence of the individuals and programs to develop individuals capable of conducting research in these areas." As defined by Section 445A of the Public Health Service Act, "the term independence, with respect to diseases, disorders, and complications of aging, means the functional ability of individuals to perform activities of daily living or instrumental activities of daily living without assistance or supervision." GOALS AND SCOPE The overall goals of the OAIC program are: 1) To facilitate the development and testing of interventions to increase or maintain abilities needed for independence of older persons. 2) To use knowledge gained in these intervention studies in developing and testing improved interventions. 3) To train researchers capable of leading and conducting research programs as described in 1) and 2) above. OAIC research projects should provide an environment for the training of such researchers. 4) To translate OAIC research findings into improvements in health care practice through demonstration and dissemination projects. The components of OAICs derive from these goals. OAICs will support: INTERVENTION STUDIES: At least one approved intervention study is required for approval of an OAIC. Proposed intervention studies must test the efficacy of interventions to prevent or ameliorate functional impairments contributing to loss of independence. Studies may be of effects on long-term disability and/or temporary disability following illness or injury. In studies of prevention interventions, a focus on subgroups at high risk for disability is encouraged where appropriate. All studies should measure direct effects on functional status and have adequate statistical power to determine important intervention effects on functional abilities should these occur. Measures of related medical and physiologic endpoints are encouraged wherever pertinent. Because older persons with multiple health problems are at especially high risk for disability, determinations of the efficacy of interventions in such persons, and analyses of the effects of different health problems on treatment efficacy, are encouraged where feasible. Tests of interventions specifically designed against disabilities resulting from the interaction of two or more comorbid conditions are also encouraged. Besides measurements of intervention effects on the above outcomes, each proposed intervention study must also include planned investigations of: o Mechanisms underlying the interventions' effects (or lack of effects) on functional status, to provide a basis for further improvements in interventions. Intervention interactions with intermediary response variables such as underlying disease mechanisms, symptoms, and behavioral factors should be measured and analyzed as needed for this purpose. o Factors affecting recruitment into the study and participants' compliance once enrolled, and to provide data for potentially wider applications of the interventions are considered pertinent and should be included. o Cost-effectiveness and effects on health care utilization (e.g., hospitalizations, nursing home admissions and stays, use of home care services) of the intervention(s) tested. Proposals for intervention studies that do not contain the above elements will be returned to applicants. Examples of types of interventions for study include: o Interventions to prevent or reduce frailty and increase physical performance abilities. Exercise, nutritional, pharmacologic, rehabilitative, surgical, and other interventions against disorders such as osteoarthritis, congestive heart failure, chronic pulmonary disease, pathologic loss of muscle mass and/or strength, protein-calorie malnutrition, dizziness, Parkinson's disease, and gait and balance problems are encouraged. o Interventions to prevent or reduce cognitive disability, affective disorders, sensory disabilities, and/or co-morbidity associated with these conditions. Studies on interventions to reduce impairments from problems such as dementing disorders, depression, and vision impairments are encouraged. In addition, interventions are encouraged against medical problems associated with these disorders, such as falls, weight loss, or incontinence in demented patients. o Interventions to reduce risk of disabling events such as hip fractures and strokes, and to reduce impairments following these events. Studies of interventions against osteoporosis and to prevent hip fracture, and studies of techniques to improve functional status after hip fracture and strokes are encouraged. o Interventions to prevent or reduce disabilities in complex functions involving combined motor, sensory, and cognitive performance. Examples include interventions to reduce urinary and fecal incontinence, and impaired driving abilities. o Interventions to prevent or reduce disabling side effects from medication use. Examples include drug withdrawal studies and testing of non-pharmacologic therapeutic alternatives, as well as testing improved pharmacologic agents or regimens. o Interventions to prevent, lessen, or shorten temporary disability from exacerbation or complications of chronic diseases of older person. Examples include transient disability associated with exacerbations of chronic pulmonary disease, deconditioning during hospitalization, and acute confusional states. o Interventions to prevent or reduce disabling sequelae of menopause and associated estrogen deficiency. Examples include osteoporotic fractures and urge incontinence. o Combined intervention strategies to prevent or ameliorate disabilities in older persons with multiple impairments. The above list is not exhaustive and the order does not reflect NIA priorities. All studies of promising interventions to enhance independence in older persons are encouraged. No priority is placed on having a diversity of intervention topics associated with a single OAIC. Applicants may find it advantageous to concentrate on one or a few topics in which their strengths are greatest. Subjects for these studies may include older persons living at home, recipients of home care, nursing home residents, hospitalized patients, and those in other pertinent clinical settings, as appropriate to each intervention study. Organizational liaisons involving one or more medical centers, nursing homes, home care services, and other care organizations are encouraged whenever appropriate for the conduct of OAIC activities. INTERVENTION DEVELOPMENT STUDIES: While OAIC intervention studies (described above) are the major OAIC research component, the OAIC center grant will support other studies to identify, develop, or refine potential interventions to preserve or increase independence. Each proposed intervention development study should present a complete plan for conduct of the proposed research, analogous in the level of detail to an individual research project grant application, in sufficient detail to allow full scientific review. Types of such studies include: o Tests of therapies on physiologic and/or behavioral factors known to affect functional status. Both beneficial and adverse effects may be studied. o Studies to identify or confirm reversible or preventible risk factors for disability and/or disabling events. Examples include behavioral factors, diseases, and previously unidentified pathophysiologic changes leading to functional impairment and/or disabling events. Large-scale epidemiologic studies are outside the scope of this RFA. RESEARCH RESOURCES CORES: Applicants may request core resource support to enhance the quality of OAIC research projects, i.e., intervention studies, intervention development studies and pilot research projects. Normally, applicants should not propose a core unless it would support at least two projects (otherwise the core could simply be included in the one project it supported). The justification for proposed cores (including the number of projects they would support) will be evaluated by peer reviewers. Routine patient care costs may not be requested, but research-related patient care costs are eligible for support. Proposed core activities must be exclusively for support of OAIC research, i.e., pilot projects, intervention studies and intervention development studies, and must be fully justified as such. Examples of possible cores include: o Recruitment/screening/assessment/registry units for potential subjects for different OAIC intervention study research protocols. o Functional assessment units to monitor functional status of subjects in OAIC studies. o Diagnostic/pathophysiologic units for studies of mechanisms of treatment response and interactions with disease mechanisms. o Biostatistical/data management units. o Cost-effectiveness analysis units. The above list is not intended to describe the full range of possible activities to be supported, nor to direct applicants towards these areas. Inclusion of research resources cores of any or all these types in a single proposed OAIC is not required or even necessarily advisable. Innovative organizational approaches are encouraged. Institutions that are recipients of NIA Geriatric Research and Training Center awards or NIH General Clinical Research Center awards who wish to apply for an OAIC award are encouraged to use core resources from these Centers for support of OAIC projects where appropriate. A Director should be named, and plans for the scientific and administrative functioning of each Research Resources Core proposed must be presented. The method for prioritizing access to core resources requested by multiple projects must be described. RESEARCH DEVELOPMENT CORE: The Research Development Core is a required component of all OAICs. This core will provide salary and other support for junior faculty and research associates to acquire abilities in all phases of research to develop interventions to enhance independence, including clinical trials, studies of mechanisms of treatment response, and cost-effectiveness/health care utilization studies. The development of persons who will have the necessary breadth and depth of experience needed to lead teams spanning this range of research is of particular priority. The components of the Research Development Core are: Junior Faculty Development Support. Support may be requested for salary and fringe benefits for junior faculty participating in OAIC intervention studies and other OAIC research. The Research Development Core should present a plan for achieving development of junior faculty supported under this component, including a mechanism for monitoring their scientific progress and development toward independence. Applicants should clearly specify the role of senior mentors in training and supervising junior faculty and research associates in their roles on these projects. A current biographical sketch (two pages maximum), a list of active research support, and a brief description of the mentor's role in proposed OAIC activities should be provided for all proposed mentors. Junior faculty and research associates receiving support through this component must participate in all phases of at least one OAIC intervention study. Although applicants are not required to identify individual junior faculty, research associates, and their specific roles in advance, they are encouraged to do so if possible, because this information is extremely useful to peer reviewers. If support is requested for "to-be-named" junior faculty or research associates, applicants must present their plans for recruiting, training, and supervising these persons. The Research Development Core may also serve to encourage the research career development of other junior faculty and research associates (in addition to those receiving salary support from this core) by coordinating the participation in OAIC research projects of other junior faculty and research associates whose salary support may come from other sources such as NIA's Geriatric Academic Program Award (GAP), Geriatric Research Institutional Training Award (GRIT), Physician Scientist Award (PSA), NIA Academic Award or Clinical Investigator Award (CIA), and Geriatric Research and Training Centers (GRTC). The overall contribution of the OAIC to the development of researchers throughout the grantee institution who can contribute to the development of independence-enhancing interventions will be considered in the evaluation of OAIC applications and funded OAICs. Didactic Training. Support may be requested for didactic training in such topics as clinical trials methodology, biostatistics, pertinent topics in disease mechanisms and related basic sciences, behavioral sciences, and health services research. Such support is not restricted to individuals receiving salary support from the core, but also may be provided to other personnel on OAIC research projects or OAIC intervention development studies. Pilot Research Projects. Support may be requested for pilot projects on topics related to the activities of the OAIC. Examples of project topics include pilot studies of new interventions and probes of disease mechanisms and their interactions with interventions. The procedures by which awardees will solicit, select, monitor, and evaluate the results of pilot projects should be specified in the application, but applicants are not required to present specific pilot projects as part of the application. Pilot projects are limited to a maximum of one year in duration, a maximum of $25,000 (direct costs) per pilot project, and a maximum of $100,000 (direct costs) per year for the total allocated to all pilot projects contained in an OAIC. Pilot project funds may be used for salaries, equipment, and supplies. Research Development Core Director. Support may be requested for a core director who will be responsible for coordination of the above activities and must report annually on the progress of all individuals supported thorough this core and other core activities. A maximum of $250,000 in total (direct plus indirect) first-year costs may be requested for the Research Development Core. Budget increments in future years will generally be limited to four percent. DEMONSTRATION AND INFORMATION DISSEMINATION PROJECTS: OAICs must include activities to translate findings from their research into health care practice. These activities would normally be expected to be conducted beginning in the second year of the project, with the first year devoted to planning. A maximum of $50,000 first-year total (direct plus indirect) costs and $80,000 annual total costs for project years two through five may be requested for these activities. Specific projects for demonstration/information dissemination activities should be described. The staffing plan and a rationale for the organization of this core should be presented. The methods and techniques to be employed for information dissemination and the audience(s) targeted and their size(s) should be defined. Examples of projects that may be supported include dissemination of research results to the public, professionals, and paraprofessionals, through symposia and in-service training. Planning and pilot activities for larger scale demonstration projects to evaluate the practicability of interventions tested in OAICs within various health care settings are also appropriate. LEADERSHIP/ADMINISTRATIVE CORE: Applicants may request funds for the OAIC Director, OAIC Administrator, and support staff. The OAIC Director should be a scientist who can provide effective administrative and scientific leadership and coordination with OAIC intervention studies. An OAIC Administrator who will assist the Director in managing the Center, addressing issues of fiscal management and compliance with institutional, PHS, NIH, and NIA policies, should be identified. A maximum of $120,000 (direct plus indirect costs) per year for this core, for salary, travel, and other expenses of the Director, Administrator, and appropriate administrative staff may be requested. Future year annual increases will generally be limited to no more than four percent. OAIC Advisory Panel. OAIC applications, regardless of whether a Leadership/Administrative Core is requested, must describe a plan and budget for the selection of experts from outside the OAIC who will meet yearly to review the progress of the OAIC and provide a written report to the OAIC Director. This review will be included in the annual OAIC Progress Report to the NIA. (A member of the NIA extramural staff assigned to each Center will routinely attend the Advisory Panel meetings and should be notified well in advance of the date scheduled). Coordination Among OAIC's. OAICs are expected to meet together every six months to compare research results and to explore possibilities for collaborative efforts. Funds should be requested to permit travel of the OAIC Director, Administrator, and Principal Investigators on all OAIC intervention studies, and intervention development studies for meetings with NIA staff and staff from other OAICs. Responsibility for organizing these meetings will rotate among OAIC sites. Required Components for an OAIC. It should be noted that the minimum required components that must be approved by the peer reviewers in order to qualify for an OAIC Award are 1) at least one intervention development study 2) a Research Development Core and 3) a Demonstration and Information Dissemination Project. III. MECHANISM AND SCALE OF SUPPORT Older Americans Independence Centers will be supported through the comprehensive center grant (P60) mechanism. The awarding of funds pursuant to this RFA is contingent on availability of funds. All pertinent DHHS, PHS, and NIH grant regulations, policies and procedures are applicable. Business management aspects of the awards will be administered in accordance with DHHS and PHS grant administration requirements by the NIH, as stated in the Public Health Service Grants policy statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Applications and management of grants will be subject to applicable PHS and NIH grant policies and NIA guidelines. Support may be requested for a period of five years. The total costs (direct plus indirect) requested for the first year may not exceed $1,500,000. Applications with budget requests exceeding this amount will not be accepted by NIA and will be returned to the applicant. Budget increments for subsequent years generally will be limited to no more than four percent. METHOD OF APPLYING AND APPLICATION REQUIREMENTS Guidelines Detailed instructions for applicants are found in "NIA Older Americans Independence Center (P60) Guidelines" (hereafter called OAIC (P60) Guidelines). This document may be obtained from: Geriatrics Program National Institute on Aging Building 3l, Room 5C27 9000 Rockville Pike Bethesda, MD 20892 Telephone: (30l) 496-6761 Eligibility Only U.S. organizations are eligible to apply. Letter of Intent If an investigator is satisfied that his/her institution is eligible and elects to apply for an OAIC grant, a letter of intent is requested (but not required) to be submitted to the Geriatrics Program at the address given above. The letter of intent should name the OAIC Director and Principal Investigators, and, if possible, should include the titles of the major research projects and cores proposed. It should be submitted by April 15, 1991. The Application The applicant must submit the application using PHS 398 (revised 10/88 - reprinted 9/89), following the OAIC (P60) Guidelines. Application kits containing this form and the necessary general instructions are available in most institutional business offices and may be obtained from the Office of Grants Inquiries, Division of Research Grants, NIH (telephone 301-496-7441). On item 2 of the face page of the application, applicants must enter: NIA RFA--Claude Pepper Older Americans Independence Center, AG-91-05. The RFA label available in the 10/88 revision of the application form PHS 398 must be affixed to the bottom of the face page and placed on top of the entire package. Failure to use this label may result in delayed processing of the application and prevent it from reaching the review committee in time for review. Please note that special OAIC Guidelines mentioned above must be used to complete the application. The NIA recommends that the application be developed in consultation with program staff. TIMETABLE FOR RECEIPT AND REVIEW OF APPLICATIONS Receipt Date The original and four copies of the application are due in the Division of Research Grants on or before May 17, 1991. Applications must be sent to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the same time the application is submitted to the Division of Research Grants and two copies of the application should be sent to: Chief, Scientific Review Office National Institute on Aging Building 3l, Room 5C12 9000 Rockville Pike Bethesda, MD 20892 The six sets of appendices may be sent to the Chief, NIA Scientific Review Office with two copies of the application. Failure of these copies to be received may prevent the application from being reviewed in time to be considered for an award. Review Schedule Applications will be received by the NIH Division of Research Grants and will be assigned to the NIA. Responsive applications will be assigned to a special review group for review. Proposals judged by the NIA Program Staff to be non-responsive (those not directed at the goals of this RFA) will be returned to the applicant without review. Because no site visits will be conducted, each application should be thorough and complete enough to stand on its own. Applications may first receive a preliminary review by a subcommittee of the review panel to establish those applications deemed to be competitive. Those proposals judged non-competitive for award will be so designated, and an abbreviated summary statement noting the major areas of concern will be sent to the Principal Investigator. Applications judged to be competitive will be given full review. The second-level review will be by the National Advisory Council on Aging. The earliest start date will be September 30, 1991. REVIEW CRITERIA The primary criterion for review by the NIA review committee in evaluating each OAIC grant application will be the effectiveness of the proposed program in contributing to increasing independence for older Americans through the conduct of research, demonstration, and dissemination projects; and development of academic leaders in geriatrics with effective research, teaching and clinical capabilities. Specific criteria related to this standard include: 1. Scientific merit of research and its expected impact on the maintenance of independent functioning of older persons. 2. Contribution of Research Resources Cores, where included, to enhancement of ongoing research, training, and pilot projects. 3. Role of the Research Development Core in providing educational and other career development opportunities for fellows and junior faculty and other professional and paraprofessional personnel associated with the Center in research techniques. Other review criteria include: 1. Leadership ability and scientific stature of the program director and his/her ability to meet the program's demands of time and effort. 2. Qualifications, experience, and commitment of the investigators responsible for core units and their ability to devote the required time and effort to the program. 3. Presence of an administrative and organizational structure conducive to attaining the objectives of the proposed program. 4. Arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, the internal communication and cooperation among investigators in the program. 5. Quality of proposed external review process. 6. Appropriateness of the total budget and budgetary requests for the individual components. 7. Academic and physical environment as it bears on patients, space, and equipment and on the potential for interaction among scientists within the center and with scientists from other departments, institutions, and Claude D. Pepper Centers. 8. Institutional commitment to the requirements of the program. 9. The adequacy of the means for protecting against risks to human subjects, animals, and/or the environment. 10. Issues relating to inclusion of women and minorities (see following special instructions). SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS: NIH policy is that, as appropriate, applicants and offerors for NIH grants, cooperative agreements, and contracts will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the diseases, disorders, or conditions under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy is intended to apply to males as well as females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale for exception to the policy must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic groups, 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. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, 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, Native Americans (including American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics) The rationale for studies on single minority populations should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are exempt. However, every effort tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study is inadequate to answer the scientific questions(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. FUNDING Although it is anticipated that up to $3.9 million will be directed to the support of OAICs in Fiscal Year 1991, issuance of OAIC awards is contingent upon the receipt of scientifically meritorious applications and allocation of appropriated funds for this purpose. In addition to FY 1991 awards, other applications responding to this RFA may be funded in Fiscal Year 1992, depending on quality of applications and availability of funds. Issuance of awards pursuant to this RFA is contingent on the availability of funds for this purpose. STAFF CONTACT Potential applicants interested in obtaining further information may write or call: Stanley L. Slater, M.D. Geriatrics Program National Institute on Aging Building 31, Room 5C27 Bethesda, MD 20892 Telephone: (301) 496-6761 This program is described in the Catalog of Federal Domestic Assistance, Number 93.866. Awards are made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grant policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. Special Terms of Awards applying to projects funded in response to this RFA are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administrative regulations at 45 CFR Part 74, and other HHS, PHS, and NIH grant administration policies. Awardees will maintain custody of and primary rights to their data developed under their awards, subject to Government rights of access, consistent with current HHS, PHS, and NIH policies. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Brought to you by Super Global Mega Corp .com