UNDERSTANDING AND ELIMINATING MINORITY HEALTH DISPARITIES Release Date: October 20, 1999 RFA: HS-00-003 Agency for Health Care Policy and Research Letter of Intent Receipt Date: December 22, 1999 Application Receipt Date: January 21, 2000 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for research program project grants to conduct research on racial and ethnic disparities in health that are amenable to improvements in health services. Projects funded under this Request for Applications (RFA) will build on previous research that has identified disparities in access to, and utilization, quality and outcomes of health care services and the excess burdens of illness and death for Blacks/African Americans, Hispanic Americans, American Indians, Alaska Natives, Asian Americans and Pacific Islanders compared to the United States non-minority population. Projects funded by AHCPR will analyze causes and contributing factors for the inequalities that are related to the delivery and practice of health care, and identify and implement strategies to eliminate them. AHCPR will support research to strengthen the science base for evaluating and implementing strategies to achieve the goals of the President’s Initiative to Eliminate Racial and Ethnic Disparities in Health: by the year 2010, eliminate differences in outcomes and health status for racial and ethnic minority populations in six clinical areas (infant mortality, cancer screening and management, cardiovascular disease, diabetes mellitus, HIV, and immunizations for both children and adults). Although an incomplete understanding of disease processes as well as non- medical determinants of health such as income and education contribute to some of the observed differences, provider, patient and organizational factors play a substantial role in the sub-optimal outcomes of these groups. For further information, access the Initiative to Eliminate Racial and Ethnic Disparities in Health Web page at: http://raceandhealth.hhs.gov/. Each research program project grant will support a broad, integrated, interdisciplinary, multi- project health services research program a center of excellence. Such centers will bring together strong teams of experienced and new researchers focused on a central theme to share essential facilities, services, knowledge, and other resources in purchasing and developing data sources, developing new methodologies, performing analyses across supported projects and working with partners and communities to conduct research and translate research into practice. Although the major goals of this RFA are to develop new knowledge and to accelerate the pace of improvements in health and health care for minority populations, applicants are also encouraged to design programs that will enable development of greater capacity for health services research undertaken by minority investigators and focused on racial and ethnic minority populations. Building such capacity entails augmenting the skills and abilities of minority researchers and institutions, and non-minority researchers and institutions interested in studying racial and ethnic minority groups as well as developing sustainable and meaningful relationships with communities and community organizations. 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 health improvement priorities for the United States. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512- 1800) or at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign, public or private nonprofit organizations, including American Indian/Alaska Native organizations, universities, clinics, units of State, Tribal and local governments, and eligible agencies of the Federal government. AHCPR, by statute, can make grants only to non-profit organizations, however, for-profit organizations may participate in grant projects as members of consortia or as subcontractors. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHCPR encourages investigators who are women, members of minority groups and persons with disabilities to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the Research Program Project (P01) Grant mechanism. AHCPR’s Guidelines for the Research Program Project Grant are available via the World Wide Web at http://www.ahcpr.gov/fund/guiderpg.htm. The applicant will have sole responsibility for the planning, direction, and execution of the proposed project. AHCPR will consider projects of up to 5 years. The anticipated award date is September 1, 2000. The P01 mechanism is designed to support multiple, interacting discrete projects focused on a central theme, involving a number of independent investigators who share knowledge, data, and common resources. A P01 must have a minimum of three and a maximum of eight discrete projects. The degree to which the projects are related and the total budget of the program will influence the total number of projects. Applicants are strongly encouraged to include cores. A core is a separately budgeted component of a P01 that provides essential facilities or services to two or more of the proposed research projects. For example, in addition to an administrative core, a P01 may include a technical core to facilitate across-institution and across- project sharing of resources in purchasing, developing and using data sources. Another potential core could be focused on dissemination and implementation of program findings. A core may not count as one of the discrete research projects. The Research Program Project may support projects that are performed at multiple sites but coordinated by a single Principal Investigator (PI) at the grantee institution. An award will be made only to the PI"s institution. Applicants are encouraged to coordinate most activities at other institutions through an administrative core located at the PI"s institution. This RFA is a one-time solicitation. AHCPR has not determined whether or how this solicitation will be continued beyond this present initiative. FUNDS AVAILABLE AHCPR expects to award up to $4.35 million in total costs (direct costs plus facilities and administrative (F&A) costs) in fiscal year 2000 to support the first year of approximately two to four P01 grants under this RFA. From the $4.35 million, the Agency will set-aside $850,000 for the study of clinical preventive services, $500,000 for the study of minority children and $500,000 for the study of chronically-ill minority elderly. The set-asides may be devoted to a single P01 or to a number of projects within one or more P01. Applicants for set-aside funds should explicitly note their intent to have a specific project considered for those funds. For the purposes of this RFA, minority children and chronically-ill minority elderly are defined as members of ethnic or racial minority populations who are under 18 years of age, or 65 years of age or older and under care for one or more medical conditions on an ongoing basis, respectively. Clinical preventive services are defined as interventions such as screening tests, counseling, immunizations and chemoprophylaxis provided in clinical practice to prevent or detect specific conditions. The actual number of applications funded is dependent on the number of high quality applications and their individual budget requirements, it is not the intent of AHCPR that the awards be equal in size. The expected size of each award is $1-2 million in total costs. Although the financial plan of AHCPR provides for this program, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. RESEARCH OBJECTIVES Background Disparities in health have been documented repeatedly over the last few decades across a broad range of medical conditions and for a wide range of ethnic and racial groups. These differences have been noted in health outcomes such as quality of life and mortality, processes of care such as utilization rates of certain services, quality and appropriateness of care, and the prevalence of certain conditions or diseases. The documentation of these wide-spread disparities has been an important contribution of outcomes and effectiveness research and health services research. Nevertheless, these insights have infrequently led to significant improvements in racial and ethnic disparities, in part, because the causes of and contributing factors to these inequalities are inadequately understood. Some of the most glaring differences in outcomes are highlighted by the President’s Initiative to Eliminate Racial and Ethnic Disparities in Health. In 1996, the infant mortality rate was nearly 2 time greater for blacks than whites. The incidence rate for cervical cancer is more than 5 times as high for Vietnamese women in the United States as for white women (47.3 vs. 8.7 cases per 100,000 women). And the prevalence of diabetes in Hispanics, Native Americans and Alaska Natives is approximately double that in whites. In addition to infant mortality, cancer screening and management, and diabetes, the President’s Initiative to Eliminate Racial and Ethnic Disparities in Health has targeted inequalities in cardiovascular disease, HIV infection and child and adult immunization for elimination by 2010 (http://raceandhealth.hhs.gov/). These disparities persist despite improvements in health for the Nation as a whole. For example, mortality from ischemic heart disease decreased 20% for the overall population but only 13% for blacks between 1987 and 1995. As minority populations continue to increase in size and proportion, the health of these groups will increasingly affect the health of the entire Nation. Also, lessons learned from understanding and eliminating disparities and improving the health care of under-served racial and ethnic groups will likely be applicable to the United States population as a whole. Minority children and chronically-ill minority elderly are of particular interest because they may be especially vulnerable to a number of the causes of inequities and may be less able to safeguard their needs and interests adequately. Similarly, greater attention to preventive care in minority populations has the potential for improving the health of the groups as well as improving our ability to prevent disease and disability for the Nation as a whole. The improvements in mammography rates for low-income black women, for example, were noted to have implications for other racial and ethnic groups, including low-income white women, whose rates have not increased as much (Makuc, 1999). While substantial attention has been paid to problems with initial access for certain interventions with resulting improvements over the past decade, far less is known about the strength of the other necessary elements of an effective prevention program: quality of screening, timeliness of follow-up, appropriateness and effectiveness of interventions, quality of long-term management, and quality of communication between clinician and patient. Etiologies for other disparities are also numerous yet inadequately understood. They include differences in biology, environment, education, health literacy, socio-economics, access, health insurance, preferences, bias and interactions with the medical system. Some argue that elimination of financial differences in access would profoundly reduce health disparities (Andrulis, 1998). Nevertheless, disparities exist within health systems. In a study of Medicare beneficiaries, providers gave less intensive treatment to blacks than to whites after controlling for other factors (Lee, 1997). A study of black and white males treated for colorectal carcinoma in the Veterans Affairs system found that all-cause mortality was higher for blacks than whites despite an absence of difference in rates of surgery, chemotherapy and radiation, suggesting that underlying racial differences are associated with mortality (Dominitz, 1998). A recent study of how physicians manage chest pain suggests that decision-making may be influenced by race and ethnicity after controlling for other factors (Schulman, 1999). Objectives and Scope Research funded under this RFA is expected to expand the knowledge base that is necessary to achieve the goals of the President’s Initiative to Eliminate Racial and Ethnic Disparities in Health. Specifically, the Initiative aims to eliminate differences in outcomes and health for racial and ethnic minority groups by the year 2010 for the following clinical areas: infant mortality, cancer screening and management, cardiovascular disease, diabetes mellitus, Human Immunodeficiency Virus, and childhood and adult immunization. Although the study of health disparities for other clinical conditions will be considered under this funding program, the emphasis is on the six areas because of the potential to impact large numbers of people. Also, the rapid elimination of health disparities is more likely in these areas because of the significant work that has already been done in understanding some of the underlying causes and in identifying strategies to diminish the inequities. This RFA will, however, focus on causes that are amenable to improvements in health services despite the fact that etiologies for the disparities are numerous and widely varied. While inequalities have not been documented for many conditions and minority sub-groups, further documentation of disparities is not of interest under this solicitation unless it is specifically linked with efforts to understand underlying causes or to eliminate the disparities. The range of potential questions that could be addressed under this solicitation is broad. In identifying underlying causes and contributing factors for the disparities, investigators may wish to address topics including patient, provider, organizational and modifiable, environmental factors. Specific issues could include but are not limited to individual health practices and health literacy, access, preferences, clinical management and decision making, quality of care, financing and other economic considerations, and service delivery. This RFA also addresses the identification and study of successful strategies to eliminate disparities which may be focused, again, on patients, providers, the organization of health care and the environment. Examples of topics that would be of interest under this solicitation include but are not limited to: Access o What are the racial and ethnic differences in the management of premature infants and what are the access-related causes for these differences? Patient and Provider Characteristics o What patient and provider characteristics are associated with failure to receive recommended preventive screening, especially in delivery systems with organized internal strategies and, using this information, what interventions can be implemented to improve screening rates? o How can predictors of patient compliance such as understanding of their disease, trust in the medical system and financing of prescriptions be assessed and addressed in a high-volume practice setting? o Are opinion leaders effective for improving the cost-effective management of hypertension for urban minority groups? Interventions o What clinical and systems-level strategies can be implemented to address the under-use of the pneumonia and influenza vaccines? o Can the opinion leader model for implementation be adapted for the care of minority populations and communities? Organizational Strategies o Why have disparities in the quality of care for patients with HIV disease been eliminated for Latinos compared with whites but not for blacks (Shapiro, 1999)? What mutable provider and organizational characteristics are predictive for receiving recommended HIV treatment and how can health care systems apply this understanding? o Are automated systems which generate reminders for both patients and providers effective for improving processes of care and glycemic control for minority patients with diabetes? o What are the strategies or tactics that have been successful for organizations that have diminished disparities in coronary artery disease and diabetes? In order for the study of disparities to impact practices, policies and outcomes more effectively, research must advance from description and hypothesis generation to definitive studies, problem solving and implementation of findings. In part, this will be accomplished by building upon existing linkages and developing new relationships between researchers and change agents. These change agents could include: payers and policy makers, both public and private, provider groups including Community Health Centers, workplace and union-based clinics, and practice networks, professional organizations on the local as well as national level, community organizations such as religious and social groups, patient organizations such as those organized around diseases, and the media including print, television, radio, and the Internet. Examples of change agents that have formed successful linkages with researchers include the Health Care Financing Administration’s Peer Review Organizations (PROs), which have been instrumental in implementing findings including the effectiveness of anticoagulation in the prevention of atrial fibrillation-associated strokes, the effectiveness of beta-blockers in elderly myocardial infarction survivors, and the importance of early administration of antibiotics in patients with community acquired pneumonia. The PROs are potential partners for work under this solicitation, under their sixth scope of work, the PROs focus will include acute myocardial infarction, heart failure, stroke, diabetes and cancer screening. Other examples of successful partnerships include: State Medicaid organizations which have worked to improve the management of otitis media in children, community health centers which have implemented programs to reduce intravenous drug use, patient organizations which have sought to increase compliance with recommendations based on the Diabetes Control and Complications Trial, professional organizations which have issued guidelines and are collecting data on providers outcomes using newly developed measures, payers who profile providers using various quality indicators such as the appropriate use of corticosteroids in premature births, and local community groups which have improved rates of cancer screening and immunization. These relationships should be utilized to identify needs and areas ripe for change and to implement new findings into practice rapidly (Tunis, 1999). Studies of efforts to improve practice have demonstrated that traditional approaches including distribution of educational material and lectures are generally ineffective while more active efforts such as academic detailing, and interactive educational meetings as well as combinations of interventions including those at an organizational level are effective (Bero, 1998). Studies that incorporate active approaches to dissemination and implementation are strongly encouraged. This RFA will focus on health disparities in Alaskan Natives, American Indians, Asian Americans, Blacks/African Americans, Hispanic Americans, and Pacific Islanders. Despite the heterogeneity of minority populations in the United States, AHCPR expects that the research findings from this RFA will be generalizable beyond the study communities. Specifically, by focusing on attributes of the ethnic and racial groups, the underlying etiologies for the disparities and components and conditions of interventions to eliminate the disparities, the studies funded under this solicitation should produce findings that are widely applicable for minority as well as majority populations across the country. While the focus of this RFA is on understanding and eliminating inequalities in health outcomes and care, we expect that this program will also enable the development of greater capacity for health services research by minority individuals and institutions and health services research focused on racial and ethnic minority groups. Such a lack of capacity has been highlighted by the Association of American Medical Colleges (AAMC, 1997). Strategies for developing greater capacity include linking less experienced individuals and teams with more experienced ones and developing formal and informal mentoring opportunities. This RFA is also expected to yield greater capacity in terms of forming new, and building upon existing, sustainable relationships between researchers, and communities and community organizations. In participatory research, community involvement enhances the validity and reliability of findings by addressing the social, cultural and economic conditions of the community. Such relationships are instrumental in identifying research needs and strategies, disseminating and implementing findings, and developing capacity for future health care planning (North American Primary Care Research Group, 1998). Successful partnerships have included those formed between academic medical centers and neighborhoods. A number of federal programs developed under the President’s Initiative to Eliminate Racial and Ethnic Disparities in Health are also seeking to enhance community endeavors to improve health (e.g., the Centers for Disease Control and Prevention’s REACH 2010 Demonstration Projects and the National Heart, Lung, and Blood Institute’s Community-Based Action Centers for Enhanced Dissemination). Research Methods In general, methodological rigor should reflect the research question, potential consequences of misleading findings, and an assessment of the level of evidence necessary for influencing change agents. For example, clinicians and policy makers were reluctant to embrace a risky therapy such as thrombolysis without a number of well-designed, randomized trials but have been more willing to extend the use of a more benign therapy such as beta- blockers for elderly patients following heart attacks based on an observational study. Applicants are encouraged to discuss the evidence needs with decision makers (Tunis, 1999). Applications that include evidence of decision makers involvement with project design and implementation are strongly encouraged. Applicants are also encouraged to submit applications across the continuum from descriptive to interventional studies, using both quantitative and qualitative methods, as appropriate. The types of methodologies will be dictated by the specific research topic and the needs of decision-makers as well as the state of the science. AHCPR recognizes that some areas have been studied in greater depth than others, allowing researchers to target their questions and interventions more effectively. Qualitative methods are valuable for furthering our understanding of the causes of the inequalities, for identifying mutable predictive factors and for developing initiatives to eliminate the differences. Sub-groups in which disparities have been diminished may be valuable sources of information. Also, sub-group analyses may be valuable for investigation of interactions between race/ethnicity, gender, age and other factors. For studies evaluating interventions to eliminate disparities, control groups are strongly encouraged to account for secular changes, as is measurement of costs and cost-effectiveness. Because of the nature of the problem, expertise from multiple disciplines may be beneficial and is also encouraged. Special attention may be necessary to address issues of cultural competency and community participation. To the extent possible, applicants should submit proposals that build on available data, will generate early results, and are modest in terms of time, scale, and cost. Existing data sources include those of AHCPR and HCFA. Research Program Project Design The P01 grant involves at least three and no more than eight inter-related individual projects bundled together under one program theme and involves a number of independent investigators from several disciplines or from several interests within one discipline. Potential themes around which programs may be developed include a specific condition, a specific ethnic or racial minority group, or a cross-cutting issue such as health literacy. This mechanism achieves an economy of effort and resources through the sharing of personnel, facilities, equipment, data and ideas. The scope of this initiative and the capacity-building aspects of the P01 allows new investigators and institutions to be drawn in to work collaboratively with a team of researchers under the bundled projects. Multiple applications focused around a similar theme from a single institution are discouraged, efforts should be made to consolidate the applications. AHCPR encourages collaboration with researchers from minority institutions. There are several features that distinguish program project grants from other assistance mechanisms. Each project within a program project grant proposal is similar to the traditional research grant application in the sense that each is reviewed for scientific merit. However, a component project is evaluated within the context of the special collaborative interrelationships and environment required for a program project. A program project grant may contain one or more core component(s), each with a separate budget, for administrative or research support services that are required for and shared solely within this particular program project. A core for dissemination and implementation may be an efficient use of resources. There is no allowance for unspecified developmental research funds (seed money) in program project grants. Each P01 has three main types of leadership: the principal investigator, project leaders, and core directors. The principal investigator is in charge of the entire P01 and sets the general over- arching theme of all the projects in the P01. Each individual project in the P01 is directed by a project leader. In addition, individual projects in the P01 may share one or more cores. Led by a core director, a core is a separately budgeted component of the P01 that provides essential facilities, administrative staff, or services for two or more of the P01’s individual projects. The cores are to create synergies among the various projects, researchers, and institutions in the program. For example, a technical core may be a separately budgeted facility that processes and analyzes data for several projects within the P01, allowing projects to link data sets and share variables. For a detailed description of the design of the P01, please see AHCPR’s Guidelines for the Research Program Project Grant. AHCPR Data AHCPR encourages research applications that will use, as is or in conjunction with other sources, data from the Medical Expenditure Panel Survey (MEPS), the Healthcare Cost and Utilization Project (HCUP), the HIV Cost and Services Utilization Study (HCSUS) and other AHCPR data. MEPS is a nationally representative survey focused on the financing and utilization of medical care in the United States. It is composed of four parts, the Household Component (HC), the Medical Provider Component (MPC), the Insurance Component (IC), and the Nursing Home Component (NHC), and is designed to yield comprehensive data that estimate the level and distribution of health care use and expenditures, monitor the dynamics of the health care delivery and insurance systems, and assess health care policy implications. It has been used to estimate the impact of changes in insurance coverage on different populations including racial and ethnic minority groups. HCUP is composed of two databases containing patient-level information for inpatient hospital stays for 1988-97. The Nationwide Inpatient Sample (NIS) includes inpatient data from a national sample of about 900 hospitals while the State Inpatient Database (SID) covers inpatient care in community hospitals in 19 States that represent more than half of all U.S. hospital discharges. The uniform data in HCUP make possible comparative studies of health care services and the use and cost of hospital care, including the effects of market forces on hospitals and the care they provide, variations in medical practice, the effectiveness of medical technology and treatments, and use of services by special populations. The databases can be linked with other sources such as the Health Resources and Services Administration’s Area Resource File. AHCPR, with supplemental funding from Health Resources and Services Administration, the National Institutes of Health and the Office of Minority Health in the Department of Health and Human Services, developed HCSUS to address a broad array of issues relevant to public policy formulation and to health services research regarding HIV. The study interviewed a national probability sample of HIV-infected adults who were receiving ongoing or regular medical care in 1996. Follow-up interviews and abstractions of data from patients" medical, pharmaceutical, and billing records were also conducted. The sample was 49% white, 33% black, 15% Hispanic and 3% other . Public use tapes containing data from the baseline interviews will be available in the summer of 1999. It is expected that all HCSUS data will be available for public use by the summer of 2000. SPECIAL REQUIREMENTS Data Privacy Pursuant to section 903(c) of the Public Health Service Act (42 USC 299a- 1(c)), information obtained in the course of any AHCPR-study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the use and purposes of the data collection. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of such identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be safeguarded. The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook, Generally Accepted Principals and Practices for Securing Information Technology Systems, and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://www.whitehouse.gov/OMB/circulars/a130/a130.html, http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf, http://csrc.nist.gov/publications/nistbul/csl96-10.txt, and http://csrc.nist.gov/publications/nistbul/itl99-04.txt, respectively. The application of these standards to subcontractors and vendors should be addressed as necessary. Rights in Data AHCPR grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHCPR funds. Such copyrights and patents are subject to a Federal government license to use and permit others to use these products and materials for AHCPR purposes. In accordance with its legislative dissemination mandate, AHCPR purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers, and subject to AHCPR budget constraints, final products maybe made available to the health care community and the public by AHCPR, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHCPR publicizes research findings but relies on grantees to publish in peer-reviewed journals and to market grant- supported products. Important legal rights and requirements applicable to AHCPR grantees are set out or referenced in the AHCPR’s grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO’s website http://www.access.gpo.gov/nara/cfr/index.html). INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS It is the policy of AHCPR that women and members of minority groups be included in all AHCPR-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 and in the NIH Guide for Grants and Contracts of March 18, 1994 . To the extent possible, AHCPR requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHCPR Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Website http://grants.nih.gov/grants/guide/index.html. AHCPR also encourages investigators to consider including children in study populations, as appropriate. AHCPR announced in the NIH Guide of May 9, 1997, that it is developing a policy and implementation plan on the inclusion of children in health services research. This Notice is available through the AHCPR Website http://www.ahcpr.gov (Funding Opportunities) and InstantFAX (see instructions under INQUIRIES). AHCPR Program staff may also provide additional information concerning these policies (see INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by December 22, 1999, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHCPR staff to estimate the potential review workload and avoid conflict of interest in the review. AHCPR will not provide responses to letters of intent. The Letter of Intent is to be sent to Joanne Book (see address under INQUIRIES). APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Applications kits are available at most institutional offices of sponsored research. They may also be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, E-mail: [email protected]. AHCPR applicants are encouraged to obtain application materials from the AHCPR Publications Clearinghouse (see INQUIRIES). In addition to the above, application procedures should conform to AHCPR’s Guidelines for the Research Program Project Grant. Applications for a P01 grant must include (1) an overall organizational plan, (2) an overarching research plan, and (3) detailed plans for the research projects. For purposes of the page limitations of section 1 through 4 of the PHS 398 form, the P01 organizational plan (including the administrative, technical, and other cores) and the overarching research plan should be considered one component with a 25 page limit. A maximum of 10 additional pages total may be used to describe the discrete research projects that the program project will undertake. The RFA label and line 2 of the application form PHS 398 (rev. 4/98) should both indicate RFA number. The RFA label must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title must also be typed on line 2 of the face page and the YES box must be marked. The sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Applicants are encouraged to read all PHS Form 398 instructions prior to preparing an application in response to this RFA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non- compliant applications will be returned. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express/courier service) At the time of submission, two additional copies of the application, labeled Advanced Copy (s) must also be sent to: Joanne Book, Program Analyst Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 6010 Executive Blvd., Suite 300 Rockville, MD 20852 Telephone: (301) 594-4039 FAX: (301) 594-3211 E-mail Address: [email protected] Applications must be received by January 21, 2000. An application received after the deadline may be acceptable if it carries a legible proof-of-mailing date, assigned by the carrier, and the proof-of-mailing is not later than 1 week prior to the deadline date. If an application is received after that date, it will be returned to the applicant without review. Application Preparation (for Using HCFA Data) For applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form PHS 398) the specific files, time periods, and cohorts proposed for the research. In consultation with the Health Care Financing Administration (HCFA), AHCPR will use this information to develop a cost estimate for borrowing the data. This estimate will be included in the AHCPR estimated cost of the grant and may affect the fundability of the application. To avoid double counting, applicants should not include the cost of the data in the budget. Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with HCFA to protect the confidentiality of data in accordance with standards set out in OMB Circular A-130, Appendix III Security of Federal Automated Information Systems. The use of the data is restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee is required to return the data to HCFA or certify that the data have been destroyed. Grantees must also comply with the confidentiality requirements of Section 903(c) of the PHS Act. See the Data Privacy Section for details on these requirements as well as references to Circular A-130 and its implementation guides from the National Institute of Standards and Technology. In developing research plans, applicants should allow time for refining, approving, and processing their data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their provider require the approval of the HCFA Administrator and may require meeting(s) with HCFA staff. HCFA data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats. Questions regarding HCFA data should be directed to the AHCPR program official listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete applications and applications determined to be unresponsive to the RFA will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by AHCPR in accordance with the review criteria stated below. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria The goals of AHCPR-supported research are to enhance the outcomes, quality, and cost, use and access of our health care system. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus receive a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. o Significance. Does this study address an important, common and/or costly problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? What will be the impact on care for racial and ethnic minorities? o Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Are the proposed data sources appropriate and adequate? Does the applicant acknowledge potential problem areas and consider alternative tactics? o Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Is the project (or work plan) well organized? o Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, children, and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human subjects, and the safety of the research environment. Special Review Criteria In addition to the general criteria above, the reviewers will assess the application’s responsiveness to the RFA and other critical aspects including: o The extent to which the research will improve our understanding of the racial and ethnic differences in access, quality, outcomes or burden of disease and/or develop strategies to eliminate them with an emphasis on the latter. o The extent to which study results will be applicable to situations beyond that of the study and contribute to reduction or elimination of disparities across a range of environments and populations. o The existence or establishment of meaningful and sustainable linkages between researchers and change agents including practitioners, professional organizations, policy makers, legislators, payers, patient and community organizations and the media in order to accelerate the incorporation of findings into practice. Letters of support or agreement to participate are strongly encouraged. Also, financial commitments from organizations toward project involvement may demonstrate significant interest. o The existence or establishment of substantive and sustainable linkages of researchers with communities and community organizations and the participation of community members in appropriate stages of the project to ensure that patient needs and priorities are addressed. A history of the relationship should be described. Inclusion of community representatives on the Program Project Advisory Board is strongly encouraged as are letters of support that clearly describe expected involvement in the study (ies). o Understanding of and means to adjust for cultural differences and variations between research participants (including patients and providers) and researchers that may impact on their interactions and the validity, reliability and generalizability of the study itself. o Development of new infrastructure including talent, methods and data systems that will enhance our capacity to study minority populations. Also, because a P01 is composed of a number of inter-related projects, grant applications will be reviewed for the merit of the individual research projects, the core components in the context and environment of the proposed program and the integrated nature of the program as a whole. Applicants are strongly advised to review the evaluation criteria in the AHCPR Guidelines for the Research Program Project Grant before preparing their applications. AWARD CRITERIA The following will be considered in making funding decisions: 1) quality of the proposed project as determined by peer review, 2) availability of funds, 3) portfolio balance with respect to the conditions, populations and strategies to understand and eliminate disparities addressed by the studies, 4) fulfillment of set-aside funding targets and 5) potential for impact. INQUIRIES Copies of the RFA and the PHS 398 grant application form are available from: AHCPR Publications Clearinghouse P.O. Box 8547 Silver Spring, MD 20907-8547 Telephone 1-800-358-9295 The RFA is also available on AHCPR’s Web site, http://www.ahcpr.gov, and through AHCPR InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call AHCPR’s Division of Communications at (301) 594-6344. AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants. Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: Joanne Book, Program Analyst Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 6010 Executive Blvd., Suite 300 Rockville, MD 20852 Telephone: (301) 594-4039 FAX: (301) 594-3211 E-mail Address: [email protected] For inquiries regarding AHCPR data sources: Medical Expenditure Panel Survey Nancy Krauss, M.S. Center for Cost and Financing Studies Agency for Health Care Policy and Research 2101 E. Jefferson Street Rockville, MD 20852 Telephone: (301) 594-0846 FAX: (301)594-2286 E-mail: [email protected] Healthcare Cost and Utilization Project Anne Elixhauser, Ph.D. Center for Organization and Delivery Studies Agency for Health Care Policy and Research 2101 E. Jefferson Street, Suite 605 Rockville, MD 20852 Telephone: (301) 594-6815 FAX: (301)594-2314 E-mail: [email protected] HIV Cost and Service Utilization Study Doris Lefkowitz, Ph.D. Center for Cost and Financing Studies Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 500 Rockville, MD 20852 Phone: (301) 594-1077 FAX: (301)594-2286 E-mail: [email protected] Direct inquiries regarding fiscal and eligibility matters to: Joan Metcalfe Grants Management Specialist Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1841 FAX: (301) 594-3210 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.226. Awards are made under authorization of Title IX of the Public Health Service Act (42 USC 299-299c-6). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92. 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. REFERENCES Association of American Medical Colleges (1997). Draft Recommendations from the AAMC Meeting on Minority Health Services Research. July, 1997. Andrulis DP (1998). Access to Care is the Centerpiece in the Elimination of Socioeconomic Disparities in Health. Ann Intern Med,129:412-416. Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA (1998). Closing the Gap between Research and Practice: an Overview of Systematic Reviews of Interventions to Promote the Implementation of Research Findings. BMJ,317:465-468. Dominitz JA, Samsa GP, Landsman O, Provenzale D (1998). Race, Treatment, and Survival among Colorectal Carcinoma Patients in an Equal-Access Medical System. Cancer,82:2312- 2320. Lee AJ, Gehlbach S, Homer DW, Reti M, Baker CS (1997). Medicare Treatment Differences for Blacks and Whites. Med Care,35:1173-1189. Makuc DM, Breen N, Freid V (1999). Low Income, Race, and the Use of Mammography. Health Serv Res,34(1 Pt 2):229-239. North American Primary Care Research Group (1998). Responsible Research with Communities: Participatory Research in Primary Care. A Policy Statement. November 6, 1998. Schulman KA, Berlin JA, Harless W, Kerner JF, Sistrunk S, Gersh BJ, Dube R, Taleghani CK, Burke JE, Williams S, Eisenberg JM, Escarce JJ (1999). The Effect of Race and Sex on Physicians" Recommendations for Cardiac Catheterization. N Engl J Med,340:618-626. Shapiro MF, Morton SC, McCaffrey DF, Senterfitt JW, Fleishman JA, Perlman JF, Athey LA, Keesey JW, Goldman DP, Berry SH, Bozzette SA (1999). Variations in the Care of HIV- Infected Adults in the United States: Results from the HIV Cost and Services Utilization Study. JAMA,281(24):2305-2315. Tunis S, Stryer D (1999). The Outcomes of Outcomes Research at AHCPR. AHCPR Pub. No. 99-R044. U.S. Preventive Services Task Force. Guide to Clinical Preventive Services (Second Edition). U.S. Department of Health and Human Services.

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