This Program Announcement expires on: Expiration Date for R01 Non-AIDS Applications: November 2, 2006 Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007 AHRQ HEALTH SERVICES RESEARCH Release Date: June 22, 2000 PA NUMBER: PA-00-111 (March 9, 2007 - The R18 portion of this FOA has been reissued as PA-07-247. (January 11, 2007 - The R01 portion of this funding opportunity has been replaced by PA-07-296, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.) Agency for Healthcare Research and Quality PURPOSE The mission of the Agency for Healthcare Research and Quality (AHRQ), formerly known as the Agency for Health Care Policy and Research (AHCPR), is to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health systems practices, including the prevention of diseases and other health conditions. AHRQ achieves this mission through health services research designed to (1) improve clinical practice, (2) improve the health care system’s ability to provide access to and deliver high quality, high-value health care, and (3) provide policymakers with the ability to assess the impact of system changes on outcomes, quality, access to, cost, and use of health care services. Consistent with a broad view of health, healthcare practices, and systems, ARHQ considers oral health to fit within the framework of this Program Announcement (PA). AHRQ’s research agenda is designed to be responsive to the needs of consumers, patients, clinicians and other providers, institutions, plans, purchasers, and public policymakers for the evidence-based information they need to improve quality and outcomes, control costs, and assure access to needed services. This PA expresses AHRQ priority interests for ongoing extramural grants for research, demonstration, dissemination, and evaluation projects to: o Support improvements in health outcomes. Drawing from literature on variations in clinical practice and associated outcomes, the documented increase in the prevalence of chronic disease, and growing interest in the impact of different delivery modalities and financing arrangements on the outcomes of care, AHRQ seeks to support research to understand and improve decision-making at all levels of the health care system, the outcomes of health care, and, in particular, what works, for whom, when, and at what cost. o Strengthen quality measurement and improvement. AHRQ is interested in a broad array of research topics, including studies to develop valid and reliable measures of the process and outcomes of care, causation and prevention of errors in health care, strategies for incorporating quality measures into programs of quality improvement, and dissemination and implementation of validated quality improvement mechanisms. o Identify strategies to improve access, foster appropriate use, and reduce unnecessary expenditures. This area focuses on issues pertaining to the types of health care services Americans use, the cost of these services and sources of payment, determinants of access to care, and whether particular approaches to health care delivery and financing, or characteristics of the health care market, alter behaviors in ways that improve access and promote cost-effective use of health care resources. AHRQ recognizes that a number of populations experience persistent disparities in health status, access to care, quality of care, and poor health care outcomes. The AHRQ research agenda includes a special focus for health services research on these populations, which include low-income groups, racial and ethnic minority groups, women, children, the elderly, individuals with special health care needs, including individuals with disabilities and those who need chronic care and end- of-life health care, and individuals living in inner-city, rural, and frontier areas. AHRQ encourages research, demonstration, dissemination, and evaluation projects for these priority populations to address outcomes, quality, access to, cost, and use of services. AHRQ encourages research using data from the Medical Expenditure Panel Survey (MEPS), the Healthcare Cost and Utilization Project (HCUP), and other AHRQ data. Information on MEPS and HCUP is available from the Data section of the AHRQ website and from AHRQ staff (see Inquiries ). AHRQ also encourages partnerships with private and public organizations to facilitate development and sharing of scientific knowledge and resources, including cost-sharing mechanisms, projects that will produce results within 2-3 years, and results that can be integrated rapidly in practice and policy. The program areas outlined in this PA are also applicable to AHRQ grants for small projects, dissertation support, health services research training and career development, and large and small conferences (see Mechanism of Support ). AHRQ’s new legislative reauthorization Healthcare Research and Quality Act of 1999," which provides more information on the Agency’s mission is available at http://www.ahrq.gov. This PA updates and supersedes AHCPR Health Services Research, PA-98- 049, published in the NIH Guide for Grants and Contracts (NIH Guide) on March 26, 1998. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, public and private nonprofit organizations including universities, clinics, units of State and local governments, firms, and foundations. For the purpose of this PA, AHRQ will make grants only to nonprofit organizations, however, for-profit organizations may participate in grant projects through consortium arrangements or as subcontractors. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHRQ encourages women, members of racial and ethnic minority groups, and persons with disabilities to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support for this PA will generally be the research project grant (R01), although research demonstration, evaluation, and dissemination projects (R18), as well as other mechanisms, may also be supported. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Research applications requesting total costs of $100,000 or less ("small project grants" or R03s) should follow the application procedures in the "AHRQ Small Project Grant Program" PA, published in the NIH Guide for Grants and Contracts (NIH Guide), February 23, 1996 and AHRQ Small Project Grant Program - Addendum, published in the NIH Guide, January 29, 1999. AHRQ also supports conference and dissertation grants (NIH Guide: small conference grants, January 26, 1996, large conference grants, May 31, 1991, dissertation research grants, March 13, 2000), and training and career development through National Research Service Award grants and fellowships and the Independent Scientist Award grants (K02) and Mentored Clinical Scientist Development Award grants (K08). Program Announcements and grants policy statements listed above are available through the AHRQ Web site http://www.AHRQ.gov (Funding Opportunities) and from the AHRQ Publications Clearinghouse (see Inquiries). For research applications requesting $500,000 or more in direct costs for any year, investigators must receive written agreement from AHRQ prior to submission that it will accept the applications (NIH Guide, August 22, 1997). RESEARCH OBJECTIVES AHRQ seeks research on a wide range of topics under the Priority Program Areas: 1) Supporting Improvements in Health Outcomes, 2) Improving Quality and Patient Safety, and 3) Identifying Strategies To Improve Access and Foster Appropriate Use and Reduce Unnecessary Expenditures. A continuing challenge to health services research is to improve the translation, dissemination, and use of research findings for clinicians, other providers, patients, consumers, policy makers, and other decisionmakers to effect needed health care changes, and to measure the impact of changes at all levels of health care delivery. AHRQ is especially interested in projects across its program areas that demonstrate innovative strategies for effecting systemic and sustained behavior changes to improve outcomes, quality, access, cost, and use, and document the impact of changes at systems, state, and community levels. PRIORITY PROGRAM AREAS o Supporting Improvements in Health Outcomes Research on clinical outcomes examines the effectiveness of different strategies for preventing, diagnosing, treating, or managing conditions that are common, expensive, and for which significant variations in practice or outcomes exist, or opportunities for improvement have been demonstrated. Research in this area also includes improving our understanding of how outcomes data can be incorporated into informed decision-making at the patient, provider, and organizational levels of the health care system. Outcomes of clinical interventions include functional status, quality of life, patient satisfaction, and costs, in addition to morbidity and mortality. A particular emphasis is on the outcomes of care provided to the elderly and those with chronic illnesses, including studies that assess when in the course of illness intervention is most effective. Research may focus on the type of delivery system or financial arrangements by which care is provided and the effects of these on clinical outcomes. Interests include: 1. Effectiveness and cost effectiveness of clinical and organizational interventions, including trials of interventions across the spectrum of health care settings (including sources of alternative and complementary medicine) and those used for multiple conditions, or innovative approaches to health care delivery to improve outcomes. 2. Assessment of the impact of diagnostic and other health care technologies on cost and patient outcomes, and how to prioritize such assessments. 3. Development and testing of practical, ready-to-use outcomes measures addressing functional status, quality of life, and severity and risk adjustment, as well as general measurement issues, and strategies for improving outcome measures for patients with multiple comorbid conditions, including incorporation of an individual patient"s values and preferences. In particular, increased use of patient- reported outcome measures as dependent variables in clinical trials offers new opportunities for ancillary studies that can enhance our understanding of the characteristics and use of these measures. 4. Development and evaluation of strategies for informed decision- making, including evaluation of alternative strategies for implementing an infrastructure for collection, analysis and presentation of data, and real-time incorporation of outcomes and evidence into decision- making for patients, providers, and policy-makers. 5. Development and evaluation of strategies for the use of outcome measures including patient-oriented measures in practice (e.g., shared decisionmaking), or development, validation and use of measures that incorporate patient values and preferences. 6. The relationship between processes and outcomes of care, including timing of services. 7. Evaluation of, and development of measures for outcomes, effectiveness, and cost effectiveness of clinical preventive services for all ages. 8. Analysis of the causes of variations in clinical practice and the use of health care technologies, including the clinical behaviors of primary care and specialty providers, provider training, patient characteristics and preferences, or other factors. 9. Observational studies using Medicare, Medicaid, or managed care data to answer discrete questions related to the outcomes, effectiveness, cost, cost-effectiveness or quality of medical care. 10. The impact of models of undergraduate, graduate, and continuing education on the knowledge, skills, and attitudes of providers and associated patient outcomes. 11. Therapeutic outcomes, including: a. Relative safety, effectiveness, and cost effectiveness of available pharmaceuticals or combinations of therapies, as well as comparison to other treatment options. b. Relationships among prescribing decisions, pharmaceutical services, use of prescription drugs, and patient outcomes. Methodological approaches may include quasi-experimental studies using existing data or experimental studies. o Improving Quality and Patient Safety The Agency encourages research to improve the capacity of the health care system to deliver quality care and protect patients from medical errors. There is increasing emphasis on understanding how to measure quality and prevent errors across the full spectrum of care, in various settings and in transition across settings, and for different population groups. Key to this understanding is the ability to describe the influence of organizational as well as clinical factors on levels of quality and occurrence of errors. Of special interest are efforts to develop and test interventions to improve quality and patient safety in these varying contexts, especially where evidence can be presented that the interventions have widespread applicability. A. Quality Measurement and Improvement. Interests include: 1. Innovative approaches to measuring quality, including the perspectives of providers, patients, and consumers. 2. Methods to identify, understand the causes of, and prevent medical errors and improve patient safety. 3. Adaptation of existing measures as well as development and validation of new measures for use with diseases, conditions, and procedures and in settings where gaps in knowledge exist, including the impact of comorbidities on measurement of quality of end- of-life care. 4. General quality measurement methods, including risk and severity adjustment, and methods for measuring functional status and quality of life. 5. Evaluation of the kinds of quality improvement systems that promote systemic and sustainable changes in clinical practice to improve the quality of care. 6. Evaluation of the appropriateness of different data sources for quality measurement, and development and evaluation of methods for using data to improve quality of care. 7. Description and testing of the effects of (1) computerized decision-support systems, (2) integrated information systems, (3) electronic medical records, (4) Internet-based information and consultation for use by patients, and (5) other information technology applications on improving quality of care. 8. Development and validation of methods for changing the behavior of clinicians, provider institutions, employers, plans, and patients to improve quality of care and patient safety. 9. Evaluation of strategies for integrating quality measurement and improvement and patient safety into office-based, worksite-based, and primary care settings, as well as acute and long-term care settings. 10. Formulation of strategies for improving the delivery of clinical preventive services (CPS), including research on quality measurement for CPS and on system changes in primary care that enhance the access to and quality of CPS. 11. Studies of the impact of public policy and other system changes, and organizational and financial arrangements, on health care quality at the national, State, and subpopulation levels. 12. Development and evaluation of typologies and measurement techniques that allow study of the effects of organizational and communication strategies on quality improvement. 13. Research on patient and consumer issues. AHRQ is particularly interested in: (1) the perceptions of care of priority populations, including those cognitively impaired, institutionalized or living with complex care decisions such as people with chronic illness or disability, including HIV/AIDS, (2) innovative ways to present information on quality to patients and consumers that increase salience, usefulness and use, and (3) strategies to assist patient and consumer communication with health professionals and participation in health care decisionmaking. B. Evidence-based Practice. Integral to improving quality of care is the development, use, and evaluation of evidence-based tools and information. Interests include: 1. Methods for optimal systematic reviews of evidence, including methodologic research on meta-analysis, decision analysis, and cost-effectiveness analysis. 2. Evaluation and comparison of different methods to implement evidence-based information and tools in diverse health care settings and/or among practitioners or various populations, including: a. Assessment of the role of organizational structure, capacity, and culture in effective use of the tools. b. Effectiveness of different types of evidence-based information and specific tools in changing behavior of practitioners, patients, and organizations. 3. Evaluation of the effects of specific evidence-based guidelines or other tools on access, utilization, quality, outcomes, costs, and/or patient satisfaction. 4. Studies of the cost effectiveness/cost benefit of important new or existing health care technologies. 5. Assessment of the extent to which evidence-based information is used in determinations of medical necessity and coverage decisions. 6. The role of informatics in dissemination of evidence-based information, and its impact on patient and clinician behavior. 7. The role of evidence-based information in the development of informatics tools and information sources, the impact of evidence-based decision making and increasing role of just-in-time information systems, and how evidence is incorporated into these systems. C. Clinical Preventive Services. Interests include: 1. Interventions to address specific patient barriers to preventive care, with specific focus on vulnerable populations, including older women, who may receive fewer or lower quality services. 2. Interventions to improve quality of screening services, including reducing false-positive and false-negative rates, improving follow-up procedures, and improving patient satisfaction. 3. Improving cost-effectiveness of preventive care through interventions to reduce overuse of services, target interventions more effectively to high-risk groups, or reduce adverse effects and costs of screening (including costs and consequences of followup in persons with positive screening results). 4. Identifying elements of preventive counseling interventions that have greatest impact on behavior change, developing more comprehensive quality measures for counseling services and other preventive care that extend beyond utilization rates. 5. Interventions to improve patient involvement in preventive care and to improve communication between clinicians and patients around screening results. o Identifying Strategies to Improve Access, Foster Appropriate Use, and Reduce Unnecessary Expenditures Research is needed on the impact of system changes on access to, cost, and use of health care services. Research is also needed to examine expenditures, cost and financing, and organizational arrangements, and to assess the effects of these interrelated factors on the delivery of health care, including preventive services, that is accessible and equitable, and that demonstrates high quality. A. Access, Costs, and Use of Health Services. Interests include: 1. Studies that use MEPS and other AHRQ data sources to assess the cost and utilization of health resources (See "AHRQ Data"). 2. Impact of the trends in health care prices, costs, and sources of payment for services on access, expenditures, and outcomes. 3. Development of new and more effective ways to measure the range of health care costs and to organize and analyze data on costs by clinical condition, sociodemographic factors, site of care, and payment sources. 4. Studies assessing the impact of different outreach and social marketing strategies to increase enrollment in public insurance (e.g., Medicaid, SCHIP) among persons eligible for coverage. 5. Assessment of the determinants of access to care and strategies to improve access, especially for underserved populations. 6. The development and use of policy-relevant models to simulate and understand behavior governing the use, cost, financing, and organization of care. B. Organization, Financing, and Delivery. Interests include studies of major changes in health care markets and studies examining how variations in health care organization, structure, and delivery affect the outcomes, quality, access to, cost, and use of care, such as: 1. New purchasing activities by employers, coalitions, and governments, and their impact on managed care organizations, providers, employees, and communities. 2. The aggregate impact of major changes in public programs and health care markets on health care costs and quality, including the impact on providers and beneficiaries. 3. Dynamics and impact of recent major changes in financial and legal arrangements such as consolidations, conversions to for-profit status, development of national ownership links among facilities, new relationships among acute, subacute, and long-term care facilities, and new methods of sharing financial risk and contracting for services on quality, cost, access, and use of services. 4. The impact of the movement of care from inpatient to outpatient settings, and from nursing homes to home care on cost and outcomes. 5. The effects of disease management and "carve-in" and "carve-out" arrangements on health care costs, accessibility, and quality of care, particularly for persons with chronic conditions. 6. Conceptual models, measures, and financial and organizational factors supporting clinical integration of health care services and studies of the impact of clinical integration on access, quality, and cost of care. 7. The implementation and use of new staffing and other clinic-level configurations, and evaluations of the effectiveness of particular models in improving access, quality, and cost of care. 8. The use of information technology applications in providing and supporting the delivery of health care and their effects on cost, quality, and access. 9. The role of nonfinancial incentives and organizational characteristics, such as organizational structure and culture, in affecting the behavior of health care organizations and units and individuals within them. 10. Evolving definitions of medical necessity used by managed care organizations to determine when and under what circumstances services will be covered, and the impact of different methods and processes for medical decisionmaking by health plans. Methods can include rigorous qualitative studies as well as quantitative research, and conceptual and methodological as well as empirical work. Research partnerships using private sector data sources, such as managed care data, are particularly encouraged. C. Primary Care Practice. The characteristics of primary care practice play a crucial role in facilitating access to and use of services, influencing health costs, and the resulting outcomes and levels of quality. Interests include: 1. Characteristics of primary care practice that lead to improvements in outcomes and quality of care. 2. Effective models of organizing, financing, and managing primary care services. 3. Factors that influence access to primary care services, including socioeconomic, cultural, and geographic factors. 4. Optimal delivery of health care, including primary care services, in low-income inner- city and rural areas. 5. Access to and availability of clinical preventive services. 6. Effects of information technology applications in primary care practice, such as computerized decision-support systems, remote monitoring of patient conditions, and electronically secure exchange of patient health data, on access to care and the costs and quality of health care. 7. Clinical decision-making in primary care, including an emphasis on facilitating shared patient-clinician decision-making. 8. Strategies for integrating quality measurement and improvement into office-based, worksite-based, and primary care settings. 9. Strategies for reducing medical errors and improving patient safety in office-based, worksite-based, and primary care settings. 10. Strategies for facilitating the integration of research findings into office-based, worksite-based, and community primary care practices. 11. Improving the quality, value, and access to health care for American workers and individuals with disabilities. 12. Effective strategies in primary care settings for eliminating racial and ethnic disparities in health-related outcomes. 13. Issues related to the outcomes, costs, and delivery of primary care services to the elderly. 14. Improved care for those at the end of life. 15. Organizational and other factors affecting the cost and quality of transitions between ambulatory and other settings, including home, hospital, and long-term care settings. 16. Health care workforce organization, including communication and coordination of services among primary care clinicians and other members of the health care team. 17. The readiness of the health care system, in particular its entry points such as emergency rooms and primary care, to recognize and respond to the effects of exposure to agents of biological or chemical terrorism. To enhance generalizable results, primary care research may involve large data bases or primary care practice-based research networks. PRIORITY POPULATIONS A number of populations are particularly vulnerable to impaired access to and suboptimal quality of care and experience poor health care outcomes. These groups, which warrant a special focus for health services research, include low-income groups, racial and ethnic minority groups, women, children, the elderly, individuals with special health care needs, including individuals with disabilities and those who need chronic care and end-of-life health care, and individuals living in inner-city, rural, and frontier areas. Persistent disparities in health status and access to appropriate health care services continue to be documented for certain groups, particularly racial and ethnic minority populations. Gender-based differences in access, quality, and outcomes are also widespread with little understanding of the reasons for these differences. Health services research must do a better job of bringing science-based information to bear on these variations so that effective solutions may be found for improving health. AHRQ encourages research to address population-specific health issues of outcomes, quality, access to, cost, and use of services in each of the Priority Program Areas. Interests include: Minority Populations 1. Understanding factors that underlie disparities in utilization and outcomes for racial and ethnic minorities including epidemiology, patient preferences and behavior, education, access, health insurance, environment, interactions with the health care system, provider expertise, preferences, and bias. 2. Evaluation of effective service delivery methods for eliminating disparities in treatment between minority and non-minority populations. 3. Effect of cultural competence on improving access to and outcomes of care for racial and ethnic minority patients. 4. Eliminating 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 (President’s Initiative to Eliminate Racial and Ethnic Disparities in Health). 5. Enhancing meaningful community participation in health services research projects. Women 1. Assessment of the effectiveness of services and treatment approaches for common, high-cost conditions in women in various age, racial/ethnic, and income groups. Research to understand and eliminate inappropriate disparities in health outcomes associated with race or ethnicity, geography, insurance status, or other non-medical factors is particularly needed. 2. Analysis of the cost, use of, and access to primary and specialty health care services among women, including the impact of changes in health systems on women’s health. 3. Development and assessment of women-specific and culturally- appropriate measures of quality, outcomes, and patient satisfaction. 4. Study of health issues related to older women, including the impact of specific clinical and organizational interventions on functional status and quality of life, with special attention given to mediating factors such as co-morbidity, fragmentation of care, and caregiver stress. 5. Research on prevention and health services with relevance to particular populations of women, including victims of family violence, lesbian women, and women with HIV/AIDS. 6. Research on women and pharmaceuticals, including gender differences in therapeutic outcomes, prescribing practices, occurrence of adverse events, and medical errors. Children Dramatic changes are occurring in the organization and financing of children"s health services, however, the knowledge base for guiding these changes or assessing their impact is not well developed. Researchers are strongly encouraged to include children in all applications and studies, as scientifically and ethically appropriate. Children"s health care research raises some distinct methodological issues that studies are encouraged to address. These include: the need for a development perspective that takes into account the variation and rapid changes in development that are characteristic of children, especially in the neonatal, infancy, early childhood, and adolescent periods, the need for considering a range of perspectives (e.g., child, family, community, society at large), the fact that children generally are much more resilient physically than are older individuals, the need to identify large sample sizes for research with children with specific conditions and/or specific developmental stages, the need to consider the child-relevant range of health care topics (e.g., preventive services through end of life care) and health care settings (including community health clinics, school and other community-based health care delivery sites, ancillary services, as well as health care settings such as community-based offices and hospital inpatient and emergency departments), the fact that many children live in poverty, the need to consider in more detail long-term outcomes and the need for longitudinal research, and ethical issues surrounding the delivery of health care to children (e.g., to adolescents). Applications with innovative and efficient research designs that can address these child-relevant issues are encouraged. Specific research interests include: 1. The urgent need for outcomes and effectiveness research in many areas of children’s health care is well documented. Specific areas of interest in outcomes and effectiveness research include: 1) developing valid and useful measures of health, functional status, quality of life, satisfaction with care, processes of care, and costs and cost- effectiveness of care applicable to children of different ages and with different health conditions, 2) assessing interventions that are unique to children, and that may involve the children’s caregivers (e.g., health promotion and disease and disability prevention services such as anticipatory guidance and counseling), 3) assessing treatments that are commonly administered to children but that may have been evaluated for safety and effectiveness only in adult populations, 4) documenting long-term effects (or lack thereof) associated with health interventions in populations of mothers, infants, and children, and 5) evaluating costs, benefits, and cost-effectiveness of care to children. 2. The development of quality measures for children that can be used to enhance accountability, support consumer choice, and develop, test, and implement quality improvement strategies in children"s health care. 3. Evidence-based research translation and quality improvement strategies are needed to form the basis of efforts to improve practice at the policy, health systems, and clinical practice levels. 4. The U.S. health care system provides the occasion for many "natural experiments" in organizational and financial arrangements for care. In addition to examining the effects of these variations and changes on children"s health outcomes (see above), there is a need to continue to carefully examine their impact on quality, cost, use, and access. 5. Local, federal, and private efforts to increase children"s enrollment in Medicaid and the State Child Health Insurance Program (Titles XIX and XXI of the Social Security Act, respectively) can be enhanced by providing an evidence base for effective strategies. There is a critical need for rigorous research on what works in outreach and other strategies. 6. AHRQ encourages researchers to address the needs of children living in inner-city, rural, and frontier areas, low-income children, minority children, female children, and children with special health care needs. 7. AHRQ encourages researchers to include adolescents and the health care settings that are used by adolescents in research about children and children"s health care. Additional guidance on AHRQ"s previous activities and current interests in children as a priority population can be found in AHRQ"s 1999 GPRA report on children as a priority population (http://www.ahrq.gov/about/gpra2001/gpra01app6.htm) and in AHRQ"s strategic plan for children as a priority population (http://www.ahrq.gov/about/stratpln.htm). Elderly Providing health care to the aging U.S. population is one of the most pressing health care challenges confronting the nation. Although the scientific knowledge base exists to extend the years of active life and prevent the onset of disability with age, current clinical practice falls far short in delivering these interventions to older people. The underuse of effective interventions, the overuse of interventions shown to be ineffective, and the misuse of others (especially polypharmacy) have all been well documented in the elderly. There is a need for studies that focus on interventions aimed at reducing well-documented disparities in health status, access, use of services, and health outcomes by gender, race/ethnicity, and socioeconomic status among the elderly. Interests include: 1. Developing cost-effective models of acute, preventive, chronic, rehabilitative, and long-term care delivery (including informal care) that improve the health and functioning of the elderly. 2. Assessing the outcomes and effectiveness of clinical, organizational, and social interventions that improve or delay decline of functional status. 3. Improving our ability to measure change in functioning across the broad range of functional levels for a diverse aging population and developing strategies to incorporate these functional status measures routinely in clinical practice. 4. Understanding the impact of comorbidities (physical and mental) on disease management, clinical decisionmaking, preventive care, and health and functional outcomes, and how best to adjust clinical practice to account for them. 5. Assessing models of collaborative care so that patients and their families can be active participants in the decision making process and age bias in clinical decision makings is minimized. 6. Understanding how best to integrate preventive, acute, chronic, and long-term care (formal and informal care), and to coordinate the delivery of care across multiple sites and settings of care, including out-patient, hospital, rehabilitation, subacute care, home care, long- term care (institutional and community care), and community-based social services. 7. Understanding the impact of financial incentives ( including health-based payments) on health care decisions and their subsequent effect on the health and outcomes of elderly. End-of-Life Health Care Further research is needed on how to provide appropriate health services for patients living with fatal or serious chronic illness (such as cancer, stroke, dementia, congestive heart failure, lung failure). While increased life span may be desirable, the goals of medical interventions for these patients also include a greater focus on preventing excess disability and assuring symptom reduction (e.g., pain and dyspnea control) or palliative care. Specific research interests include: 1. Optimal processes for advance care planning. 2. Methods of maximizing connectivity and continuity between different providers and systems of health care (e.g., nursing home, hospice, home care, acute care, ambulatory care). 3. Evaluation of the comparative costs and quality of care at different sites of end-of-life care. 4. Methods of using severity data to identify those patients in need of more extensive services. 5. Studies of ways to expand access to appropriate sites of end-of- life care (e.g., hospice, home or community-based). 6. Research on the financial and social burden of family caregivers. 7. Development of methods to improve joint patient/family/provider decision-making at the end of life. Research priorities are being developed for the additional populations listed including: individuals living in inner-city, rural, and frontier areas, individuals with special health care needs, individuals with disabilities, and low-income groups. EMERGING RESEARCH INTERESTS Two additional areas of health services research that have become increasingly important in today"s rapidly changing market-driven delivery system are research on methodologic advances, especially cost-effectiveness analysis (CEA) and research on ethical issues, which may be related to decisions based on cost effectiveness, but which also cut across the spectrum of health care delivery. Interests include: A. Cost-Effectiveness Analysis (CEA) and Other Methodological Advances that will enhance the capacity of health services research to provide needed information. Interests include: 1. Production of standardized analytical components (e.g., cost components, general population health profiling, national health utility index, and incidence-based illness burdens) to facilitate the comparability of CEA findings. 2. Exploration of the use of CEA as a framework for guiding decisions, both clinical and organizational. 3. Systematic reviews, meta-analyses, and other methods that enhance the generalizability of clinical and other research for application to practice. B. Ethical Issues raised by changes in the health care delivery system that need to be addressed. Interests include: 1. Studies on ethical issues across the spectrum of health care delivery, including equity in access to all levels of care. 2. Studies on the impact of genomics on the organization and delivery of health services. 3. Studies on changing values regarding the provision of care, from the provision of all possible care without cost considerations, to the provision of less costly care. 4. Studies to emphasize and clarify tradeoffs related to resource allocation and the tension between individual and population or societal needs. SPECIAL REQUIREMENTS AHRQ Data To the extent feasible, AHRQ applicants are encouraged to submit projects that build on available data, will generate early results, and are modest in time, scale, and cost. AHRQ encourages research applications that will use data from the Medical Expenditure Panel Survey (MEPS), the Healthcare Cost and Utilization Project (HCUP), and other AHRQ data. The MEPS is a rich data source for health care utilization, expenditure, and insurance information, directly linking data about persons and their families with information obtained from their employers, insurers, and health care providers. It is the third in a series of nationally representative surveys of medical care use and expenditures in the U.S. The 1996 MEPS updates previous survey data to reflect the changes that have occurred over the past decade. MEPS collects data on the specific health services that Americans use, how frequently they use them, the cost and source of payment for services, and information on the types and costs of private health insurance held by and available to the U.S. population. It provides a foundation for estimating the impact of changes in sources of payment and insurance coverage on different economic groups or special populations of interest, such as the poor, elderly, uninsured, and racial and ethnic minorities. Some data from the Household and Nursing Home Components of the 1996 MEPS became available for use by researchers beginning Spring 1997. The release schedule for other data through calendar year 1998 is available from the MEPS section under Data of the AHRQ Web site (http://www.ahrq.gov). The HCUP includes databases covering 1988-1997, with 1998 and 1999 data available in 2001. These all-payer databases were created through a Federal-state-industry partnership to build a multistate health care data system. The main HCUP databases contain discharge-level information for inpatient hospital stays in a uniform format with privacy protections. The Nationwide Inpatient Sample (NIS) is a nationwide probability sample of about 1000 hospitals. The State Inpatient Databases (SID) contain inpatient records for all community hospitals in 22 states. Other HCUP databases contain ambulatory surgery data from nine states. These databases can be directly linked to county-level data from the Health Resources and Services Administration"s Area Resource File and to hospital-level data from the Annual Survey of the American Hospital Association. Information on MEPS and HCUP is available from the Data section of the AHRQ Web site http://www.ahrq.gov and AHRQ staff (See INQUIRIES). CONDITIONS OF AWARD Data Privacy Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c-3(c)), information obtained in the course of any AHRQ-study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the possible uses and purposes of the data collection. In the Human Subjects section of the application, applicants must describe 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 restricted and 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://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf. The application of these confidentiality and security standards to subcontractors and vendors should be addressed as necessary. Rights in Data AHRQ 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 AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making research materials, data bases, results, and algorithms available for verification or replication by other researchers, and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer- reviewed journals and to market grant-supported products. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ’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 AHRQ that women and members of minority groups be included in all AHRQ-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, AHRQ requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ also encourages investigators to consider including children in study populations, as appropriate. AHRQ 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 AHRQ Website http://www.AHRQ.gov (Funding Opportunities) and InstantFAX (see instructions under INQUIRIES). AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Applications will be accepted at the standard application deadlines as indicated in the form PHS 398. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Applicants are encourage to read all form PHS 398 instructions prior to preparing an application in response to this PA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. AHRQ is not using the Modular Grant Application and Award process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award process, and prepare applications according to instructions provided in form PHS 398 (revised 4/98). Application 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: grantsInfo@nih.gov. AHRQ applicants are encouraged to obtain application materials from the AHRQ Publications Clearinghouse (see INQUIRIES). The PA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Complete and signed, typewritten original of the application, including the Checklist and five legible signed photocopies, must be submitted in one packet 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) Application Preparation 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 HCFA, AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made. 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 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. In carrying out its stewardship of human resource related programs, the AHRQ, at some point in the future, may begin requesting information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of sponsored research. AHRQ expects grant recipients to keep the Agency informed of publications or the impact from Agency sponsored research. REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with AHRQ peer review procedures. As part of the initial merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have high scientific merit will be discussed and assigned a priority score. General Review Criteria Review criteria for grant applications are: consistency with the Agency’s mission and research priorities, significance and originality from a scientific or technical viewpoint, adequacy of the method(s), availability of data or adequacy of the proposed plan to collect data required for the project, adequacy and appropriateness of the plan for organizing and carrying out the project, qualifications and experience of the Principal Investigator and proposed staff, reasonableness of the proposed budget and the time frame for the project in relation to the work proposed, adequacy of the facilities and resources available to the applicant, the extent to which women, minorities, and if applicable children, are adequately represented in study populations, and as applicable, the adequacy of the proposed means for protecting human subjects. AWARD CRITERIA Applications will compete for available funds with other investigator-initiated applications requesting AHRQ support. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, how well it fits AHRQ priorities, program balance, and availability of funds. INQUIRIES Copies of this PA and copies of the grant application form PHS 398 (rev. 4/98) are available from: AHRQ Publications Clearinghouse P.O. Box 8547 Silver Spring, MD 20907-8547 Telephone: 1-800-358-9295 TDD Service: 888-586-6340 The PA is also available on AHRQ’s Web site, http://www.AHRQ.gov, and through AHRQ 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 PA number). The PA will be sent at the end of the ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a week. For comments or problems concerning AHRQ InstantFax, please call (301) 594-6344. AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the PA. Written and telephone inquiries concerning this PA are encouraged. Direct inquiries regarding program matters to the contacts listed below by specific program areas: Improving Health Outcomes Carolyn Clancy, M.D. Director Center for Outcomes and Effectiveness Research Telephone: 301/594-1485 E-mail: cclancy@AHRQ.gov Quality of Care Gregg Meyer, M.D. Director, Center for Quality Measurement and Improvement Telephone: 301/594-6672 E-mail: gmeyer@AHRQ.gov Evidence-based Practice and Technology Assessment Douglas B. Kamerow, M.D. Director Center for Practice and Technology Assessment Telephone: 301/594-4026 E-mail: dkamerow@AHRQ.gov Primary Care Helen Burstin, M.D. Director Center for Primary Care Research Telephone: 301/594-1357 E-mail: hburstin@AHRQ.gov Cost and Financing Steven B. Cohen, Ph.D. Acting Director Center for Cost and Financing Studies Telephone: 301/594-6171 E-mail: scohen@AHRQ.gov Organization, Delivery, and Markets Irene Fraser, Ph.D. Director Center for Organization and Delivery Studies Telephone: 301/594-6824 E-mail: ifraser@AHRQ.gov Minority Health Francis D. Chesley, M.D. Director, Office of Research Review, Education, and Policy Telephone: 301/594-6410 E-mail: fchesley@ahrq.gov Women’s Health Marcy Gross, Women"s Health Coordinator Telephone: 301/594-2429 E-mail: mgross@AHRQ.gov Children’s Health Denise Dougherty, Ph.D., Child Health Coordinator Telephone: 301/594-2051 E-mail: ddougher@AHRQ.gov Clinical Preventive Services David Atkins, M.D. Medical Officer Center for Practice and Technology Assessment Telephone: 301/594-4016 E-mail: datkins@AHRQ.gov Cost-effectiveness Analysis and Other Methodological Advances Joanna Siegel, Sc.D.,R.N. Center for Outcomes and Effectiveness Research Telephone: 301/594-0667 AHRQ Data Sources: MEPS Household Component Nancy Krauss Center for Cost and Financing Studies Telephone: 301/594-0846 E-mail: nkrauss@AHRQ.gov MEPS Nursing Home Component Jeffrey Rhoades Center for Cost and Financing Studies Telephone: 301/594-0891 E-mail: jrhoades@AHRQ.gov HCUP-3 Kelly Carper Telephone: 301/594-3075 E-mail: kcarper@AHRQ.gov or hcupnis@AHRQ.gov or hcupsid@AHRQ.gov Direct inquiries regarding fiscal matters to: Mable L. Lam Director, Division of Grants Management Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20852 Telephone: 301/427-1448 Fax: 301/427-1462 E-mail: mlam@AHRQ.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Number 93.226. Awards are made under authorization of Title IX of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-129 (1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 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.

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