and Human Services (HHS)
EXPIRED
This Program Announcement expires on July 24, 2004, unless reissued. (see Erratum in NOT-HS-02-006) PATIENT-CENTERED CARE: CUSTOMIZING CARE TO MEET PATIENTS NEEDS Release Date: July 31, 2001 PA NUMBER: PA-01-124 (This PA has been deactivated, see NOT-HS-05-009) Agency for Healthcare Research and Quality National Institute of Mental Health PURPOSE The mission of the Agency for Healthcare Research and Quality (AHRQ) is to support and conduct research that improves the outcomes, quality, access to, and cost and utilization of health care services. 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 payment and organizational changes on outcomes, quality, access, cost, and use of health care services. In doing so, AHRQ seeks to identify and respond to the information needs of consumers, patients, clinicians and other providers, institutions, plans, purchasers, and Federal and State policy-makers, and to provide them the information they need to make evidence-based decisions. The National Institute of Mental Health (NIMH) is also co-sponsoring this Program Announcement (PA). One critical set of issues facing public and private policy-makers concerns the challenge of redesigning processes of care to enhance delivery of patient-centered care. For the purposes of this PA, patient-centered care is defined as health care that establishes a partnership among practitioners, patients and their families (when appropriate) to ensure that decisions respect patients wants, needs and preferences and solicit patients input on the education and support they need to make decisions and participate in their own care. (See Ref.# 1) A recent report from the Institute of Medicine (IOM), Crossing the Quality Chasm, noting a quality chasm between the health care we have and the health care we could have, points out that this gap is attributable in part to the fact that too often patients must adapt to the customs and usual procedures of health care organizations and professionals, rather than receiving services designed to focus on individual’s needs and preferences. (See Ref.# 2) Prior research has demonstrated that patients who are active participants in their care experience better outcomes than those who are not similarly engaged, yet promising approaches to engage individuals as co-managers of their health and health care have not been broadly applied. (See Ref. # 3) In addition, growing use of information and communications technologies could be used to respond to the IOM’s recommendation that the organizing concept of patient care be expanded from the interactions that occur within the boundaries of a clinical encounter. Thus, essential dimensions of patient-centered care include but are not limited to customized information, communication, and education, coordination and integration of care across conditions and settings, and over time, shared decision-making of clinicians with patients and families, self-efficacy and self-management skills for patients, patient’s experience of care, effective provider-patient partnership, and enhanced cultural competence of health care providers. The intent of the PA is to support redesign and evaluation of new care processes that lead to greater patient empowerment, improved patient-provider interaction, easier navigation through healthcare systems, and improved access, quality, and outcomes. Specific strategies could include, but are not limited to, electronic clinical communication, self-management programs, web-based applications for patients and/or health care providers, and shared decision-making programs. Researchers are encouraged to propose projects that emphasize chronic illness, episodes of care that extend beyond hospitalization, longitudinal care, and priority populations (e.g., inner- city areas, rural areas, including frontier areas, low-income groups, minority groups, women, children, the elderly, and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care). Further explorations of patient-centered care models among minority populations are especially encouraged. Development and evaluation of new approaches to promote patient- centered care as well as projects that expand and evaluate the use of programs previously found to be promising in select settings and circumstances are both encouraged under this PA. 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 Health People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign, public or private not- for-profit organizations, including universities, clinics, units of State and local governments, and eligible agencies of the Federal government. AHRQ, by statute, can make grants only to not-for-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. AHRQ encourages investigators who are women, members of minority groups and persons with disabilities to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support for this PA will be the research project grant (RO1). Responsibility for planning, direction and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years. Some of the topics or development of projects may be more suitable for a small project grant (projects requesting total costs of $100,000 or less) (R03). Applicants are encouraged to apply under the procedures outlined in the AHRQ Small Research Grant Program PA, published in the NIH Guide for Grants and Contracts (NIH Guide) January 2, 2001. 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). RESEARCH OBJECTIVES Background Patient-centeredness is a characteristic of the relationship between the clinician and the patient. In contrast to care that is clinician-centered or disease-focused, patient-centered care customizes treatment recommendations and decision making in response to an individual patient’s preferences and beliefs. Within the report, Crossing the Quality Chasm: and in the report recommending a framework for the National Health Care Quality Report, the IOM has included patient-centeredness as an essential component of quality care. (See Ref.#s 1&2) In this context, patient-centeredness includes both the patient’s experience of care and the presence of an effective partnership between clinician and patient (and the patient’s family, when appropriate). Recent efforts to assess the patient’s experience of care, including the Consumer Assessment of Health Plans Survey (CAHPS), now used by consumers to choose plans and by health care organizations to identify opportunities for improvement, have begun to identify important dimensions of patient-centered care. However, efforts to identify which factors promote more effective clinician-patient partnerships have received less attention. An effective clinician-patient partnership should be the product of a relationship in which the clinician’s recommendations are informed by an understanding of the individual patient’s needs and the context in which he or she lives (e.g., home life, job, family relationships) to enhance the patient’s ability to act on the information provided. Additional features of an effective clinician-patient partnership include informed, shared decision making and development of patient knowledge and skills needed for self- management of chronic illness, including mental illlness. Patients vary in the degree of autonomy and involvement with health care decision making desired, some want a high degree of involvement while others prefer to rely completely on a clinician’s recommendation. (See Ref. # 1) When a more patient-centered approach is preferred, there is limited information on the willingness or ability of providers to learn and adopt these changes into routine practice. Individuals of different races, cultures, genders and ages have different preferences and beliefs, and physicians have been found to vary in the extent to which they demonstrate a participatory decision making style. (See Ref.# 4) The degree of trust that patients have in clinicians, and ideally, the provision of culturally competent care are also essential components of patient-centered care. (See Ref. #s 4 & 5) Multiple studies have demonstrated that patients who are involved with their care decisions and management have better outcomes than those who are not. (See Ref. #s 6-9) Patient self-management, particularly for chronic conditions, has been shown to be associated with improvements in health status and decreased utilization of services. (See Ref. # 10) For example, one randomized controlled trial of a shared decision making program for benign prostatic hypertrophy showed that patients engaged in shared decision making reported significantly higher levels of satisfaction with their decisions than those who did not participate in the program. (See Ref. # 11) Despite recognition that patient-centeredness is increasingly recognized as an important professional evolution, (See Ref. # 12) and holds enormous promise for improving quality and outcomes of care for chronic illnesses, studies have demonstrated substantial opportunities for improvement. Assessments of audiotaped clinician-patient encounters have shown that the majority of interactions do not meet minimal criteria for informed decision making, (See Ref. # 13) and use of innovative approaches to engage patients in their care, particular patients with one or more chronic illnesses, have not yet become a routine part of clinical care. (See Ref. # 14) There is also an important role for patient-centeredness in the timely use of appropriate preventive services. As patients become more involved in their own prevention needs, with a greater emphasis on personal responsibility, they can advocate for their primary and secondary prevention needs. Objectives and Scope of Activity To improve the delivery of patient-centered care as an essential component of high quality care, AHRQ seeks to support research in four areas related to patient-centered care, including: (1) innovative approaches to care, (2) improved chronic illness care, (3) shared decision making and (4) patient- clinician communication. 1) Innovative Approaches to Care: The IOM’s Crossing the Quality Chasm report indicates that the health care delivery system is organized around the usual customs of clinicians and the dictates of payment mechanisms, resulting in care that is fragmented and inefficient from the perspective of individual patients. In addition, the content of care is primarily defined as the reimbursable exchange that occurs within the context of a clinical encounter (outpatient visit, hospitalization) in a specified setting rather than the response of clinicians to patients needs that occurs over time and across settings. Advances in information and communication technologies now offer new opportunities for rethinking and evaluating new opportunities for maximizing effective clinician-patient exchange to achieve patient-centered care. Reports of innovative efforts to re-engineer processes of care have focused on the use of web-based technologies for communication and inter-visit follow-up, micro-systems of care focused on patients needs, and enhanced coordination of care across settings and providers. While these innovative strategies have face validity, there is very little systematic, peer-reviewed research that documents how, when and under what circumstances they affect patients and families experiences of participation in their care. There is also interest in innovative arrangements that result in seamless care for patients and families. For example, patients with chronic conditions, such as diabetes mellitus or depression, may benefit from integrated delivery models that enhance communication and effectively integrate generalist and specialist care. There are also specialized models of care that explicitly place patients at the center of complex evaluation and treatment planning, such as cancer care or the evaluation of a breast lump. While there are some data that suggest improved patient perceptions of care, it is not clear that these arrangements impact on quality or outcomes of care. The role of clinician as navigator for patients through the health care system - across different settings and providers needs to be examined. AHRQ’s recently published PA, the Impact of Payment and Organization on Cost, Quality and Equity has identified payment mechanisms and organizational factors that facilitate or impede such efforts as a high priority area of research. This PA focuses on research that results in enhanced understanding of the content of such innovations and how their adoption affects the delivery of care from the patient’s perspective and its impact on patients participation in their care. Specifying how the impact of these efforts can be assessed is an essential component of the research encouraged by this PA. For example, coordination of care from the patient’s perspective has been challenging to measure reliably. In addition, studies of innovative approaches to patient care should include assessment of the extent to which such innovations are adopted and modified throughout the adoption phase. Illustrative questions might address: o For which patients, and which conditions, are innovative strategies, such as group visits and enhanced electronic communication, most helpful? o How and which components of practice re-engineering result in improved coordination and integration of care? What is the impact of practice redesign on patients experience of and participation in care? o What is the result of these innovative approaches on patient outcomes and quality of care? o How can patients perceptions be effectively incorporated in efforts to redesign the processes of care? 2) Chronic Illness Management: Numerous reports confirm that the burden of illness attributable to chronic illness is growing, in part due to the successes of acute medical care, and that improved management of chronic illness represents one of the most pressing challenges confronting health care in the 21st century. Studies demonstrating the importance of modifying health behaviors (e.g., smoking, exercise, diet) and application of evidence-based practices to chronic illness management consistently find substantial opportunities for improvements in care. However, there is an emerging consensus that the role of patients (and families, as appropriate) as co-managers of their health and health care has been under-estimated and under valued as a critical component of improvement efforts. Lorrig and others have shown that patients who participate in self-management programs for chronic illness experience measurable increases in health status compared with patients who do not participate, they also report greater confidence in their ability to manage their illness(es) and decreased utilization of clinician visits. (See Ref. # 7) The Chronic Care Model developed by Ed Wagner and colleagues similarly emphasizes the importance of activated patients in achieving substantial improvements in care. The promising findings demonstrated by these and other studies, however, have not been broadly replicated, raising questions about their generalizability and substainability. In addition, it is not clear to what extent selected components of these programs have been successfully integrated with other components of clinical care. The challenges offered by the need to improve chronic illness care have stimulated multiple programs in Disease Management that attempt to integrate multiple dimensions of chronic illness care in a single program organized around a single disease condition, many report including components that are consistent with a patient-centered approach to care, as defined for this PA. Since there are few peer-reviewed evaluations of these programs, it is not known to what extent the components of these programs that emphasize patient participation are effective, and for which patients. (See Ref. # 15) Moreover, since many individuals have more than one chronic condition, a critical question is which patients are most likely to benefit from and be engaged by disease-specific programs as compared with broader efforts that focus on multiple chronic conditions. Given the high prevalence of mental illnesses, it is particularly important to consider the role of disease management programs in the context of co-existing mental illness. Enhanced understanding of this issue is particularly relevant to the nation’s growing elderly population, for whom the experience of multiple chronic conditions is especially high. Specific models that are effective for vulnerable populations at greatest risk for complications from chronic illness require further consideration. Illustrative questions include: o How can efforts to improve chronic illness management most effectively engage patients participation? o How is the implementation of efforts to enhance patients experience of and participation in their chronic illness care best assessed? o How can strategies to enhance patients involvement in chronic illness care be most effectively integrated with all parts of clinical care? o How can programs shown to be effective in select circumstances and populations be tailored to the special needs of persons who are members of racial or ethnic minority populations, those with low educational attainment and those with low literacy levels? o How can greater involvement of community-based organizations, such as faith-based and other community organizations, improve chronic disease management? o Which approach to chronic illness management disease-focused or patient-centered is most effective in promoting patient participation, and for which patients? o How can strategies to improve chronic illness care effectively engage all members of the health care team? 3) Shared Decision Making: An important force in contemporary medicine for the past thirty years is the recognition of the role that many patients want to play in decision making with clinicians. No longer does the public want or expect physicians to make decisions independent of patient involvement. Instead, physicians now recognize that to serve their patients best, they need to involve patients in the decision making process. For many clinical decisions, no one intervention is clearly associated with enhanced quality of life or survival, but there are tradeoffs among different types of outcomes, such as length of survival, pain relief or preservation of function. In other cases, interventions with substantial side effects offer modest but real survival benefits. In each instance, the patient"s perspective is essential to informed decision making, particularly to weigh the value or importance of the various possible outcomes of care. Shared decision making programs have been developed to assist clinicians and patients with clinical decisions involving two or more equally effective alternatives with different risks and benefits. In some instances, these programs have been shown to result in improved patient satisfaction with the decision making process. Proponents of such programs have also reported that patients may be more risk averse than their clinicians and that overall health care utilization may decrease. A report commissioned by AHRQ in 1995 indicated that the potential for this approach to influence the dynamics of clinician-patient decision making greatly exceeded available evidence of how and for which patients and decisions these programs are most effective. Recent efforts to include informed decision making for management of menopause as a dimension by which the performance of health plans is assessed suggest a clear need to understand how complex information can be most effectively communicated to patients facing decision alternatives associated with different risks and benefits. Moreover, proliferation of health-related information on the Internet and elsewhere implies that more individuals will be exposed to information of varying credibility and quality independent of their encounters with the clinicians. There are no rigorous evaluations of how increased information about health care treatments can be integrated into the patient-clinician decision process, which patients are most likely to benefit from shared decision making, or the mechanism by which these programs enhance patients experiences of or participation in their care. Illustrative questions include: o For which types of decisions can shared decision making programs be used most effectively and how can they be integrated with clinical care? Factors that predict clinicians propensity to support this approach are of particular interest. o How can complex information about risks and benefits of alternative treatments be most effectively communicated to patients (and families, where appropriate)? o How can patients preferences for treatments, particularly for mental illness, be incorporated into clinician-patient decision making? o How should information about risks and benefits be communicated and by whom? How does this vary for patients of different ethnic or racial backgrounds, education and literacy levels? o What is the mechanism by which shared decision making approaches work improved patient knowledge, enhanced self-efficacy, and/or other pathways? 4) Patient-Clinician Communication: Numerous studies confirm the importance of effective patient-clinician communication as well as the need for improvements in this arena. For example, (See Ref. # 5) Safran’s research assessing primary care performance has shown that patient’s trust in clinicians and their assessment of his or her clinical credibility are highly predictive of individuals willingness to attempt necessary lifestyle changes as well as their experiences of primary care. Other research has shown that physicians communication styles can facilitate participatory decision making, are associated with the probability of experiencing a malpractice claim, and are likely to be an important component of providing culturally competent care. Most research suggests that despite good intentions, there are ample opportunities for clinicians to improve their communication skills, though few studies have explicitly linked communication skills with care that is culturally and linguistically appropriate. Though often linked with communication, there are many unresolved issues within the domain of cultural competency that require further research. It is not yet known how new opportunities for exchange of information between patients and clinicians or health care organizations intersect with clinicians in-person communication skills to enhance patients experience or and participation in their care. In addition, few studies of patient-clinician communication have addressed the health system context in which these exchanges occur. With the digital age, it will be important to measure the willingness of patients and providers to use alternative, more dyssynchronous forms of communication, such as e-mail. As personal health information is increasingly available to patients, through mechanisms such as open access to electronic medical records, it will be important to assess the impact on patient-clinician communication. Illustrative questions include: o How does patient access to and use of web-based technologies and other modalities (e.g., Direct-to-Consumer advertising) for health information and education influence what they need from encounters with clinicians? o How can clinicians use web-based and hand-held technologies to promote patient involvement in their care? o For which patients is e-mail communication with clinicians most effective? How does use of e-mail substitute for and/or effect the content of encounters with clinicians? o How can these new modalities for information exchange be most effectively used to enhance patient participation in care by members of racial or ethnic minorities, those with low educational attainment or low literacy levels? o How can culturally competent communication be reliably assessed? Methods Individual projects may use a combination of rigorous qualitative and quantitative methods. Qualitative methods may be especially useful in studying complex multi-tiered organizations and can either be used alone to deepen understanding of how organizational characteristics are connected to the quality and efficiency of health services or to complement quantitative methods and thereby strengthen the research design. For a detailed discussion of the use of qualitative methods in health services research, see Health Services Research , 1999, Issue No. 5, Part II. Quantitative methods should be rigorous and use state-of-the-art methodologies. Projects using such methods should be grounded in appropriate theoretical frameworks. Hypotheses-testing projects should present competing hypotheses clearly. AHRQ encourages basic methodologic research, including methods and tool development as well as more applied research. For example, the development of new measurement tools to permit accurate and valid estimates of patient participation in care, new approaches for assessing and defining health care utilization and assessment of alternative strategies for evaluating the success of patient-centered care are encouraged, as are the development and application of conceptual frameworks that enhance our understanding of how efforts to promote patient-centered care are effective in enhancing patients experience of and participation in their care. 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 into practice or policy. AHRQ encourages investigators to consider evaluations of Federal- and state-level initiatives (e.g., demonstrations) intended to enhance patient-centered care. Investigators from primary care practice-based research networks are strongly encouraged to apply for funding related to patient-centered primary care. Investigators interested in large studies are urged to contact program staff. (See Inquiries) Specifically, proposed projects with direct costs exceeding $500,000 in any one year require permission from AHRQ program staff 2 months prior to submission of the application. For research designed to use existing data, AHRQ encourages the use of data from the Medical Expenditure Panel Survey (MEPS) and other AHRQ data. The MEPS is a rich data source for health care utilization, expenditure, insurance coverage and source of payment information, directly linking data about persons and their families with information obtained from their employers and health care providers. For the survey year 2000, MEPS administered CAHPS items well as health status (SF-12 and EQ-5D) and items measuring attitudes to health and health care to all sampled adults. A parent answered CAHPS and Living with Illness measures about each of their children. These data will be released during 2002. Researchers who wish to use non-public MEPS data, such as county-level data from the Health Resources and Services Administration’s Area Resource File should examine the requirements of the CCFS Data Center. Additional information on MEPS is available from the Data section of the AHRQ website http://www.ahrq.gov. In addition, AHRQ has identified, as a special focus of research, issues related to enhancing patient-centered care for the following priority populations: 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 care, and individuals living in inner-city, rural and frontier areas. Research focused on specific conditions is also encouraged. SPECIAL REQUIREMENTS Policy Relevance and Dissemination Studies under this PA are expected (1) to contribute to our basic understanding of the impact of efforts to enhance patient-centered care, (2) to build capacity research tools, data, and teams-- to answer related policy relevant questions, and (3) to produce information in formats useful to participants in the formulation of clinical and public policy. Applicants should be concrete in describing (1) the decision-making audiences most interested in the proposed research and (2) how applicants anticipate their results being used and by what audiences. Dissemination strategies should not be limited to publication in peer-reviewed journals but may encompass a variety of approaches, such as translating results into non-technical monographs and distributing them through associations of private and public officials, educating legislators, public administrators, health plan executives, employers, and others in seminars, and outreach to mass media. Plans, time lines, personnel, and budgets for such dissemination efforts should be explicitly presented. 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 AHRQ-supported 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://csrc.nist.gov/publications/nistpubs/800-12/. 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 Federal government license to use these products and materials for AHRQ purposes. In accordance with its legislative dissemination mandate, AHRQ 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 AHRQ budget constraints, final products maybe 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 in peer-reviewed journals and to market grant-supported products. INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH INVOLVING HUMAN SUBJECTS 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 UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. 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 Website http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html. AHRQ also encourages investigators to consider including children in study populations, as appropriate. AHRQ program staff may also provide additional information concerning these policies (see also INQUIRIES). APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 5/01) available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Although applicants are strongly encouraged to use the 05/01 revision of the PHS 398 as soon as possible, the 4/98 version may be used for receipt dates until January 9, 2002. 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 encouraged to read all PHS Form 398 instructions prior to preparing an application in response to this PA. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040-MSC 7710 Bethesda, MD 29892-7710 (20817 for express/courier service) AHRQ is not using the Modular Grant Application and Award process. Applicants for funding from AHRQ should prepare applications according to instructions provided with form PHS 398 (rev. 5/01). Beginning with applications for AHRQ submitted for the February 1, 2001 receipt date, Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application unless otherwise indicated by the Agency (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html.) All investigators/applicants proposing research involving human subjects should pay particular attention to the instructions in the form PHS 398 regarding human subject involvement. The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: [email protected]. AHRQ applicants are encouraged to obtain application materials from the AHRQ Publications Clearinghouse (see INQUIRIES). On line 2 of the face page of the application, mark the yes box and type the PA number and title in the space provided. AHRQ encourages applicants to review all application form 398 instructions prior to completing an application. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. Receipt dates for R01 grant applications are three times annually: October 1, February 1, and June 1. The last date for submitting initial R01 applications in response to this PA is June 1, 2002. R03 grant applications are received on March 24, July 24, and November 24. The last date for initial R03 applications in response to this PA is July 24, 2002. Application Preparation (for Using CMS 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 398) the specific files, time periods, and cohorts proposed for the research. In consultation with Center for Medicare and Medicaid Services (CMS), previously called Health Care Financing Administration (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 CMS 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 CMS or certify that the data have been destroyed. For the sole purpose of assuring that data confidentiality is maintained, included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings. The user agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS’s approval to do so. 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 providers require the approval of the CMS Director and may require meeting(s) with CMS staff. CMS 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 CMS data should be directed to the AHRQ program official listed under INQUIRIES. In carrying out its stewardship of research 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. Applicants must also agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is active or has ended. To receive an award, applicants must agree to submit an original and 2 copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format used (WP5.1 or WP6.0 is preferable). REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness to the PA by AHRQ staff. Incomplete and/or non-responsive applications or applications not following instructions given under Application Procedures will be returned to the applicant without further consideration. Accepted applications will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures. 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 The reviewers will be asked to discuss the following aspects of the application in their written critiques in order to judge the likelihood that the proposed projects 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 attain 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. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will the effect of these studies be on the concepts or methods driving this field? 2. 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? 3. Innovation. Does the project employ innovative information technology applications, concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. 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? Is the project (or work plan) well organized? Does the proposed study team reflect the multi-disciplinary approach required to address patient safety issues? 5. 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? 6. Policy Relevance. Will the project provide Federal and State policymakers, and others participating in the formulation of such policy, with the evidence-based information they need to improve patient safety? Does the application provide a sound plan for achieving this purpose? The initial review group will also examine: proposed dissemination activities, the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders 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 and animal subjects, and the safety of the research environment. In addition, the following criteria will be applied: o The extent to which the study results will be applicable and generalizable to situations beyond that of the study and contribute to the reduction or elimination of medical errors across a range of settings, levels of care, and populations. o The extent to which meaningful and sustainable linkages between researchers and change agents (e.g., organizations, institutions, practitioners, policy makers, patients and patient advocacy groups) are in place and used to accelerate the adoption of findings into practice. 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 the PA 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 programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: Helen Burstin, MD / Kelly Morgan Center for Primary Care Research Agency for Healthcare Research and Quality 6010 Executive Boulevard Rockville, MD 20852-4908 Telephone: (301) 594-1782 Fax: (301) 594-3721 Email: [email protected] / [email protected] Carolyn Clancy, MD / Joanne Book Center for Outcomes and Effectiveness Research Agency for Healthcare Research and Quality 6010 Executive Boulevard Rockville, MD 20852-4908 Telephone: (301) 594-4039 Fax: (301) 594-3211 Email: [email protected] / [email protected] For additional information on MEPS, email [email protected] For NIMH applicants, direct inquiries regarding programmatic issues to: Junius J. Gonzales, M.D. Services Research and Clinical Epidemiology Branch Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Blvd., MSC 9631 Bethesda, MD 20892-9631 301-443-3364 [email protected] Direct inquiries regarding fiscal and administrative matters to: Michelle Burr Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1840 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-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 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 1. Institute of Medicine (IOM). Margarita P. Hurtado, Elaine K. Swift, and Janet M. Corrigan, (Eds). Committee on the National Quality Report on Health Care Delivery, Board on Health Care Services. Envisioning the National Health Care Quality Report. National Academy Press: Institute of Medicine. 2000. 2. Institute of Medicine (IOM). Committee on Health Care in America. Crossing the quality chasm: A new health system for the 21st century. National Academy Press: Institute of Medicine. 2001. 3. Holman H, Lorig K. Patients as partners in managing chronic disease. Partnership is a prerequisite for effective and efficient health care. BMJ 2000 Feb 26,320(7234):526-7. 4. Cooper-Patrick L, Gallo JJ, Gonzales JJ, Vu HT, Powe NR, Nelson C, Ford DE. Race, gender, and partnership in the patient-physician relationship. JAMA 1999 Aug 11,282(6):583-9. 5. Safran DG, Taira DA, Rogers WH, Kosinski M, Ware JE, Tarlov AR. Linking primary care performance to outcomes of care. J Fam Pract 1998 Sep,47(3):213- 20. 6. Wagner EH, Grothaus LC, Sandhu N, Galvin MS, McGregor M, Artz K, Coleman EA. Chronic care clinics for diabetes in primary care: a system-wide randomized trial. Diabetes Care 2001 Apr,24(4):695-700. 7. Wagner EH, Glasgow RE, Davis C, Bonomi AE, Provost L, McCulloch D, Carver P, Sixta C. Quality improvement in chronic illness care: a collaborative approach. Jt Comm J Qual Improv 2001 Feb,27(2):63-80. 8. Greenfield S, Kaplan S, Ware JE Jr. Expanding patient involvement in care. Effects on patient outcomes. Ann Intern Med 1985 Apr,102(4):520-8. 9. Greenfield S, Kaplan SH, Ware JE Jr, Yano EM, Frank HJ. Patients" participation in medical care: effects on blood sugar control and quality of life in diabetes. J Gen Intern Med 1988 Sep-Oct,3(5):448-57. 10. Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care 1999 Jan,37(1):5-14. 11. Barry MJ, Fowler FJ Jr, Mulley AG Jr, Henderson JV Jr, Wennberg JE. Patient reactions to a program designed to facilitate patient participation in treatment decisions for benign prostatic hyperplasia. Med Care 1995 Aug,33(8):771-82. 12. Laine C, Davidoff F. Patient-centered medicine. A professional evolution. JAMA 1996 Jan 10,275(2):152-6. 13. Braddock CH 3rd, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. Informed decision making in outpatient practice: time to get back to basics. JAMA 1999 Dec 22-29,282(24):2313-20. 14. Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract 1998 Aug-Sep,1(1):2-4. 15. Wagner EH, Davis C, Schaefer J, Von Korff M, Austin B. A survey of leading chronic disease management programs: are they consistent with the literature? Manag Care Q 1999 Summer,7(3):56-66. 16. Cohen, J, K. Beauregard, A. Monheit, S. Cohen, et al., The Medical Expenditure Panel Survey: A National Health Information Resource, Inquiry (Winter 1996/97). Health Services Research,1999,5(Part II). 17. NIMH’s references - Bridging Science and Service (http://www.nimh.nih.gov/research/bridge.htm), Translating Behav Science into Action (http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm).
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