Full Text HS-98-003 HEALTH CARE QUALITY IMPROVEMENT AND QUALITY ASSURANCE RESEARCH NIH GUIDE, Volume 26, Number 20, June 13, 1997 RFA: HS-98-003 P.T. 34 Keywords: Health Services Delivery 0730021 Agency for Health Care Policy and Research Letter of Intent Receipt Date: August 1, 1997 Application Receipt Date: September 16, 1997 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for research and demonstration projects on the use of measurement in improving the quality of health care. Applications are sought in three areas: (1) methods and measures to allow translation of scientific information about medical care into quality measures and strategies to improve clinical practice; (2) studies of the relationship between organizational change and quality measurement and improvement in health care; and (3) studies of the use of information derived from measurement about quality of care by consumers, patients, employers, providers, and insurers to make decisions. AHCPR is especially interested in projects that will produce results within one to two years, although a balance is sought between short- and long-term projects, and projects of up to five years will be considered. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. ELIGIBILITY REQUIREMENTS Applications may be submitted by public or private non- profit organizations, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. For-profit entities may participate as members of consortia or subcontractors if the applicant is non-profit. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHCPR encourages women, members of minority groups, and persons with disabilities to apply as Principal Investigators. MECHANISM OF SUPPORT The RFA mechanisms of support are the research project grant (R01), and the research demonstration project grant (R18). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The earliest anticipated award date is February 1, 1998. FUNDS AVAILABLE Depending on the availability of funds, AHCPR expects to award up to $2.0 million in fiscal year 1998 to support the first year of 8 to 10 projects under this RFA. The number of awards is dependent on the number of high quality applications and their individual budget requirements; it is not the intent of AHCPR that the awards be equal in size. Funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. RESEARCH OBJECTIVES Background AHCPR is charged with improving the quality, appropriateness, and effectiveness of health care services and access to such services. Research on quality measurement and improvement is essential to AHCPR's efforts to integrate knowledge about health care into clinical practice, especially at this time of rapid and profound changes in the health care system. There are anecdotes, but not much reliable information, about the effects of these changes on quality of care and the effectiveness of attempts to assess and assure quality. Understanding the effects of these changes requires reliable and valid information about clinical quality of care and methods for obtaining and using that information to assure and improve quality. As efforts are made to increase the efficiency with which health care is provided and to curtail unnecessary expenditures, the ability to assess and maintain or improve quality is essential. In recent years, AHCPR has undertaken a number of initiatives related to quality of care. AHCPR documents cited below may be requested from the AHCPR Clearinghouse, 800/358-9295. In particular, AHCPR has: o Developed a prototype performance measurement information system called CONQUEST. (For information on CONQUEST, see R. Heather Palmer, et al. Understanding and Choosing Clinical Performance Measures for Quality Improvement: Development of a Typology. Final Report, Contract No. 282-93-0038, Delivery Order #3. Agency for Health Care Policy and Research, January 31, 1995.) o Funded a group of cooperative agreements under the name "QSpan" (for Expansion of Quality Measures). These projects address different conditions and populations for which quality measures are scarce or nonexistent, and in some cases take different approaches. Some focus on health plan quality, others on provider performance. For details, see "Expansion of Quality Measures." AHCPR Publication No. 96-R064, rev. November 5, 1996. o Established a program called CAHPS, for Consumer Assessments of Health Plans; the program comprises cooperative agreements with a group of three consortia collaborating with AHCPR to develop a rigorously tested, standardized instrument for collecting information from plan enrollees. (For more information, see Technical Overview of Consumer Assessment of Health Plans Study. September 1996.) o Convened a meeting of experts on quality of care to discuss a series of commissioned papers on future challenges in quality of care, and to formulate responses that could be developed by the Federal government or AHCPR specifically. Many of the observations and recommendations expressed in the papers or in the discussion are reflected in this RFA. Objectives and Scope This RFA addresses three areas: methods and measures; the effects of organizational changes; and using quality-related information. AHCPR has identified the following priority populations as a special focus for research under this RFA: minority groups, women, children, persons with chronic diseases or disabilities, and the elderly. 1. Methods and Measures: Research is needed to validate performance measures; develop and test outcomes measures and severity adjustment methods; refine and expand measures of health and functional status and health-related quality of life; consider relatively neglected issues such as timeliness of care; and examine the importance of communication in quality of care. Topics and illustrative questions include: o Quality performance measures. Of interest are measures applicable across broad populations, and in particular to the priority populations cited above. How can patient care episodes be framed to permit measurement of quality of care longitudinally across the range of care settings? What measures of the characteristics associated with primary care (such as sustained partnership, family and community- centered care, and continuity of care) influence quality of care and patient outcomes? Especially in chronic disease, how can quality of care be measured in different settings for patients with multiple comorbidities? How can the reliability and validity of commonly used quality measures be evaluated or improved, or substitutes provided? What kinds of measures are most cost-effective? How do approaches such as screening, auditing, profiling, benchmarking, and implementing clinical practice guidelines change measurement requirements? o Standards and guidelines. Can performance measures derived from clinical practice guidelines be the basis for an effective system of quality improvement? Can adherence to clinical practice guidelines or explicit medical review criteria be shown to improve quality of care, as measured by outcomes, by explicit peer review, or by performance measures derived from guidelines? Are there characteristics of the guidelines that make a difference in their effectiveness in changing practice? How do measures derived from evidence-based guidelines compare with other measures in terms of changing medical practice? In terms of care outcomes? o Risk adjustment. Systems that adjust for case-mix or severity measurement systems are essential to rate-based outcome measures, but have been problematic in many ways (see L.I. Iezzoni, ed. (1994), Risk Adjustment for Measuring Health Care Outcomes, Health Administration Press, Ann Arbor). Most risk-adjustment systems intended for performance evaluation are based on mortality. Can we develop systems based on other outcomes, so that risk adjustment can be applied to performance measures for conditions (especially chronic disease) in which mortality is not the most frequent or most pertinent outcome? How can patient characteristics and other non-clinical factors best be measured and controlled for, in order to improve attribution of outcomes to the care process or the performance of individual providers? o Health status measures. How do different measures of functional status or health-related quality of life compare, in terms of: ease of administration; feasibility and appropriateness for use in performance reporting; measurement properties; sensitivity to the natural history and treatment effects of important conditions and disorders? Can the use in clinical practice of generic (as opposed to condition-specific) health status measures improve quality of care, appropriateness of clinical interventions, or other measures of performance? Are they equally applicable in specialty and primary care? What modifications are necessary in health/functional status measurement in long- term care populations? o Timeliness. Typical elements of quality measures involve evaluation of appropriateness of care and necessity for care. Seldom addressed is timeliness of care. Given that most conditions are not especially sensitive to a moderate amount of waiting time in receiving care, can measures be devised to assess the importance of timeliness in quality of care? o Communication. What aspects of provider-patient communication need to be taken into account as part of quality measurement and improvement? What are the relationships among measures of clinical quality, provider- patient-communication, and patient satisfaction? Is communication as important in specialty care as in primary care? 2. Organizational Change and Quality Measurement and Improvement. Research is needed to understand how different approaches to designing and implementing quality measurement and/or improvement can work in and across different health care delivery settings, including traditional settings as well as non-institutional arrangements such as home care. Diversity and change in the organization of health care and approaches to quality improvement offer natural laboratories for comparative studies or case descriptions; some are so complex and have been subjected to so little study that qualitative approaches will be essential. It is important that the opportunity not be missed to observe these variations and (where possible) their effects, document them, and analyze their impact. Of special interest would be a partnership among employers, payers, and providers for a collaborative innovation in quality; for example, a consortium of clinical, administrative, and research entities, with evaluation funding from AHCPR. Illustrative questions include: o What factors affect organizational willingness or readiness to implement quality measurement and/or improvement methods and programs? o What have been the measurable effects of various quality improvement techniques? Can characteristics of effective versus less effective quality improvement initiatives be identified? o After many years of widespread use of various quality improvement approaches and tools, what is the evidence that quality improvement has made a difference? o What are the effects of oversight by government, private sector organizations, or purchasers, or of efforts to certify providers or plans? o What are the quality-related effects (for example, as measured by outcomes? by patient satisfaction?) of restructuring provider roles? o How can quality measurement be used to assess the impact of the financial arrangements between the insurer and the provider? For example, capitation, global capitation, or discounted fee-for-service; carve-outs; and performance bonuses. 3. Using Quality-related Information: Here the emphasis is on the way information on quality affects decisionmaking at various levels of the system (patient, provider, purchaser, plan, and so forth). Quality-related information can include data on clinical performance, "report-card" scores, information about outcomes, consumer assessments, and information about certification or compliance with requirements of oversight bodies. The burden is on the applicant to provide a conceptual framework supporting the manner in which the information can be expected to be effective. Illustrative questions include: o What are the relationships among measures of clinical quality, provider-patient communication, and consumer assessments? How do these relationships affect consumer decisions and behaviors? How does provision to patients/consumers affect these relationships and, in turn, consumer decisions and behaviors? o When consumers are more knowledgeable about health care and health plans do they make better choices? What are the measures for assessing "improved" or "better" decisions by patients or consumers? o What measures of quality of care are most likely to lead to change in relevant provider behaviors? o What does providing information on quality to various stakeholders (consumers, providers, employers, insurers) do to alter the behavior of the other stakeholders and the dynamics of the health care system, and what are the ultimate effects on quality of care? o How can technology be used to measure quality and provide information on quality of care? SPECIAL REQUIREMENTS Demonstration grants The focus of demonstration grant (R18) applications should be on evaluation. It is not the intent of this RFA to support extensive development of data bases (beyond those necessary to answer specific research questions), disease registries, clinical guidelines, or computerized information systems, rather to demonstrate and evaluate real world application of measurement to improve quality of care. Confidentiality of Data Information obtained in the course of this study that identifies an individual or entity must be treated as confidential in accordance with section 903(c) of the Public Health Service Act. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of 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 will be safeguarded. Rights in Data AHCPR grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHCPR funds. Such copyrights and patents are subject to a Federal Government license to use these products and materials for AHCPR purposes. AHCPR purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers; and subject to AHCPR budget constraints, final products may be made available to the health care community and the public by AHCPR, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHCPR publishes research findings but relies on grantee efforts to market grant-supported products. In keeping with AHCPR's legislative mandates to make both research results and data available, copies of all products and materials developed under a grant supported in whole or in part by AHCPR funds are to be made available to AHCPR promptly and without restriction, upon request by AHCPR. The special terms of award described above are in addition to and not in lieu of otherwise applicable PHS grant policies and Federal regulations. INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups be included in all AHCPR-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. The NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains provisions that are substantially different from the 1990 policies. 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 has been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and printed in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. AHCPR follows the revised NIH Guidelines, as applicable. Investigators may obtain copies from those sources or from the AHCPR contractor, Global Exchange, Inc., listed under INQUIRIES. AHCPR is also encouraging investigators to consider including children in study populations, as appropriate. AHCPR announced in the NIH Guide, Volume 26, Number 15, 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 AHCPR's WEB site (http://www.ahcpr.gov) and InstantFAX (See instructions under INQUIRIES). AHCPR program staff may also provide information concerning these policies (See INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit by August 1, 1997, a letter of intent that includes the name, address, and telephone number of the proposed Principal Investigator and other key personnel; a descriptive title of the application; and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR to estimate the potential review workload and avoid conflicts of interest in the review. AHCPR will not provide responses to letters of intent. Letters of intent are to be addressed to: Elinor Walker Center for Quality Measurement and Improvement Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 FAX: (301) 594-2155 Email: qualrfa@ahcpr.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. State and local government applicants may use form PHS-5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov. AHCPR applicants should obtain application materials from the AHCPR contractor: Global Exchange, Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, Telephone: 301/656-3100, FAX 301/652-5264. The RFA label available in the form PHS 398 (rev. 5/95) must be affixed to the bottom of the face page of the original application. Failure to do so could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and YES must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Elinor Walker Center for Quality Measurement and Improvement Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by September 16, 1997. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with AHCPR peer review procedures. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria Review criteria for AHCPR grant applications are: significance and originality from a scientific and technical viewpoint; adequacy of the method(s); availability of data or proposed plan to collect data required for the project; adequacy 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 adequacy of the facilities and resources available to the applicant; the extent to which women and minorities are adequately represented in study populations; and where applicable, the adequacy of the proposed means for protecting human subjects. Special Review Criteria In addition to the general criteria above, the reviewers will assess the application's responsiveness to the RFA; generalizability of results; feasibility of answering the proposed research question(s) within the project period; and the anticipated impact of the results of the project. AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. Preference in funding will be accorded to meritorious applications that focus on issues concerning minority populations. Also considered will be the extent to which projects are complementary to and build on AHCPR's ongoing quality initiatives (See BACKGROUND). Projects that are complementary to these initiatives, rather than overlapping, will be considered to further program balance. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Copies of the RFA are available from: Global Exchange Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone 301/656-3100 FAX 301/652-5264 Copies of the RFA are available on AHCPR's website, http:\\www.ahcpr.gov and through AHCPR InstantFAX at 301/594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt in order to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call AHCPR's Division of Communications at 301/594-1364, ext. 1389. Direct inquiries regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations, to: Elinor Walker Center for Quality Measurement and Improvement Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone: (301) 594-1349, ext. 1326 FAX: (301) 594-2155 Email: qualrfa@ahcpr.gov Direct inquiries regarding fiscal matters to: Mable L. Lam Chief, Grants Management Staff Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852-4908 Telephone: (301) 594-1447, ext. 1165 FAX: (301) 594-3210 Email: mlam@ahcpr.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.226 and 93.180. Awards are made under authorization of Title IX of the Public Health Service Act (42 U.S.C. 299-299c-6) and Section 1142 of the Social Security Act (42 U.S.C. 1320b-12). 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. .
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