Full Text HS-98-005 QUALITY OF CARE UNDER VARYING FEATURES OF MANAGED CARE ORGANIZATIONS NIH GUIDE, Volume 26, Number 31, September 19, 1997 RFA: HS-98-005 P.T. Keywords: Agency for Health Care Policy and Research Letter of Intent Receipt Date: October 31, 1997 Application Receipt Date: January 6, 1998 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for cooperative agreements that will assess the association between features of managed care organizations, health outcomes, and quality of care for patients with chronic diseases. These cooperative agreements will be co-sponsored by the American Association of Health Plans Foundation (AAHPF) under a partnership agreement with AHCPR. Studies should focus on one or more conditions meeting the following criteria: high prevalence, association of outcomes with quality of care, ease of severity assessment with inexpensive measures, some outcomes measurable within a two-year time frame, and adequate patient numbers across the severity spectrum. Aggregations of conditions might be selected for study if the data are adequate and methodologies are sound, particularly if these conditions apply to special populations such as children, women, minority populations, or the elderly. The AAHPF and AHCPR will each contribute half of each project's funding. Applicants are asked for written permission to share with AAHPF applications that AHCPR intends to fund, along with a summary of the results of peer review of those applications. 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 domestic or foreign, public or private non-profit organizations, including universities, clinics, units of State and local governments, and other non-profit organizations and foundations. For-profit organizations are not eligible as applicants, but may participate 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 to receive grant/cooperative agreement awards. AHCPR encourages women, members of minority groups, and persons with disabilities to apply as Principal Investigators. MECHANISM OF SUPPORT The RFA mechanism of support is the cooperative agreement, U01, in which there will be substantial scientific and programmatic involvement by AHCPR and AAHPF. The total project period for applications submitted in response to this RFA may not exceed 3 years. The earliest anticipated award date is April 1, 1998. FUNDS AVAILABLE Dependent upon the availability of funds, AHCPR expects to award up to $1.5 million (direct plus indirect costs) and AAHPF a comparable amount in fiscal year 1998 to support the first year of approximately four to seven 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/AAHPF that the awards be equal in size. Funding beyond the initial budget period will depend upon annual progress reviews and the continued availability of funds. The expectation is that AHCPR and AAHPF will each contribute up to $3.5 million over a three-year period for these projects. Indirect costs awarded by AHCPR will be in accord with federally established indirect cost rates. Indirect costs awarded by AAHPF will be in accord with AAHPF's nine (9) percent limit. RESEARCH OBJECTIVES Background Managed Care Organizations (MCOs) include health plans with enrolled populations, integrated delivery systems or networks that provide comprehensive services to regular users even if users are not enrolled in a single health plan, and employer-based groups where the employer exercises essential features of managed care such as selection of preferred providers and financial incentives for cost effective treatment. Only limited research has compared quality of care and health outcomes for patients with chronic disease conditions in relation to changing structures and operations within MCOs. Information from such studies would be helpful for: (a) plans and providers to improve quality of care; (b) consumers to consider when making health care decisions; and (c) employers, certifying agencies, and public programs in making decisions about how to design and encourage development of financing and delivery systems that result in high quality of care. The quality of medical care, whether managed or not, has been criticized in many studies. Some studies have shown that practitioners frequently fail to assess patients' understanding of their illness (Cohen MZ, et al., 1994) or their ability to function (Rubenstein LV, et al., 1989; Wasson J, et al., 1992). In addition, surveys and audits regularly reveal failures to comply with well-established guidelines of care for patients with chronic conditions (see e.g., Cassell EJ, 1991; Stockwell, et al., 1994). Differences in quality of care may occur as the result of differences in innovative programs, practice patterns, organizational features, and tactics (see e.g., Wagner EH, et al. 1996). Some past research has focused on quality and outcomes of managed care vs. fee-for-service or between staff and group practice models vs. other managed care plans. In general, few differences in quality and outcomes are consistently reported (see e.g., Greenfield S, et al., 1995; Horwitz SM and Stein REK, 1990; Retchin SM, et. al., 1992). Ware et al., 1996, also found that outcomes did not differ for the average patient enrolled in HMOs compared to traditional insurance in three cities from 1986-1990. However, elderly and poor persons with chronic illness fared better with traditional coverage. In contrast to those results, Udvarhelyi, et al., 1991, found that patients with high blood pressure treated in four group practices during 1985- 1987 had more physician visits and better outcomes when covered by an HMO rather than traditional insurance. Brook, et al., studied patients with chronic illness randomly assigned to enroll in an HMO from 1974 to 1982. That study found similar health outcomes as those assigned to traditional coverage. One reason for the lack of consistent findings of differences in outcomes may be that past research has not been sufficiently sensitive to variations in quality or outcomes that may result from more specific features of MCOs such as composition of provider networks, variation in provider payment arrangements, degree of clinical integration, use of specialists, and consumer cost- sharing mechanisms. These features vary substantially within broadly defined types of health plans or MCOs. Objectives and Scope This RFA seeks applications for studies that assess the associations between MCO features and clinical performance and patient outcomes for chronic conditions. Methods o Chronic disease conditions should be selected on the basis of high prevalence, association of outcomes with quality of care, ease of severity assessment with inexpensive measures, some widely recognized outcomes measurable within a two-year time frame, and adequate patient numbers across the severity spectrum. Aggregations of conditions might be selected for study if the data are adequate and methodologies are sound, particularly if they represent problem areas for special populations such as children, women, minority populations, or the elderly. Comorbidities should be carefully considered in any study design. Patients with co-morbidities are of particular interest as subjects for study under this RFA. o Features of MCOs that may affect performance can be selected from among the range of features that generate much interest in the professional literature as well as the popular press and policy debates. Such features might include, for example: - demand management with self-care, nurse call lines, and wellness education; - staffing patterns and responsibilities, e.g., types of providers involved in primary care; - methods of establishing provider networks; - availability of specialists and sub-specialists; - methods for influencing provider practice, including risk- sharing; - clinical oversight and use of guidelines or other evidence-based tools; - utilization review protocols, e.g., for hospital emergency visits; - disease management programs. o Processes of care include preventive measures, diagnostic tests, treatments, and other patient care activities. Assessing processes of care involves measuring adherence to practice guidelines, protocols, or standards. For example, the National Heart, Lung, and Blood Institute has developed guidelines for asthma, and the Foundation for Accountability has developed preliminary measures for breast cancer, although the latter have not yet been rigorously tested. The American Diabetes Association commissioned a multidisciplinary committee to develop and test a number of standards for diabetes care. AHCPR has sponsored guidelines for several chronic diseases. One example is the treatment of heart failure. Guidelines in that area are: Unstable Angina: Diagnosis and Management, Clinical Practice Guideline, Number 10, Publication No. 94-0602, 1994; Heart Failure: Evaluation and Care of Patients With Left- Ventricular Systolic Dysfunction, Clinical Practice Guideline, Number 11, Publication No. 94-0612, 1994; and Cardiac Rehabilitation, Clinical Practice Guideline, Number 17, Publication No. 96-0672, 1995. AHCPR-sponsored guidelines are available from the AHCPR Publications Clearinghouse (see "INQUIRIES" below). Applicants should also consider the National Committee for Quality Assurance recommendations for process and outcomes indicators. Investigators should select and refine the final performance measures on the basis of a published meta-analysis or review of existing literature, consensus groups of experts, and/or judgments of advisory panels. Regardless, applicants must rigorously address validity, acceptability, and generalizability of the selected measures. o Outcome measures should include clinical and physiologic measures as well as patient self-reported measures, and should include general functional status as well as disease specific measures. To the extent possible, patient self- reports should include functioning level, disability days, time lost from work, understanding of the problems, perceived outcomes of care, and satisfaction with access to care and with interpersonal communication with providers. Selected outcome measures also must be defended with respect to validity, acceptability, and generalizability. Applicants are encouraged to use existing measures and should consider using quality measures and patient assessment questions organized or developed by AHCPR programs, but not to the exclusion of other existing measures that may be highly valuable. AHCPR does not wish to duplicate efforts already completed or underway in the development of new measures under the programs, Q-Span (Expansion of Quality Measures) or CAHPS (Consumer Assessment of Health Plans Study). For two compendia of relevant measures, see the searchable CONQUEST database now available with an introductory publication (AHCPR Pub. No. 96-0042), and CAHPS measures of consumer and patient self report assessments of health plans and satisfaction. For additional information on these programs, see "INQUIRIES" below. o A number of variables should be tested for their contribution to patient outcomes within a multivariate analysis. Patient characteristics may be important covariates with plan features in affecting quality and outcomes. Patient variables might include severity of the study condition, presence of comorbid conditions, and other factors determining compliance with treatment regimens and reporting of functional status. o The features of each MCO as well as information about the patient's illness and quality of treatment could be measured retrospectively for 6-12 months prior to the beginning of a study. After the study begins, outcomes can be assessed for approximately two years. This approach is not meant to preclude evaluating new or recently implemented clinical interventions. Any substantial change in the features of the MCO during the course of observation should be noted and examined for its independent contribution to the outcomes. Attrition from the sample should be examined for any connection with quality of care. o Generalizability of findings for each disease is highly desirable. Applicants should assess the generalizability resulting from their choice of plans, geographic or market areas, and providers and patients for study. Applicants should consider how they might maximize the generalizability of their findings across organizational forms (e.g., group or staff model Health Maintenance Organizations, preferred provider plans, etc.) and/or across all chronic conditions. Two examples of ways to advance this goal would be (a) research consortia, and (b) studies that focus on two or more chronic conditions. In addition, after award of the cooperative agreements, investigators will be expected to participate in collaborative work with other awardees and scientific experts on studies of pooled data that promote generalizability. SPECIAL REQUIREMENTS Terms and Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grants administration regulations, 45 CFR Parts 74 and 92, and other HHS and PHS grants administration policies. 1. Cooperative Activities. The administrative and funding mechanism to be used for this program will be the cooperative agreement (U01), under which there will be substantial scientific and programmatic involvement by AHCPR and AAHPF with the awardees. Cooperative activities are intended to strengthen individual studies and at the same time generate generalizable results across multiple study sites, projects, disease conditions, and patient and physician groups. These goals present scientific and management challenges, requiring collaboration among Principal Investigators and mechanisms for both linking data and preserving the integrity and confidentiality of these data. The scientific and administrative management of the cooperative work will be organized through a joint planning and coordinating committee (the Collaborative Scientific Working Group) and a joint operational committee (the Research Coordinating Center). Two external groups will serve to assure timely progress of the research partnership (the Administrative Review Council) and to assure research and data integrity and protection of human subjects (the Oversight Committee). o The Collaborative Scientific Working Group (CSWG) will serve as the core mechanism for cooperative planning and coordination of research. The CSWG will meet as a group shortly after the award of the projects to begin the process of identifying cross-cutting research questions and common measures and methods to answer the questions. The group will make joint decisions to promote uniformity in research functions, sampling design for any surveys, study measures, analytic methods, and other methodologic and substantive issues that affect generalizability and scientific integrity across individual projects. The CSWG will be especially concerned with the subset of research activities in each project that involve cross-cutting issues and analyses of pooled data. In addition, the CSWG will develop and implement common policies on protection of the pooled data, including confidentiality of patients and institutions, and management and release of pooled data files. The CSWG will be chaired by Sheldon Greenfield, M.D., the Director of the Primary Care Outcomes Research Institute of New England Medical Center, or an equivalent expert designated by AHCPR and AAHPF, who will be a consultant to both sponsors. The CSWG will be co-chaired by a scientific advisor to be named by AHCPR, and Sherrie Kaplan, Ph.D., the co-director of the Primary Care Outcomes Research Institute, or equivalent expert designated by the sponsors. The other members of the CSWG will include each project's Principal Investigator, along with two representatives from AHCPR and two from AAHPF. o The Research Coordinating Center (RCC) will have day-to- day operational responsibilities for joint development of common measures and analyses of pooled data submitted by the individual projects on cross-cutting questions. It is estimated that approximately 25% of any survey data in each study will be pooled for cross-cutting analyses. The RCC members will provide assistance with data collection, survey methods, statistical and analytic methods for the cross- cutting studies, and serve as a repository for a uniform, aggregate database for cross-cutting studies. The RCC will be chaired by Sherrie Kaplan, Ph.D., co- director of the Primary Care Outcomes Research Institute, or an equivalent expert designated by AHCPR and AAHPF, and co- chaired by project officers of AHCPR and AAHPF; it will include the Principal Investigators or their designees. Additional experts, as needed, will be added with the concurrence of the CSWG. The RCC will be sponsored both by grant funds (see "BUDGET PREPARATION" below) and AAHPF. o An Administrative Review Council (ARC) will monitor the activities and progress of individual projects, the CSWG, and the RCC on an annual basis to ensure timely completion. The ARC will also provide an informal procedure for resolving issues brought to the Council's attention by AHCPR, AAHPF, or a Principal Investigator. In addition, the ARC will be consulted on non-competitive continuation awards. The Council will be composed of external experts independent of any project but qualified to review methodologies needed for this area of research. o An Oversight Committee that is completely external to the projects and the funding agencies will be created to assure protection of human subjects as well as research and data integrity. It will be composed of a small number of authorities in medical and scientific areas that include bioethics and scientific integrity. It will also include a patient advocate. This committee will be empowered to recommend interruption of studies or interruption of the use of study data, if warranted. 2. Awardee Responsibilities. - The awardee will conduct research in accordance with the terms and conditions of the Notice of Grant Award, and will engage, as necessary, in a process of refinement and revision of selected methodologic procedures in accord with plans developed collaboratively with the CSWG and the RCC. Specifically, the awardee will undertake or participate in collection of data on measures designed jointly with others in the RCC and CSWG (about 25% of any survey measures). - The awardee will contribute data on standardized measures for pooled analyses of cross-cutting issues by the RCC. The designs for this work will be reviewed by the CSWG. The Principal Investigator or other appropriate investigator may participate in analyses, co-author reports, or be acknowledged as a contributor, depending on mutual agreements. The awardee will later have access to the pooled data for additional analyses. - The Principal Investigator will participate in a combined total of up to six meetings per year of the RCC and the CSWG, in addition to telephone and electronic conferences. - The awardee will administer some of the costs of the joint work of the RCC. (see "BUDGET PREPARATION" below). 3. AHCPR/AAHPF Responsibilities. - The sponsoring agencies will establish the scientific and monitoring committees defined above to guide the cooperative work. Scientific consultants may be engaged by the CSWG as needed, with costs borne by the sponsors. - The progress of work by each awardee will be reviewed at least annually. Awards may be terminated in cases of documented underperformance where the awardee has been given adequate notification about performance and failed to take sufficient corrective actions. BUDGET PREPARATION The following guidance will supplement the standard requirements in form PHS 398 (rev. 5/95). o The costs of clinical care provided to participants in any project will not be paid out of grant funds. o Applicants should request funds to support the joint work of the RCC, such as joint development of common measures and analyses of pooled data. Two and one-half (2.5) percent of the requested direct costs should be budgeted for this purpose as a separate line item under Other Expenses, for each year of the project. o Budgets should reflect travel by the Principal Investigator to attend a combined total of 6 one-day meetings per year of the CSWG and the RCC. These meetings will generally take place in the Washington, DC area, or the Boston, MA area. It is anticipated that the business of the CSWG and the RCC can otherwise be conducted by teleconferencing and e-mail channels. 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 (42 U.S.C. 299a-1(c)). 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 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. Such purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers. 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 its broad dissemination mandate, AHCPR encourages and promotes publication of research findings, but generally relies on grantee efforts to market grant-supported products. To enable AHCPR to fulfill its statutory obligation to make both research results and developed data available, as well as to assure the statistics developed with its support are of high quality, 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 upon request. Similarly, products shall be made available to AAHPF promptly upon its request, consistent with the applicable confidentiality statute cited above. 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. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," 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 NIH Guidelines, as applicable. Applicants may obtain copies from the above 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 for Grants and Contracts, 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"). LETTER OF INTENT Prospective applicants are asked to submit, by October 31, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the proposed Principal Investigator and other key personnel; 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. The letter of intent is to be addressed to: Bernard Friedman, Ph.D. Center for Organization and Delivery Studies or James Cooper, M.D. Center for Primary Care Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 500 Rockville, MD 20852-4908 E-mail: bfriedma@ahcpr.gov or jcooper@ahcpr.gov SEMINAR FOR PROSPECTIVE APPLICANTS AHCPR and AAHPF plan to convene a seminar for prospective applicants in Rockville, Maryland, about 6 to 8 weeks after publication of this RFA if there is sufficient interest. Applicants must pay for their own travel and accommodation costs. Attendance is not a prerequisite to applying. If interested in such a seminar, contact Dr. Bernard Friedman or Dr. James Cooper by October 17, 1997, at the appropriate e-mail address above. 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, E-mail: ASKNIH@odrockm1.od.nih.gov. AHCPR applicants are encouraged to obtain application materials from the AHCPR contractor: Global Exchange, Inc. (see "INQUIRIES"). 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 the YES box 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: Dawn French Center for Organization and Delivery Studies Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 500 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by January 6, 1998. LETTER OF AUTHORIZATION Applicants must submit a brief letter as part of the application indicating whether or not they wish their application, along with a summary of reviewer comments, to be shared with AAHPF. Only applications under consideration for funding will be shared. Applications not authorized to be shared with AAHPF will not be funded under this RFA. Meritorious applications not funded under this RFA, may be considered by AHCPR for funding in competition with all other investigator-initiated applications. 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. The AAHPF will have an opportunity to recommend qualified reviewers. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria The general review criteria for any application are: significance and originality from a scientific and technical viewpoint; adequacy of the method(s); availability of data or a 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; adequacy of the facilities and resources available to the applicant; the extent to which women, children, and minorities are adequately represented in study populations; and 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 and other critical aspects such as: o access to relevant data on patient care in MCOs and structural and operational features of MCOs, as evidenced by letters of commitment from any organization supplying data; o demonstrated ability to engage in cooperative work with outside scientists and administrative committees, and to meet goals of timeliness; o demonstrated ability to collaborate with government agencies in the performance of research studies and to participate in coordinating committees. AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. AHCPR will consider the following in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, program balance with respect to types of MCOs, populations, and chronic conditions to be studied. 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 The RFA is available on AHCPR's Web site, http://www.ahcpr.gov and through AHCPR InstantFAX at 301/594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call AHCPR's Division of Communications at 301/594-1364 ext. 1389. Copies of AHCPR publications can be requested through the: AHCPR Publications Clearinghouse P. O. Box 8547 Silver Spring, Maryland 20907 TDY(toll free): 1-800-301/586-6340 Telephone (toll free): 1-800-301/358-9295 Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations, to: Bernard Friedman, Ph.D. Center for Organization and Delivery Studies or James Cooper, M.D. Center for Primary Care Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 500 Rockville, MD 20852-4908 telephone: 301/594-1410 ext. 1475 (Friedman) 301/594-1357 ext. 1352 (Cooper) E-mail: bfriedma@ahcpr.gov or jcooper@ahcpr.gov For more information about AHCPR supported work pertaining to quality of care and consumer assessment of health plans, direct inquiries 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 Email: ewalker@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 Number 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. References Brook RH et al., 1990. Quality of ambulatory care: Epidemiology and comparison by insurance status and income. Medical Care, 8:392-433. Cassel EJ. 1991. The Nature of Suffering and the Goals of Medicine. New York: Oxford University Press. Cohen MZ, Tripp RT, Smith C, Sorofman B, Lively S. 1994. Explanatory models of diabetes: patient practitioner variation. Social Science and Medicine, 38:59-66. Greenfield S, Rogers W, Mangotich M, Carney MF, Tarlov, AR. 1995. Outcomes of patients with hypertension and non- insulin dependent diabetes mellitus treated by different systems and specialties. Results from the medical outcomes study. Journal of the American Medical Association, 274(18):1436-44. Horwitz SM, Stein REK. 1990. Health maintenance organizations vs. indemnity insurance for children with chronic illness: Trading gaps in coverage. American Journal of Diseases of Children, 144:581-6. Retchin SM, Clement DG, Rossiter LF, Brown B, Brown R, Nelson L. 1992. How the elderly fare in HMOs: outcomes from the Medicare competition demonstrations. Health Services Research, 27(5):651-69. Rubenstein LV, Calkins DR, Young RT, et al. 1989. Improving patient function: a randomized trial of functional disability screening. Annals of Internal Medicine, 111(10):836-42. Stockwell DH, Madhavan S, Cohen H, Gibson G, Alderman MH, 1994. The determinants of hypertension awareness treatment and control in an insured population. American Journal of Public Health, 84(11):1178-74. Udvarhelyi S, Jennison K, Phillips RS, Epstein AM. 1991. Comparison of the quality of ambulatory care for fee-for- service and prepaid patients. Annals of Internal Medicine, 115:394-400. Wagner EH. 1996. The promise and performance of HMOs in improving outcomes in older adults. Journal of the American Geriatrics Society, 44:1251-1257. Ware J, et al., 1996. Differences in 4-year health outcomes for elderly and poor, chronically ill patients treated in HMO and fee-for-service systems: results from the Medical Outcomes Study. Journal of the American Medical Association, 276:1039-47. Wasson J, Keller A, Rovehstein L, et al. 1992. Benefits and obstacles of health status assessment in ambulatory settings: the clinician's point of view. Medical Care, 30(5)suppl:MS42-9. .
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