Full Text HS-96-006 REFERRALS FROM PRIMARY TO SPECIALTY CARE NIH GUIDE, Volume 25, Number 8, March 15, 1996 RFA: HS-96-006 P.T. 34 Keywords: Health Services Delivery Health Care Economics Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 3, 1996 Application Receipt Date: June 12, 1996 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications to conduct research related to patient referrals from primary care to specialty care. Applications are sought for studies that (1) describe how changes in health care organization affect referral practices, and/or (2) measure quality of care, economic and other outcomes resulting from decisions by primary care providers (PCPs) who refer, or do not refer, patients to specialty providers. Research under this Request for Applications (RFA) should address issues related to referrals in the ambulatory care setting. The AHCPR has a particular interest in studies that evaluate outcomes of "discretionary" referrals within public sector and/or private health care plans as well as studies focusing on provider supply and decisionmaking by referring providers (including nonphysician PCPs). Outcomes of interest reflect quality of care and include measures of patient health status, well-being, and satisfaction as well as the financial consequences of referral or non-referral. For the purpose of this RFA: A "referral" is defined as the transfer of all or part of the responsibility for patient care; a "specialist" is defined as a provider with recognized knowledge and skills in a specific area of health care; and "discretionary" referrals are defined as those associated with nonemergent conditions, for which there is considerable variation in practice among referring providers and/or differences in expert opinion concerning the timing or indications for referral. The goal of this solicitation is to inform the policies related to referral within health plans and strengthen the scientific base underlying the evolution and use of referral protocols in ambulatory health care settings. Applicants are encouraged to form partnerships or consortia involving health plans that provide (1) the data and technical capabilities to study referral patterns, and (2) access to delivery settings in which the outcomes of referrals can be evaluated. 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. This RFA, Referrals from Primary to Specialty Care, addresses several of those objectives. 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, non-profit organizations, public or private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. The AHCPR by statute can make grants only to non-profit organizations; however, for-profit organizations can participate if the application is submitted by a non-profit organization. Racial/ethnic minorities, women, and persons with disabilities are encouraged to apply as Principal Investigator. MECHANISM OF SUPPORT This RFA will use the research project grant (R01) mechanism. Proposed projects are to be accomplished in one to two years. The anticipated award date is September 1, 1996. FUNDS AVAILABLE Dependent upon the availability of funds, AHCPR expects to award up to $1.5 million for the first year of projects under this RFA. The period of funding is not to exceed two years. 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. This is a one-time solicitation. Funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. RESEARCH OBJECTIVES Background Historically, AHCPR has supported research that examines the availability, quality, effectiveness, and costs of health care services. In the current, market-driven health care system, another major goal of research funded by AHCPR is to understand trends in the health care marketplace and their implications for the quality of care and access to that care. One of the more prominent organizational changes resulting from the rapid growth and proliferation of managed care health plans has been the introduction of mechanisms to restrict direct patient access to specialty care. Such mechanisms include gatekeeping by PCPs and increased cost sharing for those patients wishing to self-refer to specialists. Many plans also incorporate administrative review of referral decisions and financial incentives that discourage high referral rates among PCPs. In September 1995, AHCPR's Center for Primary Care Research (CPCR) convened a conference, "Research at the Interface of Primary and Specialty Care." The conference was attended by primary care and specialty providers, academicians, health services researchers, representatives of managed care organizations, consumers, employers, and other purchasers of health care. The purposes of the conference were to: (1) assess the current state of research related to consultation and referral; and (2) obtain suggestions regarding the most important referral-related questions to be addressed by future research. The presentations and discussions that occurred during the conference were carefully considered in developing this RFA. (The conference is briefly reviewed in JAMA 1995;274:1419. A more complete summary is available from Global Exchange at the address listed under INQUIRIES.) Referrals and Cost Containment Policies Cost containment efforts over the past 15 years have led to more selective use of hospital services. Recent policies have also targeted out-of-hospital services, especially the increasing number of expensive, high-technology procedures available in ambulatory settings. A considerable body of research focusing on clinical practice variations has identified significant variability in the rates at which many of these procedures are performed in one geographic region compared to another, suggesting either under or overutilization. These studies, however, do not clarify the extent to which observed variations in procedure rates are due to the practice style of specialists or to referral patterns among PCPs. The extent to which administrative plans and reimbursement mechanisms affect variations in procedure rates is also unclear. In general, specialists have been shown to use significantly more resources (tests, procedures, hospitalizations) than PCPs, even after adjusting for severity of illness (Greenfield S, Nelson EC, Zubkoff M, et al. Variations in resource utilization among medical specialties and systems of care: results of the Medical Outcomes Study. JAMA 1992;267:1624-30). Since primary care is the major source of referrals to specialists, the referral practices of PCPs in the ambulatory setting may therefore be a critical step on the pathway to increased intensity of care, despite the fact that such higher-intensity care has not been consistently linked with improved patient outcomes. On the assumption that patients of PCPs who have a greater propensity to refer to specialists generate substantially greater health expenditures than patients of PCPs who are less likely to refer, newer health care plans and reimbursement mechanisms are monitoring closely the referral practices of PCPs and offering incentives to discourage high referral rates. Certain plans conduct referral "profiling" of PCPs and evaluate intraprovider variation in referral practices. Such profiling analyses have been shown, however, to be highly problematic in the absence of adequate measures of case-mix or standard units of analysis (Salem- Schatz S, Moore G, Rucker M, Pearson SD. The case for case-mix adjustment in practice profiling. JAMA 1994;272:871-4). Delayed Referrals While excessive referrals may result in extra costs as well as exposure of patients to needless invasive and risky procedures, delayed referral or non-referral may also result in adverse outcomes, including delayed or missed diagnosis, delayed treatment, and the eventual need for more expensive interventions. The quality of care provided certain populations, such as patients insured through Medicaid/Medicare, disabled persons, and children with special needs, may be particularly vulnerable to policies that restrict referral. Research is needed that compares the outcomes of referred care to care for the same condition provided within the primary care setting. Also needed are studies to elucidate the effect of the timing of referral for specified conditions on overall costs and patient outcomes. Provider Role Ambiguity A major limitation of much of the referrals research to date is the considerable overlap and ambiguity in the roles and responsibilities of PCPs and specialists in the United States. In the absence of clearly defined boundaries, specialists have traditionally provided a substantial amount of primary care, and the profile of primary care practice has been shown to vary widely. Many of the newer health care plans require that providers in the plan assume the role of either primary care or specialist provider, and feature separate reimbursement mechanisms for each type of provider. Certain specialty groups have responded by asserting that they are better suited than PCPs to provide "principal care" for patients affected by diseases within their area of specialty. Few studies however have yet compared the quality and costs of "principal care" provided by specialists to care for comparable patients treated routinely in the primary care setting. Limited data exist on the relative expenditures incurred with referral to one type of specialist to another for the same condition (e.g., referral to a chiropractor vs neurologist vs orthopedist or other provider for low back pain); and whether the propensity to refer is related to PCP characteristics (e.g., knowledge, skills, training), patient characteristics (e.g., attitudes, preferences, socioeconomic status), financial incentives for patient or provider, or the specific condition itself. The referral activities of advanced practice nurses and physician assistants need further attention. Of interest are studies that help define how these practitioners can best interact with physicians when more specialized services are required. Studies of the unique referral issues for children, whose utilization of specialists is likely to be quite different from adults, based on disease epidemiology and availability of pediatric specialists, are particularly encouraged. Variability in Referral Practices Research from as early as the 1970s indicates that rates of referral and consultation vary widely among PCPs, suggesting a high level of provider uncertainty about appropriate referral practices, at least for some patient conditions (Calman NS, Hyman RB, Licht W. Variability in consultation rates and practitioner level of diagnostic certainty. J Fam Pract 1992;35:31-8). Those conditions associated with the greatest variation in referrals to specialists have yet to be identified. However, certain PCP observers contend that there is a set of conditions for which referral to a specialist is likely to be considered "discretionary" by the PCP. (Chao J, Galazka S, Stange K, Fedirko T. A prospective review system of nonurgent consultation requests in a family medicine residency practice. Family Med 1993;25:570-5). These are non-urgent conditions for which there is a lack of consensus among experts on the appropriate timing or indications for referral to a specialist. It is reasoned that financial or other incentives discouraging referrals by PCPs have the most restrictive impact on these "discretionary" referrals as opposed to referrals for emergent or life-saving treatment beyond the usual range of primary care practice. Further research is needed to clarify whether such incentives decrease access to beneficial services. Referral Guidelines Guidelines or protocols to help direct and coordinate the referral process and possibly reduce variations in referral practices have been developed for use in some health plans. Such protocols may greatly influence the planning of services and possible collaboration between PCPs and specialists within health care systems. Currently, however, science-based data to support the practices recommended in these protocols are lacking. Referral guidelines are also a major component of the "disease management" programs evolving within managed care plans, in which a systems approach is taken to developing provider networks for targeted diseases of high incidence and high cost. The implications of disease management programs for both clinical and economic outcomes have yet to be studied in a scientific manner. How best to interpret and incorporate into referral decisions or referral guideline development the perceptions, preferences and concerns of patients who require both primary and specialty care and/or have multiple chronic problems is also unclear. Scope and Methodological Considerations The effect of specific referral practices on the health status of patients may be difficult to measure directly and may require long-term studies. Given the urgent need for scientific data to inform evolving referral policies and practices, a focus on short-term or intermediate health outcomes, as well as economic outcomes, is appropriate for projects under this RFA. It is expected that studies comparing various referral practices will examine outcomes of care for well-defined diseases or conditions, although more global measures of outcomes may also provide useful information. Since the intended effect of most cost containment policies is to restrict referrals, this RFA addresses the implications of such policies for the quality of care delivered. However, the identification of patients with conditions that could have been referred to a specialist but were not is a particularly challenging methodological problem. Investigators are encouraged to consider innovative means of identifying "non-referrals" within their study populations and assessing the costs and outcomes of decisions to manage specific problems within primary care. Overall, about 4.5 percent of patient contacts with PCPs result in referral to a specialist. To assure generalizable results, studies involving primary data collection may therefore need to be quite large. The use of secondary data bases, especially data collected within both public sector and private managed care health systems, is encouraged. Given the relative infrequency of referrals in medical practice, very large data sets will be needed. In light of considerable ambiguity in provider roles and the possibility of significant regional variations in provider reimbursement arrangements, smaller studies of referrals and those designed to gather qualitative data about referral practices need to make explicit the organizational models of both primary and specialty care. Such studies should describe the operational features of those models within their study population as well as describe in detail the process PCPs use to direct and coordinate the care of their patients. A broad array of research questions is relevant to referral practices. The following questions are AHCPR priorities because of their relevance to emerging policy issues related to referral within health care plans: o For which conditions (or diagnoses) is there significant variability in referral practices among PCPs? To what extent do different care financing mechanisms affect this variability? o What are the quality of care, cost, and other implications of decisions by PCPs (including nonphysician PCPs) to refer or not refer patients with specific conditions? o What are the quality of care, cost, and other implications of referring or not referring at defined points of time in the disease process? o What are the quality of care, cost and other implications of "disease management" programs, when compared to care for the same diseases delivered in a traditional PCP setting? o How is the quality of care provided to defined segments of the population (e.g., children with special health care needs, disabled persons) affected by policies that restrict referrals? How do private sector health plans coordinate the care of patients with special health care needs for which public sector care management programs exist? o What are the most valid, reliable ways of "profiling" a PCP's pattern of referral? If so, what are the quality of care, cost, and other implications of different referral profiles? o How do changes in the supply and configuration of providers (including nonphysician providers) within a defined health care system affect referral practices? SPECIAL REQUIREMENTS 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. Rights in Data The AHCPR grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools and measures, software with documentation, literature searches, and analyses that 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. The 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 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. INCLUSION OF WOMEN AND MINORITIES 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, listed under INQUIRIES. AHCPR program staff may also provide information concerning this policy (See INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by May 3, 1996, a letter of intent that includes the names, addresses, and telephone numbers, 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 staff 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: David Lanier, M.D. Center for Primary Care Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Email: dlanier@po3.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. 9/92), and follow those requirements for copy submission. Application Kits are available at most institutional offices of sponsored research and may be obtained from the Office 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: girg@drgpo.drg.nih.gov. For further information, AHCPR applicants are encouraged to obtain application materials from the AHCPR contractor: Global Exchange, Inc. (SEE INQUIRIES) The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the original application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title 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 four 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) Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by June 12, 1996. If an application is received after that date, it will be returned to the applicant without review. One additional copy, labeled "Advance Copy," must be submitted simultaneously to: David Lanier, M.D. Center for Primary Care Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 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. Recommendations of the peer review committee may be reviewed subsequently by AHCPR's National Advisory Council. 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; qualifications and experience of the Principal Investigator and proposed staff; adequacy of the plan for organizing and carrying out the project; reasonableness of the proposed budget; and adequacy of the facilities and resources available to the applicant. AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. The following will be considered in making the funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Copies of this RFA and related background conference summary 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 and the background conference summary document (AHCPR Pub. No. 96-0034) can also be requested through AHCPR InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Use the key pad on the receiver when responding to prompts from InstantFAX. 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. 159. Direct inquiries regarding programmatic issues, including information on the policy of inclusion of women and minorities in study populations, to: David Lanier, M.D. Center for Primary Care Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone: (301) 594-1357 Email: dlanier@po3.ahcpr.gov Direct inquiries regarding fiscal matters to: Carol Roache Grants Management Staff Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852-4908 Telephone: (301) 594-1447 FAX: (301) 594-3210 Email: croache@po7.ahcpr.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.226. Awards are made under authorization of Title IX of the Public Health Service Act (42 U.S.C. 299-299c-6). Awards are administered under the PHS Grants Policy Statement and Federal regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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