Full Text HS-96-007 COMPUTERIZED DECISION SUPPORT SYSTEMS FOR HEALTH PROVIDERS NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA: HS-96-007 P.T. 34 Keywords: Neural Stimulation Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 7, 1996 Application Receipt Date: June 12, 1996 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications to conduct research on computerized decision support systems (CDSS) as a component of electronic medical record systems. The goal of this research is to assist providers' decisionmaking and to improve the cost- effective delivery of health services. This Request for Application (RFA) solicits applications to address one or more of the following elements for incorporating CDSS into electronic medical records: 1) Use of clinical practice guidelines in decision support systems while maintaining security and confidentiality of patient care data in different patient care settings, 2) The impact of CDSS on the effectiveness of the patient care process, patient outcomes of care, and/or cost impact on patient care, and 3) Identification and testing of factors that influence practitioner use of CDSS. Important factors surrounding the use of CDSS include: current restructuring within the health care system; a focus on a national information infrastructure (NII); progress toward establishing an electronic medical record; and the use of high performance computing and communication (HPCC) in health care. Of particular interest are studies involving the comparative effectiveness and/or cost and benefits of using CDSS within the changing health care system and the use of CDSS to disseminate practice guidelines and monitor their impact. 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 urges 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, non-profit organizations, public or private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigator. MECHANISM OF SUPPORT This RFA will use the research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested project period may not exceed three years. This RFA is a one-time solicitation. The earliest anticipated award date is September 1, 1996. FUNDS AVAILABLE Dependent upon the availability of funds, AHCPR expects to award up to approximately $1.5 million in FY 1996 to support the first year of approximately 6-10 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, as of October 1994, became a participant in the government-wide High Performance Computing and Communication (HPCC) initiative, which is an effort designed to apply high-speed and high-performance computers to help solve the nation's problems in education, energy, weather, and health. As a result of this HPCC activity, AHCPR jointly sponsored with the National Library of Medicine (NLM) an RFA entitled "Applied Research Relevant to an Electronic Medical Record." Cooperative agreements funded under this RFA and other grants continue AHCPR's history of funding research in development of databases; accessing data and retrieval of information; advancement of expert systems, decision aids, and reminder systems; and assessment of quality of care. For the purpose of this RFA, computerized decision support systems (CDSS) are computer programs that use knowledge such as clinical practice guidelines and clinical research findings, to support practitioners' decisions with evidence-based information in a patient electronic medical record. Clinical practice guidelines are defined as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical conditions. The studies supported by AHCPR that deal with CDSS typically involve a multidisciplinary team of researchers with clinical, informatics and methodological expertise, along with an understanding of the perspectives of providers, information behavior, health services research, and economics. Objectives and Scope The changing mix of payment mechanisms, benefit plans, and cost-containment strategies has widespread implications for CDSS in patient care. Of particular interest are studies involving the comparative effectiveness and/or cost and benefits of decision support systems within the changing health care system. This would include studies of applications across delivery settings and reimbursement systems; studies should consider the application of CDSS by clinicians in everyday practice, including primary care, and other office based practices. This would include the use of CDSS to disseminate practice guidelines and monitor their impact. Choice of condition and treatment options should be justified in terms of clinical and policy relevance. Topics of interest for decision support may include, but are not limited to, conditions addressed by AHCPR clinical practice guidelines. A list of guideline topics and order form may be obtained from Global Exchange, Inc. (See INQUIRIES) AHCPR desires to fund studies that focus on how to improve: 1) the outcomes of patient care, 2) the process of patient care, and 3) the cost effectiveness of care, or a combination of these. Studies addressing the following areas will receive highest program priority; however, this does not preclude applications focusing on other areas within the scope of the RFA. Studies may include: o Decision support models integrating clinical practice guidelines on networked systems which can be translated to products to improve quality of care and performance across institutional boundaries (e.g., primary care to hospitals to long-term care or home care settings). Maintenance of security and confidentiality of data requirements should be addressed. o The utility of these systems for generating performance data required by internal or external quality reporting and accountability systems, such as Health Plan Employer Data Information Set (HEDIS). o Decision support systems that are designed to facilitate prevention, early detection, diagnosis, treatment, and prescribing practices. These systems, when matched to medical review criteria and performance measures, allow assessment of improved quality of care, outcomes, and cost effectiveness. These decision support tools range from computer-generated reminders to adoption of clinical practice guidelines and treatment algorithms. o Evaluations of the medical effectiveness and economic impact (cost and benefits) of using CDSS. o Cost-utility studies that include user-friendly methods or measures for assessing patient preferences, values, and utilities, as well as improvements in provider productivity. o Identification and testing of factors that influence practitioner use of CDSS applications. o Dissemination strategies utilizing CDSS and their effect on awareness and use of information, with particular emphasis on comparing these strategies with more traditional dissemination mechanisms and processes to ascertain relative effectiveness and cost efficiency. Methods Applications must be explicit and detailed in describing databases, methods, data to be collected, instruments for data collection, and approaches to data analysis. The research plan must be justified in terms of potential for answering the proposed research question(s). AHCPR's decision support research initiative draws on a wide range of methods for applying existing medical knowledge into computerized systems. The description and rationale for choice of: hardware, software, protocols/guidelines, technology assessments, decision-analysis models, mathematical models, algorithms, logic rules, standards, vocabulary, and potential linkages to networks should be specified. The decision support systems should be existing working models or working systems. Data sources should allow for the detection, measurement, and/or control of: clinical content (based upon protocols), consensus statements, guidelines, or structured care processes; and translation of such content to algorithms for medical review criteria, performance measures, protocol algorithms, and logic rules, all within network systems. The study of sharing information across sites and standards, including content, data-exchange, and common vocabulary issues is encouraged. Proposed systems should be considered for linkage into large enterprise and national networks of aggregate knowledge sources. These systems should be capable of being accessed by multiple providers. Use of computer-generated and digital-video technology for assisting decisionmaking for health providers is welcome. Data sources should especially identify severity of illness, timeliness of diagnosis and treatment, utilization-based indicators of patient outcomes, comorbidities, relevant confounders, and costs of care when appropriate. Measures of short and long-term outcomes, as well as pre-treatment health status information, are highly valued components. 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. The description of the procedure 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. 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, Inc., 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 7, 1996, a letter of intent that includes 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 sent to: Kathleen A. McCormick, Ph.D., R.N. Center for Information Technology Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 602 Rockville, MD 20852-4908 Email: kmccormi@po5.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, 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 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 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 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: Kathleen A. McCormick, Ph.D., R.N. Center for Information Technology Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 602 Rockville, MD 20852-4908 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. 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 initial 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. 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; qualifications and experience of the Principal Investigator and proposed staff; adequacy of the plan for organizing and carrying out the project and achieving outcome measures; reasonableness of the proposed budget; and adequacy of the facilities and resources available to the applicant. 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 validity, specificity, and sensitivity of outcome(s) measures. Reviewers will also assess the applicant's description and rationale for choice of: hardware, software, protocols/guidelines, technology assessments, decision- analysis model, mathematical models, algorithms, logic rules, standards, vocabulary, and potential linkages to networks; and whether the decision support system is a working model or working system. 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 the RFA and related background materials are available from: Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 Direct inquiries regarding programmatic issues, including information on the policy of inclusion of women and minorities in study populations, to: J. Michael Fitzmaurice, Ph.D. Center for Information Technology Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 602 Rockville, MD 20852-4908 Telephone: (301) 594-1483 Email: mfitzmau@po5.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 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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