Full Text HS-95-001 RESEARCH ON EMERGENCY MEDICAL SERVICES FOR CHILDREN NIH GUIDE, Volume 23, Number 44, December 16, 1994 RFA: HS-95-001 P.T. 34, AA Keywords: 0730007 Health Care Economics Child/Maternal Health Agency for Health Care Policy and Research Health Resources and Services Administration Application Receipt Date: March 16, 1995 PURPOSE This announcement solicits applications to conduct research on (1) Severity and Acuity Measures for Illness and Injury for Children; (2) Child and Adolescent Patient Outcomes and Outcome Measures; (3) Costs of Emergency Medical Services for Children; and (4) Emergency Medical Services for Children (EMSC) System Organization, Configuration, and Operation. This solicitation represents a collaboration between the Maternal and Child Health Bureau, Health Resources and Services Administration (HRSA), and the Agency for Health Care Policy and Research (AHCPR). 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. The 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. 017-001-004374-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by non-profit organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. The AHCPR, by statute, can support only non-profit organizations. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Grant funds are additive, not substitutive; they are not to be used to replace existing resources. Also, they may not be used for delivery of services. This RFA is a one-time solicitation. The total requested project period for applications submitted in response to this RFA may not exceed three years. Applications may request a maximum total of $250,000 direct and indirect costs per year. The earliest possible award date will be September 1, 1995. Annual progress reviews by AHCPR and HRSA, and the availability of funds especially designated for this research, will determine the continuation of grants up to the three year limit. FUNDS AVAILABLE The AHCPR and HRSA expect that up to $500,000 will be available in Fiscal Year 1995 for first year support of two to three awards. RESEARCH OBJECTIVES Background The Maternal and Child Health Bureau (MCHB), HRSA, and the AHCPR have joined in a partnership to address research needs of pediatric emergency medicine. The EMSC program, authorized by the Congress in 1984, is an activity of MCHB that addresses the emergency-care needs of sick and injured children that are different from those of adults. The need for such special attention to children is supported by the report of the Institute of Medicine (IOM) Committee on Pediatric Emergency Medical Services issued in 1993 (Institute of Medicine, Emergency Medical Services for Children, Washington, DC: National Academy Press 1993). In this report, the Committee cited relative neglect of research on pediatric emergencies, and outlined a research agenda for EMSC. From that agenda, MCHB and AHCPR have selected for this RFA, four topics that fall most clearly within the area of interest common to both agencies. Research Issues Listed below are the four broad topics selected to advance knowledge about the provision of emergency medical services (EMS) to children. Examples of specific issues are provided under each broad topic. 1. Severity and Acuity Measures for Illness and Injury o Development and validation of generic scales or indexes for children, with special attention to use (1) for triage in the prehospital or emergency department (ED) setting; and (2) to adjust case mix for purposes of research or performance evaluation. o Development and validation of specific severity scales, such as measures of abdominal and chest trauma. o Development and evaluation of methods to triage patients more accurately in the field and in EDs, with particular attention to young children with possible serious illness. 2. Patient Outcomes and Outcome Measures o Development and validation of outcome measures based on functional status/disability, suitable for use in planning and evaluating rehabilitation care. o Development and validation of outcome measures suitable for research and performance evaluation. o Employing innovative approaches to longitudinal study of outcomes with a follow-up to post-hospital care. 3. Costs o Assessment of the marginal incremental cost of different approaches to improving EMSC. o Evaluation of the cost-effectiveness of different EMSC program configurations, with attention to impacts on emergency systems and the health care system, and considering a broad set of program benefits and outcomes. Examples of such configurations would be different approaches to medical control, categorization, and regionalization. o Determination of the economic consequence of pediatric trauma or severe illness to families and to taxpayers, taking into account direct and indirect costs and all types and settings of EMSC. 4. System Organization, Configuration, and Operation o Evaluation of effectiveness of interventions to upgrade EMS system components to improve care of children. Examples of such components would be equipment, protocols, and telephone advice capabilities. o Study of effectiveness and efficiency of variations in EMSC care, highlighting special population subgroups or groups in special circumstances (homeless, migrant, military, rural/urban/suburban, minority, managed care, uninsured, Medicaid, inner city). o Formulation of methods for developing population-based estimates of need for ED and pediatric intensive care unit (PICU) beds for local and regional areas, for purposes of planning and resource allocation. Applicants are encouraged to take full advantage of opportunities for efficient enhancements of available expertise, data, and other research resources. This might include collaboration with researchers and practitioners outside their own institutions, creative use of existing data, or "piggybacking" on other data collection activities. Another possibility for leveraging research resources is to conduct comparisons of outcomes where existing practice patterns or structures are known to differ (e.g., across care settings, geographical areas, insurers, or providers). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of AHCPR/HRSA that women and members of minority groups must be included in all AHCPR/HRSA supported health services 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. A new 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 some provisions that are substantially different from the 1990 policies. AHCPR plans to publish guidelines specific to AHCPR. In the interim, AHCPR will follow the NIH guidelines, as applicable. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the NIH policy from the AHCPR program staff listed under INQUIRIES. AHCPR program staff may also provide additional relevant information concerning this policy. APPLICATION PROCEDURES The application receipt date is March 16, 1995. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). State and local government agencies may use form PHS 5161 and follow those requirements for copy submission. Application kits are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-710-0267; and for AHCPR applications from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone 301-656-3100 (FAX 301-652-5264). The RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. In addition, the RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing such that it may not reach the review committee in time for review. 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Ms. Elinor Walker Center for General Health Services Extramural Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Completed applications must be received by the Division of Research Grants by March 16, 1995. If an application is received after that date, it will be returned to the applicant without review. Conference for Prospective Applicants A conference of one to two days is planned for prospective applicants, if there is sufficient interest from prospective applicants. This conference would provide programmatic and administrative information and respond to questions concerning this RFA. If convened, the conference is planned for January 13, 1995 in the Washington, DC area. Attendance is not a prerequisite to applying. Attendees must pay for their own travel and accommodation costs. Individuals with questions concerning this conference may contact Ms. Elinor Walker at telephone (301) 594-1352, ext. 108. Those interested in attending the conference should, no later than December 30, 1994, mail or FAX their names, addresses, and telephone numbers to: Outreach Department National Center for Education in Maternal and Child Health 2000 15th Street, North Arlington, VA 22201-2617 Telephone: (703) 524-7802 FAX: (703) 524-9335 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Referral Office, Division of Research Grants, NIH, for completeness, and by AHCPR/HRSA staff for responsiveness to the RFA. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications may undergo triage by an appropriate peer review group on the basis of relative competitiveness. The AHCPR/HRSA will withdraw from further consideration those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further peer review for scientific merit by a review committee of experts convened by the AHCPR. When an application is reviewed, the peer review committee may recommend further consideration for funding or no further consideration. The committee also assigns priority scores to the applications for which further consideration is recommended. Recommendations of the peer review committee may be reviewed subsequently by AHCPR's National Advisory Council for Health Care Policy, Research, and Evaluation. Review Criteria The general review criteria for these AHCPR/HRSA grant applications are: o significance and originality from a scientific and technical viewpoint; o adequacy of the proposed method(s); o availability of data or proposed plan to collect data required for the project; o adequacy of the plan for organizing and carrying out the project; o qualifications and experience of the Principal Investigator and proposed staff; o reasonableness of the proposed budget; o adequacy of the facilities and resources available to the applicant; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of experimental subjects, and the safety of the research environments. Special Review Criteria In addition to the review criteria noted above, special scientific and technical review criteria also apply. A major review criterion for evaluating applications under this solicitation is the likelihood of obtaining convincing, new information that has the potential for use to improve the delivery of emergency medical services to children. It is the task of the applicant to justify the need for the research and the potential impact of the findings on emergency medical services to children. To the extent that the proposed research is descriptive rather than analytic, investigators must justify the importance of the expected results to understanding and improving EMS services for children. Investigators are encouraged to consider the validity and implications of the major assumption underlying this RFA: that aspects of the emergency care system and products of emergency care research pertaining to adults are inadequate to the needs of children. Applications to explore or test this assumption are not ruled out, and applications based on this assumption will be strengthened by incorporating evidence in its support. AWARD CRITERIA Applications will compete for available funds with all other applications for this RFA. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, and availability of funds. The earliest anticipated date of award for applications will be September 1, 1995. INQUIRIES Inquiries concerning this RFA are encouraged. AHCPR and HRSA staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct programmatic inquiries to: Elinor Walker Center for General Health Services Extramural Research Agency for Health Care Policy and Research 2101 East Jefferson Street Rockville, MD 20852 Telephone: (301) 594-1352, ext. 108 FAX: (301) 594-2155 Email: ewalker@PO3.AHCPR.GOV Jean Athey, Ph.D. Division of Maternal, Infant, Child, and Adolescent Health Maternal and Child Health Bureau, HRSA 5600 Fishers Lane, Room 18-A-39 Rockville, MD 20857 Telephone: (301) 443-4026 FAX: (301) 443-1296 Direct inquiries regarding fiscal matters to: Ralph L. Sloat, Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street Rockville, MD 20852 Telephone: (301) 594-1447 FAX: (301) 594-3210 Email: rsloat@PO7.AHCPR.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Nos. 93.180, 93.226, and 93.127. Awards are made under authorization of the Public Health Service Act, Title IX (42 U.S.C. 299-299c-6) and Title XIX, Section 1910, as amended (42 U.S.C. 300w-9); 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 Part 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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