Full Text HS-95-004 HEALTH SERVICES RESEARCH ON ADVANCE DIRECTIVES NIH Guide, Volume 24, Number 9, March 10, 1995 RFA: HS-95-004 P.T. 34 Keywords: 0730021 0730052 Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 15, 1995 Application Receipt Date: June 20, 1995 PURPOSE The Agency for Health Care Policy and Research (AHCPR) is soliciting applications for research on advance directives. Research applications are invited for establishing and evaluating a pilot study of the effectiveness of a community focused, home-based approach to completion of advance medical care directives by individuals. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign non-profit organizations, public and 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 Investigators. MECHANISM OF SUPPORT This request for applications 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. This is a one-time solicitation. The total requested project period may not exceed two years. FUNDS AVAILABLE The AHCPR expects to make one award of up to $700,000 (total cost) over a two-year period to meet the objectives of this RFA. Funding for the first year will not exceed $350,000 total cost. This is a one time solicitation, with the first year of funding to be awarded in Fiscal Year 1995. No award will be made if, as a result of the scientific and technical review, none of the applications is judged to be of high merit. Continuation of the grant for the second year will depend on evaluation of a one-year progress review by AHCPR, and the availability of funds. RESEARCH OBJECTIVES Definition and Significance An advance directive is a means of recording a person's preferences regarding future health care decisions while the person is fully competent. Such recorded preferences may be used to guide the actual decisions that are made at a later time, should the person become incompetent. Advance directives commonly take one of two forms. A living will records the person's health care preferences in the event he or she has a terminal illness. The other form, the durable power of attorney for health care, sometimes called "medical power of attorney," or "health care proxy," records the individual chosen by the person to make decisions on his/her behalf if necessary. Thus, one form of advance directive focuses on what health care will be chosen, while the other focuses upon who is most trusted by the patient to do the choosing. These goals are not mutually exclusive and combined forms of advance directives are increasingly common. Advance directives are designed to accomplish a number of functions. They protect an individual's right to choose or to refuse various forms of health care, even in the face of the development of decisional incapacity. They provide additional assurance that the care provided for an incompetent patient will actually match that patient's personal values. They transfer a critical health-care decision point from the time of a patient's decisional incapacity to an earlier time when the person is fully competent. Historical Background In the decade of the 1960s, medicine introduced a number of technologies capable of prolonging life in critically ill patients, including cardiopulmonary resuscitation, mechanical ventilation, and renal dialysis. For a time, the excitement over the initial success of these treatments displaced concerns about the negative impact of such technologies upon patient autonomy, or about the balancing of the value of life's quality with its quantity. In concert with these technological advances, the field of biomedical ethics expanded greatly between 1970 and 1985. Early biomedical ethics discussions focused upon the value of patient autonomy, and the right of the competent patient to choose or to refuse various forms of medical care, including life-prolonging therapy. Around 1970, the earliest form of "living will" was introduced. The importance of respect for informed consent as a guiding ethical principle was firmly entrenched by the time the President's Commission for the Study of Ethical and Legal Problems in Medicine and Biomedical and Behavioral Research issued its 1983 influential report, Deciding to Forego Life-Sustaining Treatment (U.S. Government Printing Office, Washington, DC Stock number: 040-000-00470-0). That report encouraged the use of advance directives and popularized use of the generic term. Concern about use of life-sustaining technologies was outlined in two Office of Technology Assessment reports (U.S. Congress, Office of Technology Assessment: Life-Sustaining Technologies and the Elderly, OTA-BA-306, Washington, DC, U.S. Government Printing Office (GPO), July 1987; and, Institutional Protocols for Decisions about Life-Sustaining Treatments--Special Report, OTA-BA-389, Washington, DC, GPO, July 1988). More recently, the value of advance directives has been generally assumed, and attention has been devoted to refining and improving the various forms or documents which can be used to record patient preferences. At the same time, empirical research has been conducted, and many more data are available about the prevalence and effectiveness of advance directives. AHCPR has funded much of the empirical research on this question, having 10 projects currently underway and 7 projects completed. Research has been conducted in hospitals, nursing homes, physicians' offices, and the community. The Patient Self-Determination Act In 1990, Congress, prompted by concerns similar to those expressed by the President's Commission report of 1983, and by the low rates of execution of directives among the population, passed the Patient Self-Determination Act. This law directs that all patients admitted to Medicare and Medicaid certified providers, including hospitals, nursing facilities, hospices, home health agencies, and pre-paid health plans must receive some form of counselling regarding their right to refuse medical treatment and their right to complete an advance directive under the laws of their State. Patients must be asked whether they already have an advance directive, and if they do, the directive must be made part of the medical record in a manner that assures easy retrieval in a later emergency. Institutions are also required to perform some type of public outreach and education around advance directives. Some have argued that passage of this law solved the advance directive "problem" and that further research is not needed to guide policy. However, the law does not mandate discussion of advance directives in most outpatient, primary care settings, where many experts feel that these discussions would optimally occur. Given the disappointing advance directive completion rates in studies where experienced primary care providers spent a good deal of time educating and counselling patients, it is reasonable to question whether the often perfunctory methods many hospitals have used to comply with the law, such as having the admitting clerk hand the patient a brochure, could possibly have any beneficial effect. Additionally, many providers have interpreted the Patient Self-Determination Act as if it were focused solely on do-not-resuscitate (DNR) orders. This points out the problem, that while an individual's plans may be for a broad scope and level of care at the end of his or her life, these plans may be reduced to the very narrow question of whether the patient is a "DNR" or "full code." Decisions may be made as if cardiopulmonary resuscitation were the only decision that matters, or cardiopulmonary arrest is the only medical contingency for which advance planning is desirable. Also, many practitioners do not discuss advance directives with their patients even though their patients may be willing to do so (Loewy EH, Carslon RW. Archives Internal Medicine 1994; 154:2265-7). While the Patient Self-Determination Act may have changed the practice environment in a positive direction, the need for research in advance directives persists. This was recognized by the Senate Appropriations Committee which directed AHCPR to support a study in this area (S.103-318). Future Research Needs A conference was held in September 1993, supported by AHCPR, the Greenwall Foundation, The Kornfeld Foundation, and the Walter and Elsie Haas Fund. The purpose of the conference was to assess the current state-of-knowledge about decision-making for incapacitated adults, giving special attention to the role of advance directives and aiming to establish priorities for further theoretical and empirical research in this area. This invitational working conference assembled 36 leading investigators to make recommendations on the priorities for both theoretical and empirical research in the wake of the Patient Self-Determination Act. Conference participants reached consensus that future research on advance directives should focus on a broad process of communication that participants called "advance care planning." The consensus statement derived from this conference was published in a Special Supplement to the Hastings Center Report (November-December 1994 issue) entitled "Advance Care Planning: Priorities for Ethical and Empirical Research." Potential applicants under this RFA are encouraged to read this report. It is available from the National Technical Information Service (NTIS) order number PB95-147740. A limited number of copies are available from program staff listed under INQUIRIES. Specific Goals of this RFA Research under this RFA should address the issue of the low percentage of the general public who have completed an advance medical directive. Specifically, this RFA calls for a pilot project to assess the effectiveness of a community focused, home-based approach to encouraging the completion of advance medical directives, including bona fide advance directives documentation. The pilot project should be initiated in four geographic and ethnically diverse locations. It is desirable that the research should evaluate the validity of advance directives executed in this setting. Validity includes the concepts of accuracy and of stability. Accuracy in this context is the issue of how well the advance directive explains or is consistent with the person's true desires. Stability refers to how long the advance directive actually represents the person's desires. The research should address differences in motivational and procedural barriers to completing an appropriate living will or health care power of attorney. SPECIAL REQUIREMENTS 1. The AHCPR does not endorse, recommend or specify which or what particular documentation is to be used. However, it is expected that the applicant will specify and justify the advance directive documentation to be used with respect to validity, reliability, and stability of patient preferences for life sustaining treatment. 2. This pilot project should be administered by an organization with a demonstrated record of education achievements in adult learning and community involvement. The organization should affiliate with an academic institution experienced in this area. The research design must be rigorous. 3. The applicant's literature review should demonstrate evidence of substantive understanding of advance directives research supported by AHCPR as to avoid duplication and to enhance utilization of prior research. Applicants may obtain a listing of AHCPR supported projects from program staff listed under INQUIRIES. 4. The proposed research design should be sensitive to the consensus statement on behalf of the September 1993 conference participants that appears in the Special Supplement (pp S32-36) to that statement, noted above. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups must be included in all AHCPR 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 this policy from the AHCPR program staff listed under INQUIRIES. AHCPR program staff may also provide additional relevant information concerning this policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 15, 1995, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator, co-investigators and other key personnel; the applicant institution and other participating organizations or institutions; 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. The letter of intent should be sent to: Julius Pellegrino Agency for Health Care Policy And Research 2101 East Jefferson Street, EOC/Suite 502 Rockville, MD 20852-4908 APPLICATION PROCEDURES Applications are to be submitted on research 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. These forms are available at most institutional offices of sponsored research; and the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892. Applications for AHCPR support are also available from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone 301-656-3100 (FAX 301-652-5264). The RFA label available in the form PHS 398 (rev. 9/91) 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, type "RFA HS-95-004" in Section 2a on the face page of the application form and mark the "YES" box. 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 mail) At the time of submission, two additional copies of the application must be sent to: Julius Pellegrino Agency For Health Care Policy And Research 2101 East Jefferson Street, EOC/Suite 502 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by June 20, 1995. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Referral Office, Division of Research Grants, NIH, for completeness, and by AHCPR staff for responsiveness to the RFA. Incomplete applications will be returned to the applicant without further consideration. Nonresponsive applications will be transferred to a standing AHCPR or other appropriate scientific review group convened by the AHCPR for review through routine mechanisms. The determination of any application as nonresponsive will be the sole responsibility of AHCPR. Applications may undergo advance review by the peer review group on the basis of relative scientific and technical competitiveness. The AHCPR will withdraw from further consideration those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. When an application is reviewed, the peer review committee may recommend further consideration 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. The peer review process is rigorous, and only those applications judged to be of greatest merit will be recommended for further consideration. General Review Criteria The general review criteria for AHCPR 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 general review criteria noted above, the reviewers will assess applicants' treatment of the SPECIAL REQUIREMENTS of this RFA, i.e. documentation, organization, literature review, and consensus statement. AWARD CRITERIA Applications will compete for available funds with all other applications for this RFA. In making funding decisions, AHCPR will consider: quality of the proposed project as determined by peer review, availability of funds, and program balance. INQUIRIES The AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding program matters to: Julius Pellegrino, Program Staff Agency For Health Care Policy and Research 2101 East Jefferson Street, EOC/Suite 502 Rockville, MD 20852-4908 Telephone: (301) 594-1357 Ext 138 FAX: (301) 594-3721 Email: JPELLEGR@po3.ahcpr.gov Direct inquiries regarding fiscal matters to: Ralph Sloat, Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, EOC/Suite 601 Rockville, MD 20852-4908 Telephone: (301) 594-1447 Email: RSloat@po7.ahcpr.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.226. Awards are made under authorization of the Public Health Service Act, Title IX, and are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR Part 67, Subpart A, and 45 CFR Part 74 (45 CFR Part 92 for State and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372. 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 routing 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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