Full Text HS-95-004


NIH Guide, Volume 24, Number 9, March 10, 1995

RFA:  HS-95-004

P.T. 34


Agency for Health Care Policy and Research

Letter of Intent Receipt Date:  May 15, 1995
Application Receipt Date:  June 20, 1995


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


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).


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


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.


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.


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

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

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.


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.


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.


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


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.


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

General Review Criteria

The general review criteria for AHCPR grant applications are:

o  significance and originality from a scientific and technical

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

The initial review group will also examine the provisions for the
protection of experimental subjects, and the safety of the research

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.


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.


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


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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