Full Text HS-94-007

EVALUATION OF THE USE OF CLINICAL PRACTICE GUIDELINES

NIH GUIDE, Volume 23, Number 16, April 29, 1994

RFA:  HS-94-007

P.T. 34

Keywords: 
  0715123 
  AIDS 
  Burns 
  Depression 


Agency for Health Care Policy and Research
National Institute of Mental Health

Letter of Intent Receipt Date:  June 17, 1994
Application Receipt Date:  July 21, 1994

PURPOSE

The Agency for Health Care Policy and Research (AHCPR) and the
National Institute of Mental Health (NIMH) invite applications for
cooperative agreements related to evaluating AHCPR-supported clinical
practice guidelines.  Specifically, cooperative agreements are sought
to evaluate the effects of implementing practice guidelines in
primary care.  The AHCPR-supported clinical practice guidelines
relevant to this Request for Applications (RFA) are:  (1) Urinary
Incontinence in Adults; (2) Early HIV Infection:  Evaluation and
Management; (3) Sickle Cell Disease:  Screening, Diagnosis,
Management, and Counseling in Newborns and Infants; (4) Unstable
Angina:  Diagnosis and Management; and (5) Depression in Primary
Care:  Detection, Diagnosis and Treatment.  NIMH will support grants
only on the depression guideline.

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,
Evaluation of the Use of Clinical Practice Guidelines, is related to
several priority areas.  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 organizations, public and
private, including universities, clinics, State and local
governments, and non-profit foundations; or consortium of
organizations.  The AHCPR by law can support only non-profit
organizations or a consortium of organizations, if the application is
submitted by a domestic, non-profit, public or private organization.
The NIMH can directly support for-profit organizations.  Applications
from minority and women investigators are encouraged.

MECHANISM OF SUPPORT

The administrative and funding instrument for this program will be
the cooperative agreement (U01), an "assistance" mechanism in which
substantial AHCPR scientific and programmatic involvement with the
awardee is anticipated during the performance of the project.  The
total project period for each application submitted in response to
this RFA may not exceed three years.  The anticipated award date is
September 30, 1994.  Award of funding beyond the initial budget
period will depend upon annual progress reviews by the AHCPR/NIMH and
the availability of funds.

FUNDS AVAILABLE

The AHCPR expects to award a total of $750,000 for the first year to
support up to three awards.  NIMH expects to award a total of
$750,000 for the first year to support up to three awards for studies
on the depression guideline.  This is a one time solicitation.

RESEARCH OBJECTIVES

Background

A major effort of the AHCPR has been to facilitate the development
and dissemination of clinical practice guidelines to help
practitioners provide appropriate and effective care.  Evaluation of
AHCPR-supported clinical practice guidelines has been ongoing, with
several contracts and cooperative agreements underway.  An RFA for
cooperative agreements released January 24, 1992 led to the award of
agreements to demonstrate methods to evaluate the implementation of
two guidelines.  This previous RFA required the studies to be
conducted in large group practice settings and incorporate principles
of continuous quality improvement (CQI).  The current RFA does not
have these restrictions, deals with five AHCPR-supported clinical
practice guidelines, and is not directed at evaluation of the
implementation method.

Interest in clinical practice guideline development in the United
States has grown steadily in recent years, and is anticipated to
continue.  Guidelines have many possible intended and unintended
effects.  AHCPR-supported guidelines are intended to enhance the
quality, appropriateness, and effectiveness of health care.  The
authorizing legislation for the AHCPR requires  guidelines that "may
be used by physicians, educators, and health care practitioners to
assist in determining how diseases, disorders, and other health
conditions can most effectively and appropriately be prevented,
diagnosed, treated and managed clinically."  Guidelines are expected
to facilitate the appropriate use of specific interventions, while
discouraging inappropriate use.  Consequently, many guidelines are
expected to have some effect on health care costs.  Although
guidelines may have many different effects, this RFA is limited to
studying the effects specified below.

In general, the effectiveness of clinical practice guidelines in
improving the quality of health care depends on the degree to which
practitioners alter practice behavior to incorporate the guidelines.
A prerequisite to determining practice guidelines' effects on cost,
quality and appropriateness of clinical services is to assess their
effect on practitioner and patient behavior.  Practitioner behavior
is therefore an important subject for this RFA.  A review of these
issues was presented in the previous RFA (see January 24, 1992 NIH
Guide or retrieve Document 94-5007 from AHCPR Instant FAX, (301)
594-2800), and more recently by Woolf (Archives Internal Medicine
1993; 153:2646-55) and by Grimshaw and Russell (Lancet 1993; 342:
1317-22).

The effect of guidelines on health status is difficult to measure,
and may require large and long-term studies.  Nevertheless, the
effect of guidelines on health status and, in particular, on
short-term or intermediate health outcomes is also a legitimate topic
for projects under this RFA.

Specific Objectives and Methodological Considerations

Applicants may study the effects of one or more of the following
AHCPR-supported clinical practice guidelines:  (1) Urinary
Incontinence in Adults; (2) Early HIV Infection:  Evaluation and
Management; (3) Sickle Cell Disease:  Screening, Diagnosis,
Management, and Counseling in Newborns and Infants; (4) Unstable
Angina:  Diagnosis and Management; and (5) Depression in Primary
Care:  Detection, Diagnosis and Treatment.  For copies of these
guidelines, contact:

AHCPR Publications Clearinghouse
P.O. Box 8547
Silver Spring, MD  20907
Telephone:  (800) 358-9295

Each AHCPR-supported guideline is available in at least three
formats:  clinical practice guideline, quick reference guide for
clinicians, and patient guide.  Applicants may focus their
investigation on particular guideline formats or on specific
guideline components, providing that the intent and integrity of the
guidelines are preserved.  The focus of the investigation should be
specified clearly in the application.

This RFA addresses the question:  "How do these AHCPR-supported
guidelines make a difference?"  Generally, proposed evaluation
activities should take the form of experimental or quasi-experimental
designs.  The evaluation should include pre- and post-intervention
measures.  A concurrent comparison group not targeted for
intervention should be included.  The concurrent comparison group
need not be insulated from the guidelines, and may receive some
information ("attention control").  Alternative research designs may
be considered, but applicants should describe a firm scientific basis
for the approach(es) approved.  Applicants should clearly identify
the target group(s) who will be the focus of the intervention and the
methods by which the guidelines will be introduced.

Research under this RFA should evaluate one or more of the following
potential effects of clinical practice guidelines on the delivery of
primary care.  This may be done in any setting in which the research
goal(s) may be met.

o  What are the guidelines' effects on practitioner behavior?

o  What is the effect of guidelines on practitioner attitudes towards
treating or managing the subject disease/condition?

o  What is the effect of guideline implementation on health care
service utilization?

o  What is the effect of guideline implementation on health care
costs, considering both decreased costs associated with decreasing
inappropriate care and increased costs associated with improved
detection, recognition, or treatment?

o  What effects do guidelines have on patient outcomes, health
status, quality of life, or satisfaction with care for the condition
under study?

o  How can methods to measure the effect of clinical practice
guidelines be improved or made more efficient?

An additional question for research under this RFA is the following:
how is guideline implementation affected by the type of organization
or practitioner with which implementation occurs?

For those evaluating the depression guideline, the following
additional questions are suggested:

o  What is the impact of the guideline implementation on the
diagnosis, treatment (pharmacological and psychosocial), and referral
of patients suffering from depression?

o  What is the impact of the depression guideline on patients as
measured by self report and clinician ratings?

SPECIAL REQUIREMENTS

The issuance of awards will be contingent on the availability of
funds and on the quality of the applications.  No awards will be made
if, as a result of the scientific and technical review, applications
are not judged to be of high merit.  The initial review committee may
recommend support for less than the requested period or amount.

AHCPR policy regarding evaluation of clinical practice guidelines
requires that if a current or former chair, member, consultant, or
contractor staff of an  AHCPR-supported practice guideline panel is
involved in seeking a grant or contract to evaluate an
AHCPR-supported guideline that the individual helped develop, this
prior relationship must be disclosed in the grant application.  AHCPR
generally will not award a grant if there is the possible perception
of bias or lack of objectivity, except in unusual circumstances to
ensure the interests of scientific progress and public health.  (The
AHCPR policy was published in the July 23, 1993 issue of the NIH
Guide.  It is available as document number 94-5006 via AHCPR Instant
FAX, (301) 594-2800.)

Terms and Conditions of Award

The administrative and funding instrument to be used for this program
will be the cooperative agreement (U01), an assistance mechanism
(rather than an acquisition mechanism) in which substantial
AHCPR/NIMH scientific and programmatic involvement with the
awardee(s) is anticipated during the performance of the activity.
The awardee(s) will have primary responsibility for all tasks and
activities, including any sampling, protocol development, data
collection, data analysis, preparation of publications, community
involvement, and liaison with health care providers.  The AHCPR/NIMH
role in the cooperative agreement will include providing advice in
study development; priority setting; establishing two coordinating
committees; participation in preparing publications; and
disseminating research findings.

1.  Awardee Responsibilities

The awardee(s) will have primary and lead responsibility for all
activities and should describe in the application the plans to:

o  obtain all data necessary to complete the proposed evaluation(s);

o  establish and maintain suitable arrangements with health care
providers and others appropriate to the evaluation;

o  use appropriate scientific and analytical expertise to design and
complete the evaluation; and

o  share information with the AHCPR/NIMH collaborating research
official and provide feedback to guideline panels regarding any
information gained regarding how practitioners sought clarification,
revised, or otherwise adapted the guidelines for application to their
practices; and

o  cooperate with AHCPR/NIMH on coordinating committee functions,
such as data analysis, the preparation of background information, or
other analytical activities relating to the evaluation (since
committee structure and scheduling is as yet undetermined, applicants
should not budget for committee activities; additional costs
associated with committee activities are planned to be funded by
grant supplements).

The AHCPR/NIMH is committed to disseminating the products of the
evaluation as rapidly as possible.  In this context, products include
both written reports of project information and results, and the data
themselves.  The AHCPR/NIMH will have access to the products of the
evaluation upon request.  All rights of access to the data will be
consistent with AHCPR regulations 42 CFR 67, Subpart A, as well as
with section 903(c) of the PHS Act.

2.  AHCPR/NIMH Staff Responsibilities

The AHCPR/NIMH collaborator will have substantial scientific and
programmatic involvement during the conduct of this activity, through
technical assistance, advice, and coordination beyond the normal
program stewardship for grants.  Collaboration on study design,
protocol development, and analysis will occur after the award(s) is
(are) made.  Specifically, AHCPR's/NIMH's role during the project
period will include providing technical assistance, advice, and
support to the Principal Investigator in the areas of:

o  monitoring the evaluation;

o  contributing to various analyses and their presentations;

o  establishing two coordinating committees described below; and

o  disseminating project information and results through
AHCPR's/NIMH's publication program and assisting in selecting
additional mechanisms for effective dissemination.

However, AHCPR's/NIMH's role will not interfere with the individual
Principal Investigator's role and responsibility to describe the
project and present the results in scientific journals.

The AHCPR/NIMH will work with awardees and any other appropriate
parties, such as co-funding Institutes, to establish two coordinating
committees.  One committee will assist various awardees under this
RFA in selecting comparable or similar data elements, in order to
strengthen the opportunities for pooling data and making broader
analyses and inferences.  A second committee will oversee
collaborative efforts to develop joint papers and other research
products that involve pooled data, i.e., data and findings from more
than one awardee.  There may be considerable overlap in membership of
the two coordinating committees.  The AHCPR/NIMH collaborators will
be ex-officio members of each committee.

Each year's continuation award is subject to a progress review by
AHCPR/NIMH, in addition to the availability of funds.  The progress
review may involve a site visit to the awardee by AHCPR/NIMH staff
and expert consultants to AHCPR/NIMH.  The progress review will
address the awardee's progress, compliance with the basic review
criteria listed below, and adherence to the provisions of its
approved application.  If such a continuation review indicates that
insufficient progress has been made, AHCPR/NIMH may discontinue
funding.

The substantial AHCPR/NIMH involvement will apply in addition to and
not in lieu of otherwise applicable PHS policies and Federal
regulations.

If the creation of educational tools or other devices to facilitate
implementation of practice guidelines is supported in whole or in
part by the award, rights to such tools or devices will be in the
public domain.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.

This new policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43) and supersedes and strengthens
the previous policies (Concerning the Inclusion of Women in Study
Populations, and Concerning the Inclusion of Minorities in Study
Populations), which have been in effect since 1990.  The new policy
contains some new provisions that are substantially different from
the 1990 policies.  All investigators proposing research involving
human subjects should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research," which have been
published in the Federal Register of March 9, 1994 (FR 59
11146-11151), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS
of March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the NIMH
program contact listed under INQUIRIES.  The NIMH program contact may
also provide additional relevant information concerning the policy.

It is the policy of the 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 is provided that inclusion is
inappropriate with respect to the health of the subjects or the
purpose of the research.

The AHCPR supports the new NIH policy, which supersedes and
strengthens NIH's previous policies that the AHCPR had adopted.  The
AHCPR plans to publish guidelines on women and minorities specific to
the AHCPR.  In the interim, the AHCPR will follow the NIH guidelines,
as applicable.  The AHCPR program contact listed under INQUIRIES may
also provide additional relevant information concerning AHCPR's
policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 17, 1994, a
letter of intent that includes the name, address, and telephone
number of the Principal Investigator, co-investigators and other key
personnel; the guidelines selected for evaluation; member
institutions, including any other participating organizations or
institutions; and the number and title of the 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 staff to estimate the potential review workload and avoid
conflict of interests in the review.  The letter of intent is to be
sent to the Dr. James Cooper at the address listed under INQUIRIES.

APPLICATION PROCEDURES

The application receipt date is July 21, 1994.  Applications are to
be submitted on the research grant application form PHS 398 (rev.
9/91).  State and local government applicants may use form PHS 5161,
Application for Federal Assistance.  These forms are available at
most institutional offices of sponsored research; 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 label available in the PHS 398 application form must be
affixed to the bottom of the face page of the original copy of the
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-94-007" and
"Evaluation of the Use of Clinical Practice Guidelines" in Section 2a
on the face page of the application form and the YES box must be
marked.

Complete information must be submitted with the application.
Consortium arrangements typically take the form of a formal agreement
between the grantee and other organization(s).  In the grant
application, a separate budget page must be included for each
organization involved in the proposed consortium arrangement.

The completed, signed, original application, including the Checklist,
and four legible copies (two copies when using the PHS 5161) must be
sent or delivered to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

Applications submitted under this RFA must be received in the
Division of Research Grants, NIH, by July 21, 1994.  If an
application is received after that date, it will be returned to the
applicant.

One copy, labeled "Advance Copy," must be submitted simultaneously
to:

James Cooper, M.D., Project Officer
Center for General Health Services Extramural Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 502
Rockville, MD  20852-4908

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by the Referral Office,
Division of Research Grants, NIH, for completeness, and by AHCPR/NIMH
staff for responsiveness to the RFA.  Incomplete and nonresponsive
applications will be returned to the applicant without further
consideration.  The determination of any application as nonresponsive
will be the sole responsibility of AHCPR/NIMH.  Applications may
undergo triage by an appropriate peer review group on the basis of
relative competitiveness.  The AHCPR/NIMH 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 was recommended.  Recommendations of the peer review
committee will be reviewed subsequently by AHCPR's National Advisory
Council for Health Care Policy, Research, and Evaluation; or the
Mental Health National Advisory Council.  For NIMH, by law, only
applications recommended by the Mental Health National Advisory
Council can be considered for funding.  The peer review process is
rigorous, and only those applications judged to be of greatest merit
will be recommended for further consideration.

Review Criteria

The general review criteria for AHCPR/NIMH grant and cooperative
agreement applications are:  significance and originality from a
scientific and technical viewpoint; adequacy of the proposed
method(s); availability of data or proposed plan to collect data
required for the project; adequacy of the plan for organizing and
carrying out the project; qualifications and experience of the
principal investigator and proposed staff;  reasonableness of the
proposed budget; and adequacy of the facilities and resources
available to the applicant.

Special Review Criteria

In addition to the review criteria noted above, the following special
scientific and technical review criteria will apply:

o  the generalizability of the evaluation model, (e.g., the potential
to use the evaluation model to evaluate the effect of implementing
other guidelines or evaluate guidelines in similar practice
settings);

o  the degree to which the evaluation data (dependent variables) are
measures of the intended effects of AHCPR- supported guidelines and
of whether the guidelines are being utilized;

o  the feasibility of widespread implementation of the guidelines in
the manner studied;

o  the implementation assures that subject practitioners are aware of
the guidelines, and have adequate knowledge of their content, (i.e.
the application provides enough description of how implementation is
planned to assure reviewers that the implementation is feasible and
suitable); and

o  accommodation of the effect of time, i.e., secular trends and
other time-associated effects, in the concept and analysis.

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, program balance, and availability of
funds.  For applications principally assigned to NIMH, the right to
convert applications to the research project grant mechanism (R01),
as necessary, is reserved by NIMH.

INQUIRIES

Direct inquiries regarding programmatic issues, including information
on the policy of inclusion of women and minorities in study
populations, to:

James Cooper, M.D., Project Officer
Center for General Health Services Extramural Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 502
Rockville, MD  20852-4908
Telephone:  (301) 594-1354, ext. 141

Kathy Magruder, Ph.D., M.P.H.
Division of Epidemiology and Services
National Institute of Mental Health
5600 Fishers Lane, Room 10C-06
Rockville, MD  20857
Telephone:  (301) 443-3364

Harold H. Goldstein, Ph.D.
Division of Epidemiology and Services
National Institute of Mental Health
5600 Fishers Lane, Room 10C-06
Rockville, MD  20857
Telephone:  (301) 443-3364

Direct inquiries regarding fiscal matters to:

Ralph Sloat
Grants Management Office
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852-4908
Telephone: (301) 594-1447

Bruce Ringler
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-08
Rockville, MD  20857
Telephone:  (301) 443-3065

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance numbers 93.226 and 93.242.  Awards are made under
authorization of the Public Health Service Act, Title IX and Title
IV, Part A (Public Law 78-410 as amended by Public Law 99-158, 42 USC
241 and 285); and administered under the PHS Grants Policy Statement
and Federal Regulations 42 CFR 67, Subpart A, 42 CFR 52, and 45 CFR
Part 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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