Full Text HS-92-02
RFA:  HS-92-02
P.T. 34

  Clinical Medicine, General 

Agency for Health Care Policy and Research
Application Receipt Date:  March 24, 1992
The Agency for Health Care Policy and Research (AHCPR) invites
applications for cooperative agreements to demonstrate research
methods for evaluation of alternative strategies for implementation
of clinical practice guidelines and the effects of implementing
practice guidelines on the delivery of primary care in large-group
practices.  The specific clinical practice guidelines to be evaluated
are:  (1) those developed by the Joint National Committee on
Detection, Evaluation, and Treatment of High Blood Pressure (JNC),
and (2) the forthcoming guidelines for the detection and management
of depressed patients in primary care settings, developed with the
support of the AHCPR Forum on Quality and Effectiveness in Health
Care.  Studies must include an experimental or quasi-experimental
design for evaluating at least two approaches for implementing the
guidelines in group practice settings.  One method must incorporate
the principles of continuous quality improvement (CQI); additional
strategies based on relevant theories of practitioner and
organizational behavior may be selected by the Principal
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 Guidelines in Large Group Practices, is
related to the priority areas of heart disease and stroke, mental
health and mental health disorders, and clinical preventive services.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (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 non-profit entities, such as
universities, hospitals, clinics, state and local governments, and
eligible agencies of the Federal government.  Applications from
minorities and women are encouraged.
This RFA will use the cooperative agreement (U10) mechanism of
support.  The total project period for applications submitted in
response to the present RFA may not exceed three years.
This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary AHCPR peer review procedures.
The AHCPR expects to award a total of $500,000 in FY 1992 for the
support of up to three awards.  This level of support is dependent on
the receipt of a sufficient number of applications of high scientific
merit and the availability of funds for this purpose.
Patient outcomes research has several goals, including: (1)
increasing the knowledge base concerning the effectiveness of
different interventions; (2) using the information developed from
this research to improve decision-making by physicians and patients;
(3) developing and disseminating guidelines that will help physicians
provide appropriate, cost-effective care; and (4) evaluating the
effects of practice guidelines on the processes and outcomes of
patient care.  Research addressing the first two objectives is bettet
developed than the dissemination and evaluation of clinical practice
guidelines.  Assessing the extent to which practice guidelines can
influence practitioner and patient behavior to facilitate the
appropriate use of specific interventions, while discouraging
inappropriate use, is important for translating new information into
the improvement of the quality of care.  The development of practical
strategies for implementing and evaluating clinical practice
guidelines is prerequisite to ascertaining the effects of practice
guidelines on the cost, quality and appropriateness of clinical
The effectiveness of clinical practice guidelines in improving the
quality of health care is dependent upon:  (1) the extent to which
the guidelines provide useful information on the detection,
evaluation, and management of specific diseases and conditions, and
(2) the degree to which practitioners alter practice behavior to
incorporate the guidelines.  Although several guidelines have been
developed by professional organizations, insurers, utilization review
panels and others, the optimal method of implementing guidelines to
effect sustained change in behavior has remained elusive.  Previous
research has shown that even when practitioners view guidelines
favorably, they are slow to change their practices (Lomas, 1989).  A
recent survey of practice guidelines done for the Institute of
Medicine found that implementation and evaluation have received
secondary emphasis relative to development and promotion (Audet,
Eisenberg has proposed six major ways of changing physicians'
practice patterns: education, feedback, participation, administrative
rules, incentives, and penalties (Eisenberg, 1986). Education of
practitioners and feedback have produced marginal improvements, while
changes in reimbursement have decreased the utilization of
ineffective practices in some instances.  Several studies of
practitioner attitudes and behavior have demonstrated that: (1)
practitioners frequently overestimate their compliance with
recommended practices; (2) sustained behavior change requires a
commitment of the practitioners to the guidelines and their
implementation.  Other studies have noted that the development and
dissemination of consensus recommendations has had little apparent
effect on medical practice (Lomas, 1991).   This evidence suggests
that the most effective approaches for implementing practice
guidelines to improve the quality of health care have not yet been
Traditionally, assessment of quality (e.g., physician compliance with
practice guidelines) in health care has been based on the belief that
quality is best achieved by discovering "bad" practices and taking
corrective action.  Either through external quality assurance
mechanisms or regulatory standards, there is an implied or
established threshold for acceptability (Berwick, 1989).  An
alternative approach to improving the quality of medical services is
based on the principles of continuous quality improvement (CQI).
This model engages the support and participation of all members of
the health care team in an effort to achieve continuous improvement
in quality, defined to include the needs and preferences of the
patient (Kritchevsky, 1991).  In this model, all failures to achieve
quality of care can be attributed to one of two sources of error:
those that are intrinsic to the system (systemic) or those that are
external to the system (extrasystemic).  A fundamental precept of
this method is the recognition that medical care is not delivered by
a physician working in isolation, but rather requires the smooth
functioning of a team of workers and a commitment of all members of a
health care organization to the underlying philosophy of CQI.
CQI offers the potential of identifying multiple variables ---
facilitating factors and barriers --- relevant to practitioner
knowledge and behavior and the process of delivering care in practice
settings.  Preliminary reports of the use of CQI in developing and
implementing clinical algorithms for a variety of clinical problems
in a large group HMO setting indicate its promise as one method for
implementing practice guidelines (Gottlieb, 1990).  Additional
research is needed to compare a CQI approach with other methods, as
well as to test how effective this methodology is in other practice
Specific Objectives and Methodologic Considerations
One overall goal of the desired research is to evaluate strategies
for implementation of clinical practice guidelines.  Another overall
goal is to improve the understanding of the process and effects of
such implementation and to incorporate guidelines into practice.  The
proposed research is to be conducted in large group practices
providing primary care.
Two sets of guidelines will be used.  Hypertension guidelines are
available currently from the Joint National Committee (JNC), (1988)
and will be updated in October 1992.  A substantial body of
literature has demonstrated the efficacy of detection and management
of hypertension.  Although persuasive evidence that detection and
management of hypertension can result in measurable reductions in
strokes and cardiac complications has been available since at least
1972 (Veterans Administration, 1972), available data indicate that a
substantial proportion of hypertensive Americans are either not
taking action to reduce their blood pressure or whose hypertension is
not well controlled although they are on a pharmacological regimen
(DHHS, 1991).
Guidelines on the diagnosis and treatment of depressed outpatients in
primary care settings are being developed with the support of the
AHCPR and soon will be available for dissemination and
implementation.  Recent evidence suggests that practitioners fail to
detect depression in primary care settings in a substantial
proportion of patients (Wells, 1989).  Improved detection and
management of depressed patients could lead to measurable
improvements in patients' functional outcomes.  The AHCPR-supported
guidelines will not be available before April 1, 1992.  Therefore,
applicants should design their study consistent with their knowledge
of existing clinical recommendations for depression and the relevant
The following illustrate possible research areas and questions
related to the implementation of practice guidelines:
1.  The effect of practice guidelines on practitioners' knowledge and
o  How do providers evaluate new information and translate this
information to their practices?
o  Which mechanisms, e.g., incentives, penalties, administrative
rules, are most effective in improving practitioner compliance with
o  How will practitioners revise or tailor established or newly
developed guidelines to their individual patients?
2.  The effect of guidelines on practice:
o What is the relative cost-effectiveness of various strategies to
implement guidelines in terms of additional personnel or
administrative mechanisms required to improve compliance with
o  How do practitioners and organizations integrate different sets of
guidelines for the same or similar clinical problems?
o  How do practitioners and patients incorporate practice guidelines
in the context of unrelated concerns, e.g., reason for visit
unrelated to the content of the specific guidelines?
o  How do practitioners and patients prioritize among existing
guidelines for multiple problems, i.e., is there a rationale for
compliance with some guidelines and not others?
o  What are the barriers to implementation of guidelines, and how can
they be addressed?
o  What are the barriers that prevent high-risk patients from
receiving the recommended services?  How can these barriers be
modified or eliminated?
3.  The impact on patient behavior, and ultimately on patient
o  What strategies can practitioners use to modify patients' health
o  What factors influence patients' acceptance of practice
guidelines?  In what ways do the guidelines conflict with patient
expectations for service utilization?
The administrative and funding mechanism to be used to support these
awards will be cooperative agreements (U10) between each awardee and
the AHCPR.  In a cooperative agreement there is substantial Federal
programmatic involvement above and beyond the levels characteristic
for traditional program management of grants.  Modifications of
individual awardees protocols may be necessary to maximize
achievement of the objectives of this RFA by the projects funded.
Needs for such modifications may arise both before and during
implementation of the protocols and cannot always be foreseen before
the studies begin.
The Principal Investigators and key staff, under the terms of this
agreement, are required to meet with the designated program
administrator(s) three times in the first year and every six months
thereafter to standardize key measurements, review progress of
studies, and to discuss appropriate analysis techniques.  Applicants
must request support for such travel in the application.  AHCPR
anticipates that a period of four to six months at the beginning of
the study will be required to standardize definitions and
measurements across sites, and this must be indicated in the time
line of the individual projects.
Under the terms of the cooperative agreement, the awardee defines the
details of the project within the guidelines of the RFA, retains
primary responsibility for performance of the activity and for
analyzing and publishing results, and agrees to accept assistance,
close coordination, and participation of the designated program
administrator in all aspects of the scientific and technical
management of the project in accordance with this RFA and the terms
of the award.
The program regulations at 42 CFR, Part 67, Subpart A and policies
that govern the research grant programs of the PHS will prevail.  All
other pertinent DHHS and PHS grant regulations, policies, and
procedures are applicable.
The AHCPR observes NIH and ADAMHA policy requiring applicants for
cooperative agreements and research grants to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder, or condition
under study.  Special emphasis should be placed on the need to
include minorities and women in studies of diseases, disorders and
conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in research, a
clear and compelling rationale should be provided.
The composition of the proposed study group must be described in
terms of gender and race/ethnicity.  In addition, gender and
racial/ethnic issues should be addressed in developing the research
design and sample size appropriate for the scientific objectives of
the study.  This information should be included on the form PHS 398
in Section 2, A-D of the Research Plan and summarized in Section 2,
E, Human Subjects.  State and local governments using form PHS 5161
should include this information in the Program Narrative section.
Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
the AHCPR recognizes that it may not be feasible or appropriate in
all research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans, Asian/Pacific Islanders, Blacks, Hispanics).  Where
appropriate, the applicant should provide the rationale for studies
on single minority population groups.
For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.
The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.
For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
If the required information is not contained within the application,
the application will be returned.
Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.
All applications for research submitted to AHCPR are required to
address this policy with respect to the inclusion of women and
minorities.  AHCPR will not award grants for applications which do
not comply.  If the required information is not contained in the
application, the application will be returned without review.
Applications must be submitted on the PHS 398 (rev. 10/88)
application form that is available at most institutional business
offices and from the Office of Scientific Review, AHCPR, 2101 East
Jefferson Street, Rockville, MD 20852, telephone 301-227-8449.  State
and local government applicants may use form PHS 5161.
The RFA label available in the 10/88 and 9/91 revision of 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 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 box must be marked.
Submit by March 24, 1992 a signed, typewritten original of the
application, including the Checklist, and five signed, photocopies,
in one package to the following address (State and local governments
may use PHS 5161 and submit an original and two copies):
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
Applications must be received by March 24, 1992.  If an application
is received after that date, it will be returned to the applicant.
At the time of submission, an additional copy of the application,
marked "Advance Copy", must also be sent to:
Paul A. Nutting, M.D., MSPH
Center for General Health Services Extramural Research
Agency for Health Care Policy and Research
Executive Office Center, Suite 502
2101 E. Jefferson St.
Rockville, MD  20852-4908
Upon receipt, applications will be reviewed by AHCPR staff for
completeness and responsiveness.  Applications judged by the AHCPR to
be incomplete or non-responsive (those not directed to the specific
goals of this RFA) will be returned to the applicant without review.
Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific/technical
merit by a peer review group convened by the AHCPR.
Applications may be triaged by the peer review group on the basis of
relative competitiveness.  The AHCPR will withdraw from further
competition 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 scientific merit review.  A second level of review will be
provided by the National Advisory Council for Health Care Policy,
Research and Evaluation.
Listed below are the major review criteria to be used in the
evaluation of each applications received in response to this RFA:
o  significance and originality of the research project in addressing
the goals of the RFA;
o  adequacy of the methodology proposed to carry out the project;
o  adequacy of the plan for obtaining detailed medical record data to
evaluate relevant medical and nonmedical factors related to
implementation of practice guideline and patient outcomes following
o adequacy of the plan for organizing and executing the project;
o  qualifications and experience of the Principal Investigator and
proposed staff, particularly with respect to conducting research in
quality improvement and quality assurance;
o  reasonableness of the budget and the time frame for the project in
relation to the work proposed;
o  adequacy of the facilities and resources available to the grantee,
particularly in making available practice sites that are already
using a CQI approach to quality improvement and have the ability to
randomize patients and/or practitioners.
The anticipated date of award is August 1, 1992.
Written and telephone inquiries concerning this RFA are encouraged.
Direct inquiries regarding programmatic issues to:
Paul A. Nutting, M.D., MSPH
Center for General Health Services Extramural Research
Agency for Health Care Policy and Research
Executive Office Center, Suite 502
2101 E. Jefferson St.
Rockville, MD  20852-4908
Telephone:  (301)-227-8357
Direct inquiries regarding fiscal and administrative matters to:
Ralph Sloat
Chief, Grants Management Branch
Agency for Health Care Policy and Research
Executive Office Center, Suite 601
2101 E. Jefferson St.
Rockville, MD  20852-4908
Telephone:  (301)-227-8447
This program is described in the Catalog of Federal Domestic
Assistance No. 93.226.  Awards are made under authority of Title IX
of the Public Health Service Act, as amended (42 USC 299), and
administered under PHS grants policies and in accordance with program
regulations (Title 42 CFR, Part 67, Subpart A).  The requirements of
Executive Order 12372, "Intergovernmental Review of Federal
Programs," are not applicable to AHCPR research grant programs.
1.  Lomas J., Anderson G.M., Domnick-Pierre K., Vayda E., Enkin M.W.,
Hannah W.J.  Do practice guidelines guide practice? The effect of a
consensus statement on the practice of physicians.  New Engl J Med
1989; 321: 1306-1311.5.
2.  Audet A. and Greenfield S. A survey of Current Activities in
Practice Guideline Development.  Paper prepared for an IOM Meeting on
Medical Practice Guidelines: Looking Ahead, Washington, DC, November
8, 1989.
3.  Eisenberg, John M. Doctors' Decisions and the Cost of Medical
Care.  Health Administration Press, Ann Arbor, Michigan, 1986.
4.  Lomas, J. Words without action? The production, dissemination,
and impact of consensus recommendations. Ann Rev Publ Health 1991;
12: 41-65
5.  Berwick, D.M.  Continuous improvement as an ideal in health care.
New Engl J Med 1989; 320:53-56.
6.  Kritchevsky, S.B., Simmons, B.P. Continuous quality improvement.
JAMA 1991; 266: 1817-1823.
7.  Gottlieb L.K., Margolis C.Z., Schoenbaum S.C. Clinical practice
guidelines at an HMO: development and implementation in a quality
improvement model.  QRB 1990; (February) 80-86.
8.  1988 Joint National Committee. The 1988 report on the Joint
National Committee on Detection, Evaluation, and Treatment of High
Blood Pressure.  Arch Intern Med 1988; 148: 1023-1038.
9.  Veterans Administration Cooperative Study Group on
Antihypertensive Agents.  Effects of treatment on morbidity of
hypertension. III. Influence of age, diastolic pressure, and prior
cardiovascular disease: further analysis of side effects. Circulation
1972; 45: 991-1004
10.  Department of Health and Human Services, Healthy People 2000,
DHHS Publication No. (PHS) 91-50212, Washington, DC, 1991, p.391
11.  Wells K.B., Hays, R.D., Burnam A., Rogers W., Greenfield S.,
Ware J.E. Detection of depressive disorder in patients receiving
prepaid or fee for service care. JAMA 1989; 262: 3298-3302.

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