Full Text HS-98-005
 
QUALITY OF CARE UNDER VARYING FEATURES OF MANAGED CARE ORGANIZATIONS
 
NIH GUIDE, Volume 26, Number 31, September 19, 1997
 
RFA:  HS-98-005
 
P.T.


Keywords: 

 
Agency for Health Care Policy and Research
 
Letter of Intent Receipt Date:  October 31, 1997
Application Receipt Date:  January 6, 1998
 
PURPOSE
 
The Agency for Health Care Policy and Research (AHCPR) invites
applications for cooperative agreements that will assess the
association between features of managed care organizations, health
outcomes, and quality of care for patients with chronic diseases.
These cooperative agreements will be co-sponsored by the American
Association of Health Plans Foundation (AAHPF) under a partnership
agreement with AHCPR.
 
Studies should focus on one or more conditions meeting the following
criteria:  high prevalence, association of outcomes with quality of
care, ease of severity assessment with inexpensive measures, some
outcomes measurable within a two-year time frame, and adequate
patient numbers across the severity spectrum.  Aggregations of
conditions might be selected for study if the data are adequate and
methodologies are sound, particularly if these conditions apply to
special populations such as children, women, minority populations, or
the elderly.
 
The AAHPF and AHCPR will each contribute half of each project's
funding.  Applicants are asked for written permission to share with
AAHPF applications that AHCPR intends to fund, along with a summary
of the results of peer review of those applications.
 
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
encourages 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 202-512-1800.
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic or foreign, public or
private non-profit organizations, including universities, clinics,
units of State and local governments, and other non-profit
organizations and foundations.  For-profit organizations are not
eligible as applicants, but may participate as members of consortia
or as subcontractors. Organizations described in section 501(c)4 of
the Internal Revenue Code that engage in lobbying are not eligible to
receive grant/cooperative agreement awards.
AHCPR encourages women, members of minority groups, and persons with
disabilities to apply as Principal Investigators.
 
MECHANISM OF SUPPORT
 
The RFA mechanism of support is the cooperative agreement, U01, in
which there will be substantial scientific and programmatic
involvement by AHCPR and AAHPF.  The total project period for
applications submitted in response to this RFA may not exceed 3
years.  The earliest anticipated award date is April 1, 1998.
 
FUNDS AVAILABLE
 
Dependent upon the availability of funds, AHCPR expects to award up
to $1.5 million (direct plus indirect costs) and AAHPF a comparable
amount in fiscal year 1998 to support the first year of approximately
four to seven projects under this RFA.  The number of awards is
dependent on the number of high quality applications and their
individual budget requirements; it is not the intent of AHCPR/AAHPF
that the awards be equal in size.  Funding beyond the initial budget
period will depend upon annual progress reviews and the continued
availability of funds.  The expectation is that AHCPR and AAHPF will
each contribute up to $3.5 million over a three-year period for these
projects.  Indirect costs awarded by AHCPR will be in accord with
federally established indirect cost rates.  Indirect costs awarded by
AAHPF will be in accord with AAHPF's nine (9) percent limit.
 
RESEARCH OBJECTIVES
 
Background
 
Managed Care Organizations (MCOs) include health plans with enrolled
populations, integrated delivery systems or networks that provide
comprehensive services to regular users even if users are not
enrolled in a single health plan, and employer-based groups where the
employer exercises essential features of managed care such as
selection of preferred providers and financial incentives for cost
effective treatment.
 
Only limited research has compared quality of care and health
outcomes for patients with chronic disease conditions in relation to
changing structures and operations within MCOs.  Information from
such studies would be helpful for: (a) plans and providers to improve
quality of care; (b) consumers to consider when making health care
decisions; and (c) employers, certifying agencies, and public
programs in making decisions about how to design and encourage
development of financing and delivery systems that result in high
quality of care.
 
The quality of medical care, whether managed or not, has been
criticized in many studies.  Some studies have shown that
practitioners frequently fail to assess patients' understanding of
their illness (Cohen MZ, et al., 1994) or their ability to function
(Rubenstein LV, et al., 1989; Wasson J, et al., 1992).  In addition,
surveys and audits regularly reveal failures to comply with
well-established guidelines of care for patients with chronic
conditions (see e.g., Cassell EJ, 1991; Stockwell, et al., 1994).
Differences in quality of care may occur as the result of differences
in innovative programs, practice patterns, organizational features,
and tactics (see e.g., Wagner EH, et al. 1996).
 
Some past research has focused on quality and outcomes of managed
care vs. fee-for-service or between staff and group practice models
vs. other managed care plans.  In general, few differences in quality
and outcomes are consistently reported (see e.g., Greenfield S, et
al., 1995; Horwitz SM and Stein REK, 1990; Retchin SM, et. al.,
1992).  Ware et al., 1996, also found that outcomes did not differ
for the average patient enrolled in HMOs compared to traditional
insurance in three cities from 1986-1990.  However, elderly and poor
persons with chronic illness fared better with traditional coverage.
In contrast to those results, Udvarhelyi, et al., 1991, found that
patients with high blood pressure treated in four group practices
during 1985- 1987 had more physician visits and better outcomes when
covered by an HMO rather than traditional insurance.  Brook, et al.,
studied patients with chronic illness randomly assigned to enroll in
an HMO from 1974 to 1982.  That study found similar health outcomes
as those assigned to traditional coverage.  One reason for the lack
of consistent findings of differences in outcomes may be that past
research has not been sufficiently sensitive to variations in quality
or outcomes that may result from more specific features of MCOs such
as composition of provider networks, variation in provider payment
arrangements, degree of clinical integration, use of specialists, and
consumer cost- sharing mechanisms.  These features vary substantially
within broadly defined types of health plans or MCOs.
 
Objectives and Scope
 
This RFA seeks applications for studies that assess the associations
between MCO features and clinical performance and patient outcomes
for chronic conditions.
 
Methods
 
o  Chronic disease conditions should be selected on the basis of high
prevalence, association of outcomes with quality of care, ease of
severity assessment with inexpensive measures, some widely recognized
outcomes measurable within a two-year time frame, and adequate
patient numbers across the severity spectrum.  Aggregations of
conditions might be selected for study if the data are adequate and
methodologies are sound, particularly if they represent problem areas
for special populations such as children, women, minority
populations, or the elderly. Comorbidities should be carefully
considered in any study design.  Patients with co-morbidities are of
particular interest as subjects for study under this RFA.
 
o  Features of MCOs that may affect performance can be selected from
among the range of features that generate much interest in the
professional literature as well as the popular press and policy
debates.  Such features might include, for example:
- demand management with self-care, nurse call lines, and wellness
education;
- staffing patterns and responsibilities, e.g., types of providers
involved in primary care;
- methods of establishing provider networks;
- availability of specialists and sub-specialists;
- methods for influencing provider practice, including risk- sharing;
- clinical oversight and use of guidelines or other evidence-based
tools;
- utilization review protocols, e.g., for hospital emergency visits;
- disease management programs.
 
o  Processes of care include preventive measures, diagnostic tests,
treatments, and other patient care activities. Assessing processes of
care involves measuring adherence to practice guidelines, protocols,
or standards.  For example, the National Heart, Lung, and Blood
Institute has developed guidelines for asthma, and the Foundation for
Accountability has developed preliminary measures for breast cancer,
although the latter have not yet been rigorously tested. The American
Diabetes Association commissioned a multidisciplinary committee to
develop and test a number of standards for diabetes care.  AHCPR has
sponsored guidelines for several chronic diseases.  One example is
the treatment of heart failure.  Guidelines in that area are:
Unstable Angina: Diagnosis and Management, Clinical Practice
Guideline, Number 10, Publication No. 94-0602, 1994; Heart Failure:
Evaluation and Care of Patients With Left- Ventricular Systolic
Dysfunction, Clinical Practice Guideline, Number 11, Publication No.
94-0612, 1994; and Cardiac Rehabilitation, Clinical Practice
Guideline, Number 17, Publication No. 96-0672, 1995.  AHCPR-sponsored
guidelines are available from the AHCPR Publications Clearinghouse
(see "INQUIRIES" below).  Applicants should also consider the
National Committee for Quality Assurance recommendations for process
and outcomes indicators. Investigators should select and refine the
final performance measures on the basis of a published meta-analysis
or review of existing literature, consensus groups of experts, and/or
judgments of advisory panels.  Regardless, applicants must rigorously
address validity, acceptability, and generalizability of the selected
measures.
 
o  Outcome measures should include clinical and physiologic measures
as well as patient self-reported measures, and should include general
functional status as well as disease specific measures.  To the
extent possible, patient self- reports should include functioning
level, disability days, time lost from work, understanding of the
problems, perceived outcomes of care, and satisfaction with access to
care and with interpersonal communication with providers. Selected
outcome measures also must be defended with respect to validity,
acceptability, and generalizability.
 
Applicants are encouraged to use existing measures and should
consider using quality measures and patient assessment questions
organized or developed by AHCPR programs, but not to the exclusion of
other existing measures that may be highly valuable.  AHCPR does not
wish to duplicate efforts already completed or underway in the
development of new measures under the programs, Q-Span (Expansion of
Quality Measures) or CAHPS (Consumer Assessment of Health Plans
Study).  For two compendia of relevant measures, see the searchable
CONQUEST database now available with an introductory publication
(AHCPR Pub. No. 96-0042), and CAHPS measures of consumer and patient
self report assessments of health plans and satisfaction.  For
additional information on these programs, see "INQUIRIES" below.
 
o  A number of variables should be tested for their contribution to
patient outcomes within a multivariate analysis.  Patient
characteristics may be important covariates with plan features in
affecting quality and outcomes.  Patient variables might include
severity of the study condition, presence of comorbid conditions, and
other factors determining compliance with treatment regimens and
reporting of functional status.
 
o  The features of each MCO as well as information about the
patient's illness and quality of treatment could be measured
retrospectively for 6-12 months prior to the beginning of a study.
After the study begins, outcomes can be assessed for approximately
two years.  This approach is not meant to preclude evaluating new or
recently implemented clinical interventions.  Any substantial change
in the features of the MCO during the course of observation should be
noted and examined for its independent contribution to the outcomes.
Attrition from the sample should be examined for any connection with
quality of care.
 
o  Generalizability of findings for each disease is highly desirable.
Applicants should assess the generalizability resulting from their
choice of plans, geographic or market areas, and providers and
patients for study.  Applicants should consider how they might
maximize the generalizability of their findings across organizational
forms (e.g., group or staff model Health Maintenance Organizations,
preferred provider plans, etc.) and/or across all chronic conditions.
Two examples of ways to advance this goal would be (a) research
consortia, and (b) studies that focus on two or more chronic
conditions.  In addition, after award of the cooperative agreements,
investigators will be expected to participate in collaborative work
with other awardees and scientific experts on studies of pooled data
that promote generalizability.
 
SPECIAL REQUIREMENTS
 
Terms and Conditions of Award
 
These special Terms of Award are in addition to and not in lieu of
otherwise applicable OMB administrative guidelines, HHS grants
administration regulations, 45 CFR Parts 74 and 92, and other HHS and
PHS grants administration policies.
 
1.  Cooperative Activities.
 
The administrative and funding mechanism to be used for this program
will be the cooperative agreement (U01), under which there will be
substantial scientific and programmatic involvement by AHCPR and
AAHPF with the awardees.
 
Cooperative activities are intended to strengthen individual studies
and at the same time generate generalizable results across multiple
study sites, projects, disease conditions, and patient and physician
groups.  These goals present scientific and management challenges,
requiring collaboration among Principal Investigators and mechanisms
for both linking data and preserving the integrity and
confidentiality of these data.  The scientific and administrative
management of the cooperative work will be organized through a joint
planning and coordinating committee (the Collaborative Scientific
Working Group) and a joint operational committee (the Research
Coordinating Center).  Two external groups will serve to assure
timely progress of the research partnership (the Administrative
Review Council) and to assure research and data integrity and
protection of human subjects (the Oversight Committee).
 
o The Collaborative Scientific Working Group (CSWG) will serve as the
core mechanism for cooperative planning and coordination of research.
The CSWG will meet as a group shortly after the award of the projects
to begin the process of identifying cross-cutting research questions
and common measures and methods to answer the questions.  The group
will make joint decisions to promote uniformity in research
functions, sampling design for any surveys, study measures, analytic
methods, and other methodologic and substantive issues that affect
generalizability and scientific integrity across individual projects.
The CSWG will be especially concerned with the subset of research
activities in each project that involve cross-cutting issues and
analyses of pooled data.  In addition, the CSWG will develop and
implement common policies on protection of the pooled data, including
confidentiality of patients and institutions, and management and
release of pooled data files.
 
The CSWG will be chaired by Sheldon Greenfield, M.D., the Director of
the Primary Care Outcomes Research Institute of New England Medical
Center, or an equivalent expert designated by AHCPR and AAHPF, who
will be a consultant to both sponsors.  The CSWG will be co-chaired
by a scientific advisor to be named by AHCPR, and Sherrie Kaplan,
Ph.D., the co-director of the Primary Care Outcomes Research
Institute, or equivalent expert designated by the sponsors.  The
other members of the CSWG will include each project's Principal
Investigator, along with two representatives from AHCPR and two from
AAHPF.
 
o  The Research Coordinating Center (RCC) will have day-to- day
operational responsibilities for joint development of common measures
and analyses of pooled data submitted by the individual projects on
cross-cutting questions.  It is estimated that approximately 25% of
any survey data in each study will be pooled for cross-cutting
analyses.  The RCC members will provide assistance with data
collection, survey methods, statistical and analytic methods for the
cross- cutting studies, and serve as a repository for a uniform,
aggregate database for cross-cutting studies.
 
The RCC will be chaired by Sherrie Kaplan, Ph.D., co- director of the
Primary Care Outcomes Research Institute, or an equivalent expert
designated by AHCPR and AAHPF, and co- chaired by project officers of
AHCPR and AAHPF; it  will include the Principal Investigators or
their designees. Additional experts, as needed, will be added with
the concurrence of the CSWG.  The RCC will be sponsored both by grant
funds (see "BUDGET PREPARATION" below) and AAHPF.
 
o  An Administrative Review Council (ARC) will monitor the activities
and progress of individual projects, the CSWG, and the RCC on an
annual basis to ensure timely completion. The ARC will also provide
an informal procedure for resolving issues brought to the Council's
attention by AHCPR, AAHPF, or a Principal Investigator.  In addition,
the ARC will be consulted on non-competitive continuation awards.
The Council will be composed of external experts independent of any
project but qualified to review methodologies needed for this area of
research.
 
o  An Oversight Committee that is completely external to the projects
and the funding agencies will be created to assure protection of
human subjects as well as research and data integrity.  It will be
composed of a small number of authorities in medical and scientific
areas that include bioethics and scientific integrity.  It will also
include a patient advocate.  This committee will be empowered to
recommend interruption of studies or interruption of the use of study
data, if warranted.
 
2.  Awardee Responsibilities.
 
-  The awardee will conduct research in accordance with the terms and
conditions of the Notice of Grant Award, and will engage, as
necessary, in a process of refinement and revision of selected
methodologic procedures in accord with plans developed
collaboratively with the CSWG and the RCC. Specifically, the awardee
will undertake or participate in collection of data on measures
designed jointly with others in the RCC and CSWG (about 25% of any
survey measures).
 
-  The awardee will contribute data on standardized measures for
pooled analyses of cross-cutting issues by the RCC.  The designs for
this work will be reviewed by the CSWG.  The Principal Investigator
or other appropriate investigator may participate in analyses,
co-author reports, or be acknowledged as a contributor, depending on
mutual agreements.  The awardee will later have access to the pooled
data for additional analyses.
 
-  The Principal Investigator will participate in a combined total of
up to six meetings per year of the RCC and the CSWG, in addition to
telephone and electronic conferences.
 
-  The awardee will administer some of the costs of the joint work of
the RCC. (see "BUDGET PREPARATION" below).
 
3.  AHCPR/AAHPF Responsibilities.
 
-  The sponsoring agencies will establish the scientific and
monitoring committees defined above to guide the cooperative work.
Scientific consultants may be engaged by the CSWG as needed, with
costs borne by the sponsors.
 
-  The progress of work by each awardee will be reviewed at least
annually.  Awards may be terminated in cases of documented
underperformance where the awardee has been given adequate
notification about performance and failed to take sufficient
corrective actions.
 
BUDGET PREPARATION
 
The following guidance will supplement the standard requirements in
form PHS 398 (rev. 5/95).
 
o  The costs of clinical care provided to participants in any project
will not be paid out of grant funds.
 
o  Applicants should request funds to support the joint work of the
RCC, such as joint development of common measures and analyses of
pooled data.  Two and one-half (2.5) percent of the requested direct
costs should be budgeted for this purpose as a separate line item
under Other Expenses, for each year of the project.
 
o  Budgets should reflect travel by the Principal Investigator to
attend a combined total of 6 one-day meetings per year of the CSWG
and the RCC.  These meetings will generally take place in the
Washington, DC area, or the Boston, MA area. It is anticipated that
the business of the CSWG and the RCC can otherwise be conducted by
teleconferencing and e-mail channels.
 
Confidentiality of Data
 
Information obtained in the course of this study that identifies an
individual or entity must be treated as confidential in accordance
with section 903(c) of the Public Health Service Act (42 U.S.C.
299a-1(c)).  Applicants must describe in the Human Subjects section
of the application procedures for ensuring the confidentiality of
identifying information.  The description of the procedures should
include a discussion of who will be permitted access to the
information, both raw data and machine readable files, and how
personal identifiers will be safeguarded.
 
Rights in Data
 
Grantees may copyright or seek patents, as appropriate, for final and
interim products and materials including, but not limited to,
methodological tools, measures, software with documentation,
literature searches, and analyses, which are developed in whole or in
part with AHCPR funds.  Such copyrights and patents are subject to a
Federal Government license to use these products and materials for
AHCPR purposes.  Such purposes may include, subject to statutory
confidentiality protections, making research materials, data bases,
and algorithms available for verification or replication by other
researchers.  Final products may be made available to the health care
community and the public by AHCPR, or its agents, if such
distribution would significantly increase access to a product and
thereby produce public health benefits.  Ordinarily, to accomplish
its broad dissemination mandate, AHCPR encourages and promotes
publication of research findings, but generally relies on grantee
efforts to market grant-supported products.  To enable AHCPR to
fulfill its statutory obligation to make both research results and
developed data available, as well as to assure the statistics
developed with its support are of high quality, copies of all
products and materials developed under a grant supported in whole or
in part by AHCPR funds are to be made available to AHCPR promptly
upon request.  Similarly, products shall be made available to AAHPF
promptly upon its request, consistent with the applicable
confidentiality statute cited above.
 
INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY
POPULATIONS INVOLVING HUMAN SUBJECTS
 
It is the policy of AHCPR that women and members of minority groups
be included in all AHCPR-supported 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.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research," published in the Federal Register of
March 28, 1994 (FR 59 14508-14513), and printed in the NIH GUIDE FOR
GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.  AHCPR
follows the NIH Guidelines, as applicable.
 
Applicants may obtain copies from the above sources or from the AHCPR
contractor, Global Exchange, Inc., listed under "INQUIRIES."
 
AHCPR is also encouraging investigators to consider including
children in study populations, as appropriate. AHCPR announced in the
NIH Guide for Grants and Contracts, Volume 26, Number 15, May 9,
1997, that it is developing a policy and implementation plan on the
inclusion of children in health services research.  This notice is
available through AHCPR's Web site (http://www.ahcpr.gov/) and
InstantFAX (see instructions under "INQUIRIES").
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by October 31, 1997, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the proposed
Principal Investigator and other key personnel; 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 to estimate the
potential review workload and avoid conflicts of interest in the
review.  AHCPR will not provide responses to letters of intent.
 
The letter of intent is to be addressed to:
 
Bernard Friedman, Ph.D.
Center for Organization and Delivery Studies
or
James Cooper, M.D.
Center for Primary Care Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 500
Rockville, MD  20852-4908
E-mail: bfriedma@ahcpr.gov
 or      jcooper@ahcpr.gov
 
SEMINAR FOR PROSPECTIVE APPLICANTS
 
AHCPR and AAHPF plan to convene a seminar for prospective applicants
in Rockville, Maryland, about 6 to 8 weeks after publication of this
RFA if there is sufficient interest. Applicants must pay for their
own travel and accommodation costs.  Attendance is not a prerequisite
to applying.  If interested in such a seminar, contact Dr. Bernard
Friedman or Dr. James Cooper by October 17, 1997, at the appropriate
e-mail address above.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  State and local government applicants
may use form PHS-5161-1, Application for Federal Assistance (rev.
5/96), and follow those requirements for copy submission.
Application kits are available at most institutional offices of
sponsored research and may be obtained from the Division of
Extramural Outreach and Information Resources, Office of Extramural
Research, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD  20892-7910, telephone 301/710-0267, E-mail:
ASKNIH@odrockm1.od.nih.gov.
 
AHCPR applicants are encouraged to obtain application materials from
the AHCPR contractor:  Global Exchange, Inc. (see "INQUIRIES").
 
The RFA label available in the form PHS 398 (rev. 5/95) must be
affixed to the bottom of the face page of the original application.
Failure to do so 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 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/courier service)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Dawn French
Center for Organization and Delivery Studies
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 500
Rockville, MD  20852-4908
 
Applications submitted under this RFA must be received in the
Division of Research Grants, NIH, by January 6, 1998.
 
LETTER OF AUTHORIZATION
 
Applicants must submit a brief letter as part of the application
indicating whether or not they wish their application, along with a
summary of reviewer comments, to be shared with AAHPF.  Only
applications under consideration for funding will be shared.
Applications not authorized to be shared with AAHPF will not be
funded under this RFA. Meritorious applications not funded under this
RFA, may be considered by AHCPR for funding in competition with all
other investigator-initiated applications.
 
REVIEW CONSIDERATIONS
 
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with AHCPR peer review
procedures.  The AAHPF will have an opportunity to recommend
qualified reviewers.  As part of the merit review, all applications
will receive a written critique, and also may undergo a process in
which only those applications deemed to have the highest scientific
merit will be discussed and assigned a priority score.
 
General Review Criteria
 
The general review criteria for any application are: significance and
originality from a scientific and technical viewpoint; adequacy of
the method(s); availability of data or a 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; adequacy of the facilities and resources available
to the applicant; the extent to which women, children, and minorities
are adequately represented in study populations; and the adequacy of
the proposed means for protecting human subjects.
 
Special Review Criteria
 
In addition to the general criteria above, the reviewers will assess
the application's responsiveness to the RFA and other critical
aspects such as:
 
o  access to relevant data on patient care in MCOs and structural and
operational features of MCOs, as evidenced by letters of commitment
from any organization supplying data;
 
o  demonstrated ability to engage in cooperative work with outside
scientists and administrative committees, and to meet goals of
timeliness;
 
o  demonstrated ability to collaborate with government agencies in
the performance of research studies and to participate in
coordinating committees.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other
applications under this RFA.  AHCPR will consider the following in
making funding decisions:  quality of the proposed project as
determined by peer review, availability of funds, program balance
with respect to types of MCOs, populations, and chronic conditions to
be studied.
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.
Copies of the RFA are available from:
 
Global Exchange, Inc.
7910 Woodmont Avenue, Suite 400
Bethesda, MD  20814-3015
Telephone 301/656-3100
FAX 301/652-5264
 
The RFA is available on AHCPR's Web site, http://www.ahcpr.gov and
through AHCPR InstantFAX at 301/594-2800.  To use InstantFAX, you
must call from a facsimile (FAX) machine with a telephone handset.
Follow the voice prompt to obtain a copy of the table of contents,
which has the document order number (not the same as the RFA number).
The RFA will be sent at the end of the ordering process.  AHCPR
InstantFAX operates 24 hours a day, 7 days a week.  For questions
about this service, call AHCPR's Division of Communications at
301/594-1364 ext. 1389.
 
Copies of AHCPR publications can be requested through the:
 
AHCPR Publications Clearinghouse
P. O. Box 8547
Silver Spring, Maryland 20907
TDY(toll free): 1-800-301/586-6340
Telephone (toll free): 1-800-301/358-9295
 
Written and telephone inquiries concerning this RFA are encouraged.
Direct inquiries regarding programmatic issues, including information
on the inclusion of women, minorities, and children in study
populations, to:
 
Bernard Friedman, Ph.D.
Center for Organization and Delivery Studies
or
James Cooper, M.D.
Center for Primary Care Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 500
Rockville, MD  20852-4908
telephone: 301/594-1410 ext. 1475 (Friedman)
           301/594-1357 ext. 1352 (Cooper)
E-mail: bfriedma@ahcpr.gov or jcooper@ahcpr.gov
 
For more information about AHCPR supported work pertaining to quality
of care and consumer assessment of health plans, direct inquiries to:
 
Elinor Walker
Center for Quality Measurement and Improvement
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 502
Rockville, MD  20852-4908
Telephone: 301/594-1349 ext. 1326
Email: ewalker@ahcpr.gov
 
Direct inquiries regarding fiscal matters to:
 
Mable L. Lam
Chief, Grants Management Staff
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852-4908
Telephone:  301/594-1447 ext. 1165
FAX 301/594-3210
Email:  mlam@ahcpr.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Number 93.226 and 93.180.  Awards are made under
authorization of Title IX of the Public Health Service Act (42 U.S.C.
299-299c-6) 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 67, Subpart A, and 45 CFR
Parts 74 and 92.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.
 
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 routine 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.
 
References
 
Brook RH et al., 1990.  Quality of ambulatory care: Epidemiology and
comparison by insurance status and income. Medical Care, 8:392-433.
 
Cassel EJ. 1991.  The Nature of Suffering and the Goals of Medicine.
New York: Oxford University Press.
 
Cohen MZ, Tripp RT, Smith C, Sorofman B, Lively S. 1994. Explanatory
models of diabetes: patient practitioner variation.  Social Science
and Medicine, 38:59-66.
 
Greenfield S, Rogers W, Mangotich M, Carney MF, Tarlov, AR. 1995.
Outcomes of patients with hypertension and non- insulin dependent
diabetes mellitus treated by different systems and specialties.
Results from the medical outcomes study.  Journal of the American
Medical Association, 274(18):1436-44.
 
Horwitz SM, Stein REK. 1990. Health maintenance organizations vs.
indemnity insurance for children with chronic illness: Trading gaps
in coverage.  American Journal of Diseases of Children, 144:581-6.
 
Retchin SM, Clement DG, Rossiter LF, Brown B, Brown R, Nelson L.
1992. How the elderly fare in HMOs: outcomes from the Medicare
competition demonstrations.  Health Services Research, 27(5):651-69.
 
Rubenstein LV, Calkins DR, Young RT, et al. 1989.  Improving patient
function: a randomized trial of functional disability screening.
Annals of Internal Medicine, 111(10):836-42.
 
Stockwell DH, Madhavan S, Cohen H, Gibson G, Alderman MH, 1994.  The
determinants of hypertension awareness treatment and control in an
insured population.  American Journal of Public Health,
84(11):1178-74.
 
Udvarhelyi S, Jennison K, Phillips RS, Epstein AM. 1991. Comparison
of the quality of ambulatory care for fee-for- service and prepaid
patients.  Annals of Internal Medicine, 115:394-400.
 
Wagner EH. 1996.  The promise and performance of HMOs in improving
outcomes in older adults.  Journal of the American Geriatrics
Society, 44:1251-1257.
 
Ware J, et al., 1996.  Differences in 4-year health outcomes for
elderly and poor, chronically ill patients treated in HMO and
fee-for-service systems: results from the Medical Outcomes Study.
Journal of the American Medical Association, 276:1039-47.
 
Wasson J, Keller A, Rovehstein L, et al. 1992. Benefits and obstacles
of health status assessment in ambulatory settings: the clinician's
point of view.  Medical Care, 30(5)suppl:MS42-9.
 
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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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