Full Text HS-98-003
 
HEALTH CARE QUALITY IMPROVEMENT AND QUALITY ASSURANCE RESEARCH
 
NIH GUIDE, Volume 26, Number 20, June 13, 1997
 
RFA:  HS-98-003
 
P.T. 34

Keywords: 
  Health Services Delivery 
  0730021 

 
Agency for Health Care Policy and Research
 
Letter of Intent Receipt Date:  August 1, 1997
Application Receipt Date:  September 16, 1997
 
PURPOSE
 
The Agency for Health Care Policy and Research (AHCPR) invites
applications for research and demonstration projects on the use of
measurement in improving the quality of health care.  Applications
are sought in three areas: (1) methods and measures to allow
translation of scientific information about medical care into quality
measures and strategies to improve clinical practice; (2) studies of
the relationship between organizational change and quality
measurement and improvement in health care; and (3) studies of the
use of information derived from measurement about quality of care by
consumers, patients, employers, providers, and insurers to make
decisions.
 
AHCPR is especially interested in projects that will produce results
within one to two years, although a balance is sought between short-
and long-term projects, and projects of up to five years will be
considered.
 
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 public or private non- profit
organizations, including universities, clinics, units of State and
local governments, non-profit firms, and non-profit foundations.
For-profit entities may participate as members of consortia or
subcontractors if the applicant is non-profit.  Organizations
described in section 501(c)4 of the Internal Revenue Code that engage
in lobbying are not eligible.
 
AHCPR encourages women, members of minority groups, and persons with
disabilities to apply as Principal Investigators.
 
MECHANISM OF SUPPORT
 
The RFA mechanisms of support are the research project grant (R01),
and the research demonstration project grant (R18). Responsibility
for the planning, direction, and execution of the proposed project
will be solely that of the applicant. The earliest anticipated award
date is February 1, 1998.
 
FUNDS AVAILABLE
 
Depending on the availability of funds, AHCPR expects to award up to
$2.0 million in fiscal year 1998 to support the first year of 8 to 10
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 that the awards be equal
in size. Funding beyond the initial budget period will depend upon
annual progress reviews by AHCPR and the availability of funds.
 
RESEARCH OBJECTIVES
 
Background
 
AHCPR is charged with improving the quality, appropriateness, and
effectiveness of health care services and access to such services.
Research on quality measurement and improvement is essential to
AHCPR's efforts to integrate knowledge about health care into
clinical practice, especially at this time of rapid and profound
changes in the health care system.
 
There are anecdotes, but not much reliable information, about the
effects of these changes on quality of care and the effectiveness of
attempts to assess and assure quality. Understanding the effects of
these changes requires reliable and valid information about clinical
quality of care and methods for obtaining and using that information
to assure and improve quality.
 
As efforts are made to increase the efficiency with which health care
is provided and to curtail unnecessary expenditures, the ability to
assess and maintain or improve quality is essential.
 
In recent years, AHCPR has undertaken a number of initiatives related
to quality of care.  AHCPR documents cited below may be requested
from the AHCPR Clearinghouse, 800/358-9295.  In particular, AHCPR
has:
 
o  Developed a prototype performance measurement information system
called CONQUEST. (For information on CONQUEST, see R. Heather Palmer,
et al. Understanding and Choosing Clinical Performance Measures for
Quality Improvement: Development of a Typology.  Final Report,
Contract No. 282-93-0038, Delivery Order #3. Agency for Health Care
Policy and Research, January 31, 1995.)
 
o  Funded a group of cooperative agreements under the name "QSpan"
(for Expansion of Quality Measures).  These projects address
different conditions and populations for which quality measures are
scarce or nonexistent, and in some cases take different approaches.
Some focus on health plan quality, others on provider performance.
For details, see "Expansion of Quality Measures."  AHCPR Publication
No. 96-R064, rev. November 5, 1996.
 
o  Established a program called CAHPS, for Consumer Assessments of
Health Plans; the program comprises cooperative agreements with a
group of three consortia collaborating with AHCPR to develop a
rigorously tested, standardized instrument for collecting information
from plan enrollees. (For more information, see Technical Overview of
Consumer Assessment of Health Plans Study. September 1996.)
 
o  Convened a meeting of experts on quality of care to discuss a
series of commissioned papers on future challenges in quality of
care, and to formulate responses that could be developed by the
Federal government or AHCPR specifically. Many of the observations
and recommendations expressed in the papers or in the discussion are
reflected in this RFA.
 
Objectives and Scope
 
This RFA addresses three areas: methods and measures; the effects of
organizational changes; and using quality-related information.
 
AHCPR has identified the following priority populations as a special
focus for research under this RFA: minority groups, women, children,
persons with chronic diseases or disabilities, and the elderly.
 
1.  Methods and Measures:  Research is needed to validate performance
measures; develop and test outcomes measures and severity adjustment
methods; refine and expand measures of health and functional status
and health-related quality of life; consider relatively neglected
issues such as timeliness of care; and examine the importance of
communication in quality of care.
 
Topics and illustrative questions include:
 
o  Quality performance measures.  Of interest are measures applicable
across broad populations, and in particular to the priority
populations cited above.  How can patient care episodes be framed to
permit measurement of quality of care longitudinally across the range
of care settings?  What measures of the characteristics associated
with primary care (such as sustained partnership, family and
community- centered care, and continuity of care) influence quality
of care and patient outcomes?  Especially in chronic disease, how can
quality of care be measured in different settings for patients with
multiple comorbidities?  How can the reliability and validity of
commonly used quality measures be evaluated or improved, or
substitutes provided?
 
What kinds of measures are most cost-effective?  How do approaches
such as screening, auditing, profiling, benchmarking, and
implementing clinical practice guidelines change measurement
requirements?
 
o  Standards and guidelines.  Can performance measures derived from
clinical practice guidelines be the basis for an effective system of
quality improvement?  Can adherence to clinical practice guidelines
or explicit medical review criteria be shown to improve quality of
care, as measured by outcomes, by explicit peer review, or by
performance measures derived from guidelines?  Are there
characteristics of the guidelines that make a difference in their
effectiveness in changing practice?  How do measures derived from
evidence-based guidelines compare with other measures in terms of
changing medical practice?  In terms of care outcomes?
 
o  Risk adjustment.  Systems that adjust for case-mix or severity
measurement systems are essential to rate-based outcome measures, but
have been problematic in many ways (see L.I. Iezzoni, ed. (1994),
Risk Adjustment for Measuring Health Care Outcomes, Health
Administration Press, Ann Arbor).  Most risk-adjustment systems
intended for performance evaluation are based on mortality.  Can we
develop systems based on other outcomes, so that risk adjustment can
be applied to performance measures for conditions (especially chronic
disease) in which mortality is not the most frequent or most
pertinent outcome?  How can patient characteristics and other
non-clinical factors best be measured and controlled for, in order to
improve attribution of outcomes to the care process or the
performance of individual providers?
 
o  Health status measures.  How do different measures of functional
status or health-related quality of life compare, in terms of: ease
of administration; feasibility and appropriateness for use in
performance reporting; measurement properties; sensitivity to the
natural history and treatment effects of important conditions and
disorders? Can the use in clinical practice of generic (as opposed to
condition-specific) health status measures improve quality of care,
appropriateness of clinical interventions, or other measures of
performance?  Are they equally applicable in specialty and primary
care?  What modifications are necessary in health/functional status
measurement in long- term care populations?
 
o  Timeliness.  Typical elements of quality measures involve
evaluation of appropriateness of care and necessity for care.  Seldom
addressed is timeliness of care. Given that most conditions are not
especially sensitive to a moderate amount of waiting time in
receiving care, can measures be devised to assess the importance of
timeliness in quality of care?
 
o  Communication.  What aspects of provider-patient communication
need to be taken into account as part of quality measurement and
improvement?  What are the relationships among measures of clinical
quality, provider- patient-communication, and patient satisfaction?
Is communication as important in specialty care as in primary care?
 
2.  Organizational Change and Quality Measurement and Improvement.
Research is needed to understand how different approaches to
designing and implementing quality measurement and/or improvement can
work in and across different health care delivery settings, including
traditional settings as well as non-institutional arrangements such
as home care.
 
 Diversity and change in the organization of health care and
approaches to quality improvement offer natural laboratories for
comparative studies or case descriptions; some are so complex and
have been subjected to so little study that qualitative approaches
will be essential.  It is important that the opportunity not be
missed to observe these variations and (where possible) their
effects, document them, and analyze their impact.  Of special
interest would be a partnership among employers, payers, and
providers for a collaborative innovation in quality; for example, a
consortium of clinical, administrative, and research entities, with
evaluation funding from AHCPR.
 
Illustrative questions include:
 
o  What factors affect organizational willingness or readiness to
implement quality measurement and/or improvement methods and
programs?
 
o  What have been the measurable effects of various quality
improvement techniques?  Can characteristics of effective versus less
effective quality improvement initiatives be identified?
 
o  After many years of widespread use of various quality improvement
approaches and tools, what is the evidence that quality improvement
has made a difference?
 
o  What are the effects of oversight by government, private sector
organizations, or purchasers, or of efforts to certify providers or
plans?
 
o  What are the quality-related effects (for example, as measured by
outcomes? by patient satisfaction?) of restructuring provider roles?
 
o  How can quality measurement be used to assess the impact of the
financial arrangements between the insurer and the provider?  For
example, capitation, global capitation, or discounted
fee-for-service; carve-outs; and performance bonuses.
 
3.  Using Quality-related Information:  Here the emphasis is on the
way information on quality affects decisionmaking at various levels
of the system (patient, provider, purchaser, plan, and so forth).
Quality-related information can include data on clinical performance,
"report-card" scores, information about outcomes, consumer
assessments, and information about certification or compliance with
requirements of oversight bodies.  The burden is on the applicant to
provide a conceptual framework supporting the manner in which the
information can be expected to be effective.
 
Illustrative questions include:
 
o  What are the relationships among measures of clinical quality,
provider-patient communication, and consumer assessments?  How do
these relationships affect consumer decisions and behaviors?  How
does provision to patients/consumers affect these relationships and,
in turn, consumer decisions and behaviors?
 
o  When consumers are more knowledgeable about health care and health
plans do they make better choices?  What are the measures for
assessing "improved" or "better" decisions by patients or consumers?
 
o  What measures of quality of care are most likely to lead to change
in relevant provider behaviors?
 
o  What does providing information on quality to various stakeholders
(consumers, providers, employers, insurers) do to alter the behavior
of the other stakeholders and the dynamics of the health care system,
and what are the ultimate effects on quality of care?
 
o  How can technology be used to measure quality and provide
information on quality of care?
 
SPECIAL REQUIREMENTS
 
Demonstration grants
 
The focus of demonstration grant (R18) applications should be on
evaluation.  It is not the intent of this RFA to support extensive
development of data bases (beyond those necessary to answer specific
research questions), disease registries, clinical guidelines, or
computerized information systems, rather to demonstrate and evaluate
real world application of measurement to improve quality of care.
 
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.  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
 
AHCPR 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.  AHCPR purposes may include, subject to statutory
confidentiality protections, making research materials, data bases,
and algorithms available for verification or replication by other
researchers; and subject to AHCPR budget constraints, 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 distribution, AHCPR publishes
research findings but relies on grantee efforts to market
grant-supported products.  In keeping with AHCPR's legislative
mandates to make both research results and data available, 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
and without restriction, upon request by AHCPR.
 
The special terms of award described above are in addition to and not
in lieu of otherwise applicable PHS grant policies and Federal
regulations.
 
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.
 
The 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 provisions that are
substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research," which has been 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 revised NIH Guidelines, as
applicable.
 
Investigators may obtain copies from those 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, 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).
 
AHCPR program staff may also provide information concerning these
policies (See INQUIRIES).
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by August 1, 1997, a
letter of intent that includes the name, address, and telephone
number of the proposed Principal Investigator and other key
personnel; a descriptive title of the application; 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.
 
Letters of intent are to be addressed 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
FAX:  (301) 594-2155
Email:  qualrfa@ahcpr.gov
 
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 301/435-0714, email:
ASKNIH@odrockm1.od.nih.gov.
 
AHCPR applicants should obtain application materials from the AHCPR
contractor:  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. 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 YES 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:
 
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
 
Applications submitted under this RFA must be received in the
Division of Research Grants, NIH, by September 16, 1997. If an
application is received after that date, it will be returned to the
applicant without review.
 
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.  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
 
Review criteria for AHCPR grant applications are: significance and
originality from a scientific and technical viewpoint; adequacy of
the 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; the extent to which women and minorities
are adequately represented in study populations; and where
applicable, 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; generalizability of
results; feasibility of answering the proposed research question(s)
within the project period; and the anticipated impact of the results
of the project.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other
applications under 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.
 
Preference in funding will be accorded to meritorious applications
that focus on issues concerning minority populations.
 
Also considered will be the extent to which projects are
complementary to and build on AHCPR's ongoing quality initiatives
(See BACKGROUND).  Projects that are complementary to these
initiatives, rather than overlapping, will be considered to further
program balance.
 
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
 
Copies of the RFA are available on AHCPR's website,
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 in order 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.
 
Direct inquiries regarding programmatic issues, including information
on the inclusion of women, minorities, and children in study
populations, 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
FAX:  (301) 594-2155
Email:  qualrfa@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 Nos. 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.
 
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