HEALTH CARE QUALITY IMPROVEMENT AND QUALITY ASSURANCE RESEARCH

NIH GUIDE, Volume 22, Number 19, May 21, 1993



PA NUMBER:  PA-93-084



P.T. 34



Keywords:

  Health Care Administration 

  Health Services Delivery 



Agency for Health Care Policy and Research



PURPOSE



The purpose of this program announcement (PA) is to stimulate

research and evaluation projects addressing health care quality

improvement and quality assurance.  Important in its own right, this

area of research takes on added prominence in the context of health

care reform.  As efforts are made to increase the efficiency with

which health care is provided and to curtail unnecessary

expenditures, measuring and assessing the adequacy of care is

critical to assure that quality is not sacrificed.  The Agency for

Health Care Policy and Research (AHCPR) is particularly interested in

research and evaluation projects that will produce results within one

to two years, although projects of longer duration will also be

considered.



HEALTH 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.  Applications

responding to this PA could be related to many 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 and foreign non-profit

organizations, public and private, including universities, clinics,

units of State and local governments, non-profit firms, and

non-profit foundations.  Applications from minority and women

investigators are encouraged.



MECHANISM OF SUPPORT



This PA will use the research project grant (RO1).  Responsibility

for the planning, direction, and execution of the proposed project

will be solely that of the applicant.  Most projects are expected to

vary from one to two years in length.  This PA is in effect through

July 1, 1995.



RESEARCH OBJECTIVES



Background.  The Omnibus Budget Reconciliation Act of 1989, P.L.

101-239, established AHCPR for the purpose of enhancing the quality,

appropriateness, and effectiveness of health care services; and

access to such services.  The AHCPR accomplishes this through the

establishment of a broad base of scientific research; and the

promotion of improvements in clinical practice and in the

organization, financing, and delivery of health care services.

Continuing support of research on quality improvement and quality

assurance is essential to AHCPR's efforts to integrate knowledge

about the effectiveness of health care into clinical practice.

Moreover, focused research on quality improvement and quality

assurance is particularly important at this time of health care

reform.



To refine a research agenda responsive to current needs, the AHCPR

convened a conference in March 1992 to examine research priorities in

quality improvement and quality assurance.  The conference provided a

forum for discussion among health care providers, researchers, policy

makers, and quality improvement and quality assurance professionals

working in both public and private delivery settings.  Although there

are a variety of definitions of quality review terms, the working

definitions that emerged over the course of the conference are used

here.  Quality improvement refers to a set of specific approaches to

improving performance, as indicated by objective measures, and using

techniques such as organizational redesign, cross-functional

management, and/or processes of continuous improvement, such as

quality improvement teams and a focus on customer-oriented

objectives.  Quality assurance refers to a wide range of internal and

external methods used to assess the incidence or levels of quality

problems and assure that quality is achieved.



Several common themes were articulated at the agenda setting

conference.  First, information technologies are both a driving force

behind and a major source of concern in evolving quality improvement

and quality assurance systems. Second, the field of quality

improvement holds promise for major changes in organization and

practice.  But there is currently little sound evidence of its

effects on either health care outcomes or delivery system efficiency.

Finally, there is a strong interest across the practice, research,

and payer communities in evaluating models of quality improvement to

identify:  the aspects of the methods and processes that work best in

different organizational environments, and the factors that

facilitate or hinder their effectiveness.  A full report of the March

conference including comprehensive background papers and summaries of

identified research issues "Putting Research to Work in Quality

Improvement," AHCPR Pub No. 93-0001, is scheduled for publication in

Spring 1993.  Applicants may also refer to the NIH Guide

Announcement, Volume 21, No. 10, March 13, 1992, on "Effective

Dissemination of Health and Clinical Information and Research Issues"

(also available as AHCPR Publication No. 92-0045).  Issues addressed

in that announcement continue to be of interest, but are not repeated

here.  Applicants may request copies of these documents from the

AHCPR Hotline, 800-358-9295.



Objectives



The objective of this PA is to stimulate new grant applications in

the four priority areas described below:



1.  Methods and Measures:  Improving methods and measures is

essential to facilitate the translation of state-of-the-art

information about medical effectiveness into better medical

management, including measures relevant to consumers' engagement in

decisions about quality health care.  Research issues center on

medical review criteria, performance standards, and improving the

science of quality assessment and improvement.  Illustrative

questions include:



o  What are the best methods for developing, implementing, and

evaluating explicit medical review criteria? Where expert panels are

the source of criteria, how do composition of the panels and the

methods by which they operate affect acceptability and utility of

panel recommendations?  What are the differences in content and

usefulness of nationally versus locally developed criteria?



o  What data are needed on the process and outcome of care to help

improve quality?  How can patient care episodes be framed to permit

measurement of quality of care longitudinally across the complete

range of care settings?  How can the contribution to outcome of

patient characteristics and other non-clinical factors be measured?

How can they be controlled for, to improve clarity of attribution of

outcomes to the care process?  What aspects of provider-patient

communication should be addressed in quality assurance and quality

improvement systems?



o  What methods of feedback regarding quality of care for

practitioners, patients/consumers, and systems are most likely to

lead to change in practice patterns?  What elements of practice are

most amenable to change?



o  How can the reliability and validity of commonly used quality

measures be evaluated or improved, or substitutes provided?  Is the

incorporation of these measures into quality assurance or quality

improvement systems cost effective?  How do approaches such as

screening, auditing, profiling, and implementing clinical practice

guidelines change measurement requirements?  How do such strategies

compare in effectiveness and cost?



2.  Information Technologies:  Research priorities for information

technologies focus on availability, quality, and specificity of data

for quality assessment and on specific ways to address the social and

behavioral barriers to using new information technologies such as

automated medical records and decision support systems, or to

development and availability of comprehensive data.  Illustrative

questions include:



o  How effective are automated information systems as tools for

improving the quality of patient care?  How are the data in existing

information systems used, and what elements should be added to

improve the systems, quality measurement, and quality of care?  Do

they allow for more efficient delivery of care?



o  How can patient-specific and provider-specific probabilities and

utilities be optimally incorporated into decision support systems?



o  What are the factors that influence the adoption of information

systems technology in quality assurance and improvement programs?

What innovations of technology, or initiatives in policy or

legislation have the potential to resolve the problems of privacy and

confidentiality of patient-based electronic records?  What are the

barriers to their implementation?



3.  The Organization of Quality Improvement and Assurance: Research

on organization and system issues is necessary if new methods and

measures are to be incorporated effectively into ongoing health care

programs.  Relevant issues include organizational readiness and

capacity to accept and use new methods and technologies,

institutional and professional culture, and public demands and

expectations.  Research is needed on:  how different approaches to

designing and implementing quality improvement can be structured to

work in and across different health care delivery settings, including

institutional and noninstitutional long-term care; how responsibility

for monitoring quality is allocated among internal and external

review entities; and what resources are needed to assure and improve

health care quality.  There is a continuing need for descriptive and

comparative information on what is happening in quality review

systems throughout the country, as well as a need for more

information on State and Federal regulation, accreditation programs,

and certification systems.  Illustrative questions include:



o  What factors affect organizational readiness to adopt quality

improvement methods and programs?  How do management variables

influence the process of care and decision making, and how do these,

in turn, influence care outcomes?



o  What have been the measurable effects on the cost, quality, and

effectiveness of the health care provided by organizations using

quality improvement?  How have improvements been achieved?  Can

characteristics of effective versus less effective quality

improvement be measured?



o  What are the effects of oversight?  Can an optimal relationship be

identified between an external and internal review of quality of care

in a delivery setting?  How does external review stimulate, support,

or subvert internal quality improvement or quality assurance?



o  What common measures or tools of quality improvement are

needed/used to link participants in integrated community systems?

How can the use of common measures be facilitated?



4.  Using Quality-related Information:  Information on quality of

care is of increasing interest to patients, purchasers of insurance,

and providers alike; and is crucial to managed competition approaches

to health care reform.  Illustrative questions include:



o  Does providing information about quality of care to patients, or

information about patient experiences and expectations to clinicians

and provider organizations, improve care?  At what stage or stages in

the quality improvement process should this exchange of information

take place?



o  How do patients and purchasers make judgments about quality and

effectiveness of health care?  What are the effects of data about

quality on patient health-related behaviors, health care seeking

behavior, or satisfaction with care?



o  What information about quality of care do patients and purchasers

perceive as useful in making informed decisions when they choose

among providers?  How can they be assisted in interpreting and using

quality improvement and quality assurance data?  Does the

availability of this information improve their decisions in some

measurable way?



o  What can be learned from existing partnerships between health care

providers and purchasers regarding quality improvement and quality

assurance goals?  Can their approaches to using information about

quality be evaluated objectively and related to success in achieving

quality improvement and quality assurance goals?



o  Does provision of quality-related information encourage

development of common measures across modes of care and facilities so

that longitudinal and population-based evaluation of quality of care

becomes possible?



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND

MINORITIES IN RESEARCH STUDY POPULATIONS



The AHCPR requires all applicants for 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 must be placed on including

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 must be provided.



This policy applies to all AHCPR research grants.  The AHCPR will not

award grants for applications which do not comply. If the application

does not contain the required information, it will be returned

without review.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of

the study.  This information should be included in the form PHS 398

in Sections 1 to 4 of the Research Plan and summarized in Section 5,

Human Subjects.



Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However,

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., American

Indians/Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics).

Where appropriate, the applicant must provide the rationale for

studies on single minority population groups.



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

minorities.



Peer reviewers will address specifically whether the applicant's

research plan 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.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS

398 (rev. 9/91), and will be accepted at the standard application

deadlines as indicated in the application kit.  State and local

governments may use Form PHS 5161 and submit an original and two

copies of the application.



Application kits are available at most institutional offices of

sponsored research; from the Office of Grants Inquiries, Division of

Research Grants, National Institutes of Health, Westwood Building,

Room 449, Bethesda, MD 20892, telephone 301/710-0267; and from the

Office of Scientific Review, Agency for Health Care Policy and

Research, Suite 602, 2101 East Jefferson Street, Rockville MD 20852,

telephone 301-227-8449.  The title and number of the PA must be typed

in section 2a on the face page of the application.



The completed original application and five legible copies must be

sent or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



The Division of Research Grants (DRG) will not accept any application

in response to this announcement that is essentially the same as one

currently pending initial review, unless the applicant withdraws the

pending application.  The DRG will not accept any application that is

essentially the same as one already reviewed.  This does not preclude

the submission of substantial revisions of applications already

reviewed, but such applications must include an introduction

addressing the previous critique.



Applicants are encouraged to apply by the earliest possible

submission date.  The first due date is June 1, 1993.  Thereafter,

through July 1995, the due dates for new applications are October 1,

February 1, and June 1.  Applications for R01 grants must be received

by the Division of Research Grants, NIH.  An application received

after the deadline may be acceptable if it carries a legible proof-

of-mailing date assigned by the carrier and the proof-of-mailing date

is not later than 1 week prior to the deadline date.



REVIEW CONSIDERATION



Upon receipt, applications will be reviewed for completeness and

responsiveness.  Incomplete applications will be returned to

applicants without further consideration.  Review criteria for grant

applications are significance and originality from a scientific and

technical viewpoint; adequacy of the method to carry out the project;

availability of the data or the proposed plan to collect data

required for the project; qualifications and experience of the

principal investigator and proposed staff; adequacy of the plan for

organizing and carrying out the project; reasonableness of the

proposed budget; and adequacy of the facilities and resources

available to the applicant.



Applications will be evaluated in accordance with the criteria stated

above for scientific/technical merit by an appropriate peer review

group.  Applications assigned to the AHCPR and requesting total

direct costs in excess of $50,000 may be reviewed by the National

Advisory Council for Health Care Policy, Research, and Evaluation.

Funding will be based on recommendations from the peer review and

AHCPR's Council.



AWARD CRITERIA



Applications will compete for available funds with all other

applications.  The following will be considered in making funding

decisions:  quality of the proposed project as determined by peer

review, availability of funds, and program balance among research

areas of the announcement.  The anticipated dates of award for

applications are 10 months from the date of submission.  The AHCPR is

particularly interested in funding policy relevant proposals that can

be completed within one to two years.



INQUIRIES



Those considering applying in response to this PA are strongly

encouraged to discuss their project with AHCPR program administrators

before formal submission.  The AHCPR welcomes the opportunity to

clarify any issues or questions from potential applicants.  Direct

inquiries regarding programmatic issues to:



Bertha D. Atelsek

Center for General Health Services Extramural Research

Agency for Health Care Policy and Research

2101 East Jefferson Street, Suite 502

Rockville, MD  20852

Telephone:  (301) 227-8352, Ext. 111



Direct inquiries regarding fiscal matters to:



Ralph Sloat

Agency for Health Care Policy and Research

2101 East Jefferson Street, Suite 601

Rockville, MD  20852

Telephone:  (301) 227-8447



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance No. 93.180 and 93.226.  Awards are made under

authorization of the Public Health Service Act, Title IX, as amended

(Public Laws 101-239 and 102-410) and administered under PHS grants

policies and Federal Regulations 42 CFR Part 67, Subpart A, and 45

CFR Part 74 (45 CFR Part 92 for State and local governments).  This

program is not subject to the intergovernmental review requirements

of Executive Order 12372.



.

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