HEALTH SERVICES RESEARCH ON CLINICAL PREVENTIVE SERVICES

NIH GUIDE, Volume 23, Number 24, June 24, 1994



PA NUMBER:  PA-94-076



P.T. 34



Keywords:

  Health Services Delivery 

  Alcohol/Alcoholism 

  Disease Prevention+ 

  Oral Diseases 



Agency for Health Care Policy and Research

National Institute on Alcohol Abuse and Alcoholism

National Institute on Dental Research



PURPOSE



The Agency for Health Care Policy and Research (AHCPR), the National

Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National

Institute of Dental Research (NIDR) invite health services research

applications that will examine methods to improve the cost

effectiveness and/or quality of clinical preventive services, or that

will improve access to clinical preventive services.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This program

announcement (PA), Health Services Research on Clinical Preventive

Services, is related to the priority areas of clinical preventive

services as well as related objectives from other 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.

017-001-004374-1) 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, for-profit and

non-profit organizations, public and private, including universities,

clinics, units of State or local governments, firms, and foundations.

The AHCPR can support only non-profit organizations.  Applications from

minority and women investigators are encouraged.



MECHANISM OF SUPPORT



This PA uses the research project grant (R01) mechanism.

Responsibility for the planning, direction, and execution of the

proposed project will be solely that of the applicant.



RESEARCH OBJECTIVES



Background



The AHCPR's purpose is to enhance the quality, appropriateness, and

effectiveness of health care services through the establishment of a

broad base of scientific research and through the promotion of

improvements in clinical practice and in the organization, financing

and delivery of health care services.  This PA encourages research that

furthers this purpose by helping translate disease-prevention knowledge

into improved clinical preventive services.  Preventive services are

interventions intended to prevent disease or disability, or prevent

specific sequelae from diseases.  When initiated or delivered to

individuals in a personal health care setting, these services are

considered clinical preventive services.  Examples are counseling for

disease risk factors including advice to reduce health risks, screening

for early detection of disease, chemoprophylaxis for individuals

exposed to infections, and immunizations.  The NIAAA and NIDR join

AHCPR in interest in these areas when the study outcomes are related to

alcohol use or oral health, respectively.



Most national health care reform proposals include preventive services

as a necessary component of the health care system.  Effective

prevention programs have the potential to reduce diseases and

associated use of medical services; this, in turn, may contribute to

slowing the rate of increase in health care costs.  The

cost-effectiveness of specific methods and procedures for providing

individual clinical preventive services must be determined by

science-based research, and ways to improve cost-effectiveness must be

sought.  At the same time, there must be assurance that these services

are of high quality and are readily accessible.



Research Goals



For this PA, "efficacy" refers to the probability of benefit under

ideal conditions, while "effectiveness" refers to benefit that can be

expected in typical situations.  Factors that can change the

probability of benefit of interventions, and thus also their

effectiveness, include provider behaviors, skills, and techniques; and

patient adherence/compliance and other characteristics.  For preventive

service programs, management and institutional characteristics may also

affect benefit by increasing the proportion of targeted people

receiving the intervention.



Recommendations for clinical preventive services are presented in the

U.S. Preventive Services Task Force's Guide to Clinical Preventive

Services.  While efficacy of these clinical preventive services is

generally accepted, the community benefit of many prevention programs

has been disappointing.  Research under this PA should lead to improved

effectiveness of clinical preventive services in the community.



This PA seeks health services research on efficacy-proven clinical

preventive services, not research on preventive services for which

efficacy has not yet been established.  Research is sought in the

following three areas.  These areas are interrelated, and applications

may address one, two, or all three areas.



1.  Cost-effectiveness



Cost constraints and movement towards competitive contracting for

clinical services will increase the need for reliable and acceptable

cost-effectiveness data.  Coverage for services, bundled services, and

exclusions of services may be determined on the basis of

cost-effectiveness and outcomes analyses.  Cost-effectiveness studies

examine the cost of alternatives to achieve a desired goal.  Costs

include direct medical costs, indirect costs, and psychological costs.

Effectiveness relates to patient outcomes, and may include outcomes

other than morbidity or mortality, such as functional status and

quality of life. Examples of research topics include:



o  Cost-effectiveness of specific preventive services;



o  Comparison of practice standards, protocols, recommendations, and

methods for the delivery of preventive services currently suggested by

various organizations;



o  Effects of different practice management patterns on

cost-effectiveness of clinical preventive services:



o  Cost-effectiveness of different approaches to health maintenance

intended to preserve health and improve an individual's functional

capacity, such as counseling and health education services, including

approaches using certified non-physician providers;



o  Cost-effectiveness of clinical strategies for prevention of disease

and disabilities that would otherwise lead to long-term care;



o  Evaluation of "bundling" preventive services, including

cost-effectiveness of various preventive service "packages;" and



o  Advantages/disadvantages of innovative approaches for the delivery

of infant, child, and adolescent clinical preventive services,

particularly to underserved/vulnerable populations.



Methods Development.  In addition to dollar costs, preventive services

should be evaluated in other dimensions as well.  It is important to

develop and apply methods for assessing outcomes of clinical preventive

services including:  incorporation of quality-of-life measures and

patient preferences into standardized methods of comparison; risk

adjustment methods that allow for accurate comparisons of outcomes of

clinical preventive services; and development of outcomes measures that

incorporate functional assessment.



This list is illustrative only and is not meant to be restrictive.

Important elements of original investigations in this area include the

structure and concept of the analysis, the comparisons used, the use of

appropriate descriptive and evaluative ratios such as relative risk,

and the bases for sensitivity analyses.



2.  Quality



Quality issues include timeliness, appropriateness of technique or

procedure, avoidance of harm from the service, and relevance of the

technique/procedure to the recipient.  Many organizations are working

to refine and formalize reliable and accurate quality measures.  Often

ambulatory care quality assessments are based on analysis of

administrative data or claims and some measure of patient satisfaction.

The feedback of comparative information is used as a stimulus for

quality improvement.  Although the administrative data- or claims-based

analyses of preventive services can be broad in scope, there are

limitations to the depth of analysis.  Provision of services may be

reported on claims, but such data provide no indication of the

service's quality.  Assessment of service quality has been difficult.

Research is needed to develop more meaningful and efficient methods for

measuring and improving the quality of clinical preventive services.

Examples of research include, but are not limited to, the following:



o  What are the best measures of the quality of clinical preventive

services?  What is the comparative validity of patient reports, chart

review, facility report card, or claims data?  How can

quality-of-service measures be standardized for fair comparison?



o  What are the best methods to ensure that follow-up of abnormal

screening test results is timely; for example, how can the follow-up

process be improved for patients with abnormal Papanicolaou tests?



3.  Access



Improved availability of health care services for all citizens is a

fundamental principle of most health care reform proposals.  While

availability may improve under health care reform, access may not

necessarily improve for all people.  Many factors affect access.

Reducing preventive service access barriers may require a comprehensive

preventive health systems management approach.  In this sense, a

preventive health system can be viewed as the sum of available

resources for preventive services, and the organization,

prioritization, and implementation of those resources.  Systems

management research may help determine the appropriate infrastructure

and personnel needs for delivering clinical preventive services.



If health care reform removes financial barriers for individuals not

presently covered, there may be more demand for both acute care and

preventive health services.  Preventive services that must be provided

by physicians may not receive as much attention by either patients or

physicians as treatment services.  Competing demand for treatment

services from physician providers may cause provision of preventive

services to decline.  New strategies to use nonphysician providers for

clinical preventive services may increase capacity, and preserve or

increase access to preventive services.  For example, the feasibility

of nurses performing sigmoidoscopy, as part of a team in a controlled

system, has recently been demonstrated.



Technologic support also may increase access to clinical preventive

health services.  Computer-assisted information management may be

useful.  Health systems management research can define methods for

integrating computer techniques into a comprehensive health plan for

delivering preventive services.



Examples of research include, but are not limited to, the following:



o  Comparisons of technological support in different managed care

systems and identification of characteristics that improve the delivery

of preventive services;



o  Evaluation of the effect of new management systems/approaches on

workforce needs; Implications, quality determinants, and feasibility of

nursing and allied health professionals providing clinical preventive

services in a logical, documented, and coordinated fashion;



o  Effectiveness of computer-based information systems in improving

clinical preventive services access, and enhancement of such systems;



o  Advantages of different strategies to promote the use of available

clinical preventive health services; and



o  Comparison of methods to increase the delivery of recommended

clinical preventive services for those who come in for other health

care and fail to get preventive services (missed opportunities), and

for those who do not come in for health care (outreach).



Research Interests of NIAAA



Under the general framework of this PA, NIAAA has special interest in

research related to alcohol use.  Advice about alcohol use and brief

interventions to reduce problem drinking have consistently been shown

to be effective in reducing alcohol consumption and associated harmful

consequences (Bein, Miller, Tonigan, Addictions 88:315-336, 1993).

These interventions have been implemented in a variety of health care

settings and the cost-effectiveness of these procedures needs to be

directly evaluated. Prevention of alcohol misuse may also serve as a

co-factor in use of other medical services.  Of particular interest is

the primary care setting, in which cost-effectiveness, quality of care,

and accessibility of preventive medical services may be affected by

type of intervention.



Examples of research may include, but are not limited to:



o  Modeling of current patterns of preventive services that address

alcohol use.  This includes attention to characteristics of different

health care settings and special populations in order to identify

optimal interventions and alcohol use or abuse on service usage.

Settings could include office-based practices, emergency rooms, health

maintenance organizations, or public health clinics. Special at-risk

groups of interest could include adolescents, women of childbearing

age, minority individuals or inner-city or rural populations.



o  Cost-effectiveness of these interventions in improving other

health-care utilization patterns.



Related to the implementation of cost-effective preventive

interventions is the study of methods to change attitudes of service

providers to improve their acceptance of preventive alcohol

interventions.



Research Interest of NIDR



Under the general framework of this PA, NIDR invites applications for

research in which the dependent variable of interest is a component of

oral health.



STUDY POPULATIONS



INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS



It is the policy of the NIH that women and members of minority groups

and their subpopulations must be included in all NIH supported

biomedical and behavioral research projects involving human subjects,

unless a clear and compelling rationale and justification is provided

that inclusion is inappropriate with respect to the health of the

subjects or the purpose of the research.  This new policy results from

the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43)

and supersedes and strengthens the previous policies (Concerning the

Inclusion of Women in Study Populations, and Concerning the Inclusion

of Minorities in Study Populations), which have been in effect since

1990.  The new policy contains some new provisions that are

substantially different from the 1990 policies.  All investigators

proposing research involving human subjects should read the "NIH

Guidelines for Inclusion of Women and Minorities as Subjects in

Clinical Research," which were published in the Federal Register of

March 20 1994 (FR 59 14508-14513), and printed in the NIH GUIDE FOR

GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.



Investigators may obtain copies from these sources or from the NIAAA or

NIDR program contact listed under INQUIRIES.  The NIAAA or NIDR program

contact may also provide additional relevant information concerning the

policy.



AHCPR supports this NIH policy, which supersedes and strengthens NIH's

previous policies that the AHCPR had adopted.  The AHCPR plans to

publish guidelines on women and minorities specific to the AHCPR.  In

the interim, the AHCPR will follow the NIH guidelines, as applicable.

The AHCPR program contact listed under INQUIRIES may also provide

additional relevant information concerning AHCPR's policy.



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 government

agencies may use form PHS 5161 and follow those requirements for copy

submission.  Application kits are available at most institutional

offices of sponsored research; from the Office of Grants Information,

Division of Research Grants, National Institutes of Health, Westwood

Building, Room 449, Bethesda, MD 20892, telephone 301-710-0267; and for

AHCPR applications from Global Exchange Inc., 7910 Woodmont Avenue,

Suite 400, Bethesda, MD 20814-3015, telephone 301-656-3100 (FAX

301-652-5264).  The title and number of the PA must be typed in Section

2a on the face page of the application.



The completed, signed, 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.



REVIEW CONSIDERATIONS



Upon receipt, applications will be reviewed for completeness and

responsiveness.  Incomplete applications will be returned to applicants

without further consideration. Review criteria for are:



o  scientific and technical significance of proposed research;



o  appropriateness and adequacy of the research approach and

methodology proposed to carry out the research;



o  qualifications and research experience of the Principal Investigator

and staff, particularly, but not exclusively, in the area of the

proposed research;



o  availability of data or a well designed plan for gathering data

necessary to perform the research;



o  appropriateness of the proposed budget and duration in relation to

the proposed research.



Applications will be reviewed for scientific and technical merit in

accordance with the criteria stated above by an appropriate peer review

group.  Applications recommended for funding consideration by the peer

review group will be reviewed by an appropriate National Advisory

Council; review by Council may be based on policy considerations as

well as scientific merit.



There is interest in prevention-related research among other components

of the National Institutes of Health.  Applications may be referred to

appropriate Institutes for consideration of funding or co-funding.



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.  The earliest

anticipated date of award is 10 months from the date of submission.



INQUIRIES



Those considering applying in response to this PA are strongly

encouraged to discuss the project with program administrators in

advance of formal submission.  The AHCPR, NIAAA, and NIDR welcome the

opportunity to clarify any issues or questions from potential

applicants.



Direct inquiries regarding programmatic issues, including information

on the policy of inclusion of women and minorities in study

populations, to:



James K. Cooper, M.D.

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) 594-1354, ext. 141



Kendall J. Bryant, Ph.D.

Division of Clinical and Prevention Research

National Institute on Alcohol Abuse and Alcoholism

6000 Executive Boulevard, Suite 505

Rockville, MD  20892-7003

Telephone:  (301) 443-8820



Patricia S. Bryant, Ph.D.

Behavior, Pain, Oral Function and Epidemiology Program

National Institute of Dental Research

Westwood Building, Room 509

Bethesda, MD  20892

Telephone:  (301) 496-7784



Direct inquiries regarding fiscal matters to:



Ralph Sloat

Grants Management Officer

Agency for Health Care Policy and Research

2101 East Jefferson Street, Suite 601

Rockville, MD  20852

Telephone:  (301) 594-1447



Edward B. Ellis

Grants Management Specialist

National Institute on Alcohol Abuse and Alcoholism

6000 Executive Boulevard, Suite 504

Rockville, MD  20892-7003

Telephone:  (301) 443-4706



Teresa Ringler

Chief, Grants Management Office

National Institute of Dental Research

Westwood Building, Room 510

Bethesda, MD  20892

Telephone:  (301) 594-7629



AUTHORITY AND REGULATIONS



These programs are described in the Catalog of Federal Domestic

Assistance Nos. 93.226, 93.273, and 93.121.  Awards are made under

authorization of Titles IX and IV, and Section 301 of the Public Health

Service Act.  Awards are administered under the PHS Grants Policy

Statement; and Federal Regulations 42 CFR Part 67 Subpart A, 42 CFR

Part 52, 45 CFR Part 46, and 45 CFR Part 74 (45 CFR Part 92 for State

and local governments).  These programs are not subject to the

intergovernmental review requirements of Executive Order 12372.



.

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