Full Text AA-95-001

HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS

NIH GUIDE, Volume 23, Number 40, November 18, 1994

RFA:  AA-95-001

P.T. 34

Keywords: 
  Alcohol/Alcoholism 
  Health Services Delivery 


National Institute on Alcohol Abuse and Alcoholism

Letter of Intent Receipt Date:  February 6, 1995
Application Receipt Date:  March 21, 1995

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks
health services research and research training grant applications
that are aimed at developing a knowledge base to improve the
efficiency and effectiveness of services for alcohol-related
problems.  Such a knowledge base includes both treatment and
preventive interventions.  This Request for Applications (RFA)
invites research applications related to improving the availability,
accessibility, delivery, quality, cost effectiveness, impact, and
outcomes of alcohol-related treatment and prevention services.

The research objectives include, but are not limited to, four major
areas:  (1) determining impacts of financing and reimbursement
mechanisms on alcohol-related health care program availability,
accessibility, delivery, organization, content, quality, and
outcomes; (2) assessing sources of variation in the utilization and
cost of treatment services and prevention interventions for alcohol-
related problems; (3) identifying and assessing the effectiveness and
outcomes of alcohol-related treatment and preventive services; and
(4) identifying factors that influence the organization, management,
and delivery of treatment and prevention services for alcohol-related
problems across regions, populations, and settings.

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 RFA,
Health Services Research on Alcohol-Related Problems, is related to
the priority areas of alcohol abuse reduction and alcoholism
treatment.  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, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) (R29) awards or Institutional Research
Training Grants (T32).

MECHANISMS OF SUPPORT

Research support may be obtained through applications for a regular
research project grant (R01) or FIRST (R29) award.  Applicants may
also submit Investigator-Initiated Interactive Research Project
Grants (IRPGs) under this RFA.  Interactive Research Project Grants
require the coordinated submission of related regular research
project grant applications and, to a limited extent, FIRST award
applications from investigators who wish to collaborate on research,
but do not require extensive shared physical resources.

The NIAAA also seeks to increase the pool of health services
researchers who have expertise in the alcohol field.  The NIAAA
encourages interested institutions to undertake programs of research
training and career development in the area of alcohol-related health
services research.  Under this RFA, up to $250,000 has been targeted
to award one or two Institutional Research Training Grants (T32).  A
copy of the NIH announcement for National Research Service Awards for
Institutional Research Training Grants, as published in the NIH Guide
for Grants and Contracts, Vol. 23, No. 21, June 3, 1994, may be
obtained from the program staff listed under INQUIRIES.

Potential applicants may obtain copies of other NIAAA announcements
from the National Clearinghouse for Alcohol and Drug Information,
P.O. Box 2345, Rockville, Maryland, 20852, telephone: 301-468-2600 or
1-800-729-6686.  Further information on grant mechanisms and areas of
research interest may be obtained from the program staff listed under
INQUIRIES.

FUNDS AVAILABLE

It is estimated that up to $4 million will be available for
approximately 16 grant awards under this RFA in FY 1995.  This level
of support is dependent on the receipt of a sufficient number of
applications of high scientific merit.  The NIAAA estimates that the
average grant size will be approximately $250,000 in total costs for
the first year.  Although the financial plans of NIAAA provide for
the support of this program, the award of grants pursuant to this RFA
is contingent upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

In June 1992, "The ADAMHA Reorganization Act" (Public Law 101-321)
directed NIAAA to expand its program of health services research.
Health services research is defined in the legislation as "research
endeavors that study the impact of the organization, financing and
management of health services on the quality, cost, access to and
outcomes of care" (Section 409).  Health services research also is
concerned with identifying factors that influence the effectiveness
of health services in "real world" settings.

This RFA invites research grant applications related to understanding
and improving the financing, utilization, effectiveness, and
organization of health services for the prevention and treatment of
alcohol-related problems.

For the purposes of this RFA, health services research includes:  (a)
the assessment of the impact of health services and the effects of
organizational and financing arrangements in "real world" clinical
settings on the quality and outcomes of care provided to patients
with alcohol abuse and alcoholism or with medical problems consequent
to alcoholism and (b) the assessment of the effectiveness of
prevention services as well as their financing, organization,
management, implementation, cost, and utilization.  As directed by
subsequent legislation (P.L. 103-43), for the purposes of this RFA
health services research does not include studies of the efficacy of
specific preventive, diagnostic, and treatment services where the
analysis is directed at the individual as distinct from the service
system.

Applications whose main objective is to establish and support
treatment or prevention services are not eligible for funding under
this RFA.  Support for research-related treatment, rehabilitation, or
prevention services and programs may be requested only for those
particular costs and for that period of time required by the
research.  These costs must be justified in terms of research
objectives, methods, and designs that promise to yield important
generalizable knowledge and/or to make a significant contribution to
theoretical concepts.

Applicants should adopt the most carefully controlled and rigorous
research designs feasible in conducting treatment and prevention
services research and studies (see Lettieri 1992; Sechrest, Persin,
and Bunker 1990; Cook and Campbell 1979).  As elaborated in the
"Review Criteria" section of this RFA, applications will judged on
the basis of the scientific and technical merit of the proposed
research as well as on the adequacy and appropriateness of the
proposed methodology.  Applicants may wish to consult generic
publications in health services research as well as alcohol-specific
examples of prevention and treatment research.

The following list of research topics is for illustrative purposes.
Topics not mentioned below that fall within the research objectives
of this RFA will also be accepted.

Financing and Reimbursement of Services

o  Investigating the impact of innovative financing and reimbursement
approaches on the quality, cost effectiveness, and supply of alcohol
treatment and/or prevention services as well as demand for and
barriers to those services.

o  Assessing how alternative managed care systems affect
availability, quality, cost, and outcomes of treatment and prevention
services.

o  Developing uniform ways to measure insurance benefits and payments
for treatment and prevention of alcohol-related problems in order to
compare performance of alternative health plans.  Alcohol-related
problems include medical consequences of alcohol abuse and alcoholism
such as alcohol poisoning, or cardiovascular, gastrointestinal and/or
neurological disorders.

o  Identifying the impacts of changes in compensation incentives on:
the behavior of consumers, clinicians, and institutions; treatment
appropriateness and outcomes; and the nature and extent of prevention
services within the health care system.

o  Modelling and assessing impacts of health care reform legislation
and other policy changes on the organization, management, financing,
availability, appropriateness, and cost of alternative
alcohol-related health policies and treatment/prevention services.

Utilization and Cost of Services

o  Identifying health service factors and individual characteristics
influencing access to, or compliance with, treatment or preventive
interventions for alcohol-related problems (including symptomatic
medical problems), particularly among underserved, uninsured, and
HIV-infected populations.

o  Identifying care-seeking behavior of people with alcohol problems,
including utilization of informal resources (e.g., self-help groups)
and alternative (e.g., acupuncture) health resources as well as
general medical and specialty alcohol services.

o  Developing standardized criteria for identifying episodes of
alcohol treatment to apply in longitudinal analyses of cost and
utilization data.

o  Determining whether or not prevention programs have significant
effects on the utilization and cost of treatment services.

o  Determining the extent to which costs of treatment or prevention
services are offset by subsequent reductions in health care costs.
For example, evaluating characteristics of individuals, programs,
service systems, and insurance benefits associated with greater cost
offsets and cost effectiveness.

Effectiveness and Outcomes of Services

o  Developing and assessing criteria to classify and measure
objectives, components, and processes involved in delivering major
types of treatment services or prevention interventions for alcohol-
related problems; examining linkages between treatment content,
quality of care, and functional as well as alcohol-specific outcomes;
and examining linkages (e.g., process evaluations) between prevention
content, its method of delivery, and alcohol outcomes.

o  Assessing the effectiveness of brief interventions to treat or
prevent problem drinking and its medical and social consequences.
Health services treatment research may assess brief interventions in
inpatient or outpatient acute and specialty as well as primary care
settings.

o  Assessing adequacy and appropriateness of treatment and prevention
services to meet needs and demands of different groups such as women,
youth, minorities, rural residents, and the elderly.

o  Determining the impact of organization, financing, and management
on the effectiveness of research-based treatment and prevention
interventions when they are delivered to heterogeneous populations in
natural rather than experimental settings.

o  Developing classification or measurement systems for use by
clinicians to better assign patients to treatment modalities or to
improve outcomes, particularly prevention and management of post-
treatment relapse.

o  Applying cost effectiveness research to estimate the costs and
effectiveness of particular alcohol-related health services
(including treatment and prevention) from the perspective of
consumers or their families as well as from the perspectives of
payers, providers, or employers.

o  Assessing the effects of participation in Alcoholics Anonymous on
treatment utilization, outcome, and cost.

Service System Delivery, Organization, and Management

o  Examining organization and management of alcohol treatment and
prevention services, including social, economic, demographic,
geographic, legal or health policy, and other factors that may
facilitate or impede effective and efficient linkage and delivery of
those services.

o  Determining the impact of system-level, service integration
initiatives on the coordination, comprehensiveness and continuity of
alcohol treatment and prevention services.

o  Identifying different organizational models needed for delivery of
alcohol treatment and prevention services to different subpopulations
such as the elderly, youth, women, minorities, rural residents, or
HIV-positive individuals.

o  Developing and testing innovative management approaches to improve
productivity and efficiency in implementing treatment and prevention
services.

o  Examining organizational, provider, and consumer responses to
changes in the following areas:  (a) financing and reimbursement
policies, (b) structural aspects of managed care systems, (c)
insurance coverage characteristics of populations in the service
area, (d) number and characteristics of other organizations and
providers in the area, and (e) demographic factors such as population
density, and/or other factors that may lead to changes in
organizational and provider behavior with ultimate consequences for
access to and outcomes of treatment and prevention services.

o  Investigating factors that influence how preventive interventions
or treatment services reach the appropriate target populations; are
distributed to be accessible to those populations; are utilized in an
effective manner; are adopted with sufficient commitment from policy
makers to make them viable; and are implemented with adequate
resources.

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
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 have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by February 6, 1995, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the
information that it contains allows NIAAA staff to estimate the
potential review workload and to avoid conflict of interest in the
review.

The letter of intent is to be sent to:

Mark Green, Ph.D.
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Room 409
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-4375
FAX:  (301) 443-6077

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301-710-0267; and from the NIAAA staff listed under
INQUIRIES.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

Applicants for support mechanisms other than R01 (i.e., T32 or R29)
must cite the relevant program announcement on line 2a in addition to
listing the current RFA.  Applications for the FIRST Award (R29) must
include at least three sealed letters of reference attached to the
face page of the original application.  FIRST Award (R29)
applications submitted without the required number of reference
letters will be considered incomplete and will be returned without
review.

Page limits and limits on size of type are strictly enforced.  Non-
conforming applications will be returned without being reviewed.

Applicants from institutions that have a General Clinical Research
Center (GCRC), funded by the NIH Division of Research Resources may
wish to identify the Center as a resource for conducting the proposed
research.  If so, a letter of agreement from either the GCRC program
director or principal investigator should be included in the
application material.

Submit a signed, typewritten original of the application, including
the checklist, and three signed, photo copies in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to Dr. Mark Green at the address listed under
LETTER OF INTENT.

Applications must be received by March 21, 1995.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA 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 by DRG
and for responsiveness by the NIAAA.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, DRG staff may contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.  Applications that are
complete and responsive to the RFA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by
the NIAAA in accordance with the review criteria stated below.

As part of the initial merit review, a process (triage) may be used
by the initial review group in which applications will be determined
to be competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be non
competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.  The second level of review will be
provided by the National Advisory Council on Alcohol Abuse and
Alcoholism.

Review Criteria

Criteria to be used in the scientific and technical merit review of
alcohol-related health services research grant applications will
include the following:

1.  The scientific, technical, health or medical significance, and
originality of the proposed research to alcohol-related health
services and the goals of this RFA.

2.  The appropriateness and adequacy of the research design and
methodology proposed to carry out the research.

3.  The adequacy of the qualifications (including level of education
and training) and relevant research experience of the principal
investigator and key research personnel.

4.  The feasibility of implementing the project (including
recruitment of subjects, implementation of the intervention or
innovation, cooperation of relevant organizations, and/or
availability and quality of necessary data).

5.  The availability of adequate facilities, general environment for
the conduct of the proposed research, other resources, and
collaborative arrangements necessary for the research.

6.  The appropriateness of budget estimates and duration in relation
to the proposed research.

7.  Adequacy of plans to include both genders and minorities and
their subgroups as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects will
also be evaluated.

The initial review group will also examine the provisions for the
protection of human subjects and the safety of the research
environment.

The review criteria for FIRST Awards (R29) are contained in the FIRST
program announcement (revised February 1994).  The review criteria
for Institutional Research Training Grant (T32) applications are
contained in the NIH program announcement for National Research
Service Awards for Institutional Research Training Grants dated June
3, 1994.

AWARD CRITERIA

Applications recommended for approval by the National Advisory
Council on Alcohol Abuse and Alcoholism will be considered for
funding on the basis of the overall scientific and technical merit of
the application as determined by peer review, NIAAA programmatic
needs and balance, and the availability of funds.  NIAAA is
interested in maintaining a portfolio of research activities that is
balanced among the four major issues described in the RESEARCH
OBJECTIVES section of this RFA.  In order to expedite the achievement
of such balance, special consideration will be given to applications
that focus on:  (a) Financing and Reimbursement of Services or (b)
Service System Delivery, Organization, and Management.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct general inquiries regarding health services research to:

Robert B. Huebner, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-0786
FAX:  (301) 443-8774
Email:  bhuebner@willco.niaaa.nih.gov

Direct inquiries regarding health services treatment research to:

Harold I. Perl, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-0788
FAX:  (301) 443-8774
Email:  hperl@willco.niaaa.nih.gov

Direct inquiries regarding health services prevention research to:

Michael Hilton, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-8753
FAX:  (301) 443-8774
Email:  mhilton@willco.niaaa.nih.gov

Direct inquiries regarding health services epidemiologic research to:

Harold Yahr, Ph.D.
Division of Biometry and Epidemiology
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 594-6230
FAX:  (301) 443-8614
Email:  hyahr@willco.niaaa.nih.gov

Direct inquiries regarding research training and career development
opportunities to:

Frances Cotter, M.P.H.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-1207
FAX:  (301) 443-8774
Email:  fcotter@willco.niaaa.nih.gov

Direct inquiries regarding fiscal matters to:

Linda Hilley
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-0915
FAX:  (301) 443-3891
Email:  lhilley@willco.niaaa.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance, No. 93.273.  Awards are made under the authorization of
the Public Health Service Act, Sections 301 and 464H, and
administered under the PHS policies and Federal Regulations at Title
42 CFR Part 52 and 45 CFR Part 74.  This program is not subject to
the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

References

Cook, T.D. and Campbell, D.T.  Quasi-Experimentation: Design and
Analysis Issues for Field Settings.  Boston: Houghton Mifflin, 1979.

Lettieri, D.J.  A Primer of Research Strategies in Alcoholism
Treatment Assessment.  DHHS Pub. No. (ADM) 92-1882.  Rockville, MD:
National Institute on Alcohol Abuse and Alcoholism, 1992.

Sechrest, L.; Persin, E.; and Bunker, J., eds.  Research Methodology:
Strengthening Causal Interpretations of Nonexperimental Data. DHHS
Pub. No. (PHS) 90-3454. Rockville, MD: Agency for Health Care Policy
and Research, 1990.

.

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