HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS

Release Date:  March 6, 1998

PA NUMBER:  PAS-98-037

P.T.

National Institute on Alcohol Abuse and Alcoholism

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks health
services research grant proposals which are aimed at developing a knowledge base
to improve the delivery of services for alcohol-related problems.  Such a
knowledge base includes both treatment and preventive interventions.  This
program announcement (PA) invites research proposals to test strategies for
improving the availability, accessibility, delivery, quality, effectiveness,
cost-effectiveness, and outcomes of alcohol-related treatment and prevention
services.

The research objectives include, but are not limited to, the broad goal of
advancing scientific understanding of the effects of organizational structures
and processes, as well as financing and reimbursement mechanisms (specifically
the combination of organizational structures and financing mechanisms that
constitute managed care) on the availability, accessibility, utilization,
delivery, content, quality, outcomes, cost, and cost-effectiveness of alcohol
treatment services.  Objectives also include studying the effectiveness and cost-
effectiveness of alcohol prevention services in reducing the demand for health
care services.  Also of key importance is improving the methodological tools,
data reporting systems, and analysis techniques useful for conducting health
services research.

This program announcement replaces the announcement "Health Services Research on
Alcohol-Related Problems" (PA-96-021) issued February 1996.

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, 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, D.C.
20402-9325 (Telephone: 202-512-1800).

ELIGIBILITY

Applications may be submitted by domestic and foreign, for-profit and non-profit,
public and private organizations, 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.

MECHANISM OF SUPPORT

Research support may be obtained through applications for a regular research
project grant (R01) or Small Grant (R03).  Applications are also encouraged for
Exploratory/Developmental Grants (R21), which are limited to up to 2 years for
up to 100,000 for direct costs per year.  Applicants for Exploratory/
Developmental Grants will need to cite the program announcement for Secondary
Analysis of Existing Health Services Data Sets PA-97-066 in addition to this
announcement in their application.  Applicants may also submit Investigator-
Initiated Interactive Research Project Grants under this program announcement. 
Interactive Research Project Grants require the coordinated submission of related
regular research project grant applications from investigators who wish to
collaborate on research.

Potential applicants for Exploratory/Developmental Grants may obtain copies of
the specific announcements from the NIAAA Home Page at http://www.niaaa.nih.gov
or from the Office of Scientific Affairs, NIAAA, 6000 Executive Boulevard, Suite
409, MSC 7003, Bethesda, MD 20892-7003, telephone: 301-443-4375 or FAX 301-443-
6077.  Further information on grant mechanisms and areas of research interest may
be obtained from program staff listed under INQUIRIES.

FUNDS AVAILABLE

It is estimated that up to $6 million will be available for FY 1998 and FY 1999
to fund approximately 24 grant awards under this announcement.  This level of
support is dependent on the receipt of a sufficient number of applications of
high scientific merit.  Awards must be made within NIH cost containment
guidelines.  Applicants are encouraged to contact NIAAA program staff to review
these guidelines. Although the financial plans of the NIAAA provide for the
support of this program, the award of grants pursuant to this program
announcement is contingent upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

Health services research is defined 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" (PL 101-321, Section 409).  Health services
research also is concerned with assessing the effectiveness of health services
in applied clinical settings.

For the purposes of this program announcement, health services research includes:
(a) the assessment of the impact of treatment 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
program announcement, health services research does not include studies of the
efficacy of specific preventive, diagnostic, and treatment modalities.

Applications whose main objective is to establish and support treatment or
prevention service programs are not eligible for funding under this program
announcement.  Support for the costs of research-related treatment,
rehabilitation, or prevention services and programs may be requested only for
those particular costs related to the implementation of the research project and
for that period of time required by the research project.  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 research designs appropriate to alcohol-related treatment
and prevention services research studies (see Lettieri 1992; Sechrest, Persin,
and Bunker 1990; Cook and Campbell 1979; Gold et al. 1996).  Research designs
should contain a judicious mixture of both scientific rigor and thoughtful
responses to the exigencies of conducting research in "real world," applied
settings.  Applicants may wish to consult publications in health services
research (e.g., Altman and Reinhardt 1996) as well as alcohol-specific examples
of prevention and treatment research.

The following list of research topics is for illustrative purposes.  Proposals
on topics not explicitly mentioned below, but which fall within the research
objectives of this program announcement, will also be accepted.  However, highest
program priority is for research on the topics listed below.  These were
identified by the National Advisory Council on Alcohol Abuse and Alcoholism as
the most promising areas for continued investment in health services research. 
Of the areas listed below, organization, financing, managed care, and cost-
effectiveness are least well-represented in the portfolio of currently-funded
grants.  By contrast, effectiveness and outcome studies are relatively more
numerous.  The desire to balance the portfolio consequently gives greater
priority to the former topics and less to the latter.  However, strong
applications in all areas will be considered for funding.

Managed Care.  Few issues have generated as much controversy in the general
health care arena and in the delivery of alcohol services as the consequences of
managed care.  Despite the rapid growth of managed behavioral health care, little
is known about how alcohol services are delivered under managed care
arrangements.  To address this knowledge gap, researchers should:

1.  Conduct research on the financial, organizational, and management
arrangements known as "managed care" and their effects on the accessibility,
utilization, quality, cost, and outcomes of alcohol treatment services.

2.  Conduct research that describes and monitors the characteristics and trends
of managed care plans for alcohol treatment.

Organization.  The system that delivers alcohol treatment and prevention services
is complex with many interconnected elements.  The task of understanding this
system is made more difficult in the current era of rapid change, in which new
structures and roles are quickly emerging as others are re-defined.  This rapid
change creates a special need for research to:

1.  Develop comprehensive models of the varied elements of the alcohol treatment
system and explain the relationships, structure, incentives, integration, and
interaction at work in those components.

2.  Study the role played by Government -- as purchaser, provider, and regulator
-- in the provision, delivery, and quality of alcohol treatment services.

3.  Identify the factors that impede or facilitate the receipt of care by
different client populations and the characteristics of the treatment services
received by those client populations.

Financing.  Arrangements for financing alcohol services are similarly undergoing
rapid and fundamental change.  It is critical to understand the intended and
unintended consequences of these changes.  To understand these impacts, research
should:

1.  Study the allocation of risks and incentives within private and public
arrangements for the financing of alcohol treatment services and the consequences
of alternate financing arrangements.

2.  Identify the factors that determine which individuals will be insured for
alcohol-related services and the extent of the insurance coverage for those
services.

Access and Utilization.  Issues of access to and utilization of services focus
on whether individuals who need services actually receive them, as well as on the
quantity and mix of services that are received.  These questions are particularly
important for planning purposes, as well as for promoting equitable access to
treatment services.  Research should:

1.  Study the individual-, organizational-, and sociocultural-level factors that
affect access to and utilization of alcohol treatment, with emphasis on exploring
the interaction of these factors .

2.  Determine whether group differences in utilization rates reflect differences
in need or the existence of inequities in access to treatment.

Effectiveness and Outcomes.  Some of the most compelling questions about alcohol
treatment have to do with what works -- that is, "What are the outcomes of
different treatment modalities, for different types of clients, in different
settings," and "What factors help to make treatment services effective?"  In
health services research, the focus is on outcomes in practice settings and under
typical rather than ideal conditions. Efficacy studies of treatment outcomes
under ideal, experimental conditions are not appropriate under the terms of this
announcement but may be submitted in regular research grant applications. 
Instead research should:

1.  Study whether treatments that have been shown to be efficacious in controlled
trials are also effective in real life clinical settings.

2.  Investigate the relative effectiveness of competing treatment strategies for
specific forms of disorders and affected populations.

Costs and Cost-Effectiveness.  As the health care system changes, payers,
providers, governments and consumers will make a host of decisions that will
determine how dollars are spent for alcohol treatment.  Making wise choices
involves balancing costs against outcomes.  These considerations suggest that
future research should:

1.  Compare the costs of alcohol treatment programs with their outcomes,
benefits, and cost offsets.

Prevention.  While there have been many studies assessing prevention outcomes in
terms of reduced drinking, fewer traffic accidents, or reduced incidence of
cirrhosis or other chronic diseases, researchers have seldom taken the additional
step of assessing whether these reductions have lowered subsequent demand for
health care.  To close this gap in current knowledge, research should:

1.  Measure the effectiveness and cost-effectiveness of alcohol prevention in
reducing the demand for health care services.

2.  Assess the outcomes of prevention activities among populations having a high
level of health care services use or at risk for high-cost care events.

Methodology.  In health services research, as in other areas of research,
advances in methodology are needed to produce the sophisticated tools that are
used to build the knowledge base.  To facilitate such progress, researchers
should:

1.  Improve existing measures of alcohol services delivery by working towards
common definitions and measures and by testing the reliability and validity of
those measures.

2.  Enhance national-level data collection and reporting systems suitable for
monitoring and analyzing alcohol health services delivery.

3.  Refine methods used to analyze existing data sets relevant to alcohol health
services research.

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
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 20, 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.

 APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted at the standard application deadlines as indicated in
the application kit.  Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7710, Bethesda, MD 20892-7910, telephone 301-710-0267, email,
asknih@od.nih.gov.  The title and number of the program announcement must be
typed in section 2 of the face page of the application.

The completed original application and five legible copies must be sent or
delivered to:

CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants)
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817-7710  (for express/courier service)

REVIEW CONSIDERATIONS

Applications that are complete will be evaluated for scientific and technical
merit by an appropriate peer review group convened in accordance with the
standard NIH peer review procedures.  As part of the initial merit review, all
applications will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit, generally the top
half of the applications under review, will be discussed, assigned a priority
score, and receive a second level review by the appropriate national advisory
council.

Review Criteria

The five criteria to be used in the evaluation of grant applications are listed
below.  To put those criteria in context, the following information is contained
in instructions to the peer reviewers.

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered by the reviewers in assigning the
overall score weighting them as appropriate for each application.  Note that the
application does not need to be strong in all categories to be judged likely to
have a major scientific impact and thus deserve a high priority score.  For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

Significance:  Does this study address an important problem?  If the aims of the
application are achieved, how will scientific knowledge be advanced? What will
be the effect of these studies on the concepts or methods that drive this field?

Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

Innovation:  Does the project employ novel concepts, approaches or methods?  Are
the aims original and innovative?  Does the project challenge existing paradigms
or develop new methodologies or technologies?

Investigator:  Is the investigator appropriately trained and well-suited to carry
out this work?  Is the work proposed appropriate to the experience level of the
principal investigator and other researchers (if any)?

Environment:  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence of institutional support?

Budget:  Is the requested budget and estimation of time to completion of the
project appropriate for the proposed research?

In addition, plans for the recruitment and retention of subjects will be
evaluated as will the adequacy of plans to include both genders and minorities
and their subgroups as appropriate for the scientific goal of the research.

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

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.

INQUIRIES

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

Inquiries regarding programmatic issues may be directed to:

For general information:

Robert 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) 443-0787
FAX:  (301) 443-8774
Email:  bhuebner@willco.niaaa.nih.gov

For studies on access, utilization, cost, and prevention:

Mike 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

For studies on effectiveness, outcomes, and methods:

Harold 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

For studies on organization, financing, and managed care:

Wendy Smith, 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) 443-8771
FAX:  (301) 443-8774
Email:  wsmith@willco.niaaa.nih.gov

Direct inquiries regarding fiscal matters to:

Edward Ellis
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-4706
FAX:  (301) 443-3891
Email:  eellis@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 or 45 CFR Part 95, as
applicable.  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.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.

References

Altman, S.H. and Reinhardt, U.E.  Strategic Choices for a Changing Health Care
System.  Chicago:  Health Administration Press, 1996.

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

Gold, M.J., Siegel, J.E., Russell, L.B., and Weinstein, M.C. Cost-Effectiveness
in Health and Medicine.  New York:  Oxford University Press, 1996.

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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