Full Text AA-94-005

HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS

NIH GUIDE, Volume 22, Number 36, October 8, 1993

RFA:  AA-94-005

P.T. 34

Keywords: 
  Alcohol/Alcoholism 
  Disease Prevention+ 
  Treatment, Medical+ 
  Health Services Delivery 
  Health Care Economics 


National Institute on Alcohol Abuse and Alcoholism

Letter of Intent Receipt Date:  December 20, 1993
Application Receipt Date:  January 24, 1994

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks
health services research and research training grant applications to
develop a knowledge base that can be used to improve the efficiency
and effectiveness of services for alcohol-related problems.  Both
prevention interventions and treatment services are important
components of the health services that a society delivers to its
population.  To be comprehensive, health services research seeks to
evaluate both treatment and prevention services.  This Request for
Applications (RFA) invites research grant applications related to
improving the accessibility, quality, cost effectiveness, impact, and
outcome of alcohol-related treatment services and prevention
interventions.

The research objectives include:  (l) determining impacts of
financing and reimbursement mechanisms on consumer and provider
behavior and on health care accessibility, organization, content,
quality, and outcomes; (2) identifying factors that influence
organization, management, supply, accessibility, and appropriateness
of alcohol treatment and prevention services for alcohol-related
problems across regions, populations, and settings; (3) identifying
factors influencing the impact of alcohol-related health policies and
interventions on outcomes in communities as well as clinical
settings; (4) identifying ways to improve the effectiveness of
alcohol-related health services (including treatment of medical
consequences such as cirrhosis of the liver or alcoholic
cardiomyopathy) delivered in general medical as well as alcohol
treatment settings; for example, brief interventions and referral,
anticipatory guidance, monitoring outcomes, quality assurance, and
patient-service matching; (5) identifying ways to improve the
effectiveness of preventive interventions for reducing alcohol
problems, including educational and media approaches, deterrents for
drunk driving and violence, and community-based initiatives; and (6)
assessing sources of variation in utilization, cost offsets, and cost
effectiveness of treatment services and prevention interventions for
problems related to alcohol abuse and alcoholism.

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

Applications may be submitted by domestic and foreign, public and
private, non-profit and for-profit organizations, such as
universities, colleges, hospitals, research institutes, insurance or
managed care organizations, units of State and local governments, and
eligible agencies of the Federal government.  Women and minority
investigators are encouraged to apply.  Foreign institutions are not
eligible for First Independent Research Support and Transition
(FIRST) Awards (R29).

MECHANISMS OF SUPPORT

Research support may be obtained through applications for a regular
research grant (R01) or FIRST award (R29).  Applicants may also
submit Investigator-Initiated Interactive Research Project Grants
under this RFA.  Interactive Research Project Grants require the
coordinated submission of related 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.  Program Project Grants applications (P01)
will not be accepted under this RFA.

The NIAAA also seeks to increase the pool of health services
researchers who have expertise in the alcohol field.  The NIAAA
encourages interested individuals and/or 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 program announcement PA-92-31
for National Research Service Awards for Institutional Grants and
information on other research training and career development
opportunities may be obtained from the program contact person listed
under INQUIRIES.

Potential applicants may obtain copies of specific announcements from
the National Clearinghouse for Alcohol and Drug Information, P.O. Box
2345, Rockville, MD 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 $12 million in total will be available for
approximately 50 to 60 grants under this RFA in FY 1994.  This level
of support is dependent on the receipt of a sufficient number of
applications of high scientific merit.  Although this program is
provided for in the financial plans of the NIAAA, the award of grants
pursuant to this RFA is also 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 applications related to understanding and
improving the financing, organization, management, and effectiveness
of health services for the prevention and treatment of alcohol-
related problems.

The intent of health services treatment research is to assess 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 as well as medical problems consequent to alcoholism.
Not included in health services treatment research is efficacy
research (Public Law 103-43), experimental studies designed to
determine how successfully a specific treatment intervention reduces
problematic consumption or symptoms related to alcohol use.

The intent of health services prevention research is to assess the
effectiveness of preventive interventions in reducing alcohol-related
problems and/or contributing risk factors.  In addition to
intervention studies in health care settings, prevention services
research may occur in a variety of other settings (e.g., worksites,
schools and local communities) and may focus on financing,
organization, management, enforcement, and utilization of prevention
services as well as their effectiveness.

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 research
designs feasible in conducting treatment and prevention services
research/studies (see Lettieri 1992; Sechrest et al. 1991; Cook and
Campbell 1979; Holder and Howard 1992).  Applicants may wish to
consult generic publications in health services research as well as
alcohol-specific examples of prevention and treatment research (see
References below).

The following list of research topics is for illustrative purposes.
Topics not mentioned are not necessarily excluded from consideration
under this RFA.

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 interventions 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  Modeling 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.

o  Assessing the intended and unintended financial incentives
(positive and negative) that operate in the proposed or reformed
health care system and determining their impact.

Organization, Management, and Availability of Resources

o  Examining organization and management of alcohol treatment and
prevention services, including social, economic, demographic, legal
or health policy, and behavioral factors that 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 or HIV-positive individuals.

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

o  Examining organizational and provider responses to changes in:
(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  Assessing adequacy and appropriateness of treatment and prevention
services to meet needs and demands of different groups such as women,
youth, minorities, and the elderly.  For example, assessing the
appropriateness and effectiveness of DWI treatment programs or
preventive drinking-driving countermeasures among these groups.

o  Investigating factors that influence how preventive interventions
or treatment services are made available to and utilized by and are
implemented with adequate resources.

o  Assessing the impact of AA membership on treatment utilization,
outcome, and cost.

Effectiveness 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  Improving effectiveness of treatment and prevention services by
improving their quality.

o  Assessing the full range of impacts 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.  Prevention research may assess the impacts
of anticipatory guidance and counselling in health care or other
community settings regarding risks of drinking (e.g., server
intervention).

o  Using natural experiments to assess the effectiveness of
government policies, interventions, or financing arrangements to
prevent or treat alcohol problems (e.g., policies affecting alcohol
availability, price, and youth access; or financing arrangements
affecting treatment access, quality, and outcome).

o  Determining the effectiveness of behavioral interventions aimed at
alcohol problems; interventions to prevent, for example, drinking and
driving, worksite-related alcohol problems, or exposure to HIV or
tuberculosis facilitated by alcohol use.

o  Determining the effectiveness of research-based treatment and
prevention interventions when they are delivered to heterogeneous
populations in natural rather than experimental settings.  These
natural settings may include, for example, clinics, hospitals, work
sites, schools, or local communities.

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

o  Assessing the effectiveness of preventive services that transcend
particular problems (e.g., primary prevention in health care systems
or media and educational approaches).

Utilization and Cost of Services

o  Identifying health service factors and individual characteristics
influencing access, adherence, or responsiveness to treatment or
preventive interventions for alcohol-related problems (including
symptomatic medical ones), 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 services.

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

o  Determining whether 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.

o  Expanding 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.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING
IMPLEMENTATION OF NIH POLICIES CONCERNING
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

Applications for NIH grants and cooperative agreements are required
to include both women and minorities in study populations for
clinical research, unless compelling scientific or other
justification for not including either women or minorities is
provided.  This requirement is intended to ensure that research
findings will be of benefit to all persons at risk of the disease,
disorder, or condition under study.  For the purpose of these
policies, clinical research involves human studies of etiology,
treatment, diagnosis, prevention, or epidemiology of diseases,
disorders or conditions, including but not limited to trials; and
minorities include U.S. racial/ethnic minority populations
(specifically:  American Indians or Alaskan Natives, Asian/Pacific
Islanders, Blacks, and Hispanics).

NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of U.S.
racial/ethnic minority populations.  However, applicants are urged to
assess carefully the feasibility of including the broadest possible
representation of minority groups.

Applications must include a description of the composition of the
proposed study population by gender and racial/ethnic group, and the
rationale for the numbers and kinds of people selected to
participate.  This information should be included in the form PHS 398
in Sections 1-4 of the Research Plan and summarized in Section 5,
Human Subjects.

Applications must incorporate in their study design gender and/or
minority representation appropriate to the scientific objectives of
the work proposed.  If representation of women or minorities in
sufficient numbers to permit assessment of differential effects is
not feasible or is not appropriate, the reasons for this must be
explained and justified.  The rationale may relate to the purpose of
the research, the health of the subjects, or other compelling
circumstances (e.g., if in the only study population available, there
is a disproportionate representation in terms of age distribution,
risk factors, incidence/prevalence, etc., of one gender or
minority/majority group).

If the required information is not contained within the application,
the review will be deferred until it is complete.  Peer reviewers
will address specifically whether the research plan in the
application conforms to these policies.  If gender and/or minority
representation/ justification are judged to be inadequate, reviewers
will consider this as a deficiency in assigning the priority score to
the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants that do not comply with these policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 20, 1993, 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 subsequent applications, 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.
Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard
Rockville, MD  20892
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 program administrator
listed under INQUIRIES.

The RFA label available in the PHS (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.  Page limits and limits on size of type are strictly
enforced.  Applicants for FIRST Awards (R29) are reminded that such
applications must include three letters of reference.  Non-conforming
applications will be returned without being reviewed.

Applicants from institutions that have a General Clinical Research
Center (GCRC), funded by the NIH National Center for 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.

The signed original, including the checklist, and three signed,
legible copies of the completed application must be sent 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:

Mark Green, Ph.D.
Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 443-4375
FAX:  (301) 443-6077

Applications must be received by January 24, 1994.  If an application
is received after that date, it will be assigned to the next review
cycle and will compete with all other investigator-initiated research
grant applications.  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

The Division of Research Grants, NIH, serves as a central point for
receipt of applications for most discretionary PHS grant programs.
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NIAAA.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NIAAA staff will 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 may be triaged by an NIAAA peer review group on the
basis of relative competitiveness.  The NIH will withdraw from
further competition those applications judged to be non-competitive
for award and notify the applicant Principal Investigator and
institutional official.  Those applications judged to be competitive
will undergo further scientific merit review.  Those applications
that are complete and responsive will be evaluated in accordance with
the criteria stated below for scientific/technical merit by an
appropriate peer review group convened by the NIAAA.  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 research grant applications will include the following:

1.  The scientific, technical, health, or medical significance and
originality of the proposed research.

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

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

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

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 reasonableness of budget estimates and duration for the
proposed research.

7.  Where applicable, the adequacy of procedures to protect or
minimize effects on human subjects and the environment.

8.  Conformance of the application to the NIH policy on inclusion of
women and minorities in study populations.

The review criteria for FIRST Awards (R29) are contained in the FIRST
program announcement.  The review criteria for Institutional Research
Training Grant (T32) applications are contained in program
announcement PA-92-31, National Research Service Awards for
Institutional Grants dated January 1992.  Both are available from
staff listed under INQUIRIES.

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

Potential applicants are encouraged to seek preapplication
consultation and may contact the individuals listed below for
consultation in preparing an application under this RFA.

Direct programmatic inquiries regarding health services treatment
research to:

Cherry Lowman, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
5600 Fishers Lane, Room 14C-20
Rockville, MD  20857
Telephone:  (301) 443-0796
FAX:  (301) 443-8774

Direct inquiries regarding fiscal matters to:

Elsie Fleming
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
5600 Fishers Lane, Room 16-86
Rockville, MD  20857
Telephone:  (301) 443-4703
FAX:  (301) 443-3891

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, "Grants for Research Projects," and Title 45 CFR
Parts 74 and 92, "Administration of Grants and 45 CFR Part 46,
"Protections of Human Subjects."  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency Review.

References

I. Health Services Research

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Ginzberg, E., ed. Health Services Research: Key to Health Policy.
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Cook, T.D. and Campbell, D.T.  Quasi-Experimentation:  Design and
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Drummond, M.F.; Stoddart, G.L.; and Torrance, G.W.  Methods for the
Economic Evaluation of Health Care Programmes. New York: Oxford
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Ginzberg, E., ed. Health Services Research: Key to Health Policy.
Cambridge, MA:Harvard University Press, 1991.

Grady, M.L, and Schwartz, H.A., eds. Medical Effectiveness Research
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Policy and Research, 1992.

Lohr, K.N. (ed.) Advances in health status assessment: Fostering the
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Newhouse, J. P.  Controlled experimentation as research policy. In:
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Pauly, M.V.  Effectiveness research and the impact of financial
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Sechrest, L.; Persin, E.; and Bunker, J., eds.  Research Methodology:
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Steinwachs, D.M.  Redesign of delivery systems to enhance
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Manning, W.G.; Keeler, E.B.; Newhouse, J.P.; Sloss, E.M.; and
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Moos, R.H.; Finney, J.W.; and Cronkite, R.C.  Alcoholism Treatment:
Context, Process and Outcome.  New York: Oxford University Press,
1990.

Morse, B.J. and Elliott, D.S. The effects of ignition interlock
devices on DUI recidivism: Findings from a longitudinal study in
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Moskowitz, J.M. The primary prevention of alcohol problems: A
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O'Malley, P.M. and Wagenaar, A.C.  Effects of minimum drinking age
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.

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