Full Text AA-97-001
 
HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS
 
NIH GUIDE, Volume 25, Number 41, November 29, 1996
 
RFA:  AA-97-001
 
P.T. 34

Keywords: 
  Alcohol/Alcoholism 
  Health Services Delivery 

 
National Institute on Alcohol Abuse and Alcoholism
 
Letter of Intent Receipt Date:  March 21, 1997
Application Receipt Date:  April 24, 1997
 
PURPOSE
 
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks
health services research grant applications that 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 Request for
Applications (RFA) invites research grant applications related to
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, five major
areas: (1) determining the effects 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 access and
utilization 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) evaluating the cost, cost-effectiveness,
cost-benefit, and cost-utility of alcohol-related treatment and
prevention services; and (5) identifying organizational and
managerial factors that influence the 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
202-512-1800).
 
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.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) Awards (R29).  Regular research
project grant applications (R01) from foreign institutions are
limited to three years.
 
MECHANISM OF SUPPORT
 
Research support may be obtained through applications for a regular
research project grant (R01) or FIRST (R29) Award.  Applications are
also encouraged for exploratory/developmental grants (R21), which are
limited to up to two years for up to $70,000 per year for direct
costs.  Applicants may also submit Investigator-Initiated Interactive
Research Project Grants (IRPG) 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.
Program Project Grant applications (P01) will not be accepted under
this RFA.
 
Potential applicants for FIRST (R29) Awards, or
exploratory/developmental (R21) 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, Willco Building, Suite 409, 6000 Executive Boulevard 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 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 1997.  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 the 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
 
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 everyday
practice.
 
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 modalities.
 
Applications whose main objective is to establish and support
treatment or prevention service programs 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 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 the most rigorous research designs feasible
in conducting their alcohol-related treatment and prevention services
research 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 be 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.  The NIAAA is particularly
interested in applications that address the effects of managed care
on access, utilization, cost, cost-effectiveness, and outcomes of
alcohol services.
 
Financing and Reimbursement of Services
 
o  Investigating the effects of 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.
 
o  Identifying the impact of changes in compensation incentives on 1)
the behavior of consumers, clinicians, and institutions; 2) treatment
appropriateness; 3) treatment outcomes; and 4) the nature and extent
of prevention services within the health care system.
 
o  Modeling and assessing the impact 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.
 
Access and Utilization of Services
 
o  Identifying health service factors and individual characteristics
influencing access to, or compliance with, treatment or preventive
interventions for alcohol-related problems, particularly among
underserved, uninsured, and HIV-infected populations.
 
o  Assessing how alternative managed care systems affect access and
utilization of treatment and prevention services.
 
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 utilization
data.
 
o  Determining whether prevention programs have significant effects
on the utilization of treatment services.
 
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  Examining alternative managed care systems to assess the effect of
these arrangements on the effectiveness and outcomes of
alcohol-related treatment and prevention interventions.
 
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  Assessing the effects of participation in Alcoholics Anonymous on
treatment utilization, outcome, and cost.
 
Cost Analyses of 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  Applying cost effectiveness, cost-benefit and cost-utility
analyses to 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  Applying cost effectiveness, cost-benefit and cost-utility
analyses to alcohol-related health services within managed health
care systems.
 
o  Effects of managed care on costs of alcohol-related health
services.
 
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  Evaluating the effect of different organizational models of
managed care on the availability, quality, cost, and outcomes of
treatment and prevention 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.
 
Examining organizational, provider, and consumer responses to changes
in the following areas:  (a) financing and reimbursement policies,
(b) structural aspects of managed care systems, 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.
 
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 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.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by March 21, 1997, a
letter ofc intent that includes a descriptive title of the proposed
research, the name,c address, and telephone number of the Principal
Investigator, the identities ofc 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:
 
RFA-AA-97-001
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. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714,
email:  ASKNIH@odrockm1.od.nih.gov.
 
The RFA label available in the PHS 398 (rev. 5/95) 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 2 of the face page of the application form and the YES box must
be marked. Applications for support mechanisms other than R01 (i.e.,
an R29) must cite the relevant program announcement on line 2 in
addition to listing the current RFA.
 
Applications for FIRST awards (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 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.
 
Submit a signed, typewritten original of the application, including
the checklist and three signed photocopies in one package to:
 
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)
 
At the time of submission, two additional copies of the application
must also be sent to:
 
RFA-AA-97-001
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Room 409
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Rockville, MD  20852-7003 (for express/courier service)
 
Applications must be received by April 24, 1997.  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 and must be prepared in
the format of a revised application.
 
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 review
process may be used by the initial review group in which applications
may or may not be discussed based on their scientific merit relative
to other applications received in response to the RFA.  Applications
that are fully discussed will be assigned a priority score.
Applications that are not discussed will be withdrawn from further
considerations 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 in the context of
alcohol-related health services and relevance to 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 these 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) and
Exploratory/Developmental Grants (R21) are contained in their program
announcements.
 
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 proposal as determined by peer review, NIAAA programmatic needs
and balance, and the availability of funds. NIAAA is particularly
interested in managed care and alcohol-related health services.
Special consideration will be given to applications that focus on the
effects of managed care arrangements on access, utilization, cost,
cost-effectiveness, and outcomes of alcohol services.
 
INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding applications under this RFA 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 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:  (3010 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 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
 
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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