Full Text DA-93-002

SERVICES RESEARCH IN DRUG ABUSE TREATMENT

NIH GUIDE, Volume 22, Number 3, January 22, 1993

RFA:  DA-93-002
      (previously DA-93-02)

P.T. 34

Keywords: 
  Drugs/Drug Abuse 
  Health Services Delivery 
  Health Care Economics 


National Institute on Drug Abuse

Letter of Intent Receipt Date:  March 1, 1993
Application Receipt Date:  April 16, 1993

PURPOSE

This Request for Applications (RFA) will support a program of health
services research in the field of drug abuse treatment.  Research
should be directed toward any of the following: (1) understanding the
impact of organization, structure, financing, management, and
staffing on the availability and accessibility of treatment service
resources, upon program content and function, and upon treatment
effectiveness; (2) understanding the role of treatment program
environment, organization, structure, and operation on mechanisms of
service delivery as these are related to access to treatment,
retention in treatment, or compliance with treatment; and (3)
improving the ability of treatment programs to match clients with
appropriate levels of treatment and appropriate treatment services,
to measure the cost-effectiveness of treatment, and to deal with
special populations.

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,
Services Research in Drug Abuse Treatment, is related to the priority
area of alcohol and other drugs.  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 foreign and domestic, 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.  Women
and minority investigators are encouraged to apply.  Applications are
especially encouraged from State and municipal governments with
research units and/or State and municipal governments collaborating
with university-based research units.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual
research grant (R01).  Responsibility for the planning, direction,
and execution of the proposed project will be solely that of the
applicant.  Support will be provided for a period of up to five years
(renewable for subsequent periods) subject to continued availability
of funds and progress achieved.  This RFA is a one-time solicitation.
Future unsolicited competing continuation applications will compete
with all investigator-initiated applications and be reviewed
according to the customary peer review procedures.  Because the
nature and scope of the research proposed in response to this RFA may
vary, the size of an award will also vary.

FUNDS AVAILABLE

It is anticipated that approximately $3.0 million will be available
to support the first year of the services research program.  However,
it is anticipated that approximately 8 to 10 new awards will be made
under this announcement.

If required in support of research objectives, funds may be expended
on drug abuse treatment costs, rental and operation of facilities,
approved renovation and modification of facilities (subject to limits
and conditions specified in Public Health Service grant policy), and
other costs normally allowable under existing Public Health Service
grants policy.  Funds may not be used for new construction or to
replace existing treatment funding.

RESEARCH OBJECTIVES

Background

Section 4640(d)(2) of the ADAMHA Reorganization Act of 1992 directs
NIDA to develop a program of health services research, and defines
health services research 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."

Estimates of treatment services and funding sources are available
from the National Drug and Alcoholism Treatment Unit Survey
(NIDA/NIAAA, 1990), the State Alcohol and Drug Abuse Profile study
(NIDA/NIAAA, 1992).  However, these studies are deficient in
describing treatment service delivery systems, factors influencing
availability and accessibility of services, the influence of
financing and health care coverage, and the impact of these factors
upon treatment effectiveness and cost-effectiveness.  Compared with
publicly-funded treatment, clients with private funding pay more per
visit on average ($2,450 vs. $1,240) and stay in treatment for
shorter durations (Gerstein and Harwood, 1990:203).  Anecdotal
reports on the impact of private funding for treatment suggest that
the accessibility of drug abuse treatment services may often be more
dependent upon availability of funding than upon need.  Whether this
is true or not, research indicates that treatment services vary
widely from program to program in quality and effectiveness (Ball and
Ross, 1991:243; D'Aunno and Vaughn, 1992).

There is evidence that retention, which has been linked to positive
treatment outcomes, is influenced by the availability and quality of
services.  Dennis et al. (1992) reports higher retention among
eligible methadone maintenance clients who received augmented
vocational and educational services than among those who received the
standard levels of service.  Joe, Simpson, and Hubbard (1991) found
that treatment tenure was related to professional diagnosis of
problems, to more structured treatment, and to the type and frequency
of services provided.  Recently, research has focused on improving
treatment by providing more and better treatment services in order to
improve retention and treatment outcomes (Simpson, Chatham, and Joe,
1993).

McLellan and others (1982) have stated that drug abuse treatment is
most effective when treatment services are matched to individual
needs.  However, augmented treatment services may not always be cost
effective.  In the context of limited treatment resources, there is
also a need to determine the relative costs and benefits of
individual treatment services.  In a study conducted by McLellan et
al. (1983), improvement was related both to client characteristics
(the severity of the patient's psychopathology) and to the services
received. Regardless of additional treatment services received,
patients with the most severe psychopathology improved the least,
while patients with little psychopathology improved the most.  An
additional treatment service, psychotherapy, significantly affected
the outcomes only of the middle group, those with mild to moderate
psychopathology in addition to their substance abuse problem.

The assessment of potential benefit for treatment services is
important for problem areas other than psychopathology.  Dennis et
al. (1992) reports that methadone maintenance clients who have a
moderate level of marketable skills but who lack training, a high
school diploma, appropriate work tools or clothes, or entre into the
job market benefit to a greater extent from vocational and employment
services than clients with severely impaired employability.  Although
a clear need exists to maximize the effectiveness of limited
treatment resources, little research has been carried out to
determine the relative costs and benefits of providing augmented
treatment services.

These and other studies suggest that treatment effectiveness may
depend on the availability, accessibility, cost, and quality of
treatment services as much as on the particular treatment model
employed.  However, there is relatively little knowledge regarding
what service delivery systems exist or how these may be improved to
increase the effective delivery of treatment.

Program Description

Applicants are advised to review existing information relevant to
drug abuse treatment health services research and to design studies
using the most rigorous methodological and analytic designs feasible
to investigate the impact of treatment service structure and
organization, staffing, standards, financing, and management upon the
content, suitability, quality, cost, availability and accessibility,
and effectiveness of drug abuse treatment services.  A variety of
research strategies are appropriate, including those involving
primary data collection at the clinic, local area, or system level,
studies that make use of existing data bases, such as provider/payor
data bases (e.g., Medicaid or HMO), treatment outcome studies (e.g.,
Treatment Outcome Prospective Study), or clinic data archives, and
conceptual and methodological work.  A range of approaches is
appropriate, including individual and multi-disciplinary approaches
from fields including, but not limited to, economics, sociology,
criminal justice, psychology, public health, and other relevant
social sciences. It is intended that this program of research
encourage innovation in research strategies, use of existing data in
ways that maximize its usefulness, and studies that have both
scientific and public policy relevance.  This program of research
emphasizes timely transfer of results.  Awardees will be encouraged
to participate in research coordination activities to maximize the
utility of the research, including review and dissemination
activities.  Areas of particular research interest include the
following:

Treatment Services Structure, Organization, and Delivery

o  Studies to define and characterize the organization, financing,
management, and quality of treatment services, in relation to
treatment content and the client populations and subgroups served.

o  Development and testing of models to improve the availability,
accessibility, and delivery of appropriate treatment services within
typical treatment contexts and environments.

o  Investigation of treatment program environment, organization,
structure, staffing, and operation on mechanisms of service delivery
as these are related to access to treatment, retention in treatment,
compliance with treatment, quality and comprehensiveness of services
received, and treatment outcomes.  For example, are outcomes better
for drug treatment combined with comprehensive services, and is it
more effective to deliver comprehensive services in the treatment
program than to provide referral to outside sources for such
services?

Financing of Services

o  Investigation of the effects of different models/mechanisms of
funding and financing on treatment service resources, on the
organization, structure, management, staffing and function of
treatment programs, on treatment content, on treatment service
utilization, on the populations and subgroups served, on the
assessment of client/patient need for services, and on treatment
effectiveness and cost-effectiveness.

o  Investigation of minimally necessary services.  What is the
incremental value of increased levels of care and different
combinations of services, how do these differ among the populations
and subgroups served, and how may this be optimized with regard to
client characteristics?

Quality and Effectiveness of Services

o  Studies to describe the relationship between client/patient
characteristics and treatment program structure, organization, and
operation with regard to delivery of appropriate treatment services.
Development and testing of models to improve the appropriateness of
the services delivered and to increase the effectiveness of matching
and referral processes.

o  Investigation of availability, accessibility, suitability,
content, quality, cost, and effectiveness of drug abuse treatment
services and delivery systems for special populations, including
women, adolescents, and minorities.

o  Effectiveness of the structure and organization of outreach
services on entry into treatment.

o  Effectiveness of outreach service delivery systems explicitly
directed to reducing HIV risk behaviors of drug abusers.

o  Development and testing of measures of cost, effectiveness,
cost-benefits and cost-effectiveness of treatment services, including
standardized models which could be incorporated in a range of
research activities.

The importance of a sound research plan and qualified research staff
cannot be over-emphasized.  It is recommended that investigators use
the most rigorous methodology consistent with the purposes of the
research.  Where controlled trials are not feasible, other types of
controls may be used, including case controls, equivalent comparison
groups, regression-discontinuity, or other designs.

Where appropriate, investigators are encouraged to offer HIV testing
and counseling in accordance with current guidelines to subjects
identified during the course of the research as being at risk for HIV
acquisition or transmission.  In high risk populations, investigators
are encouraged to assess the effects of new interventions on the
acquisition and transmission of infectious diseases, including HIV.

STUDY POPULATIONS

NIH POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS
IN RESEARCH

Applications for clinical research grants and cooperative agreements
that involve human subjects are required to include minorities and
both genders in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder, or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders,
and conditions which disproportionately affect them.  This policy
applies to all research involving human subjects and human materials,
and applies to males and females of all ages.  If one gender and/or
minorities are excluded or are inadequately represented in this
research, particularly in proposed population-based studies, a clear
compelling rationale for exclusion or inadequate representation
should be provided.  The composition of the proposed study population
must be described in terms of gender and racial/ethnic group,
together with a rationale for its choice.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., American
Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks,
Hispanics).  Investigators must provide the rationale for studies on
single minority population groups.

Applications for support of research involving human subjects must
employ a study design with minority and/or gender representation (by
age distribution, risk factors, incidence/prevalence, etc.)
appropriate to the scientific objectives of the research.  It is not
an automatic requirement for the study design to provide statistical
power to answer the questions posed for men and women and
racial/ethnic groups separately; however, whenever there are
scientific reasons to anticipate differences between men and women,
and racial/ethnic groups, with regard to the hypothesis under
investigation, applicants should include an evaluation of these
gender and minority group differences in the proposed study.  If
adequate inclusion of one gender and/or minorities is impossible or
inappropriate with respect to the purpose of the only study
population available, there is a disproportionate representation of
one gender or minority/majority group, the rationale for the study
population must be well explained and justified.

The NIH funding components will not make awards of grants,
cooperative agreements or contracts that do not comply with this
policy.  For research awards which are covered by this policy,
awardees will report annually on enrollment of women and men, and on
the race and ethnicity of subjects.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 1, 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 NIDA 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:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room l0-42
Rockville, MD  20857
Telephone:  301-443-2755

APPLICATION PROCEDURES

Applications received after April 16, 1993, will be returned to the
applicant without review.

The RFA label in the PHS form 398 application kit must be affixed to
the bottom of the original face page.  Failure to use the RFA label
and to follow instructions could result in delayed processing of the
application such that it may not reach the review committee in time
for review.

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91).  Application kits are available at most
institutional offices of sponsored research and may be obtained from
the Office of Grant Inquiries, Division of Research Grants, National
Institutes of Health, Westwood Building, Room 240, Bethesda, MD
20892, telephone (301) 496-7441.  The title and number of this
announcement, "Services Research in Drug Abuse Treatment, DA-93-02"
must be typed in item 2a on the face page of the application, and the
"YES" box must be marked.

Submit a signed, typewritten original of the application and three
signed photocopies 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:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room l0-42
Rockville, MD  20857

REVIEW PROCEDURES

Applications received under this announcement will be assigned to an
NIDA initial review group (IRG) in accordance with established PHS
referral guidelines.  The IRGs, consisting primarily of non-Federal
scientific and technical experts, will review the applications for
scientific and technical merit in accordance with the standard NIH
peer review procedures.  Notification of the review recommendations
will be sent to the applicant after the initial review.  Applications
will receive a second-level review by an appropriate Advisory
Council, whose review may be based on policy considerations as well
as scientific merit.  Only applications recommended for further
consideration by the Council may be considered for funding.

AWARD CRITERIA

Applications recommended for further consideration by an appropriate
Advisory Council will be considered for funding on the basis of
overall scientific and technical merit of the proposal as determined
by peer review, appropriateness of budget estimates, program needs
and balance, policy considerations, adequacy of provisions for the
protection of human subjects, and availability of funds.

The anticipated date of award is September 30, 1993.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

Frank M. Tims, Ph.D.
National Institute on Drug Abuse
5600 Fishers Lane, Room l0A-30
Rockville, MD  20857
Telephone:  (301) 443-4060

Direct inquiries regarding fiscal matters to:

Ms. Shirley Ann Denney
Chief, Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710

Schedule

Applications will be reviewed according to the following review
schedule:

Application Receipt Date:  April 16, 1993
Initial Review:            June 1993
Advisory Council:          September 1993
Earliest Date of Award:    September 1993

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.279.  Awards are made under authorization of the
Public Health Service Act, Section 301, and administered under PHS
policies and Federal Regulations at Title 42 CFR 52 "Grants for
Research Projects", Title 45 CFR Part 74 & 92, "Administration of
Grants" and 45 CFR Part 46, "Protection of Human Subjects". Title 42
CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient
Records" may also be applicable to these awards.  This program is not
subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.

References

Ball, J.C., and A. Ross.  The effectiveness of methadone maintenance
treatment.  New York:  Springer-Verlag, 1991.

D'Aunno, T., and T.E. Vaughn.  Variations in methadone treatment
practices: Results from a national study.  Journal of the American
Medical Association, 1992, 267, 253-258.

Dennis, M.L., G.T. Karuntzos, and J.V. Rachal.  Accessing additional
community resources through case management to meet the needs of
methadone clients.  In R.S. Ashery (Ed.), Progress and issues in case
management. National Institute on Drug Abuse Research Monograph 127.
DHHS Pub. No. (ADM) 92-1946.  Washington, DC:  U.S. Government
Printing Office, 1992, pp. 54-78.

Gerstein, D.R., and H.J. Harwood (Eds).  Treating drug problems.
Vol. 1. Washington, DC:  National Academy Press, 1990.

Joe, G.W., D.D. Simpson, and R.L. Hubbard.  Treatment predictors of
tenure in methadone maintenance.  Journal of Substance Abuse, 1991,
3, 73-84.

McLellan, A.T., L. Luborsky, C.P. O'Brien, G.E. Woody, and K.A.
Druley.  Is treatment for substance abuse effective?  Journal of the
American Medical Association, 1982, 247, 1423-1428.

McLellan, A.T., G.E. Woody, L. Luborsky, C.P. O'Brien, and K.A.
Druley. Increased effectiveness of substance abuse treatment:  A
prospective study of patient-treatment "matching."  J Nervous and
Mental Disease, 1983, 171, 597-605.

NIDA/NIAAA.  State resources and services related to alcohol and
other drug abuse problems, fiscal year 1990:  An analysis of state
alcohol and drug abuse profile data.  DHHS Pub. No. (ADM) 92-1905.
Washington, DC: U.S. Government Printing Office, 1992.

NIDA/NIAAA.  National Drug and Alcoholism Treatment Unit Survey
(NDATUS): 1989 Main Findings Report.  DHHS Pub. No. (ADM) 91-1729.
Washington, DC:  U.S. Government Printing Office, 1990.

Simpson, D.D., L.R. Chatham, and G.W. Joe.  Cognitive enhancements to
treatment in DATAR:  Drug abuse treatment for AIDS risk reduction.
In J. Inciardi, F. Tims, and B. Fletcher (Eds.), Innovative
approaches to the treatment of drug abuse:  Program models and
strategies.  Westport, CT: Greenwood Press, 1993.

.

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