Full Text PA-95-027

STUDIES ON THE LINKAGE OF DRUG ABUSE TREATMENT AND MEDICAL CARE

NIH GUIDE, Volume 24, Number 4, February 3, 1995

PA NUMBER:  PA-95-027

P.T. 34

Keywords: 
  Drugs/Drug Abuse 
  Treatment, Medical+ 
  Mental Disorders 


National Institute on Drug Abuse

PURPOSE

The purpose of this program announcement is to stimulate research
projects (R01) on various models and strategies for linking drug
abuse treatment with medical care, with special attention to effects
on the prevention, incidence and progression of medical (including
mental) disorders in drug abusing populations and the cost and
effectiveness of linked treatment.

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, Studies on the Linkage of Drug Abuse Treatment and
Medical Care, 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 domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This program announcement will use the National Institutes of Health
(NIH) individual research project grant (R01).  Research projects
requiring substantial programmatic support, such as the establishment
of new comprehensive services or the addition of a substantial
component to an existing program, are encouraged under this
announcement.  If required in support of research objectives, funds
may be expended on drug abuse treatment costs, other medical
treatment costs, rental and operation of facilities, approved
renovation and modification of facilities (subject to limits and
conditions specified in the PHS grants policy), and other costs
normally allowable under existing PHS grants policy.  Funds may not
be used for new construction or to replace existing treatment
funding.

RESEARCH OBJECTIVES

Summary

Research studies are sought to investigate various models and
strategies for linking drug abuse treatment with medical care, with
special attention to effects on the prevention, incidence and
progression of medical (including mental) disorders in drug abusing
populations and the cost and effectiveness of both the drug abuse and
other medical treatment.  "Linkage," in the context of this research
program, is defined as including both drug abuse treatment and
medical care, the latter to include (a) primary and/or acute care,
and (b) public health aspects of medical care (e.g., immunizations
and screening for sexually transmitted diseases).  Although not
required, it is strongly encouraged that care related to mental
disorders in drug abusers be included as an important component of
linkage.

The multiple foci of this research program include effects of the
activities of well-described and controlled linkage programs on (1)
drug abuse and medical treatment recruitment, engagement, retention
and adherence; (2) the epidemiology of the medical sequelae of drug
abuse, looking, for example, at the need for primary care services
and the effects of those services; and (3) drug abuse and medical
treatment effectiveness and cost-effectiveness.  Specialized studies
are encouraged of linkage efforts impacting on the aforementioned
variables for vulnerable subgroups, e.g., those with comorbid mental
disorders, those at-risk for or infected with HIV, prostitutes,
homeless populations.

Background

The spread of the AIDS epidemic among drug abusers has placed demands
on the primary medical care system.  This has led to the realization
that the separation between the drug abuse treatment and primary
medical care systems causes difficulties providing the combination of
effective services that are required to address the needs of the drug
abusers and the public health problem of the associated infectious
illnesses.  The issues include difficulties (1) identifying and
providing drug treatment for the drug abusers who appear for
treatment in the primary care system; (2) specifying and meeting the
needs for primary medical care of drug abusers who are enrolled in
drug abuse treatment; and (3) mounting effective outreach efforts for
drug abusers not enrolled in either type of treatment, but who are in
danger of acquisition/transmission of these diseases.

Identification of these issues led to a program of linkage
demonstration projects, initially sponsored by both NIDA and the
Health Resources and Services Administration (HRSA), to demonstrate
the feasibility of a broad range of models for the delivery of
comprehensive, integrated services to drug abusers who are initially
involved in either primary medical care or substance abuse treatment.
Linkage demonstration projects are being continued under the
sponsorship of the Center for Substance Abuse Treatment (CSAT) of the
Substance Abuse and Mental Health Services Administration (SAMHSA).

From the service user's perspective, the models and strategies
represented in the organization of the "linked" services in the
linkage demonstration projects can be described as centralized (i.e.,
all services are offered at one location: "one-stop shopping");
decentralized (i.e., clients must go to different sites to receive
different services); mixed (i.e., basic services are offered at each
location, but specialized services are offered only at some); or
transitional (i.e., services are initially centralized, but change to
decentralized over time).  Virtually all projects offered drug use
screening, primary care screening and some form of case management as
linkage mechanisms, with a smaller number also emphasizing cross-
training of staff and specialized staff meetings.  Specific efforts
in colocation of staff and/or services, cross-program staff meetings
and logistical coordination were also being attempted by some of the
grantees.

Barriers to implementation of linkage were classified as: (1)
regulatory, (e.g., licensure of drug treatment facilities, zoning and
local political issues); (2) structural, (e.g., organizational issues
that have made the coordination of drug treatment and primary care
difficult, problems specific to the treatment of special populations
like HIV seropositives, active drug users or the indigent, problems
related to staff mix requirements, factors that decrease drug users
seeking treatment or retention in treatment; (3) clinical (e.g.,
problems integrating with tertiary care that is needed for HIV
seropositives); and (4) attitudinal/training (e.g., attitudes that
decrease the likelihood that primary care providers will recognize
those with substance abuse problems, training needed for drug abuse
counselors to identify primary care needs in clients).

Program Description

Examples of areas of research interest that examine the question of
the implications of linkage, as defined in the "Summary" section
above, of drug abuse treatment and medical care include but are not
limited to the following.  Both generation of new data and analyses
of existing data sets will be considered for support, and studies
addressing cost, effectiveness, and cost/effectiveness are
encouraged.  In this context applications from both new and existing
linkage projects will be considered.

o  Epidemiological investigations that document the occurrence of
various medical disorders in the drug abusing population served by
linkage efforts compared with a similar population exposed to
different levels or types of such efforts.

o  Transmission-related research that, for example, examines the
effectiveness of linkage strategies in minimizing the probability of
transmission of tuberculosis, HIV, other sexually transmitted
diseases, hepatitis B, etc.

o  Studies of linkage strategies hypothesized to be more effective
with special subpopulations of drug abusers, (e.g., minorities, gays,
bisexuals, women, pregnant women, adolescents, HIV seropositives,
prostitutes, the mentally ill, those involved in the criminal justice
system).

o  Research that focuses on the HIV seropositive drug abuser in terms
of identifying and testing linkage strategies that may be effective
in maximizing the likelihood that these individuals will receive
optimal medical treatment, avoid relapse to drug-related and sexual
risk behaviors and minimize the probability of further transmission
of either the HIV or associated infectious illnesses.

o  Research that focuses on the increasing appearance of tuberculosis
in drug abusing populations, including the epidemic of multi-drug
resistant tuberculosis (MDR-TB) in (largely) HIV seropositive
subpopulations.

o  Studies of the role of other supportive or enabling services
(e.g., outreach transportation; child care; psychological services;
housing; nutrition and diet; vocational programs; family assistance;
legal services) in linkage programs.

o  Studies of the effect of linkage strategies as incentives for
recruitment into, retention in, adherence to and  (following drug
relapse) return to both drug abuse treatment and primary medical
care.

o  Studies of case management as a mechanism for effective linkage.

o  Studies of the impact of cross-training and continuing education
of both drug abuse treatment and primary medical staff on the
likelihood of identification of client problems in the area of non-
specialization, prescription of optimal treatment (including
appropriate referral) and, consequent likelihood of successful
treatment.

o  Ethnographic studies of determinants of adherence to
recommendations in the areas of both drug abuse treatment and primary
medical care.

o  Studies that focus on linkage strategies that include outreach to
sex partners, family members, and others in the social networks of
the drug abusers.

o  Studies that focus on the identification of substance abusers in
primary care or other medical/psychiatric settings and strategies
effective in linking these patients with drug abuse treatment.

o  Research that focuses on drug users who, initially, will only
accept either primary care, limited medical care for a problem that
they perceive as emergent, or drug abuse treatment, but who refuse
the full range of services.

o  Research focusing on the identification and overcoming of barriers
to the effective implementation of linkage efforts.

o  Studies that examine the impact of legal, ethical, economic, and
governmental policy issues on the development and effective
implementation of linkage strategies.

o  Studies that examine the organizational relationships and
behavioral determinants of successful linkage programs (relative to
interactions among diverse organizations and disciplines).

All applications should address issues of project feasibility and
collaborative arrangements, study design, sampling procedures,
implementation of the intervention, instrumentation and measurement,
data collection, quality control, tracking of clients, followup, and
data analysis, as 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.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

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

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91) 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 Office of Grants Information, Division of
Research Grants, National Institutes of Health, Westwood Building,
Room 449, Bethesda, MD 20892, telephone 301/710-0267.  The title and
number of the program announcement must be typed in Section 2a on the
face page of the application.

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

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

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS
referral guidelines.  Applications will be reviewed for scientific
and technical merit in accordance with the standard NIH peer review
procedures.  Following scientific-technical review, the applications
will receive a second-level review by the appropriate national
advisory council.

Applications that are complete and responsive to the program
announcement will be evaluated for scientific and technical merit by
an appropriate peer review group convened in accordance with 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 applications under review, will be
discussed assigned a priority score, and receive a second level
review by the appropriate national advisory council or board.

Review Criteria

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the methodology and/or
experimental approach proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  availability of the resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research; and

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

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

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to that IC.  The following will be considered
in making funding decisions:

o  quality of the proposed project as determined by peer review o
availability of funds
o  program priority

For applications assigned to the NIDA an additional award criterion
concerns the degree to which at least the following components are
included in the proposed linkage: (a) primary and/or acute care, and
(b) public health aspects of medical care (e.g., immunizations and
screening for sexually transmitted diseases).  Although not required,
it is strongly encouraged that care related to mental disorders in
drug abusers be included as an important component of linkage.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Sander G. Genser, M.D., M.P.H.
Division of Clinical Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 11A-33
Rockville, MD  20857
Telephone:  (301) 443-1801
FAX:  (301) 443-2317
Email:  sgenser@aoada.ssw.dhhs.gov

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
Email:  gfleming@aoada2.ssw.dhhs.gov

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, Title IV, Part A (Public Law 78- 410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 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.  This
is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.

.

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