Philadelphia,
Pennsylvania
19104
Purpose:
The aim of this study is to test for improvements in treatment outcomes for primary care
patients with at-risk drinking when cared for using telephone disease management (TDM)
compared to those treated with usual care. Based on our pilot data, TDM for at-risk
drinking may be a viable method for reducing alcohol consumption in this population.
Hypotheses: The hypotheses for this research plan are: 1. A significantly greater
proportion of patients assigned to TDM will obtain improvement in drinking outcomes compared
to usual care. 2. TDM will lead to greater access to behavioral health care and higher
intensity of treatment relative to usual care. This effect will be moderated by logistics
such as transportation problems, physical functioning, and employment status. 3. More
patients assigned to TDM will receive guideline adherent care.
Study summary:
We propose to randomize 200 patients with at-risk drinking from four primary care clinics at
the PVAMC and three Community Based Outpatient Clinics (CBOCs). Patients will be identified
for participation by 1. referrals from primary care clinicians based on existing screening
and clinical exams or 2. from the screening of a random subset of patients with an
appointment in the primary care clinic. A baseline assessment will establish eligibility
for participation in the study. The baseline assessment will also allow identification of
those patients who screen positive but do not have a definable behavioral health problem and
those with severe symptoms who may need more intensive help than provided by the study.
Consenting eligible patients will be randomly assigned to TDM or the lower intensity
intervention of usual care. For those patients assigned to usual care, the physician will
administer further evaluations and treatment as he/she sees fit. For those assigned to TDM,
the primary care provider remains the agent of treatment, but a Behavioral Health Specialist
(BHS) is made available to: maintain regularly scheduled telephone contact, develop a
treatment plan, monitor treatment effectiveness, assess and encourage treatment adherence,
and offer support and education. The role of the health specialist is defined by a
treatment manual that adheres to the recommendations of VA practice guidelines. TDM is
based on a chronic care model of treatment and includes a minimum of three BAI sessions.
The health specialist will communicate assessment information with the PCP in order to
coordinate treatment decisions.
The principal outcomes of the study relate to reduction in alcohol use within recommended
guidelines as well as access and utilization of behavioral health services over the course
of 12 months. Results favoring TDM may provide a low-cost, highly efficient mechanism for
integrating behavioral health with primary care for these patients. This project thus meets
several of the priority areas for HSR&D funding including improving access to care, the
implementation of practice guidelines, use of telemedicine, and patient-centered care.
Criteria:
Inclusion Criteria:
- be 18 years of age and over, male or female.
- meet criteria for at-risk drinking as defined by drinking more than 21 standard
drinks per week (14 for women or those over age 65).
Exclusion Criteria:
- show an absence of any of the following:
1. active suicidal ideation,
2. regular current use of illicit substances other than alcohol
3. diagnosis of current alcohol dependence
4. current hallucinations and delusions
5. current symptoms of PTSD
6. a history of mania or hypomania.
- have adequate hearing to participate in telephone assessments and access to a
telephone. Subjects will also show an absence of other barriers to verbal
communication (e.g., aphasia) and will be cognitively intact (Brief Orientation
Memory and Concentration task greater than 15 for those over age 54).
- not actively participating in specialized addiction treatment within the prior
3-months.
- not currently enrolled in another clinical trial
- not expected to move from the VISN 4 area within 12 months
Primary Contact:
Principal Investigator
David W. Oslin, MD
Philadelphia VA Medical Center, Philadelphia, PA