Verified by Department of Veterans Affairs January 2007
Sponsored by:
Department of Veterans Affairs
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00419315
Purpose
A randomized study of Alcohol Care Management for the treatment of alcohol dependence in primary care settings.
Condition
Intervention
Phase
Alcohol Dependence
Behavior: Alcohol Care Management
Phase IV
MedlinePlus related topics: Alcoholism
Study Type: Interventional Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Primary Care Based Disease Management for Alcohol Dependence
Further study details as provided by Department of Veterans Affairs:
Primary Outcomes:
-Treatment Engagement
-Secondary Outcomes: Alcohol Use
Expected Total Enrollment: 250
Study start: March 2007;
Expected completion: July 2010
Last follow-up: January 2010;
Data entry closure: July 2010
Background: Alcohol dependence is one of the leading causes of disability worldwide. Despite the availability of efficacious treatments less than 20% of individuals with alcohol dependence are actively engaged in treatment. Within the VA system systematic screening was implemented to increase the identification of patients with both abuse and dependence.
However, there continues to be a marked discrepancy in the care offered or accessed among those identified with alcohol dependence. Existing treatment guidelines suggest that all persons with dependence receive care in specialty addiction treatment.
Data from our center indicate that among those individuals screened in primary care who have AUDIT - C scores of greater than 7, only 30% are formally evaluated with 50% receiving only brief advice and 20% having no evidence of assessment or referral. Of those assessed and referred to specialty care only 60% attend an initial visit and only 33% meet the EPRP performance measure of 2 visits per month for 90 days.
This disparity in treatment access exists even though Veterans self report a desire to cut down and readiness to change drinking behaviors. (VA ACQUIP) and a willingness to consider pharmacotherapy.
Aims: Available evidence suggests that primary care may be a key component in the identification of alcohol dependent patients, delivery of initial interventions, and to the success of addiction treatment. Indeed, the vast majority of screening and new case identification occurs within primary care.
The primary aims of this proposal are to test the effectiveness of a primary care based Alcohol Care Management (ACM) program and to evaluate the barriers and facilitators to accessing and engaging individuals into treatment. The ACM program uses a Behavioral Health Specialist to deliver care focused on the use of pharmacotherapy in combination with psychosocial support (Medication Management).
This model may overcome barriers to care such as frequent intensive visit schedules often required in specialty settings, stigma associated with specialty care or group therapy approaches, access to specialty care in remote areas, and the current focus on a 12 step model of treatment.
Secondary aims are to establish the acceptability of primary care based treatments and defining treatment modifiers such as age, barriers, co-occurring depression, and pharmacogenetic response.
(Full text of clinical trial announcement)