A Randomized Clinical Trial of Alcohol Care Management

Alcohol Dependence Clinical Trial

Official title:

Primary Care Based Disease Management for Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419315
• Other study ID #: IIR 06-058
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2007
• Last updated: April 24, 2015
• Start date: August 2007
• Est. completion date: July 2011

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

A randomized study of Alcohol Care Management for the treatment of alcohol dependence in primary care settings.

Description:

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 >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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• be men and women = 18 years of age;

• meet criteria for alcohol dependence;

• drink more than an average of 2 drinks per day prior to study entry (over the last 60 days);

• have adequate hearing to participate in assessment

Exclusion Criteria:

• show no evidence of current abuse or dependence of illicit substances other than marijuana;

• no current hallucinations;

• no current symptoms of mania;

• be relatively cognitively intact

• not actively participate in specialized addition or behavioral health treatment within the prior 12 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• Alcohol Care Management
Care management for alcohol dependence with a focus on pharmacotherapy
• Usual Care
Usual care included a referral to a specialty addiction treatment program.

Locations

Country	Name	City	State
United States	Philadelphia VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Oslin DW, Lynch KG, Maisto SA, Lantinga LJ, McKay JR, Possemato K, Ingram E, Wierzbicki M. A randomized clinical trial of alcohol care management delivered in Department of Veterans Affairs primary care clinics versus specialty addiction treatment. J Gen — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Engagement	This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial.	6 months	Yes
Secondary	Percent Days of Heavy Alcohol Use	This is a measure during the 6 month of the percentage of 30 days in which a subject had at least 1 day of heavy drinking as defined by drinking more than 4 standard drinks in a day (3 or more for women).	6 months	Yes