search
Back to results

A Randomized Clinical Trial of Alcohol Care Management

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Alcohol Care Management
Usual Care
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring alcoholism, primary care, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Syracuse VA Medical Center, Syracuse, NY
  • Philadelphia VA Medical Center, Philadelphia, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alcohol Care Management

Usual Care

Arm Description

Care management for alcohol dependence delivered in primary care

Usual care included a referral to specialty addiction treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
January 4, 2007
Last Updated
April 24, 2015
Sponsor
US Department of Veterans Affairs
search

1. Study Identification

Unique Protocol Identification Number
NCT00419315
Brief Title
A Randomized Clinical Trial of Alcohol Care Management
Official Title
Primary Care Based Disease Management for Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
alcoholism, primary care, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol Care Management
Arm Type
Experimental
Arm Description
Care management for alcohol dependence delivered in primary care
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care included a referral to specialty addiction treatment
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Care Management
Intervention Description
Care management for alcohol dependence with a focus on pharmacotherapy
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Usual care included a referral to a specialty addiction treatment program.
Primary Outcome Measure Information:
Title
Treatment Engagement
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percent Days of Heavy Alcohol Use
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W. Oslin, MD
Organizational Affiliation
Philadelphia VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse VA Medical Center, Syracuse, NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Philadelphia VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24052453
Citation
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 Intern Med. 2014 Jan;29(1):162-8. doi: 10.1007/s11606-013-2625-8. Epub 2013 Sep 20. Erratum In: J Gen Intern Med. 2016 Apr;31(4):449.
Results Reference
result
PubMed Identifier
30003479
Citation
Rotenberg JR, Leong SH, Maisto SA, McKay JR, Possemato K, Ingram E, Oslin DW. Post-intervention Durability of Alcohol Care Management: 1-Year Follow-up of a Randomized Controlled Trial. J Gen Intern Med. 2018 Oct;33(10):1626-1628. doi: 10.1007/s11606-018-4567-7. No abstract available.
Results Reference
derived

Learn more about this trial

A Randomized Clinical Trial of Alcohol Care Management

We'll reach out to this number within 24 hrs