A Randomized Clinical Trial of Alcohol Care Management

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Alcohol Dependence	Behavioral: Alcohol Care Management; Behavioral: Usual Care	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	163 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Primary Care Based Disease Management for Alcohol Dependence
Study Start Date :	August 2007
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	July 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Alcohol Care Management; Care management for alcohol dependence delivered in primary care	Behavioral: Alcohol Care Management; Care management for alcohol dependence with a focus on pharmacotherapy
Active Comparator: Usual Care; Usual care included a referral to specialty addiction treatment	Behavioral: Usual Care; Usual care included a referral to a specialty addiction treatment program.

Outcome Measures

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Primary Outcome Measures :

1. Treatment Engagement [ Time Frame: 6 months ]
   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 :

1. Percent Days of Heavy Alcohol Use [ Time Frame: 6 months ]
   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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, New York
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States, 13210
United States, Pennsylvania
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator:	David W. Oslin, MD	Philadelphia VA Medical Center, Philadelphia, PA

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00419315 History of Changes
Other Study ID Numbers:	IIR 06-058
First Posted:	January 8, 2007
Results First Posted:	November 11, 2014
Last Update Posted:	May 12, 2015
Last Verified:	April 2015

Keywords provided by VA Office of Research and Development:

alcoholism; primary care; treatment

Additional relevant MeSH terms:

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders	Ethanol; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs