Considering Healthier Drinking Options in Collaborative Care
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of a collaborative care
      intervention for evidence based management of alcohol use disorders in primary care settings
      within the Veterans Administration Puget Sound Health Care System (Seattle and American Lake
      Divisions). The study will test whether patients offered the collaborative care intervention
      have fewer heavy drinking days at 12 months follow-up and to be abstinent or drinking below
      recommended limits without problems.
    

Detailed description: 
      The proposed study will evaluate the effectiveness of a collaborative care intervention for
      evidence-based management of alcohol use disorders in primary care settings. The
      investigators will specifically test whether patients offered Collaborative Care:

      Have fewer heavy drinking days at 12 months follow-up; and Are more likely to be abstinent or
      drinking below recommended limits without problems at 12 months follow-up.

      Research Design:

      The study is a randomized controlled encouragement trial. Consenting patients who complete
      all baseline assessments will be randomized to be offered the Collaborative Care (CC)
      intervention or receive Usual Care and will be assessed prospectively. Due to the powerful
      effect of alcohol assessments on drinking behavior, a cohort of men identified through
      VISTA/CPRS queries as being potentially eligible for the study will be followed
      electronically for the following year. A random 25% sample of these men will serve as a "no
      contact control group" and will have no contact with the study. The remaining 75% will be
      eligible for screening and recruitment.

      Methodology The study will enroll up to 400 subjects (age < 65 years) with probable alcohol
      use disorders, in order to randomize 300 subjects who complete all baseline assessments.
      Eligibility criteria include a recent AUDIT-C screening score ≥ 5, phone number available in
      CPRS, and frequent heavy drinking days in the past four weeks (≥ 5 drinks for men, ≥4 drinks
      for women).

      The CC intervention will consist of offering subjects: 1) an in-depth baseline assessment, 2)
      frequent (weekly first, then monthly) visits with a nurse care manager, 3) alcohol dependence
      medications prescribed by a Nurse Practitioner. An interdisciplinary CC team will supervise
      nurse care managers weekly.

      All enrolled participants will have telephone surveys at baseline, 3 months and 12 months;
      and lab testing at baseline and 12 months. Main study outcomes include: 1) number of heavy
      drinking days in the past four weeks, and 2) abstinence or drinking below recommended limits
      at 12 months. Secondary analyses will compare CC and Usual Care groups on process measures of
      engagement in alcohol-related care, secondary drinking outcomes, laboratory markers,
      health-related quality of life, health care utilization, and health care costs. For the
      observational cohort, secondary analyses will compare drinking behaviors (AUDIT-C scores),
      alcohol-related diagnoses, and health care utilization between men who have no contact with
      study procedures and other subgroups who are eligible for screening and recruitment.

      The investigators hypothesize that subjects in the intervention group will decrease their
      frequency of heavy drinking and will be more likely to be abstinent or drinking below
      recommended limits at 12 months follow-up.
    

Intervention name(s): Collaborative Care Intervention
Intervention type(s): Behavioral
Intervention description(s): See description of Intervention arm
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment