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Considering Healthier Drinking Options in Collaborative Care (CHOICE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Group Health Cooperative
Sponsor:
Collaborators:
VA Puget Sound Health Care System
University of Washington
Medical University of South Carolina
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT01400581
First received: February 17, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Alcohol Use Disorder
Behavioral: Collaborative Care Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Collaborative Care for Primary Care Patients With Alcohol Use Disorders

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • 1) number of heavy drinking days [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    During the phone survey to be conducted at 12 months post enrollment, subjects will complete an instrument to assess their number of heavy drinking days in the past 4 weeks

  • 2) abstinence or drinking below recommended limits [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Engagement in alcohol-related care [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • secondary drinking outcomes and laboratory markers [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • health-related quality of life [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • health care utilization [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • health care costs [ Time Frame: 12-months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Collaborative Care [CC] Intervention
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.
Behavioral: Collaborative Care Intervention
See description of Intervention arm
No Intervention: Usual Care
Observational

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • AUDIT-C score 5 or more
  • Age less than 65 at time of AUDIT-C screen
  • Phone number available in electronic medical record
  • Frequent heavy drinking reported during brief telephone screen (8 heavy drinking days in past 4 weeks, 5 or more drinks in a day for men, 4 or more for women; OR 4 heavy drinking days past four weeks and prior alcohol treatment or attendance at AA)

Exclusion Criteria:

  • Missing address or phone number in electronic medical record
  • Warning flag regarding violent behavior in medical record
  • Patient participating in addictions treatment
  • Primary care provider or patient indicates not to contact patient
  • Barriers to telephone assessment (hearing, non-English)
  • Unable to provide adequate collateral contacts
  • Cognitive impairment
  • Unstable or acute medical, surgical, or psychiatric problem requiring emergency care
  • Not available for follow-up (planning to move, life expectancy <1 yr, hospice)
  • Pregnancy
  • VA employee
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400581

Contacts
Contact: Katharine A Bradley, MD, MPH 206-287-2900 bradley.k@ghc.org

Locations
United States, Washington
Group Health Research Institute Recruiting
Seattle, Washington, United States, 98101
Contact: Julie Richards, MPH    206-287-2100    richards.je@ghc.org   
Principal Investigator: Katharine Bradley, MD, MPH         
Sub-Investigator: Evette Ludman, PhD         
Sponsors and Collaborators
Group Health Cooperative
VA Puget Sound Health Care System
University of Washington
Medical University of South Carolina
Investigators
Principal Investigator: Katharine A Bradley, MD, MPH Group Health
  More Information

No publications provided

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT01400581     History of Changes
Other Study ID Numbers: 1R01 AA018702
Study First Received: February 17, 2011
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Alcohol Drinking
Disease
Drinking Behavior
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014