Considering Healthier Drinking Options in Collaborative Care (CHOICE)
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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 |
- 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 ]
- 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 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 |
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| Contact: Katharine A Bradley, MD, MPH | 206-287-2900 | bradley.k@ghc.org |
| 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 | |
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: | October 3, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Alcohol Drinking Drinking Behavior |
ClinicalTrials.gov processed this record on June 18, 2013