Considering Healthier Drinking Options in Collaborative Care (CHOICE)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 17, 2011 | ||||
| Last Updated Date | October 3, 2012 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01400581 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Considering Healthier Drinking Options in Collaborative Care | ||||
| Official Title ICMJE | Collaborative Care for Primary Care Patients With Alcohol Use Disorders | ||||
| Brief 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Alcohol Use Disorder | ||||
| Intervention ICMJE | Behavioral: Collaborative Care Intervention
See description of Intervention arm |
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01400581 | ||||
| Other Study ID Numbers ICMJE | 1R01 AA018702 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Group Health Cooperative | ||||
| Study Sponsor ICMJE | Group Health Cooperative | ||||
| Collaborators ICMJE |
|
||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Group Health Cooperative | ||||
| Verification Date | October 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||