Considering Healthier Drinking Options in Collaborative Care

Alcohol Use Disorder Clinical Trial

— CHOICE  

Official title:

Collaborative Care for Primary Care Patients With Alcohol Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400581
• Other study ID #: 1R01AA018702
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: September 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• AUDIT-C score 5 or more (modification described below)

• Age less than 65 at time of AUDIT-C screen (modification described below)

• 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

Prior to the start of the trial these changes were made (VA IRB approval: 8/2011):

• Changed from AUDIT-C score =5 for both men and women TO: AUDIT-C score =5 for men; AUDIT-C score =4 for women (to increase the pool of potentially eligible women)

• From age 65 years and younger to age =75 years

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Collaborative Care Intervention
See description of Intervention arm

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	Medical University of South Carolina, University of Washington, VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bradley KA, Bobb JF, Ludman EJ, Chavez LJ, Saxon AJ, Merrill JO, Williams EC, Hawkins EJ, Caldeiro RM, Achtmeyer CE, Greenberg DM, Lapham GT, Richards JE, Lee AK, Kivlahan DR. Alcohol-Related Nurse Care Management in Primary Care: A Randomized Clinical Tr — View Citation

Bradley KA, Ludman EJ, Chavez LJ, Bobb JF, Ruedebusch SJ, Achtmeyer CE, Merrill JO, Saxon AJ, Caldeiro RM, Greenberg DM, Lee AK, Richards JE, Thomas RM, Matson TE, Williams EC, Hawkins E, Lapham G, Kivlahan DR. Patient-centered primary care for adults at high risk for AUDs: the Choosing Healthier Drinking Options In primary CarE (CHOICE) trial. Addict Sci Clin Pract. 2017 May 17;12(1):15. doi: 10.1186/s13722-017-0080-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) number of heavy drinking days		at 12 months
Primary	2) abstinence or drinking below recommended limits without problems		at 12 months
Secondary	Engagement in alcohol-related care		12-months
Secondary	secondary drinking outcomes and laboratory markers		12-months
Secondary	health-related quality of life		12-months
Secondary	health care utilization		12-months
Secondary	health care costs		12-months
Secondary	Outcomes 1-7 listed above and secondary drinking, readiness to change, and engagement outcomes.		at 3-months