Considering Healthier Drinking Options in Collaborative Care
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 10/15/2017 |
| Start Date: | November 2011 |
| End Date: | December 2015 |
Collaborative Care for Primary Care Patients With Alcohol Use Disorders
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.
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.
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.
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.
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
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