Collaborative Care for Primary Care Patients With Alcohol Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- 1) number of heavy drinking days
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Collaborative Care Intervention (Behavioral)
Usual Care
Observational
结局指标
主要结局
1) number of heavy drinking days
时间窗: at 12 months
2) abstinence or drinking below recommended limits without problems
时间窗: at 12 months
次要结局
- health-related quality of life(12-months)
- health care costs(12-months)
- Outcomes 1-7 listed above and secondary drinking, readiness to change, and engagement outcomes.(at 3-months)
- secondary drinking outcomes and laboratory markers(12-months)
- health care utilization(12-months)
- Engagement in alcohol-related care(12-months)