Brief Intervention for ICU Patients with Alcohol Use Disorders- a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 237
- 试验地点
- 5
- 主要终点
- Reported total amount of alcohol consumed during preceding week
研究概览
简要总结
Patients non-electively admitted to intensive care units (ICUs) will be screened for eligibility. The investigators will include adult patients with risk level alcohol use, defined by AUDIT-C score (>5 for females, >6 for males). Informed consent will be obtained from the patient in the end or shortly after the ICU treatment, when they have regained sufficient cognitive function. 600 patients will be randomized to receive either routine treatment or a brief intervention (BI). The BI includes a 20 minute discussion with pre-educated study personnel, option to discussion with a social worker and written material. Primary outcome measure is the amount of alcohol used during the preceding week (g/week), at 6 and 12 months after study entry. The information will be obtained 1)in an interview by a study team member blinded for the intervention arm at 6 months 2) A letter of a telephone interview at 12 months. AUDIT score, EQ-5D and mortality will also be recorded.
An interim analysis by an external reviewer will be performed after the primary outcome has been recorded for 200 patients,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Unlike other team members, the investigator interviewing the patients will be unaware of the treatment group. The patient will be encouraged not to reveal the treatment group to the investigator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AUDIT-C score >5 (women) and >6 (men)
- •Non-elective admission to the ICU
排除标准
- •Terminal illness (expected to survive less than 6 months), palliative care
- •Diagnosed severe mental illness (psychos, severe depression, bipolar disorder, personality disorder)
- •Cognitive disability
- •Diagnosed dementia
- •Impaired level of consciousness at discharge from the ICU (expected to remain unchanged >2 days
- •Other substance abuse (excluding cigarette smoking)
- •Ongoing treatment for alcohol dependency
- •Insufficient language skills (finnish/swedish)
- •Expected difficulty in getting contacted by mail or telephone (no permanent address or telephone in use)
结局指标
主要结局
Reported total amount of alcohol consumed during preceding week
时间窗: 12 months after study enrollment
The patients are interviewed and the amount of alcohol consumed during the last week is recorded and converted in grams
次要结局
- Mortality(One year after study enrollment)
- Quality of life(One year after study enrollment)
- Change in AUDIT score(12 months after study enrollment)
研究者
Johanna Hastbacka
Dr
University of Helsinki