Reducing Alcohol Use Among Elective Surgical Patients Using Adaptive Interventions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Alcohol consumption as measured by the timeline follow-back
研究概览
简要总结
This sequential, multiple assignment, randomized trial will test treatments designed to reduce alcohol use before and after surgery to promote surgical health and long-term wellness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed consent form, baseline survey, and enrollment phone call
- •Willingness to comply with all study procedures and availability for the duration of the study
- •Scheduled for select major elective surgery (non-cancer) in the next 5-12 weeks
- •Score ≥ 5 on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) based on research linking this score with increased risk of surgical complications
- •Access to a smart device or computer access with internet or wi-fi connection throughout the study period
排除标准
- •Exclude participants enrolled in another research study focused on alcohol use
- •History of severe alcohol withdrawal
- •Unable to speak, understand, or read English
研究组 & 干预措施
Enhanced Usual Care then Usual Surgical Care
Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
干预措施: Usual surgical care (post-operative) (Behavioral)
Enhanced Usual Care then Post-operative Health Coaching
Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
干预措施: Postoperative Virtual Health Coaching (Behavioral)
Enhanced Usual Care then On-Track
Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
干预措施: On-Track (Post-operative) (Behavioral)
Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)
Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
干预措施: Postoperative Virtual Health Coaching (Behavioral)
Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)
Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
干预措施: On-Track (Post-operative) (Behavioral)
Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching
Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
干预措施: Preoperative Virtual Health Coaching (Behavioral)
Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching
Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
干预措施: Postoperative Virtual Health Coaching (Behavioral)
Preoperative Virtual Health Coaching then On-Track
Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
干预措施: Preoperative Virtual Health Coaching (Behavioral)
Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)
Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
干预措施: Preoperative Virtual Health Coaching (Behavioral)
Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)
Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
干预措施: Postoperative Virtual Health Coaching (Behavioral)
Enhanced Usual Care then Usual Surgical Care
Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
干预措施: Enhanced Usual Care (pre-operative) (Behavioral)
Enhanced Usual Care then Post-operative Health Coaching
Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
干预措施: Enhanced Usual Care (pre-operative) (Behavioral)
Enhanced Usual Care then On-Track
Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
干预措施: Enhanced Usual Care (pre-operative) (Behavioral)
Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)
Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
干预措施: Enhanced Usual Care (pre-operative) (Behavioral)
Enhanced Usual Care alone
Only completed first randomization. Study withdrawal prior to re-randomization
干预措施: Enhanced Usual Care (pre-operative) (Behavioral)
Preoperative Virtual Health Coaching then Usual Surgical Care
Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
干预措施: Preoperative Virtual Health Coaching (Behavioral)
Preoperative Virtual Health Coaching then Usual Surgical Care
Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
干预措施: Usual surgical care (post-operative) (Behavioral)
Preoperative Virtual Health Coaching then On-Track
Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
干预措施: On-Track (Post-operative) (Behavioral)
Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)
Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
干预措施: On-Track (Post-operative) (Behavioral)
Preoperative Virtual Health Coaching only
Only completed first randomization. Study withdrawal prior to re-randomization.
干预措施: Preoperative Virtual Health Coaching (Behavioral)
结局指标
主要结局
Alcohol consumption as measured by the timeline follow-back
时间窗: 10 months after surgical discharge
Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of alcohol use including average drinks/day.
次要结局
- Alcohol Use Disorder Identification test (AUDIT)(Up to 10 months after surgical discharge)
- World Health Organization Drinking (WHO) Risk Level(10 months after surgical discharge)
研究者
Lara Coughlin
Associate Professor of Psychiatry
University of Michigan