Reducing Alcohol use among Elective Surgical Patients using Adaptive Interventions

使用适应性干预措施减少择期手术患者的饮酒量

• 批准号: 10616682
• 负责人: Anne Christie Fernandez
• 金额: $ 62.4万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-05 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10616682
• 关键词: Abstinence; Address; Adult; Alcohol abuse; Alcohol consumption; Alcoholism; Alcohols; American; Area; Behavior; Caring; Dose; Early treatment; Electronic Health Record; Event; Feedback; Health; Health Priorities; Health Services; Health system; Healthcare; Heterogeneity; Improve Access; Individual; Intervention; Interview; Length of Stay; Life; Link; Mainstreaming; Measures; Monitor; Morbidity - disease rate; Motivation; National Institute on Alcohol Abuse and Alcoholism; Operative Surgical Procedures; Outcome; Participant; Patient Recruitments; Patients; Perioperative; Postoperative Complications; Postoperative Period; Precision Health; Randomized; Randomized, Controlled Trials; Reporting; Research; Risk; Risk Factors; Role; Sequential Multiple Assignment Randomized Trial; Surgical complication; Testing; Time; Treatment Efficacy; Work; adaptive intervention; addiction; age stratification; alcohol abuse therapy; alcohol intervention; alcohol monitoring; alcohol risk; care episode; drinking; efficacy evaluation; efficacy testing; follow-up; health care settings; high risk; individual response; individualized medicine; innovation; intervention effect; lifestyle factors; mHealth; mortality; personalized approach; prevent; primary outcome; recruit; reduced alcohol use; remote delivery; remote intervention; responders and non-responders; screening; secondary outcome; sex; social stigma; surgery outcome; surgical risk; telehealth; tool; treatment as usual; treatment response; virtual coach; virtual health

Project Summary/Abstract Surgery is a pivotal life event during which the acuity and imminence of surgical risk can motivate patients to make major changes to behaviors and lifestyle factors to optimize surgical health. Preoperative alcohol consumption (>2 drinks a day) is a common surgical risk factor linked to increased postoperative complications. Appropriately timed interventions could promote short- and long-term alcohol use reduction and prevent excess surgical morbidity and mortality. However, the dearth of research in this area limits our ability to intervene effectively or leverage motivation at critical time points. This study uses a sequential, multiple assignment, randomized trial (SMART) to test the efficacy of adaptive interventions for elective surgical patients reporting high-risk alcohol use. These adaptive interventions use decision rules at critical points during the surgical episode of care to modify treatment type and intensity based on early treatment response. The specific aims are: 1) Test the efficacy of adaptive interventions that begin with preoperative ‘Virtual Coaching’ relative to Enhanced Usual Care on reducing alcohol use, surgical complications, and hospital length of stay; and 2) Identify the most efficacious second-stage intervention to sustained alcohol use reduction after surgery among early treatment responders and non-responders. Elective surgical patients (N = 440) will be randomized before surgery to either Virtual Coaching or Enhanced Usual Care. Initial treatment response will be assessed at the 2-month follow up for the perioperative period. Early responders (i.e., abstinence or low-risk alcohol use) will be re-randomized to postoperative strategies, either continued Virtual Coaching or stepped down to Usual Care. Early non-responders (i.e., not abstinent or low risk drinking), will be re-randomized to alternative postoperative strategies, either ‘On-track,’ a mobile health intervention that incorporates self- monitoring and progress feedback, or a combined intervention (Virtual Coaching + On-Track). Outcomes will be measured at 2-, 6-, and 12-month follow-ups and via electronic health records. Secondary aims are: 1) Identify the best performing adaptive interventions; and 2) Identify baseline and time varying moderators of intervention efficacy. Results of this study will have wide-ranging implications for innovating and moving beyond static alcohol interventions in healthcare settings and will advance surgical health optimization research. This study is consistent with the priorities of the National Institute of Alcohol Abuse and Alcoholism which seeks to advance addiction health services by integrating alcohol treatment into mainstream healthcare, thereby improving access and decreasing stigma. The adaptive interventions developed in this study enables real-time treatment tailoring based on individual’s response to first stage interventions, a critical advance in care consistent with national precision health priorities which seek to tailor treatment to individual needs.

项目摘要/摘要 手术是一项关键的生活事件 对行为和生活方式因素进行重大改变，以优化手术健康。术前酒精 消费（每天2饮料）是与术后增加有关的常见手术危险因素 并发症。适当的定时干预措施可以促进短期和长期的饮酒减少和 预防过多的手术发病率和死亡率。但是，在这一领域的研究死亡限制了我们的能力 有效干预或在关键时间点利用动机。这项研究使用了一个连续的多个 分配，随机试验（SMART），以测试选择性手术的自适应干预效率 报告高危饮酒的患者。这些自适应干预措施在关键点使用决策规则 基于早期治疗反应的治疗类型和强度的手术发作。 具体目的是：1）测试从术前“虚拟教练”开始的自适应干预效率 相对于减少酒精使用，手术并发症和住院时间的平常护理增强； 2）确定手术后最有效的第二阶段干预以减少持续的酒精含量 在早期治疗响应者和无反应者中。选修手术患者（n = 440）将是 手术前随机分组以进行虚拟教练或增强常规护理。初始治疗反应将 在定期期间的2个月后续时间进行评估。早期响应者（即节制或低风险 饮酒）将被重新融合到术后策略，要么继续进行虚拟教练或踏入 到通常的护理。早期的非反应者（即不戒酒或低风险饮酒）将被重新融合到 替代术后策略是“轨道” 监视和进度反馈或组合干预措施（虚拟教练 + ON-TRACK）。结果会 在2个，6个月和12个月的随访中以及通过电子健康记录进行测量。次要目标是：1） 确定表现最佳的自适应干预措施； 2）确定基线和时间变化的主持人 干预效率。这项研究的结果将对创新和移动具有广泛的影响 除了医疗保健环境中的静态酒精干预之外，还将推进手术健康优化 研究。这项研究与国家酒精滥用和酒精中毒研究所的优先事项一致 试图通过将酒精治疗纳入主流医疗保健中来推进成瘾卫生服务， 从而改善污名和减少污名。本研究中制定的自适应干预措施使 实时治疗根据个人对第一阶段干预的反应量身定制，这是关键的进步 与国家精确健康优先事项一致的护理，该优先事项试图根据个人需求量身定制治疗。