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 手术是人生的关键事件，在此期间手术风险的敏锐性和迫在眉睫可以激励患者 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 饮酒(每天两杯)是手术后增加的常见风险因素。 并发症。适当时机的干预可以促进短期和长期酒精使用的减少和 防止过高的外科发病率和死亡率。然而，这方面研究的匮乏限制了我们的能力 在关键时刻进行有效干预或利用动力。这项研究使用了顺序、多次 随机试验(SMART)测试择期手术适应性干预效果的分配 报告高风险饮酒的患者。这些适应性干预在关键时刻使用决策规则 根据早期治疗反应调整治疗类型和强度的手术护理。这个 具体目标是：1)测试从术前虚拟教练开始的适应性干预的有效性 与加强日常护理相比，减少酒精使用、手术并发症和住院时间； 2)确定手术后持续减少酒精使用的最有效的第二阶段干预 在早期治疗应答者和无应答者中。择期手术患者(N=440)将 手术前随机接受虚拟教练或增强型日常护理。初步治疗反应将 在围手术期2个月的随访中进行评估。早期响应者(即禁欲或低风险 酒精使用)将被重新随机化为术后策略，要么是继续虚拟教练，要么是步进式 降到日常护理。早期无反应者(即不禁酒或低风险饮酒)将被重新随机分配到 另一种术后策略，要么是在轨道上，要么是一种结合了自我治疗的移动健康干预 监控和进度反馈，或组合干预(虚拟教练+跟踪)。结果将会 在2个月、6个月和12个月的随访中并通过电子健康记录进行测量。次要目标是：1) 确定最佳的适应性干预措施；以及2)确定基线和随时间变化的主持人 干预效果。这项研究的结果将对创新和移动具有广泛的影响 在医疗保健环境中超越静态酒精干预，并将促进外科健康优化 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 该组织寻求通过将酒精治疗纳入主流医疗来推进成瘾健康服务， 从而改善了可获得性并减少了耻辱。这项研究中开发的适应性干预措施使 根据个体对第一阶段干预的反应进行实时治疗定制，这是在 护理符合国家精确的卫生优先事项，寻求根据个人需求量身定做治疗。