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.

项目总结/摘要 手术是一个关键的生命事件，在此期间，手术风险的紧迫性和紧迫性可以激励患者 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>2杯）是一种常见的手术风险因素，与术后增加有关。 并发症适时的干预可以促进短期和长期的酒精使用减少， 防止过高的手术发病率和死亡率。然而，这一领域的研究不足限制了我们的能力， 在关键时间点进行有效干预或调动积极性。这项研究使用了一个连续的，多个 分配，随机试验（SMART），以测试择期手术适应性干预的有效性 报告高危酒精使用的患者。这些适应性干预措施在关键点使用决策规则， 根据早期治疗反应调整治疗类型和强度的外科治疗事件。的 具体目标是：1）测试适应性干预的有效性，开始与术前“虚拟教练” 相对于强化的产后护理，减少酒精使用、手术并发症和住院时间; 2）确定最有效的第二阶段干预措施，以减少术后持续饮酒 在早期治疗反应者和无反应者之间。择期手术患者（N = 440）将 手术前随机分为虚拟指导组和增强型护理组。初始治疗反应将 在围手术期2个月随访时进行评估。早期响应者（即，禁欲或低风险 酒精使用）将被重新随机分配至术后策略，要么继续虚拟指导，要么分步进行 去了精神病院早期无应答者（即，未戒酒或低风险饮酒），将重新随机分配至 替代的术后策略，或者是“跟踪”，一种移动的健康干预， 监测和进度反馈，或组合干预（虚拟辅导+跟踪）。成果将 在2个月、6个月和12个月随访时以及通过电子健康记录进行测量。次要目标是：1） 确定表现最佳的适应性干预措施; 2）确定基线和随时间变化的调节因素， 干预效果这项研究的结果将对创新和移动 超越了医疗机构中的静态酒精干预，并将促进外科健康优化 research.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 该计划旨在通过将酒精治疗纳入主流医疗保健来促进成瘾健康服务， 从而改善获得服务的机会并减少耻辱感。本研究中开发的适应性干预措施使 根据个人对第一阶段干预措施的反应进行实时治疗，这是 与国家精准卫生优先事项相一致的护理，力求根据个人需要量身定制治疗。