Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications, and CBT4CBT: A randomized clinical trial in a diverse patient population

通过简短干预、药物和 CBT4CBT 促进住院后酒精治疗的参与：针对不同患者群体的随机临床试验

• 批准号: 10372677
• 负责人: E. Jennifer Edelman
• 金额: $ 67.06万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10372677
• 关键词: Academic Medical Centers; Accident and Emergency department; Acute; Address; Advocate; Alcohol consumption; Alcohols; Behavior Therapy; Behavioral; Biological Markers; Black, Indigenous, People of Color; Caring; Clinical Trials; Cognitive Therapy; Collaborations; Computerized Cognitive Behavioral Therapy; Computers; Cost Effectiveness Analysis; Data; Disadvantaged; Discrimination; Dissemination and Implementation; Educational Status; Effectiveness of Interventions; Emergency department visit; Ethnic Origin; Ethnic group; Evaluation; Fright; Future; Health Promotion; Health Services; Health Services Accessibility; Heavy Drinking; Hospitalization; Hospitals; Hybrids; Individual; Interview; Left; Mediation; Medical; Medicine; Morbidity - disease rate; Outcome; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Plant Roots; Process; Process Measure; Race; Randomized Clinical Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Reproducibility; Research; Research Design; Resources; Sampling; Standardization; Stigmatization; Structural Racism; Surveys; Technology; Telephone; Time; United States; United States Food and Drug Administration; Urban Hospitals; Withdrawal; Work; addiction; alcohol abuse therapy; alcohol consequences; alcohol intervention; alcohol use disorder; base; brief intervention; care outcomes; clinically relevant; compare effectiveness; cost; cost-effectiveness ratio; digital intervention; disparity reduction; effectiveness evaluation; effectiveness implementation design; ethnic minority population; evidence base; food insecurity; health care service utilization; health disparity; hospital readmission; housing instability; implementation science; incremental cost-effectiveness; indexing; information gathering; innovation; longitudinal analysis; medical complication; mortality; multidisciplinary; patient population; phosphatidylethanol; primary outcome; racial and ethnic; racial diversity; racial minority; response; routine care; secondary outcome; social health determinants; three-arm trial; trial design

ABSTRACT Alcohol use disorder (AUD) is a major cause of morbidity and mortality, yet often goes untreated. This is particularly true among individuals of diverse racial and ethnic backgrounds. Acute medical hospitalization provides an untapped opportunity to address the AUD treatment gap. To date, AUD-related care has focused on treatment of acute withdrawal and addressing associated acute medical complications without addressing the underlying AUD. This overlooks an opportunity “treatable” moment. There are a range of behavioral and medication treatments that may be initiated prior to hospital discharge to address AUD. However, we lack data on the optimal approach to enhance post-discharge AUD treatment engagement and alcohol reduction. Further, the influence of structural racism on more proximal social determinants of health (SDOH, e.g., housing instability, medical mistrust) among patients hospitalized with AUD and their resulting impact on treatment engagement and alcohol use post-discharge has not been well characterized. We propose a 3-arm randomized trial to compare the impact of: 1) a specific brief intervention, the Brief Negotiated Interview with referral and 2-week telephone booster (BNI) delivered by a health promotion advocate alone to the additional 2) provision of medications for AUD (BNI+MAUD), and 3) the computer-based platform of cognitive behavioral therapy (CBT4CBT; BNI+MAUD+CBT4CBT) among a diverse sample of 450 patients hospitalized with untreated AUD at a large, urban academic medical center. The primary outcome is engagement in formal AUD treatment at 30 days post-hospital discharge. Secondary outcomes include formal AUD treatment engagement at 90 days, changes in alcohol use (by self-report and the alcohol biomarker, phosphatidylethanol), and, the exploratory outcome of healthcare utilization (Aim 1). We will explore whether the effectiveness of the interventions differ across and within racial and ethnic groups and based on SDOH (Aim 2). Consistent with a hybrid type 1 effectiveness-implementation design, we will conduct an implementation-focused process evaluation to inform future implementation, including process outcomes, perspectives from clinicians and staff, and cost (Aim 3). Building on new and longstanding collaborations, the study team includes individuals with expertise in addiction medicine in hospital settings; behavioral interventions, including brief interventions and technology-delivered cognitive behavioral therapy; health disparities research; clinical trials; longitudinal analysis; and implementation science. Study components are readily-scalable and rooted in strong evidence. This proposal offers innovation given the 1) hospital focus for AUD treatment initiation; 2) evaluation of added benefit of medications and CBT4CBT to BNI; 3) focus on evaluation of differential effects by race, ethnicity and SDOH; 4) consideration of the impact of structural racism in all aspects of study design and implementation with a highly qualified team. The study has potential for high impact by generating data on reproducible and scalable approaches to transform hospital-based AUD treatment initiation nationally.

摘要 酒精使用障碍（AUD）是发病率和死亡率的主要原因，但往往得不到治疗。这是 在不同种族和民族背景的个人中尤其如此。急性医疗住院 为解决AUD治疗差距提供了一个尚未利用的机会。到目前为止，与审计相关的护理已经集中在 治疗急性戒断和解决相关的急性医学并发症， 基础澳元。这忽略了一个机会“可治疗”的时刻。有一系列的行为和 出院前可能开始的药物治疗，以解决AUD。然而，我们缺乏数据。 关于提高出院后AUD治疗参与度和减少酒精的最佳方法。 此外，结构性种族主义对更接近健康的社会决定因素的影响（SDOH，例如，壳体 不稳定性、医疗不信任）及其对治疗的影响 参与度和出院后饮酒的情况尚未得到很好的描述。我们提出了一个三臂 随机试验比较的影响：1）一个特定的简短干预，简短的谈判采访， 转诊和2周的电话助推器（BNI）由健康促进倡导者单独提供给额外的 2)提供AUD药物（BNI+MAUD），以及3）基于计算机的认知行为平台 在450例因以下原因住院的患者的不同样本中进行了CBT 4CBT治疗（BNI+MAUD+ CBT 4CBT） 在一个大型的城市学术医疗中心接受治疗。主要成果是参与正式澳元 出院后30天治疗。次要结局包括正式AUD治疗参与 90天时，酒精使用的变化（通过自我报告和酒精生物标志物磷脂酰乙醇），以及 医疗保健利用的探索性结局（目标1）。我们会探讨 干预措施在种族和族裔群体之间和内部各不相同，并以SDOH为基础（目标2）。一致的 混合类型1有效性-实施设计，我们将进行一个以实施为中心的过程 为未来实施提供信息的评价，包括过程结果、临床医生和工作人员的观点， 成本（目标3）在新的和长期的合作基础上，研究小组包括个人， 在医院环境中的成瘾医学专业知识;行为干预，包括简短的干预， 科技认知行为治疗;健康差异研究;临床试验;纵向 分析;实施科学。研究组件易于扩展，并植根于强有力的证据。 该提案提供了创新，因为1）医院关注AUD治疗启动; 2）评估增加的 药物和CBT 4CBT对BNI的益处; 3）重点评价种族、民族和 4）在研究设计和实施的各个方面考虑结构性种族主义的影响 拥有一支高素质的团队该研究通过生成关于可重现性和 可扩展的方法，以改变全国范围内基于医院的AUD治疗启动。