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: 10491299
• 负责人: E. Jennifer Edelman
• 金额: $ 72.79万
• 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/10491299
• 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; Health Disparities Research; 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; evidence base; food insecurity; future implementation; health care service utilization; hospital readmission; housing instability; implementation science; incremental cost-effectiveness; indexing; information gathering; innovation; longitudinal analysis; medical complication; mortality; multidisciplinary; patient population; phosphatidylethanol; primary outcome; process evaluation; 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.

抽象的 饮酒障碍（AUD）是发病率和死亡率的主要原因，但经常不脱离。这是 在多样性的种族和种族背景的个人中尤其如此。急性医疗医院 提供了一个未开发的机会来解决AUD治疗差距。迄今为止，与听力有关的护理集中 治疗急性戒断并解决相关的急性医疗并发症，而无需解决 基础澳元。这忽略了机会“可以治疗”的时刻。有一系列行为和 可以在出院前开始以解决AUD的药物治疗。但是，我们缺乏数据 关于增强入院后AUD治疗参与和减少酒精的最佳方法。 此外，结构性种族主义对更近端的健康决定性的影响（SDOH，例如住房 不稳定，医疗不信任）在住院的患者中，对治疗的影响 订婚后订婚和饮酒尚未得到很好的特征。我们提出了3臂 随机试验比较以下影响：1）特定的简短干预措施，简短的谈判访谈与 由健康促进倡导者提供的转诊和2周的电话助推器（BNI）单独提供给其他 2）提供AUD的药物（BNI+MAUD），3）基于计算机的认知行为平台 在450名住院治疗的潜水员样本中，治疗（CBT4CBT; BNI+MAUD+CBT4CBT） 在一个大型城市学术医学中心未经治疗的AUD。主要结果是参与正式AUD 院后出院30天的治疗。次要结果包括正式的AUD治疗参与 在90天后，酒精使用变化（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结果（AIM 1）。我们将探讨是否有效 干预措施在种族和族裔中以及基于SDOH（AIM 2）的情况下有所不同。与a一致 混合1型有效性实施设计，我们将进行以实施为中心的过程 评估以告知未来实施，包括过程成果，临床医生和员工的观点， 和成本（目标3）。研究团队以新的和长期合作的合作为基础，包括 在医院环境中成瘾医学方面的专业知识；行为干预，包括简短的干预措施和 技术传递的认知行为疗法；健康差异研究；临床试验；纵向 分析;和实施科学。研究成分很容易估计，并植根于有力的证据。 考虑到1）医院专注于AUD治疗计划，该建议提供了创新； 2）添加的评估 药物的好处和CBT4CBT对BNI的好处； 3）专注于评估种族，种族和 SDOH; 4）考虑结构种族主义在研究设计和实施各个方面的影响 与一支高素质的团队。该研究通过生成可重复的数据和 可扩展的方法在全国范围内改变基于医院的AUD治疗计划。