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 酒精使用障碍 (AUD) 是发病和死亡的主要原因，但常常得不到治疗。 对于不同种族和民族背景的人来说尤其如此。 为解决 AUD 治疗缺口提供了一个尚未开发的机会 迄今为止，与 AUD 相关的护理已成为重点。 关于急性戒断的治疗和解决相关的急性医疗并发症而不解决 这忽略了一个“可治疗”的机会，有一系列的行为和机会。 出院前可能开始的药物治疗以解决 AUD 然而，我们缺乏数据。 加强出院后 AUD 治疗参与和戒酒的最佳方法。 此外，结构性种族主义对更直接的健康社会决定因素（SDOH，例如住房）的影响 AUD 住院患者的不稳定、医疗不信任）及其对治疗的影响 出院后的参与度和饮酒情况尚未得到很好的描述，我们建议采用三臂模型。 随机试验来比较以下方面的影响：1）具体的简短干预，即简短协商访谈 由健康促进倡导者单独向其他患者提供转介和为期 2 周的电话加强服务 (BNI) 2) 提供 AUD 药物 (BNI+MAUD)，以及 3) 基于计算机的认知行为平台 治疗（CBT4CBT；BNI+MAUD+CBT4CBT）在 450 名住院患者的不同样本中进行 在大型城市学术医疗中心未接受 AUD 治疗的主要结果是参与正式的 AUD。 出院后 30 天的治疗次要结果包括正式的 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果（目标 1）。 干预措施在种族群体之间和种族群体内部有所不同，并且基于 SDOH（目标 2）。 混合类型 1 有效性实施设计，我们将进行以实施为重点的流程 评估为未来的实施提供信息，包括流程结果、忠诚者和工作人员的观点， 研究团队以新的和长期的合作为基础，包括以下人员： 医院环境中成瘾医学的专业知识，包括简短的干预和 技术提供的认知行为治疗；健康差异研究； 分析；实施和科学。 鉴于 1) 医院重点关注 AUD 治疗启动 2) 评估补充，该提案提供了创新； 药物和 CBT4CBT 对 BNI 的益处；3) 重点评估不同种族、民族和群体的不同影响； SDOH；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，该研究通过生成可重复的数据而具有巨大的影响力。 在全国范围内转变以医院为基础的 AUD 治疗启动的可扩展方法。