Department of Internal Medicine, Yale School of Medicine, 367 Cedar Street, ES Harkness Memorial Hall, Suite 401, New Haven, CT, 06510, USA.
Yale Program in Addiction Medicine, Yale School of Medicine, New Haven, CT, USA.
Addict Sci Clin Pract. 2023 Sep 19;18(1):55. doi: 10.1186/s13722-023-00407-9.
Alcohol use disorder (AUD) commonly causes hospitalization, particularly for individuals disproportionately impacted by structural racism and other forms of marginalization. The optimal approach for engaging hospitalized patients with AUD in treatment post-hospital discharge is unknown. We describe the rationale, aims, and protocol for Project ENHANCE (ENhancing Hospital-initiated Alcohol TreatmeNt to InCrease Engagement), a clinical trial testing increasingly intensive approaches using a hybrid type 1 effectiveness-implementation approach.
We are randomizing English and/or Spanish-speaking individuals with untreated AUD (n = 450) from a large, urban, academic hospital in New Haven, CT to: (1) Brief Negotiation Interview (with referral and telephone booster) alone (BNI), (2) BNI plus facilitated initiation of medications for alcohol use disorder (BNI + MAUD), or (3) BNI + MAUD + initiation of computer-based training for cognitive behavioral therapy (CBT4CBT, BNI + MAUD + CBT4CBT). Interventions are delivered by Health Promotion Advocates. The primary outcome is AUD treatment engagement 34 days post-hospital discharge. Secondary outcomes include AUD treatment engagement 90 days post-discharge and changes in self-reported alcohol use and phosphatidylethanol. Exploratory outcomes include health care utilization. We will explore whether the effectiveness of the interventions on AUD treatment engagement and alcohol use outcomes differ across and within racialized and ethnic groups, consistent with disproportionate impacts of AUD. Lastly, we will conduct an implementation-focused process evaluation, including individual-level collection and statistical comparisons between the three conditions of costs to providers and to patients, cost-effectiveness indices (effectiveness/cost ratios), and cost-benefit indices (benefit/cost ratios, net benefit [benefits minus costs). Graphs of individual- and group-level effectiveness x cost, and benefits x costs, will portray relationships between costs and effectiveness and between costs and benefits for the three conditions, in a manner that community representatives also should be able to understand and use.
Project ENHANCE is expected to generate novel findings to inform future hospital-based efforts to promote AUD treatment engagement among diverse patient populations, including those most impacted by AUD.
Clinicaltrials.gov identifier: NCT05338151.
酒精使用障碍(AUD)通常会导致住院,特别是对那些受到结构种族主义和其他形式的边缘化影响不成比例的人。在出院后让住院 AUD 患者参与治疗的最佳方法尚不清楚。我们描述了 Project ENHANCE(通过增强医院发起的酒精治疗来提高参与度)的基本原理、目标和方案,这是一项使用混合 1 型有效性-实施方法测试越来越密集方法的临床试验。
我们正在从康涅狄格州纽黑文市的一家大型城市学术医院中随机分配英语和/或西班牙语的未经治疗的 AUD 患者(n=450)至以下三组:(1)单独进行简短谈判访谈(带有转介和电话强化)(BNI);(2)BNI 加酒精使用障碍的药物辅助治疗(BNI+MAUD);或(3)BNI+MAUD+计算机为基础的认知行为疗法培训(CBT4CBT,BNI+MAUD+CBT4CBT)。干预措施由健康促进倡导者提供。主要结果是出院后 34 天 AUD 治疗参与度。次要结果包括出院后 90 天的 AUD 治疗参与度和自我报告的酒精使用和磷脂酰乙醇的变化。探索性结果包括卫生保健的利用。我们将探索干预措施对 AUD 治疗参与度和酒精使用结果的有效性是否因种族和族裔群体的差异而有所不同,这与 AUD 的不成比例影响相一致。最后,我们将进行以实施为重点的过程评估,包括在三种情况下收集个体层面和提供者层面与患者层面的成本、成本效益指数(有效性/成本比)和成本效益指数(收益/成本比、净收益[收益减去成本])之间的统计比较。个体和群体水平的有效性 x 成本以及成本 x 收益的图表将以社区代表也应该能够理解和使用的方式描绘三种情况下成本与有效性以及成本与收益之间的关系。
预计 Project ENHANCE 将产生新的发现,为未来在不同患者群体中促进 AUD 治疗参与度的基于医院的努力提供信息,包括那些受 AUD 影响最大的群体。
Clinicaltrials.gov 标识符:NCT05338151。