测试一种新的远程医疗治疗模式对初级保健患者酒精使用障碍的效果：一项随机对照试验方案。

Testing a new model of telehealth-delivered treatment for primary care patients with alcohol use disorder: A randomized controlled trial protocol.

机构信息

Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Michigan Innovations in Addiction Care through Research & Education, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI 48109, USA.

Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI 48109, USA; Department of Emergency Medicine, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI 48109, USA; Department of Health Behavior and Health Education, School of Public Health, University of Michigan, 1415 Washington Heights, Ann Arbor, MI 48109, USA.

出版信息

Contemp Clin Trials. 2024 Jul;142:107549. doi: 10.1016/j.cct.2024.107549. Epub 2024 Apr 26.

DOI:10.1016/j.cct.2024.107549

PMID:38679140

Abstract

BACKGROUND

The majority of adults suffering from alcohol use disorders (AUD) do not receive treatment. To address this gap in care, we must develop new models to increase identification, engagement and delivery of accessible and effective treatment. This paper describes the protocol for a randomized controlled trial (RCT) testing a novel telehealth treatment model for primary care patients with untreated AUD.

METHODS

We aim to recruit 300 adults across 2 healthcare systems for this two-arm RCT. Participants, initially identified for recruitment based on AUD-related indicators in their electronic health record (EHR), are RCT-eligible if they meet AUD criteria (mild, moderate, severe), report ≥ 3 drinking days/week in past 30 days, and have not received AUD psychotherapy in the past 90 days. Participants are randomized to an intervention or enhanced usual care control (EUC) condition, both individually-delivered. The intervention includes a telephone-delivered motivational interviewing (MI) engagement session and 8 sessions of MI-Cognitive Behavioral Therapy (MI-CBT). EUC involves AUD psychoeducation, advice to reduce drinking and seek treatment, and provision of community resources. Outcomes will be measured at 3-, 6-, and 12-months; primary outcomes include: AUD psychotherapy initiation and engagement (within the study and external community) and alcohol consumption (percent drinking days and heavy drinking days).

CONCLUSIONS

This study addresses whether proactive patient identification and engagement and delivery of patient-centered telehealth psychotherapy to patients with untreated AUD is effective in increasing treatment use and improving alcohol outcomes. If effective, this could be a highly scalable model for reducing the public health impact of AUD.

TRIAL REGISTRATION

ClinicalTrials.gov # NCT05410561. University of Michigan HUM00204315. Ann Arbor VA IRB #1655886.

摘要

背景

大多数患有酒精使用障碍（AUD）的成年人都未接受治疗。为了解决这一护理差距，我们必须开发新的模式来提高识别、参与和提供可及且有效的治疗的能力。本文介绍了一项随机对照试验（RCT）的方案，该试验测试了一种针对初级保健患者中未经治疗的 AUD 的新型远程医疗治疗模式。

方法

我们旨在通过两个医疗保健系统招募 300 名成年人参加这项两臂 RCT。根据电子健康记录（EHR）中的 AUD 相关指标初步确定参与者是否有资格参加 RCT，如果他们符合 AUD 标准（轻度、中度、重度）、报告过去 30 天中有≥3 天饮酒、并且在过去 90 天内未接受过 AUD 心理治疗，则符合 RCT 条件。参与者被随机分配到干预组或增强的常规护理对照组（EUC），均为个体提供。干预措施包括电话提供的动机性访谈（MI）参与会议和 8 次 MI-认知行为疗法（MI-CBT）。EUC 包括 AUD 心理教育、减少饮酒和寻求治疗的建议以及提供社区资源。将在 3、6 和 12 个月时测量结果；主要结果包括：AUD 心理治疗的开始和参与（在研究内和外部社区）和饮酒量（饮酒天数百分比和重度饮酒天数）。