成人酒精使用障碍的远程医疗参与和治疗策略：一项连续的多任务随机试验方案。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-07-09 DOI:10.1016/j.cct.2025.108003

Erin E. Bonar , Kelley Kidwell , Lyndsay Chapman , Maureen A. Walton , Kai Zheng , Carrie Bourque , Deborah Manderachia , Olivia E. Robinson , Alaa A. Eissa , Shayla E. Dailey , Frank Dolecki Jr , Olivia D. Teasdale , Alanah NanCoff , Emily E. Chizek , Tyleah S. Tyner , Alesha L. Miller , Lewei (Allison) Lin

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引用次数: 0

摘要

背景：美国成人酒精使用障碍（AUD）的治疗率很低。拥有电子健康记录（EHRs）的医疗保健系统可以识别AUD患者，并进行外展治疗，以减少饮酒和/或AUD症状。在这里，我们描述了一项连续、多任务、随机试验（SMART）的方案，该方案采用多种技术驱动的适应性干预（adi），以增加大型医疗保健系统中成年人的AUD护理和改善结果。方法：我们计划招募400名成年人参加这个两阶段的SMART。根据EHR中酒精指标确定的潜在参与者的资格标准进行筛选：当前饮酒，AUD和缺乏当前AUD心理治疗。参与者被随机分配到第一阶段干预：1个简短的动机访谈（MI）为重点的电话会议，或4 周的交互式治疗信息通过患者门户系统传递。在4周后的测试中，无反应者被重新随机分配到第一阶段干预的增强剂量（即，额外的电话会议或4 周的信息传递）或通过视频/电话进行8次mi -认知行为治疗（MI-CBT）协议。结果（例如，饮酒、治疗利用）在入组后4、8和12个月进行测量。结论：这项创新的SMART评估了AUD参与和护理模型中关键技术驱动的ADI策略。我们将确定最有效的初始策略（电话会话与门户消息传递），在无反应者中，我们将评估最有效的后续策略（额外的1期剂量与MI-CBT）。结果将告知可扩展ADIs的效用，以参与和改善未经治疗的AUD患者的预后。试验注册：ClinicalTrials.gov #NCT05594238。密歇根大学HUM00210546。NCT注册号：NCT05594238。

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Telehealth engagement and treatment strategies for adults living with alcohol use disorder: A sequential multiple assignment randomized trial protocol

Background

Treatment rates for alcohol use disorder (AUD) among adults in the United States (US) are low. Healthcare systems with electronic health records (EHRs) could identify those experiencing AUD and conduct outreach followed by treatment to reduce drinking and/or AUD symptoms. Here, we describe the protocol for a sequential, multiple assignment, randomized trial (SMART) of multiple technology-driven adaptive interventions (ADIs) to increase AUD care and improve outcomes among adults within a large healthcare system.

Methods

We plan to enroll 400 adults in this two-stage SMART. Potential participants identified by alcohol indicators in the EHR are screened for eligibility criteria: current drinking, AUD, and lack of current AUD psychotherapy treatment. Participants are randomized to Stage 1 interventions: 1 brief motivational interviewing (MI)-focused phone session, or 4 weeks of interactive therapeutic messaging delivered via a patient-portal like system. Non-responders at a 4-week post-test are re-randomized to an enhanced dose of their Stage 1 intervention (i.e., additional phone session or 4 weeks of messaging) or to an 8-session MI-Cognitive Behavioral Therapy (MI-CBT) protocol via video/phone. Outcomes (e.g., drinking, treatment utilization) are measured at 4-, 8-, and 12-months post-enrollment.

Conclusions

This innovative SMART evaluates critical technology-driven ADI strategies within an AUD engagement and care model. We will identify the most effective initial strategy (phone session vs. portal messaging) and, among non-responders, we will assess the most effective follow-up strategy (additional Stage 1 dose vs. MI-CBT). Outcomes will inform the utility of scalable ADIs to engage and improve outcomes for patients with untreated AUD.

Trial registration

ClinicalTrials.gov #NCT05594238. University of Michigan HUM00210546.

NCT registration: NCT05594238.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.