This paper reports the results of a hybrid effectiveness-implementation randomized trial that systematically varied levels of human oversight required to support the implementation of a digital medicine intervention for persons with mild-to-moderate alcohol use disorder (AUD). Participants were randomly assigned to three groups representing possible digital health support models within a health system: self-monitored use (SM; n = 185), peer-supported use (PS; n = 186), or a clinically integrated model CI; (n = 187). Across all three groups, the percentage of self-reported heavy drinking days dropped from 38.4% at baseline (95% CI [35.8%, 41%]) to 22.5% (19.5%, 25.5%) at 12 months. The clinically integrated group showed significant improvements in mental health and quality of life compared to the self-monitoring group (p = 0.011). However, higher attrition rates in the clinically integrated group warrant consideration in interpreting this result. Results suggest that making a self-guided digital intervention available to patients may be a viable option for health systems looking to promote alcohol risk reduction. This study was prospectively registered at clinicaltrials.gov on 7/03/2019 (NCT04011644).

本文报告了一项混合有效性实施随机试验的结果，该试验系统地改变了支持对轻度至中度酒精使用障碍 (AUD) 患者实施数字医学干预所需的人力监督水平。参与者被随机分配到三组，代表卫生系统内可能的数字健康支持模式：自我监控使用（SM； n = 185）、同伴支持使用（PS； n = 186）或临床综合模型 CI； （ n = 187）。在所有三组中，自我报告的酗酒天数百分比从基线时的 38.4%（95% CI [35.8%，41%]）下降至 12 个月时的 22.5%（19.5%，25.5%）。与自我监测组相比，临床整合组的心理健康和生活质量显着改善（ p = 0.011）。然而，在解释这一结果时需要考虑临床整合组中较高的流失率。结果表明，为患者提供自我指导的数字干预可能是寻求促进降低酒精风险的卫生系统的一个可行选择。该研究于 2019 年 7 月 3 日在 ClinicalTrials.gov 前瞻性注册（NCT04011644）。