Abstract
This paper reports results of a hybrid effectiveness-implementation randomized trial that systematically varied levels of human oversight required to support 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 (n = 185), peer-supported use (n = 186), or a clinically integrated model (n = 187). Across all three groups, percentage of risky 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 quality of life compared to the self-monitoring group (p = 0.011). However, higher rates of attrition in the clinically integrated group warrants 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.