Abstract
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.