JMIR Publications

ABSTRACT

Background:

The rising burden of alcohol-associated liver disease (ALD) calls for effective interventions. Alcohol cessation remains the only intervention known to reduce long-term ALD morbidity and mortality. Integrating treatment for alcohol use disorder (AUD) with medical and hepatology care shows significant promise.

Objective:

Here, we conduct a randomized, controlled, Type 1 hybrid effectiveness-implementation trial in ALD patients to evaluate an evidence-based smartphone app for AUD (Connections). The primary aim is to (1) compare the effectiveness of the Connections app plus usual care to the effectiveness of usual care alone on days of alcohol abstinence for ALD patients and (2) assess the implementation of the Connections app in the ALD population using a multi-level model of system change to determine facilitators and barriers to the successful adoption of the app at the patient, provider, and clinic levels.

Methods:

Study procedures were approved by the Institutional Review Board (IRB) on 3/13/2024. Patients are recruited from General Hepatology and Multidisciplinary Clinics in Wisconsin and Michigan. Participants are randomized to an intervention (Connections + treatment as usual (TAU)) or no intervention (TAU). During the six-month enrollment period, participants complete monthly e-surveys measuring alcohol consumption and quarterly e-surveys measuring patient health indicators and behaviors. Patients earn up to $240 for participation.

Results:

Recruitment began June 2024 and is ongoing. As of 2/26/2026, 144 participants have been enrolled in the study. Of these, 65 (45.1%) have completed all the study activities. We aim to recruit 298 participants through 2027, with analysis following.

Conclusions:

Implementation insights highlight the importance of flexibility and strong provider relationships. Challenges include reliance on technology, which limits access for patients with low digital literacy, and the risk of loss to follow-up. This trial is the first fully powered effectiveness-implementation study of a mobile health app for alcohol cessation in ALD, testing a new care model that integrates multidisciplinary expertise.