Implementation of Mobile-Based Programs for Alcohol Cessation in the Treatment of Alcohol-associated Liver Disease: Protocol for a Type 1 Hybrid Implementation-Effectiveness Trial.
Source: PubMed, NCBI / U.S. National Library of Medicine
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 with medical and hepatology care shows significant promise. This study aims to conduct a randomized, controlled, type 1 hybrid implementation-effectiveness trial in patients with ALD to evaluate an evidence-based smartphone app for alcohol use disorder (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 patients with ALD and (2) assess the implementation of the Connections app in the ALD population using a multilevel model of system change to determine facilitators and barriers to the successful adoption of the app at the patient, provider, and clinic levels. Study procedures were approved by the Institutional Review Board on March 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) or no intervention (treatment as usual). During the 6-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 US $240 for participation. This study was fund
Abstract
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 with medical and hepatology care shows significant promise. This study aims to conduct a randomized, controlled, type 1 hybrid implementation-effectiveness trial in patients with ALD to evaluate an evidence-based smartphone app for alcohol use disorder (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 patients with ALD and (2) assess the implementation of the Connections app in the ALD population using a multilevel model of system change to determine facilitators and barriers to the successful adoption of the app at the patient, provider, and clinic levels. Study procedures were approved by the Institutional Review Board on March 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) or no intervention (treatment as usual). During the 6-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 US $240 for participation. This study was funded in September 2023. Recruitment began in June 2024 and is ongoing. As of February 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 and results publication estimated in 2028. 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 implementation-effectiveness study of a mobile health app for alcohol cessation in ALD, testing a new care model that integrates multidisciplinary expertise. DERR1-10.2196/94231.