Testing an mHealth System for Integrating Alcohol Use Treatment with Hepatology Care for Patients with Alcohol-associated Liver Disease

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Alcohol-associated liver disease (ALD) rates have risen markedly over the past 15 years, becoming the most common indication for liver transplantation in the U.S. and generating the majority of healthcare and cost burden among all liver diseases. With the COVID pandemic, these trends have worsened, and it is estimated that, if nothing is done to stem the tide, ALD-related mortality will double by 2040. Despite decades of medical research, alcohol cessation remains the only intervention that substantially decreases long-term ALD morbidity and mortality. However, only 10-15% of ALD patients access alcohol use treatment in the first year after their diagnosis, with women even less likely to access treatment compared to men. Despite these gaps, surprisingly few behavioral interventions for alcohol cessation have been tested in ALD patients, and, of those that have been tested, integrated alcohol cessation treatment alongside medical and hepatology care has had the most impact at reducing alcohol use. To address these critical research gaps, the investigators will perform a randomized, controlled, Type 1 hybrid implementation-effectiveness trial in a population of ALD patients to evaluate the effectiveness of CHESS Health Connections (a smartphone app for alcohol cessation shown to significantly reduce risky drinking in a prior randomized clinical trial of patients with severe alcohol use disorder). Patients will be enrolled in both general hepatology and multidisciplinary ALD clinics (which include integrated alcohol use treatment professionals alongside hepatology providers) at two large tertiary care centers (University of Wisconsin and University of Michigan). Aim 1 will compare the effectiveness of CHESS plus usual care (n=180) versus usual care (n=181) on days of abstinence over 6 months. Aim 2 will assess implementation of CHESS through qualitative interviews of key patient, provider, and clinic-level stakeholders using the Replicating Effective Programs framework and implementation costs. Our secondary/exploratory analyses will examine intervention effects on health outcomes including depression, anxiety, insomnia, AUD treatment engagement, and liver health. We will examine key moderators (age, sex, rurality, presence of formal AUD treatment, and stage of ALD) and mediators (relatedness, competence, autonomous motivation) on outcomes. We will also examine the impact of the CHESS app on measures of chronic liver impairment using the Model for End-Stage Liver Disease-Sodium score. This study will build on over a decade of work in adapting and using CHESS in various populations with alcohol use disorder. This study is highly innovative in three ways: 1) it is the first fully powered effectiveness trial of a proven smartphone app for alcohol cessation in ALD patients, 2) it will test a new model of care for delivering alcohol cessation treatment to ALD patients, and 3) it will utilize a novel collaboration of systems engineering and medical researchers with expertise in ALD, digital health, and implementation science. If successful, this study holds promise to provide critically needed alcohol use resources to ALD patients and potentially set a new standard of care.