This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months.

The goal of this project is to implement and evaluate an evidence-based mHealth system to help patients diagnosed with ALD with alcohol cessation. Connections is a mobile health app developed by CHESS Health to support patients with alcohol use disorders. 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 (UW) and University of Michigan (UM)). The hypothesis is that the implementation of an adapted version of Connections for patients with ALD will improve rates of alcohol cessation and improve liver function.

• Aim 1 (described in this record) will assess the effectiveness of the Connections app plus usual care (n=149) compared to usual care (n=149) on days of alcohol abstinence over 6 months.
• Aim 2 will assess the implementation of the Connections app through qualitative interviews of key patient, provider, and clinic-level stakeholders using the Replicating Effective Programs framework. Aim 2 follows the study intervention phase and is not part of this record.

Secondary analyses will examine use of the Connections app on health outcomes (including depression, anxiety, insomnia, liver health, and quality of life) and health behaviors (including engagement with alcohol use disorder (AUD) and/or ALD treatments and ongoing alcohol use). Key moderators (including age, sex, race, ethnicity, marital status, rurality, and ALD severity) and mediators (including relatedness, competence, autonomous motivation) on outcomes will be explored. The impact of the Connections app on measures of chronic liver impairment documented in the health record will be examined.

Inclusion Criteria:

• Diagnosis of ALD (any stage)

• Alcoholic liver disease (ALD) encompasses a spectrum of hepatic injuries caused by long-term alcohol abuse. For this study, participants will have a diagnosis of ALD or evidence of the combination of liver disease and alcohol misuse in electronic health record.

• Alcohol use within the last 6 months

• Receiving care at UW or Henry Ford Health + MSU

  • Either the general hepatology clinic or the multidisciplinary ALD clinic

• Able to read and write proficiently in English

• Willing and able to use a smartphone app

Exclusion Criteria:

• Actively listed for liver transplant or history of liver transplant before being enrolled in the study. Participants added to a liver transplant list after being enrolled in the study will be allowed to continue their participation
• In hospice care
• Has severe cognitive impairment (as described in electronic health record including dementia, delirium, and/or unable to maintain cognitive alertness during screening--as determined by study staff.)

Participant-level data that have been de-identified will be deposited and made available in a data repository maintained by NIAAA and referenced as NIAAA-DA. The National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) is a data repository that houses and shares human subjects' data generated by NIAAA-funded research.

Data released through NIAAA-DA are assigned a citation that includes a Global Unique Identifier (GUID). The GUID is a unique persistent identifier maintained by NIAAA-DA to ensure the data can be permanently identified. The citation and GUID are available on the study page and are provided with each download.

Data will be shared with the general research community at the time of an associated outcomes publication, or the end of the award/support period, whichever comes first. Data will be retained in NIAAA-DA for the life of the repository.