Evaluating the impact of telemedicine on alcohol use in liver disease patients

Impact of the Coronavirus 2019 (COVID-19) Pandemic on Patient Outcomes, Telehealth Care Delivery, and Treatment for Unhealthy Alcohol Use in Vulnerable Patients With Advanced Liver Disease Across Two Healthcare Systems

This study is testing if a new telemedicine program for alcohol treatment can help people with liver disease reduce their drinking better than standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 2 sites (San Francisco, California and 1 other locations)
• Trial ID: NCT05191446 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a stepped alcohol treatment approach delivered via telemedicine for patients with chronic liver disease who engage in unhealthy alcohol use. Participants will be randomized into two groups: one receiving stepped alcohol treatment, which includes motivational interviewing and potential referral to addiction medicine, and the other receiving usual care. The study aims to assess patient outcomes and alcohol use over a 12-month period, with follow-up assessments at 6 and 12 months. The research is conducted across three sites, focusing on integrating care for patients with liver disease and alcohol use disorder.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with chronic liver disease and unhealthy alcohol use as defined by NIAAA criteria.

Not a fit: Patients with severe medical or psychiatric conditions, those currently enrolled in formal treatment for alcohol use, or pregnant or breastfeeding women may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of alcohol use in patients with liver disease, potentially enhancing their overall health outcomes.

How similar studies have performed: Previous studies have indicated that integrated care approaches for alcohol use disorder in patients with liver disease can be beneficial, suggesting this study builds on established findings.

Eligibility criteria

Inclusion criteria:

1. Men and women age ≥ 18 years.
2. Diagnosis of chronic liver disease (CLD).
3. Unhealthy alcohol use, defined as more than moderate amount of alcohol use within the prior 30 days by National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria defined as on average more than 1 drink/day (7 drinks per week) for women and more than 2 drinks per day (14 drinks per week) for men, or on average at least one heavy drinking day (4+ drinks in a day for women and 5+ for men) per week in the prior 30 days. A standard drink is \~14 g of alcohol.
4. Ability to access a telephone or a digital device (i.e., computer, tablet or smart phone).

Exclusion criteria:

1. Severe medical or psychiatric conditions or evidence of acute alcohol intoxication preventing participation in the study
2. Are currently enrolled in formal treatment for unhealthy alcohol use, excluding self or mutual-help groups (e.g., Alcoholics Anonymous).
3. Women who are pregnant or breastfeeding or unwilling to use birth control.
4. Language preference other than English or Spanish.
5. Unwilling or unable to provide informed consent.

Where this trial is running

San Francisco, California and 1 other locations

• University of california San Francisco — San Francisco, California, United States (Enrolling_by_invitation)
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Mandana Khalili, M.D. — University of California, San Francisco
• Study coordinator: Mandana Khalili, M.D.

Conditions Liver Diseases; Alcohol Use Disorder