Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use
United States180 participantsStarted 2022-02-01
Plain-language summary
The study consists of a randomized controlled trial evaluating the efficacy and feasibility of a stepped alcohol treatment using telemedicine on unhealthy alcohol use in patients with chronic liver disease receiving care in hepatology practices at three sites. Patients who meet eligibility criteria will be randomized to one of two study arms: 1) Stepped Alcohol Treatment (SAT) or, 2) Usual Care (UC). Participants will be randomized separately by site. SAT includes 3 sessions of motivational interviewing followed by referral to addiction medicine for patients who do not reduce unhealthy drinking. Trial outcome measures will be complete at 6 and 12 months following baseline enrollment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women age ≥ 18 years.
✓. Diagnosis of chronic liver disease (CLD).
✓. 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.
✓. Ability to access a telephone or a digital device (i.e., computer, tablet or smart phone).
Exclusion criteria
✕. Severe medical or psychiatric conditions or evidence of acute alcohol intoxication preventing participation in the study
✕. Are currently enrolled in formal treatment for unhealthy alcohol use, excluding self or mutual-help groups (e.g., Alcoholics Anonymous).
✕. Women who are pregnant or breastfeeding or unwilling to use birth control.