Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder; Liver Diseases
• Interventions: Behavioral: Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use; Other: Usual Care (UC)

• Registration Number: NCT05191446
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

Background/Rationale: Unhealthy alcohol use is consumption of alcohol at more than the "moderate" levels of up to 1 drink per day (7/week) for women and up to 2 drinks per day (14/week) for men, as defined by NIAAA. Unhealthy alcohol use is prevalent in chronic liver disease (CLD), and for many patients no level of alcohol could be considered safe. Guidelines recommend integrated multidisciplinary care, but evidence-based strategies to address alcohol use beyond brief counseling are rarely provided in hepatology practices. A recent study showed that most veterans with cirrhosis and coexisting AUD do not receive behavioral treatment or pharmacotherapy for AUD. Similarly, in a study of cirrhosis patients \[\~70% alcohol-associated liver disease (ALD)\] hospitalized at 4 safety net hospitals, less than half reported abstinence from alcohol, while 39% reported daily alcohol use, and alcoholic hepatitis accounted for the highest in-hospital mortality compared to other comorbidities. The investigators are focusing on these important outcomes in this study. Current guidelines recommend that brief intervention, pharmacotherapy, and referral to treatment should be offered to patients with ALD including those with alcohol use disorder (AUD) or advanced CLD of any etiology who drink alcohol at more than moderate amounts. Our approach follows these guidelines.

Overall approach: The investigators will enroll a total of 180 patients (90 assigned to stepped care, 90 to usual care) with liver disease and alcohol use; 60 patients will be recruited from each of the three study sites (two Veterans Administrations Healthcare System sites in Palo Alto and San Francisco as well as a safety net public clinic in San Francisco, CA). This intent-to-treat outcome study will include all patients recruited, whether or not they complete the interventions.

Recruitment: Hepatology practices at all three sites routinely screen patients for alcohol use. Eligible patients will be identified using the electronic medical record and, following permission from their provider, patients will be contacted about the study. Patients may also be referred directly by their hepatology providers. Interested patients who meet all eligibility criteria will be consented to participate in the study. The investigators will include English and Spanish speakers using bicultural and bilingual clinical research coordinators. Following enrollment, participants will have baseline, 3-, 6-, and 12-month assessments. Participants will be offered $50 for completing the baseline, 3-, and 6-month, and $100 for 12-month assessments.

Baseline assessment: At baseline, patient demographics (age, sex, race/ethnicity, income, education, insurance), medical history, medications, etiology of CLD, presence of cirrhosis or hepatic decompensation, history of illicit drugs, laboratory tests of liver function and COVID-19 will be captured using the electronic medical record. Measures of alcohol use will be performed using validated measures. Patients will then undergo randomization.

Randomization to study arms: Patients who meet study criteria will be randomized to one of two study arms: 1) Stepped Alcohol Treatment (SAT) or, 2) Usual Care (UC). See "Arms and Interventions" section for details.

Follow-up Assessments: A research staff member not participating in patient care will conduct follow-up interviews. He/she will be blinded to participants' treatment condition. Participants will be contacted by telephone at 3, 6 and 12 months to complete the measures. Patient reporting via telephone follow-up has been reliable in prior studies but a biomarker of alcohol use will also be performed to validate reports of alcohol abstinence

Statistical analysis: Repeated measures analyses will be conducted within a generalized linear mixed model (GLMM) framework. These models accommodate the range of continuous, count, and discrete outcomes that will be measured. Analyses will include treatment condition (SAT vs UC) as a between-subjects effect. Time (baseline, 3-month, 6-month, and 12-months) will be a repeated effect and the treatment x time interaction will be examined. Analyses will account for clustering of patients within study site.

Sample size: Sample size was determined using data from prior studies of MI and stepped care interventions for unhealthy alcohol use in individuals with liver disease and other populations, for the primary outcome (less than moderate alcohol use) and the secondary outcome of drinks per week.

Anticipated results: The investigators anticipate that SAT participants will be more likely than UC to reduce or be abstinent from alcohol use at the 3-, 6- and 12-month follow-up. The investigators also anticipate that SAT participants will have better clinical outcomes (less new or worsening clinical decompensation or hospitalizations) than controls at follow-up. The investigators will also explore COVID-19 related outcomes in both arms, e.g., infection rates, hospitalization and clinical outcomes.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-13
• Study Start: 2022-02-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2026-01-31
• Study Completion: 2026-02-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use	Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use	For participants randomized to SAT, consistent with stepped care, treatment will begin with lower intensity services that are stepped up, if necessary, at a predefined time point. Step 1 consists of three motivational interviewing (MI)sessions delivered every 2 weeks. At the 3-month assessment, those with non-response to MI, defined as continued unhealthy alcohol use in the prior 14 days, will be referred to on site physician managed addiction specialty services (Step 2) for higher intensity services.
Usual Care (UC)	Usual Care (UC)	UC participants will receive their usual services in hepatology. They will also be given publicly available patient education materials regarding risk associated with unhealthy drinking (mail/email or in-person if desired) and will be asked to follow up with their physician should they have questions about information provided in the handouts. UC participants' hepatology provider will be notified if AUDIT-C scores are greater than 3 at baseline. All UC participants will have access to alcohol and other substance use treatment available to patients at their respective sites.

Primary Outcome Measures

Name	Time	Method
Change in alcohol use	6 months after enrollment	Less than moderate alcohol use in the prior 14 days at month 6 follow-up. Alcohol use survey questions will assess usual drinking frequency (days per week) and typical number of standard drinks consumed, in order to compute average number of drinks per week; and number of days of hazardous drinking (5+ drinks for men and, and 4+ drinks per women) in the past 30 days, using the Timeline Followback Method.

Secondary Outcome Measures

Name	Time	Method
Alcohol use cessation	6 and 12 months after enrollment	Alcohol use will be assessed at 6 months and 12 months following enrollment, using the Timeline Followback Method.
Liver-related outcomes	6 and 12 months after enrollment	Worsening liver function tests, new or worsening hepatic decompensation or new diagnosis of cirrhosis in those without advanced CLD, number of hospitalizations, Child-Pugh (A, B, and C) and Model of End stage Liver Disease (MELD) labs will be captured using electronic medical record data.
Drinks per week	6 and 12 months after enrollment	Alcohol use will be assessed at 6 months and 12 months following enrollment, using the Timeline Followback Method.

Trial Locations

Locations (2)

University of california San Francisco; 🇺🇸 San Francisco, California, United States

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States