Systematic Referral to Alcohol Use Dependency Treatment in Patients With Alcohol-related Liver Disease: a RCT
NCT Number: NCT06493773
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Liver Diseases, Alcoholic|Alcohol Use Disorder|Treatment Adherence
Interventions: BEHAVIORAL: Offer of referral to specialized alcohol use disorder treatment
Sponsor: Zealand University Hospital
Collaborators: Novavi Køge og Novavi Roskilde (alcohol abuse treatment centres)|Center for Clinical Research and Prevention
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 203
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2028-06-01
Locations: Department of Medicine, Zealand University Hospital, Køge, 4600, Denmark

Summary:
To evaluate the efficacy of systematically referring newly diagnosed ALD patients to AUD treatment on alcohol abstinence after 6 months. The investigators will conduct a randomized controlled superiority trial with parallel group design, hypothesis blinding and blinded outcome assessment comparing A) a referral to specialized AUD treatment (intervention) and B) standard care (control). The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.

Primary Outcome Measures: Self-reported alcohol abstinence in the last 30 days at 6 months followup, Self-reported alcohol abstinence (defined as zero consumption of alcohol) throughout the last 30 days assessed after 6 months assessed by the timeline followback method (questionnaire), measurement of phosphatidylethanol, and review of electronic medical records., 6 months after baseline
Secondary Outcome Measures: Self-reported alcohol abstinence in the last 30 days at 3 months followup, Self-reported alcohol abstinence (defined as zero consumption of alcohol) throughout the last 30 days assessed after 3 months assessed by the timeline followback method (questionnaire) and review of electronic medical records., 3 months after baseline|Rate of online AUD treatment, Any online treatment for alcohol use disorder after 6 months, 6 months after baseline|Rate of in-person AUD treatment, Any in-person treatment for alcohol use disorder after 6 months, 6 months after baseline|Rate of AUD treatment, Number of received sessions of treatment for alcohol use disorder after 6 months, 6 months from baseline|Reduction in drinks per week, Reduction in drinks per week after 3 and 6 months compared to baseline (yes or no), 6 months from baseline|Reduction in phosphatidylethanol, Reduction in phosphatidylethanol value at 6 months compared to baseline (yes or no), 6 months from baseline|Complications from liver disease, Time to first decompensation event, which is defined as variceal haemorrhage, ascites grade 2 or worse, or hepatic encephalopathy West-Haven grade 2 or worse, 3 years from baseline|All-cause mortality, time to death, 3 years from baseline|Progression of liver disease, Progression in liver fibrosis grade assessed by transient elastography or progression to a worse Child-Pugh class (A to B or C and B to C, 3 years from baseline