To evaluate the efficacy of systematically offering newly diagnosed ALD patients to AUD treatment, in the hepatology clinic, 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 offer to specialized AUD treatment (intervention) and B) standard care (control). Existing observational cohort ALD members will contribute to the control group in addition to the randomized controls. The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.
The investigators have designed a randomized controlled superiority trial to investigate the effectiveness of systematically offering AUD treatment in the hepatology clinic to newly diagnosed ALD patients to increase the proportion that are abstaining from alcohol after 6 months compared to standard care. The study will be embedded in an existing observational cohort from which already included participants will be used as controls in the RCT (n = 89). Please see Figure 1 for the flow of participants in the study. From november, 2025, the investigators will start to randomize eligible participants. Randomization will take place in connection with the first visit in the observational cohort study. Study participants randomized as controls will receive standard care through their treating physicians, which consists of individualized education on the nature of ALD as well as encouragement of alcohol use cessation. Patients in the intervention group will receive standard care in addition to an offer of AUD treatment in the hepatology clinic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
221
Patients are offered specialized alcohol use disorder treatment in the hepatology clinic by an experienced AUD therapist from the AUD facility. Also medical AUD treatments will be offered to support abstinence.
Department of Medicine, Zealand University Hospital
Køge, Køge, Denmark
RECRUITINGSelf-reported alcohol abstinence in the last 30 days at 6 months followup in combination with phosphatidylethanol level at 6 months
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) and review of medical charts and measurement of phosphatidylethanol at 6 months
Time frame: 6 months after baseline
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 and no indications of alcohol use in medical charts.
Time frame: 3 months after baseline
Rate of AUD treatment
Any treatment for alcohol use disorder after 6 and 12 months
Time frame: 6 and 12 months after baseline
Rate of individuel AUD treatment
Any individuel treatment for alcohol use disorder after 6 and 12 months
Time frame: 6 and 12 months after baseline
Rate of AUD treatment
Number of received sessions of treatment for alcohol use disorder after 6 and 12 months
Time frame: 6 and 12 months from baseline
Reduction in drinks per week
Reduction in drinks per week after 3, 6 and 12 months compared to baseline (yes or no)
Time frame: 3, 6 and 12 months from baseline
Reduction in phosphatidylethanol
Reduction in phosphatidylethanol value at 6 and 12 months compared to baseline (yes or no)
Time frame: 6 and 12 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
Time frame: 3 years from baseline
All-cause mortality
time to death
Time frame: 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
Time frame: 3 years from baseline
Duration of AUD treatment
Duration of AUD treatment
Time frame: 6 and 12 months from baseline
Group AUD treatment sessions
Amount of group AUD treatment sessions
Time frame: 6 and 12 months from baseline
Self-reported abstinence last 30 days after 12 months and phosphatidylethanol level after 12 months
Self-reported alcohol abstinence last 30 days by 12 months assessed by the timeline followback method (questionnaire) and review of electronic medical records in combination with measured phosphatidylethanol level.
Time frame: 12 months
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