The Liver Care Trial: screening for liver disease in individuals attending treatment for alcohol use disorder-study protocol for a randomized controlled study

BACKGROUND: Early diagnosis of alcohol-related liver disease (ALD) can improve survival if it leads to alcohol abstention or very light consumption. It is possible to screen for liver fibrosis, an asymptomatic condition of ALD that can lead to cirrhosis, by an easy and non-invasive approach called transient elastography. It has not yet been established whether screening for liver fibrosis reduces alcohol consumption among individuals with alcohol use disorders compared to standard treatment. In addition, it is important to address whether receiving a screening result indicating no ALD could lead to increased alcohol consumption (the certificate-of-health effect). This paper describes a study protocol aiming to evaluate alcohol drinking outcomes after screening for liver fibrosis among individuals receiving community-based treatment for alcohol use disorder.

METHODS: The study follows a randomized, controlled trial design (RCT) with concealed allocation in a 2:1 ratio to the intervention group or the control group. Blinded outcome assessments will be conducted for both parallel groups. A total of 408 participants will be randomized to receive both transient elastography and blood tests (intervention group, n = 272) or standard of care consisting of a blood test (control group, n = 136). Participants are adults receiving outpatient treatment for alcohol use disorder at three specialized centres in Denmark with no known liver disease. The primary outcome is abstinence or light consumption (≤ 10 units/week, 1 unit = 12 g alcohol) throughout the last 30 days, evaluated 6 months after randomization using the validated timeline follow-back method, supplemented by review of electronic health records. Secondary outcomes include quality of life and motivation to reduce alcohol intake. Qualitative studies will explore emotional impacts of screening on participants' and health professionals' barriers to the implementation of screening.

DISCUSSION: This study has the potential to offer important insights into the effect of screening for liver fibrosis on alcohol consumption among individuals who are attending treatment for alcohol use disorder. Furthermore, the study will provide insights into user and health professionals' experiences related to screening. Findings may have implications for the implementation of non-invasive screening for chronic liver disease in individuals receiving alcohol use disorder treatment.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05855031. Registered on the 20th of April 2023.