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

Abstract

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 noninvasive 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 usual 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 is a protocol for a study that aims to evaluate the efficacy of screening for liver fibrosis with transient elastography on alcohol use outcomes in individuals who are receiving treatment for alcohol use disorder in the community. 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 patients will be randomized to receive both transient elastography and blood tests (intervention group, n = 272) or usual care consisting of a blood test (control group, n = 136). The primary outcome will be abstinence or light consumption (≤ 10 units per week, 1 unit = 12 g alcohol) throughout the last 30 days, as evaluated six months after randomization. Secondary outcomes include health-related quality of life and motivation to reduce alcohol intake. The “certificate-of-health effect” will be assessed by comparing abstinence or light alcohol consumption after six months between the screen-negative patients and the controls. Additionally, qualitative studies will explore the emotional impact 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. Trial registration ClinicalTrials.gov NCT05855031. Registered on the 20th of April 2023.