DIALS – DIAgnosis of Liver diseaSe in primary care

Research question What is the most clinical and cost-effective method of selecting at risk people in primary care for referral to secondary care for management of chronic liver disease? Background Mortality rates from liver disease have increased 400% in the UK since 1970. Most deaths occur in people aged 18-65 years making it the third biggest cause of premature death in working age. In early stages, liver disease is usually asymptomatic even among persons with cirrhosis. There is currently a lack of defined pathways for identifying people with liver disease in primary care and most patients are diagnosed incidentally. Aims and objectives We aim to conduct a cluster randomised controlled trial in primary care of inviting people at risk of chronic liver disease for a liver health check to detect cirrhosis versus standard of care. We will further explore the acceptability and cost-effectiveness of implementing a primary care liver health check in diverse primary care settings. Our main objective is to establish the effectiveness of a liver health check in detecting cirrhosis in persons at risk of chronic liver disease, to identify the minimum combinations of FIB4, ELF and TE required to diagnose cirrhosis in the at-risk population and in each individual risk group and to provide recommendations for future testing pathways. Methods We will perform a two-arm parallel group cluster-randomised controlled trial with internal pilot and with embedded process evaluation and economic evaluation. We will include adults at increased risk of liver disease due to excess alcohol consumption, type 2 diabetes, obesity, or abnormal ALT. The liver health check is a complex intervention underpinned by three main components: invitation to testing, evaluation for liver disease using non-invasive fibrosis tests (FIB4, ELF, and Fibroscan), and templates for recording results and ensuring appropriate patients are referred to secondary care for further evaluation. The primary outcome will be a comparison of rates of diagnosis of liver cirrhosis between intervention and control groups based on clinical consensus within 12 months of practice randomisation. We plan to randomise 74 practices to each group with a cluster size of 300 for a total of 42,000 patients. Timelines for delivery Month 0–9: Protocol, database and intervention development, ethics approvals Month 8-30: Site selection, training and set-up Month 10-41: Randomisation, recruitment and testing Month 20: Internal pilot assessment (10-month pilot phase) Month 12–49: Process evaluation Month 50: Data lock Month 51–55: Data analysis, manuscript preparation & submission Anticipated impact and dissemination This will be the first major randomised controlled trial investigating the effectiveness of a liver health check. This evidence will be incorporated into future evidence-based guidelines to guide the management of persons at risk of liver disease in primary care. We will publish our findings in scientific journals and co-present our work at national and international conferences. We anticipate that key stakeholders will include those who are at higher risk of developing liver disease, patients, primary care physicians and integrated care boards. We will use a variety of mechanisms such as speaking on local radio stations, holding in person events and creating project summaries to inform and engage them. The British Liver Trust will use its channels to communicate and disseminate results.