Co-production, refinement and evaluation of a model of psychosocial peer support and liaison with alcohol, liver and mental health services to improve quality of life and clinical outcomes for people with alcohol-related liver disease (CALM study)

Research Question Does psychosocial peer support improve quality of life and clinical outcomes for people with alcohol-related liver disease (ARLD)? Background Alcohol is the commonest cause of liver disease in Europe. In England, it leads to over 27,000 hospital admissions and costs the NHS over £3.5 billion each year. Deaths directly attributable to alcohol have increased by 46% from 2019 to 2023. People with ARLD often have alcohol dependence and mental health needs such as anxiety and depression. However, healthcare services for alcohol addiction, mental health and liver disease are separately commissioned and challenging for patients to access due to their complex social situation, systemic barriers and stigma around mental health and alcohol. Peer support workers, with lived experience of the condition, have successfully improved engagement and management of people with complex long-term conditions such as hepatitis C. We do not know whether they could help people with ARLD seek healthcare and change their lifestyle. Aim We aim to refine and test the feasibility of delivering a model of peer support (CALM) provided for 6 months to reduce alcohol use and improve quality of life in people with ARLD who have not engaged with liver services. Objectives Work package (WP) 1: Refine CALM using co-production. WP2: Test the feasibility of delivering CALM in a randomised controlled trial (RCT). WP3: Conduct an embedded process evaluation to facilitate implementation, ensure intervention fidelity and refine theory of change. WP4: Test a cost-effectiveness framework of the CALM intervention to enable future full cost-effectiveness analysis and modelling of long-term health and cost impacts. Methods WP1. We will use an iterative series of 4 co-production workshops using nominal group technique with stakeholders and people with lived experience to refine the CALM intervention. WP2. We will conduct a two-centre feasibility RCT of CALM versus standard care in 50 people with ARLD to determine whether service users will participate in and be retained in the trial for 12 months. We will test the feasibility of collecting data on alcohol use, quality of life and engagement with health and care services, which will be outcomes in a future definitive trial. WP3. We will conduct interviews with peer support workers, participants, researchers and stakeholders (including commissioners). Information gathered will be used to identify methods to improve trial processes, to assess fidelity of the intervention, to refine the CALM model and to inform future implementation. WP4. With PPIE input, we will design a bespoke health and care service utilisation questionnaire to test the feasibility of collecting data for a future full health economic evaluation and long-term modelling study. Timelines for delivery Total duration: 30 months WP1: M1-9 WP2/3: M5-27 WP4: M7-30 Final report and dissemination M30 Anticipated impact and dissemination We will publish our findings in the medical literature and present them at clinical conferences. We will disseminate our findings to service users through our patient advisory group and our established network of patient support groups and the British Liver Trust. If proven feasible we will develop a funding proposal for a definitive clinical- and cost-effectiveness trial with embedded implementation strategy.