Title: Does knowledge of liver fibrosis affect high risk drinking behaviour (KLIFAD)? A feasibility randomised controlled trial.
Funder: Department of Health and Social Care

Abstract: Research question Does knowledge of liver fibrosis as detected by fibroscan impact on drinking behaviour in people attending alcohol services? We propose a feasibility randomised controlled trial in three different alcohol treatment settings to establish the required information to undertake a future national trial. Background Alcohol related liver disease now represents the second commonest cause of working life years lost in men and the fifth in women. Deaths from cirrhosis have risen 5 fold over the last few decades and currently at least 45% of all cirrhosis diagnoses are made at the time of an acute hospital presentation with decompensation when the outlook and potential for treatment is poor. Earlier diagnosis of alcohol related liver disease gives the opportunity for NICE approved interventions for both alcohol (brief advice and alcohol treatment programmes) and liver disease (variceal screening, liver cancer screening) which are proven to improve outcomes. Up until recently we did not have a reliable test for liver fibrosis and liver enzymes are a very unreliable means of detecting and staging liver disease. Fibroscan is a technology which can detect and quantify liver fibrosis reliably. It is a technique which is easy to learn and reproducible and can potentially be introduced into alcohol treatment programmes. It is not known currently if an individuals knowledge of liver fibrosis stage impacts on reducing drinking, the key determinate of later outcome. Aims and Objectives We aim to prove the feasibility of fibroscan in 3 different alcohol treatment setting, community clinics, a central hub and an alcohol detoxification facility as representative of the types of alcohol treatment undertaken nationally in order to develop a future national study to prove effectiveness. Methods We will develop a standardised framework for direct feedback of fibroscan results to patients to ensure a consistent message and reduce the risk of a normal scan producing inappropriate reassurance. We will then develop a series of patient video recovery stories using the methodology already employed in the NEON study. This will provide a series of stories which will reflect different patients and different liver disease stages. When these are available we will undertake a randomised controlled trail of fibroscan delivered by alcohol workers and video feedback against standard NHS care for people attending three different alcohol treatment services. This will identify barriers to and effective ways of delivery. A strong PPI group is established to provide key inputs in these studies. Qualitative analysis by focus groups and individual interviewing will establish thematic barriers and enablers which arose during the study to inform the larger future trial design. Timelines for delivery This study will be delivered in 24 months. Anticipated Impact and Dissemination Reducing alcohol intake in those at risk of ARLD is a major health challenge. This study will provide key information of barriers to implementation and potential effect to enable a major national study. Such a study would change clinical practice. Dissemination of results would be by peer reviewed publication and presentation at meetings both for liver and the addiction community.

Lay abstract: Background to Liver disease and current diagnosis Alcohol-related liver disease is a major cause of early death. People develop liver failure because of a build-up of scar tissue in the liver (damage to it). When this goes on for too long it leads to the liver becoming hardened by scar (cirrhosis) and if further damage is done then the liver can fail. The problem is that often symptoms become obvious only too late in the disease for medical help. Fibroscan is a simple kind of ultrasound which can diagnose the early stages of liver scarring (damage) before symptoms develop. The patient is present for the test which means they can be told how much liver scarring they have straight away. Interventions to motivate reduction in drinking levels &reduce the risk of liver disease Fibroscan is not part of routine health care for people seeking help for alcohol problems. We don t know whether being told that you have liver scarring from your fibroscan result reduces alcohol consumption if you are a heavy drinker. At the moment, if you are alcohol dependent you are treated by a personalised programme which aims to help address the reasons you currently drink. We plan to see if it possible to add Fibroscan results to current treatment and if that helps to motivate people to reduce their drinking and reduce their risk of cirrhosis. There will be three types of results given after a Fibroscan: normal liver scarred liver but not yet as bad as cirrhosis cirrhosis These categories risk giving false reassurance to people who at the moment have no obvious liver scarring (normal liver). To reduce this risk we plan to develop, with patient groups, information offered with these fibroscan test results. Patient & Public Involvement Patients felt strongly the face to face result given after fibroscan should be added to by patient experiences in the form of video. This would help people understand the meaning of the result to them and reinforce the message of the results they ve been given. We plan to interview and record three patient stories, one from each of the above categories of the fibroscan results, describing their recovery from alcohol dependence that followed Interventions We will test if it is possible to do fibroscans by a research trial in three alcohol treatment centres. We will assign half of the patients to having a fibroscan with feedback of the results and to watch the video stories; the other half will having normal care. We will look at how helpful fibroscan results are compared to normal alcohol treatment three months after the fibroscan. Our findings from this research trial will be collected and enable us to answer our key questions.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: ORAL AND GASTROINTESTINAL