Title: Real World Implementation of AlcoChange: A Smartphone Digital Therapeutic to Improve Outcomes from Alcohol-Related Liver Disease
Funder: Department of Health and Social Care

Abstract: Research question: What is the efficacy of AlcoChange, in addition to usual care for reducing alcohol use in patients with alcohol-related liver disease (ARLD), compared with usual care alone? Background: Liver disease is now the second most common cause of preventable death in the UK. This is primarily (80%) due to excess alcohol use. Ongoing alcohol use is a key predictor of morbidity and mortality in ARLD. However, widespread failings in the management of ARLD in the acute setting have been documented. AlcoChange is a digital therapeutic (DTx), which has demonstrated reductions in alcohol use amongst hospitalised ARLD patients in a pilot study. Aims and Objectives: Primary Objective: Evaluate the efficacy of AlcoChange to reduce alcohol use in ARLD patients. Secondary Objectives: Define the cost-effectiveness of secondary care implementation of AlcoChange. Understand barriers to implementation of AlcoChange into clinical practice. Measure the effects of AlcoChange on health-related quality of life. ? Prepare the business development strategy, if the primary endpoint is met, for AlcoChange to be commercialised and implemented. Methods: A stepped-wedge randomised controlled trial (RCT) will be conducted in 6 clusters (18 centres). Patients with ARLD and ongoing alcohol use (n=324) will be recruited over 18 months. The primary endpoint will be self-reported alcohol use at 180 days. Timelines: Set up of the data platform, the RCT, and qualitative work to inform the toolkit for delivery of the intervention, will take place from month 0-6. The RCT will start recruiting in month 7. Recruitment will continue for 18 months, with final patient data being delivered in month 31. Data cleaning, analysis, interpretation, dissemination and commercialisation plan will take place in month 31-36. Impact and Dissemination: The work will be disseminated through academic journals, and targeted discussion with patients, clinicians, commissioners, and guidance producers such as NICE.

Lay abstract: Deaths from liver disease in the UK are rising at an alarming rate, with an increase of 400% since 1970. In the same period, death rates from other major killer diseases, such as heart disease and cancer, have either remained stable or decreased. This is primarily due to increasing alcohol consumption within the population. In fact, alcohol-related harm costs the NHS more than &pound;3.5 billion each year. Urgent action is now required to deal with liver-related deaths, which can be prevented by reducing alcohol consumption in high-risk patients with liver disease. Currently, in hospitals, this is dealt with through Alcohol Care Teams reviewing patients admitted with alcohol-related liver disease. However, this level of intervention may not be enough to benefit these high-risk patients, and there are also increasing numbers of patients year-on-year so there is not enough capacity to review each patient. We have developed AlcoChange, a smartphone app with an optional breathalyser (breath alcohol meter) that allows self-monitoring of alcohol use, and the app provides motivational messages to encourage people to stay sober. AlcoChange has already been shown to have positive benefits in an initial study carried out at the Royal Free Hospital in London, but still needs to be tested in a much larger trial with a greater number of hospitals and patients. The aim of our proposed project is to carry out a clinical trial to assess if AlcoChange can help to reduce alcohol consumption in patients with liver disease. This could help us reduce the number of hospital admissions and deaths associated with alcohol-related liver disease. We will also speak to patients and care-providers to examine the actual experiences with AlcoChange &ndash; we will use this information to guide how we use AlcoChange within the NHS. The results of our clinical trial will be published, and together with a cost analysis, will support the continued business development of the AlcoChange product. At every stage, we will involve patients and the public to ensure our research is relevant, clear, acceptable and useful. One patient with a history of alcohol-related liver disease is a collaborator on this grant. If successful, we will enlist a second to join our team. Both representatives will help with the study design, developing study information, interpreting findings and drafting publications, including lay summaries. Based on the findings from our previous work, we estimate that the AlcoChange product could result in savings of &pound;100-&pound;200 million per year for the NHS and significantly reduce hospital admissions. As a result, the product would provide an alternative, and much needed, strategy to support patients with liver disease where reducing alcohol consumption is essential for increasing survival rates.

Research activity codes: 6.3 MEDICAL DEVICES;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: ORAL AND GASTROINTESTINAL