AlcoChange: a smartphone app and breathalyser device to reduce alcohol-related harm

INTERVENTION: This is a 'cluster stepped wedge' trial. Each of the 6 'clusters' will include 3 hospitals to give a total of 18 sites. All clusters will start in the 'control' condition ‐ not using AlcoChange. At evenly distributed points in the recruitment period, one cluster selected at random, will switch to the 'intervention' condition and start using AlcoChange. At the end of the trial all clusters will have experience of AlcoChange. The researchers will design condition‐specific patient information packs. In the control condition, they will ask patients to consent to provide their data. In the intervention condition, they will ask patients to consent to providing their data and to using AlcoChange. Ward staff will identify patients and refer them to alcohol specialist nurses. The nurses will discuss the study as it is currently presented at the recruiting site, and ask eligible patients to take part. While the site is in the control condition, the message from the nursing staff will be along the lines of “we are currently taking part in a research study in this hospital to explore ways of helping excessive drinkers cut down. Would you like to take part in the study? We would ask you to fill in several questionnaires over the next 6 months. The study will not interfere with your treatment in any way ‐ that would be agreed between you and your doctor.” In the intervention condition the message from the nursing staff will be along the lines of “we are currently taking part in a research study in this hospital to explore ways of helping excessive drinkers cut down. Would you like to take part in the study? If so, we will provide you with an app and some equipment to plug int CONDITION: Alcohol‐related liver disease ; Digestive System ; Alcoholic liver disease PRIMARY OUTCOME: Proportion of patients who are abstinent or reduced drinking to low‐risk levels (<14 units/week), measured using the Timeline Follow Back method (TLFB) (data collected for the previous 28 days) at 180 days INCLUSION CRITERIA: 1. Adults aged 18 years or older 2. Admission with ARLD (alcoholic hepatitis or cirrhosis – diagnosed clinically or by imaging/biopsy), alcohol use within 1 month of admission, referred to alcohol care team 3. Access to appropriate smartphone 4. Willing and able to give written informed consent 5. Sufficient English to understand the instructions for using the AlcoChange device SECONDARY OUTCOME: ; 1. Self‐reported alcohol use over the previous 28 days measured using TLFB at 90 and 180 days; 2. Self‐reported drink‐free days over the previous 90 days measured using patient questionnaire at 90 and 180 days; 3. Heavy drinking days over the previous 28 days, calculated from the TLFB and defined as =60 g alcohol/day for males and =40 g/day for females; at 90 and 180 days; 4. App usage data (for participants recruited under the intervention condition) at 90 and 180 days; 5. Liver function measured using Model For End‐Stage Liver Disease (MELD) score, United Kingdom Model for End‐Stage Liver Disease (UKELD) score, and Child‐Pugh score at 180 days; 6. Health‐related quality of life (HRQoL) measured using EuroQoL (EQ‐5D 5L) questionnaire at 90 and 180 days; 7. Quality‐adjusted life years (QALYs) measured using HRQoL data from the EQ‐5D‐5L questionnaire combined with survival data at 180 days; 8. Health care resource use and costs measured using questionnaire at 90 and 180 days; 9. Hospital admissions measured using medical notes check at 90 and 180 days; 10. Loss of capacity measured by clinician assessment at 90 and 180 days; 11. Alcohol use measured using biomarker analysis (urine ethylglucoronide measurement) at 180 days; ; Exploratory outcomes:; 1. Severity of ArLD measured using saliva sample for microbiome analysis at baseline and 180 days;