Reducing alcohol use in patients with alcohol-related liver disease Digestive System
Conditions
Interventions
When the potential participant’s medical condition has been stabilised (for example, after they have been treated for alcohol withdrawal), they will be referred to the Hospital Alcohol Team and assess
Sponsors
University Hospitals Plymouth NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients >=18 years 2. Able and willing to provide informed consent 3. Clinical diagnosis of ArLD by at least one of the following methods 3.1. Radiological appearance of fatty infiltration of the liver or cirrhosis 3.2. Histological findings of cirrhosis or alcoholic steatohepatitis 3.3. Signs consistent with chronic liver disease on physical examination 4. High risk alcohol consumption (>50 units/week for males and >35 units/week for females) within 4 weeks prior to hospital admission 5. AUDIT score >15 during current hospital admission 6. Diagnosis of alcohol dependence as defined in ICD-10 meeting at least three of the following conditions: 6.1. Strong desire or sense of compulsion to take alcohol 6.2. Difficulties in controlling alcohol-consuming behaviour in terms of its onset, termination, or levels of use 6.3. A physiological withdrawal state when alcohol use has ceased or been reduced, as evidenced by: the characteristic withdrawal syndrome; or use of alcohol with the intention of relieving or avoiding withdrawal symptoms 6.4. Evidence of tolerance, such that increased doses of alcohol are required in order to achieve effects originally produced by lower doses 6.5. Progressive neglect of alternative pleasures or interests because of alcohol use, increased amount of time necessary to obtain or consume alcohol or to recover from its effects 6.6. Persisting with alcohol use despite clear evidence of overtly harmful consequences
Exclusion criteria
Exclusion criteria: 1. Any condition with an estimated life expectancy of less than 6 months 2. Patients participating in concurrent interventional research 3. Participants who have significant difficulties in adequate understanding of English such that they are unable to benefit from the trial intervention or sufficiently understand the trial documentation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Number of patients screened and recruited 2. Retention rate at 90 and 180 days measured by number of recruited patients attending follow-up visits 3. Fidelity of delivery of FIT and TAU (trained FIT practitioner will check each ALN’s fidelity early in the trial using dedicated fidelity assessment tools). Feedback and supervision throughout the trial 4. Intervention engagement – number of successful FIT phone calls and visits by 180 days 5. Completeness of data collection by 180 days (to include number of completed questionnaires, number of missing items within a questionnaire by time point) | — |
Secondary
| Measure | Time frame |
|---|---|
| Participant reported and other clinical outcomes: Primary outcome measure: Alcohol use (grams of pure alcohol/week) at baseline and 180 days post-baseline. Alcohol use will be assessed using the Timeline Follow-Back technique which is used to determine a patient’s alcohol use over the 7 days preceding days. Completed at 28, 90 and 180 days post baseline Secondary outcome measures: 1. Severity of Alcohol Dependence Questionnaire (SADQ) baseline, 28, 90 and 180 days 2. EQ-5D-5L questionnaire to measure health-related Quality of life at baseline, 28, 90 and 180 days 3. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) to measure mental wellbeing (including short form version (SWEMWBS)) at baseline, 28, 90 and 180 days 4. Health, social care and wider care services utilisation will be determined using a resource use questionnaire completed at baseline, day 90 and day 180 5. Self-reported re-hospitalisation within 180 days post-baseline or, if unobtainable, determined using hospital records at 180 days 6. Self-reported time to relapse to regular alcohol use at 28, 90 and 180 days Exploratory biochemistry outcomes: 7. Urinary biomarkers (ethyl glucuronide/sulphate) at 180 days | — |
Countries
England, United Kingdom
Outcome results
None listed