Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)?: protocol for a feasibility randomised controlled trial

Subhani, Mohsan; Jones, Katy A; Sprange, Kirsty; Rennick-Egglestone, Stefan; Knight, Holly; Morling, Joanne R; Enki, Doyo G; Wragg, Andrew; Ryder, Stephen D

Abstract

Introduction: Heavy drinkers in contact with alcohol services do not routinely have access to testing to establish the severity of potential liver disease. Transient elastography by FibroScan can provide this information. A recent systematic review suggested providing feedback to patients based on markers of liver injury can be an effective way to reduce harmful alcohol intake. This randomised control trial aims to establish the feasibility of conducting a larger national trial to test the effectiveness of FibroScan advice and alcohol recovery video stories in changing high-risk drinking behaviour in community alcohol services common to United Kingdom practice.

Methods and analysis: This feasibility trial consists of three work packages (WP). WP1: To draft a standardised script for FibroScan operators to deliver liver disease-specific advice to eligible participants having FibroScan. WP2: To create a video library of alcohol recovery video stories for use in the feasibility RCT (WP3). WP3: To test the feasibility of the trial design, including the FibroScan script and video stories developed in WP1 and WP2 in a one-to-one individual randomised trial in community alcohol services. Semi-structured interviews will be conducted at six months follow up for qualitative evaluation. Outcomes will be measures of the feasibility of conducting a larger RCT related to participant recruitment and follow-up, intervention delivery, including the use of the KLIFAD FibroScan scripts and videos, clinical outcomes and the acceptability and experience of the intervention and trial-related procedures. Data analysis will primarily be descriptive to address the feasibility aims of the trial. All proposed analyses will be documented in a Statistical Analysis Plan.

Ethics and dissemination: This trial received favourable ethical approval from the West of Scotland Research Ethics Service (WoSRES) on 20th January 2021, REC reference: 20/WS/0179. Results will be submitted for publication to a peer-reviewed journal.

Citation

Subhani, M., Jones, K. A., Sprange, K., Rennick-Egglestone, S., Knight, H., Morling, J. R., …Ryder, S. D. (2021). Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)?: protocol for a feasibility randomised controlled trial. BMJ Open, 11(11), Article e054954. https://doi.org/10.1136/bmjopen-2021-054954

• Journal Article Type: Article
• Acceptance Date: Oct 18, 2021
• Online Publication Date: Nov 3, 2021
• Publication Date: 2021-11
• Deposit Date: Nov 30, 2021
• Publicly Available Date: Dec 2, 2021
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 11
• Issue: 11
• Article Number: e054954
• DOI: https://doi.org/10.1136/bmjopen-2021-054954
• Keywords: Alcohol. FibroScan. Alcohol-related liver disease. Alcohol recovery stories
• Public URL: https://nottingham-repository.worktribe.com/output/6542949
• Publisher URL: https://bmjopen.bmj.com/content/11/11/e054954