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

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

doi:10.1136/bmjopen-2021-054954

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

BMJ Open. 2021 Nov 3;11(11):e054954. doi: 10.1136/bmjopen-2021-054954.

Authors

Mohsan Subhani^{1

2}, Katy A Jones³, Kirsty Sprange⁴, Stefan Rennick-Egglestone⁵, Holly Knight⁶, Joanne R Morling^{7

2

6}, Doyo G Enki⁸, Andrew Wragg², Stephen D Ryder^{7

2}

Affiliations

¹ Nottingham Digestive Diseases Biomedical Research Centre (NDDC), School of Medicine, University of Nottingham, Nottingham, UK mohsan.subhani@nottingham.ac.uk.
² NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.
³ Academic Unit of Mental Health and Clinical Neuroscience, School of Medicine, C24 Institute of Mental Health, University of Nottingham, Nottingham, UK.
⁴ Nottingham Clinical Trials Research Unit, University of Nottingham, Nottingham, UK.
⁵ School of Health Sciences,Institute of Mental Health, University of Nottingham, Nottingham, UK.
⁶ Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK.
⁷ Nottingham Digestive Diseases Biomedical Research Centre (NDDC), School of Medicine, University of Nottingham, Nottingham, UK.
⁸ School of Medicine, University of Nottingham, Nottingham, UK.

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 (RCT) aims to establish the feasibility of conducting a larger national trial to test the effectiveness of FibroScan advice and Alcohol Recovery Video Stories (ARVS) in changing high-risk drinking behaviour in community alcohol services common to UK 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 ARVS 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 6 months follow-up for qualitative evaluation. Outcomes will be measures of the feasibility of conducting a larger RCT. These outcomes will relate to: participant recruitment and follow-up, intervention delivery, including the use of the Knowledge of LIver Fibrosis Affects Drinking trial 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 20 January 2021, REC reference: 20/WS/0179. Results will be submitted for publication to a peer-reviewed journal.

Trial registration number: ISRCTN16922410.

Keywords: gastroenterology; hepatology; public health.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Drinking Behavior
Feasibility Studies
Humans
Knowledge*
Liver Cirrhosis* / diagnostic imaging
Randomized Controlled Trials as Topic
Scotland

Grants and funding

MR/P008348/1/MRC_/Medical Research Council/United Kingdom