Protocol for a randomised trial testing a community fibrosis assessment service for patients with suspected non-alcoholic fatty liver disease: LOCal assessment and triage evaluation of non-alcoholic fatty liver disease (LOCATE-NAFLD)

David Brain; James O'Beirne; Ingrid J Hickman; Elizabeth E Powell; Patricia C Valery; Sanjeewa Kularatna; Ruth Tulleners; Alison Farrington; Leigh Horsfall; Adrian Barnett

doi:10.1186/s12913-020-05233-2

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Protocol for a randomised trial testing a community fibrosis assessment service for patients with suspected non-alcoholic fatty liver disease: LOCal assessment and triage evaluation of non-alcoholic fatty liver disease (LOCATE-NAFLD)

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Protocol for a randomised trial testing a community fibrosis assessment service for patients with suspected non-alcoholic fatty liver disease: LOCal assessment and triage evaluation of non-alcoholic fatty liver disease (LOCATE-NAFLD)

David Brain, James O'Beirne, Ingrid J Hickman, Elizabeth E Powell, Patricia C Valery, Sanjeewa Kularatna, Ruth Tulleners, Alison Farrington, Leigh Horsfall and Adrian Barnett

BMC Health Services Research, Vol.20, 335

2020

DOI: https://doi.org/10.1186/s12913-020-05233-2

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Abstract

Background: Non-alcoholic fatty liver disease (NAFLD) is the most common type of chronic liver disease in Australia and its recent increase mirrors the obesity and type 2 diabetes epidemics. Currently, many patients who present to primary care with abnormal liver function tests or steatosis on liver ultrasound are referred for assessment in secondary care. Due to the large number of patients with NAFLD, this results in long waits for clinical and fibrosis assessment, placing unnecessary burden on the public hospital system. Methods: We will conduct a 1:1 parallel randomised trial to compare two alternative models of care for NAFLD. Participants will be randomised to usual care or the LOCal Assessment and Triage Evaluation (LOCATE) model of care and followed for 1 year. We will recruit patients from the non-neighbouring Sunshine Coast and Metro South Hospital and Health Services (HHSs) in Queensland, Australia. Our primary outcome of interest is time to diagnosis of high-risk NAFLD, based on the number of participants in each arm of the study who receive a diagnosis of clinically significant fibrosis. Two hundred and 34 participants will give us a 95% power to detect a 50% reduction in the primary outcome of time to diagnosis of high-risk disease. We will also conduct an economic evaluation, evaluating the cost-effectiveness of the new model of care. We will also evaluate the implementation of the new model of care. Discussion: It is anticipated that the results of this study will provide valuable new information regarding the management of NAFLD in the Australian setting. A relatively simple change to care could result in earlier identification of patients with significant liver disease and lower overall costs for the health system. Results will be directly disseminated to key staff for further distribution to consumers, policy- and decision-makers in the form of evidence briefs, plain language summaries and policy recommendations.

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Title: Protocol for a randomised trial testing a community fibrosis assessment service for patients with suspected non-alcoholic fatty liver disease: LOCal assessment and triage evaluation of non-alcoholic fatty liver disease (LOCATE-NAFLD)
Authors: David Brain (Author) - Queensland University of Technology
James O'Beirne (Author) - University of the Sunshine Coast
Ingrid J Hickman (Author) - University of Queensland
Elizabeth E Powell (Author) - University of Queensland
Patricia C Valery (Author) - QIMR Berghofer Medical Research Institute
Sanjeewa Kularatna (Author) - Queensland University of Technology
Ruth Tulleners (Author) - Queensland University of Technology
Alison Farrington (Author) - Queensland University of Technology
Leigh Horsfall (Author) - University of Queensland
Adrian Barnett (Author) - Queensland University of Technology
Publication details: BMC Health Services Research, Vol.20, 335; 10
Publisher: BioMed Central Ltd.
Date published: 2020
DOI: 10.1186/s12913-020-05233-2
ISSN: 1472-6963
Copyright note: Copyright © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Organisation Unit: University of the Sunshine Coast, Queensland; School of Health and Behavioural Sciences - Legacy
Language: English
Record Identifier: 99450974702621
Output Type: Journal article

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