OCal Assessment and Triage Evaluation of Non-Alcoholic Fatty Liver Disease (LOCATE-NAFLD)

Not Applicable

Completed

• Conditions: on-Alcoholic Fatty Liver Disease; Non-Alcoholic Fatty Liver Disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Public Health - Health service research

• Registration Number: ACTRN12620000158965
• Lead Sponsor: Queensland University of Technology

Brief Summary

The LOCATE-NAFLD trial tested whether putting a Fibroscan service in a community setting could reduce how long it took to diagnose high-risk non-alcoholic fatty liver disease. We recruited patients after they’d been referred to one of three specialist liver clinics in Queensland public hospitals, and randomised half of them to receive a Fibroscan outside of the specialist service. Once they had their scan, the information was given to their GP and the specialist. If it turned out they were low-risk, they could be managed by their GP. If their scan showed they had signs of more serious liver disease, the specialist reassessed their risk level and they could often be seen in clinic sooner. We found that participants who had the earlier scan got diagnosed up to a year earlier. This is important, as if this scan could be done around the same time the GP is making the referral, patients may not need to go and see a specialist at all. This means there would be fewer people on the wait list to see specialists who don’t need to be there, and patients who need specialist assessment urgently won’t need to wait as long. Our research also found that patients and healthcare users are comfortable having this scan done by a nurse outside of the hospital, meaning that if the model was implemented in the ‘real world’, there would be good uptake from healthcare users.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-13
• Study Completion: 2022-04-29
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Patients will be included if they:
• Have had NAFLD diagnosed or suspected by their GP (from a GP referral letter).
• Are aged between 18 and 75 years old.
• Understand the consent procedures and give their full consent (See Section 13.1.2).
• Consent to access of their data from Queensland Health and MBS and PBS.

Exclusion Criteria

Patients will be excluded if they:
• Are pregnant.
• Have advanced cardiac disease or another terminal illness.
• Have high current alcohol consumption, defined as two or more standard drinks per day.
• Have Hepatitis B or C (extracted from the GP referral letter).
• Require priority review at the Hepatology Clinic
• Have been evaluated in a specialist hepatology clinic in the previous 12 months.
• Have plans to leave the area within the next 12 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified