LOCal Assessment and Triage Evaluation of Non-Alcoholic Fatty Liver Disease (LOCATE-NAFLD)
AUSHIDataset description
The data are the de-identified individual participant data. They include the participants'questionnaire data at baseline and 12 month follow-up; the data from the Fibroscan; the health data extracted from the participants notes.Identifiers
Source Study
Trial name (public)
LOCal Assessment and Triage Evaluation of Non-Alcoholic Fatty Liver Disease (LOCATE-NAFLD)Trial acronym
LOCATE-NAFLD
Trial ID
ACTRN12620000158965
Purpose
Diagnosis
Phase
Not Applicable
Funding
Government body,National Health and Medical Reserach Council
Scientific enquiries
Prof Adrian Barnett
Brief Summary
LOCATE-NAFLD is a randomised trial, comparing two alternative models of care for NAFLD (usual care versus LOCATE-NAFLD care). Participants randomised to the intervention will be screened in the community with a non-invasive device called a Fibroscan, a scan they may otherwise have waited months to receive. The scan results can then determine if their disease, with high risk patients sent to a specialist, and low-risk patients returned to the care of their GP, reducing unnecessary hospital appoin .... Read more
Key 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.
Key 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.
Can healthy volunteers participate?
No
Population
Sample Size 98
Min. age 18 Years
Max. age 75 Years
Sex Both males and females
Condition category Non-Alcoholic Fatty Liver Disease
Condition code Oral and Gastrointestinal , Public Health
Intervention
Intervention code Early detection / Screening
The starting point for patients is when they visit a GP. If the GP has sufficient concerns about the patient’s liver health, they will write a referral letter requesting a specialist hepatology clinic. The GP may also request blood tests, or have already performed those tests. Referral letters will be screened by a hepatologist at the Sunshine Coast and Princess Alexandra Hospitals to identify patients eligible for the study. The details of potential patients will be recorded for potential recru .... Read more
Comparison
Control group Active
For those participants randomised to usual care, their referral letters will be dealt with in the usual way, and the patients wait to see a hepatologist at a hospital outpatient clinic, which can have waiting lists of 3 months or longer.
Outcomes
Outcome: Time from baseline to diagnosis of high-risk NAFLD (significant fibrosis result - TE over 8.2 kPa). Fibrosis measurement is provided by the fibroscan results.Timepoint: On completion of scan
Outcome: Evaluate the cost-effectiveness of the new model of care. This will be measured using hospital data, participant Medicare/Pharmaceutical Benefits Scheme cost and healthcare usage data, and QALYs based on quality of life results from pre- and post- participant screening.Timepoint: Twelve months post baseline
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
All final non-identifiable data sets will be available once the main papers have been published. All collected data will be shared except MBS and PBS data.
When will data be available?
Ater publication of main papers (approx. June 2022). No end date.
Available to whom?
Available publicly
Available for what types of analyses?
Any purpose