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Assessment and management of people with non-alcoholic fatty liver disease in primary care

Towards collaborative management of people with non-alcoholic fatty liver disease (NAFLD): exploring a pragmatic approach to risk stratification pathways for NAFLD across the care continuum.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000563167
Acronym
TCM-NAFLD
Enrollment
1000
Registered
2019-04-10
Start date
2019-04-30
Completion date
2021-04-30
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The overall goal of this project is to increase the detection and referral of NAFLD patients with advanced hepatic fibrosis and cirrhosis to the Gastroenterology Departments at the Princess Alexandra and Logan Hospitals and to reduce the number of unnecessary referrals to these specialist outpatient clinics. Referrals to secondary care and evaluation of the outcomes of referrals after introduction of the integrated NAFLD pathway will be performed. Calculation of the costs and potential healthcare savings of the NAFLD pathway in comparison with standard care will be undertaken.

Interventions

This study will use an interrupted time-series design (before and after new pathway implementation). Practical NAFLD Pathway: Patients 18 years or older attending collaborating Metro South primary care practices with a diagnosis of NAFLD will be eligible for inclusion. Initial risk stratification will be performed using NAFLD Fibrosis Score (NFS) and Fibrosis-4 (Fib-4) tests. Both the Fib-4 and NFS provide cut off scores for low, indeterminate and high risk of advanced fibrosis. Patients with l

This study will use an interrupted time-series design (before and after new pathway implementation). Practical NAFLD Pathway: Patients 18 years or older attending collaborating Metro South primary care practices with a diagnosis of NAFLD will be eligible for inclusion. Initial risk stratification will be performed using NAFLD Fibrosis Score (NFS) and Fibrosis-4 (Fib-4) tests. Both the Fib-4 and NFS provide cut off scores for low, indeterminate and high risk of advanced fibrosis. Patients with low FiB-4 (<1.3) and low NFS (<-1.455) are considered to have a low risk of advanced fibrosis and will remain in primary care, with ongoing assessment and management of metabolic cormorbidites (obesity, type 2 diabetes, hypertension, dyslipidemia) and reappraisal of fibrosis risk after 3 years. Patients with Fib-4>3.25 or NFS>0.675 are at high risk of advanced fibrosis and will be referred to secondary care for hepatology assessment. Patients with indeterminate FIB-4 or NFS scores will have second-line assessment with FibroScan and/or an ELF test in Primary Care, and will be referred to secondary care for further assessment if LSM>8.2 or ELF test>9.8. As many patients as possible in the indeterminate group will have both a Fibroscan and an ELF test. However some patients may not be suitable for Fibroscan due to body habitus/ rib spacing; other patients may be unable to provide a blood sample for the ELF test. Patients referred for secondary care will be reviewed by a Hepatologist as per standard of care and may have further investigations as deemed necessary to determine their level of fibrosis.

Sponsors

Prof. Elizabeth Powell
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

>18yrs of age GP - Diagnosed or suspected NAFLD No other liver diseases Alcohol consumption no greater than 2 standard drinks per day People whose primary language is other than English may be included as long as there is an interpreter to read the Patient Information and Consent Form and ask questions if necessary from the person seeking consent.

Exclusion criteria

The only exclusions will be patients who are unable to provide informed consent for themselves,

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026