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Trial registered on ANZCTR


Registration number
ACTRN12619000563167
Ethics application status
Approved
Date submitted
3/04/2019
Date registered
10/04/2019
Date last updated
10/04/2019
Date data sharing statement initially provided
10/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment and management of people with non-alcoholic fatty liver disease in primary care
Scientific title
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.
Secondary ID [1] 297884 0
Nil KNown
Universal Trial Number (UTN)
U1111-1231-1061
Trial acronym
TCM-NAFLD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic fatty liver disease 312257 0
Condition category
Condition code
Public Health 310803 310803 0 0
Health service research
Oral and Gastrointestinal 310835 310835 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314113 0
Early detection / Screening
Comparator / control treatment
The control treatment refers to "standard care" provided by the patient's General Practitioner over the 12 month period prior to commencement of the intervention.
Control group
Historical

Outcomes
Primary outcome [1] 319649 0
The number of NAFLD patients with possible advanced fibrosis referred to secondary care
will be compared pre and post pathway intervention via an audit of referrals.
Timepoint [1] 319649 0
3 years post pathway implementation
Primary outcome [2] 319674 0
proportion of referred patients diagnosed with advanced fibrosis after secondary care review will be recorded via medical records review
Timepoint [2] 319674 0
3 years post pathway implementation
Primary outcome [3] 319675 0
proportion of NAFLD patients avoiding referral after risk stratification in primary care. Data will be reported by collaborating Primary Care Physicians via an internal audit.
Timepoint [3] 319675 0
3 years post pathway implementation
Secondary outcome [1] 369015 0
the number of patients diagnosed with NAFLD in the primary care practices before and after initiation of the pathway will be determined by pre and post pathway implementation audits of medical records including referrals
Timepoint [1] 369015 0
3 years post pathway implementation
Secondary outcome [2] 369160 0
Assessment of the Integrated NAFLD Pathway: The electronic patient record system of collaborating Metro South primary care practices will be interrogated to obtain data on pathway use. Secondary care electronic medical records of referred patients will be interrogated to obtain patient demographic and clinical information, and presence or absence of advanced fibrosis. The diagnostic performance of the pathway in identifying cases of advanced fibrosis will be compared with the standard care.
Timepoint [2] 369160 0
3 years post pathway implementation
Secondary outcome [3] 369163 0
Calculation of healthcare resource use and costs for each pathway: All NAFLD related healthcare resource use (including lab tests and investigations) will be collected and recorded using information from the medical records of collaborating general practices, as well as hospital based digital records for emergency department presentations, outpatient activity and inpatient activity. Healthcare resource use will be costed at market rates (healthcare perspective) using published values and unit costs from the collaborating facilities. This information will be used in cost-consequences (stochastic) modelling to describe the potential impact on patients, community healthcare providers and hospitals of implementing the Integrated NAFLD pathway versus Standard Care over a 5 year (primary) time horizon and patient lifetime models. This modelling will include estimates of appropriate and inappropriate referrals generated, as well as rates of complications and mortality based on a structured literature review of NAFLD health state transitions and outcomes. This modelling will also permit the estimation of an incremental cost per appropriate referral generated of the new versus current pathway that can be considered in light of a full array of consequences (including undesirable consequences associated with delayed detection and referrals). An assessment of the sensitivity of results to potential uncertainty in measured resource use, effectiveness, time-horizon, discounting, and unit costs will be undertaken (probabilistic sensitivity analyses).
Timepoint [3] 369163 0
post pathway implementation

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The only exclusions will be patients who are unable to provide informed consent for themselves,

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The pathway followed by participants will depend on their initial risk stratification, as described in the Intervention
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2019
Actual
Date of last participant enrolment
Anticipated
30/04/2021
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13548 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 13549 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 26171 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 26172 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 302407 0
Government body
Name [1] 302407 0
Metro South Health
Country [1] 302407 0
Australia
Primary sponsor type
Individual
Name
Prof. Elizabeth Powell
Address
Dept. Gastroenterology and Hepatology
Princess Alexandra Hospital
Metro South Hospital and Health Service
199 Ipswich Rd, Woolloongabba,
Brisbane, QLD 4102
Country
Australia
Secondary sponsor category [1] 302301 0
None
Name [1] 302301 0
Address [1] 302301 0
Country [1] 302301 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303076 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 303076 0
Ethics committee country [1] 303076 0
Australia
Date submitted for ethics approval [1] 303076 0
06/02/2019
Approval date [1] 303076 0
21/03/2019
Ethics approval number [1] 303076 0
HREC/2019/QMS/49780

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92382 0
Prof Elizabeth Powell
Address 92382 0
Dept. Gastroenterology and Hepatology, Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
Brisbane QLD 4102
Country 92382 0
Australia
Phone 92382 0
+61 7 3443 8015
Fax 92382 0
Email 92382 0
[email protected]
Contact person for public queries
Name 92383 0
Leigh Horsfall
Address 92383 0
Dept. Gastroenterology and Hepatology, Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
Brisbane QLD 4102
Country 92383 0
Australia
Phone 92383 0
+61 7 3176 1055
Fax 92383 0
Email 92383 0
[email protected]
Contact person for scientific queries
Name 92384 0
Elizabeth Powell
Address 92384 0
Dept. Gastroenterology and Hepatology, Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
Brisbane QLD 4102
Country 92384 0
Australia
Phone 92384 0
+61 7 3443 8015
Fax 92384 0
Email 92384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.