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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
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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.
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Secondary ID [1]
297884
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Nil KNown
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Universal Trial Number (UTN)
U1111-1231-1061
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Trial acronym
TCM-NAFLD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic fatty liver disease
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Condition category
Condition code
Public Health
310803
310803
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0
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Health service research
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Oral and Gastrointestinal
310835
310835
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
314113
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Early detection / Screening
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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.
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Control group
Historical
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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3 years post pathway implementation
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Primary outcome [2]
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proportion of referred patients diagnosed with advanced fibrosis after secondary care review will be recorded via medical records review
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Assessment method [2]
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Timepoint [2]
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3 years post pathway implementation
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Primary outcome [3]
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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.
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Assessment method [3]
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Timepoint [3]
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3 years post pathway implementation
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Secondary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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3 years post pathway implementation
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Secondary outcome [2]
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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.
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Assessment method [2]
369160
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Timepoint [2]
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3 years post pathway implementation
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Secondary outcome [3]
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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).
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Assessment method [3]
369163
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Timepoint [3]
369163
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post pathway implementation
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
The only exclusions will be patients who are unable to provide informed consent for themselves,
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
The pathway followed by participants will depend on their initial risk stratification, as described in the Intervention
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/04/2019
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Actual
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Date of last participant enrolment
Anticipated
30/04/2021
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Actual
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Date of last data collection
Anticipated
30/04/2024
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
13548
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [2]
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Logan Hospital - Meadowbrook
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Recruitment postcode(s) [1]
26171
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
26172
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4131 - Meadowbrook
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Metro South Health
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Address [1]
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The Centres for Health Research, Metro South Hospital and Health Service
Level 7, Translational Research Institute
37 Kent St, Woolloongabba,
Brisbane, QLD 4102
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Country [1]
302407
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Australia
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Primary sponsor type
Individual
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Name
Prof. Elizabeth Powell
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Address
Dept. Gastroenterology and Hepatology
Princess Alexandra Hospital
Metro South Hospital and Health Service
199 Ipswich Rd, Woolloongabba,
Brisbane, QLD 4102
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
302301
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Country [1]
302301
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Metro South Health Human Research Ethics Committee
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Ethics committee address [1]
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Level 7, Translational Research Institute 37 Kent St, Woolloongabba Brisbane, QLD 4102
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Ethics committee country [1]
303076
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Australia
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Date submitted for ethics approval [1]
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06/02/2019
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Approval date [1]
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21/03/2019
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Ethics approval number [1]
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HREC/2019/QMS/49780
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Summary
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.
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Trial website
nil
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Trial related presentations / publications
nil yet
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Public notes
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Contacts
Principal investigator
Name
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Prof Elizabeth Powell
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Address
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Dept. Gastroenterology and Hepatology, Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
Brisbane QLD 4102
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Country
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Australia
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Phone
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+61 7 3443 8015
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Fax
92382
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Email
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[email protected]
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Contact person for public queries
Name
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Leigh Horsfall
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Address
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Dept. Gastroenterology and Hepatology, Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
Brisbane QLD 4102
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Country
92383
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Australia
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Phone
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+61 7 3176 1055
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Fax
92383
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Email
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[email protected]
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Contact person for scientific queries
Name
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Elizabeth Powell
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Address
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Dept. Gastroenterology and Hepatology, Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
Brisbane QLD 4102
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Country
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Australia
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Phone
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+61 7 3443 8015
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Fax
92384
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Email
92384
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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