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Trial registered on ANZCTR


Registration number
ACTRN12617001293358
Ethics application status
Approved
Date submitted
22/03/2017
Date registered
7/09/2017
Date last updated
17/07/2019
Date data sharing statement initially provided
17/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of a Chronic Disease Management Model in patients with decompensated liver disease: The Australian Liver Failure Trial (ALFIE)
Scientific title
Efficacy and cost effectiveness of a chronic disease management model in patients with decompensated cirrhosis.
Secondary ID [1] 291264 0
None
Universal Trial Number (UTN)
Trial acronym
ALFIE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Decompensated Liver Disease 302585 0
Liver Cirrhosis 302586 0
Condition category
Condition code
Oral and Gastrointestinal 302112 302112 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
The intervention will include multiple components. Coordinated care and management by a registered nurse with at least 2 years experience in hepatology will be provided to patients randomised to the intervention group. This will include a home visit (within one week of discharge from hospital) of varying duration (it is expected that the assessment will take around 1 hour), weekly telephone reviews for 3 months (from 5-30 minutes depending on the symptoms for review), reminders prior to appointments, planned admissions for paracentesis, and close biochemistry monitoring, protocol driven diuretic titration and extensive education, Content of the contact will include monitoring and management of signs and symptoms, medication review, education and self-management advice, care coordination and education and involvement of family. There will be enhanced communication with GPs post discharge and ensure that assessment by a hepatologist occurs within 1 month of discharge from hospital. After 3 months, contact will reduce depending on stability and symptoms. An individualised care plan will be developed signed off by the specialist and communicated to the GP. The intervention will continue until the study end which will be 24 months from the first patient randomised. As recruitment will stop 12 months from first randomisation, the maximum intervention is 24 months and the minimum is 12 months.
Intervention code [1] 297579 0
Treatment: Other
Comparator / control treatment
Patients in the control group will continue hospital and out of hospital management via usual care processes. They will have usual access to hepatologists and GPs. Usual care patients will have no contact with Chronic Liver Failure Nurses until a final end of study interview. Surveys will be mailed 3-monthly to the control group during the trial.
Control group
Active

Outcomes
Primary outcome [1] 301550 0
Emergency liver-related hospital admission rates - patient case notes and hospital databases will be searched to record emergency attendances and admissions and whether they were Liver-related and how many days were spent in ICCU.
Timepoint [1] 301550 0
Admissions will be collected at 12 months and at the end of the trial (24 months post trial commencement date/recruitment start).
Secondary outcome [1] 332999 0
Incremental cost effectiveness and quality of life assessed using the EuroQoL 5 Dimensions (EQ5D5L) questionnaire and the Chronic Liver Disease Questionnaire (CLDQ).
Timepoint [1] 332999 0
The surveys for QOL will be administered at baseline, 3 months, 6 months and then 6 monthly until end of trial (24 months post trial commencement date/recruitment start).
Secondary outcome [2] 333000 0
Disease severity
Timepoint [2] 333000 0
Disease severity will be assessed using the Child Pugh and MELD score at baseline, 3 months, 6 months then 6-monthly until end of study (24 months post trial commencement date/recruitment start).
Secondary outcome [3] 333001 0
Quality of Care - adherence to hepatology protocols will be assessed using locally developed data collection tools assessing specific protocol outcomes.
Timepoint [3] 333001 0
Adherence to protocols will be assessed at baseline for the intervention group and at study end (24 months post trial commencement date/recruitment start) for both groups. Assessment at baseline will determine for the intervention group what activities need to be conducted in order to meet protocols (ie have they had an ultrasound in the last 6 months) and assist with the development of the care plan.
Secondary outcome [4] 333002 0
Patient satisfaction will be determined with a short survey used previously in the pilot study. A sample of usual care and intervention patients will be asked to participate in a semi-structured telephone interview to assess their experience of care.
Timepoint [4] 333002 0
End of study (24 months post trial commencement date/recruitment start).
Secondary outcome [5] 337844 0
Patient knowledge using the Cirrhosis Knowledge Assessment Questionnaire (currently being validated)
Timepoint [5] 337844 0
Baseline, 3 months, 6 months, then 6-monthly until study end (24 months post trial commencement date/recruitment start).
Secondary outcome [6] 338515 0
Mortality
Timepoint [6] 338515 0
24 months after recruitment start.
Secondary outcome [7] 338516 0
Medication Adherence using the Ask-12 Medication Adherence Tool
Timepoint [7] 338516 0
Baseline and study end (24 months post trial commencement date/recruitment start).
Secondary outcome [8] 338517 0
Attendance (or non-attendance) at liver-related outpatient appointments (medical, allied health, radiology, endoscopy) will be collected by auditing patient case notes and electronic systems at the hospital to record appointments.
Timepoint [8] 338517 0
12 months after consent and at end of trial (24 months post start of trial/recruitment)
Secondary outcome [9] 338518 0
Self management ability using the Partners In Health Scale
Timepoint [9] 338518 0
Baseline, 3 months, 6 months then 6 monthly until study end (24 months post trial commencement date/recruitment start).

Eligibility
Key inclusion criteria
Cirrhosis of the liver
Current admission with an episode of decompensation including ascites, encephalopathy, variceal bleed, SBP, or HRS OR Admission within last 6 months with decompensation episode as above and is currently Childs Pugh score B or C.
Able to comprehend and sign an informed consent form (West Haven Criteria 0-1)
Age > 18
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active HCC
Involvement in a multidisciplinary heart failure program
Active management by Palliative care services or expected survival of <3 months
Currently on the liver transplant waiting list

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified by disease aetiology - Alcohol, Hepatitis C, Other.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Stratified by disease aetiology,
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be performed according to an intention-to-treat protocol. Differences between groups for hospitalization rates, quality indicators, satisfaction rates and self-management scores will be assessed using negative binomial regression, which is appropriate for count data with evidence of over-dispersion. All models will allow adjustment for baseline values and other co-variates. Suitable transformations will be applied in the case of non-normally distributed data.
For the economic analysis mean costs between the intervention and control groups will be compared and incremental cost effectiveness ratios presented with confidence intervals. Cost effectiveness acceptability curves for varying threshold values of cost effectiveness will also be presented. An assessment of the sensitivity of the results obtained to variation in measured resource use, effectiveness and/or unit costs will be undertaken using appropriate one-way and multi-way sensitivity analysis. Differences between groups in quality of life scores will be assessed using mixed effects regression to account for the repeated measures (every 3 months) and subsequent within-subject correlation. Survival analysis will be performed using Cox regression with results presented as Kaplan-Meir survival curves.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 8794 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 8795 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 8796 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 8797 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 16918 0
5000 - Adelaide
Recruitment postcode(s) [2] 16917 0
5011 - Woodville
Recruitment postcode(s) [3] 16919 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 16920 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 295719 0
Hospital
Name [1] 295719 0
Gastroenterology at Queen Elizabeth Hospital
Address [1] 295719 0
28 Woodville Rd,
Woodville South SA 5011
Country [1] 295719 0
Australia
Funding source category [2] 297280 0
Hospital
Name [2] 297280 0
The Royal Adelaide Hospital
Address [2] 297280 0
Port Road
Adelaide SA 5000
Country [2] 297280 0
Australia
Funding source category [3] 297281 0
Hospital
Name [3] 297281 0
Lyell McEwin Hospital
Address [3] 297281 0
Haydown Rd,
Elizabeth Vale SA 5112
Country [3] 297281 0
Australia
Funding source category [4] 297282 0
Hospital
Name [4] 297282 0
Sir Charles Gairdner Hospital
Address [4] 297282 0
G Block, Hospital Ave,
Nedlands WA 6009
Country [4] 297282 0
Australia
Funding source category [5] 297284 0
Hospital
Name [5] 297284 0
Flinders Medical Centre
Address [5] 297284 0
Flinders Drive
Bedford Park SA 5042
Country [5] 297284 0
Australia
Funding source category [6] 297285 0
University
Name [6] 297285 0
Flinders University of South Australia
Address [6] 297285 0
Sturt Rd,
Bedford Park SA 5042
Country [6] 297285 0
Australia
Funding source category [7] 303320 0
Government body
Name [7] 303320 0
NHMRC
Address [7] 303320 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [7] 303320 0
Australia
Primary sponsor type
Hospital
Name
Southern Adelaide Local Health Network
Address
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 294565 0
None
Name [1] 294565 0
Address [1] 294565 0
Country [1] 294565 0
Other collaborator category [1] 279670 0
Hospital
Name [1] 279670 0
The Queen Elizabeth Hospital
Address [1] 279670 0
28 Woodville Rd,
Woodville South SA 5011
Country [1] 279670 0
Australia
Other collaborator category [2] 279671 0
Hospital
Name [2] 279671 0
The Royal Adelaide Hospital
Address [2] 279671 0
Port Road
Adelaide SA 5000
Country [2] 279671 0
Australia
Other collaborator category [3] 279672 0
Hospital
Name [3] 279672 0
Lyell McEwin Hospital
Address [3] 279672 0
Haydown Rd,
Elizabeth Vale SA 5112
Country [3] 279672 0
Australia
Other collaborator category [4] 279673 0
Hospital
Name [4] 279673 0
Sir Charles Gairdner Hospital
Address [4] 279673 0
G Block, Hospital Ave,
Nedlands WA 6009
Country [4] 279673 0
Australia
Other collaborator category [5] 279674 0
University
Name [5] 279674 0
Flinders University of South Australia
Address [5] 279674 0
Sturt Rd,
Bedford Park SA 5042
Country [5] 279674 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297021 0
CALHN HREC
Ethics committee address [1] 297021 0
L3 Roma Mitchell House, North Terrace, Adelaide
Ethics committee country [1] 297021 0
Australia
Date submitted for ethics approval [1] 297021 0
20/09/2017
Approval date [1] 297021 0
31/10/2017
Ethics approval number [1] 297021 0

Summary
Brief summary
Randomised Controlled Multi Centre Trial to research the effectiveness of a chronic disease management model to care for patients with decompensated liver disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72742 0
A/Prof Alan Wigg
Address 72742 0
c/- Gastroenterology Level 3
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 72742 0
Australia
Phone 72742 0
+61 08 8204 5511
Fax 72742 0
+61 08 8204 3943
Email 72742 0
alan.wigg@sa.gov.au
Contact person for public queries
Name 72743 0
Mrs Rachel Wundke
Address 72743 0
c/- Gastroenterology Level 3
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 72743 0
Australia
Phone 72743 0
+61 08 8204 6989
Fax 72743 0
+61 08 8204 3943
Email 72743 0
rachel.wundke@sa.gov.au
Contact person for scientific queries
Name 72744 0
A/Prof Alan Wigg
Address 72744 0
c/- Gastroenterology Level 3
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 72744 0
Australia
Phone 72744 0
+61 08 8204 5511
Fax 72744 0
+61 08 8204 3943
Email 72744 0
alan.wigg@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
intention to treat statistical analyses only
What supporting documents are/will be available?
No other documents available
Summary results
No Results