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Trial registered on ANZCTR


Registration number
ACTRN12609000403235
Ethics application status
Approved
Date submitted
31/03/2009
Date registered
2/06/2009
Date last updated
13/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of a Liver Failure Service for patients with cirrhosis
Scientific title
Impact of a Liver Failure Service for patients with cirrhosis
Secondary ID [1] 283776 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Liver Disease (Cirrhosis of the liver) 4547 0
Condition category
Condition code
Other 4838 4838 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6-month liver failure program. Liver failure nurses start this service in hospital with some brief education and nutrition assessment. Then a visit to the patient's home 5-7 days after discharge from hospital of 1-1.5 hours duration providing follow-up education and advice. Action plans will be provided to the patient where appropriate - general action plans for cirrhosis as well as very targeted plans regarding the management of ascites and encephalopathy may be given. Medication advice will be provided including indications of all prescribed medications, the importance of compliance, and any side effects that may be experienced. Nutrition advice regarding high protein, low salt diets and the improtance of nutrition in the care of the liver will be covered. After the home visit the patient will receive weekly telephone calls by the liver failure nurses until the patient has been reveiwed in the outpatient clinic by their specialist. At this time the specialist in conjunction with the liver failure nurse and patient will decide on a 'stable' or 'unstable' pathway plan. If unstable, a home visit may again be warranted after outpatient review and/or weekly/fortnightly telphone calls as indicated. Once stable, patients can access the liver failure service for rapid response as suggested on their action plans. Incidents which may trigger rapid response include significant weight gain or loss, distended abdomen, shortness of breath, confusion, diarrhoeah or constipation, medication side effects, difficulty eating/poor diet intake etc.
Intervention code [1] 4313 0
Treatment: Other
Comparator / control treatment
Standard Treatment. This consists of usual outpatient care which includes entry onto surveillance programs for varices and hepatoma (if necessary) and regular outpatient reviews with their specialist. Their treatment is ongoing.
Control group
Active

Outcomes
Primary outcome [1] 5697 0
Number of occupied bed days in hospital. This measure will be collected by the trial nurses prospectively in each of the groups by monitoring inpatient admissions under gastroenterology.
Timepoint [1] 5697 0
Six months from index admission
Secondary outcome [1] 241607 0
Readmission Rate. This measure will be collected by the trial nurses prospectively in each of the groups by monitoring inpatient admissions under gastroenterology.
Timepoint [1] 241607 0
Six months from index admission

Eligibility
Key inclusion criteria
Patient with cirrhosis of the liver admitted into hospital with a liver-related problem
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with difficulty with english language, have another chronic disease which is their primary health issue managed by another specialty team, reside interstate or outside catchment area, have liver disease managed privately or at another hospital, or are 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)
Allocation involves contacting the holder of the allocation schedule who is in another department.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 237084 0
Government body
Name [1] 237084 0
Southern Adelaide Health Service Out Of Hospital (OOH) Strategy
Address [1] 237084 0
Population & Primary Health Care
Mark Oliphant Building Science Park
Laffer Drive
Bedford Park SA 5042
Country [1] 237084 0
Australia
Primary sponsor type
Individual
Name
Alan Wigg, Acting Head of Hepatology and Liver Transplant Medicine Unit
Address
Hepatology and Liver Transplant Medicine Unit
C/-Department of Gastroenterology Level 3
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 4589 0
Individual
Name [1] 4589 0
Rachel Wundke
Address [1] 4589 0
Department of Gastroenterology Level 3
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country [1] 4589 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239185 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 239185 0
Room 2A 221
Flinders medical Centre
Bedford Park SA 5042
Ethics committee country [1] 239185 0
Australia
Date submitted for ethics approval [1] 239185 0
31/03/2009
Approval date [1] 239185 0
05/05/2009
Ethics approval number [1] 239185 0
100/09

Summary
Brief summary
A six-month study exploring the effectiveness of a a liver failure program for patients who have cirrhosis of the liver and are admitted to hospital with a liver-related issue.
Trial website
Trial related presentations / publications
Efficacy of a chronic disease management model for patients with chronic liver failure.
Wigg AJ, McCormick R, Wundke R, Woodman RJ.
Clin Gastroenterol Hepatol. 2013 Jul;11(7):850-8.e1-4.
Public notes

Contacts
Principal investigator
Name 29454 0
Dr Alan Wigg
Address 29454 0
c/- Level 3 Gastroenterology
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 29454 0
Australia
Phone 29454 0
+61 88204 5511
Fax 29454 0
Email 29454 0
alan.wigg@health.sa.gov.au
Contact person for public queries
Name 12701 0
Ms Rachel Wundke
Address 12701 0
Flinders Medical Centre
Hepatology and Liver Transplant Medicine Unit
Flinders Drive
Bedford Park SA 5042
Country 12701 0
Australia
Phone 12701 0
+61 8 8204 6989
Fax 12701 0
+61 8 8204 3943
Email 12701 0
rachel.wundke@health.sa.gov.au
Contact person for scientific queries
Name 3629 0
Dr Alan Wigg
Address 3629 0
Flinders Medical Centre
Hepatology and Liver Transplant Medicine Unit
Flinders Drive
Bedford Park SA 5042
Country 3629 0
Australia
Phone 3629 0
+61 8 8204 3941
Fax 3629 0
+61 8 8204 3943
Email 3629 0
alan.wigg@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary