A home-based, multidisciplinary liver optimisation program for the first 28 days after an admission for acute-on-chronic liver failure (LivR Well)

Not Applicable

Completed

Conditions: cirrhosis
acute-on-chronic liver failure
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Registration Number: ACTRN12621001703897

Lead Sponsor: Monash Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 104

Inclusion Criteria

Adult patients
Acute hepatic decompensation characterised by ascites, variceal haemorrhage, hepatorenal syndrome, hepatic encephalopathy, jaundice
Diagnosis of acute-on-chronic liver failure (ACLF) using the European Foundation of the Study of Liver Failure using the Chronic Liver Failure criteria (EF-CLIF) and which includes age and white cell count. Severity is graded according to the number of organ failures
Requiring consultation from at least 3 allied health clinicians

Exclusion Criteria

•Greater than grade 2 hepatic encephalopathy
•Severe chronic extrahepatic disease
•Human immunodeficiency virus (HIV) or ongoing immunosuppressive treatments
•Admission for scheduled procedure or treatment
•Moribund or receiving end-of-life care
•Active malignancy including hepatocellular carcinoma
•Receiving regular albumin infusions for treatment of chronic hepatorenal syndrome (excluding those for periprocedural circulatory support following large volume paracentesis)
•Refractory ascites managed with a intra-peritoneal catheter in-situ
•Inability to provide informed consent
•Residing outside the local hospital service catchment or deemed ineligible for home visits due to staff safety or occupational hazard concerns
•Residing in a residential aged care facility

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary composite outcome: death, waitlisting for liver transplantation or 30-day readmission. This outcome will be assessed through access to the electronic health record for the health service. This is a multi-site service spanning 3 tertiary centres, secondary hospitals and a catchment of more than 1 million people in south-east Victoria. For patients referred to the statewide liver transplant service, this outcome will be assessed by directly requesting medical records.[ 90 days post-intervention commencement];30-day readmission rate. Admissions and costs data from hospital finance department and clinical data from review of medical records. [ ];30-day readmission rate. Admissions and costs data from hospital finance department and clinical data from review of medical records. [ 30 days from commencement of program]

Secondary Outcome Measures

Name	Time	Method
Changes in liver disease severity using Model-for-Endstage-Liver Disease Score (MELD)[ 90 days post-intervention commencement];Quality of life using CLDQ[ 90 days post-intervention commencement];Cost-effectiveness compared to standard care. This will be assessed with a cost-effectiveness analysis to demonstrate absolute difference using admissions (including Hospital in the Home) data from hospital finance record reflecting cost to the healthcare system. Further economic assessment using the Incremental Cost Effectiveness Ratio and quality adjusted life years will be undertaken[ 90 days post-intervention commencement];Changes in liver disease severity using Child-Turcotte-Pugh score[ 90 days post-intervention commencement];Changes in quality of life using EuroQoL 5D[ 90 days post-intervention commencement]