None listed
Conditions
Brief summary
Acute-on-chronic-liver failure has a rising global healthcare burden with both 28-day mortality and 30-day readmission rates greater than 30%. Compared to other chronic conditions, those with ACLF have reduced access to coordinated ambulatory care. LivR Well is a multidisciplinary, home-based liver optimisation program implemented in the first 28 days after an ACLF admission. Components will include pharmacy, dietetics, physiotherapy, neuropsychiatry and social work in addition to medical and nursing input. This randomised controlled trial aims to demonstrate an improvement in mortality and readmission through early intervention in this cohort.
Interventions
The 28 day intervention will be delivered through ‘Hospital in the Home’ (HITH), a medically-led ambulatory care program supported by physical clinics and home-visits by the nursing team. HITH is able to deliver many aspects of acute hospital care in the community, for otherwise stable patients. This includes diagnosis and management of acute conditions that would typically require bed-based care Patients will have access to up to three, 1 hour home visits per week by nursing staff and physiotherapists. Nursing aspects of the home visits will include routine vital sign assessment (heart rate, respiratory rate, blood pressure, pulse oximetry and temperature), blood tests requested by medical staff (full blood count, urea/creatinine/electrolytes, liver function tests, international normalised ratio), administration of quality of life assessments at baseline/week 6/week 12 (Chronic Liver Disease Questionnaire and EuroQoL 5D), and general enquiry regarding concerns and wellbeing. Nursing staff can escalate to medical staff whenever a concern is raised. The patients will attend a hospital-based ambulatory care liver clinic weekly, for up to 2 hours duration, for a medical and nursing review with dietitian, social work, addiction medicine specialists and pharmacist consultations as required. Patients could be referred to LivR Well from an outpatient context, the emergency department or the inpatient ward. All severity of liver disease is eligible unless the patient is receiving end of life care. There are no cut-offs for MELD score or Child Turcotte Pugh score. The intervention will be personalised to the patient based on the criteria below. Intervention adherence will be assessed by attendance at scheduled appointments and undertaking of investigations requested. Adherence will be monitored on a central database and strategies used to improve fidelity will include direct contact with patients by the hepatology research nurse. Physiotherapy is indicated if diagnosed with sarcopenia, had a fall in last 6 months or standardised falls risk assessment score suggests increased falls risk. Exercises prescribed will be tailored to individual patients but include falls risk reduction exercises to be performed across up to 3x 60 minute sessions, for the duration of the intervention. Exercises will include those designed for balance training eg alternate leg weight bearing and those designed for sarcopenia eg seated chair push ups. The exercises will be tailored at the discretion of the treating physiotherapist. Outcomes will be assessed using the 6 minute walk test at baseline and day 28 Dietitian is indicated if diagnosed with sarcopenia, diabetes, alcohol dependence and/or a standardised malnutrition risk assessment score suggests malnutrition. Tasks will include implementing a personalised high protein, low salt diet plan including a late-evening snack Social Work is indicated if the patient requires long term home support services, has an established disability or is aged >65 years. Tasks will include referral for council services, aged care assessment Neuropsychiatry assessment is indicated if there is concern from the medical team regarding cognition outside potentially treatable hepatic encephalopathy. This assessment will not result in provision of therapies but may enable the patient longer term access to appropriate support services including the National Disability Support Scheme. A pharmacist review is indicated if the patient takes at least 5 different medications regularly (polypharmacy) and/or requires titration of diuretic or lactulose doses
Sponsors
Study design
Eligibility
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