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Impact of a Chronic Disease Management Model in patients with decompensated liver disease: The Australian Liver Failure Trial (ALFIE)

Efficacy and cost effectiveness of a chronic disease management model in patients with decompensated cirrhosis.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001293358
Acronym
ALFIE
Enrollment
147
Registered
2017-09-07
Start date
2018-09-14
Completion date
2020-05-01
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 appoin

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.

Sponsors

Southern Adelaide Local Health Network
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026