A randomized multicenter trial of a chronic disease management intervention for decompensated cirrhosis. The <underline>A</underline>ustra<underline>l</underline>ian <underline>L</underline>iver <underline>F</underline>a<underline>i</underline>lur<underline>e</underline> (ALFIE) trial

Background and aims:Improving the care of decompensated cirrhosis (DC) is a significant clinical challenge. The primary aim of this trial was to assess the efficacy of a chronic disease management (CDM) model to reduce liver-related emergency admissions (LREA). Secondary aims were to assess model effects on quality-of-care and patient reported outcomes. Approach and results:Study design was a two-year, multicenter, randomized controlled study with 1:1 allocation of a CDM model versus usual care. The study setting involved both tertiary and community care. Participants were randomly allocated following a DC admission. The intervention was a multifaceted CDM model coordinated by a liver nurse. 147 participants (Intervention=75, Control=71) were recruited with a median MELD score of 19. For the primary outcome, there was no difference in the overall LREA rate for the Intervention group versus Control group (IRR 0.89; 95% CI 0.53-1.50, p=0.666) or in actuarial survival (HR=1.14; 95% CI 0.66-1.96, p=0.646). However, there was a reduced risk of LREA due to encephalopathy in the Intervention versus Control group (Hazard ratio=1.87; 95% CI 1.18-2.96, p=0.007). Significant improvement in quality-of-care measures was seen for performance of bone density (p=<0.001), vitamin D testing (p=<0.001) and HCC surveillance adherence (p=0.050). For assessable participants (44/74 Intervention, 32/71 Controls) significant improvements in patient-reported outcomes at 3 months were seen for self-management ability and quality of life as assessed by visual analog scale (p=0.044). Conclusions:This CDM intervention did not reduce overall LREA events and may not be effective in DC for this endpoint.