ABSTRACT
Background and Aim: Acute-on-chronic liver failure (ACLF) is a global health care challenge, with a 28-day mortality rate of 33.9% and 30-day readmission rate of 37%.1,2 Management of ACLF is often complicated by multiorgan involvement, need for intensive care support, sarcopenia/frailty, and lack of universally accepted diagnostic criteria.3,4 Health care resource utilization is high. Our aims were to assess the safety, efficacy, acceptability, and cost of LivR Well, a new model of intensive, multidisciplinary ambulatory care for patients with ACLF. Method(s): We conducted a prospective, single-arm, mixed-methods study at Monash Health, a large Victorian tertiary network. Adult patients were enrolled from the inpatient ward, emergency department, or outpatient clinic in the first 28 days after a formal diagnosis of ACLF. ACLF was defined using Asian Pacific Association for the Study of the Liver criteria (an acute hepatic insult manifesting as jaundice and coagulopathy, complicated by ascites and/or encephalopathy within 4 weeks).5 Study criteria and the LivR Well intervention are shown in Figure 1. Patients were admitted to hospital in the home and received nursing visits up to 3 times a week and a weekly clinic medical review. Patients accessed physiotherapy, pharmacy, dietetics, social work, addiction medicine, and neuropsychiatry if appropriate. Blood test results were monitored weekly, and patients were followed up for 12 weeks. Health-related quality of life (HRQoL) was measured using EQ-5D and the Chronic Liver Disease Questionnaire (CLDQ) at baseline and Week 6. A qualitative substudy was undertaken to assess acceptability, with interviews performed between Weeks 6 and 12. The primary outcome was safety. Secondary outcomes were readmission, liver disease severity, HRQoL, symptom burden (CLDQ), acceptability, and health care resource utilization. Result(s): Fifty-nine patients (median age, 51 years [IQR, 45-59];66% male) were enrolled between March 2021 and April 2022. Forty-four patients completed the 28-day program, with two deaths (at Days 16 and 27), one drop-out due to COVID-19 requiring isolation, eight patients discharged due to failure to attend, and four patients who remain active in the program. There were no reported adverse events. Alcohol misuse was the most frequent liver disease etiology (73%). There was a significant reduction in median Model for End-Stage Liver Disease-Sodium (MELDNa) score from 16 at baseline (IQR, 12-21) to 15 at Day 28 (IQR, 11-18;P < 0.001). Sarcopenia prevalence decreased from baseline to Day 28 but did not reach statistical significance (27% vs 19%, P = 0.48). HRQoL significantly improved from a median baseline CLDQ score of 4.34 (IQR, 3.37-5.08) to 4.75 (IQR, 3.97-5.81;P = 0.02), with specific improvement in the domains of activity (P = 0.04), fatigue (P = 0.02), and worry (P = 0.001). The qualitative study highlighted universal themes of high acceptability, improved health literacy/insight, and increased autonomy. The median self-reported health perception using a visual analog scale significantly improved from 64% (IQR, 42-77%) to 72% (IQR, 50-80%;P = 0.05). The 28-day mortality rate was 3%, and the 30-day readmission rate was 14%. The median LivRWell program cost was A$4947. The total 6-month median direct health care cost for each LivR Well patient improved from a median of A$30 913 before LivR Well (IQR, $11 201-$61 464) to $784 after LivR Well (IQR, $0-$18 117;P < 0.001). The total direct health care cost for this cohort was reduced by 71%, from $1.16 million before to $335 000 after LivR Well, largely driven by a 40% reduction in 30-day readmission. Conclusion(s): LivR Well is a world-first multidisciplinary ambulatory care program for patients with ACLF. Our feasibility study supported the safety, potential efficacy, and cost-effectiveness of such an intervention, with lower than expected 30-admission, 28-day mortality, and total health care cost for this complex cohort. There was a small, but significant improvement in MELD-Na score, HRQoL, and self-rep rted health perception. We are further evaluating the clinical and economic impact of LivR Well as part of a randomized controlled trial comparing it with standard ambulatory care.