A Nonrandomized Pilot Study to Investigate the Acceptability and Feasibility of LivR Well: A Multifaceted 28-Day Home-Based Liver Optimization Program for Acute-on-Chronic Liver Failure
Natalie L.Y. Ngu , Edward Saxby , Thomas Worland , Patricia Anderson , Lisa Stothers , Jo Hunter , Alexander T. Elford , Phil Ha , Imogen Hartley , Andrew Roberts , Dean Seah , George Tambakis , Declan Connoley , Anita Figredo , Dilip Ratnam , Danny Liew , Benjamin Rogers , William Sievert , Sally Bell , Suong Le
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Abstract
Background and Aims
Acute-on-chronic liver failure (ACLF) has a 22%–74% 28-day mortality rate and 30%–40% 30-day readmission rate. We investigated the acceptability and feasibility of a multimodal community intervention for ACLF.
Methods
A single-arm nonrandomized pilot study of consecutive participants with ACLF was conducted in a tertiary health service. Participants received weekly medical and nursing reviews, dietetics, physiotherapy, pharmacy, social work, addiction medicine, and neuropsychiatry, where indicated. A digital platform included remote weight monitoring and online surveys. The primary outcome was acceptability/feasibility. Secondary outcomes included safety, mortality, readmission, liver disease severity, and costs.
Results
Fifty-nine patients were enrolled with median age 51 years (interquartile range (IQR): 45–59); majority alcohol etiology (74%),and median Model for End-Stage Liver Disease Sodium score 16 (IQR: 12–21). LivR Well was acceptable with low attrition (8 of 59), adherence to the program including home visits (mean 8.4 ± 4.2) and consultations (mean 2.4 ± 1.5) per patient. This was supported by positive feedback and themes identified through a qualitative subanalysis. Feasibility was demonstrated by recruitment rate of 4.94 patients/month and 86% completion. Mortality was lower than expected at 3%, 30-day readmission rate was 15%, and median Model for End-Stage Liver Disease Sodium score reduced to 15 (P = .01). Median 6-month costs reduced from $30,454 (IQR: $21,953–$65,657) to $17,657 ($4249–$42,876) (P = .009). The total 6-month health-care cost was $1,868,859 (95% confidence interval 1,081,821–2,655,897) compared to $2,518,227 (95% confidence interval 1,959,610–3,076,844).
Conclusion
LivR Well was acceptable, feasible, and safe with low short-term mortality and readmission rates. Health-care costs were reduced by 26% driven by a 40% reduction in 30-day readmission. Further evaluation includes a randomized controlled trial of LivR Well compared to standard care.