CirrhoCare: A real-world, randomised controlled study, to determine the clinical and cost effectiveness of CirrhoCare digital home monitoring and management in patients with decompensated cirrhosis

Research Question: Is CirrhoCare, through digital-monitoring and actionable decision-making algorithms, clinically effective in reducing cirrhosis complications compared to standard-care?

Background: Liver disease ranks the 3rd commonest cause of premature UK-deaths with NHS costs >£4.53bn/annum, mostly from decompensated cirrhosis complications (114,347-patients). Admissions last several weeks, requiring high-cost, intensive therapies. Following hospital-discharge, standard-outpatient follow-up occurs within 4 weeks and 8-12 weeks, thereafter.

However, 37% of patients are readmitted with new complications within 4 weeks.

Current care-pathways are reactive, failing to manage complications early in the community, resulting in high treatment costs, through late presentations.

CirrhoCare, is a UKCA-marked, digital-therapeutic-system, consisting of clinical-grade sensors, smartphone-app and clinician-facing dashboard incorporating decision-facilitating algorithms.

CirrhoCare provides proactive management, through community remote-monitoring (aligning with NHSX plans), and actionable-insights that diagnose complications early, allowing timely, cost-effective, community-interventions, for all (aligning to i4i Challenge-programme remit).

Aims and Objectives: Deliver a multi-centre RCT in 214 decompensated cirrhosis patients, evaluating CirrhoCare against standard-care over 3-months; Success defined by reduction in liver-related complications requiring hospital intervention for CirrhoCare management versus Standard care-pathway.

Primary Objective: To assess the clinical effectiveness of CirrhoCare s digital-therapeutic management system for cirrhosis complications, through a multi-centre RCT, with blinded outcome assessment.

Secondary Objectives: Assess the cost-effectiveness of CirrhoCare implementation compared to standard care Identify the barriers to implementing CirrhoCare in real-world clinical practice Measure impacts of CirrhoCare on health-related quality-of-life and disease severity Develop the business and commercialisation strategy to implement CirrhoCare, including a stakeholder engagement plan Methods Decompensated cirrhosis patients from 12 high-volume NHS-trusts, including high BAME representation and social inequality, screened prior to hospital discharge.

Main Inclusion-criteria: Adults ≥18years, any sex and racial background; cirrhosis of any aetiology; Recent hospitalization for acute decompensation (ascites, dehydration, gastrointestinal-bleed, hepatic encephalopathy, and infections); cirrhosis severity-risk defined by EF-CLIF-AD-Score >45 points.

Main Exclusion-criteria: chronic comorbid diseases including cardio-pulmonary and renal failure; established malignancy; active viral infections/COVID-19; any disorders likely to impact on study engagement.

Given a baseline event rate of 60%, and target treatment rate of 35% with15% loss-to-follow-up, 214 patients will be randomised (electronically-generated randomisation code), 1:1, at 90% power (alpha-5%).

Patients will be followed for 3 months in Cirrhocare and standard-care arms, with telephone contacts at 4 and 8 weeks; and a clinic visit at 12 weeks.

In addition, CirrhoCare managed patients will undergo daily monitoring, and 2-way communication with interventions, as clinically indicated. All hospital interventions, in both arms, will be independently adjudicated.

Deliverables and Timelines: CirrhoCare technical environment-Jan-2023 Ethics and regulatory approvals-Mar-2023 Site Contracts and first patient onboarding-Apr 2023 First visit in Last patient-Jul-2024 Completion of Clinical study report, with Health economic and data analysis-Mar-2025 Commercialisation plan and regulatory dossier for NICE/HTA submissions Anticipated Impacts Patients: Decreased hospitalisation and morbidity Clinicians: Efficiencies in clinical workflow; directs attention to patients with greatest need NHS: adheres to goals of cost-effective