LiverCare - a palliative care intervention for patients with liver cirrhosis: study protocol for a multi-center, pragmatic, non-randomised clinical trial

BACKGROUND: In the transition from compensated to decompensated cirrhosis, median survival decreases from 12 to two years, and patients face some of the highest rates of unplanned hospital admissions. Despite existing recommendations, palliative care is not routinely offered to this population. The aim of this study is to evaluate the effectiveness and implementation of an interdisciplinary palliative care intervention for patients with cirrhosis and their informal caregivers. METHODS: The LiverCare study is a multi-center, mixed-method, pragmatic, non-randomised clinical study with a hybrid type 1 effectiveness-implementation design. The study is conducted in hepatology departments across four hospitals in three of Denmark's five regions. It is guided by the British Medical Research Council and Reach, Effectiveness, Adaption, Implementation, Monitor frameworks and includes both a feasibility study and a mixed-method process evaluation. The LiverCare intervention is grounded in a palliative approach, emphasising open, exploratory palliative care conversations. The intervention is integrated into routine outpatient care and the palliative care conversations are delivered by hepatologists and liver nurses who attended a specially designed course within palliative care. Eligible participants are adults with decompensated liver cirrhosis of any etiology who meet at least one general and one disease-specific palliative care indicator, assessed using the Supportive and Palliative Care Indicators Tool. Informal caregivers are invited to participate in the intervention. Palliative care conversations are initiated following a formal invitation and continue after four to ten weeks and then every six months up to 36 months or until study withdrawal or death. The primary outcome is healthcare utilization, defined as the number and length of hospital admissions, compared to a historic cohort. Secondary outcomes include outpatient contacts, symptom burden, quality of life, and caregiver burden. The study also includes cost-effectiveness and cost-utility analysis. DISCUSSION: Insights gained from the study will inform future implementation strategies and contribute to the advancement of palliative care practices in hepatology. The results will further support education, training, and competence development for healthcare professionals caring for patients with advanced liver disease. TRIAL REGISTRATION: The study is registered on clinicaltrials.gov (NCT05431946), approved by The Danish Data Protection Agency and reported to the Committee on Health Research Ethics (20222000-31).