Palliative Care for Patients With Liver Cirrhosis (LiverCare)

Palliative Care for Patients With Liver Cirrhosis - a Multicentre Intervention Study

Background: Patients with liver cirrhosis rarely receive palliative care although the Danish Health Authorities and WHO recommend it. The lacking palliative intervention is probably owed to a physician culture focused on life-prolonging active treatment at any cost and unclarities, and misperceptions about palliative care, which is perceived by many as exclusively for cancer patients and something that marks the end of active treatment.

Study aim: Measure the effect of palliative care on the patient burden, caregiver burden, and the utilization of healthcare services.

Study design: Prospective multi-center intervention study with end of study at the patients' death. We will use a 3-faceted endpoint 1) Patient burden measured by change in Hospital Anxiety and Depression Scale, 2) caregiver burden by a change in Zarit Caregiver Burden Questionnaire, and 1) health care system burden as the difference in number, length, and indication for hospital admissions and need for outpatient services.

Patients: We will prospectively include 200 patients with liver cirrhosis (approx. 50 from each of 4-5 sites: Esbjerg, Herlev, Hvidovre, Århus) who have 2 or more items checked on the Supportive and Palliative Care Indicators Tool. Control groups will be identified from two non-participating hospitals and matched regarding age, gender, number of comorbidities, and alcohol and caregiver status.

Methods: The intervention will be advanced care planning with conversations and actions built around a standardized symptom identification tool (EORTC QLQ-C15-PAL). Advance care planning is the collaborative process between patients and health care professionals of planning future health care. The assignment of a contact nurse to each participant is a key part of the intervention.

Results: We will measure patient and caregiver burden at inclusion, after 4-6 weeks, 4-6 months, and every 6 months until the patient dies. All use of health care services will be registered. The use of health care services during the terminal 2 years will be compared that of control patients.

Study Overview

• Status: Enrolling by invitation
• Conditions: Liver Cirrhosis; Quality of Life; Nurse-Patient Relations; End of Life Care
• Intervention / Treatment: Behavioral: Advance Care Planning and the consequent actions

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Denmark
  • Esbjerg, Denmark, 6700
    • Hospital of South West Jutland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with liver cirrhosis

Description

Inclusion Criteria:

1. Liver cirrhosis of any etiology (diagnosed clinically, by imaging or histological features) as predominant chronic illness
2. 2 or more items checked on the Supportive and Palliative Care Indicators Tool (SPICT™, appendix)
3. Expressed desire for palliative support from the patient and relatives
4. Ability to give informed consent

Exclusion Criteria:

1. Inability to give informed consent
2. Age < 18 years
3. Ongoing contact with specialized palliative care teams or hospice
4. Other chronic life-threatening illness than liver cirrhosis is more likely to become the cause of death within 1-2 years.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Palliative Care arm; Intervention by Advance care planning (ACP) conversation:The goal is the identification, assessment, and treatment of physical, psychosocial, or spiritual symptoms and problems. Advance care actions:These are the actions taken to fulfill the advance care plan and can include, but are not limited to:treatments: pharmacological, psychosocial (priest, psychologist, etc.) referrals: rehabilitation, specialized palliative care team, hospice, etc. communication initiatives with relatives, primary care, public authorities	Behavioral: Advance Care Planning and the consequent actions; The palliative care intervention is based on the advance care planning process and the actions taken as a consequence of these conversations. The goal is the identification, assessment, and treatment of physical, psychosocial, or spiritual symptoms and problems. Advance care actions These are the actions taken to fulfill the advance care plan and can include, but are not limited to: treatments: pharmacological, psychosocial (priest, psychologist, etc.) referrals: rehabilitation, specialized palliative care team, hospice, etc. communication initiatives with relatives, primary care, public authorities; Other Names: Questionnaires
Non-participating arm; Will continue standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-subject change in patient burden	Change in Hospital Anxiety and Depression Scale	From date of inclusion until the date of death from any cause, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-subject change in caregiver burden	Change in Zarit Caregiver Burden Questionnaire	From date of inclusion until the date of death from any cause, assessed up to 100 months
Inter-group difference in health care system burden	The difference in the use of health care services between intervention and control groups from 2 non-participating hospitals. The difference will be assessed by a review of electronic patient files and sundhed.dk.	From date of inclusion until the date of death from any cause, assessed up to 100 months

Collaborators and Investigators

• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
• Collaborators: Aarhus University Hospital; Hvidovre University Hospital; Herlev Hospital
• Investigators: Principal Investigator: Mette M Lauridsen, Head of Liver Research

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis; Death
• Other Study ID Numbers: LiverCare Denmark

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No