Palliative Care for Patients With Liver Cirrhosis

NCT ID: NCT05431946

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2028-08-01

Brief Summary

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.

Conditions

End of Life Care; Liver Cirrhosis; Nurse-Patient Relations; Quality of Life

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Advance Care Planning and the consequent actions

Intervention Type: BEHAVIORAL

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

Non-participating arm

Will continue standard of care

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Questionnaires

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mette M Lauridsen

Role: PRINCIPAL_INVESTIGATOR

Head of Liver Research

Locations

Hospital of South West Jutland

Esbjerg, , Denmark

Countries

Denmark

Other Identifiers

LiverCare Denmark

Identifier Type: -

Identifier Source: org_study_id