Palliative Care for Patients With Liver Cirrhosis

NCT05431946 | Enrolling By Invitation DMC

• 1 other identifier: LiverCare Denmark
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intra-subject change in caregiver burden

  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

  From date of inclusion until the date of death from any cause, assessed up to 100 months

Study Arms (2)

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

Non-participating arm

Will continue standard of care

Interventions

Advance Care Planning and the consequent actions 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

Also known as: Questionnaires

Palliative Care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with liver cirrhosis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Herlev Hospital: collaborator
• Aarhus University Hospital: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (1)

Hospital of South West Jutland

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Advance Care Planning; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mette M Lauridsen

  Head of Liver Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: June 24, 2022
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

DK (1)