Palliative Care for Patients With Liver Cirrhosis

Quality of Life Clinical Trial

— LiverCare  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05431946
• Other study ID #: LiverCare
• Status: Enrolling by invitation
• Start date: August 1, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: August 2023
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death
• End of Life Care
• Fibrosis
• Liver Cirrhosis
• Nurse-Patient Relations
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Denmark	Hospital of South West Jutland	Esbjerg

Sponsors (4)

Lead Sponsor	Collaborator
Hospital of South West Jutland	Aarhus University Hospital, Herlev Hospital, Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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