Palliative Care for Patients With Liver Cirrhosis (LiverCare)

• ClinicalTrials.gov Identifier: NCT05431946
• Recruitment Status: Enrolling by invitation
• First Posted: June 24, 2022
• Last Update Posted: June 24, 2022
• Sponsor: Hospital of South West Jutland
• Collaborators: Herlev Hospital; Hvidovre University Hospital; Aarhus University Hospital
• Information provided by (Responsible Party): Hospital of South West Jutland

Study Description

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.

Condition or disease	Intervention/treatment
End of Life Care; Liver Cirrhosis; Nurse-Patient Relations; Quality of Life	Behavioral: Advance Care Planning and the consequent actions

Study Design

• Study Type: Observational
• Estimated Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Palliative Care for Patients With Liver Cirrhosis - a Multicentre Intervention Study
• Estimated Study Start Date: August 1, 2022
• Estimated Primary Completion Date: August 1, 2024
• Estimated Study Completion Date: August 1, 2026

Groups and Cohorts

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 Name: Questionnaires
Non-participating arm; Will continue standard of care

Outcome Measures

Primary Outcome Measures :

1. Intra-subject change in patient burden [ Time Frame: From date of inclusion until the date of death from any cause, assessed up to 100 months ]
   Change in Hospital Anxiety and Depression Scale

Secondary Outcome Measures :

1. Intra-subject change in caregiver burden [ Time Frame: From date of inclusion until the date of death from any cause, assessed up to 100 months ]
   Change in Zarit Caregiver Burden Questionnaire
2. Inter-group difference in health care system burden [ Time Frame: From date of inclusion until the date of death from any cause, assessed up to 100 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients with liver cirrhosis

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.

Contacts and Locations

Locations

Denmark

Hospital of South West Jutland

Esbjerg, Denmark, 6700

Sponsors and Collaborators

Hospital of South West Jutland

Herlev Hospital

Hvidovre University Hospital

Aarhus University Hospital

Investigators

• Principal Investigator: Mette M Lauridsen; Head of Liver Research

More Information

• Responsible Party: Hospital of South West Jutland
• ClinicalTrials.gov Identifier: NCT05431946
• Other Study ID Numbers: LiverCare
• First Posted: June 24, 2022
• Last Update Posted: June 24, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Liver Cirrhosis; Fibrosis; Death; Pathologic Processes; Liver Diseases; Digestive System Diseases