Clinical trial NCT05431946: Palliative Care for Patients With Liver Cirrhosis
Official title: Palliative Care for Patients With Liver Cirrhosis - a Multicentre Intervention Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: End of Life Care
Liver Cirrhosis
Nurse-Patient Relations
Quality of Life
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Aarhus University Hospital
name: Hvidovre University Hospital
First posted: 2022-06-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with liver cirrhosis

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.


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.

Primary outcomes:
measure: Intra-subject change in patient burden
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 100 months
Secondary outcomes:
measure: Intra-subject change in caregiver burden
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 100 months
measure: Inter-group difference in health care system burden
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 100 months
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of South West Jutland
Study officials:
affiliation: Head of Liver Research
name: Mette M Lauridsen
role: PRINCIPAL_INVESTIGATOR
References: