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Enrolling by Invitation

NCT Number: NCT05431946

Palliative Care for Patients With Liver Cirrhosis

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.

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Key information

Conditions

End of Life Care Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Nurse-Patient Relations Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of South West Jutland

Esbjerg, 6700, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Liver cirrhosis of any etiology (diagnosed clinically, by imaging or histological features) as predominant chronic illness
  • 2 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

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: Questionnaires

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • Aarhus University Hospital
  • Herlev Hospital
  • Hvidovre University Hospital

Registry information

Official study title

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

Acronym: LiverCare

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 24, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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