Palliative Care for Patients With Liver Cirrhosis

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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 p

Первичные конечные точки

• Intra-subject change in patient burden [Срок оценки: From date of inclusion until the date of death from any cause, assessed up to 100 months]

Вторичные конечные точки (2)

• Intra-subject change in caregiver burden [Срок оценки: 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 [Срок оценки: From date of inclusion until the date of death from any cause, assessed up to 100 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Дания · 1 центр

• Hospital of South West Jutland — Esbjerg

Публикации

• O'Connell MB, Jacobsen BG, Teisner AS, Bager P, Hamberg ML, Mendahl J, Marsaa K, Guldin MB, Kimer N, Lauridsen MM, Ladegaard L. LiverCare - a palliative care intervention for patients with liver cirrhosis: study protocol for a multi-center, pragmatic, non-randomised clinical trial. BMC Palliat Care. 2026 Jun 16. doi: 10.1186/s12904-026-02182-1. Online ahead of print. PMID 42304310
• Gronkjaer LL, Jacobsen BG, Teisner AS, Bager P, Hamberg ML, Mendahl J, Marsaa K, Guldin MB, Kimer N, Lauridsen MM, O Connell MB. The LiverCare intervention: implementing structured palliative care in hepatology - a multicenter mixed-methods feasibility study in patients with cirrhosis. BMC Palliat Care. 2026 Apr 22;25(1):164. doi: 10.1186/s12904-026-02104-1. PMID 42021258

Идентификаторы

NCT: NCT05431946 · LiverCare Denmark

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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