Palliative Care for Patients With Liver Cirrhosis - a Multicentre Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Intra-subject change in patient burden
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Intra-subject change in patient burden
时间窗: From date of inclusion until the date of death from any cause, assessed up to 100 months
Change in Hospital Anxiety and Depression Scale
次要结局
- Inter-group difference in health care system burden(From date of inclusion until the date of death from any cause, assessed up to 100 months)
- Intra-subject change in caregiver burden(From date of inclusion until the date of death from any cause, assessed up to 100 months)