EU PAL-COPD: Evaluation of the ICLEAR-EU intervention to integrate palliative care in the treatment of people with advanced COPD and their family caregivers: An international stepped wedge cluster RCT in six European countries.

慢性阻塞性肺疾病（COPD）是一种毁灭性的限制生命的肺部疾病，具有很高的个人和社会负担。在世界范围内，慢性阻塞性肺病是第三大死亡原因。慢性阻塞性肺病患者的症状负担与肺部慢性阻塞性肺病患者的症状负担一样严重和沉重。虽然许多国家为慢性阻塞性肺病患者提供姑息治疗，但欧洲呼吸系统医院团队并未很好地将慢性阻塞性肺病患者的姑息治疗和良好的临终关怀纳入其治疗。欧盟PAL-COPD项目是一个多学科、跨专业、国际和跨部门的项目，旨在评估ICLEAR-EU干预在欧洲不同医疗保健系统中对晚期COPD患者的临床和成本效益。ICLEAR-EU是一项以人为本、以家庭为中心的非药物服务干预，医院的呼吸内科团队与跨学科姑息治疗团队和初级保健团队合作，促进共同决策和预先护理规划，改善症状治疗和舒适护理，并防止病情加重后再次住院。ICLEAR-EU是基于英国开发和试点测试的现有干预措施。在欧盟PAL-COPD中，ICLEAR-EU的有效性将通过一项阶梯楔形聚类随机对照试验在6个欧洲国家18家医院的1224名晚期COPD患者中进行评估。因此，这是第一个将姑息治疗系统地纳入晚期COPD患者呼吸护理的大规模国际试验。还包括成本效益、稳健的混合方法、分组分析以及深入的过程和执行评估。欧盟PAL-COPD将改善COPD患者及其家人的福祉和赋权，并通过为复杂的姑息治疗和临终关怀需求提供创新的服务模式，推进最先进的水平。用户和涉众的参与在整个项目中是至关重要的。

Chronic Obstructive Pulmonary Disease (COPD) is a devastating life-limiting lung disease with a high personal and societal burden. Worldwide, COPD is the third leading cause of death. The symptom burden of people with COPD is as severe and burdensome as the symptom burden of people with lung COPD. While palliative care in many countries is available for people with lung COPD, palliative care and good end-of-life care for people with COPD are not well integrated into their treatment by respiratory hospital teams in Europe. The EU PAL-COPD project is a multidisciplinary, interprofessional, international and intersectoral project aiming at evaluating the clinical and cost-effectiveness of the ICLEAR-EU intervention for people with advanced COPD in different healthcare systems in Europe. ICLEAR-EU is a person-centred and family-centred non-pharmacological service intervention in which respiratory teams in the hospital collaborate with interdisciplinary palliative care teams and with primary care to promote shared decision-making and advance care planning, improve symptom treatment and comfort care, and prevent re-hospitalization after an exacerbation. ICLEAR-EU is based on an existing intervention developed and pilot tested in the UK. In EU PAL-COPD, the effectiveness of ICLEAR-EU will be assessed with a stepped wedge cluster RCT in 1,224 people with advanced COPD in 18 hospitals across six European countries. It is hence the first large-scale international trial on systematic integration of palliative care in respiratory care for people with advanced COPD. Cost-effectiveness, robust mixed methods subgroup analyses and in-depth process and implementation evaluations are also included. EU PAL-COPD will improve the well-being and empowerment of people with COPD and their families and advance the state of the art by providing an innovative service model to the complex palliative and end-of-life care needs. User and stakeholder involvement is crucial throughout the project.