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.

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.