Integrating palliative care into respiratory care for people with advanced COPD: study protocol for the international EU PAL-COPD stepped wedge cluster randomised controlled trial of the ICLEAR-EU intervention
Year: 2026
Type: article
Study design: Study Protocol
Abstract: Introduction Individuals with advanced chronic obstructive pulmonary disease (COPD) often experience significant symptom burden, unmet care needs and frequent hospitalisations, yet remain underserved by palliative care. Evidence suggests palliative care can improve quality of life and reduce avoidable hospital readmissions but robust multi-country randomised evaluations are lacking. Building on a successful pilot subsequently adapted, this protocol presents the EU PAL-COPD study evaluating the ICLEAR-EU intervention to reduce potentially avoidable respiratory-related readmission within 90 days and improve quality of life for individuals with advanced COPD and their families across European health systems.Methods and analysis A stepped-wedge cluster randomised controlled trial evaluating the effectiveness of the ICLEAR-EU intervention in Belgium, the UK, the Netherlands, Hungary, Denmark and Portugal, comparing ICLEAR-EU to usual care. ICLEAR-EU is an integrated non-pharmacological service intervention for hospitalised patients with advanced COPD to identify and address palliative care needs. Hospitals (clusters) cross over from usual care to intervention in four 6-month wedges after a 30-day transition/training period. Eligible participants are community-dwelling adults with advanced COPD admitted ≥48 hours for an acute exacerbation; each may nominate a family caregiver. We aim to enrol 1224 patients across 18 hospitals (three per country). The primary endpoint is the percentage of patients with respiratory-related hospital readmissions within 90 days of baseline (or until death if within 90 days). Secondary endpoints include patient and family caregiver quality of life, well-being, healthcare utilisation and cost-effectiveness at 30- and 90-day follow-up. Process evaluation will be conducted throughout. Analyses follow intention-to-treat using mixed-effects models accounting for clustering, time and country. The statistical analysis plan is provided as supplementary material.Ethics and dissemination Ethics approval was obtained in all participating countries and hospitals. Findings on effectiveness, cost-effectiveness and process evaluation will be disseminated via academic channels and established project communication channels.Trial registration number ISRCTN45800298.
Source: BMJ Open Respiratory Research
Authors: Michelle Martine Huub Van Der Meer, Julie Stevens, Frederick Daenen, Nancy Preston, Paul Marsden, Anne Wichmann, Kim Beernaert, Laure Dombrecht, Ágnes Csikós, Mogens Grønvold, Nanna Maria Hammer, Peter May, Diogo Queiroz Almeida, Sandra Martins Pereira, Pablo Hernández-Marrero, Els Verschuur, Libby Sallnow, Luc Deliens, Koen Pardon
Institutions: Vrije Universiteit Brussel, Lancaster University, Manchester University NHS Foundation Trust, Radboud University Medical Center, Ghent University, University of Pecs, University of Copenhagen, King's College London, Universidade Católica Portuguesa, Universidade dos Açores, Fundação Gaspar Frutuoso, University College London
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,085
Funders: Universidade de Aveiro, European Respiratory Society, UK Research and Innovation, Amsterdam University Medical Centers, European Commission, University of Wollongong, Universiteit Maastricht, Vrije Universiteit Brussel, Staatssekretariat für Bildung, Forschung und Innovation, Nemzeti Kutatási, Fejlesztési és Innovaciós Alap, European Health and Digital Executive Agency
Awards: 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., Evaluation of the ICLEAR-EU intervention to integrate palliative care in thetreatment of people with advanced COPD and their family caregivers: Aninternational stepped wedge cluster RCT in six European countries.
OpenAlex ID: W7225169930