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
12 affiliations
- 1End-of-Life Care Research Group, Vrije Universiteit Brussel, Brussels, Belgium
- 2Lancaster University, Lancaster, UK
- 3Manchester University NHS Foundation Trust, Manchester, UK
- 4Radboud University Medical Center, Nijmegen, Netherlands
- 5End-of-Life Care Research Group, Ghent University, Ghent, Belgium
- 6Pecsi Tudomanyegyetem - University of Pécs, Pécs, Hungary
- 7Kobenhavns Universitet, Copenhagen, Denmark
- 8King’s College London, London, UK
- 9Universidade Catolica Portuguesa, Porto, Portugal
- 10Universidade dos Açores | Fundação Gaspar Frutuoso (FGF), Ponta Delgada, Portugal
- 11Long Alliantie Nederland, Amersfoort, Netherlands
- 12University College London, London, UK
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.
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BibTeX
@article{meer2026integrating,
title = {{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}},
author = {Michelle Martine Huub Van Der Meer and Julie Stevens and Frederick Daenen and Nancy Preston and Paul Marsden and Anne Wichmann and Kim Beernaert and Laure Dombrecht and Ágnes Csikós and Mogens Grønvold and Nanna Maria Hammer and Peter May and Diogo Queiroz Almeida and Sandra Martins Pereira and Pablo Hernández-Marrero and Els Verschuur and Libby Sallnow and Luc Deliens and Koen Pardon and consortium EU PAL-COPD and Mishka Beutels and Yvonne Engels and Manon Wubbels and Kim Eecloo and Marie Van de Walle and Catherine Walshe and Paul Marsden and Tim Gatheral and Didar Karadag Akkaya and Elham Nikram and Maria Conceição Silva and Eva Poszgai and Balázs Daniel Fülöp and Réka Gajdócsi and André Ribeiro},
journal = {BMJ Open Respiratory Research},
year = {2026},
month = nov,
doi = {10.1136/bmjresp-2026-004150},
url = {https://doi.org/10.1136/bmjresp-2026-004150},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - 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
AU - Michelle Martine Huub Van Der Meer
AU - Julie Stevens
AU - Frederick Daenen
AU - Nancy Preston
AU - Paul Marsden
AU - Anne Wichmann
AU - Kim Beernaert
AU - Laure Dombrecht
AU - Ágnes Csikós
AU - Mogens Grønvold
AU - Nanna Maria Hammer
AU - Peter May
AU - Diogo Queiroz Almeida
AU - Sandra Martins Pereira
AU - Pablo Hernández-Marrero
AU - Els Verschuur
AU - Libby Sallnow
AU - Luc Deliens
AU - Koen Pardon
AU - consortium EU PAL-COPD
AU - Mishka Beutels
AU - Yvonne Engels
AU - Manon Wubbels
AU - Kim Eecloo
AU - Marie Van de Walle
AU - Catherine Walshe
AU - Paul Marsden
AU - Tim Gatheral
AU - Didar Karadag Akkaya
AU - Elham Nikram
AU - Maria Conceição Silva
AU - Eva Poszgai
AU - Balázs Daniel Fülöp
AU - Réka Gajdócsi
AU - André Ribeiro
PY - 2026
DA - 2026/11/02
JO - BMJ Open Respiratory Research
DO - 10.1136/bmjresp-2026-004150
UR - https://doi.org/10.1136/bmjresp-2026-004150
AB - 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.
SN - 2052-4439
ER -