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.

Project Information

EU PAL-COPD

Grant agreement ID: 101136621

DOI

10.3030/101136621

EC signature date 8 December 2023

Start date 1 January 2024

End date 31 December 2028

Funded under

• Health

Total cost

€ 5 162 444,33

EU contribution

€ 5 162 444,25

Coordinated by

VRIJE UNIVERSITEIT BRUSSEL
Belgium

Periodic Reporting for period 1 - 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.)

Reporting period: 2024-01-01 to 2025-06-30

Summary of the context and overall objectives of the project

Chronic Obstructive Pulmonary Disease (COPD) is one of the leading causes of death worldwide and places a heavy burden on patients, their families, and healthcare systems. People with advanced COPD often experience severe breathlessness, fatigue, and psychological distress. Despite this, palliative care is rarely integrated into standard respiratory care, leaving many patients and families without adequate support in dealing with symptoms, decision-making, and end-of-life planning.

The EU PAL-COPD project (https://eupal-copd.eu/) responds to this urgent need. It evaluates ICLEAR-EU, an innovative service model that embeds palliative care into hospital-based respiratory care and strengthens collaboration with community and primary care services. ICLEAR-EU stands for Identification, Communication, Levels of Escalation, Advance Care Planning, and continuous Review of patient and caregiver needs.

The overall objectives are to:
- Adapt and standardise the existing UK-based ICLEAR model into ICLEAR-EU for use across Europe.
- Test its effectiveness and cost-effectiveness through a large international stepped wedge cluster randomised controlled trial in 18 hospitals across six countries, including 1,224 people with advanced COPD.
- Evaluate its impact on patients, families, and healthcare providers, particularly in terms of quality of life, empowerment, reduced hospitalisations, and support for preferred place of care.
- Understand implementation processes and conditions for sustainability across diverse healthcare systems.

By building robust evidence on effectiveness and feasibility, EU PAL-COPD aims to transform the way palliative care is integrated into COPD treatment in Europe, improving patient well-being while supporting more sustainable healthcare delivery.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the first reporting period (January 2024 – June 2025), the consortium focused on adaptation, preparation, and feasibility testing. Key achievements include:

- Governance and coordination: Establishment of the Supervisory Board, Management Board, and International Scientific Advisory Board, ensuring scientific and ethical oversight.
- Adaptation of the intervention (ICLEAR-EU): Through workshops and co-design with patients, caregivers, clinicians, and stakeholders, the UK-based ICLEAR model was adapted to the European context, producing a standardised version with clear implementation manuals.
- Training development: A multi-country training package for respiratory and palliative care teams was designed, including online modules, case-based learning, and communication skills training.
- Trial preparation: A comprehensive protocol for the stepped wedge trial was finalised, harmonised across six national ethics committees, and supported by a secure REDCap platform for data collection.
- Feasibility testing: Pilot studies in several hospitals confirmed the acceptability of ICLEAR-EU and the practicality of the data collection tools.
- Cost-effectiveness framework: Methods and instruments were developed for assessing healthcare use, quality of life, and long-term economic outcomes.

Together, these efforts have created a strong foundation for the start of the main trial in the next reporting period.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

EU PAL-COPD is the first large-scale international trial to systematically evaluate palliative care integration in COPD treatment. Its contributions beyond the current state of the art include:

- A standardised, person- and family-centred model (ICLEAR-EU) that can be implemented across different health systems.
- Evidence on cost-effectiveness of integrated palliative care in COPD, an area with virtually no large-scale data.
- Equity-focused analyses, assessing how gender, age, socioeconomic background, and geographical setting affect outcomes.
- A rich implementation evaluation, identifying barriers and facilitators for uptake in diverse hospital and community settings.

The expected long-term impact is a scalable and transferable model of care that reduces avoidable hospitalisations, improves patient and caregiver quality of life, and supports health systems in providing more sustainable care for chronic conditions.

EU PAL-COPD ICLEAR chart

EU PAL-COPD's consortium