Design and deployment of the STEEER-AF trial to evaluate and improve guideline adherence: a cluster-randomized trial by the European Society of Cardiology and European Heart Rhythm Association
Author:
Sterliński Maciej1ORCID, Bunting Karina V23ORCID, Boriani Giuseppe4ORCID, Boveda Serge5ORCID, Guasch Eduard6789ORCID, Mont Lluís7910ORCID, Rajappan Kim11ORCID, Sommer Philipp12ORCID, Mehta Samir13ORCID, Sun Yongzhong13ORCID, Gale Chris P141516ORCID, van Deutekom Colinda17ORCID, Van Gelder Isabelle C17ORCID, Kotecha Dipak231819ORCID, , Allali Yann, Champsi Asgher, Deneke Thomas, Greeley Kaitlyn, Guy-Moyat Benoît, Laredo Mikael, Mobley Alastair, Ventura Maximina, Stanbury Mary, Lobban Trudie, Robinson Thompson, Potpara Tatjana, Marijon Eloi, Defaye Pascal, Baudinaud Pierre, Kochhaeuser Simon, Rauch Ursula, Sinner Moritz F, Proietti Marco, Diemberger Igor, Russo Vincenzo, Tubek Stanislaw, Buchta Piotr, Balsam Pawel, García-Izquierdo Eusebio, Roca Luque Ivo, Guerra Jose M, Thomas Dewi, Sohaib Afzal, Davies Mark J, Piot Olivier, Escande William, De Chillou Christian, De Guillebon Maxime, Anselme Frédéric, Cianci Andrea, Garcia Rodrigue, Maury Philippe, Pavin Dominique, Gandjbakhch Estelle, Sacher Frédéric, Hasni Karim, Garnier Fabien, Guenancia Charles, Lellouche Nicolas, Willems Stephan, Borlich Martin, Metzner Andreas, Ebert Hans-Holger, Shin Dong-In, Duncker David, Spitzer Stefan G, Nordbeck Peter, Tilz Roland R, Mazza Andrea, Valzania Cinzia, Padeletti Margherita, Bertini Matteo, Boriani Giuseppe, Imberti Jacopo F, Fumagalli Stefano, Rapacciuolo Antonio, Lica Gorzynska Monika, Gorlo Adam, Kostkiewicz Marcin, Sobieszek Grzegorz, Skrzyński Andrzej S, Gajda Robert, Wilk-Manowiec Hanna, Blicharz Jaroslaw, Gmiński Wiktor K, Czerski Tomasz, Bisbal Felipe, Anguera Ignasi, Lozano Teresa, Osca Joaquin, Merino Jose L, Calvo Naiara, Fernández-Armenta Juan, Acosta Juan, Rivas-Gandara Nuria, Cabanas Pilar, Trucco Emilce, Bond Richard, Ang Richard, Morais Shawn A A, Siong Ng Fu, Bates Mattew G D, Pedersen Michala, Raine Daniel T, Kalla Manish, Lovell Matthew J, Finlay Malcolm, Hasan Bhuiyan Arif, Qureshi Norman, Heidbuchel Hein, Döhner Wolfram, Iung Bernard, Price Susanna, Pürerfellner Helmut, Casadei Barbara, Kirchhof Paulus, Lyon Alex R, Banya Winston, Hatala Robert, Raatikainen Pekka
Affiliation:
1. Arrhythmia Center, National Institute of Cardiology , Warsaw , Poland 2. Institute of Cardiovascular Sciences, University of Birmingham , Medical School, Vincent Drive, Birmingham B15 2TT , UK 3. Cardiology Department, University Hospitals Birmingham NHS Foundation Trust , Birmingham , UK 4. Division of Cardiology, Department of Biomedical, Metabolic and Neural Sciences, Policlinico di Modena, University of Modena and Reggio Emilia , Modena , Italy 5. Heart Rhythm Management Department, Cardiology, Clinique Pasteur , Toulouse , France 6. Cardiology Department, Clinic Barcelona , Barcelona , Spain 7. Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) , Barcelona , Spain 8. Medicine Department, Universitat de Barcelona , Barcelona , Spain 9. Centro de Investigación Médica en Red—Enfermedades Cardiovasculares (CIBERCV) , Madrid , Spain 10. Arrhythmias Section, Cardiovascular Clinical Institute, Hospital Clínic, Universitat de Barcelona , Barcelona , Spain 11. Cardiology Department, Oxford University Hospitals NHS Foundation Trust , Headley Way, Oxford , UK 12. Clinic for Electrophysiology, Heart and Diabetes Center NRW , Georgstraße 11, Bad Oeynhausen , Germany 13. Birmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research , Birmingham , UK 14. Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds , Leeds , UK 15. Leeds Institute of Data Analytics, University of Leeds , Leeds , UK 16. Department of Cardiology, Leeds Teaching Hospitals , Leeds , UK 17. Department of Cardiology, University of Groningen, University Medical Centre Groningen , Groningen , The Netherlands 18. NIHR Birmingham Biomedical Research Centre , Heritage Building, Mindelsohn Way, Birmingham B15 2TH , UK 19. West Midlands NHS Secure Data Environment, University Hospitals Birmingham NHS Foundation Trust , Mindelsohn Way, Birmingham B15 2GW , UK
Abstract
Abstract
Aims
The aim is to describe the rationale, design, delivery, and baseline characteristics of the Stroke prevention and rhythm control Treatment: Evaluation of an Educational programme of the European society of cardiology in a cluster-Randomized trial in patients with Atrial Fibrillation (STEEER-AF) trial.
Methods and results
STEEER-AF is a pragmatic trial designed to objectively and robustly determine whether guidelines are adhered to in routine practice and evaluate a targeted educational programme for healthcare professionals. Seventy centres were randomized in six countries (France, Germany, Italy, Poland, Spain, and UK; 2022–23). The STEEER-AF centres recruited 1732 patients with a diagnosis of atrial fibrillation (AF), with a mean age of 68.9 years (SD 11.7), CHA2DS2-VASc score of 3.2 (SD 1.8), and 647 (37%) women. Eight hundred and forty-three patients (49%) were in AF at enrolment and 760 (44%) in sinus rhythm. Oral anticoagulant therapy was prescribed in 1543 patients (89%), with the majority receiving direct oral anticoagulants (1378; 89%). Previous cardioversion, antiarrhythmic drug therapy, or ablation was recorded in 836 patients (48.3%). Five hundred fifty-one patients (31.8%) were currently receiving an antiarrhythmic drug, and 446 (25.8%) were scheduled to receive a future cardioversion or ablation. The educational programme engaged 195 healthcare professionals across centres randomized to the intervention group, consisting of bespoke interactive online learning and reinforcement activities, supported by national expert trainers.
Conclusion
The STEEER-AF trial was successfully deployed across six European countries to investigate guideline adherence in real-world practice and evaluate if a structured educational programme for healthcare professionals can improve patient-level care.
Clinical Trial Registration
Clinicaltrials.gov, NCT04396418.
Funder
Boehringer Ingelheim BMS/Pfizer Alliance Bayer Daiichi Sankyo, and Boston Scientific Oxford National Institute for Health Research Biomedical Research Centre Birmingham British Heart Foundation Accelerator
Publisher
Oxford University Press (OUP)
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