Adjusting Early Warning Score by clinical assessment: a study protocol for a Danish cluster-randomised, multicentre study of an Individual Early Warning Score (I-EWS)
Lars Simon Rasmussen,
Kasper Karmark Iversen,
Theis Lange,
Gitte Bunkenborg,
Pernille B Nielsen,
Martin Schultz,
Caroline Sophie Langkjaer,
Anne Marie Kodal,
Niels Egholm Pedersen,
John Asger Petersen,
Michael Dan Arvig,
Christian Sahlholt Meyhoff,
Morten Bestle,
Bibi Hølge-Hazelton,
Anne Lippert,
Ove Andersen
Affiliations
Lars Simon Rasmussen
10 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
Kasper Karmark Iversen
2 Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark
Theis Lange
Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark
Gitte Bunkenborg
14 Department of Anesthesiology, Holbaek Hospital, Holbaek, Denmark
Pernille B Nielsen
1 Department of Emergency Medicine, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark
Martin Schultz
CopenAge; Copenhagen Center for Clinical Age Research, University of Copenhagen, Copenhagen, Denmark
Caroline Sophie Langkjaer
3 Department of Emergency Medicine, Nordsjaellands Hospital, Hillerod, Denmark
Anne Marie Kodal
4 Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital, Hillerod, Denmark
Niels Egholm Pedersen
5 Department of Anaesthesia, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
John Asger Petersen
6 Department of Day Surgery, Amager and Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark
Michael Dan Arvig
10 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
Christian Sahlholt Meyhoff
10 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
Morten Bestle
Department of Anaesthesiology and Intensive care, Nordsjaellands Hospital, Hillerod, Denmark
Bibi Hølge-Hazelton
12 Research Support Unit, Zealand University Hospital Roskilde, Roskilde, Denmark
Anne Lippert
15 Copenhagen Academy for Medical Education and Simulation, Herlev, Denmark
Ove Andersen
10 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
Introduction Track and trigger systems (TTSs) based on vital signs are implemented in hospitals worldwide to identify patients with clinical deterioration. TTSs may provide prognostic information but do not actively include clinical assessment, and their impact on severe adverse events remain uncertain. The demand for prospective, multicentre studies to demonstrate the effectiveness of TTSs has grown the last decade. Individual Early Warning Score (I-EWS) is a newly developed TTS with an aggregated score based on vital signs that can be adjusted according to the clinical assessment of the patient. The objective is to compare I-EWS with the existing National Early Warning Score (NEWS) algorithm regarding clinical outcomes and use of resources.Method and analysis In a prospective, multicentre, cluster-randomised, crossover, non-inferiority study. Eight hospitals are randomised to use either NEWS in combination with the Capital Region of Denmark NEWS Override System (CROS) or implement I-EWS for 6.5 months, followed by a crossover. Based on their clinical assessment, the nursing staff can adjust the aggregated score with a maximum of −4 or +6 points. We expect to include 150 000 unique patients. The primary endpoint is all-cause mortality at 30 days. Coprimary endpoint is the average number of times per day a patient is NEWS/I-EWS-scored, and secondary outcomes are all-cause mortality at 48 hours and at 7 days as well as length of stay.Ethics and dissemination The study was presented for the Regional Ethics committee who decided that no formal approval was needed according to Danish law (J.no. 1701733). The I-EWS study is a large prospective, randomised multicentre study that investigates the effect of integrating a clinical assessment performed by the nursing staff in a TTS, in a head-to-head comparison with the internationally used NEWS with the opportunity to use CROS.Trial registration number NCT03690128.
