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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)
  1. Pernille B Nielsen1,2,
  2. Martin Schultz1,2,
  3. Caroline Sophie Langkjaer3,
  4. Anne Marie Kodal4,
  5. Niels Egholm Pedersen5,
  6. John Asger Petersen6,
  7. Theis Lange7,8,
  8. Michael Dan Arvig9,10,
  9. Christian Sahlholt Meyhoff10,11,
  10. Morten Bestle4,10,
  11. Bibi Hølge-Hazelton12,13,
  12. Gitte Bunkenborg14,
  13. Anne Lippert15,
  14. Ove Andersen10,16,
  15. Lars Simon Rasmussen5,10,
  16. Kasper Karmark Iversen1,2,10
  1. 1 Department of Emergency Medicine, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark
  2. 2 Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark
  3. 3 Department of Emergency Medicine, Nordsjaellands Hospital, Hillerod, Denmark
  4. 4 Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital, Hillerod, Denmark
  5. 5 Department of Anaesthesia, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
  6. 6 Department of Day Surgery, Amager and Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark
  7. 7 Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark
  8. 8 Center for Statistical Science, Peking University, Beijing, China
  9. 9 Department of Emergency Medicine, Slagelse Hospital, Slagelse, Denmark
  10. 10 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
  11. 11 Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark
  12. 12 Research Support Unit, Zealand University Hospital Roskilde, Roskilde, Denmark
  13. 13 Department of Regional Studies, University of Southern Denmark, Odense, Denmark
  14. 14 Department of Anesthesiology, Holbaek Hospital, Holbaek, Denmark
  15. 15 Copenhagen Academy for Medical Education and Simulation, Herlev, Denmark
  16. 16 Clinical Research Centre, Amager and Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark
  1. Correspondence to Pernille B Nielsen; pernille.brok.nielsen{at}regionh.dk

Abstract

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.

  • risk management
  • emergency medicine
  • clinical deterioration
  • early warning scores
  • rapid response systems
  • health and safety
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Footnotes

  • Contributors PBN, KKI, MS, CSL has drafted the manuscript. AMK, GB, NEP, JAP, MDA, CSM, MB, AL, BH-H, OA, TL and LSR contributed to the discussion, reviewed and edited the manuscript. KKI had the original idea for the study. All authors read and approved the final manuscript.

  • Funding The work is supported by the Laerdal Foundation, the Gangsted Foundation, Candys Foundation, the Herlev-Gentofte Hospital Research Foundation and the Capital Region Research Foundation.

  • Disclaimer The funders have no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of manuscripts; or in the decisions to publish.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The study and substudy were presented for the Regional Ethics committee who decided that no formal approval was needed according to Danish law (J.no. 1701733, J. no. H-18053090).The study data management has been approved by the Danish Data Protection agency (j.no.: HGH-2017–116 I-suite med no. 06030).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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