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)

Pernille B Nielsen; Martin Schultz; Caroline Sophie Langkjaer; Anne Marie Kodal; Niels Egholm Pedersen; John Asger Petersen; Theis Lange; Michael Dan Arvig; Christian Sahlholt Meyhoff; Morten Bestle; Bibi Hølge-Hazelton; Gitte Bunkenborg; Anne Lippert; Ove Andersen; Lars Simon Rasmussen; Kasper Karmark Iversen

doi:10.1136/bmjopen-2019-033676

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)

BMJ Open. 2020 Jan 7;10(1):e033676. doi: 10.1136/bmjopen-2019-033676.

Authors

Pernille B Nielsen^{1

2}, Martin Schultz^{3

2}, Caroline Sophie Langkjaer⁴, Anne Marie Kodal⁵, Niels Egholm Pedersen⁶, John Asger Petersen⁷, Theis Lange^{8

9}, Michael Dan Arvig^{10

11}, Christian Sahlholt Meyhoff^{11

12}, Morten Bestle^{5

11}, Bibi Hølge-Hazelton^{13

14}, Gitte Bunkenborg¹⁵, Anne Lippert¹⁶, Ove Andersen^{11

17}, Lars Simon Rasmussen^{6

11}, Kasper Karmark Iversen^{3

2

11}

Affiliations

¹ Department of Emergency Medicine, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark pernille.brok.nielsen@regionh.dk.
² Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
³ Department of Emergency Medicine, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
⁴ Department of Emergency Medicine, Nordsjaellands Hospital, Hillerod, Denmark.
⁵ Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital, Hillerod, Denmark.
⁶ Department of Anaesthesia, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
⁷ Department of Day Surgery, Amager and Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.
⁸ Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
⁹ Center for Statistical Science, Peking University, Beijing, China.
¹⁰ Department of Emergency Medicine, Slagelse Hospital, Slagelse, Denmark.
¹¹ Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
¹² Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.
¹³ Research Support Unit, Zealand University Hospital Roskilde, Roskilde, Denmark.
¹⁴ Department of Regional Studies, University of Southern Denmark, Odense, Denmark.
¹⁵ Department of Anesthesiology, Holbaek Hospital, Holbaek, Denmark.
¹⁶ Copenhagen Academy for Medical Education and Simulation, Herlev, Denmark.
¹⁷ Clinical Research Centre, Amager and Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.

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.

Keywords: clinical deterioration; early warning scores; emergency medicine; health and safety; rapid response systems; risk management.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Algorithms
Cause of Death
Clinical Deterioration
Cross-Over Studies
Denmark
Early Warning Score*
Hospital Mortality
Humans
Length of Stay
Multicenter Studies as Topic
Nursing Assessment* / methods
Nursing Staff, Hospital*
Prognosis
Prospective Studies
Randomized Controlled Trials as Topic
Vital Signs

Associated data

ClinicalTrials.gov/NCT03690128