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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)

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Nielsen, PB, Schultz, M, Langkjaer, CS, Kodal, AM, Pedersen, NE, Petersen, JA, Lange, T, Arvig, MD, Meyhoff, CS, Bestle, M, Hølge-Hazelton, B, Bunkenborg, G, Lippert, A, Andersen, O, Rasmussen, LS & Iversen, KK 2020, '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, bind 10, nr. 1, s. e033676. https://doi.org/10.1136/bmjopen-2019-033676

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Nielsen, Pernille B ; Schultz, Martin ; Langkjaer, Caroline Sophie ; Kodal, Anne Marie ; Pedersen, Niels Egholm ; Petersen, John Asger ; Lange, Theis ; Arvig, Michael Dan ; Meyhoff, Christian Sahlholt ; Bestle, Morten ; Hølge-Hazelton, Bibi ; Bunkenborg, Gitte ; Lippert, Anne ; Andersen, Ove ; Rasmussen, Lars Simon ; Iversen, Kasper Karmark. / 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). I: BMJ Open. 2020 ; Bind 10, Nr. 1. s. e033676.

Bibtex

@article{fe113be1e9dd4c6e8b9ae6f07b8f6089,
title = "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)",
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.",
author = "Nielsen, {Pernille B} and Martin Schultz and Langkjaer, {Caroline Sophie} and Kodal, {Anne Marie} and Pedersen, {Niels Egholm} and Petersen, {John Asger} and Theis Lange and Arvig, {Michael Dan} and Meyhoff, {Christian Sahlholt} and Morten Bestle and Bibi H{\o}lge-Hazelton and Gitte Bunkenborg and Anne Lippert and Ove Andersen and Rasmussen, {Lars Simon} and Iversen, {Kasper Karmark}",
note = "{\circledC} Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2020",
month = "1",
day = "7",
doi = "10.1136/bmjopen-2019-033676",
language = "English",
volume = "10",
pages = "e033676",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Adjusting Early Warning Score by clinical assessment

T2 - a study protocol for a Danish cluster-randomised, multicentre study of an Individual Early Warning Score (I-EWS)

AU - Nielsen, Pernille B

AU - Schultz, Martin

AU - Langkjaer, Caroline Sophie

AU - Kodal, Anne Marie

AU - Pedersen, Niels Egholm

AU - Petersen, John Asger

AU - Lange, Theis

AU - Arvig, Michael Dan

AU - Meyhoff, Christian Sahlholt

AU - Bestle, Morten

AU - Hølge-Hazelton, Bibi

AU - Bunkenborg, Gitte

AU - Lippert, Anne

AU - Andersen, Ove

AU - Rasmussen, Lars Simon

AU - Iversen, Kasper Karmark

N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2020/1/7

Y1 - 2020/1/7

N2 - 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.

AB - 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.

U2 - 10.1136/bmjopen-2019-033676

DO - 10.1136/bmjopen-2019-033676

M3 - Journal article

VL - 10

SP - e033676

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 1

ER -

ID: 58942461