Individual Early Warning Score (I-EWS)

NCT ID: NCT03690128

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-10-31

Brief Summary

Early Warning Score (EWS) is a clinical scoring system used in hospitals in Denmark and internationally to systematically observe admitted patients using a standardised response algorithm. Consisting of a score based on the patients' vital signs, it only leaves limited space for individual assessment. Patient safety but also resource utilisation is a key issue in health systems today. We have developed a new individual EWS system (I-EWS) that reintroduces the individual clinical assessment for a more personalised observation. Our hypothesis is that I-EWS will not increase the mortality among hospitalised patients compared to EWS but will improve workflow by reducing unnecessary observations and freeing staff resources, potentially leading to improved patient care. The impact of I-EWS on mortality, the occurrence of critical illness, and usage of staff resources will be evaluated in a prospective, cluster randomised, non-inferiority study conducted at eight hospitals in Denmark.

Detailed Description

Every year more than 250,000 patients are admitted in the Capital Region of Denmark. During admissions, the clinical track and trigger system "Early Warning Score" (EWS) is used to systematically observe and detect acutely deteriorating patients. The system is designed to prevent serious adverse events like unanticipated transfer to the intensive care unit, cardiac arrest and unexpected death. EWS consists of standardized measurements of the patient's vital signs and an escalation protocol that determines further actions based on the aggregated EWS score. At admission, and as a minimum twice a day, nurses measure vital signs on all hospitalized patients. Depending on the predetermined cut-off values (i.e. heart rate above 150 bpm = 3 points) an aggregated score is calculated. Based on the total score, the escalation protocol determines the time interval for the next measurement as well as a clinical action (i.e. call for attending doctor). EWS is developed to detect and to treat potentially deterioration of disease that might lead to critical illness and death. In its current form, there is only limited room for individual clinical assessment.

A standardized track and trigger system like EWS does not differentiate between different types of disease or the patient's individual physiological response. Therefore, there is a potential risk that the system fails to detect a patient with an abnormal stress response. Additionally; patients suffering from chronic illness might have different normal values than healthy patients, leading to unnecessarily excess observation, measurement, and suboptimal usage of limited staff resources.

Previous studies have shown that Early Warning System scores perform well for prediction of cardiac arrest and death within 48 hours, although the impact on health outcomes and resource utilization remains uncertain, often owing to methological limitations.

It is possible, but never studied before, whether the combination of vital signs with individual clinical assessment is a better tool for identifying hospitalized high-risk patients than the existing algorithms.

Further improvement and optimizing of the EWS is necessary, as there is potential to improve patient care and use staff resources more appropriate.

The purpose of the study is to investigate the impact of the I-EWS that has a systematic involvement of clinical assessment and the possibility to adjust the score, whilst keeping the same escalation protocol. I-EWS will be compared to the existing EWS with a focus on mortality, critical illness, and the use of staff resources.

Our hypothesis is that I-EWS, where clinical assessment is given a more prominent role will not increase the mortality among hospitalized patients but can reallocate personnel resources.

I-EWS is built in to electronic patient journal system "Sundhedsplatformen" it is only available in Sundhedsplatformen (SP) at hospitals assigned to I-EWS. Four hospitals are randomized to use I-EWS for 6,5 months, the remaining four hospitals are control hospitals using the current EWS in this period.

After 6,5 months a single cross-over will be preformed, and the previous control hospitals will use I-EWS over the next 6,5 months and the previous intervention hospitals, will go back to the current EWS for this period.

EWS scores and subsequent actions are documented in real time in SP. The first two weeks and final four weeks of each period will be excluded due to a implementation period. Data regarding patients, interventions and serious adverse events during hospitalization (i.e., cardiac arrest, the request of MET or unexpected death) will be accessed through SP and the Danish Central Registries (The Danish National Patient Registry, the Civil Registration System, DanArrest). After extraction, all data will be depersonalization and stored at a secured network in accordance with the current guidelines for data management in the Capital Region of Denmark.

Conditions

Early Warning Score; Risk Stratification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Arm - standard EWS procedure

Standard use of the current implement Early Warning System, based on the principles of the National Early Warning Score and with a standard escalation protocol.

Group Type: ACTIVE_COMPARATOR

Standard EWS - Control (Trigger Tool)

Intervention Type: BEHAVIORAL

Standard EWS - Based on principles of National Early Warning Score (NEWS)

Intervention Arm - I-EWS

Implementation of Individual Early Warning Score (I-EWS) with a systematic clinical assessment with a standard escalation protocol as intervention 7 parameters (Respiration rate, pulse, saturation, systolic blood pressure, consciousness, temperature, Oxygen) are registered , an aggregated score is generated. In the electronic patient journal (Sundhedsplatformen), the nursing staff is asked to reevaluate the aggregated score based on their clinical assessment of the patient. The aggregated score can be upgraded with up to 6 points and downgraded with up to 4.

This new I-EWS score interacts with the standard escalation protocol which defines the observation frequency and relevant clinical actions.

Group Type: ACTIVE_COMPARATOR

I-EWS with incorporated clinical assessment (Trigger Tool)

Intervention Type: BEHAVIORAL

In relation to systematic measurement of vital parameters the nursing staff will perform an individual clinical assessment of the patient and adjust the I-EWS score accordingly.

Interventions

I-EWS with incorporated clinical assessment (Trigger Tool)

In relation to systematic measurement of vital parameters the nursing staff will perform an individual clinical assessment of the patient and adjust the I-EWS score accordingly.

Intervention Type: BEHAVIORAL

Standard EWS - Control (Trigger Tool)

Standard EWS - Based on principles of National Early Warning Score (NEWS)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All patients ≥18 years of age admitted more than 24 hours to a ward at participating hospitals will be included.

Participating hospitals are

• Herlev & Gentofte Hospital
• Nordsjaellands Hospital
• Bispebjerg Hospital
• Rigshospitalet, Glostrup - Medical Ward
• Amager & Hvidovre Hospital
• Zealand University Hospital
• Slagelse Hospital
• Holbaek Hospital

Exclusion Criteria

• Wards not using standard EWS, paediatric, obstetric and intensive, due to they use special variations (Pediatric early warning score, Obstetric Early warning Score or continous monitoring).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kasper Iversen

Principal Investigator, Associate Professor, Consultant, DMSci

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kasper Iversen, MD, DMSci

Role: STUDY_DIRECTOR

Department of Cardiology, Herlev Hospital

Locations

Bispebjerg Hospital

Copenhagen, Capital Region of Denmark, Denmark

Amager & Hvidovre Hospital

Copenhagen, Capital Region of Denmark, Denmark

Herlev & Gentofte Hospital

Copenhagen, Capital Region of Denmark, Denmark

Rigshospital, Glostrup, Medical Ward

Glostrup Municipality, Capital Region of Denmark, Denmark

Nordsjaellands Hospital

Hillerød, Capital Region of Denmark, Denmark

Holbaek Hospital

Holbæk, Region of Zealand, Denmark

Zealand University Hospital (Roskilde & Køge)

Roskilde, Region of Zealand, Denmark

Slagelse Sygehus

Slagelse, Region of Zealand, Denmark

Countries

Denmark

References

Nielsen PB, Langkjaer CS, Schultz M, Kodal AM, Pedersen NE, Petersen JA, Lange T, Arvig MD, Meyhoff CS, Bestle MH, Holge-Hazelton B, Bunkenborg G, Lippert A, Andersen O, Rasmussen LS, Iversen KK. Clinical assessment as a part of an early warning score-a Danish cluster-randomised, multicentre study of an individual early warning score. Lancet Digit Health. 2022 Jul;4(7):e497-e506. doi: 10.1016/S2589-7500(22)00067-X. Epub 2022 May 19.

Reference Type: DERIVED

PMID: 35599143 (View on PubMed)

Nielsen PB, Schultz M, Langkjaer CS, Kodal AM, Pedersen NE, Petersen JA, Lange T, Arvig MD, Meyhoff CS, Bestle M, Holge-Hazelton B, Bunkenborg G, Lippert A, Andersen O, Rasmussen LS, Iversen KK. 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.

Reference Type: DERIVED

PMID: 31915173 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

17017332

Identifier Type: -

Identifier Source: org_study_id