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Early Warning ScoreNCT03690128

Individual Early Warning Score (I-EWS)

A study testing I-EWS with incorporated clinical assessment (Trigger Tool) in people with Early Warning Score and Risk Stratification, run by Herlev Hospital at 8 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Early Warning Score, Risk Stratification
What is being tested?
I-EWS with incorporated clinical assessment (Trigger Tool)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150,000 participants
Where
8 sitesDenmark
Study dates
1 Oct 2018to 31 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • Amager \& Hvidovre Hospital
  • Zealand University Hospital
  • Slagelse Hospital
  • Holbaek Hospital

Who cannot join

  • 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).

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Denmark8 sites
  • Bispebjerg Hospital

    Copenhagen, Capital Region of Denmark, 2400

  • Amager & Hvidovre Hospital

    Copenhagen, Capital Region of Denmark, 2650

  • Herlev & Gentofte Hospital

    Copenhagen, Capital Region of Denmark, 2730

  • Rigshospital, Glostrup, Medical Ward

    Glostrup Municipality, Capital Region of Denmark, 2600

  • Nordsjaellands Hospital

    Hillerød, Capital Region of Denmark, 3400

  • Holbaek Hospital

    Holbæk, Region of Zealand, 4300

  • Zealand University Hospital (Roskilde & Køge)

    Roskilde, Region of Zealand, 4000

  • Slagelse Sygehus

    Slagelse, Region of Zealand, 4200

Other trials in Denmark

About this study

Official title: Individual Early Warning Score (I-EWS) - Does Clinical Assessment Improve Detection of Acute Deterioration in Hospitalized Patients - a Cluster-randomized Trial

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.

Read the 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.

Being tested
I-EWS with incorporated clinical assessment (Trigger Tool), Standard EWS - Control (Trigger Tool)
Keywords
Clinical deterioration, Risk stratification, Patient Safety, Early Warning Score, Monitoring, Clinical assessment
Medical subject headings
Clinical Deterioration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-EWS with incorporated clinical assessment (Trigger Tool)Behavioural

    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.

  • Standard EWS - Control (Trigger Tool)Behavioural

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

Study groups in NCT03690128
Study groupRoleWhat they receive
Control Arm - standard EWS procedureActive comparatorStandard use of the current implement Early Warning System, based on the principles of the National Early Warning Score and with a standard escalation protocol.
Receives: Behavioral: Standard EWS - Control (Trigger Tool)
Intervention Arm - I-EWSActive comparatorImplementation 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.
Receives: Behavioral: I-EWS with incorporated clinical assessment (Trigger Tool)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All Cause mortality at 30 days

    Time frame starts at the beginning of the index admission, defined as first admission in the study period.

    Measured: 30 days after index admission

  2. The number of NEWS/I-EWS scores per patient per day

    Measured: Assessed after one year, after completion of the study

Secondary outcomes (3)
  1. Length of hospital stay

    Calculated as days from date of index admission to date of discharge

    Measured: 30 days

  2. All Cause mortality at 2 days

    Time frame starts at the beginning of the index admission, defined as first admission in the study period.

    Measured: 2 days (48 hours) after index admission

  3. All Cause mortality at 7 days

    Time frame starts at the beginning of the index admission, defined as first admission in the study period.

    Measured: 7 days (168 hours) after index admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2018
  2. Study start1 Oct 2018
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective, cluster randomized, cross-over, non-inferiority study
Masking
None (open label)
Enrolment
150,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03690128
Sponsor's protocol ID
17017332
Status last verified
Nov 2019
First submitted
26 Sep 2018
Last updated
4 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35599143
  • 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.

    PubMed 31915173

Questions about this trial

What is this clinical trial studying?

A study testing I-EWS with incorporated clinical assessment (Trigger Tool) in people with Early Warning Score and Risk Stratification, run by Herlev Hospital at 8 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cause mortality at 30 days (time frame: 30 days after index admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03690128, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.

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