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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Early Warning Score, Risk Stratification
- 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 group | Role | What they receive |
|---|---|---|
| Control Arm - standard EWS procedure | Active comparator | 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. Receives: Behavioral: Standard EWS - Control (Trigger Tool) |
| Intervention Arm - I-EWS | Active comparator | 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. 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.
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
The number of NEWS/I-EWS scores per patient per day
Measured: Assessed after one year, after completion of the study
Secondary outcomes (3)
Length of hospital stay
Calculated as days from date of index admission to date of discharge
Measured: 30 days
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
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.
- First posted1 Oct 2018
- Study start1 Oct 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Warning ScoreStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kasper Iversen, Herlev Hospital
- Investigators
- Kasper Iversen, MD, DMSci, Study director, Department of Cardiology, Herlev Hospital
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 35599143Nielsen 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Early Warning Score (I-EWS) - Does Clinical Assessment Improve Detection of Acute Deterioration in Hospitalized Patients - a Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT03690128
- Acronym / sponsor ID
- 17017332
- Conditions
- Early Warning Score, Risk Stratification
- Keywords
- Clinical deterioration, Risk stratification, Patient Safety, Early Warning Score, Monitoring, Clinical assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150,000 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, cluster randomized, cross-over, non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Control Arm - standard EWS procedure | Active comparator | Behavioral: Standard EWS - Control (Trigger Tool)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. |
| Intervention Arm - I-EWS | Active comparator | Behavioral: I-EWS with incorporated clinical assessment (Trigger Tool)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Arm - I-EWS |
| Standard EWS - Control (Trigger Tool)Standard EWS - Based on principles of National Early Warning Score (NEWS) | Behavioural | Control Arm - standard EWS procedure |
Primary outcome
All Cause mortality at 30 days
Time frame: 30 days after index admission
Time frame starts at the beginning of the index admission, defined as first admission in the study period.
The number of NEWS/I-EWS scores per patient per day
Time frame: Assessed after one year, after completion of the study
3 secondary outcomes
Length of hospital stay
Time frame: 30 days
All Cause mortality at 2 days
Time frame: 2 days (48 hours) after index admission
All Cause mortality at 7 days
Time frame: 7 days (168 hours) after index admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Derived from this study: PubMed 35599143Nielsen 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.
- Derived from this study: PubMed 31915173Nielsen 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.
- Individual participant dataSharing planned: Undecided
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Rapid Response Teams - How and Who?
Hospital Rapid Response Team, Early Warning Score
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasper Iversen, MD, DMSci study director
Department of Cardiology, Herlev Hospital
8 sites in 1 country: see every site and its status.
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.