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Individual Early Warning Score (I-EWS)

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ClinicalTrials.gov Identifier: NCT03690128
Recruitment Status : Completed
First Posted : October 1, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Kasper Iversen, Herlev Hospital

Tracking Information
First Submitted Date  ICMJE September 26, 2018
First Posted Date  ICMJE October 1, 2018
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • Length of hospital stay [ Time Frame: 30 days ]
    Calculated as days from date of index admission to date of discharge
  • All Cause mortality at 2 days [ Time Frame: 2 days (48 hours) after index admission ]
    Time frame starts at the beginning of the index admission, defined as first admission in the study period.
  • All Cause mortality at 7 days [ Time Frame: 7 days (168 hours) after index admission ]
    Time frame starts at the beginning of the index admission, defined as first admission in the study period.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2019)
  • Frequency of changes in I-EWS scores that lead to an escalation or de-escalation in the escalation protocol [ Time Frame: Assessed after one year, after completion of the study ]
  • Comparison of changes in EWS score due to I-EWS modification (intervention group) and due to temporary or chronic acceptable values (control group) [ Time Frame: Assessed after one year, after completion of the study ]
  • The number of Cardiac arrests* during hospital stay, reported in numbers (%) [ Time Frame: Assessed after one year, after completion of the study ]
    *Definition - Presence of a clinical cardiac arrest (as defined in the resuscitation guidelines) in patients without a DNAR (Do Not Attempt Resuscitation) order. Registered in DANARREST.
  • The number of Cardiac arrests* during hospital stay, reported in number per 10,000 ward days [ Time Frame: Assessed after one year, after completion of the study ]
    *Definition - Presence of a clinical cardiac arrest (as defined in the resuscitation guidelines) in patients without a DNAR (Do Not Attempt Resuscitation) order. Registered in DANARREST.
  • Scores generating a call for Mobile Emergency team (MET) reported in absolute number (%) [ Time Frame: Assessed after one year, after completion of the study ]
  • Scores generating a call for Mobile Emergency team (MET) reported in absolute per 10,000 ward days [ Time Frame: Assessed after one year, after completion of the study ]
  • Scores generating a call for the attending doctor, reported in absolute number (%) [ Time Frame: Assessed after one year, after completion of the study ]
  • Scores generating a call for the attending doctor, reported per 10,000 ward days [ Time Frame: Assessed after one year, after completion of the study ]
  • All cause mortality - Subgroup analysis of patients admitted to Herlev-Gentofte Hospital [ 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.
  • All cause mortality - Subgroup analysis of patients admitted to Nordsjaellands Hospital [ 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.
  • All cause mortality - Subgroup analysis of patients admitted to Bispebjerg Hospital [ 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.
  • All cause mortality - Subgroup analysis of patients admitted to Glostrup Hospital (Medical Ward) [ 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.
  • All cause mortality - Subgroup analysis of patients admitted to Amager-Hvidovre Hospital [ 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.
  • All cause mortality - Subgroup analysis of patients admitted to Zealand University Hospital [ 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.
  • All cause mortality - Subgroup analysis of patients admitted to Slagelse Hospital [ 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.
  • All cause mortality - Subgroup analysis of patients admitted to Holbaek Hospital [ 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.
  • All cause mortality - Subgroup analysis of patients Age ≤ 39 years [ 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.
  • All cause mortality - Subgroup analysis of patients Age 40 to 69 years [ 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.
  • All cause mortality - Subgroup analysis of patients Age ≥ 70 years [ 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.
  • All cause mortality - Subgroup analysis of patients diagnosed with cardiovascular disease [ 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.
  • All cause mortality - Subgroup analysis of patients diagnosed with cancer disease [ 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.
  • All cause mortality - Subgroup analysis of patients diagnosed with pulmonary disease [ 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.
  • All cause mortality - Subgroup analysis of patients diagnosed with infectious disease [ 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.
  • All cause mortality - Subgroup analysis of patients diagnosed with neurological disease [ 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.
  • All cause mortality - Subgroup analysis of patients diagnosed with surgical condition [ 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 - Subgroup analysis of patients admitted to Herlev-Gentofte Hospital [ 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 - Subgroup analysis of patients admitted to Nordsjaellands Hospital [ 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 - Subgroup analysis of patients admitted to Bispebjerg Hospital [ 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 - Subgroup analysis of patients admitted to Amager-Hvidovre Hospital [ 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 - Subgroup analysis of patients admitted to Zealand University Hospital [ 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 - Subgroup analysis of patients admitted to Slagelse Hospital [ 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 - Subgroup analysis of patients admitted to Holbaek Hospital [ 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 - Subgroup analysis of patients Age ≤ 39 years [ 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 - Subgroup analysis of patients Age 40 to 69 years [ 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 - Subgroup analysis of patients Age ≥ 70 years [ 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 - Subgroup analysis of patients diagnosed with cancer [ 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 - Subgroup analysis of patients diagnosed with cardiovascular disease [ 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 - Subgroup analysis of patients diagnosed with pulmonary disease [ 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 - Subgroup analysis of patients diagnosed with infectious disease [ 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 - Subgroup analysis of patients diagnosed with neurological disease [ 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 - Subgroup analysis of patients diagnosed with surgical condition [ 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.
Original Other Pre-specified Outcome Measures
 (submitted: September 27, 2018)
  • The number of EWS scores per patient per day [ Time Frame: Assessed after one year, after completion of the study ]
  • The number of I-EWS scores per patient per day [ Time Frame: Assessed after one year, after completion of the study ]
  • Frequency of changes in I-EWS scores that lead to an escalation or de-escalation in the escalation protocol [ Time Frame: Assessed after one year, after completion of the study ]
  • Comparison of changes in EWS score due to I-EWS modification (intervention group) and due to temporary or chronic acceptable values (control group) [ Time Frame: Assessed after one year, after completion of the study ]
  • The number of Cardiac arrests* during hospital stay, reported in numbers [ Time Frame: Assessed after one year, after completion of the study ]
    If there is no difference in the mean length of hospital stay we will report this outcome measures. * *Definition - Presence of a clinical cardiac arrest (as defined in the resuscitation guidelines) in patients without a DNAR (Do Not Attempt Resuscitation) order. Registered in DANARREST.
  • The number of Cardiac arrests* during hospital stay, reported in number per 10,000 ward days [ Time Frame: Assessed after one year, after completion of the study ]
    If there is no difference in the mean length of hospital stay we will report this outcome measures. **Definition - Presence of a clinical cardiac arrest (as defined in the resuscitation guidelines) in patients without a DNAR (Do Not Attempt Resuscitation) order. Registered in DANARREST.
  • The number of Mobile Emergency team (MET) calls that result in assessment of patients at the wards, reported in absolute number [ Time Frame: Assessed after one year, after completion of the study ]
  • The number of Mobile Emergency team (MET) calls that result in assessment of patients at the wards per 10,000 ward days [ Time Frame: Assessed after one year, after completion of the study ]
  • The number of calls for the attending doctor, reported in absolute number (%) [ Time Frame: Assessed after one year, after completion of the study ]
  • The number of calls for the attending doctor per 10,000 ward days [ Time Frame: Assessed after one year, after completion of the study ]
  • All cause mortality - Subgroup analysis of patients diagnosed with cardiovascular disease [ 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.
  • All cause mortality - Subgroup analysis of patients diagnosed with cancer disease [ 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.
  • All cause mortality - Subgroup analysis of patients diagnosed with pulmonary disease [ 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.
  • All cause mortality - Subgroup analysis of patients diagnosed with infectious disease [ 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.
  • All cause mortality - Subgroup analysis of patients diagnosed with neurological disease [ 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.
  • All cause mortality - Subgroup analysis of patients diagnosed with surgical condition [ 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.
 
Descriptive Information
Brief Title  ICMJE Individual Early Warning Score (I-EWS)
Official Title  ICMJE Individual Early Warning Score (I-EWS) - Does Clinical Assessment Improve Detection of Acute Deterioration in Hospitalized Patients - a Cluster-randomized Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A prospective, cluster randomized, cross-over, non-inferiority study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Early Warning Score
  • Risk Stratification
Intervention  ICMJE
  • Behavioral: 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.
  • Behavioral: Standard EWS - Control (Trigger Tool)
    Standard EWS - Based on principles of National Early Warning Score (NEWS)
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Behavioral: Standard EWS - Control (Trigger Tool)
  • Active Comparator: 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.

    Intervention: Behavioral: I-EWS with incorporated clinical assessment (Trigger Tool)
Publications * 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. 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2018)
150000
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
189000
Actual Study Completion Date  ICMJE October 31, 2019
Actual Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03690128
Other Study ID Numbers  ICMJE 17017332
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kasper Iversen, Herlev Hospital
Study Sponsor  ICMJE Herlev Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kasper Iversen, MD, DMSci Department of Cardiology, Herlev Hospital
PRS Account Herlev Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP