Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Individual Early Warning Score (I-EWS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Early Warning Score Risk Stratification Behavioral: I-EWS with incorporated clinical assessment (Trigger Tool) Behavioral: Standard EWS - Control (Trigger Tool) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150000 participants
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
Official Title: Individual Early Warning Score (I-EWS) - Does Clinical Assessment Improve Detection of Acute Deterioration in Hospitalized Patients - a Cluster-randomized Trial
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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.
Behavioral: Standard EWS - Control (Trigger Tool)
Standard EWS - Based on principles of National Early Warning Score (NEWS)

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.

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.




Primary Outcome Measures :
  1. 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.

  2. The number of NEWS/I-EWS scores per patient per day [ Time Frame: Assessed after one year, after completion of the study ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 30 days ]
    Calculated as days from date of index admission to date of discharge

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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 ]
  2. 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 ]
  3. 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.

  4. 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.

  5. Scores generating a call for Mobile Emergency team (MET) reported in absolute number (%) [ Time Frame: Assessed after one year, after completion of the study ]
  6. 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 ]
  7. Scores generating a call for the attending doctor, reported in absolute number (%) [ Time Frame: Assessed after one year, after completion of the study ]
  8. 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 ]
  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690128


Locations
Layout table for location information
Denmark
Bispebjerg Hospital
Copenhagen, Capital Region Of Denmark, Denmark, 2400
Amager & Hvidovre Hospital
Copenhagen, Capital Region Of Denmark, Denmark, 2650
Herlev & Gentofte Hospital
Copenhagen, Capital Region Of Denmark, Denmark, 2730
Rigshospital, Glostrup, Medical Ward
Glostrup, Capital Region Of Denmark, Denmark, 2600
Nordsjaellands Hospital
Hillerød, Capital Region Of Denmark, Denmark, 3400
Holbaek Hospital
Holbæk, Region Of Zealand, Denmark, 4300
Zealand University Hospital (Roskilde & Køge)
Roskilde, Region Of Zealand, Denmark, 4000
Slagelse Sygehus
Slagelse, Region Of Zealand, Denmark, 4200
Sponsors and Collaborators
Herlev Hospital
Investigators
Layout table for investigator information
Study Director: Kasper Iversen, MD, DMSci Department of Cardiology, Herlev Hospital
  Study Documents (Full-Text)

Documents provided by Kasper Iversen, Herlev Hospital:
Statistical Analysis Plan  [PDF] July 11, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kasper Iversen, Principal Investigator, Associate Professor, Consultant, DMSci, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03690128    
Other Study ID Numbers: 17017332
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kasper Iversen, Herlev Hospital:
Clinical deterioration
Risk stratification
Patient Safety
Early Warning Score
Monitoring
Clinical assessment