- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04425694
Implementation and Evaluation of an Electronic Early Warning Score (e-EWS) System
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Early Warning Score (EWS), also known as "track-and-trigger" system, is a tool designed to help clinicians efficiently identify and track patients who have or develop acute illness, and make timely clinical responses. An EWS is calculated based on values from a number of physiological parameters (e.g. respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness, and temperature) to obtain an aggregated score, which indicates a patient's health status. It is mostly used by ward nurses to monitor their patients; when a patient's EWS has exceeded a set threshold, the nurse should attend to the patient more closely and consider for intervention e.g. call a doctor. The philosophy of EWS is that it improves patient safety by enabling ward staff to detect patients' deterioration early so that timely intervention can be administered within the "golden period for treatment".
In the U.K., an EWS system called the National Early Warning Score (NEWS) was first released in 2012 (NEWS, 2012). The NEWS was the first system to standardize the calculation and charting of acute-illness severity and has been widely adopted across the National Health Service (NHS). Recently, in December 2017, NEWS2 has been released and it is an updated version of the NEWS (NEWS2, 2017). NEWS2 can be readily computerized and has already been integrated with some NHS hospitals' electronic health record systems. The Updated Report of a Working Party of NEWS2 states that "There are potential advantages of automated calculation of the NEW score and automated alert systems." (p. 6). Therefore, the objective of this proposed study is to implement and evaluate an electronic EWS (e-EWS) system in a selected surgical ward at Tune Mun Hospital (TMH).
At TMH, the current practice of obtaining ward patients' EWS is a manual process: firstly, a care giver measures a patient's specified physiological parameters by using the appropriate monitoring instruments; secondly, the care giver writes down the values of the parameters on a paper chart; thirdly, the paper chart is handed over to a nurse; and finally, the nurse calculates the EWS. The process is performed on a designated regular time interval.
There are two main drawbacks of the manual EWS process: firstly, it is inefficient because there are usually multiple patients in a ward and some physiological variables take time to measure. Therefore, in a busy ward, missed physiological measures and irregular measurement-taking intervals are often reported. These problems lead to staff ignoring EWS calculations. Secondly, when EWS are calculated, nurses often do so for patients who already show deteriorating conditions. This counters the original intent of EWS, which is to help identify patients with early signs of deterioration. These drawbacks compromise clinicians' ability to detect patient deterioration early, which could potentially compromise patient safety.
A potential solution is to automate the manual EWS process. Some hospitals in Hong Kong, for example, Tseung Kwan O Hospital has already adopted an e-EWS system in some of its wards. The e-EWS system is connected to a physiological monitor, which takes various physiological measurements. The system has an auto-charting module, which automatically captures patients' physiological measurements in an electronic chart (e-chart) and calculates their EWS. All the information in the auto-charting module is then wirelessly transferred to a central display in the ward's nurses station. The central display shows patients' status in terms of EWS and issues alerts when any EWS has exceeded a set threshold. The e-EWS system is not only capable of auto-charting but also provides an alert mechanism to help nurses detect early deterioration.
However, while the e-EWS system could potentially reduce ward staff's workload and improve patient safety, its effectiveness can only be realized through good HF design that matches users' expectations, requirements and work practices.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Tuen Mun Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All F3B ward nursing staff
Exclusion Criteria:
- Staff not in F3B ward
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
F3B ward staff
The e-EWS system will be implemented in a selected surgical ward (F3B ward) in Tuen Mun Hospital.
All F3B ward staff will use the system and evaluate its effectiveness.
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The e-EWS system is connected to a physiological monitor, which takes various physiological measurements.
The system has an auto-charting module, which automatically captures patients' physiological measurements in an electronic chart (e-chart) and calculates their EWS.
All the information in the auto-charting module is then wirelessly transferred to a central display in the ward's nurses station.
The central display shows patients' status in terms of EWS and issues alerts when any EWS has exceeded a set threshold.
The e-EWS system is not only capable of auto-charting but also provides an alert mechanism to help nurses detect early deterioration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Changes in the number of successful detection of deteriorating cases
Time Frame: from the beginning of the study to the 6th month later
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from the beginning of the study to the 6th month later
|
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Changes in the number of cardiopulmonary resuscitations (CPRs)
Time Frame: from the beginning of the study to the 6th month later
|
from the beginning of the study to the 6th month later
|
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Changes in the number of ICU or high dependency unit transfer
Time Frame: from the beginning of the study to the 6th month later
|
from the beginning of the study to the 6th month later
|
|
Changes in the number of assistance calls to doctors
Time Frame: from the beginning of the study to the 6th month later
|
from the beginning of the study to the 6th month later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in application-specific self-efficacy
Time Frame: from the beginning of the study to the 6th month later
|
This outcome will be measured by the 7-point Likert scale, with scores ranging from 1 (very strongly disagree) to 7 (very strongly agree).
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from the beginning of the study to the 6th month later
|
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Changes in ward staff's perceived usefulness of the e-EWS system
Time Frame: from the beginning of the study to the 6th month later
|
This outcome will be measured by the 7-point Likert scale, with scores ranging from 1 (very strongly disagree) to 7 (very strongly agree).
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from the beginning of the study to the 6th month later
|
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Changes in ward staff's perceived ease of use of the e-EWS system
Time Frame: from the beginning of the study to the 6th month later
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This outcome will be measured by the 7-point Likert scale, with scores ranging from 1 (very strongly disagree) to 7 (very strongly agree).
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from the beginning of the study to the 6th month later
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Changes in ward staff's perceived behavioral control
Time Frame: from the beginning of the study to the 6th month later
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This outcome will be measured by the 7-point Likert scale, with scores ranging from 1 (very strongly disagree) to 7 (very strongly agree).
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from the beginning of the study to the 6th month later
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Changes in ward staff's attitude towards the e-EWS system
Time Frame: from the beginning of the study to the 6th month later
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This outcome will be measured by the 7-point Likert scale, with scores ranging from 1 (very strongly disagree) to 7 (very strongly agree).
|
from the beginning of the study to the 6th month later
|
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Changes in ward staff's intention to use
Time Frame: from the beginning of the study to the 6th month later
|
This outcome will be measured by the 7-point Likert scale, with scores ranging from 1 (very strongly disagree) to 7 (very strongly agree).
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from the beginning of the study to the 6th month later
|
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Changes in ward staff's perceived work performance
Time Frame: from the beginning of the study to the 6th month later
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This outcome will be measured by the 7-point Likert scale, with scores ranging from 1 (very strongly disagree) to 7 (very strongly agree).
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from the beginning of the study to the 6th month later
|
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Changes in ward staff's perceived workload
Time Frame: from the beginning of the study to the 6th month later
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This outcome will be measured by the 7-point Likert scale, with scores ranging from 1 (very strongly disagree) to 7 (very strongly agree).
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from the beginning of the study to the 6th month later
|
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Changes in the quality of patient care
Time Frame: from the beginning of the study to the 6th month later
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This outcome will be measured by the 7-point Likert scale, with scores ranging from 1 (very strongly disagree) to 7 (very strongly agree).
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from the beginning of the study to the 6th month later
|
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Changes in the workflow
Time Frame: from the beginning of the study to the 6th month later
|
This outcome will be measured by the 7-point Likert scale, with scores ranging from 1 (very strongly disagree) to 7 (very strongly agree).
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from the beginning of the study to the 6th month later
|
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Changes in the accuracy of the technology
Time Frame: from the beginning of the study to the 6th month later
|
This outcome will be measured by the 7-point Likert scale, with scores ranging from 1 (very strongly disagree) to 7 (very strongly agree).
|
from the beginning of the study to the 6th month later
|
|
Changes in ward staff's personal experiences in current clinical unit
Time Frame: from the beginning of the study to the 6th month later
|
This outcome will be measured by the 4-point Likert scale, with scores ranging from 1 (strongly disagree) to 4 (strongly agree).
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from the beginning of the study to the 6th month later
|
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Comments and suggestions of the system
Time Frame: from the beginning of the study to the 6th month later
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Ward staff's opinions will be collected by a semi-structured interview.
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from the beginning of the study to the 6th month later
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Royal College of Physicians. National Early Warning Score (NEWS): Standardising the assessment of acute illness severity in the NHS. Report of a working party. London: RCP, 2012.
- Royal College of Physicians. National Early Warning Score (NEWS) 2: Standardising the assessment of acute-illness severity in the NHS. Updated report of a working party. London: RCP, 2017.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- e-EWS 20200526
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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