NCT04425694

Brief Summary

Early Warning Score (EWS) is a tool designed to help clinicians efficiently identify and track patients who have or develop acute illness, and make timely clinical responses. The calculation and charting of EWSs at Tuen Mun Hospital (TMH) is a manual process at present. The purpose of this study is to automate the EWS calculation and charting process using an electronic EWS (e-EWS) system. 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 human factors (HF) design that matches users' expectations, requirements and work practices. Therefore, our aim is to carry out HF methods in order to inform design of the e-EWS system before its implementation in a selected surgical ward in the hospital. After its implementation, we will also conduct evaluation of the e-EWS system to assess its effectiveness with respect to clinical outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

June 8, 2020

Last Update Submit

June 8, 2020

Conditions

Keywords

patient safetyelectronic Early Warning Score systemhuman factors

Outcome Measures

Primary Outcomes (4)

  • Changes in the number of successful detection of deteriorating cases

    from the beginning of the study to the 6th month later

  • Changes in the number of cardiopulmonary resuscitations (CPRs)

    from the beginning of the study to the 6th month later

  • Changes in the number of ICU or high dependency unit transfer

    from the beginning of the study to the 6th month later

  • Changes in the number of assistance calls to doctors

    from the beginning of the study to the 6th month later

Secondary Outcomes (13)

  • Changes in application-specific self-efficacy

    from the beginning of the study to the 6th month later

  • Changes in ward staff's perceived usefulness of the e-EWS system

    from the beginning of the study to the 6th month later

  • Changes in ward staff's perceived ease of use of the e-EWS system

    from the beginning of the study to the 6th month later

  • Changes in ward staff's perceived behavioral control

    from the beginning of the study to the 6th month later

  • Changes in ward staff's attitude towards the e-EWS system

    from the beginning of the study to the 6th month later

  • +8 more secondary outcomes

Study Arms (1)

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.

Device: e-EWS system

Interventions

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.

F3B ward staff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be selected from the runner nurses and the ward manager in a selected surgical ward (F3B ward) at Tuen Mun Hospital (TMH).

You may qualify if:

  • All F3B ward nursing staff

You may not qualify if:

  • Staff not in F3B ward

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuen Mun Hospital

Hong Kong, Hong Kong

Location

Related Publications (2)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 11, 2020

Study Start

November 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations