The Prevention of Failure to Rescue" Using Early Warning Scoring (VitalCare)

This study has been completed.
Sponsor:
Information provided by:
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01197326
First received: September 3, 2010
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

The purpose of this study is to assess if, compared with standard paper-based systems, an automated Early Warning System (EWS) resident in a spot check patient monitor, can help to identify patients in the acute care settings but outside of the intensive care unit, who may be experiencing physiological instability and who are in need of rapid clinical intervention by a Rapid Response Team (RRT)/ Medical Emergency Team (MET).

The development of such an automated system by offers a unique opportunity to assess its user-friendliness, labour-saving effect, feasibility and clinical utility. Accordingly, we plan to conduct a research program aimed at assessing this new approach toward patient monitoring.

This study will use the hospital's Standard of Care protocol for the monitoring of vital signs (including timing and vital signs collected) and a commercially available automatic spot check monitor to collect data. No investigational procedures or devices are associated with this protocol.


Condition Intervention
Non-random Sample of Inpatient on Medical-surgical Wards
Device: Use the MP5 EWS monitor to measure routine vital signs

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of IntelliVue Patient Monitor MP5 Rel. G.1 for the Prevention of "Failure to Rescue" Using Early Warning Score

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Does the use of the EWS monitor significantly decrease the mean duration of delay before activation a MET/RRT intervention and the proportion of calls where there is a >30 minute delay between the detection for MET/RRT call criteria and team activation? [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Do nurses feel that their current MET/RRT system is satisfactory and do they think that their current vital sign monitoring and recording system is satisfactory? [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.
Device: Use the MP5 EWS monitor to measure routine vital signs
All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device.
Group 2
Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.
Device: Use the MP5 EWS monitor to measure routine vital signs
All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We plan to observe a non-probability, convenience sample of patients which will consist primarily of acutely ill hospitalized adult patients (at least 18 years of age). We will also enroll 1-2 pediatric units to be used as pilot data, since there is less available empiric data published in the literature. Study participants will be recruited from all eligible patients during the enrollment period who are having vital signs monitoring performed as Standard of Care.

Criteria

Inclusion Criteria:

  • all patients admitted to the study units during the period of data collection

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197326

Locations
Australia, Victoria
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Philips Healthcare
  More Information

No publications provided by Philips Healthcare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen K. Giuliano/Principal Scientist, Philips Healthcare
ClinicalTrials.gov Identifier: NCT01197326     History of Changes
Other Study ID Numbers: BUD33108
Study First Received: September 3, 2010
Last Updated: September 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Philips Healthcare:
patient deterioration
unplanned ICU admissions
rapid response teams

ClinicalTrials.gov processed this record on April 21, 2014