The Prevention of Failure to Rescue" Using Early Warning Scoring (VitalCare)
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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 |
- 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 ]
- 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 |
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.
Inclusion Criteria:
- all patients admitted to the study units during the period of data collection
Exclusion Criteria:
- None
Contacts and Locations 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 June 18, 2013