The Prevention of Failure to Rescue" Using Early Warning Scoring (VitalCare)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 3, 2010 |
| Last Updated Date | September 7, 2010 |
| Start Date ICMJE | August 2009 |
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01197326 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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 ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | The Prevention of Failure to Rescue" Using Early Warning Scoring |
| Official Title ICMJE | The Use of IntelliVue Patient Monitor MP5 Rel. G.1 for the Prevention of "Failure to Rescue" Using Early Warning Score |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| 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. |
| Condition ICMJE | Non-random Sample of Inpatient on Medical-surgical Wards |
| Intervention ICMJE | 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. |
| Study Group/Cohort (s) |
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| Publications * | Bellomo R, Ackerman M, Bailey M, Beale R, Clancy G, Danesh V, Hvarfner A, Jimenez E, Konrad D, Lecardo M, Pattee KS, Ritchie J, Sherman K, Tangkau P; Vital Signs to Identify, Target, and Assess Level of Care Study (VITAL Care Study) Investigators. A controlled trial of electronic automated advisory vital signs monitoring in general hospital wards. Crit Care Med. 2012 Aug;40(8):2349-61. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 100 |
| Completion Date | June 2010 |
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Australia |
| Administrative Information | |
| NCT Number ICMJE | NCT01197326 |
| Other Study ID Numbers ICMJE | BUD33108 |
| Has Data Monitoring Committee | No |
| Responsible Party | Karen K. Giuliano/Principal Scientist, Philips Healthcare |
| Study Sponsor ICMJE | Philips Healthcare |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Philips Healthcare |
| Verification Date | September 2010 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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