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NCT04026555 · ClinicalTrials.gov registry record · NA
Realtime Streaming Clinical Use Engine for Medical Escalation
A NA study of Clinical Deterioration and Hospital Medicine, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 2,780
- Enrollment target
- 1
- Study location
NCT04026555 is a NA study of Clinical Deterioration and Hospital Medicine that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 2,780 participants, below the 13,600-participant average among 3 other Clinical Deterioration trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04026555, a NA study of Clinical Deterioration and Hospital Medicine, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,780 participants
- Enrollment target
- 1
- Study location
Study Summary
The escalation of care for patients in a hospitalized setting between nurse practitioner managed services, teaching services, step-down units, and intensive care units is critical for appropriate care for any patient. Often such "triggers" for escalation are initiated based on the nursing evaluation of the patient, followed by physician history and physical exam, then augmented based on laboratory values. These "triggers" can enhance the care of patients without increasing the workload of responder teams. One of the goals in hospital medicine is the earlier identification of patients that require an escalation of care. The study team developed a model through a retrospective analysis of the historical data from the Mount Sinai Data Warehouse (MSDW), which can provide machine learning based triggers for escalation of care (Approved by: IRB-18-00581). This model is called "Medical Early Warning Score ++" (MEWS ++). This IRB seeks to prospectively validate the developed model through a pragmatic clinical trial of using these alerts to trigger an evaluation for appropriateness of escalation of care on two general inpatients wards, one medical and one surgical. These alerts will not change the standard of care. They will simply suggest to the care team that the patient should be further evaluated without specifying a subsequent specific course of action. In other words, these alerts in themselves does not designate any change to the care provider's clinical standard of care. The study team estimates that this study would require the evaluation of \~ 18380 bed movements and approximately 30 months to complete, based on the rate of escalation of care and rate of bed movements in the selected units.
Conditions Studied
Interventions
- OTHER MEWS++ Monitoring
- OTHER Predictor Score
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,780 participants |
| Start Date | 2019-06-18 |
| Est. Completion | 2020-03-19 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04026555
The ClinicalTrials.gov registry entry for NCT04026555 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,780 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 13,600-participant average among 3 other Clinical Deterioration trials with a reported enrollment target (80% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Clinical Deterioration appearing as the primary indexed condition, and to 2 interventions - of which MEWS++ Monitoring is the first listed.
NCT04026555 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04026555 about?
NCT04026555 is a clinical study titled "Realtime Streaming Clinical Use Engine for Medical Escalation". The escalation of care for patients in a hospitalized setting between nurse practitioner managed services, teaching services, step-down units, and intensive care units is critical for appropriate care for any patient. Often such "triggers" for escalation are initiated based on the nursing evaluation...
What is the current status of trial NCT04026555?
This trial is currently completed. It is a NA study. The enrollment target is 2,780 participants. The study started on 2019-06-18. Estimated completion is 2020-03-19.
What conditions does trial NCT04026555 study?
This clinical trial studies the following conditions: Clinical Deterioration, Hospital Medicine, Monitoring, Physiologic.
What interventions are being tested in trial NCT04026555?
The interventions under investigation include: MEWS++ Monitoring (OTHER), Predictor Score (OTHER).
Who is sponsoring clinical trial NCT04026555?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04026555 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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