CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,780 enrolled
Drug / intervention
MEWS++ Monitoring +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04026555
NCT04026555N/ACompleted

Realtime Streaming Clinical Use Engine for Medical Escalation

Icahn School of Medicine at Mount Sinai·interventional·Posted Jul 19, 2019·Updated Jan 14, 2025

In Brief

A clinical study evaluating MEWS++ Monitoring and Predictor Score for Clinical Deterioration and 2 related conditions. Completed, enrolled 2,780 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 19, 2019
Enrollment StartJun 18, 2019
Primary CompletionMar 19, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.0 years ago

Interventions

MEWS++ Monitoringother

Patient's electronic medical record data will undergo processing by a machine learning algorithm (MEWS++).

Predictor Scoreother

A score predicting the likelihood that the patient will experience a deterioration in their clinical condition within six hours will be generated. If the prediction score exceeds a predetermined threshold, an alert will be sent to the provider. The alerting protocol is tiered, with both a low and high threshold. If the score is above the low threshold, nursing will be notified. If the score is above the high threshold, RRT will be notified.