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N/A N=2,780 Prevention

Realtime Streaming Clinical Use Engine for Medical Escalation

Clinical Deterioration · Hospital Medicine · Monitoring, Physiologic

Enrolled (actual)
2,780
Serious AEs
Results posted
Jan 2025
Primary outcome: Primary: Overall Rate of Escalation — 12.3; 11.3 escalations per 1,000 patient bed days — p=< 0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
MEWS++ Monitoring (Other); Predictor Score (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Icahn School of Medicine at Mount Sinai
Primary completion
Mar 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Rate of Escalation
12.3; 11.3 < 0.001 sig
SECONDARY
Number of Participants Requiring Blood Pressure Support
239; 142 <0.001 sig
SECONDARY
Number of Participants Requiring Respiratory Support
15; 5
SECONDARY
Number of Participants Who Experienced a Cardiac Arrest Episode
0; 0
SECONDARY
Mortality Rate
104; 117; 81; 83; 87; 98 0.045 sig
SECONDARY
Notification Frequency - Number of Alerts Sent Per Day to Providers
6.7; 5.4; 4.5; 3.5; 2.2; 1.9
SECONDARY
Number of Calls
SECONDARY
Sensitivity and Specificity of the RRT Alert
0.88; 0.33; 0.15; 0.95

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.

Eligibility Criteria

Inclusion Criteria

  • All patients age 18 or greater who were admitted to a general care unit selected for each arm.

Exclusion Criteria

  • Any admitted patient who has a "Do Not Resuscitate (DNR)" and/or a "Do Not Intubate (DNI)" order in the EHR,
  • any patient made "level of care" by RRT as documented in REDCap.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04026555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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