Skip to content

Realtime Streaming Clinical Use Engine for Medical Escalation

Realtime Streaming Clinical Use Engine for Medical Escalation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04026555
Acronym
ReSCUE-ME
Enrollment
2780
Registered
2019-07-19
Start date
2019-06-18
Completion date
2020-03-19
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Deterioration, Hospital Medicine, Monitoring, Physiologic

Keywords

Medical Early Warning Systems, Patient Monitoring, Electronic Health Record, Big Data, Critical Care, Machine Learning

Brief 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.

Detailed description

Objectives: Mount Sinai Hospital has developed a Rapid Response Team (RRT) system designed to give general floor care providers additional support for patients who may be requiring a higher level of care. This system enables both nurses and physicians to notify the RRT and have a critical care team evaluate the patients. During the period of 03/01/2018 to 09/17/2018, Mount Sinai Hospital floor units on 10W and 10E units made 357 rapid response team (RRT) calls with only 58 leading to an actual increase in the level of care (true positive rate \ 16%). Similarly, the Electronic Health Record (EHR) generated 839 sepsis Best Practice Alerts (BPAs) yet only five led to escalations in care (true positive rate \ 0.5%). The results above would imply that over 168 evaluations need to be made to identify a single case where the patient required an escalation in care. The goal of ReSCUE-ME is to evaluate prospective model performance and identify the best spot which the study team can incorporate MEWS++ into RRT and Primary providers workflow. The primary endpoint is rate of escalation of care on 10W and 10E during the study period. Background: In a prior study, the group has demonstrated that a machine learning model (MEWS++) significantly outperformed a standard, manually calculated MEWS score on a large retrospective cohort of hospitalized patients. To develop this model, the study team used a data set (Approved by the Program for Protection of Human Subjects Institutional Review Board (IRB) IRB-18-00581) of 96,645 patients with 157,984 hospital encounters and 244,343 bed movements. The study team found that MEWS++ was superior to the standard MEWS model with a sensitivity of 81.6% vs. 44.6%, specificity of 75.5% vs. 64.5%, and area under the receiver operating curve of 0.85 vs. 0.71. Encouraged by this prior result, the study team is seeking to evaluate the model in a prospective study. A silent pilot of the ReSCUE-ME alerts has been running on 10E and 10W since Feb 2019. The study team has continuously monitoring the alert performance via a real-time web-based dashboard. The results are summarized below: * Median # of alerts to primary team, per floor, per day: 8 * Median # of alerts to RRT, per floor, per day: 4 * Sensitivity 0.76, Specificity 0.68, AUC 0.77 * Accuracy 0.69, Precision 0.3, F1 Score 0.43 This performance compares very favorably to the performance seen in the retrospective historical cohort used to develop the MEWS++ model: * Sensitivity 0.82, Specificity 0.76, AUC 0.85 * Accuracy 0.76, Precision 0.12, F1 Score 0.19

Interventions

OTHERMEWS++ Monitoring

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

OTHERPredictor Score

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.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

No masking is completed as the information/waiver of consent sheet for the two arms needed to be individualized.

Intervention model description

For each patient, real-time data from clinical and administrative systems will be used by ReSCUE-ME to produce a MEWS++ score predicting the likelihood that the patient will require escalation of care within the next 6 hours. Upon the patient being admitted to the unit, the patient will be evaluated based on any update in the EHR. If the prediction score exceeds a high threshold, the RRT team will be notified directly. If the score is between a low threshold and the high threshold , the nursing team will be notified and increased nursing monitoring will be initiated. If the patient has met criteria for increased nursing monitoring, a refractory 8-hour refractory window will be applied during which no nursing alerts will be sent. However if the score exceeds the high threshold, the RRT team will be notified. Throughout the trial, the performance of the alerts will be monitored via web-based dashboards. If the performance is poor, the high and low thresholds will be adjusted.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall Rate of Escalation10 monthsRate of escalation of care from floor to Stepdown, Telemetry, ICU, per 1,000 patient bed days.

Secondary

MeasureTime frameDescription
Number of Participants Requiring Blood Pressure Support10 monthsNumber of participants requiring blood pressure support agents such as initiation of vasopressor medication or administration of fluid bolus.
Number of Participants Requiring Respiratory Support10 monthsNumber of participants requiring respiratory support intervention such as initiation of nasal cannula to high flow or frequency of intubation.
Number of Participants Who Experienced a Cardiac Arrest Episode10 monthsThe number of patients who had a cardiac arrest.
Notification Frequency - Number of Alerts Sent Per Day to Providers10 monthsThe number is calculated as average number of alerts sent per day over all the days in the study period.
Number of Calls10 monthsThe average number of calls to RRT made per patient, regardless of alert. Not evaluated.
Sensitivity and Specificity of the RRT Alert10 monthsThe performance of the alert will be evaluated by calculating the sensitivity, specificity, positive predictive value, negative predictive value, precision, recall, and F1-score. This will be done both for the overall escalation rate and if possible for individual escalations (ICU, step-down, telemetry) and death.
Mortality RateDuration of hospital stay, until discharge, regardless of stay length for patients who died in hospital, or 30 days after admission, starting from date of admission, up to 6 weeks.Number of Mortalities - Combined In-hospital and 30-day mortality. Mortalities only counted once. 30-day mortality includes those patients who died in-hospital within 30 days.

Countries

United States

Participant flow

Pre-assignment details

All patients admitted to the study units were enrolled. There were no opt-outs.

Participants by arm

ArmCount
MEWS++ Monitoring
This consists of all the patients that will be receiving MEWS++ escalation monitoring and provider alerting. MEWS++ Monitoring: Patient's electronic medical record data will undergo processing by a machine learning algorithm (MEWS++). Predictor Score: 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.
1,488
Standard of Care Monitoring
Patients in the control arm will have a score calculated but no alert will be sent. Predictor Score: 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.
1,252
Total2,740

Baseline characteristics

CharacteristicMEWS++ MonitoringStandard of Care MonitoringTotal
Age, Continuous67.2 years
STANDARD_DEVIATION 17
65.1 years
STANDARD_DEVIATION 17.8
66.2 years
STANDARD_DEVIATION 17.4
BMI27.1 kg per meters squared
STANDARD_DEVIATION 7.68
26.5 kg per meters squared
STANDARD_DEVIATION 9.1
26.9 kg per meters squared
STANDARD_DEVIATION 8.34
Elixhauser Score2.2 units on a scale
STANDARD_DEVIATION 1.4
2.2 units on a scale
STANDARD_DEVIATION 1.4
2.2 units on a scale
STANDARD_DEVIATION 1.4
Ethnicity (NIH/OMB)
Hispanic or Latino
472 Participants433 Participants905 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1016 Participants819 Participants1835 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
First Deterioration Score on Admission0.56 proportion probability
STANDARD_DEVIATION 0.1
0.57 proportion probability
STANDARD_DEVIATION 0.096
0.57 proportion probability
STANDARD_DEVIATION 0.098
Race/Ethnicity, Customized
Asian
83 Participants94 Participants177 Participants
Race/Ethnicity, Customized
Black
367 Participants287 Participants654 Participants
Race/Ethnicity, Customized
Missing
17 Participants22 Participants39 Participants
Race/Ethnicity, Customized
Other
480 Participants448 Participants928 Participants
Race/Ethnicity, Customized
White
541 Participants401 Participants942 Participants
Sex: Female, Male
Female
762 Participants666 Participants1428 Participants
Sex: Female, Male
Male
726 Participants586 Participants1312 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
104 / 1,488117 / 1,252
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Overall Rate of Escalation

Rate of escalation of care from floor to Stepdown, Telemetry, ICU, per 1,000 patient bed days.

Time frame: 10 months

ArmMeasureValue (NUMBER)
Intervention - Alert SentOverall Rate of Escalation12.3 escalations per 1,000 patient bed days
Control - Standard of Care MonitoringOverall Rate of Escalation11.3 escalations per 1,000 patient bed days
Comparison: IPTW Poisson regression was used to model the number of escalations per visit with an offset of the log transformed length of stay normalized per 1000 bed days. Treatment effect is expressed in terms of adjusted incidence rate ratio (IRR) per 1000 patient bed days.p-value: <0.00195% CI: [1.16, 1.78]Regression, Poisson
Secondary

Mortality Rate

Number of Mortalities - Combined In-hospital and 30-day mortality. Mortalities only counted once. 30-day mortality includes those patients who died in-hospital within 30 days.

Time frame: Duration of hospital stay, until discharge, regardless of stay length for patients who died in hospital, or 30 days after admission, starting from date of admission, up to 6 weeks.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention - Alert SentMortality RateCombined in-hospital and 30-day104 Participants
Intervention - Alert SentMortality RateIn-hospital mortality81 Participants
Intervention - Alert SentMortality Rate30-d mortality87 Participants
Control - Standard of Care MonitoringMortality RateCombined in-hospital and 30-day117 Participants
Control - Standard of Care MonitoringMortality RateIn-hospital mortality83 Participants
Control - Standard of Care MonitoringMortality Rate30-d mortality98 Participants
Comparison: IPTW log-binomial regression models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).p-value: 0.04595% CI: [0.58, 0.99]Regression, Logistic
Secondary

Notification Frequency - Number of Alerts Sent Per Day to Providers

The number is calculated as average number of alerts sent per day over all the days in the study period.

Time frame: 10 months

Population: No statistical analysis performed

ArmMeasureGroupValue (MEAN)Dispersion
Intervention - Alert SentNotification Frequency - Number of Alerts Sent Per Day to ProvidersPrimary Alerts4.5 alerts per dayStandard Deviation 2.3
Intervention - Alert SentNotification Frequency - Number of Alerts Sent Per Day to ProvidersTotal Alerts6.7 alerts per dayStandard Deviation 3
Intervention - Alert SentNotification Frequency - Number of Alerts Sent Per Day to ProvidersRRT Alerts2.2 alerts per dayStandard Deviation 1.7
Control - Standard of Care MonitoringNotification Frequency - Number of Alerts Sent Per Day to ProvidersTotal Alerts5.4 alerts per dayStandard Deviation 2.5
Control - Standard of Care MonitoringNotification Frequency - Number of Alerts Sent Per Day to ProvidersPrimary Alerts3.5 alerts per dayStandard Deviation 1.9
Control - Standard of Care MonitoringNotification Frequency - Number of Alerts Sent Per Day to ProvidersRRT Alerts1.9 alerts per dayStandard Deviation 1.5
Secondary

Number of Calls

The average number of calls to RRT made per patient, regardless of alert. Not evaluated.

Time frame: 10 months

Population: Data were not collected for this outcome measure.

Secondary

Number of Participants Requiring Blood Pressure Support

Number of participants requiring blood pressure support agents such as initiation of vasopressor medication or administration of fluid bolus.

Time frame: 10 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention - Alert SentNumber of Participants Requiring Blood Pressure Support239 Participants
Control - Standard of Care MonitoringNumber of Participants Requiring Blood Pressure Support142 Participants
Comparison: IPTW log-binomial regres- sion models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).p-value: <0.00195% CI: [1.39, 2.18]Regression, Logistic
Secondary

Number of Participants Requiring Respiratory Support

Number of participants requiring respiratory support intervention such as initiation of nasal cannula to high flow or frequency of intubation.

Time frame: 10 months

Population: No statistical comparison performed due to low rate of events.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention - Alert SentNumber of Participants Requiring Respiratory Support15 Participants
Control - Standard of Care MonitoringNumber of Participants Requiring Respiratory Support5 Participants
Secondary

Number of Participants Who Experienced a Cardiac Arrest Episode

The number of patients who had a cardiac arrest.

Time frame: 10 months

Population: No statistical comparison performed due to no events.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention - Alert SentNumber of Participants Who Experienced a Cardiac Arrest Episode0 Participants
Control - Standard of Care MonitoringNumber of Participants Who Experienced a Cardiac Arrest Episode0 Participants
Secondary

Sensitivity and Specificity of the RRT Alert

The performance of the alert will be evaluated by calculating the sensitivity, specificity, positive predictive value, negative predictive value, precision, recall, and F1-score. This will be done both for the overall escalation rate and if possible for individual escalations (ICU, step-down, telemetry) and death.

Time frame: 10 months

Population: Patients in the intervention arm.

ArmMeasureGroupValue (NUMBER)
Intervention - Alert SentSensitivity and Specificity of the RRT AlertSensitivity0.88 proportion
Intervention - Alert SentSensitivity and Specificity of the RRT AlertSpecificity0.33 proportion
Intervention - Alert SentSensitivity and Specificity of the RRT AlertPositive Predictive Value0.15 proportion
Intervention - Alert SentSensitivity and Specificity of the RRT AlertNegative Predictive Value0.95 proportion
Post Hoc

Likelihood of Earlier Hospital Discharge

Hazard ratio for faster earlier discharge for patients who got an alert

Time frame: Duration of hospital stay, starting from admission, up to the day of discharge, regardless of the length of hospital stay, up to 1 year.

Population: Patients who survived to hospital discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention - Alert SentLikelihood of Earlier Hospital Discharge1407 Participants
Control - Standard of Care MonitoringLikelihood of Earlier Hospital Discharge1,169 Participants
p-value: 0.1495% CI: [0.98, 1.18]Regression, Cox
Post Hoc

Time to ICU Escalation

Time in hours between alert and transfer to an ICU

Time frame: From time of alert until transfer to an ICU, assessed up to discharge from the hospital or death

ArmMeasureValue (MEDIAN)
Intervention - Alert SentTime to ICU Escalation49.7 hours
Control - Standard of Care MonitoringTime to ICU Escalation57.8 hours

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026