Clinical Deterioration, Hospital Medicine, Monitoring, Physiologic
Conditions
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
Patient's electronic medical record data will undergo processing by a machine learning algorithm (MEWS++).
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Overall Rate of Escalation | 10 months | Rate of escalation of care from floor to Stepdown, Telemetry, ICU, per 1,000 patient bed days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Blood Pressure Support | 10 months | Number of participants requiring blood pressure support agents such as initiation of vasopressor medication or administration of fluid bolus. |
| Number of Participants Requiring Respiratory Support | 10 months | Number 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 Episode | 10 months | The number of patients who had a cardiac arrest. |
| Notification Frequency - Number of Alerts Sent Per Day to Providers | 10 months | The number is calculated as average number of alerts sent per day over all the days in the study period. |
| Number of Calls | 10 months | The average number of calls to RRT made per patient, regardless of alert. Not evaluated. |
| Sensitivity and Specificity of the RRT Alert | 10 months | 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. |
| Mortality Rate | 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. | 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
| Arm | Count |
|---|---|
| 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 |
| Total | 2,740 |
Baseline characteristics
| Characteristic | MEWS++ Monitoring | Standard of Care Monitoring | Total |
|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 17 | 65.1 years STANDARD_DEVIATION 17.8 | 66.2 years STANDARD_DEVIATION 17.4 |
| BMI | 27.1 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 Score | 2.2 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 Participants | 433 Participants | 905 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1016 Participants | 819 Participants | 1835 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| First Deterioration Score on Admission | 0.56 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 Participants | 94 Participants | 177 Participants |
| Race/Ethnicity, Customized Black | 367 Participants | 287 Participants | 654 Participants |
| Race/Ethnicity, Customized Missing | 17 Participants | 22 Participants | 39 Participants |
| Race/Ethnicity, Customized Other | 480 Participants | 448 Participants | 928 Participants |
| Race/Ethnicity, Customized White | 541 Participants | 401 Participants | 942 Participants |
| Sex: Female, Male Female | 762 Participants | 666 Participants | 1428 Participants |
| Sex: Female, Male Male | 726 Participants | 586 Participants | 1312 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 104 / 1,488 | 117 / 1,252 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention - Alert Sent | Overall Rate of Escalation | 12.3 escalations per 1,000 patient bed days |
| Control - Standard of Care Monitoring | Overall Rate of Escalation | 11.3 escalations per 1,000 patient bed days |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention - Alert Sent | Mortality Rate | Combined in-hospital and 30-day | 104 Participants |
| Intervention - Alert Sent | Mortality Rate | In-hospital mortality | 81 Participants |
| Intervention - Alert Sent | Mortality Rate | 30-d mortality | 87 Participants |
| Control - Standard of Care Monitoring | Mortality Rate | Combined in-hospital and 30-day | 117 Participants |
| Control - Standard of Care Monitoring | Mortality Rate | In-hospital mortality | 83 Participants |
| Control - Standard of Care Monitoring | Mortality Rate | 30-d mortality | 98 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention - Alert Sent | Notification Frequency - Number of Alerts Sent Per Day to Providers | Primary Alerts | 4.5 alerts per day | Standard Deviation 2.3 |
| Intervention - Alert Sent | Notification Frequency - Number of Alerts Sent Per Day to Providers | Total Alerts | 6.7 alerts per day | Standard Deviation 3 |
| Intervention - Alert Sent | Notification Frequency - Number of Alerts Sent Per Day to Providers | RRT Alerts | 2.2 alerts per day | Standard Deviation 1.7 |
| Control - Standard of Care Monitoring | Notification Frequency - Number of Alerts Sent Per Day to Providers | Total Alerts | 5.4 alerts per day | Standard Deviation 2.5 |
| Control - Standard of Care Monitoring | Notification Frequency - Number of Alerts Sent Per Day to Providers | Primary Alerts | 3.5 alerts per day | Standard Deviation 1.9 |
| Control - Standard of Care Monitoring | Notification Frequency - Number of Alerts Sent Per Day to Providers | RRT Alerts | 1.9 alerts per day | Standard Deviation 1.5 |
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.
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention - Alert Sent | Number of Participants Requiring Blood Pressure Support | 239 Participants |
| Control - Standard of Care Monitoring | Number of Participants Requiring Blood Pressure Support | 142 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention - Alert Sent | Number of Participants Requiring Respiratory Support | 15 Participants |
| Control - Standard of Care Monitoring | Number of Participants Requiring Respiratory Support | 5 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention - Alert Sent | Number of Participants Who Experienced a Cardiac Arrest Episode | 0 Participants |
| Control - Standard of Care Monitoring | Number of Participants Who Experienced a Cardiac Arrest Episode | 0 Participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention - Alert Sent | Sensitivity and Specificity of the RRT Alert | Sensitivity | 0.88 proportion |
| Intervention - Alert Sent | Sensitivity and Specificity of the RRT Alert | Specificity | 0.33 proportion |
| Intervention - Alert Sent | Sensitivity and Specificity of the RRT Alert | Positive Predictive Value | 0.15 proportion |
| Intervention - Alert Sent | Sensitivity and Specificity of the RRT Alert | Negative Predictive Value | 0.95 proportion |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention - Alert Sent | Likelihood of Earlier Hospital Discharge | 1407 Participants |
| Control - Standard of Care Monitoring | Likelihood of Earlier Hospital Discharge | 1,169 Participants |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention - Alert Sent | Time to ICU Escalation | 49.7 hours |
| Control - Standard of Care Monitoring | Time to ICU Escalation | 57.8 hours |