An interventional study of EWS Nursing Alerts and Wireless Remote Sensor in Escalation of Care, Cardiopulmonary Arrest and Respiratory Arrest, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention
The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH). The investigators hypothesize that the use of an automated early warning system (EWS) that identifies patients at risk of clinical deterioration, with notification of nurses on the GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24 hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse oximeter to establish feasibility and to develop algorithms for a real-time event detection system (RDS) in these high-risk patients.
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This study's enrollment of 20,031 is above the median of 105 across 896 interventional studies indexed under Sepsis.
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Exclusion Criteria:
Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices.
Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors.
Behavioral: EWS Nursing Alerts · Device: Wireless Remote Sensor
An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.
A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood.
Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm
The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.
Time frame: Within 24 hrs of an EWS alert
Clinical Outcomes and Process Measures
length of stay
Time frame: Hospital discharge
| Milestone | Control | Nurse Notification of EWS Alert |
|---|---|---|
| Started | 10120 | 9911 |
| Completed | 10120 | 9911 |
| Not completed | 0 | 0 |
The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.
| participants | Control | Nurse Notification of EWS Alert |
|---|---|---|
| Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm | 426 | 444 |
length of stay
| days | Control | Nurse Notification of EWS Alert |
|---|---|---|
| Clinical Outcomes and Process Measures | 6.92 (3.82 to 12.67) | 7.07 (3.99 to 12.15) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | 0/10,120 (0%) | 0/10,120 (0%) |
| Nurse Notification of EWS Alert | — | 0/9,911 (0%) | 0/9,911 (0%) |
| Age, Continuous(years) | Control | Nurse Notification of EWS Alert | Total |
|---|---|---|---|
| Median | 57 (44 to 69) | 57 (44 to 70) | 57 (44 to 70) |
| Sex: Female, Male(Participants) | Control | Nurse Notification of EWS Alert | Total |
|---|---|---|---|
| Female | 5355 | 5308 | 10663 |
| Male | 4765 | 4603 | 9368 |
| Race (NIH/OMB)(Participants) | Control | Nurse Notification of EWS Alert | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4864 | 4790 | 9654 |
| White | 5062 | 4934 | 9996 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 194 | 187 | 381 |
| Region of Enrollment(participants) | Control | Nurse Notification of EWS Alert | Total |
|---|---|---|---|
| United States | 10120 | 9911 | 20031 |
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine