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Machine Learning
Machine Learning Monitoring for Clinical Deterioration
N/A
Recruiting
Research Sponsored by AgileMD, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admitted to an eCART-monitored medical-surgical unit (scoring location)
18 years old
Must not have
Younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the outcome of covid-19 mortality will be tracked across 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a tool that predicts when hospitalized patients may need intensive care or die, then offers guidance to help care teams intervene.
Who is the study for?
This trial is for adults over 18 years old who are admitted to specific hospital wards where the eCARTv5 monitoring system is used. It's not open to those under 18 or patients in wards without this technology.
What is being tested?
The study tests a machine learning tool, eCARTv5, integrated into hospitals' electronic health records. It predicts which patients might soon need intensive care by analyzing their vital signs and lab results.
What are the potential side effects?
Since this trial involves a diagnostic tool rather than medication, there aren't traditional side effects. However, there may be risks related to data privacy or potential stress from increased monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am admitted to a unit with eCART monitoring.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the outcome of covid-19 mortality will be tracked across 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the outcome of covid-19 mortality will be tracked across 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hospital mortality for elevated risk patients
Secondary study objectives
ICU-free days following an eCART elevation
Total hospital length of stay (LOS) for elevated risk patients
Ventilator-free days following an eCART elevation
Other study objectives
COVID-19 Length of Stay (LOS)
COVID-19 Mortality
Sepsis Length of Stay (LOS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Intervention Arm (experimental): eCARTv5 will monitor all adult medical-surgical (ward) patients at hospitals that implement the tool in their EHR. A pre vs. post analysis will be done to compare the impact of the tool at the intervention hospitals.
Group II: Control ArmActive Control1 Intervention
Control Arm (active comparator): hospital sites that do not implement eCARTv5 will be active comparator.
Find a Location
Who is running the clinical trial?
Department of Health and Human ServicesFED
232 Previous Clinical Trials
905,927 Total Patients Enrolled
AgileMD, Inc.Lead Sponsor
University of Wisconsin, MadisonOTHER
1,237 Previous Clinical Trials
3,170,979 Total Patients Enrolled
University of ChicagoOTHER
1,062 Previous Clinical Trials
810,136 Total Patients Enrolled
BayCare Health SystemOTHER
4 Previous Clinical Trials
704 Total Patients Enrolled
Dana P Edelson, MD, MSStudy ChairAgileMD, Inc.
2 Previous Clinical Trials
166 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am admitted to a unit with eCART monitoring.You are not in a hospital unit where patients are monitored using eCART.I am under 18 years old.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.