- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04570488
Predicting Favorable Outcomes in Hospitalized Covid-19 Patients
December 22, 2022 updated by: NYU Langone Health
Testing use of predictive analytics to predict which COVID-19+ patients are at low risk for an adverse event (ICU transfer, intubation, mortality, hospice discharge, re-presentation to the ED, oxygen requirements exceeding nasal cannula at 6L/Min) in the next 96 hours
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To assess if display of low risk of adverse event in EPIC can safely reduce length of stay and plan for discharge.
Study Type
Observational
Enrollment (Actual)
1415
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult hospitalized COVID19+ patients predicted to have no adverse event at 96 events with a threshold at 90% PPV, with at least one low risk during their admission who are discharged alive and have not been in the ICU
Description
Inclusion Criteria: Adult hospitalized COVID19+ patients predicted to have no adverse event at 96 events with a threshold at 90% PPV, with at least one low risk during their admission who are discharged alive and have not been in the ICU
Exclusion Criteria: Age < 18 years not hospitalized for COVID19+.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Quality improvement - Display
Display of risk score/ colored flag in Epic patient list column; will be viewable to all frontline workers
|
Display of risk score/ colored flag in Epic patient list column
|
|
No Display
No display ("hidden") of risk score/ colored flag in Epic patient list column; not viewable to all frontline workers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in days from first low-risk score to discharge
Time Frame: 96 Hours
|
Reduction in days from first low-risk score to discharge
|
96 Hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in length of stay (LOS)
Time Frame: 96 hours
|
Reduction in LOS for green patients that have not been in the ICU
|
96 hours
|
|
Reduction in GTD vs. LOS
Time Frame: 96 hours
|
Reduction in GTD vs. LOS for all green patients discharged alive vs all patients discharged alive
|
96 hours
|
|
No change in 30 day re-ED presentation or hospital admission rate for cohort
Time Frame: 96 hours
|
No change in 30 day re-ED presentation or hospital admission rate for cohort
|
96 hours
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Re-presentation to ED
Time Frame: 96 hours
|
96 hours
|
|
Readmission to hospital
Time Frame: 96 hours
|
96 hours
|
|
Mortality
Time Frame: 96 hours
|
96 hours
|
|
Postdischarge mortality
Time Frame: 96 hours
|
96 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan Austrian, MD, NYU Langone Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2020
Primary Completion (Actual)
December 7, 2021
Study Completion (Actual)
December 7, 2021
Study Registration Dates
First Submitted
September 25, 2020
First Submitted That Met QC Criteria
September 29, 2020
First Posted (Actual)
September 30, 2020
Study Record Updates
Last Update Posted (Actual)
December 27, 2022
Last Update Submitted That Met QC Criteria
December 22, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAU COVID19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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