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Predicting Favorable Outcomes in Hospitalized Covid-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04570488
Recruitment Status : Completed
First Posted : September 30, 2020
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
COVID Corona Virus Infection Adverse Event Other: EPIC risk score display Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Display of risk score/ colored flag in Epic patient list column vs. no display ("missing"); will be viewable to all frontline workers
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participant and data analyst(s) are blinded
Primary Purpose: Health Services Research
Official Title: Predicting Favorable Outcomes in Hospitalized Covid-19 Patients
Actual Study Start Date : May 15, 2020
Actual Primary Completion Date : December 7, 2021
Actual Study Completion Date : December 7, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Display of risk score/ colored flag in Epic patient list column; will be viewable to all frontline workers
 Other: EPIC risk score display
Display of risk score/ colored flag in Epic patient list column
No Intervention: Control
No display ("hidden") of risk score/ colored flag in Epic patient list column; not viewable to all frontline workers


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in days from first low-risk score to discharge [ Time Frame: 96 Hours ]
    Reduction in days from first low-risk score to discharge


Secondary Outcome Measures :
  1. Reduction in length of stay (LOS) [ Time Frame: 96 hours ]
    Reduction in LOS for green patients that have not been in the ICU

  2. 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

  3. 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


Other Outcome Measures:
  1. Re-presentation to ED [ Time Frame: 96 hours ]
  2. Readmission to hospital [ Time Frame: 96 hours ]
  3. Mortality [ Time Frame: 96 hours ]
  4. Postdischarge mortality [ Time Frame: 96 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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+.

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570488


Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jonathan Austrian, MD NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04570488    
Other Study ID Numbers: PAU COVID19 RCT
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections