NCT04570488

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,415

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

1.6 years

First QC Date

September 25, 2020

Last Update Submit

December 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction in days from first low-risk score to discharge

    Reduction in days from first low-risk score to discharge

    96 Hours

Secondary Outcomes (3)

  • Reduction in length of stay (LOS)

    96 hours

  • Reduction in GTD vs. LOS

    96 hours

  • No change in 30 day re-ED presentation or hospital admission rate for cohort

    96 hours

Other Outcomes (4)

  • Re-presentation to ED

    96 hours

  • Readmission to hospital

    96 hours

  • Mortality

    96 hours

  • +1 more other outcomes

Study Arms (2)

Quality improvement - Display

Display of risk score/ colored flag in Epic patient list column; will be viewable to all frontline workers

Other: EPIC risk score display

No Display

No display ("hidden") of risk score/ colored flag in Epic patient list column; not viewable to all frontline workers

Interventions

Display of risk score/ colored flag in Epic patient list column

Quality improvement - Display

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

  • Major VJ, Jones SA, Razavian N, Bagheri A, Mendoza F, Stadelman J, Horwitz LI, Austrian J, Aphinyanaphongs Y. Evaluating the Effect of a COVID-19 Predictive Model to Facilitate Discharge: A Randomized Controlled Trial. Appl Clin Inform. 2022 May;13(3):632-640. doi: 10.1055/s-0042-1750416. Epub 2022 Jul 27.

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Jonathan Austrian, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2020

First Posted

September 30, 2020

Study Start

May 15, 2020

Primary Completion

December 7, 2021

Study Completion

December 7, 2021

Last Updated

December 27, 2022

Record last verified: 2022-12

Locations