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Prognostic Models for COVID-19 Care

NCT04689711 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2022-01-20

No results posted yet for this study

Summary

Approximately 20% of patients hospitalized with COVID-19 require intensive care and possibly invasive mechanical ventilation (MV). Patient preferences with COVID-19 for MV may be different, because intubation for these patients is often prolonged (for several weeks), is administered in settings characterized by social isolation and is associated with very high average mortality rates. Supporting patients facing this decision requires providing an accurate forecast of their likely outcomes based on their individual characteristics.

The investigators therefore aim to:

1. Develop 3 CPMs in each of 2 hospital systems (i.e., 6 distinct models) to predict:

i) the need for MV in patients hospitalized with COVID-19; ii) mortality in patients receiving MV; iii) length of stay in the ICU.
2. Evaluate the geographic and temporal transportability of these models and examine updating approaches.

1. To evaluate geographic transportability, the investigators will apply the evaluation and updating framework developed (in the parent PCORI grant) to assess CPM validity and generalizability across the different datasets.
2. To evaluate temporal transportability, the investigators will examine both the main effect of calendar time and also examine calendar time as an effect modifier.
3. Engage stakeholders to facilitate best use of these CPMs in the care of patients with COVID-19.

Conditions

  • Covid19

Sponsors & Collaborators

  • Northwell Health

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • David M Kent, MD, MS · Tufts Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04689711 on ClinicalTrials.gov