CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04689711
NCT04689711N/ACompleted

Generalizable Prognostic Models for Patient-Centered Decisions in COVID-19

Tufts Medical Center·observational·Posted Dec 30, 2020·Updated Jan 20, 2022

In Brief

An observational study for Covid19. Completed, enrolled 21 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 30, 2020
Enrollment StartDec 7, 2020
Primary CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.5 years ago