Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04689711
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2020-11-20
Brief Title:
Prognostic Models for COVID-19 Care
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Generalizable Prognostic Models for Patient-Centered Decisions in COVID-19
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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
The investigators therefore aim to
1 Develop 3 CPMs in each of 2 hospital systems ie 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
Detailed Description:
There has been a proliferation of COVID-19 clinical prediction models CPMs reported in the literature across health systems but the validity and potential generalizability of these models to other settings is unknown Generally most hospitals and systems do not have a sufficient number of cases and outcomes to develop models fit to their local population and predictor variables are not uniformly and reliably obtained across systems Therefore pooling and harmonizing data resources and assessing generalizability across different sites is urgently needed to create tools that may help support decision making across settings In addition since best practices are rapidly evolving over time eg proning minimizing paralytics lung-protective volumes remdesivir dexamethasone or other treatments updating and recalibrating these CPMs is crucially important
In the current PCORI Methods project the investigators developed a CPM evaluation and updating framework including both conventional and novel performance measures The investigators will use this framework to evaluate COVID-19 prognostic models in the largest cohort of COVID-19 patients examined to date spanning 2 datasets from very different settings As the COVID-19 pandemic affects different regions with subsequent waves expected identifying the most accurate robust and generalizable prognostic tools is needed to guide patient-centered decision making across diverse populations and settings
In the current PCORI Methods project the investigators developed a CPM evaluation and updating framework including both conventional and novel performance measures The investigators will use this framework to evaluate COVID-19 prognostic models in the largest cohort of COVID-19 patients examined to date spanning 2 datasets from very different settings As the COVID-19 pandemic affects different regions with subsequent waves expected identifying the most accurate robust and generalizable prognostic tools is needed to guide patient-centered decision making across diverse populations and settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None