Prognostic Models for COVID-19 Care

NCT ID: NCT04689711

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2021-08-31

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 (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.

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 (e.g., 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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• COVID-19 patient survivor
• Family member/caregiver of patient hospitalized for COVID-19
• Physician with experience caring for COVID-19 patients
• Other provider (pastoral care, nursing, respiratory therapy) with experience caring for COVID-19 patients

Exclusion Criteria

• Not proficient in reading or speaking English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David M Kent, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Northwell Health (The Feinstein Institutes for Medical Research)

Manhasset, New York, United States

Countries

United States

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.pcori.org/research-results/2016/understanding-and-improving-accuracy-clinical-prediction-models-heart-disease

Parent study funded through the Patient Centered Outcome Research Institute (PCORI) to develop evaluation and updating framework for clinical prediction models used in this study.

Other Identifiers

PCORI-ME-1606-35555

Identifier Type: -

Identifier Source: org_study_id