COVID EHR COHORT at the University of Wisconsin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,634,381
- Locations
- 1
- Primary Endpoint
- Mortality due to COVID-19
Study Overview
Brief Summary
This cohort study will obtain electronic health record (EHR) data (limited data set) from 21 health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health systems with large numbers of COVID-19 patients to explore whether smoking status, cancer history, and other risk factors among patients diagnosed with COVID-19 are associated with mortality and/or COVID-19 disease severity/complications. Each site will provide data from their health system EHR on a regular basis that includes all patients identified as having COVID-19 at some point in the interval from February 1, 2020, through January 31, 2022.
Detailed Description
This cohort study will obtain electronic health record (EHR) data (limited data set) from 21 health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health systems with large numbers of COVID-19 patients to explore whether smoking status, cancer history, and other risk factors among patients diagnosed with COVID-19 are associated with mortality and/or COVID-19 disease severity/complications. The Cancer Center Cessation Initiative (C3I) is a project launched by the US National Cancer Institute (NCI) to improve the rate at which NCI-designated Cancer Centers provide evidence-based smoking cessation to patients diagnosed with and treated for cancer. The C3I is coordinated at the University of Wisconsin-Center for Tobacco Research and Intervention (UW-CTRI) and the University of Wisconsin Carbone Cancer Center (UWCCC). Twenty-one health systems across the U.S. will provide EHR data to the UW-CTRI coordinating center on all COVID-19 patients identified during the period from February 1, 2020, through January 31, 2022.
Current EHR-based data elements collected will include:
Evidence of COVID-19: ICD-10-CM diagnosis of COVID-19, COVID-19 PCR lab test, and/or COVID-19 antigen lab test
Healthcare system encounter type: inpatient, outpatient, emergency department (ED), urgent care, or other
SES/Demographics variables: insurance status, education, housing status, sex, age, race/ethnicity, height, weight, body mass index
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 0 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •COVID-19 ICD-10-CM diagnosis (U07.1 or J12.82) during a healthcare visit and/or
- •COVID-19 positive PCR test and/or
- •COVID-19 positive antigen test
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mortality due to COVID-19
Time Frame: February 1, 2020, through January 31, 2022
In analyses of hospitalized patients, all-cause mortality in patients with COVID-19 illness vs discharge from hospital (binary outcome)
COVID-19 Severity
Time Frame: February 1, 2020, through January 31, 2022
In analyses of hospitalized patients, COVID-19 severity as measured by intubation for respiratory support (i.e., patient required intubation during hospitalization; binary outcome)
Secondary Outcomes
No secondary outcomes reported