CEC-UW: COVID EHR COHORT at the University of Wisconsin

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Completed

CT.gov ID

NCT04506528

Collaborator

National Cancer Institute (NCI) (NIH)

1,634,381

Enrollment

Location

19.7

Actual Duration (Months)

83049.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Cancer Nicotine Dependence Pulmonary Disease Cardiovascular Diseases Immunosuppression Disorders

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

Comorbid diseases: chronic asthma, chronic COPD, chronic bronchiectasis, diabetes mellitus, cardiovascular disease, chronic renal disease, on dialysis, immunocompromised [due to SLE lupus, rheumatoid arthritis, organ transplant, HIV, Crohn's], pregnant, cancer (lymphomas, leukemias, lung/respiratory, rectal, breast, prostate, pancreas), hypertension, depression, anxiety, alcohol abuse, pro- clotting disorders, and anti-clotting disorders

Tobacco use variables: smoking status (current, former, never), passive smoke exposure for never smoker, years since quitting (for former smokers), packs smoked per day, years of smoking, pack years, smokeless tobacco user, and marijuana use

Signs and symptoms: temperature, pulse, systolic blood pressure, diastolic blood pressure, oxygen saturation, septic shock, pneumonia, chills, muscle aches/myalgia, rhinorrhea, sore throat, chronic cough, shortness of breath, nausea or vomiting, headache, abdominal pain, diarrhea, dizziness, impaired consciousness, acute cerebrovascular event, ataxia, seizure, taste impairment, smell impairment, vision impairment, nerve pain, and skeletal muscular pain

COVID-19 treatment variables: ICU admission, required supplemental oxygen, intubated for ventilator use, noninvasive positive pressure, and number of days hospitalized

COVID-19 medications including (but not limited to): chloroquine, hydroxychloroquine, tocilizumab, remdesivir, dexamethasone, convalescent plasma, and ascorbic acid

Classes of other medications used: nicotine replacement therapies (NRTs), varenicline medications; blood thinners, steroids, angiotensin converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), short-acting adrenergic bronchodilators, long-acting adrenergic bronchodilators, anticholinergic bronchodilators, bronchodilators combos, inhaled corticosteroids (includes combo medications), and inhaled corticosteroid bronchodilators

Lab tests: COVID-19 PCR test, COVID-19 Antigen test, Albumin, ALT, Bicarbonte, BUN, Calcium, C-Reactive Protein, High Sensitivity, C-Reactive Protein, Creatinine, D-DIMER, ESR, Ferritin, Hematocrit, HgbA1c., INR, LDH, Leukocytes, Platelet Count, Potassium, Procalcitonin, Sodium, Troponin-I, Troponin-T

For the initial paper(s) to be prepared based on these data, the main analytic methods will include GUIDE classification and regression tree models. However, whole sample methods will also be used as complementary analytic methods, which will vary with regard to outcome type: i.e., logistic regression for binary outcomes and Cox proportional hazard analyses for time-to-event outcomes. Initial analyses will focus on hospitalized COVID-19 patients. Later waves of analyses may use different analytic approaches and address different questions.

Participating healthcare systems:

Duke University (Duke Health)
Hackensack Meridian Health
Mayo Clinic
Memorial Sloan Kettering Cancer Center
University of Michigan (Michigan Medicine)
Mount Sinai Health System
Northwestern University
New York University (NYU Langone Health)
University of California Davis (University of California Davis Comprehensive Cancer Center / UC Davis Health)
University of California San Francisco
University of North Carolina at Chapel Hill (UNC Health)
University of Chicago
University of Illinois at Chicago
University of Kansas (University of Kansas Medical Center)
University of Maryland
University of Utah (University of Utah Health)
University of Wisconsin (UW Health)
Vanderbilt University (Vanderbilt University Medical Center)
Virginia Commonwealth University (VCU Health System/Massey Cancer Center)
Washington University St Louis
Yale University (Yale New Haven Hospital)

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1634381 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

COVID EHR COHORT at the University of Wisconsin

Actual Study Start Date :

Jun 11, 2020

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with COVID-19 Analyses of the cohort data will include (1) all patients, or (2) hospitalized patients meeting specific inclusion criteria.

Outcome Measures

Primary Outcome Measures

Mortality due to COVID-19 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention	Madison	Wisconsin	United States	53711

Sponsors and Collaborators

University of Wisconsin, Madison
National Cancer Institute (NCI)

Investigators

Principal Investigator: Betsy Rolland, PhD, MLIS, MPH, University of Wisconsin, Madison
Principal Investigator: Michael C Fiore, MD, MPH, MBA, University of Wisconsin Center for Tobacco Research and Intervention
Study Director: Karen L Conner, MPH, University of Wisconsin Center for Tobacco Research and Intervention