COVID EHR COHORT at the University of Wisconsin (CEC-UW)

August 30, 2022 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1634381

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53711
        • University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with COVID-19 in the 21 participating healthcare systems

Description

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:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
February 1, 2020, through January 31, 2022
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)
February 1, 2020, through January 31, 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0609
  • A534253 (Other Identifier: UW Madison)
  • SMPH/MEDICINE (Other Identifier: UW Madison)
  • OISE-20-66590-1 (Other Grant/Funding Number: National Cancer Institute (CRDF Contract))
  • CTRI (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The Limited data set will be secured, cleaned, harmonized, and undergo initial analyses in mid to late 2022.The existing Data Transfer and Use Agreements (DTUA) negotiated with each 21 participating health systems precludes the University of Wisconsin (UW) from sharing these data with any entity at this time. This was a requirement of the UW IRB prior to transferring the de-identified site data sets to UW. Starting in 2023, investigators desiring access to CEC-UW data will need to apply for access via an NCI contractor organization, Information Management Services (IMS; https://www.imsweb.com/).

IPD Sharing Time Frame

Data will be available starting in 2023; no decision yet on how long data will be available but likely multiple years.

IPD Sharing Access Criteria

Scientists at the 21 participating healthcare systems will be given priority in terms of access to study data; data sharing with other scientists not affiliated with the 21 participating healthcare systems will be determined in consultation with the study funder (National Cancer Institute).

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe