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临床试验/NCT04506528
NCT04506528已完成不适用

COVID EHR COHORT at the University of Wisconsin

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 1,634,381 人开始时间: 2020年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,634,381
试验地点
1
主要终点
Mortality due to COVID-19

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Mortality due to COVID-19

时间窗: 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

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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