Preop COVID Testing Patterns

NCT ID: NCT04838119

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 375692 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-08-23

Brief Summary

This study is an investigation of preoperative asymptomatic COVID screening nationwide. The hypothesis is that because these tests are performed without reference to pretest probability of COVID-19 disease, unlike tests based on symptoms or close contact with infected individuals, these studies may represent a more unbiased sample of the local population prevalence of asymptomatic COVID disease burden.

Detailed Description

Study will gather publicly reported, aggregated statistics on positive COVID tests over time and across geographically diverse parts of the United States, summarized weekly, from the onset of the pandemic in Spring 2020 to the present time. Study will also gather contemporaneous data on weekly community COVID cases diagnosed, local positive test percentage, hospital admissions and ICU admissions for COVID-19, and deaths from COVID 19. Similar data will be obtained from a coalition of approximately 20 academic medical centers from around the United States, with Wake Forest School of Medicine, Department of Anesthesiology serving as the coordinating center. No individual patient information will be collected. Aggregated testing data, hospital disease burden, and local disease prevalence are all publicly reported.

Data will analyzed as interrupted time series.

Conditions

COVID-19

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with a preoperative asymptomatic COVID screening test

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• having preoperative asymptomatic COVID testing
• > or = 18 years of age

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

B S Segal, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Locations

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00071985

Identifier Type: -

Identifier Source: org_study_id