Clinical trial NCT04320862: COVID-19 Pandemic Response Network
Official title: Pandemic Response Network: Duke Community Health Watch
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV-2
Coronavirus
Influenza -Like Illness
Lower Resp Tract Infection
Upper Resp Tract Infection
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 9207
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals in the Duke Health region as well as individuals beyond the Duke Health region

Brief summary: Coronavirus Disease 19 (COVID-19) represents an unprecedented challenge to the operations and population health management efforts of health care systems around the world. The "Pandemic Research Network (PRN): Duke Community Health Watch" study leverages technology, clinical research, epidemiology, telemedicine, and population health management capabilities to understand how to safely COVID-19. The target population is individuals in the Duke Health region as well as individuals beyond the Duke Health region who have flu-like symptoms, a viral test order for COVID-19, confirmed COVID-19, or concern for exposure to COVID-19. A subgroup of particular interest within the target population is health care workers (HCW) and families of HCW. Community members will enroll in the study electronically and for 28 days will be reminded via email or SMS to submit signs and symptoms related to COVID-19. Participants who report symptoms will be provided information about COVID-19 testing (if needed) and established mechanisms to seek care within Duke Health. Instructions for telemedicine and in-person visits, which is available publicly at https://www.dukehealth.org/covid-19-update, will be presented to participants. Participants who are unable to report symptoms independently may be contacted via telephone by Population Health Management Office (PHMO) or Clinical Events Classification (CEC) team members. Data collected through the "Pandemic Response Network (PRN): Duke Community Health Watch" study will be used for three objectives.

* First, to characterize the epidemiological features of COVID-19. Specifically, we will have a high-risk subgroup of HCW and families of HCW that we enroll.
* Second, to develop models that predict deterioration and the need for inpatient care, intensive care, and mechanical ventilation.
* Third, to develop forecast models to estimate the volume of inpatient and outpatient resources needed to manage a COVID-19 population.

The primary risk to study participants is loss of protected health information. To address this concern, all data will be stored in Duke's REDCap instance and the Duke Protected Analytics Compute Environment (PACE).


Eligibility criteria: Inclusion Criteria:

* flu-like symptoms
* a viral test order for COVID-19
* confirmed COVID-19
* concern for exposure to COVID-19

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of participants who experience inpatient admission
timeFrame: 2 months
Secondary outcomes:
measure: Number of participants admitted to the intensive care unit
timeFrame: 2 months
measure: Number of participants requiring mechanical ventilation
timeFrame: 2 months
measure: Number of deceased participants
timeFrame: 2 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Becky Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: