Canadian COVID-19 Emergency Department Registry
- Conditions
- Covid-19
- Registration Number
- NCT04702945
- Lead Sponsor
- University of British Columbia
- Brief Summary
Coronavirus Disease 2019 (COVID -19) is the largest public health crisis in over a century. There is an urgent need for high-quality population-level data to understand modifiable risks for disease severity, transmissibility, and to develop evidence-based prevention (i.e. vaccination), treatment and resource allocation strategies.
The Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) created a population-based registry of suspected and confirmed consecutive cases of COVID-19. The purpose of this registry is to derive and validate clinical decision rules, evaluate diagnostic tests and vaccine effectiveness, and complete cohort, case-control and observational studies to inform the pandemic response.
- Detailed Description
This national multi-centre registry is designed to enroll population-based consecutive eligible patients presenting with suspected or confirmed COVID-19 to 50 emergency departments in eight Canadian provinces from March 1 2020 and data collection is ongoing for the duration of the pandemic.
Data will be abstracted from the medical chart and entered into a central, web-based REDCap database. The investigators adopted the ISARIC variables into the database where there was a match. The investigators will develop standardized operating procedures for screening of potentially eligible patients, data entry and follow-up. Current data dictionaries are kept on the registry's website (https://canadiancovid19registry.org/).
At 30 days, the investigators will contact patients by telephone to obtain verbal consent for follow-up. The investigators will measure the Veterans Rand 12-item Health Survey (VR12), calculate the WHO Ordinal Outcome Scale and ask contextual questions in consenting patients. The VR12 will be measured at 60 days, and 6 and 12 months. The contextual questions were developed with input from patients with lived experience with COVID-19 infection and addressed cultural, racial, gender, socioeconomic and self-isolation issues.
The Health Data Research Network facilitated the development of a unique data flow of personal health identifiers and study identification numbers from each province for all participating institutes. This will allow linkage of registry data with national administrative data repositories.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200000
- Meeting the WHO suspect COVID-19 criteria: Fever (self-reported or subjective fever) and at least one symptom/sign of respiratory illness (e.g., flu-like illness, cough, shortness of breath)
- Presenting to the emergency department and tested for COVID-19 in the emergency department
No exclusion criteria in Period 1
Period 2 started on the date which each province expanded testing criteria allowing clinicians to test patients based on clinical suspicion or policy.
Inclusion Criteria:
- Presenting to the emergency department within 14 days of a positive COVID-19 (by self-report or in medical chart) and presents with clinical symptoms consistent with COVID-19
- Tested for COVID-19 in the emergency department, or within 24 hours after emergency department arrival.
Exclusion Criteria
- Patients tested for COVID-19 in the context of an elective admission (e.g., planned hip revision)
- Patients tested for COVID-19 and seen in the emergency department directly by another service (e.g., trauma team activation)
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Confirmed COVID-19 diagnosis 14 days Biological specimen is tested positive for SARS-CoV-2 using reverse transcription polymerase chain reaction (RT PCR). The specimen had to be drawn within two weeks of the emergency department visit if the patient presented with a COVID-19-related complication. If the initial test was negative, the patient had to have a positive specimen within 14 days of the index visit.
- Secondary Outcome Measures
Name Time Method Hospital admission 30 days Any hospital admission within 30 days of index emergency department visit captured in medical chart.
Hospital re-admissions 30 days Any hospital re-admissions within 30 days of index emergency department visit date captured in medical chart.
Mechanical ventilation 30 days Any mechanical ventilation during any hospital visit within 30 days of index emergency department visit captured in medical chart.
Emergency department revisits 30 days Any emergency department revisits within 30 days of index emergency department visit captured in medical chart.
30 day mortality 30 days Any death captured within 30 days of index emergency department visit captured by medical charts.
Clinical recovery 30 days Captured through telephone follow-up using the World Health Organization Ordinal Outcome Scale at 30 days after index emergency department visit. The scale is scored from 1 to 8 ('1'= no limitations to activities, '8'=death) to measure clinical improvement at 30 days.
Patient quality of life 12 months Captured through telephone follow-up using the Veterans Rand 12-item Health Survey at 30 days, 60 days, and 6 and 12 months after index emergency department visit.
Trial Locations
- Locations (50)
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Northeast Community Health Centre
🇨🇦Edmonton, Alberta, Canada
Peter Lougheed Centre
🇨🇦Calgary, Alberta, Canada
Rockyview General Hospital
🇨🇦Calgary, Alberta, Canada
Royal Inland Hospital
🇨🇦Kamloops, British Columbia, Canada
Eagle Ridge Hospital
🇨🇦Port Moody, British Columbia, Canada
Lions Gate Hospital
🇨🇦North Vancouver, British Columbia, Canada
Surrey Memorial Hospital
🇨🇦Surrey, British Columbia, Canada
Cobequid Community Health Centre
🇨🇦Lower Sackville, Nova Scotia, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Halifax Infirmary
🇨🇦Halifax, Nova Scotia, Canada
Hants Community Hospital
🇨🇦Windsor, Nova Scotia, Canada
Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
Hôtel-Dieu de Lévis
🇨🇦Lévis, Quebec, Canada
Royal Victoria Hospital (MUHC)
🇨🇦Montréal, Quebec, Canada
Hôpital du Saint-Sacrement (CHU de Québec)
🇨🇦Québec, Quebec, Canada
Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
Institut universitaire de cardiologie et de pneumologie de Québec
🇨🇦Québec, Quebec, Canada
South Health Campus
🇨🇦Calgary, Alberta, Canada
Abbotsford Regional Hospital
🇨🇦Abbotsford, British Columbia, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Kelowna General Hospital
🇨🇦Kelowna, British Columbia, Canada
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Mount Saint Joseph Hospital
🇨🇦Vancouver, British Columbia, Canada
Dartmouth General Hospital
🇨🇦Dartmouth, Nova Scotia, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Hotel Dieu Hospital
🇨🇦Kingston, Ontario, Canada
Juravinski Hospital
🇨🇦Hamilton, Ontario, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
London Health Sciences Centre (University Hospital)
🇨🇦London, Ontario, Canada
London Health Sciences Centre (Victoria Hospital)
🇨🇦London, Ontario, Canada
Health Science North
🇨🇦Sudbury, Ontario, Canada
The Ottawa Hospital - Civic Campus
🇨🇦Ottawa, Ontario, Canada
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Hospital
🇨🇦Toronto, Ontario, Canada
North York General Hospital
🇨🇦Toronto, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Hôpital du Sacré-Coeur
🇨🇦Montréal, Quebec, Canada
Centre Hospitalier de l'Université Laval (CHU de Québec)
🇨🇦Québec, Quebec, Canada
Hôpital Saint-François d'Assise (CHU de Québec)
🇨🇦Québec, Quebec, Canada
Montréal General Hospital (MUHC)
🇨🇦Montréal, Quebec, Canada
Hôpital de l'Enfant-Jésus (CHU de Québec)
🇨🇦Québec, Quebec, Canada
Hôtel-Dieu de Québec (CHU de Québec)
🇨🇦Québec, Quebec, Canada
Royal University
🇨🇦Saskatoon, Saskatchewan, Canada
Regina General Hospital
🇨🇦Regina, Saskatchewan, Canada
Saskatoon City Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
St Paul's Hospital
🇨🇦Saskatoon, Saskatchewan, Canada