Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) - Population-based Registry of Suspected and Confirmed COVID-19 Cases
试验速览
- 阶段
- 不适用
- 入组人数
- 200,000
- 试验地点
- 50
- 主要终点
- Confirmed COVID-19 diagnosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- 未提供
结局指标
主要结局
Confirmed COVID-19 diagnosis
时间窗: 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.
次要结局
- Hospital admission(30 days)
- Hospital re-admissions(30 days)
- Mechanical ventilation(30 days)
- Emergency department revisits(30 days)
- 30 day mortality(30 days)
- Clinical recovery(30 days)
- Patient quality of life(12 months)
研究者
Corinne Hohl
Associate Professor
University of British Columbia