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Unity Health, St. Michael's campus

COVID-19 Cohort Study (CCS): Study of the epidemiology of COVID-19 in healthcare workers and their households

Information Sheet and Consent Form for Healthcare Workers

Status: Not yet enrolling

Study investigator: Dr. Matthew Muller, Infection Prevention and Control, St. Michael’s Hospital, (416) 864-5568
Funder: Weston Foundation


What is the purpose of the study?
To better understand how many people develop COVID-19 infection, how often infection is spread in households, and whether there are microbes or early immune responses (in our nose) that protect or make people more susceptible to infection. We are also studying the psychological impact of working during the pandemic. This study is for research purposes. It is being be conducted across six Toronto-area hospitals and will enroll 800 healthcare workers and their household members.

Who is being asked to participate? 
People working in an acute care hospital who:
    • are 18 to 75 years old
    • work at least 20 hours per week (physicians and nurse practitioners who care for ill patients at least 8 hours per week are also eligible)
    • available for the next 3 months (not retiring or going on leave) and
    • have convenient access to a computer or a cell phone with internet access (to complete surveys and receive information about the study)

What do I need to do if I decide to participate?
    1) An online survey at enrolment to assess your current risk factors (~15 minutes)
    2) Short online surveys every week about whether you have had any symptoms (~2 minutes).  Every fifth week, the survey will be a bit longer and ask about your exposure to ill people (~5-7 minutes)
    3) If you develop an acute respiratory illness (cough, fever, shortness of breath, excessive tiredness):
            i. Have a swab collected to test for COVID-19 at your workplace, your MD, NP, or a COVID assessment centre  – AND let the study access the results – OR - if you are at home when you become ill: Collect your own nasal swab and send it to the study for testing;
            ii. Complete online illness reports every day you have symptoms (~ 5 minutes for the first and ~2 minutes for all others); You will be informed by phone of test results submitted through the study.
    4) If you agree (optional): provide blood specimens at the beginning and end of the study to test for infections without symptoms. We will email you with details about dates and locations if you agree. If these dates do not coincide with a scheduled work shift, we will work with you to find one that does.
    5) At the end of the study, complete the “impact of events” scale to assess the stress of working during the pandemic (~3-5 minutes)


If you have others living in your home…
We ask that you involve them in the study to help us measure risk factors for transmission within households. Everyone who sleeps in the same dwelling as you 3 nights per week, on average, is being asked to participate.

If others in your home join the study, you are asked to…
    • Do the 4 things listed above AND
    • Give us an email address to contact the adults so we can send them an invitation to participate
    • Do a very short online survey about each child (about 2 minutes per child)
    • Complete weekly symptom reports for everyone in your home (about 1 minute per person)
    • Collect [or supervise the collection] of swabs to test for COVID-19 for ill children and complete illness reports for them (~ 2 minutes per day)
    • If someone in your home becomes ill, collect [or supervise the collection] of nasal swabs and pledgets (small absorbent papers put in the nose) for yourself and/or your children on Days 1, 3, 5, 7 & 10 to test for immune responses - to see if there are differences in the microbes in the noses of people who get COVID-19 and those who don’t. This is asked of ALL households where a person has COVID-19 and about 1 in 3 households where a person submits a swab that tests negative for COVID-19.

Adults (18 years or older) are asked to do:
    1) one baseline questionnaire (~5 to 15 minutes)
    2) an online report every 5th week (~5-7 minutes)
    3) if they develop an acute respiratory illness (cough, fever, shortness of breath, excessive tiredness):
            i. Submit swabs for testing to their MD, NP, or COVID-19 assessment centre and inform the study of the submission and results – or - Collect their own nasal swab to test for COVID-19 and send it to the study; and
            ii. Complete online illness reports every day they have symptoms (~ 5 minutes for the first and ~2 minutes for all others)
    4) if someone else in the home becomes ill, collect swabs and pledgets (small absorbent papers) on Days 1, 3, 5, 7 & 10 to test for immune responses. This is asked of ALL households where a person has COVID-19 and about 1 in 3 households where a person submits a swab that tests negative for COVID-19.



How long will the study last?
The study will last until the end of this new virus spread in Ontario. This means that the study will be at least 4 months and may be as long as 12 months.