Covid19NCT04782427
COVID-19 Infections and Mortality in Long-term Care Facilities During the First Wave
An observational study of Covid19 and Death, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal at 1 site in Canada.
Trial summary
The medical charts of all COVID-19 cases (n=1200) from 17 long-term care facilities in Montreal, Canada will be reviewed, to compare patients who survived to patients who did not survive. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19, Death, Infection Viral
- What is being tested?
- COVID-19 infection
- How many people
- 1,197 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2021to 13 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Most of the residents living in the long-term care facilities are elderly and frail, with a high prevalence of major neurocognitive disorders and low life expectancy. However, some patients are more robust (e.g. residents of wandering wards) or younger (e.g. residents with heavy neurological or mental health diagnoses).
Who may be able to join
- Resident of a long-term care facility within the CIUSSS Centre-Sud-de-l'Île-de-Montréal
- Nosocomial COVID-19 infection diagnosis between March 23rd and July 11th 2020
Who cannot join
- Admission to the long-term care facility after July 11th 2020
- COVID-19 infection which was not acquired within the long-term care facility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Infections and Mortality in Montreal Long-term Care Facilities During the First Wave: a Retrospective Cohort Study
The medical charts of all COVID-19 cases (n=1200) from 17 long-term care facilities in Montreal, Canada will be reviewed, to compare patients who survived to patients who did not survive. Through multilevel logistic regression, the risk of death will be estimated for institutional predictors of mortality, while controlling for individual risk factors.
Individual covariates include clinical features (age, sex, Charlston comorbidity index, SMAF autonomy score, severity criteria) and medical treatments (IV fluids, anticoagulation, oxygen, regular opiates, corticosteroids). Aggregate covariates include epidemiological data (attack rates, timing of outbreak) and institutional characteristics (number of beds, air exchange per hour, presence of a dedicated COVID-19 unit at the time of outbreak, staff compliance to infection control measures, staff infection rates, understaffing, proportion of semi-private rooms, proportion of wandering wards and other special units).
Read the detailed description
A lot has been written about individual risk factors for COVID-19 death, mostly in the hospitalized population. However, even though most deaths around the world have occurred among the frail and elderly, little is known about the risk factors specific to the long-term care population.
In this retrospective cohort study, the investigators will review the medical charts of all COVID-19 cases (n=1200) from 17 long-term care facilities in Montreal, Canada, to compare patients who survived to patients who did not survive. Through multilevel logistic regression, the risk of death will be estimated for institutional predictors of mortality, while controlling for individual risk factors. The objective is to influence local and national policies in long-term care facilities, in the hopes of avoiding the tragic spring 2020 outcomes during subsequent waves of COVID-19 or future pandemics.
Covariates in the models will be drawn from a review of the medical literature and known risk factors for COVID-19 death. Individual-level covariates include clinical features (age, sex, Charlston comorbidity index, SMAF autonomy score, severity criteria) as well as medical treatments (IV fluids, anticoagulation, oxygen, regular opiates, corticosteroids). Aggregate-level covariates include epidemiological data (attack rates, timing of outbreak) and institutional characteristics (number of beds, air exchange per hour, presence of a dedicated COVID-19 unit at the time of outbreak, staff compliance to infection control measures, staff infection rates, understaffing, proportion of semi-private rooms, proportion of wandering wards and other special units).
- Conditions
- Covid19, Death, Infection Viral, Infections, Respiratory, Infection, Coronavirus, Elderly Infection
- Being tested
- COVID-19 infection
- Medical subject headings
- COVID-19, Death, Virus Diseases, Respiratory Tract Infections, Coronavirus Infections, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 infectionOther
Case of nosocomial infection within the long-term care facility
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
COVID-19 as a primary or secondary cause of death
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Jan 2021
- Primary completion13 Apr 2021
- Study completion13 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
- Sponsor type
- Other government
- Collaborators
- Université de Montréal
- Responsible party
- Principal investigator, Sophie Zhang, Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
- Investigators
- Sophie Zhang, M.D., Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782427
- Sponsor's protocol ID
- CentreSuddeMontréal
- Status last verified
- Jul 2021
- First submitted
- 2 Mar 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified information will be shared, except if there are patient confidentiality issues.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Infections and Mortality in Montreal Long-term Care Facilities During the First Wave: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04782427
- Acronym / sponsor ID
- CentreSuddeMontréal
- Conditions
- Covid19, Death, Infection Viral, Infections, Respiratory, Infection, Coronavirus, Elderly Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,197 participants (actual)
- Lead sponsor
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-MontréalOther government
- Collaborators
- Université de Montréal
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 May 2021 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The medical charts of all COVID-19 cases (n=1200) from 17 long-term care facilities in Montreal, Canada will be reviewed, to compare patients who survived to patients who did not survive. Through multilevel logistic regression, the risk of death will be estimated for institutional predictors of mortality, while controlling for individual risk factors.
Individual covariates include clinical features (age, sex, Charlston comorbidity index, SMAF autonomy score, severity criteria) and medical treatments (IV fluids, anticoagulation, oxygen, regular opiates, corticosteroids). Aggregate covariates include epidemiological data (attack rates, timing of outbreak) and institutional characteristics (number of beds, air exchange per hour, presence of a dedicated COVID-19 unit at the time of outbreak, staff compliance to infection control measures, staff infection rates, understaffing, proportion of semi-private rooms, proportion of wandering wards and other special units).
Detailed description
A lot has been written about individual risk factors for COVID-19 death, mostly in the hospitalized population. However, even though most deaths around the world have occurred among the frail and elderly, little is known about the risk factors specific to the long-term care population.
In this retrospective cohort study, the investigators will review the medical charts of all COVID-19 cases (n=1200) from 17 long-term care facilities in Montreal, Canada, to compare patients who survived to patients who did not survive. Through multilevel logistic regression, the risk of death will be estimated for institutional predictors of mortality, while controlling for individual risk factors. The objective is to influence local and national policies in long-term care facilities, in the hopes of avoiding the tragic spring 2020 outcomes during subsequent waves of COVID-19 or future pandemics.
Covariates in the models will be drawn from a review of the medical literature and known risk factors for COVID-19 death. Individual-level covariates include clinical features (age, sex, Charlston comorbidity index, SMAF autonomy score, severity criteria) as well as medical treatments (IV fluids, anticoagulation, oxygen, regular opiates, corticosteroids). Aggregate-level covariates include epidemiological data (attack rates, timing of outbreak) and institutional characteristics (number of beds, air exchange per hour, presence of a dedicated COVID-19 unit at the time of outbreak, staff compliance to infection control measures, staff infection rates, understaffing, proportion of semi-private rooms, proportion of wandering wards and other special units).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Most of the residents living in the long-term care facilities are elderly and frail, with a high prevalence of major neurocognitive disorders and low life expectancy. However, some patients are more robust (e.g. residents of wandering wards) or younger (e.g. residents with heavy neurological or mental health diagnoses).
Key inclusion criteria (2 listed)
- Resident of a long-term care facility within the CIUSSS Centre-Sud-de-l'Île-de-Montréal
- Nosocomial COVID-19 infection diagnosis between March 23rd and July 11th 2020
Key exclusion criteria (2 listed)
- Admission to the long-term care facility after July 11th 2020
- COVID-19 infection which was not acquired within the long-term care facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 infectionCase of nosocomial infection within the long-term care facility | Other | – |
Primary outcome
Death
Time frame: 28 days
COVID-19 as a primary or secondary cause of death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: Yes. All deidentified information will be shared, except if there are patient confidentiality issues.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Zhang, M.D. principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Death, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.