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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04782427
Other study ID # CentreSuddeMontréal
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date May 13, 2021

Study information

Verified date July 2021
Source Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 1197
Est. completion date May 13, 2021
Est. primary completion date April 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Admission to the long-term care facility after July 11th 2020 - COVID-19 infection which was not acquired within the long-term care facility

Study Design


Intervention

Other:
COVID-19 infection
Case of nosocomial infection within the long-term care facility

Locations

Country Name City State
Canada CIUSSS Centre-Sud-de-l'Île-de-Montréal Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death COVID-19 as a primary or secondary cause of death 28 days
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