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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04397848
Other study ID # 3189
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 14, 2020
Est. completion date July 3, 2020

Study information

Verified date November 2020
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

An online survey will be sent to healthcare workers (HCWs) in acute care hospitals to explore a variety of risk factors for negative psychological outcomes and levels of anxiety, depression and post-traumatic stress symptoms using validated scales. It is important to understand the sources of negative psychological impact on HCWs during this COVID-19 pandemic before hospitals and organizations can address and develop support programs to mitigate the stresses experienced by healthcare workers. Addressing and supporting the needs of our HCWs will be paramount in this COVID-19 pandemic and future outbreaks.


Description:

Previous work conducted by our group during the 2003 SARS outbreak demonstrated symptoms of post-traumatic stress disorder (PTSD) and depression in healthcare workers (HCWs) working in high-risk areas. Similar reports are emerging with regards to HCWs during COVID-19 which may affect staff mental health outcomes which may have effects on staff absenteeism and retention. The study is a cross-sectional, multi-centered, hospital-based online survey conducted at several Toronto hospitals. Participants will be recruited to participate in the voluntary study via an internal e-mail that will contain a short description of the study and a link to the online survey. The survey will take approximately 25 minutes to complete. The study group will include HCW s from high-risk units (Emergency, ICU, and COVID-19 units) with a comparison group of HCWs who are not directly involved in the assessment or management of patients with COVID-19. This study will evaluate the psychological impact of the COVID-19 pandemic on HCW's and identify risk factors that may place HCWs at greater risk for negative psychological outcomes. The survey will gather information such as s basic, non-identifying demographic information, hospital and unit of work, quarantine and isolation, work with patients diagnosed with COVID-19, loss of loved ones to COVID-19, understanding of the reasons for PPE/ infection control directives, perceptions of risk to self and family, sources of support. As well, Toronto is in the unique situation of having been at the centre of the 2003 Canadian SARS outbreak and presently experiencing the impact of the COVID-19. The investigators propose that COVID-19 might have a differential impact on the psychological wellbeing of current HCWs depending on whether they practiced during SARS. Our survey will explore the differences of the psychological impact of the COVID-19 pandemic on healthcare workers who lived through the SARS outbreak and those who did not. The following validated scales are embedded in the survey to evaluate the psychological impact of the COVID pandemic: Impact of Event Scale-Revised (IES-R), Generalized Anxiety Disorder -7 (GAD-7) , and Patient Health Questionnaire (PHQ-9). Open-ended questions will also provide respondents the opportunity to relate aspects of working during the COVID-19 pandemic that are most difficult and to provide additional comments on their unique experiences.


Recruitment information / eligibility

Status Completed
Enrollment 3852
Est. completion date July 3, 2020
Est. primary completion date July 3, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: HCW currently working at Toronto based hospitals: University Health Network (UHN), Sunnybrook Health Sciences and William Osler Health System. Exclusion Criteria: Not a healthcare worker

Study Design


Locations

Country Name City State
Canada University Health Network Toronto Ontario

Sponsors (4)

Lead Sponsor Collaborator
University Health Network, Toronto Sunnybrook Health Sciences Centre, University of Toronto, William Osler Health System

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impact of Event Scale - Revised (IES-R) Scale to evaluate Post-traumatic Stress Disorder symptoms Two weeks
Primary General Anxiety Disorder (GAD-7) Scale to evaluate anxiety symptoms Two weeks
Primary Patient Health Questionnaire (PHQ-9) Scale to evaluate depressive symptoms Two weeks
Secondary Qualitative Data Qualitative data will be coded and analyzed to show emerging themes. Two weeks
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