Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000808943
Ethics application status
Approved
Date submitted
27/07/2020
Date registered
11/08/2020
Date last updated
11/08/2020
Date data sharing statement initially provided
11/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Patient Perspective Survey on Masking or De-Masking the Medical Staff amid COVID-19 Pandemic
Scientific title
A Patient Perspective Survey on Masking or De-Masking the Medical Staff amid COVID-19 Pandemic
Secondary ID [1] 301882 0
nil known
Universal Trial Number (UTN)
U1111-1256-1499
Trial acronym
nil
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
COVID-19 318391 0
Cross Infection 318392 0
Condition category
Condition code
Respiratory 316406 316406 0 0
Other respiratory disorders / diseases
Infection 316569 316569 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a study-specific survey focusing on determining the patient's perceptions of mask-wearing by medical staff and the relationship with the daily consumption of COVID19 information. It takes approximately 1-2 minutes to complete the anonymous written questionnaire survey.
Patients need to complete the survey only once when they are admitted to the hospital, there is no follow up survey for that particular patient. However, if they are readmitted to our hospital during the study period (March to August 2020), they are potentially surveyed again, but this is not patient-specific but time-specific, i.e., admissions during the study period




Intervention code [1] 318176 0
Not applicable
Comparator / control treatment
chronological comparison between the 1st COVID-19 pandemic wave and the 2nd wave of patient's media consumption surrounding coronavirus and their opinions on mask use by medical staff
We started to collect data from the end of March 2020 and stopped in early May 2020, this period corresponds the 1st wave in Victoria, which was mostly imported COVID cases that peaked during this period.
We restarted to collect data in the beginning of July 2020 and would expect to complete in the end of August 2020, this period corresponds the second wave in Victoria, where there is more community-based COVID transmissions that will peak during this period.
Control group
Historical

Outcomes
Primary outcome [1] 324561 0
Patient perceptions of mask wearing by medical staff will be assessed using study-specific survey,
Patient attitude towards mask wearing by medical staff will be assessed against several timepoints when important policies issued during the course:
1. WHO recommended the public to wear masks in the end of March 2020
2. Victoria recommended to wear masks in public places in early July 2020
3. Victoria announced mandatory mask wearing when going out of homes in the end of July 2020
Timepoint [1] 324561 0
At time of single cross-sectional survey completed amid COVID-19 pandemic, covering two peak periods from March to August 2020, and including 3 important policy timepoints during the study period, which are:
1. WHO recommended the public to wear masks in the end of March 2020
2. Victoria recommended to wear masks in public places in early July 2020
3. Victoria announced mandatory mask wearing when going out of homes in the end of July 2020
Secondary outcome [1] 384974 0
Patient's media consumption of COVID19 will be assessed using study-specific survey,
The volume of daily information consumption will be checked along the course of COVID pandemic in Victoria
Timepoint [1] 384974 0
At time of single cross-sectional survey completed amid COVID-19 pandemic, covering two peak periods from March to August 2020.

Eligibility
Key inclusion criteria
Patients admitted to Maroondah and Box Hill Hospital of Eastern Health for surgical or medical reasons
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Younger than 16 years
- Intellectual disability or dementia
- Language barrier, visual or hearing impairment
- Suspected or confirmed COVID-19

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used:
1. Percentage of patients in each category will be compared between the first wave/period (end of March to early May 2020) and the second wave/period (July to August 2020)
2. Qualitative data from patients' comments will be summarized and quantified as appropriate

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
500
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17154 0
Maroondah Hospital - Ringwood East
Recruitment hospital [2] 17155 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 30834 0
3135 - Ringwood East
Recruitment postcode(s) [2] 30835 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 306302 0
Hospital
Name [1] 306302 0
Maroondah Hospital
Country [1] 306302 0
Australia
Primary sponsor type
Hospital
Name
Maroondah Hospital
Address
1-15 Davey Drive
East Ringwood
VIC 3135
Country
Australia
Secondary sponsor category [1] 306795 0
Hospital
Name [1] 306795 0
Box Hill Hospital
Address [1] 306795 0
8 Arnold Street
Box Hill
VIC 3128
Country [1] 306795 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306517 0
Eastern Health Research & Ethics Committee
Ethics committee address [1] 306517 0
Level 2
5 Arnold Street
Box Hill
VIC 3128
Ethics committee country [1] 306517 0
Australia
Date submitted for ethics approval [1] 306517 0
15/05/2020
Approval date [1] 306517 0
04/06/2020
Ethics approval number [1] 306517 0
LR20-032

Summary
Brief summary
With the emergence of the novel COVID-19 virus, medical staff are continuing to expose and put themselves at risk in their day to day work. This virus is known to spread through primarily droplet exposure. Frontline medical staff are at highest risk in being exposed to droplets from the potential asymptomatic or mild COVID-19 individuals. A simple, but effective, means to reduce droplet spread is the use of face masks. However, wearing face masks outside operating theatres is not routine practice in Australian Hospitals, as such, there is concern that it could cause fear and anxiety in already stressed patients. Such concern has caused a dilemma among some medical staff with regards to masking or de-masking while at work. In order to find out whether this concern is real, i.e., how patients feel about the change in practice by medical staff wearing face masks, we designed this written questionnaire survey to examine patients’ attitudes towards masking the medical staff at work during COVID-19 pandemic.
Trial website
nil
Trial related presentations / publications
nil
Public notes
This project was pre-approved in mid-March 2020 by our local Ethics Committee (before we commenced the study) via emailing, in which it stated: "You can regard this as approval in anticipation of a low risk application. This expedited approval process acknowledges the need to be adaptable to the challenges COVID- 19 presents as well as the opportunities to learn from this experience".
We submitted our formal low risk ethics application with the pre-approval email in May 2020, that's why our final Ethics approval date was in June 2020.
Pre-approval email is available upon request

Contacts
Principal investigator
Name 104134 0
Dr Aihua Wu
Address 104134 0
Department of Anaesthesia
Maroondah Hospital
1-15 Davey Drive
East Ringwood
VIC 3135
Country 104134 0
Australia
Phone 104134 0
+61398713448
Fax 104134 0
Email 104134 0
[email protected]
Contact person for public queries
Name 104135 0
Dr Aihua Wu
Address 104135 0
Department of Anaesthesia
Maroondah Hospital
1-15 Davey Drive
East Ringwood
VIC 3135
Country 104135 0
Australia
Phone 104135 0
+61398713448
Fax 104135 0
Email 104135 0
[email protected]
Contact person for scientific queries
Name 104136 0
Dr Aihua Wu
Address 104136 0
Department of Anaesthesia
Maroondah Hospital
1-15 Davey Drive
East Ringwood
VIC 3135
Country 104136 0
Australia
Phone 104136 0
+61398713448
Fax 104136 0
Email 104136 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, which are already non-identifiable.
When will data be available (start and end dates)?
Immediately following publication. No end date.
Available to whom?
Anyone who wishes to access the data.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Data are available indefinitely by emailing the principal investigator Dr Aihua Wu at [email protected]


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.