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Trial registered on ANZCTR


Registration number
ACTRN12621000533897
Ethics application status
Approved
Date submitted
25/03/2021
Date registered
6/05/2021
Date last updated
6/05/2021
Date data sharing statement initially provided
6/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Coronavirus in Victorian Healthcare and Aged care workers (COVIC-HA) Cohort Study
Scientific title
Coronavirus in Victorian Healthcare and Aged care workers (COVIC-HA) Cohort Study
Secondary ID [1] 302665 0
None
Universal Trial Number (UTN)
U1111-1260-5739
Trial acronym
COVIC-HA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 319579 0
Anxiety 319580 0
Post-traumatic stress 319581 0
Subjective wellbeing 319582 0
SARS-CoV-2 infection 320062 0
Condition category
Condition code
Mental Health 317522 317522 0 0
Depression
Mental Health 317523 317523 0 0
Anxiety
Public Health 317524 317524 0 0
Health service research
Infection 317991 317991 0 0
Other infectious diseases
Respiratory 319304 319304 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The COVIC-HA Cohort Study aims to establish a cohort of 1850 Victorian healthcare and aged care workers across four different settings (first responders, hospitals, primary care, aged care) to comprehensively examine the impacts of the COVID-19 pandemic on healthcare and aged care workers and workplaces over time using a mixed-methods approach. Workers from different occupational groups (doctors, nurses, paramedics, allied health, personal care assistants and support staff) will be included. The key research activities of the study will be conducted in two phases:

Phase 1
All Participants will be invited to complete two quantitative surveys – a baseline survey and a follow-up survey at 6 months, and consent to data linkage. Each survey (at baseline and 6 months) should take approximately 15 minutes to complete. Survey data collected will include demographic, health and wellbeing data, and information about workers perceptions of their organisation’s response to the COVID-19 pandemic. Data linkage will be done with the following administrative health datasets: a) Commonwealth Datasets: Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS); b) Victorian Datasets: Victorian Admitted Episode Database (VAED), Victorian Emergency Minimum Dataset (VEMD), Ambulance Victoria (AV) dataset

Phase 2:
A subset of the cohort will be invited to consent to voluntary participation in two additional study components, to be conducted approximately mid-way between the two quantitative surveys:
• Blood sampling for SARS-CoV-2 serology (antibodies to the COVID-19 virus): A sub-sample of 600 participants will be selected for testing for serological markers of exposure to SARS-CoV-2, comprising workers without a history of confirmed SARS-CoV-2 infection.
• An interview to explore personal experiences of the COVID-19 pandemic: A sub-sample of participants will be purposively recruited for semi-structured interviews to explore their lived experiences of COVID-19. Selection will be based on characteristics determined from quantitative data (e.g. gender, work role, socioeconomic status, exposure to COVID-19) to ensure a diverse range of perspectives is represented. Up to 90 participants will be selected to complete an interview at around the time of the baseline survey. The interview length will depend on how much each participant wants to say, but it could take about 30 minutes.

Depending on participant engagement, thematic findings and COVID-19 infection patterns, some participants may be asked to participate in a second round of qualitative interviews at 6 months.

Additionally, semi-structured one-on-one interviews will be conducted with senior management personnel from each participating site. We will recruit 2-3 senior management personnel from each participating site to explore systems in place for controlling workplace risks and policies and programs in place to prepare and support workers during the COVID-19 pandemic.
Intervention code [1] 318951 0
Not applicable
Comparator / control treatment
The serology component of the study involves a blood test for antibodies to the COVID-19 virus suggestive of undetected infection. Selected group will comprise workers who have either a) undergone a period of quarantine following contact with a confirmed COVID-19 case or b) not undergone a period of quarantine. Hospital workers will be used as the reference comparator group, and the ‘reference comparator’ exposure will be ‘confirmed SARS-CoV-2 infection’
Control group
Active

Outcomes
Primary outcome [1] 325558 0
Depression, as measured by Patient Health Questionnaire-9 (PHQ-9) score:
Timepoint [1] 325558 0
Baseline survey, and at 6 months post baseline survey
Primary outcome [2] 325559 0
Anxiety, as measured by Generalised Anxiety Disorder 7-item scale (GAD-7) score
Timepoint [2] 325559 0
Baseline survey, and at 6 months post baseline survey
Secondary outcome [1] 388392 0
Resilience, as measured by the Connor-Davidson Resilience Scale 2-item (CD-RISC-2)
Timepoint [1] 388392 0
Baseline survey, and at 6 months post baseline survey
Secondary outcome [2] 388393 0
Subjective wellbeing/life satisfaction, as measured by the Personal Wellbeing Index-Adult (PWI-A)
Timepoint [2] 388393 0
Baseline survey, and at 6 months post baseline survey
Secondary outcome [3] 388394 0
Post-traumatic stress, as measured by Impact of Event Scale-6 (IES-6) score
Timepoint [3] 388394 0
Baseline survey, and at 6 months post baseline survey
Secondary outcome [4] 388395 0
General health/health related quality of life, as measured by item 1 of the 36-item Short Form Survey Instrument (SF-36)
Timepoint [4] 388395 0
Baseline survey, and at 6 months post baseline survey
Secondary outcome [5] 389810 0
Serological evidence of SARS-CoV-2 infection, as measured by Anti-SARS-CoV-2 NCP ELISA (IgG)
Timepoint [5] 389810 0
Baseline
Secondary outcome [6] 395061 0
Healthcare and aged care workers' lived experiences of the COVID-19 pandemic as assessed by thematic analysis of semi-structured interviews.
Timepoint [6] 395061 0
A subset of participants will be selected to complete an interview at around the time of the baseline survey.
Secondary outcome [7] 395062 0
Healthcare and aged care workers' perceptions of workplace responses to the pandemic as assessed by thematic analysis of semi-structured interviews
Timepoint [7] 395062 0
A subset of participants will be selected to complete an interview at around the time of the baseline survey.

Eligibility
Key inclusion criteria
Adults aged 18 years and above who have worked in healthcare and aged care settings in Victoria during the COVID-19 pandemic and are working in these settings at the time of the baseline survey.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
As the survey will only be offered in English and recruitment will be conducted online, participation will not be possible by people who are not reasonably fluent in written English or do not have access to the Internet.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Physical and psychosocial health will be assessed using standardised self-report measures of general health, quality of life, anxiety, stress, depression, burnout, professional fulfilment and resilience that are sensitive to changes with time.

Survey data will be analysed using STATA version 16. Descriptive statistics will be used to describe the characteristics of the sample. Primary outcomes will be summarised by the factors of interest using means (standard deviation) or frequencies (percentages) or graphical displays where appropriate. Linear mixed effects models will be used to allow comparison of continuous outcomes between groups. These comparisons will be made at baseline, and of change between baseline and follow-up assessments. The regression models will include fixed effect terms for settings (hospital, ambulance, aged care, primary care) and the stratification factors of Covid-19 exposure, age, gender and occupational group (where possible and relevant). Random intercepts will be included to account for the clustering of HCWs within hospitals, aged care facilities and primary care facilities, allowing the random intercept variances and error variances to differ between settings, where possible. For analysis of binary outcomes, similar random effect models will be used to estimate risk ratios and 95% confidence intervals using a logarithmic link function, or using a logistic link marginalised to obtain risk ratios if convergence problems occur.

Transcripts from qualitative interviews will be analysed thematically by qualitative researchers using NVivo according an established method described by Braun and Clarke. Researchers will work together to establish a hierarchy of themes, constructed during repeated readings of all transcripts. The final set of themes will then be used to search all transcripts.

With a target of 100 workers from each of 8 hospitals (a total of 800 hospital workers), 350 workers from aged care facilities, and 300 paramedics (a total sample size of 1450 workers), then with 80% power and a 5% two-sided level of significance, an effect size of 0.26 standard deviation units can be detected when comparing outcomes between hospital workers and paramedics; 0.31 units when comparing outcomes between hospital and aged care facility workers; and an effect size of 0.29 units when comparing aged care facility workers and paramedics. This assumes that the intracluster correlation for hospitals and aged care facilities is 0.02, with a squared coefficient of variation of sizes of hospitals and aged care facilities of 0.50. To allow for attrition of up to 10% across the two surveys, we will aim to recruit an additional 162 workers across the relevant groups (generating a total sample size of 1612 workers). We will also aim to recruit up to 200 workers from primary care practices.

With these sample sizes, assuming 10% of hospital workers were infected with COVID-19, 20% were furloughed and 70% were neither infected nor furloughed, then when comparing outcomes between exposure groups within hospitals, there is 80% power (at a 5% significance level) to detect an effect size of 0.33 standard deviation units when comparing outcomes of workers infected with COVID-19 to outcomes of workers neither infected nor furloughed, an effect size of 0.38 units when comparing outcomes of workers infected with COVID-19 to outcomes of workers furloughed, and an effect size of 0.25 units when comparing workers furloughed to workers neither infected nor furloughed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18191 0
The Alfred - Melbourne
Recruitment hospital [2] 18192 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 18193 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [4] 18194 0
Frankston Hospital - Frankston
Recruitment hospital [5] 18491 0
Monash Children’s Hospital - Clayton
Recruitment hospital [6] 18492 0
Dandenong Hospital - Dandenong
Recruitment hospital [7] 18493 0
Casey Hospital - Berwick
Recruitment hospital [8] 18494 0
Caulfield Hospital - Caulfield
Recruitment hospital [9] 18495 0
Sandringham Hospital - Sandringham
Recruitment postcode(s) [1] 32248 0
3004 - Melbourne
Recruitment postcode(s) [2] 32249 0
3168 - Clayton
Recruitment postcode(s) [3] 32250 0
3144 - Malvern
Recruitment postcode(s) [4] 32251 0
3199 - Frankston
Recruitment postcode(s) [5] 32809 0
3175 - Dandenong
Recruitment postcode(s) [6] 32810 0
3806 - Berwick
Recruitment postcode(s) [7] 32811 0
3162 - Caulfield
Recruitment postcode(s) [8] 32812 0
3191 - Sandringham
Recruitment postcode(s) [9] 33720 0
3186 - Brighton
Recruitment postcode(s) [10] 33721 0
3060 - Fawkner
Recruitment postcode(s) [11] 33722 0
3085 - Macleod
Recruitment postcode(s) [12] 33723 0
3145 - Malvern East
Recruitment postcode(s) [13] 33724 0
3977 - Cranbourne
Recruitment postcode(s) [14] 33725 0
3134 - Ringwood

Funding & Sponsors
Funding source category [1] 307105 0
Government body
Name [1] 307105 0
Office of Health and Medical Research, Victorian Government
Address [1] 307105 0
50 Lonsdale Street, Melbourne, Victoria, 3000
Country [1] 307105 0
Australia
Funding source category [2] 307419 0
Commercial sector/Industry
Name [2] 307419 0
WorkSafe Victoria
Address [2] 307419 0
1 Malop Street, Geelong VIC 3220
Country [2] 307419 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Public Health and Preventive Medicine (SPHPM)
553 St Kilda Road Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 307675 0
None
Name [1] 307675 0
Address [1] 307675 0
Country [1] 307675 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307219 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 307219 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 307219 0
Australia
Date submitted for ethics approval [1] 307219 0
08/10/2020
Approval date [1] 307219 0
28/10/2020
Ethics approval number [1] 307219 0
68086 (Local Reference: Project 680/20)

Summary
Brief summary
The Coronavirus in Victorian Healthcare and Aged Care Workers (COVIC-HA) study will aim to enrol more than 1,500 Victorian frontline HCWs across hospital, ambulance, aged care and primary care settings, and monitor them over time for mental health changes, impacts on physical health, and evidence of COVID-19 infection. Workplace preparedness and responses will also be investigated, to identify strategies that delivered good outcomes for HCWs. Findings will be delivered to the Victorian Department of Health and Human Services, WorkSafe and other key stakeholders to inform evidence-based responses that are matched to the needs of HCWs and safeguard their health and wellbeing in the context of COVID-19 and future health threats.
Trial website
https://www.monash.edu/medicine/covic-ha/home
Trial related presentations / publications
Public notes
We will recruit workers from Ambulance Victoria, hospitals within the Monash Partners network (Alfred Health, Peninsula Health, Monash Health, Cabrini Health), primary care practices that are members of the Monash Practice Based Research Network (MonReN), Regis residential aged care facilities (Brighton, Cranbourne, East Malvern, Fawkner, Macleod & Ringwood homes) and aged care facilities affiliated with Monash Health.

Contacts
Principal investigator
Name 106450 0
Prof Karin Leder
Address 106450 0
Monash University School of Public Health and Preventive Medicine
553 St Kilda Road, Melbourne VIC 3004
Country 106450 0
Australia
Phone 106450 0
+61 3 9903 0577
Fax 106450 0
+61 3 9903 0556
Email 106450 0
karin.leder@monash.edu
Contact person for public queries
Name 106451 0
Ms Josphin Johnson
Address 106451 0
Monash University School of Public Health and Preventive Medicine
553 St Kilda Road, Melbourne VIC 3004
Country 106451 0
Australia
Phone 106451 0
+61 3 99030118
Fax 106451 0
Email 106451 0
josphin.johnson@monash.edu
Contact person for scientific queries
Name 106452 0
Dr Sarah McGuinness
Address 106452 0
Monash University School of Public Health and Preventive Medicine
553 St Kilda Road, Melbourne VIC 3004
Country 106452 0
Australia
Phone 106452 0
+61 3 99030118
Fax 106452 0
Email 106452 0
sarah.mcguinness@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results