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Trial registered on ANZCTR


Registration number
ACTRN12621000545864p
Ethics application status
Not yet submitted
Date submitted
2/03/2021
Date registered
10/05/2021
Date last updated
10/05/2021
Date data sharing statement initially provided
10/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Group Clinical Supervision for Midwives in Sydney
Scientific title
To identify work related burnout in midwives who attend/don't attend Group Clinical Supervision sessions: A cluster randomised control trial.
Secondary ID [1] 303582 0
nil known
Universal Trial Number (UTN)
U111-1265-5275
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
work-related burnout 320950 0
Condition category
Condition code
Mental Health 318758 318758 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group Clinical Supervision will be delivered monthly to the intervention sites (maternity units in the Sydney region). All midwives, excluding senior midwives in roles such as Clinical Educator, manager or Clinical Midwifery Consultant will be asked to participate in the study and attend the sessions. Each session will be face to face and run for 45-60 minutes, and attendance at one session per month is encouraged, with a minimum of 3 sessions within a six month period recommended. Each session will be an open group of up to 8 participants. During the sessions, midwives will be encouraged to discuss a clinical situation and be encouraged to reflect on their experience of the event(s) to further develop their professional competence whilst also feeling safe, supported and empowered. A trained Clinical Supervision facilitator will deliver the sessions. The time-period for the Clinical Supervision to be delivered will be two years. Participants will be asked to complete a survey every 6 months. Liaison with the site PI/managers of the intervention sites will occur to ensure participants are attending the sessions. Liaison will regularly occur with the PIs of the control arm sites to ensure participants complete the surveys.
Intervention code [1] 319868 0
Behaviour
Intervention code [2] 320122 0
Prevention
Comparator / control treatment
The control group will be midwives who do not receive the Group Clinical Supervision intervention,
Control group
Active

Outcomes
Primary outcome [1] 326704 0
Levels of stress and burnout in midwives as identified by completion of the Copenhagen Burnout Inventory (CBI),
Timepoint [1] 326704 0
baseline, and 6, 12, 18, and 24 (primary endpoint) months post-intervention commencement.
Secondary outcome [1] 392408 0
The attrition of midwifery workforce in the maternity units in Sydney hospitals as identified by HR data from NSW Health.
Timepoint [1] 392408 0
reviewed at six monthly intervals post-intervention commencement for the 2 year duration of the study
Secondary outcome [2] 393423 0
Perception of midwifery workplace culture using the Australian Midwifery Workplace Culture (AMWoC) survey tool as part of the 6 monthly online REDCap survey.
Timepoint [2] 393423 0
reviewed at six monthly intervals post-intervention commencement for the 2 year duration of the study
Secondary outcome [3] 393424 0
Efficacy of the Clinical Supervision sessions (intervention sites only) from completion of the tool: Clinical Supervision Evaluation Questionnaire (CSEQ)
Timepoint [3] 393424 0
reviewed at six monthly intervals post-intervention commencement for the 2 year duration of the study

Eligibility
Key inclusion criteria
Registered midwives employed in Public Hospitals in the Greater Sydney geographical area, working for maternity units within hospitals that have consented to being part of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Senior midwifery staff such as Managers, Unit Managers, Educators and Clinical Midwifery Consultants.
Any midwives employed by agencies.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study aims to recruit twelve maternity sites. The primary outcome will be levels of midwifery burnout using the Copenhagen Burnout Inventory (CBI). Assuming that 67% of midwives will have moderate or higher levels of burnout, (the finding from the WHELM study) (Hunter et al, 2018), a sample size of 744 with 372 (six maternity sites with 62 participants) per study arm will achieve 80% power to detect a 15% decrease in moderate or greater burnout with an a level of 0.05 and intra-class correlations of 0.03. To compensate for attrition and other potential threats on effect size, the target midwife sample size was increased by 20% to 894 (447 per arm).

Hunter, B., et al., Work, Health and Emotional Lives of Midwives in the United Kingdom: the UK WHELM study, in Project commissioned by the Royal College of Midwives. 2018, Cardiff University: Cardiff, UK.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/01/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
15/12/2023
Actual
Sample size
Target
894
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18836 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 19368 0
Canterbury Hospital - Campsie
Recruitment hospital [3] 19369 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 19370 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [5] 19371 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [6] 19372 0
Fairfield Hospital - Prairiewood
Recruitment hospital [7] 19373 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [8] 19374 0
St George Hospital - Kogarah
Recruitment hospital [9] 19375 0
The Sutherland Hospital - Caringbah
Recruitment hospital [10] 19376 0
Wollongong Hospital - Wollongong
Recruitment hospital [11] 19377 0
Blacktown Hospital - Blacktown
Recruitment hospital [12] 19378 0
Auburn Hospital & Community Health Services - Auburn
Recruitment postcode(s) [1] 33333 0
2050 - Camperdown
Recruitment postcode(s) [2] 33947 0
2194 - Campsie
Recruitment postcode(s) [3] 33948 0
2170 - Liverpool
Recruitment postcode(s) [4] 33949 0
2200 - Bankstown
Recruitment postcode(s) [5] 33950 0
2560 - Campbelltown
Recruitment postcode(s) [6] 33951 0
2176 - Prairiewood
Recruitment postcode(s) [7] 33952 0
2065 - St Leonards
Recruitment postcode(s) [8] 33953 0
2217 - Kogarah
Recruitment postcode(s) [9] 33954 0
2229 - Caringbah
Recruitment postcode(s) [10] 33955 0
2500 - Wollongong
Recruitment postcode(s) [11] 33956 0
2148 - Blacktown
Recruitment postcode(s) [12] 33957 0
2144 - Auburn

Funding & Sponsors
Funding source category [1] 308002 0
Government body
Name [1] 308002 0
National Health and Medical Research Council
Country [1] 308002 0
Australia
Primary sponsor type
University
Name
University of Technology, Sydney
Address
15 Broadway
Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 309411 0
None
Name [1] 309411 0
Address [1] 309411 0
Country [1] 309411 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 307996 0
The Sydney Local Health District HREC – Royal Prince Alfred Hospital
Ethics committee address [1] 307996 0
50 Missenden Road
Camperdown
NSW 2050
Ethics committee country [1] 307996 0
Australia
Date submitted for ethics approval [1] 307996 0
01/07/2021
Approval date [1] 307996 0
Ethics approval number [1] 307996 0
Ethics committee name [2] 307997 0
UTS HREC
Ethics committee address [2] 307997 0
15 Broadway
Ultimo
NSW 2007
Ethics committee country [2] 307997 0
Australia
Date submitted for ethics approval [2] 307997 0
30/07/2021
Approval date [2] 307997 0
Ethics approval number [2] 307997 0

Summary
Brief summary
This research aims to investigate the effectiveness of Group Clinical Supervision (GSC) within maternity units in twelve Sydney’s public hospitals. The project will explore whether regular access to GCS affects midwives’ perceptions of workplace culture, their intentions to stay in or leave the profession and actual staff retention rates. The level of midwifery burnout will be the primary outcome. The study will include a cluster randomised controlled trial (RCT) with measurement tools that include the Australian Midwifery Workplace Culture (AMWoC) survey tool, the Clinical Supervision Evaluation Questionnaire (CSEQ), the Copenhagen Burnout Inventory (CBI), and workforce data showing staff turnover rates and sick leave from maternity units within the Local Health Districts. The hypotheses are: that regular GCS will improve midwives’ perceptions of their workplace culture and lower their levels of work-related burnout; Midwives with positive perceptions of their workplace culture will be more likely to remain in their profession, and that Maternity units offering regular GCS will have lower levels of midwifery staff attrition than others.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109174 0
A/Prof Christine Catling
Address 109174 0
School of Nursing and Midwifery
University of Technology Sydney
15 Broadway
Ultimo
NSW 2070
Country 109174 0
Australia
Phone 109174 0
+61 0295144912
Fax 109174 0
Email 109174 0
[email protected]
Contact person for public queries
Name 109175 0
Christine Catling
Address 109175 0
School of Nursing and Midwifery
University of Technology Sydney
15 Broadway
Ultimo
NSW 2070
Country 109175 0
Australia
Phone 109175 0
+610295144912
Fax 109175 0
Email 109175 0
[email protected]
Contact person for scientific queries
Name 109176 0
Christine Catling
Address 109176 0
School of Nursing and Midwifery
University of Technology Sydney
15 Broadway
Ultimo
NSW 2070
Country 109176 0
Australia
Phone 109176 0
+61 0295144912
Fax 109176 0
Email 109176 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, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator, A/Prof Christine Catling, [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10856Study protocol  [email protected] 381529-(Uploaded-10-05-2021-08-10-05)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseGroup Clinical Supervision for midwives and burnout: a cluster randomized controlled trial.2022https://dx.doi.org/10.1186/s12884-022-04657-4
N.B. These documents automatically identified may not have been verified by the study sponsor.