ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

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]

Levels of stress and burnout in midwives as identified by completion of the Copenhagen Burnout Inventory (CBI),

Timepoint [1]

baseline, and 6, 12, 18, and 24 (primary endpoint) months post-intervention commencement.

Secondary outcome [1]

The attrition of midwifery workforce in the maternity units in Sydney hospitals as identified by HR data from NSW Health.

Timepoint [1]

reviewed at six monthly intervals post-intervention commencement for the 2 year duration of the study

Secondary outcome [2]

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]

reviewed at six monthly intervals post-intervention commencement for the 2 year duration of the study

Secondary outcome [3]

Efficacy of the Clinical Supervision sessions (intervention sites only) from completion of the tool: Clinical Supervision Evaluation Questionnaire (CSEQ)

Timepoint [3]

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]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

Canterbury Hospital - Campsie

Recruitment hospital [3]

Liverpool Hospital - Liverpool

Recruitment hospital [4]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment hospital [5]

Campbelltown Hospital - Campbelltown

Recruitment hospital [6]

Fairfield Hospital - Prairiewood

Recruitment hospital [7]

Royal North Shore Hospital - St Leonards

Recruitment hospital [8]

St George Hospital - Kogarah

Recruitment hospital [9]

The Sutherland Hospital - Caringbah

Recruitment hospital [10]

Wollongong Hospital - Wollongong

Recruitment hospital [11]

Blacktown Hospital - Blacktown

Recruitment hospital [12]

Auburn Hospital & Community Health Services - Auburn

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2194 - Campsie

Recruitment postcode(s) [3]

2170 - Liverpool

Recruitment postcode(s) [4]

2200 - Bankstown

Recruitment postcode(s) [5]

2560 - Campbelltown

Recruitment postcode(s) [6]

2176 - Prairiewood

Recruitment postcode(s) [7]

2065 - St Leonards

Recruitment postcode(s) [8]

2217 - Kogarah

Recruitment postcode(s) [9]

2229 - Caringbah

Recruitment postcode(s) [10]

2500 - Wollongong

Recruitment postcode(s) [11]

2148 - Blacktown

Recruitment postcode(s) [12]

2144 - Auburn

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke St
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Technology, Sydney

Address

15 Broadway
Ultimo, NSW 2007

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

The Sydney Local Health District HREC – Royal Prince Alfred Hospital

Ethics committee address [1]

50 Missenden Road
Camperdown
NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/07/2021

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

UTS HREC

Ethics committee address [2]

15 Broadway 
Ultimo
NSW 2007

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

30/07/2021

Approval date [2]

Ethics approval number [2]

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

A/Prof Christine Catling

Address

School of Nursing and Midwifery
University of Technology Sydney
15 Broadway
Ultimo
NSW 2070

Country

Australia

Phone

+61 0295144912

Fax

[email protected]

Contact person for public queries

Name

Christine Catling

Address

School of Nursing and Midwifery
University of Technology Sydney
15 Broadway
Ultimo
NSW 2070

Country

Australia

Phone

+610295144912

Fax

[email protected]

Contact person for scientific queries

Name

Christine Catling

Address

School of Nursing and Midwifery
University of Technology Sydney
15 Broadway
Ultimo
NSW 2070

Country

Australia

Phone

+61 0295144912

Fax

[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.	Type	Citation	Link	Email	Other Details	Attachment
10856	Study 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

Source	Title	Year of Publication	DOI
Embase	Group Clinical Supervision for midwives and burnout: a cluster randomized controlled trial.	2022	https://dx.doi.org/10.1186/s12884-022-04657-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically