Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001007123
Ethics application status
Approved
Date submitted
28/10/2018
Date registered
15/07/2019
Date last updated
19/11/2020
Date data sharing statement initially provided
15/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the effect of a shared leadership system for maternity emergency teams on team performance ?
Scientific title
What is the effect of a shared leadership system for maternity emergency teams on team performance ?
Secondary ID [1] 296450 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternity Emergencies 310227 0
Leadership within Maternity Emergency Teams 310229 0
Condition category
Condition code
Reproductive Health and Childbirth 308959 308959 0 0
Childbirth and postnatal care
Public Health 309002 309002 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The developed system of shared leadership (dual leadership) will be compared to traditional vertical leadership in a simulated maternity emergency using a comparative trial with a counterbalanced, crossover design.

Participants will be attendees (midwives, midwifery students, obstetric doctors and anaesthetic doctors) at the simulation training course “Maternity Emergency Management” (MEM). The course is delivered by an interprofessional team of clinician educators (midwifery/obstetrics and anaesthetics) with training in simulation delivery and debriefing. The setting is a simulation centre which is co-located with a tertiary maternity hospital. Up to 14 participants per course will be divided into two teams who will participate in 2 research scenarios each during the MEM course day. ( research scenarios will be 2&5 (one team) and 3&6 (second team)).
The research scenarios are a fully immersive simulation scenario with a high-fidelity human mannequin. Each intact team of 6-7 participants will be called to an emergency and be expected to assess and manage the "patient" as they would in real life. These scenarios will be similar in the diagnostic approach and management required by the team. Teams will be trained in the use of a cognitive aid during non-research scenarios (scenarios 1&4) to enable singular or shared leadership to be practiced prior to participation in the scenario ustilising the respective leadership structure. Non-research scenarios are immersive scenarios in the "rapid cycle deliberate practice style". Teams will "tag in" and "tag out" of caring for the patient.

All scenarios will happen in the course of one day with each team participating in the non-research scenarios and 2 research scenarios each. Non-research scenarios last 30-45 minutes, Research scenarios last 5-10 minutes and are followed by a 20-40 minute debriefing.


Teamwork scores (primary outcome) for shared and singular leadership will be compared within groups. Teamwork scores will be assessed during the emergency phase (that is the time after the emergency alarm is activated). The leadership type and scenario order will be counterbalanced to reduce the impact of the learning curve through the day. A latin Square will be used to ensure counterbalancing and the order of the implementation of the course each day will be determined by a randomisation.
Intervention code [1] 312775 0
Treatment: Other
Comparator / control treatment
Comparator - dual leadership using a system informed by literature review and staff interviews/ input. Dual leadership system will be supported by cognitive aid which is to be developed for the trial.

Control- traditional singular leadership supported by cognitive aid which is to be developed for the trial.
Control group
Active

Outcomes
Primary outcome [1] 307926 0
Teamwork score as assessed by validated teamwork tool ( Auckland team behaviour Tool)
Timepoint [1] 307926 0
emergency phase of simulated scenario. Assessed retrospectively by video review. Videos will be assessed together on completion of recruitment to avoid rater drift over time.
Secondary outcome [1] 353360 0
1) Clinical performance will be assessed by combination of time to critical intervention (scenario specific) and completion of checklist of clinical interventions ( in development)
Timepoint [1] 353360 0
Assessed by retrospective video review - following completion of recruitment
Secondary outcome [2] 353361 0
Participant self assessed work load
Timepoint [2] 353361 0
As assessed by participants using NASA TLX immediately post scenario

Eligibility
Key inclusion criteria
Consenting participants at the Maternity Emergency Management (MEM) course - doctors, midwives.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
non consent.

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)
no
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Latin square will be used to ensure counterbalancing of scenarios/intervention. Random number generator will be used to randomise the sequence of courses.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
repeated measures ANOVA

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/07/2019
Actual
19/07/2019
Date of last participant enrolment
Anticipated
29/10/2021
Actual
Date of last data collection
Anticipated
29/10/2021
Actual
Sample size
Target
24
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 24491 0
4101 - South Brisbane
Recruitment postcode(s) [2] 27116 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 301045 0
Charities/Societies/Foundations
Name [1] 301045 0
Mater Foundation
Country [1] 301045 0
Australia
Primary sponsor type
University
Name
Monash University
Address
1 Wellington Road
Clayton, VIC 3800
Country
Australia
Secondary sponsor category [1] 300644 0
Hospital
Name [1] 300644 0
Mater Mothers' Hospital
Address [1] 300644 0
1 Raymond Terrace
South Brisbane, QLD, 4101
Country [1] 300644 0
Australia
Other collaborator category [1] 280837 0
Hospital
Name [1] 280837 0
Gold Coast University Hosptial
Address [1] 280837 0
1 Hospital Boulevard, Southport, QLD 4215
Country [1] 280837 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301800 0
Mater Miseracordiea LTD HREC
Ethics committee address [1] 301800 0
Ethics committee country [1] 301800 0
Australia
Date submitted for ethics approval [1] 301800 0
Approval date [1] 301800 0
18/09/2018
Ethics approval number [1] 301800 0
HREC/18/MHS/108

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88150 0
Dr Sarah Janssens
Address 88150 0
Mater Health
Department of Obstetrics and Gynaecology
Ground floor Aubigny Place
1 Raymond Terrace
South Brisbane QLD 4101
Country 88150 0
Australia
Phone 88150 0
+61 7 31638855
Fax 88150 0
Email 88150 0
[email protected]
Contact person for public queries
Name 88151 0
Sarah Janssens
Address 88151 0
Mater Health
Department of Obstetrics and Gynaecology
Ground floor Aubigny Place
1 Raymond Terrace
South Brisbane QLD 4101
Country 88151 0
Australia
Phone 88151 0
+61 7 31638855
Fax 88151 0
Email 88151 0
[email protected]
Contact person for scientific queries
Name 88152 0
Sarah Janssens
Address 88152 0
Mater Health
Department of Obstetrics and Gynaecology
Ground floor Aubigny Place
1 Raymond Terrace
South Brisbane QLD 4101
Country 88152 0
Australia
Phone 88152 0
+61 7 31638855
Fax 88152 0
Email 88152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
this would potentially breech privacy or local governance protocols


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2896Study protocol  [email protected] 376273-(Uploaded-08-07-2019-08-55-08)-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
No additional documents have been identified.