Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000223235
Ethics application status
Approved
Date submitted
1/12/2017
Date registered
12/02/2018
Date last updated
6/07/2021
Date data sharing statement initially provided
6/07/2021
Date results information initially provided
6/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Who is leading maternity teams? An observational study of leadership sharing in maternity teams and the relationship to teamwork performance.
Scientific title
Who is leading maternity teams? An observational study of leadership sharing and teamwork performance.
Secondary ID [1] 292452 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Leadership within Maternity Emergency Teams
304063 0
Teamwork within Maternity Emergency Teams. 304064 0
Condition category
Condition code
Reproductive Health and Childbirth 303390 303390 0 0
Childbirth and postnatal care
Public Health 305247 305247 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Multidisciplinary teams participating in immersive simulation scenarios of obstetric emergencies will be viewed retrospectively by trained raters. Simulation scenarios are delivered within an 8 hour simulation course. Participants undergo an introductory session including a 45 minute interactive teaching session on principles of crisis resource management. Scenarios last 10-15 minutes and are followed by a 20-40 minute debrief conducted by a trained facilitator. Participants participate in or observe 6 simulated scenarios during the course. Active participation in the 2-4 scenarios occurs for each participant. Scenarios include maternal collapse ( 2 cases), uterine inversion, post partum haemorrhage, eclampsia and shoulder dystocia
Intervention code [1] 298630 0
Not applicable
Comparator / control treatment
Teams will be coded for leadership distribution by coding verbal utterances. A coding system has been developed a priori following a literature review including leadership functions taxonomies and assessment tools. Ten subject matter experts have contributed to refining the tool and it has been piloted on a small sample of scenarios and found to be useful. Two independent raters will view videos with the transcriptions and code utterances. Leadership distribution will be determined by how distributed leadership utterances are within the team members present (not just a designated leader). Teams with high (top 50%) leadership distribution will be compared to teams with low leadership distribution. (lower 50%).
Control group
Active

Outcomes
Primary outcome [1] 302776 0
Teamwork score - Auckland Team Behaviour Score
Timepoint [1] 302776 0
Scoring is per scenario, scored retrospectively via analysis of video data. Each team is scored independently. Team composition is not stable ( as it isn't in real life) so no in tact team is scored twice however, individuals may be present in different teams.
Primary outcome [2] 304400 0
Clinical teamwork scale
Timepoint [2] 304400 0
Scoring is per scenario, scored retrospectively via analysis of video data. Each team is scored independently. Team composition is not stable ( as it isn't in real life) so no in tact team is scored twice however, individuals may be present in different teams.
Secondary outcome [1] 336988 0
Time to critical management (measured in minutes and seconds)
- measured as time from declaration of the emergency to institution of critical management:
- uterine inversion scenarios this is defined as replacement of the uterus (only for uterine inversion scenario)
- PPH secondary to retained placenta this is defined as the time that the decision is made to transfer to the operating room for surgical treatment. (only for retained placenta scenario)

These time point have been decided on by a panel of subject matter experts and designed specifically for this study. Other simulation studies have used similar "time to implement" critical management measures specific to the simulation scenario.

Timepoint [1] 336988 0
Scoring is per scenario, scored retrospectively via analysis of video data. Each team is scored independently. Team composition is not stable ( as it isn't in real life) so no in tact team is scored twice however, individuals may be present in different teams.
Secondary outcome [2] 341826 0
checklist of clinical performance measures as a composite outcome.
Developed for this study following review of national and international guidelines for management and refined by a panel of subject matter experts.

Retained placenta scenario:
Apply oxygen
Commence BP, HR and sats monitoring
Commence IV Fluid bolus
Insert second IV line
Send bloods – FBC, Coag G&S or X match
Administer IM oxytocin
Administer IM ergometrine
Commence IV oxytocin
Insert IDC
Perform uterine tone assessment and massage
Examine lower genital tract for trauma
Examine placenta
Decision to go to theatre (Time___________)

Uterine inversion scenario
Apply oxygen
Commence BP, HR and sats monitoring
Commence IV Fluid bolus
Insert second IV line
Send bloods – FBC, Coag G&S or X match
Does not administer oxytocics prior to replacement
Does not perform further traction on cord
Assesses fundus
Perform vaginal examination
Replace uterus manually (Time_________)
Continues manual replacement until uterine contraction confirmed
Commence oxytocin infusion one uterus replaced
Decision to go to theatre
Timepoint [2] 341826 0
Scoring is per scenario, scored retrospectively via analysis of video data. Each team is scored independently. Team composition is not stable ( as it isn't in real life) so no in tact team is scored twice however, individuals may be present in different teams.

Eligibility
Key inclusion criteria
Participants at the "Maternity Emergency Management" (MEM) course at Mater Education. Includes Doctors, Midwives and midwifery students.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Groups of participants in which any team member has not consented to participate or have video storage.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Scenarios will be rated for leadership distribution via coding of leadership utterances. Teamwork will be rated via both the Auckland team Behaviours Tool and the Clinical Teamwork scale to support validity of the Auckland team Behaviour tool. Clinical performance will be rated via checklist and time to critical intervention.

14 scenarios will be required for an power of 80% to detect a significant change in teamwork scores with an alpha of 0.05.

Mean teamwork scores, and clinical performance measures will be compared via unpaired t test if normally distributed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/09/2016
Date of last participant enrolment
Anticipated
16/03/2018
Actual
16/03/2018
Date of last data collection
Anticipated
30/04/2018
Actual
30/04/2018
Sample size
Target
14
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9920 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 18729 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 297020 0
Charities/Societies/Foundations
Name [1] 297020 0
Mater Foundation
Country [1] 297020 0
Australia
Primary sponsor type
Hospital
Name
Mater Health
Address
Mater Education
Duncombe Building
Raymond Terrace
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 296019 0
University
Name [1] 296019 0
Monash University
Address [1] 296019 0
Clayton Campus
Wellington Road
Clayton
Victoria 3800
Country [1] 296019 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298205 0
MML HREC
Ethics committee address [1] 298205 0
Aubigny Place
South Brisbane QLD 4101
Ethics committee country [1] 298205 0
Australia
Date submitted for ethics approval [1] 298205 0
Approval date [1] 298205 0
18/03/2016
Ethics approval number [1] 298205 0
HREC/ 15 /MHS/121

Summary
Brief summary
Simulation training is used to develop both clinical and teamwork skills. Effective teamwork, including allocation of leadership is an important factor in providing high quality patient care in emergencies. This project aims to evaluate how maternity teams share leadership and during emergencies and determine if leadership sharing is related to teamwork and clinical performance.
Trial website
N/A
Trial related presentations / publications
Public notes
Attachments [1] 2405 2405 0 0
/AnzctrAttachments/373318-Auckland RATER.pdf (Supplementary information)
Attachments [2] 2406 2406 0 0
/AnzctrAttachments/373318-Clinical Teamwork scale.pdf (Supplementary information)

Contacts
Principal investigator
Name 76330 0
Dr Sarah Janssens
Address 76330 0
Mater Mothers' Hospital
Ground Floor Aubigny Place
1 Raymond Terrace
South Brisbane QLD 4101
Country 76330 0
Australia
Phone 76330 0
+61 7 31638111
Fax 76330 0
Email 76330 0
[email protected]
Contact person for public queries
Name 76331 0
Sarah Janssens
Address 76331 0
Mater Mothers' Hospital
Ground Floor Aubigny Place
1 Raymond Terrace
South Brisbane QLD 4101
Country 76331 0
Australia
Phone 76331 0
+61 7 31638111
Fax 76331 0
Email 76331 0
[email protected]
Contact person for scientific queries
Name 76332 0
Sarah Janssens
Address 76332 0
Mater Mothers' Hospital
Ground Floor Aubigny Place
1 Raymond Terrace
South Brisbane QLD 4101
Country 76332 0
Australia
Phone 76332 0
+61 7 31638111
Fax 76332 0
Email 76332 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
participants not consented for this.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Leadership sharing in maternity emergency teams: a... [More Details]

Documents added automatically
No additional documents have been identified.