Trial Review

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
ACTRN12612001088831
Ethics application status
Approved
Date submitted
9/10/2012
Date registered
11/10/2012
Date last updated
6/08/2019
Date data sharing statement initially provided
6/08/2019
Date results information initially provided
6/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Multidisciplinary Operating Room Simulations for Improved Teamwork and Information Sharing
Scientific title
A simulation-based intervention for operating room teams to improve teamwork and information sharing and reduce patient harm
Secondary ID [1] 281365 0
Nil
Universal Trial Number (UTN)
Trial acronym
MORSim
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Teamwork in the operating theatre 287590 0
Condition category
Condition code
Surgery 287916 287916 0 0
Other surgery
Public Health 287920 287920 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A one-day course involving a didactic lecture on teamwork and effective communication, three immersive scenarios of acute surgical cases and educational debriefs.
Intervention code [1] 285827 0
Other interventions
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288130 0
Harm, as defined by the American College of Surgeons' National Surgical Quality Improvement Program.
Timepoint [1] 288130 0
The year before and the year after the intervention, identified by chart review.
Secondary outcome [1] 299467 0
Behavioural Markers of Risk Index scores for information sharing in the operating theatre.
Timepoint [1] 299467 0
Up to 200 cases observed in the months before and after the intervention.
Secondary outcome [2] 299468 0
Shared mental models as measured by a card sorting exercise, Situational Awareness Global Assessment Technique, and by counts of correctly identified information probes
Timepoint [2] 299468 0
During the scenarios in the intervention.
Secondary outcome [3] 299469 0
Attitudes to teamwork and safety, as by the Safety Attitudes Questionnaire.
Timepoint [3] 299469 0
Before the course and approximately 6 months after the course.
Secondary outcome [4] 299470 0
Medical managment of the scenarios as measured by systematic subjective and objective ratings
Timepoint [4] 299470 0
During the scnearios in the intervention.
Secondary outcome [5] 299471 0
Emotional intelligence as measured by the Trait Emotional Intelligence Questionnaire (Short Form) and The Cambridge BEhaviour Scale
Timepoint [5] 299471 0
During the scenarios in the intervention.
Secondary outcome [6] 299472 0
Physiologic responses to stress as measured by heart rate, via a Zephyr monitor, and subjective timings of increased stress provided by participants via visual analogue scale.
Timepoint [6] 299472 0
During the scenarios in the intervention.
Secondary outcome [7] 299473 0
Communication patterns as coded from video recordings of the simulations. The codes will be time-stamped markers including who was speaking to whome and what type of utterance it was (question, statement, instruction etc).
Timepoint [7] 299473 0
During the scenarios in the intervention.

Eligibility
Key inclusion criteria
Currently working in Auckland City Hospital on Level 8 or in Midlemore Hospital in general surgery operating rooms.
Written, informed consent
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anaesthetists not yet at ATY-1 training level
Anaesthetic technicians who have not yet passed their final NZATS exam

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be asked to attend the intervention days by members of the project team and allocated a day according to their availability.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will not be formally randomised to a day. However, the order of scenarios will be randomised on a given day using the Microsoft Excel random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2012
Actual
15/10/2012
Date of last participant enrolment
Anticipated
Actual
1/07/2013
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 4589 0
New Zealand
State/province [1] 4589 0

Funding & Sponsors
Funding source category [1] 286121 0
Government body
Name [1] 286121 0
Health Workforce New Zealand
Country [1] 286121 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 284934 0
None
Name [1] 284934 0
Address [1] 284934 0
Country [1] 284934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288168 0
Central Regional Ethics Committee New Zealand
Ethics committee address [1] 288168 0
PO Box 5013
Wellington 6145
Ethics committee country [1] 288168 0
New Zealand
Date submitted for ethics approval [1] 288168 0
31/01/2012
Approval date [1] 288168 0
16/04/2012
Ethics approval number [1] 288168 0
CEN/12/03/002

Summary
Brief summary
Observational research of operating theatre teams supports the proposition that failures in teamwork and communication are common and lead directly to compromised patient care and reduced productivity. High fidelity, immersive patient simulation is an exciting new technology that provides both a test laboratory for the study of medical error and health care teams, and a powerful medium for implementing change in the way health care teams function. This study is focused on measuring the impact of a simulation-based course on teamwork in the operating room.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34806 0
Prof Jennifer Weller
Address 34806 0
Centre for Medical and Health Sciences Education University of Auckland Private Bag 92 019 Auckland 1142
Country 34806 0
New Zealand
Phone 34806 0
+64 9 923 9459
Fax 34806 0
Email 34806 0
[email protected]
Contact person for public queries
Name 18053 0
Prof Jennifer Weller
Address 18053 0
Centre for Medical and Health Sciences Education
University of Auckland
Private Bag 92 019
Auckland 1142
Country 18053 0
New Zealand
Phone 18053 0
+64 9 923 9459
Fax 18053 0
Email 18053 0
[email protected]
Contact person for scientific queries
Name 8981 0
Prof Jennifer Weller
Address 8981 0
Centre for Medical and Health Sciences Education
University of Auckland
Private Bag 92 019
Auckland 1142
Country 8981 0
New Zealand
Phone 8981 0
+64 9 923 9459
Fax 8981 0
Email 8981 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
We will take individual requests for data but privacy prevents us from releasing it without approval.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproved scores for observed teamwork in the clinical environment following a multidisciplinary operating room simulation intervention.2016
N.B. These documents automatically identified may not have been verified by the study sponsor.