Plain English Summary
Background and study aims
Non-technical skills such as communication, teamwork, leadership, situation awareness and decision making have been shown to correlate with patient safety in the operating room. Equally, failures to perform sufficiently in these skills have been identified as root causes in over 60% of major surgical complications. Crew Resource Management (CRM) - training was originally developed by the aviation industry to enhance non-technical skills of flight crews in order to improve flight safety. CRM training has subsequently also been used to train teams in high-risk areas of healthcare such as emergency medicine and anesthesia,and more recently, surgical teams with positive effects on team performance and safety culture. Although non-technical skills are thought to be essential for safe and efficient team performance in the operating room, these skills are not routinely taught in structured curricula in surgical residency programs in Canada.
The aim of this study is to validate a comprehensive CRM-curriculum to teach non-technical skills to surgical residents early on in their residency training in order to shorten the learning curve and move the acquisition of these skills out of the operating room.
Who can participate?
All surgical residents in the University of Toronto residency program that begin PGY1 training in July 2012.
What does the study involve?
The CRM-curriculum will be validated in this study involving three study arms, each comprising 12 surgical residents from the University of Toronto Surgical Residency Program. The study group, consisting of residents in the first postgraduate year (PGY1), will receive structured training in non-technical skills through didactic courses, video material, high-fidelity simulation, and web-based e-learning modules for home study. The control group (PGY1) will receive conventional residency training. A comparison group of senior residents (PGY5) will be evaluated to demonstrate the degree of natural non-technical skills acquisition, i.e. learning on the job. The study and control groups will be evaluated for non-technical skills and performance in a simulated crisis scenario at baseline and after the training period, and re-evaluated at 1 year to test for skill retention. The comparison group will only be evaluated once regarding performance in a simulated crisis scenario.
What are the possible benefits and risks of participating?
Participation in the study may be beneficial for the study group since they will acquire valuable skills that are likely to improve their performance in the operating room, in particular increasing their preparedness and performance in a crisis situation. The control group will be offered to also receive the training at the end oft he study period. There are no known risks associated with participation in the study.
Where is the study run from?
Allan Waters Family Simulation Centre and Li Ka Shing Knowledge Institute, at 209 Victoria Street, Toronto, Ontario.
When is study starting and how long is it expected to run for?
The study is expected to begin in July 2012 and end in August 2013.
Who is funding the study?
St. Michael's Hospital (Canada)
Who is the main contact?
Dr. Nicolas Dedy
dedyn@smh.ca
Trial website
Contact information
Type
Scientific
Primary contact
Dr Teodor Grantcharov
ORCID ID
Contact details
St. Michael's Hospital
30 Bond Street
CC Rm. 16-056
Toronto
M5B 1W8
Canada
grantcharovt@smh.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Teaching surgical residents about non-technical skills: Validation of a comprehensive curriculum for CRM -Training in a surgical residency program
Acronym
Study hypothesis
First hypothesis: Teaching non-technical skills such as communication, teamwork and leadership to surgical residents early on in their training will result in:
1. A change in attitudes towards non-technical skills
2. Enhanced knowledge about non-technical skills, human error and limitations and
3. Measurable behavioral changes with enhanced performance in a surgical crisis simulation
Second hypothesis: Surgical residents that underwent a special training in non-technical skills in their first postgraduate year will demonstrate:
1. A faster learning curve with regards to non-technical skills and performance in a crisis simulation than a control group undergoing conventional training and
2. After the training will perform equally or better in a surgical crisis simulation than a comparison group of postgraduate year 5 residents with no structured non-technical skills training.
Third hypothesis: Non-technical skills learned in a curriculum will be transferable to the real operating room.
Ethics approval
Not provided at time of registration
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Not available in web format, please contact Nicolas Dedy, Dedyn@SMH.ca to request a patient information sheet
Condition
Surgical education; non-technical skills and teamwork training in surgery
Intervention
Study group: 12 surgical residents in the first postgraduate year (PGY1), that will receive CRM-training through the curriculum.
Control group: 12 surgical residents (PGY1) that will receive conventional residency training.
Comparison group: 12 senior surgical residents (PGY5) be evaluated regarding non-technical skills acquired "naturally", i.e. without structured CRM-training, during 5 years of conventional residency training.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Performance in standardized, simulated crisis scenarios with regard to non-technical skills [Oxford Non-technical skills (NOTECHS) and Non-Technical Skills for Surgeons (NOTSS) rating scales]
Secondary outcome measures
1. Change in attitudes towards safety and non-technical skills and CRM-training
2. Performance in a knowledge test of non-technical skills, human error and -limitations
Overall trial start date
01/07/2012
Overall trial end date
01/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All surgical residents in the University of Toronto residency program that begin PGY1 training in July 2012 and have given written informed consent to participate in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12 participants in study group, 12 in control group, 12 in comparison group
Participant exclusion criteria
1. Pregnant women
2. Residents who declined participation
Recruitment start date
01/07/2012
Recruitment end date
01/09/2013
Locations
Countries of recruitment
Canada
Trial participating centre
St. Michael's Hospital
Toronto
M5B 1W8
Canada
Funders
Funder type
Hospital/treatment centre
Funder name
St. Michael's Hospital (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list