UT southwestern Medical Center
Dallas, Texas, 75390, United States
Location contact
Ganesh Sankaranarayanan, PhD
CONTACT
Ganesh Sankaranarayanan, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT06917183
The goal of this study is to evaluate the current use of Operating Room Black Box (ORBB)data in order to develop simulation-based training that improves intraoperative outcomes and safety, and to assess barriers and facilitators to its implementation.
There are 3 Aims for this study that the investigator will test, but the Aim that is the interventional portion of this study is only reported here in Aim 2 - Establish the validity and effectiveness of high-fidelity immersive virtual simulation-based training in improving operating room quality and safety.
Trial opening soon.
Get Notified20 year–65 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75390, United States
Ganesh Sankaranarayanan, PhD
CONTACT
Ganesh Sankaranarayanan, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
The study will use a mixed within and between subjects' design with two groups - control, and simulation. Due to the dedicated time needed to enroll and complete the sessions along with the need for complete novice subjects, the investigator will recruit medical students at UT Southwestern Medical Center (UTSW) from all years for the simulation group. For the Control group, the investigator will recruit participants from our OR team with a minimum of 5 years of experience at Clements University Hospital (CUH) consisting of surgeons, residents, scrub techs, circulating nurses, anesthesiologists, Certified Registered Nurse Anesthetists (CRNAs) or first assists. Subjects will be randomized into either a control group (didactic) or experimental group (didactic with virtual simulation training). Pre-test: Both groups will take a knowledge assessment test (Multiple choice) that measures baseline knowledge in performing surgical safety checklist. Immediately after that, the participants will be asked to perform the surgical safety checklist once on the simulator. For uniform standard, all participants will choose the role of a surgeon. Both groups will then complete an online introductory module on surgical safety checklists that will be specifically created for use at UTSW. Subjects in the experimental group will then practice on the simulator for 8 sessions with each session not exceeding an hour. The 8 sessions will be completed within three weeks of the pre-test. Deliberate practice will be used to achieve satisfactory scores in the training. A total of 3 scenarios, which will be selected from expert inputs and align with institute priority, will be selected for the training. Post-test: At the end of three weeks, subjects from both groups will once again take the online knowledge test followed by performing the checklists on the simulator. Transfer test: One week after post-test, subjects from both groups will perform surgical safety checklists in a simulated operating room at the UTSW Simulation Center to assess predictive validity. For other team members during the transfer test, the investigator will use the research team and volunteers from the surgical service team. The transfer test performance will be videotaped for assessment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Training for performing surgical safety checklist for a period of 4 weeks.
Time frame: Baseline, at one month post intervention
Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB
Time frame: Baseline, at 3 months post intervention
Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB
Time frame: Baseline, at 5 months post intervention
Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB
Contact information is provided by the study sponsor or research team.
University of Texas Southwestern Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.