Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Demonstrate Effectiveness of Virtual Simulator in Improving OR Performance
• Intervention / Treatment: Other: Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ganesh Sankaranarayanan, PhD; Phone Number: 2067347458; Email: Ganesh.Sankaranarayanan@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
      • Contact: Ganesh Sankaranarayanan, PhD; Phone Number: 2067347458; Email: Ganesh.Sankaranarayanan@UTSouthwestern.edu
      • Contact: Email: ganesh.sankaranarayanan@utsouthwestern.edu
      • Principal Investigator: Ganesh Sankaranarayanan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• OR service with a minimum of 5 years of experience that includes surgeons, residents, scrub techs, circulating nurses, anesthesiologists, CRNAs or first assists

Exclusion Criteria:

• OR team members (surgeons, scrub techs, circulating nurses, anesthesiologists, CRNAs or first assists) with less than 5 years of experience

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1: Control; Group 1 participants will not receive any additional training except for instutionally mandated training
Experimental: Group 2: Simulation; Group 2 will practice on the simulator one session every day for 4 weeks.	Other: Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator; Training for performing surgical safety checklist for a period of 4 weeks.
Experimental: Group 3: Simulation with repeated reinforcement; Group 3 participants will practice on the simulator one session every day for 4 weeks and will continue to practice on the simulator once per week for an additional two months to a total of 8 sessions.	Other: Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator; Training for performing surgical safety checklist for a period of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in surgical safety checklist performance at 1 month post intervention	Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB	Baseline, at one month post intervention
Change in surgical safety checklist performance 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	Baseline, at 3 months post intervention
Change in surgical safety checklist performance 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	Baseline, at 5 months post intervention

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Ganesh Sankaranarayanan, PhD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Reality; Simulation; OR Team Performance
• Other Study ID Numbers: STU-2024-0975; AHRQ (Other Grant/Funding Number: 1R01HS029874-01A1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No