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临床试验/NCT06917183
NCT06917183尚未招募不适用

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

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2027年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
Change in surgical safety checklist performance at 1 month post intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Group 1: Control

No Intervention

Group 1 participants will not receive any additional training except for instutionally mandated training

Group 3: Simulation with repeated reinforcement

Experimental

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.

干预措施: Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator (Other)

Group 2: Simulation

Experimental

Group 2 will practice on the simulator one session every day for 4 weeks.

干预措施: Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator (Other)

结局指标

主要结局

Change in surgical safety checklist performance at 1 month post intervention

时间窗: 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

Change in surgical safety checklist performance at 3 months post intervention

时间窗: 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

Change in surgical safety checklist performance at 5 months post intervention

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ganesh Sankaranarayanan

Associate Professor

University of Texas Southwestern Medical Center

研究点 (2)

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