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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05628519
Other study ID # CAST2 N°20-119
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date February 1, 2022

Study information

Verified date November 2022
Source Claude Bernard University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Trauma patient care requires collaboration and interaction with close relationship between many stakeholders from different professions (senior doctor, intern, nurse, nurse helpers, surgeons, etc). This is a stressful situation where decision and action need to be quick, decisive and coordinate. In this situation, quality of care and patient safety depends on a good interprofessional communication. The acquisition of advanced communication skills, team management and leadership, stress management are essentials elements in the practice of Intensive and trauma care. However, advanced structured training or assessment of theses skills is lacking in medical education or Healthcare professionals training. The study therefore, aimed to develop a global and attractive training to help healthcare professionals to improve their skills. Captain SonarTM is a naval battle game where two teams each composed of four participants clash. Each player has a well-defined role and it is imperative to communicate in a closed loop to advance in the game. This game also includes components similar to support for shock management: stress, speed of action, central communication and teamwork of four protagonists (Team Leader-Captain, intern-Second, nurse-Mechanic, Nurse help-Detector). It may improve team building, team leadership, interprofessional work, communication, stress management. The study hypothesis is that this board game would have an impact on the performance of professionals when facing a multiple trauma simulated patient. (differences in terms of technical and non-technical performance. Different use of closed loop communication, Different stress management, different efficiency and interprofessional collaboration with potentially a reduction in the timing of treatment being delivered in trauma room)


Description:

All the teams of 4 participants and 1 medical Student previously trained will then benefit from a training session either exposed to captain sonar or into the control arm with monopoly. High-fidelity and multiprofessional simulation session based on the incoming of a severe traumatized patient will be held. These sessions will take place on high-fidelity mannequins lent by the CLESS (Lyonnais Center for Health Simulation Education) in pavilion H of Édouard Herriot Hospital, within the Trauma Center (in situ). The same scenario will be presented for all groups (exposed and controls) with the same objectives of realization and the same complexity. An audio-visual recording will take place during each session in order to allow the evaluation of the study criteria on technical and non technical skills between the participants a posteriori of the simulation session.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Professional working at the Unit Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Captain Sonar Exposition
Captain SonarTM is a naval battle game where two teams each composed of four participants clash. Each player has a well-defined role and it is imperative to communicate in a closed loop to advance in the game. This game also includes components similar to support for Trauma care: stress, speed of action, central communication and teamwork of four protagonists (Team Leader- Captain, intern-Second, nurse-Mechanic, Caregiver-Detector). This short video describes the rules and the Game progress: https://vimeo.com/173614346.
Monopoly Exposition
Participant will be invited to play to Monopoly during 60 min

Locations

Country Name City State
France Anesthesiology and Intensive care medicine, H Building, Hopital Edouard Herriot, Hospices Civils de Lyon Lyon Rhone

Sponsors (3)

Lead Sponsor Collaborator
Claude Bernard University Laboratoire Interuniversitaire de Biologie de la Motricité, Research on Healthcare Performance Lab U1290

Country where clinical trial is conducted

France, 

References & Publications (3)

El-Shafy IA, Delgado J, Akerman M, Bullaro F, Christopherson NAM, Prince JM. Closed-Loop Communication Improves Task Completion in Pediatric Trauma Resuscitation. J Surg Educ. 2018 Jan - Feb;75(1):58-64. doi: 10.1016/j.jsurg.2017.06.025. Epub 2017 Aug 2. — View Citation

Gawande AA, Zinner MJ, Studdert DM, Brennan TA. Analysis of errors reported by surgeons at three teaching hospitals. Surgery. 2003 Jun;133(6):614-21. — View Citation

Neily J, Mills PD, Young-Xu Y, Carney BT, West P, Berger DH, Mazzia LM, Paull DE, Bagian JP. Association between implementation of a medical team training program and surgical mortality. JAMA. 2010 Oct 20;304(15):1693-700. doi: 10.1001/jama.2010.1506. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Technical skills Total time of care in the trauma room, in seconds Measured during simulation session. Within 20 minutes of the simulation
Primary Non technical skills use of closed loop communications:
- count of the number of closed loops/minute
Measured during simulation session. Within 20 minutes of the simulation
Primary Stress profile and stress management Visual Analog Scale of Stress, from 0 to 100 maximum immediately after simulation
Secondary Demographic data Demographic data (sex, age, previous experience as health care professional, experience in simulation, experience in gaming, experience in stress management) At Baseline
Secondary Debriefing Evaluation Debriefing Assessment in Simulation in Healthcare (DASH) evaluated by team leader, nurse and facilitator, from 6 to 42 maximum immediately After Debriefing
Secondary Influence of exposure on Performance, communication and stress management Visual analogic Scale, from 0 to 100 maximum immediately After simulation
Secondary Technical skills grid Technical performance score (Grid out of 100 points); from 0 to 100 maximum Measured during simulation session. Within 20 minutes of the simulation.
Secondary Technical skills key tasks Completion time for 5 key tasks (Hemocue result, blood pressure result, sample) in seconds Blood, realization of the FAST Ultrasound, Departure for OR/CT). Measured during simulation session. Within 20 minutes of the simulation.
Secondary Technical skills self efficacy Self Efficacy estimation on Several cases, from 0 to 100 maximum Visual analog scale of support performance felt after the simulation session; Measured during simulation session. Within 20 minutes of the simulation.
Secondary Non technical skills crew ressource 1 Non technical skills score : from 0 to 54 maximum Measured during simulation session. Within 20 minutes of the simulation.
Secondary Non technical skills crew ressource 2 Non technical skills Score 2: from 1 to 5 maximum Measured during simulation session. Within 20 minutes of the simulation.
Secondary Non technical skills communication anticipation Rate of anticipation of each participation (initiation of an act without prior request by the Team leader); Measured during simulation session. Within 20 minutes of the simulation.
Secondary Non technical skills quality of team communication Visual Analog Scale quality of team communication, from 0 to 100 maximum. immediately after simulation
Secondary Non technical skills confidence for team leader Visual Analog Scale of confidence in the team and the team leader , from 0 to 100 maximum. immediately after simulation
Secondary Visual Analog Scale type of stress Visual Analog Scale of stress immediately after the simulation session
Secondary Anxiety profile Stait Trait Anxiety Inventory Trait, from 20 to 80 maximum. immediately after the simulation session;
Secondary Stress profiles and stress management physiological measurement heart rate variability Physiological stress assessment of 2 of each team members will be performed throughout inclusion (during exposure and during simulation) and measured by non-invasive and continuous recording:
- Heart and respiratory rates and heart rate variability (Hexoskin® t-shirt)
During Simulation within the 20 minutes of simulation
Secondary Stress profiles and stress management electrodermal activity Electrodermal activity, reflecting the stress and activation of individuals (Empatica E4 watch on the wrist non-dominant) During Simulation within the 20 minutes of simulation
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