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Captain Sonar Impact on Trauma Patient Management (CAST2)

Primary Purpose

Trauma Injury

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Captain Sonar Exposition
Monopoly Exposition
Sponsored by
Claude Bernard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Trauma Injury focused on measuring Healthcare professionals, Technical Skills, Non Technical Skills, Crew ressource Management, Stress evaluation and management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Professional working at the Unit Exclusion Criteria: None

Sites / Locations

  • Anesthesiology and Intensive care medicine, H Building, Hopital Edouard Herriot, Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Captain Sonar

Placebo Monopoly

Arm Description

Participants will receive a training by a game session at Captain SonarTM of 60 min (including 15 min of presentation and prize in hand of the game) against a standardized investigator team

The control group participants will benefit from a 60 min session to play a "Placebo" game: monopoly

Outcomes

Primary Outcome Measures

Technical skills
Total time of care in the trauma room, in seconds
Non technical skills
use of closed loop communications: - count of the number of closed loops/minute
Stress profile and stress management
Visual Analog Scale of Stress, from 0 to 100 maximum

Secondary Outcome Measures

Demographic data
Demographic data (sex, age, previous experience as health care professional, experience in simulation, experience in gaming, experience in stress management)
Debriefing Evaluation
Debriefing Assessment in Simulation in Healthcare (DASH) evaluated by team leader, nurse and facilitator, from 6 to 42 maximum
Influence of exposure on Performance, communication and stress management
Visual analogic Scale, from 0 to 100 maximum
Technical skills grid
Technical performance score (Grid out of 100 points); from 0 to 100 maximum
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).
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;
Non technical skills crew ressource 1
Non technical skills score : from 0 to 54 maximum
Non technical skills crew ressource 2
Non technical skills Score 2: from 1 to 5 maximum
Non technical skills communication anticipation
Rate of anticipation of each participation (initiation of an act without prior request by the Team leader);
Non technical skills quality of team communication
Visual Analog Scale quality of team communication, from 0 to 100 maximum.
Non technical skills confidence for team leader
Visual Analog Scale of confidence in the team and the team leader , from 0 to 100 maximum.
Visual Analog Scale type of stress
Visual Analog Scale of stress
Anxiety profile
Stait Trait Anxiety Inventory Trait, from 20 to 80 maximum.
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)
Stress profiles and stress management electrodermal activity
Electrodermal activity, reflecting the stress and activation of individuals (Empatica E4 watch on the wrist non-dominant)

Full Information

First Posted
May 18, 2022
Last Updated
November 24, 2022
Sponsor
Claude Bernard University
Collaborators
Research on Healthcare Performance Lab U1290, Laboratoire Interuniversitaire de Biologie de la Motricité
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1. Study Identification

Unique Protocol Identification Number
NCT05628519
Brief Title
Captain Sonar Impact on Trauma Patient Management
Acronym
CAST2
Official Title
Captain Sonar Impact on Trauma Patient Management
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Claude Bernard University
Collaborators
Research on Healthcare Performance Lab U1290, Laboratoire Interuniversitaire de Biologie de la Motricité

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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)
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Injury
Keywords
Healthcare professionals, Technical Skills, Non Technical Skills, Crew ressource Management, Stress evaluation and management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control Trial, double blind
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Captain Sonar
Arm Type
Experimental
Arm Description
Participants will receive a training by a game session at Captain SonarTM of 60 min (including 15 min of presentation and prize in hand of the game) against a standardized investigator team
Arm Title
Placebo Monopoly
Arm Type
Placebo Comparator
Arm Description
The control group participants will benefit from a 60 min session to play a "Placebo" game: monopoly
Intervention Type
Behavioral
Intervention Name(s)
Captain Sonar Exposition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Monopoly Exposition
Intervention Description
Participant will be invited to play to Monopoly during 60 min
Primary Outcome Measure Information:
Title
Technical skills
Description
Total time of care in the trauma room, in seconds
Time Frame
Measured during simulation session. Within 20 minutes of the simulation
Title
Non technical skills
Description
use of closed loop communications: - count of the number of closed loops/minute
Time Frame
Measured during simulation session. Within 20 minutes of the simulation
Title
Stress profile and stress management
Description
Visual Analog Scale of Stress, from 0 to 100 maximum
Time Frame
immediately after simulation
Secondary Outcome Measure Information:
Title
Demographic data
Description
Demographic data (sex, age, previous experience as health care professional, experience in simulation, experience in gaming, experience in stress management)
Time Frame
At Baseline
Title
Debriefing Evaluation
Description
Debriefing Assessment in Simulation in Healthcare (DASH) evaluated by team leader, nurse and facilitator, from 6 to 42 maximum
Time Frame
immediately After Debriefing
Title
Influence of exposure on Performance, communication and stress management
Description
Visual analogic Scale, from 0 to 100 maximum
Time Frame
immediately After simulation
Title
Technical skills grid
Description
Technical performance score (Grid out of 100 points); from 0 to 100 maximum
Time Frame
Measured during simulation session. Within 20 minutes of the simulation.
Title
Technical skills key tasks
Description
Completion time for 5 key tasks (Hemocue result, blood pressure result, sample) in seconds Blood, realization of the FAST Ultrasound, Departure for OR/CT).
Time Frame
Measured during simulation session. Within 20 minutes of the simulation.
Title
Technical skills self efficacy
Description
Self Efficacy estimation on Several cases, from 0 to 100 maximum Visual analog scale of support performance felt after the simulation session;
Time Frame
Measured during simulation session. Within 20 minutes of the simulation.
Title
Non technical skills crew ressource 1
Description
Non technical skills score : from 0 to 54 maximum
Time Frame
Measured during simulation session. Within 20 minutes of the simulation.
Title
Non technical skills crew ressource 2
Description
Non technical skills Score 2: from 1 to 5 maximum
Time Frame
Measured during simulation session. Within 20 minutes of the simulation.
Title
Non technical skills communication anticipation
Description
Rate of anticipation of each participation (initiation of an act without prior request by the Team leader);
Time Frame
Measured during simulation session. Within 20 minutes of the simulation.
Title
Non technical skills quality of team communication
Description
Visual Analog Scale quality of team communication, from 0 to 100 maximum.
Time Frame
immediately after simulation
Title
Non technical skills confidence for team leader
Description
Visual Analog Scale of confidence in the team and the team leader , from 0 to 100 maximum.
Time Frame
immediately after simulation
Title
Visual Analog Scale type of stress
Description
Visual Analog Scale of stress
Time Frame
immediately after the simulation session
Title
Anxiety profile
Description
Stait Trait Anxiety Inventory Trait, from 20 to 80 maximum.
Time Frame
immediately after the simulation session;
Title
Stress profiles and stress management physiological measurement heart rate variability
Description
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)
Time Frame
During Simulation within the 20 minutes of simulation
Title
Stress profiles and stress management electrodermal activity
Description
Electrodermal activity, reflecting the stress and activation of individuals (Empatica E4 watch on the wrist non-dominant)
Time Frame
During Simulation within the 20 minutes of simulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Professional working at the Unit Exclusion Criteria: None
Facility Information:
Facility Name
Anesthesiology and Intensive care medicine, H Building, Hopital Edouard Herriot, Hospices Civils de Lyon
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69008
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12796727
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. doi: 10.1067/msy.2003.169.
Results Reference
background
PubMed Identifier
20959579
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.
Results Reference
background
PubMed Identifier
28780315
Citation
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.
Results Reference
background

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Captain Sonar Impact on Trauma Patient Management

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