Trial of Multidisciplinary Team Stress and Performance in Immersive Simulation for Management of Infant in Shock
1 other identifier
interventional
48
1 country
1
Brief Summary
The objective of this randomized trial is to study the effect of stress on performance and the effect of repetition of simulation sessions on performance and stress. This study is a randomized controlled trial including 48 participants who composed 12 multidisciplinary teams (MDTs). Each MDT was made up of 4 persons: an emergency physician, a resident, a nurse, and an ambulance driver who usually compose an emergency team of the French Emergency Medical Service (EMS). 6 MDTs underwent 9 simulation sessions over 1 year (Repetitive SIm Group). 6 MDTs underwent 3 simulation sessions over 1 year (Control Group). Evidence of the existence of stress was assessed in 3 ways: salivary cortisol, Holter parameters, and psychological stress questionnaires. The impact of stress on overall team performance, on technical procedure, and on teamwork, is evaluated by specific validated scales. Detection of post-traumatic stress (PTSD) is performed by self-evaluation on the 7th day and after one month. The perspective is to concomitantly evaluate technical and non-technical performance, and the impact of stress on both. This is the first randomized trial studying repetition of simulation sessions and its impact on both clinical performance and stress as explored by objective and subjective assessments. The investigators expect that stress decreases team performance and that repeated simulation increases team performance. The investigators expect no variation of stress parameters regardless of level of performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 19, 2015
CompletedFirst Posted
Study publicly available on registry
April 23, 2015
CompletedOctober 13, 2016
October 1, 2016
1.1 years
March 19, 2015
October 12, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Salivary Cortisol (SC) during high-fidelity simulation as measure of biological stress response
1 year
Electrophysiological stress response profile made up of: Heart Rate (HR), Blood Pressure (BP), and Holter parameters (PNN50, HF/BH) during high-fidelity simulation
1 year
Psychological stress response profile made up of: scores on State-Trait Anxiety Inventory (STAI), Impact of Event Scale - Revised (IES-R), Posttraumatic Stress Disorder Checklist Scale (PCLS) questionnaires during high-fidelity simulation
1 year
Secondary Outcomes (3)
Effect of repetitive simulation sessions on technical skills performance profile made up of: scores of Team Average Performance Assessment Scale (TAPAS), IO access performance assessment scale
1 year
Effect of repetitive simulation sessions on non-technical performance profile made up of: scores of Clinical Teamwork Scale (CTS), Behavioural Assessment Tool (BAT)
1 year
Effect of repetitive simulation sessions on stress response profile made up of: SC, HR, BP, PNN50, HF/BH, STAI, IES-R, PCLS
1 year
Study Arms (2)
Repetitive Sim Group
ACTIVE COMPARATOR9 simulation sessions
Control Group
ACTIVE COMPARATOR3 simulation sessions
Interventions
9 simulation sessions over 1 year for Repetitive Sim Group and 3 simulation sessions over 1 year for Control Group
Eligibility Criteria
You may qualify if:
- Multidisciplinary team made up of 4 persons:
- an emergency physician with less than seven years of experience ,
- a resident,
- a nurse,
- and an ambulance driver.
You may not qualify if:
- Past history and/or psychiatric disease that modifies stress response,
- Pacemaker or implantable defibrillator,
- Treatment with a medication having a potential effect on stress parameters.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GHAZALI
Poitiers, 86000, France
Related Publications (3)
Ghazali DA, Breque C, Sosner P, Lesbordes M, Chavagnat JJ, Ragot S, Oriot D. Stress response in the daily lives of simulation repeaters. A randomized controlled trial assessing stress evolution over one year of repetitive immersive simulations. PLoS One. 2019 Jul 25;14(7):e0220111. doi: 10.1371/journal.pone.0220111. eCollection 2019.
PMID: 31344077DERIVEDGhazali DA, Darmian-Rafei I, Ragot S, Oriot D. Performance Under Stress Conditions During Multidisciplinary Team Immersive Pediatric Simulations. Pediatr Crit Care Med. 2018 Jun;19(6):e270-e278. doi: 10.1097/PCC.0000000000001473.
PMID: 29432402DERIVEDGhazali DA, Ragot S, Breque C, Guechi Y, Boureau-Voultoury A, Petitpas F, Oriot D. Randomized controlled trial of multidisciplinary team stress and performance in immersive simulation for management of infant in shock: study protocol. Scand J Trauma Resusc Emerg Med. 2016 Mar 25;24:36. doi: 10.1186/s13049-016-0229-0.
PMID: 27012938DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel A GHAZALI, MD
University Hospital of Poitiers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2015
First Posted
April 23, 2015
Study Start
August 1, 2013
Primary Completion
September 1, 2014
Last Updated
October 13, 2016
Record last verified: 2016-10