title: Randomized controlled trial of multidisciplinary team stress and performance in immersive simulation for management of infant in shock: study protocol.
abstract: BACKGROUND
  Human error and system failures continue to play a substantial role in adverse outcomes in healthcare. Simulation improves management of patients in critical condition, especially if it is undertaken by a multidisciplinary team. It covers technical skills (technical and therapeutic procedures) and non-technical skills, known as Crisis Resource Management. The relationship between stress and performance is theoretically described by the Yerkes-Dodson law as an inverted U-shaped curve. Performance is very low for a low level of stress and increases with an increased level of stress, up to a point, after which performance decreases and becomes severely impaired. The objectives of this randomized trial are to study the effect of stress on performance and the effect of repeated simulation sessions on performance and stress.
  
  
  METHODS
  This study is a single-center, investigator-initiated randomized controlled trial including 48 participants distributed in 12 multidisciplinary teams. Each team is made up of 4 persons: an emergency physician, a resident, a nurse, and an ambulance driver who usually constitute a French Emergency Medical Service team. Six multidisciplinary teams are planning to undergo 9 simulation sessions over 1 year (experimental group), and 6 multidisciplinary teams are planning to undergo 3 simulation sessions over 1 year (control group). Evidence of the existence of stress will be assessed according to 3 criteria: biological, electrophysiological, and psychological stress. The impact of stress on overall team performance, technical procedure and teamwork will be evaluated. Participant self-assessment of the perceived impact of simulations on clinical practice will be collected. Detection of post-traumatic stress disorder will be performed by self-assessment questionnaire on the 7(th) day and after 1 month.
  
  
  CONCLUSIONS
  We will 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, which is explored by objective and subjective assessments. We expect that stress decreases team performance and that repeated simulation will increase it. We expect no variation of stress parameters regardless of the level of performance.
  
  
  BACKGROUND
  ClinicalTrials.gov registration number NCT02424890.
authors.affiliation: Emergency Department and Emergency Medical Service, University Hospital of Poitiers, 2 rue de la Miletrie, Poitiers, 86000, France. aiham@hotmail.com.|INSERM-CIC1402, University Hospital of Poitiers, 2 rue de la Miletrie, Poitiers, 86000, France. aiham@hotmail.com.|Simulation Laboratory, Faculty of Medicine, University of Poitiers, 6 rue de la Miletrie, Poitiers, 86000, France. aiham@hotmail.com.
authors.forename: Daniel Aiham
authors.initials: DA
authors.lastname: Ghazali
authors.affiliation: INSERM-CIC1402, University Hospital of Poitiers, 2 rue de la Miletrie, Poitiers, 86000, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Ragot
authors.affiliation: Simulation Laboratory, Faculty of Medicine, University of Poitiers, 6 rue de la Miletrie, Poitiers, 86000, France.
authors.forename: Cyril
authors.initials: C
authors.lastname: Breque
authors.affiliation: Emergency Department and Emergency Medical Service, University Hospital of Poitiers, 2 rue de la Miletrie, Poitiers, 86000, France.
authors.forename: Youcef
authors.initials: Y
authors.lastname: Guechi
authors.affiliation: Pediatric Emergency Department, University Hospital of Poitiers, 2 rue de la Miletrie, Poitiers, 86000, France.
authors.forename: Amélie
authors.initials: A
authors.lastname: Boureau-Voultoury
authors.affiliation: Surgical Critical Care Unit, University Hospital of Poitiers, 2 rue de la Miletrie, Poitiers, 86000, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Petitpas
authors.affiliation: Simulation Laboratory, Faculty of Medicine, University of Poitiers, 6 rue de la Miletrie, Poitiers, 86000, France.|Pediatric Emergency Department, University Hospital of Poitiers, 2 rue de la Miletrie, Poitiers, 86000, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Oriot
mesh_terms: D000223:Adaptation, Psychological; D003422:Critical Care; D005602:France; D006801:Humans; D007223:Infant; D033183:Interdisciplinary Communication; D008297:Male; D010348:Patient Care Team; D016544:Patient Simulation; D012769:Shock / Q000628:therapy*; D013315:Stress, Psychological; D013647:Task Performance and Analysis
keywords: Multidisciplinary team; Performance; Randomized controlled trial; Simulation; Stress