Randomized controlled trial of multidisciplinary team stress and performance in immersive simulation for management of infant in shock: study protocol

Abstract

BackgroundHuman 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.MethodsThis 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 7th day and after 1 month.DiscussionWe 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.Trial registrationClinicalTrials.gov registration number NCT02424890

Effectiveness of Debriefing towards Healthcare Professionals’ Nontechnical Skills: A Critical Review

“…There were six quantitative studies, whereas the remaining were qualitative and mixed method as summarized in the respective tables. The details of the selection process are presented in the PRISMA flow chart ( Figure 1 Ghazali et al 2016;Sayaka et al 2016), one non-randomized controlled trial , one basic simulation and debriefing (Markus et al 2016), one mixed method approach (Jorm et al 2016) and a video recording analysis (Dimitrios et al 2016) were included in the review.…”

“…a. Inter-professionals (medical and nursing students) (Markus et al 2016) and emergency physician, resident, nurse, and ambulance driver (Ghazali et al 2016) b. Students (Postgraduate Year 1) (Sayaka et al 2016) and 2 All of the studies involved simulation learning followed by debriefing except the study by which utilized actual surgical procedures to analyse deficiencies of performance of nontechnical skills.…”

Salivary Cortisol Increases after One Immersive Simulation but the Repetition of Sessions does not Blunt it

“…Here are reported the results of the analysis of biological stress during immersive simulations of a randomized controlled trial registered by ClinicalTrials.gov under the number NCT02424890 (a WHO-approved primary registry) and published [22]. The study protocol, information form, and consent form were approved by the Comité de Protection des Personnes III de la region Ouest.…”

“…Noninclusion criteria were pregnancy, any disease that could induce modifications related to stress, or worsen in relation to stress and/ or psychiatric disease modifying stress response, treatment with medication having a potential effect on stress parameters like steroids or hormone replacement therapy. Recruitment, inclusion and exclusion criteria, and randomization were detailed in the study protocol [22]. Among the 48 participants, 26 were males (54.2%) and 22 females (45.8%).…”

“…The high-fidelity simulation used a mannequin (SimNewB*, Laerdal®), and scenarios were played in a simulated crash room (with all the equipment) in the Simulation Laboratory of Poitiers. Details of content of sessions and their structure were described in the study protocol [22].…”