Impact of a Hand-held Digital Cognitive Aid to Anticipated a Simulated Crisis Situation for Resident
NCT ID: NCT06487208
Last Updated: 2025-01-28
Study Results
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Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2024-03-07
2024-12-12
Brief Summary
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Detailed Description
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Despite the inevitable risk of errors, solution exist to reduce them, including the use of cognitive aids such as the digital application MAX or the SFAR paper checklists. The value of these aids is well documented and supported by extensive literature. Nevertheless, those tools are still underutilized in clinical practice, likely due to negative perceptions and, a lack of familiarity among doctors.
Thus, the investigators believe that the systematic anticipation of perioperative complications and their management through a digital cognitive aid in daily practice could improve patient care by enhancing the overall performance of doctors and healthcare teams.
Primary objective: Demonstrate that the systematic anticipation of potential major perioperative complications, by using a digital cognitive aid, improves global performance in managing a critical situation. The primary outcome is measure with a composite score including both technical and no technical performance.
Secondary objectives: Several secondary outcomes measures: Comparison between the two groups of the technical and no technical performance. Stress during the simulation, self confidence level, the difference between the required competency level and the level that participant estimates have. And evaluation of biological stress response through sympathetic and parasympathetic indices calculated from electrophysiological variables via a connected watch.
Nature and conduct of the study: A prospective, randomized, controlled, single center study (Lyon). The study will be conducted in simulation at CLESS (Claude Bernard University Lyon 1) with participants being anesthesia and critical care residents in the consolidation and advanced phases. A single scenario will be used for the study. Each resident will be randomized into either the interventional group (anticipaMAX) or the control group. The intervention will take place during the five minutes preceding the start of the scenario. During this period, volunteers in the interventional group will be instructed to use the five minutes to consider potential complications and anticipate their management with the help of the MAX tool. Volunteers in the control group will be free to organize themselves as they wish, with the same medical file elements and the MAX application at their disposal. During the scenario, facilitator intervention will be standardized to ensure the comparability between the two groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Placebo
No intervention
Placebo
No intervention
AnticipaMax
The subjects will be instructed to use the 5 minutes to consider potential complications, prioritize them, and anticipate their management. The facilitators will have a neutral role with pre-determined standardized responses and will ensure the correct use of the Max tool during this time period
Use of a digital cognitive aid in order to anticipate a critical situation
Use of a digital cognitive aid in order to anticipate a critical situation
Interventions
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Use of a digital cognitive aid in order to anticipate a critical situation
Use of a digital cognitive aid in order to anticipate a critical situation
Placebo
No intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Claude Bernard University
OTHER
Responsible Party
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Lilot Marc
Principal Investigator
Principal Investigators
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Jean-Christophe Cejka, Ph.D
Role: STUDY_DIRECTOR
Université Claude Bernard Lyon 1
Locations
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HENKEME Mathieu
Lyon, Auvergne-Rhône-Alpes, France
Countries
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References
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Evain JN, Perrot A, Vincent A, Cejka JC, Bauer C, Duclos A, Rimmele T, Lehot JJ, Lilot M. Team planning discussion and clinical performance: a prospective, randomised, controlled simulation trial. Anaesthesia. 2019 Apr;74(4):488-496. doi: 10.1111/anae.14602. Epub 2019 Feb 15.
Paraschiv AP, Balanca B, Lilot M, Aigle L, Lehot JJ, Cejka JC. Use of a Digital Cognitive Aid Improves Memorization of Military Caregivers After High-Fidelity Simulations of Combat Casualty Care. Mil Med. 2023 Jan 4;188(1-2):e295-e300. doi: 10.1093/milmed/usab175.
Truchot M, Balanca B, Wey PF, Tazarourte K, Lecomte F, Le Goff A, Leigh-Smith S, Lehot JJ, Rimmele T, Cejka JC. Use of a Digital Cognitive Aid in the Early Management of Simulated War Wounds in a Combat Environment, a Randomized Trial. Mil Med. 2020 Aug 14;185(7-8):e1077-e1082. doi: 10.1093/milmed/usz482.
Claverie D, Trousselard M, Sigwalt F, Petit G, Evain JN, Bui M, Guinet-Lebreton A, Chassard D, Duclos A, Lehot JJ, Rimmele T, Canini F, Lilot M. Impact of stress management strategies and experience on electrodermal activity during high-fidelity simulation of critical situations. Br J Anaesth. 2020 Nov;125(5):e410-e412. doi: 10.1016/j.bja.2020.07.024. Epub 2020 Aug 21. No abstract available.
Lelaidier R, Balanca B, Boet S, Faure A, Lilot M, Lecomte F, Lehot JJ, Rimmele T, Cejka JC. Use of a hand-held digital cognitive aid in simulated crises: the MAX randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):1015-1021. doi: 10.1093/bja/aex256.
Other Identifiers
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AnticipaMax
Identifier Type: -
Identifier Source: org_study_id
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