Impact on Performance of the Use of a Digital Cognitive Aid in Simulated Crisis and Stress Situations

NCT03839017 | Completed

• 1 other identifier: SIMMAXMARCHERYAN2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The previous investigators' studies (MAX, Lelaidier et al, BJA 2017, \& SIMMAXMARCHERYAN) clearly showed that the use of a digital cognitive aid in the hand of the leader significantly improves the management of anaesthesia and intensive care emergencies as well as basic combat casualty care. The present study exclusively deals with the advanced management of simulated combat casualties by military doctors and nurses using the same digital cognitive aid adapted for MARCHE RYAN algorithm.

Conditions

War Injury

Keywords

Forward medicalization; Cognitive aid; Crisis situation; High-fidelity simulation; Performance

Outcome Measures

Primary Outcomes (1)

• Technical Performance: percentage of actions and steps in the MARCHE RYAN protocol performed by each subject with or without the CA MAX

  As compared to a Reference Task List including between 11 and 16 critical actions to be performed. This grid was used to rate technical performance in each scenario. Each action was recorded: 0 (action not performed), 1 (action performed at the wrong time, with the wrong dosage or inaccurately) or 2 (action performed correctly and at the right time). The individual scores were summed and transformed into a percentage of the maximum achievable score. Statistical analysis and calculation of the number of pairs required: The analysis of the effect of the use of MAX CA on learners' technical performance will be carried out using a 3-factor repeated-measure ANOVA: the use of MAX, the scenario, and whether the scenario is played first or second. A post-hoc analysis by the Bonferroni test will be carried out to compare the groups.

  Time 0-30 minutes

Secondary Outcomes (1)

• Non technical skills performance measured using the TEAM scale, MAX+ vs MAX-

  Time 0-30 minutes

Study Arms (2)

Digital cognitive aid

EXPERIMENTAL

The leader uses a digital cognitive aid designed as a smartphone app during advanced combat casualty care. Intervention: Device: SIMMAXMARCHERYAN2 Digital cognitive aid during the management of simulated war wounded.

Device: SIMMAXMARCHERYAN2

Without digital cognitive aid

EXPERIMENTAL

The leader practices advanced combat casualty care without the digital cognitive aid designed as a smartphone app. Intervention: Device: SIMMAXMARCHERYAN2 Without digital cognitive aid during the management of simulated war wounded.

Device: SIMMAXMARCHERYAN2

Interventions

SIMMAXMARCHERYAN2 DEVICE

Digital cognitive aid during the management of simulated war wounded.

Digital cognitive aid; Without digital cognitive aid

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Military doctors and Nurses
• Under initial or continuous training of Combat Casualty Care 3rd level
• Agreed to use the cognitive aid

You may not qualify if:

• Doesn't agree to use the cognitive aid

Sponsors & Collaborators

• CEJKA Jean-Christophe: lead

Study Sites (1)

CESimMO

Toulon, PACA, 83000, France

Location

Related Publications (1)

• Paraschiv AP, Cejka JC, Lilot M, Aigle L, Lehot JJ, Balanca B. Impact of a Digital Cognitive Aid on the Performance of Military Healthcare Teams During Critical Care Management in a Warfront Injury Situation: A Simulation Randomized Controlled Study. Simul Healthc. 2022 Jun 1;17(3):163-169. doi: 10.1097/SIH.0000000000000623. Epub 2021 Dec 15.

  PMID: 34934026 DERIVED

Related Links

• Précloux P, Wey P-F, Bérend M. et al. Opération " Pamir " : bilan et analyse de l'activité des postes médicaux de Rôle 1 à partir du Registre santé de l'avant pour l'année 2011. Médecine et Armées 2014, 42, 4: 299-308
• Hoffmann et al. Épidémiologie des blessés de guerre français en Afghanistan : de la blessure à la réinsertion. Urgences 2015 - Congrès de la Société Française de Médecine d'Urgence, At Paris, Volume : Chapitre 83
• Holcomb JB. Major scientific lessons learned in the trauma field over the last two decades. PLoS Med 2017, 14(7): e1002339
• Holcomb JB, Stansbury LG, Champion HR et al. Understanding casualty care statistics. 2006, Repéré à PubMed.gov. DOI : 10.1097/01.ta.0000203581.75241.f1
• Jones C, Bond C. 68W. Advanced Field Craft. Combat Medic Skills. 2010, AAOS (American Academy of Orthopaedic Surgeons). Jones and Bartlett Publishers USA
• École du Val-de-Grâce. Enseignement du Sauvetage au Combat. 2012
• McSwayn NE, Butler FK. Prehospital Trauma Life Support. Military Seventh Edition. 2011, Mosby Jems Elsevier USA
• Selye H. Le stress de la vie. Le problème de l'adaptation 1975. Gallimard, coll. " L'avenir de la science ", 2e édition
• Morgenstern J. Performance Under Pressure. Psychology 2017, 24 (2) : 168-88
• Boet S, Granry J-C, Savoldelli G. La simulation en santé. De la théorie à la pratique. 2013, Springer-Verlag France
• Lelaidier R, Balança B, Boet S, Faure A, Lilot M, Lecomte F, Lehot J-J, Rimmelé T, Cejka J-C. Use of a hand-held digital cognitive aid in simulated crises: the MAX randomized controlled trial. BJA, Nov. 2017, vol. 119, 5 : 1015-
• Marshall S D. Lost in translation? Comparing the effectiveness of electronic-based and paper-based cognitive aids. British Journal of Anaesthesia, Oct. 2017, 0 (0): 1-3
• Lehot J J, Le Goff A, Wegrzyn J, Barthelemy-Bougault J, Wey P-F, Cavallo J-D. Enseignement par simulation : un exemple de coopération civilo-militaire. Médecine et Armées 2017, 45, 5 : 611-616
• Cooper S, Wakelam A. Leadership of resuscitation teams: 'Lighthouse Leadership'. Resuscitation 1999; 42: 27-45
• Cooper S, Cant R, Connell C, Porter J E, Symmons M, Nestel D, Liaw S Y. Measuring teamwork performance: Validity testing of the Team Emergency Assessment Measure (TEAM) with clinical resuscitation teams. Resuscitation 2016; 101: 97-101

Study Officials

• Jean J Lehot, MD, PhD

  Claude Bernard University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching Hospital Practitioner

Model Details: With or without the cognitive aid

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 12, 2019
• Study Start: January 29, 2019
• Primary Completion: November 21, 2019
• Study Completion: February 21, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

FR (1)