High Fidelity Simulation vs Standard Teaching Training of Cardiac Resuscitation (SIMCARE)

High Fidelity Simulation In Medecine Education

High fidelity Simulation has spread from anesthesiology to other disciplines such as internal medicine, pediatrics, and emergency medicine . Over the past decade, the use of simulation in medical education has increased exponentially. The term ''simulation'' spans a wide variety of formats, from the low-tech actor portraying a standardized patient to high-fidelity mannequin-based human patient simulation (HPS). HPS is able of both simulating realistic patient encounters and giving real-time, physiologically accurate feedback. Studies thus far show that use of simulation in training medical students and residents is helpful in strengthening students' knowledge and in evaluating their performance. Students appreciate simulation-based education as ''an opportunity to learn new skills in a safe environment .

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: Laerdal®; Behavioral: huma patient based training; Behavioral: traditionally teaching

Detailed Description

This was a randomized, controlled trial of a simulation- based educational intervention designed to increase medicine student's clinical skills in cardiac arrest procedures .The investigators included 181 fifth-year medical students rotating in the emergency department of Fattouma Bourguiba University hospital of Monastir (Tunisia) during the period from January 2013 to January 2014.Students were randomized into two groups using a random number generator to an intervention group (simulatortrained, n = 99) or a control group (traditionally teaching, n =82).

The investigators conducted a prospective, randomized, non-blinded study to determine whether simulation based training is superior to traditional teaching in the assessment and management of simulated patients presenting with myocardial infarction (MI) complicated by ventricular fibrillation.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • University of Monastir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medecine students

Exclusion Criteria:

• Non Medecine students

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: huma patient based training; Students randomized to receive simulation training .The mannequin Siman 3G laerdal® displays multiple physiologic and pharmacologic responses. Three volunteers were involved in the scenario while the others were observers through an audiovisual projection. Students participating in the scenario were given 15 minutes to evaluate and manage a 60-year-old man with a known history of coronary artery disease and diabetes who presented to the emergency department with chest pain revealing an acute ST elevation myocardial infarction complicated by ventricular fibrillation. Students were required to recognize and manage ventricular fibrillation when the patient became pulseless and unresponsive. After performing the simulation, the entire group was convened for debriefing of the case.	Device: Laerdal®; simulation- based educational intervention; Behavioral: huma patient based training; Students randomized to receive simulation training .The mannequin Siman 3G laerdal® displays multiple physiologic and pharmacologic responses. Three volunteers were involved in the scenario while the others were observers through an audiovisual projection. Students participating in the scenario were given 15 minutes to evaluate and manage a 60-year-old man with a known history of coronary artery disease and diabetes who presented to the emergency department with chest pain revealing an acute ST elevation myocardial infarction complicated by ventricular fibrillation. Students were required to recognize and manage ventricular fibrillation when the patient became pulseless and unresponsive. After performing the simulation, the entire group was convened for debriefing of the case.
Active Comparator: traditionally teaching; students received a traditional course using slides during 60 minutes about the management of cardio pulmonary resuscitation according to the latest recommendations of the AHA. This course is offered by the same trainer who participated in the simulation session. Students were free to ask questions as the progress of education. The same educational objectives were treated with the two groups.	Behavioral: traditionally teaching; Control group students received a traditional course using slides during 60 minutes about the management of cardio pulmonary resuscitation according to the latest recommendations of the AHA. This course is offered by the same trainer who participated in the simulation session. Students were free to ask questions as the progress of education. The same educational objectives were treated with the two groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
better acquisition of cognitive skills for students	Pretest using 20 multiple choice questions after randomization. A second round of the same testing was then conducted for both groups just after the course (posttest). The test score range from 0 to 20 (maximum). The difference between the rating of the post-test and pre-test identifies the delta score of the student.	just after randomisation (one day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction 5 point likert scale	Students rated their satisfaction level with a 5 point likert scale framed as attitude toward simulation compared with control group: dissatisfied (1 point), fairly satisfied (2 points), neither satisfied (3points), satisfied (4 points), and very satisfied (5 points).	just after randomisation (one day)

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Hamdi Boubaker, MD, Emergency Department , university Hospital of Monastir 5000 TUNISIA; Principal Investigator: Mohamed habib GRISSA, MD, Emergency Department , university Hospital of Monastir 5000 TUNISIA

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): June 29, 2015

Study Record Updates

• Last Update Posted (Estimate): June 20, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Medical education; simulation; ACLS
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 12345 (Danish Center for Healthcare Improvements)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided