Study Design
This randomized controlled study took place in a French university medical simulation center from December 2018 to February 2020.
According to the French ethic and regulatory law, article R1121-1 of the public health code, ethical approval for the study was waived by the national ethical committee (CPP, Comité de Protection des Personnes).
It was registered at the register of epidemiologic studies of Toulouse University Hospital (RnIPH 2019-53) and has also been declared to National Commission of Informatics and Liberty (CNIL number: 2206723 v0). The University Hospital signed a commitment of compliance to the reference methodology MR-004.
All participants provided written informed consent to participate.
Participants
Participants were residents within the 2nd year, 3rd year or 4th year post-graduate of Emergency Medicine at Toulouse University.
In the curriculum of a resident in Emergency Medicine in Toulouse University, a 2nd year participates to 2 simulation of crisis medical situation within the year, 4 sessions for a 3rd year and a 4th year.
The criterion for non-inclusion was the resident's refusal to participate in the study.
Study protocol
The planning of the simulation sessions was fully integrated into the curriculum of the Emergency Medicine residents according to a simulation training program [15]. Each session was developed in accordance with the French National Health Authority (Haute Autorité de Santé).
The session was led by one simulation instructor and one medical expert. The instructors belong to a group of 9 instructors (7 from a University Hospital and 2 from a General Hospital, including 2 nurses and 7 physicians) with a university degree in simulation training. The medical experts are emergency physicians (n = 15) with at least 5-year experience and specific knowledge in pediatrics, advanced life support, obstetrics, resuscitation, and airway management. The overall purpose of these sessions was to learn communication skills, knowledge of respective roles (leadership/fellowship), involvement in shared decision-making and team coordination.
A simulation session was intended for a complete medical team composed of an emergency physician (resident), a nurse and a medical support worker.
Each simulation session lasted 1 hour and was divided into 3 parts: briefing (15 minutes), simulated practice (15 minutes) and debriefing (30 minutes). The briefing prepared the team for the simulated practice, created a positive learning environment, encouraged the emotional security and introduced the clinical situation. Debriefing was conducted by the instructor and the medical expert according to the RUST model and the good-judgement practice [16].
In the simulation, participants' performance was based on the assessment of CRM skills, a set of non-technical skills required to manage medical emergencies [17].
This assessment was carried out immediately after the debriefing by the simulation instructor and the expert physician who conducted the debriefing and were trained in the use of this assessment grid.
Participant demographics were collected using a paper questionnaire to be completed before the simulation session.
This data was then transferred to an anonymized Excel file.
In the Confederate group, two confederates playing the role of a nurse and a medical support worker were part of the session.
They were asked to take no initiatives and to wait for the participant instructions without guidance.
In the Control group, there was no confederate. An interprofessional group composed of a nurse and a medical support worker from the Emergency Department which were operating during the simulated practice but unfamiliar with the scenarios beforehand. They were asked to act as health professionals just as they would in a real-life situation.
Scenarios used in the study
The scenarios were created by the different pedagogical managers of the simulation centers, in collaboration with the medical and paramedical trainers of each discipline. Each scenario was validated by the research team according to a standardized grid (Appendix A). It made it possible to evaluate the authenticity through the characteristics of a "complex problem" and the relevance of the professional situation described to promote learning to manage a critical situation in an interprofessional team.
Their design took into account the possibility of adapting the scenario on certain aspects related to environmental specificities linked to the learners' working conditions (emergency room, pre-hospital environment, ward…). Several professional situations were modelled in order to expose teams to various crisis situations such as cardiac arrest, difficult airway management, traumatic shock (Appendix B). The scenarios have been designed to avoid participants being confronted with the unexpected death of a patient. Indeed, this type of experience did not show any significant benefit in terms of learning and would have interfere with an environment that learners can trust to be grounded with honesty and safety [18].
Confederates
Confederates were health professionals of the Emergency Department of the University Hospital. They have all benefited from a training-course in medical education. This is a five-day training course in order to master active teaching techniques, to integrate the specificities of the professional context into the practice of emergency care and to harmonize evaluation techniques. Within this framework, they were also trained in the use of full-scale simulation and specifically in the role of confederate during a three-day training course.
Thirteen confederates participated in the study out of 24 trainers available at the Emergency department (Table 1).
They were selected on a voluntary basis and according to their availability.
Table 1
Confederates’ demographic characteristics (Confederate group)
Demographic Characteristics
|
Confederates (n = 13)
|
Mean age ± SD
|
44.7 ± 4.2
|
Gender, n (%) Female
|
7 (54)
|
Professional Category, n (%)
Medical support worker
Nurse
|
6 (46)
7 (54)
|
Years of work experience, mean ± SD
|
18.8 ± 4.3
|
Years of experience as a trainer, mean ± SD
|
6.5 ± 3.7
|
Number of simulation sessions/year/trainer, mean ± SD
|
27.7 ± 24.2
|
Number with more than 25 simulation sessions/year, n (%)
|
5 (38)
|
Rating Scale
At the end of the simulation session, the resident was assessed on CRM performance according to the Ottawa Global Rating Scale (OGRS), composed of the assessment of 5 CRM skills (leadership, communication, problem solving, resource use, situational awareness) scored between 1 and 7, and the assessment of Overall Performance scored between 1 and 7: the score of 1 corresponding to the novice level where all CRM skills require significant improvement, and the score of 7 corresponding to an advanced level where improvement in CRM skills (if any) remains minimal (Appendix C) [19]. The inter-rater measurement difference in this evaluation grid is very small (Intraclass Correlation Coefficient > 0.6 interpreted as good according to Cicchetti) [20].
Outcomes
The primary outcome for assessing the performance of the participants was the average scores obtained by the residents in each group (Control and Confederate) on the OGRS Overall Performance during the simulated practice.
The secondary outcomes for assessing each CRM performance of the residents were the average scores obtained by participants in each group (Control and Confederate) on 5 skills: leadership, communication, problem solving, resource utilization and situational awareness.
Randomization
A planning of the simulation sessions on the study inclusion period had been prepared. The randomization of the sessions was realized by the Clinical Research Unit at Toulouse University Hospital in a 1:1 ratio, into 2 groups: Control group and Confederate group.
The confederates were attributed to each session according to the randomization.
No sessions were excluded prior to randomization (Fig. 1).
Statistical Analysis
The number of simulation sessions was determined on the primary assumption that participants in the Confederate group would have a 0.4 point variability on the OGRS Overall Performance, compared to participants in the Control group [19]. Based on Cohen's definition of statistical analyses in behavior science, a standard deviation of 0.5 was used [21]. Given the initial hypothesis, a two-tailed test with a power of 80% was used. With these parameters, the number of simulation sessions required is a minimum of 50 sessions, i.e. two groups of 25 sessions.
Statistical analysis of the anonymized data was performed using BiostaTGV® software. All study variables were analyzed individually, checking for missing data and outliers. No imputation method was used for missing values.
The distribution of the quantitative variables was represented by the mean followed by the standard deviation after checking for normality. The comparative analyses were performed using the Student's test after checking for application criteria (distribution of values according to a Gaussian Normal Law). The threshold of statistical significance allowing to reject the H0 hypothesis, according to which the means are equal in the two groups, was considered reached when the risk of error was less than 5% (p-value < 0.05).