Participant orientation | Orientation to the simulator | Expectations and intro: 20 minutes. Prior to the simulation, this was a short recap of the expectations and purpose of the simulation, as well as the study protocol. All the professionals must had been trained in Advanced Life Care Support (ACLS) in the Simulation Center prior to the TH simulation. Realistic simulation run: 60 minutes. The start point was the patient arrival to the ED. The finish point was the action of the guidewire crossing the lesion during the PCI procedure. Debriefing: 60 minutes. The debriefing should take place immediately after the simulation was completed. |
| Orientation to the environment | The participants were oriented to the environment according to the proposed HT procedure. There was a real body-size mannequin that was used both to do the TH procedure and to be transferred from one unit to the other according to the timeline of the simulation. The professionals being trained were trained in different sections of the hospital. Therefore, they started at the Emergency Department (ED), then went to the cath lab and finished at the intensive care unit (ICU). 15 minutes for orientation, 30 minutes for each section (ED, cath lab, ICU) and 15 minutes for conclusion, for a total of 2 hours training. The content for the training was specific for each of the scenarios. |
Simulator type | Simulator make and model | The training was performed using the original Proteus Cooling System (Zoll Circulation Inc) with sham temperature targets. |
| Simulator functionality | The simulator was the real Proteus device with connections to a software that mimicked the temperature of the patient for each time point. It was possible to determine specific temperatures according to the scenario. The limitations were the same inherent to any simulator, i.e., no human being was involved as part of the simulator, only mannequins, so there was no feedback regarding bleedings or subjective feelings. Arrhythmias were simulated using monitors and defibrillators. |
Simulation environment | Location | The simulation was conducted in situ clinical environment. Therefore, they started at the Emergency department, then went to the cath lab and finished at the intensive care unit (ICU). |
| Equipment | It was used one of the 3 original Proteus Cooling Systems™ (Zoll Circulation Inc™) available at the hospital, each of them located at the ED, cath lab and ICU. Also, there were real defibrillators available in each of the units. |
| External stimuli | There were external stimuli such as background noise in all the units. We secured that the simulation training did not interfere in real clinical practice in each of the units, once the simulations were performed in the real units of the hospital. |
Simulation event/ scenario | Event description | All the scenarios were previously programmed and scripted, and they would change according to the training’s reactions. All scenarios were STEMI patients with meet inclusion and exclusion criteria’s that would have had been included in the trial and therefore required TH. They all followed the consistent pathway and progression of the TH across the different units were they were performed. |
| Learning objectives | - Assigning roles and responsibilities upfront for each team member; - Execution of assigned tasks in a timely manner; - Execution of relevant protocol steps in parallel to reduce total procedural time. |
| Group vs. individual practice | The simulation was conducted in groups, once the TH is a multidisciplinary procedure. |
| Use of adjuncts | No other adjuncts were used. |
| Facilitator/ operator characteristics | All the facilitators were from the multidisciplinary team involved directly and responsible for the therapeutic hypothermia procedure. They were all high-skill experienced health care professionals. |
| Pilot testing | A total of 5 pilot testing’s with 2-hour duration were conducted one month prior to the full training of the team, so that pitfalls could be corrected and optimizations could be implemented. |
| Actors/ standardized/ simulated patients | All the simulations were performed in mannequins. There were no actors involved. All the scenarios were conducted by experienced clinicians with experience in simulator education. |
Instructional design | Duration | The total duration of each simulation was 140 minutes. |
Timing | The simulation should be performed prior to the initiation of the clinical trial. All the professionals involved in the TH procedure should be trained. |
Frequency/ repetitions | There was only one formal training / simulation per professional, but there would be the possibility of re-training if the clinical team considered necessary to repeat the process for quality enhancement. |
Clinical variation | A unique template script was used for the training once all the situations involved the same scenario: a STEMI patient that should undergo therapeutic hypothermia concomitant to the percutaneous coronary intervention |
Standards/assessment | As a multi-disciplinary team, all the professionals were assessed at the end of the debriefing to understand if they had assimilated the concepts and if they were able to apply it in the clinical practice, but there was no formal testing at the end of the simulation. |
Adaptability of intervention | All the simulations were performed in groups, but with individual learning focus on the role of each multidisciplinary professional in the TH procedure. |
Range of difficulty | Therapeutic hypothermia is a very complex procedure, therefore all the scenarios were focused on a critical situation involving STEMI and primary PCI concomitant to the TH. |
Nonsimulation interventions and adjuncts | As for the nonsimulation interventions, a debriefing should take place immediately after the simulation was completed, and was performed in small group discussions. |
Integration | The intervention was integrated into curriculum as part of the armamentarium for all the multidisciplinary team in our facility, as a new skill for all the different professionals. |
Feedback and/ or debriefing | Source | The feedback was performed using the simulator itself, the computer through a didactic approach from the facilitator. |
Duration | The total duration of each simulation was 140 minutes. |
Facilitator presence | At least one high-skilled experienced facilitator was present in all the simulations. |
Facilitator characteristics | All the facilitators were from the multidisciplinary team involved directly and responsible for the therapeutic hypothermia procedure. They were all high-skill experienced health care professionals. |
Content | The simulation focused on teamwork and development of clinical skills in all the aspects of therapeutic hypothermia. |
Structure/method | The debriefing was performed using the simulator itself, the computer through a didactic approach from the facilitator. The whole simulation was revised, all the possible diversions were corrected and all the clarifications and questions were solved. |
Timing | The feedback was conducted both concurrent to the simulation event, with guidance and orientation when necessary, as well as an extensive debriefing at the end of the simulation. |
Video | Video could be recorded during the simulation to help in the education feedback when necessary, especially during the final debriefing when appropriate, but it was not compulsory to record all the simulation events. |
Scripting | A unique template script was used for the training once all the situations involved the same scenario: a STEMI patient that should undergo therapeutic hypothermia concomitant to the percutaneous coronary intervention. |