Examining the Effect of a Scripted Debriefing on Resuscitation Performance in Pediatrics

Study Overview
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Brief Summary
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The investigative team's purpose for conducting this research is to improve effective and efficient translation and implementation of evidence based advanced life support practice to providers of care for children. This specific project aims to accomplish 2 major goals. The investigators aim to evaluate the utility of a debriefing script specifically designed to facilitate debriefing when used by novice Pediatric Advanced Life Support instructors during low and high realism simulation-based learning. Secondly, the investigators hope to evaluate the effectiveness of high realism simulation vs. low realism simulation in achieving PALS-based educational outcomes, such as knowledge and skill acquisition. The investigators hypothesize that SCRIPTED debriefing by novice instructors following low and high fidelity simulation-based learning will : Improve the cognitive performance and knowledge of multidisciplinary team members as assessed by a cognitive performance tool and multiple choice testing compared with more traditional, NON-SCRIPTED debriefing; Improve the behavioural, teamwork and communication skills of multidisciplinary team members as assessed by a validated assessment tool compared with more traditional, NON-SCRIPTED debriefing; The investigators hypothesize that HIGH REALISM simulation-based learning will: Improve the cognitive performance and knowledge of multidisciplinary team members as assessed by a cognitive performance tool and multiple choice testing compared with more traditional, LOW REALISM simulation; Improve the behavioural, teamwork and communication skills of multidisciplinary team members as assessed by a validated assessment tool compared with more traditional, LOW REALISM simulation;

Official Title
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Examining Pediatric Resuscitation Education Using Simulation and Scripted Debriefing: A Multicenter, Randomized Controlled Trial

Conditions
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Pediatric Cardiac Arrest (Simulated)

Intervention / Treatment
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* Other: Debriefing Script
* Other: High Physical Realism Simulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Novice Instructors): senior residents (general pediatric, emergency medicine, pediatric subspecialty) in year three of training or above nursing staff, respiratory therapists or paramedics with greater than 5 years of clinical experience recent PALS certification within the past 2 years Inclusion Criteria (Team composition) 1 or 2 pediatric nurses, 2 physicians (residents/fellows in pediatrics, anesthesia, family medicine, emergency medicine, pediatric emergency medicine, pediatric critical care or pediatric anesthesia) and/or 1 pediatric respiratory therapist or 1 pediatric transport paramedic Exclusion Criteria (Novice Instructors): experienced instructors, defined as having taught three or more courses for healthcare professionals where simulation was followed by debriefing Exclusion Criteria (Team composition) N/A
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-Scripted Debriefing, Low Realism Simulation<br>A debriefing script was designed for novice instructors to facilitate a 20-minute debriefing session. In this arm, novice instructors were provided the scenario learning objectives but NO SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing. The simulation scenario itself was conducted with an infant simulator. The low realism group had the simulator with the compressor turned off, thus eliminating the functionality of physical findings. | |
| Experimental: Scripted debriefing, Low Realism<br>In this arm, novice instructors were provided the scenario learning objectives WITH A DEBRIEFING SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing USING THE SCRIPT. The lo realism group had the simulator with the compressor turned on, thus eliminating the functionality of physical findings. | Other: Debriefing Script<br>* A debriefing script was designed for novice instructors to facilitate a 20-minute debriefing session. It was developed in iterative steps: (a) review of PALS learning objectives; (b) categorization of script content; (c) development of scripted language; (d) formatting into a cognitive aid and (e) pilot testing script for usability with subsequent edits before implementation in the study. All novice instructors received the scenario 2 weeks prior to the study session. Instructors randomized to scripted debriefing were also given the script with no instruction on how to use it except on the day of the study, to use and follow the script as closely as possible during the debriefing session. All instructors held a clipboard while observing the simulation session; to hold the debriefing script and/or take notes. This allowed for blinding of the video reviewers as to which study arm the team had been randomized. Debriefing sessions were limited to 20-minutes in duration.<br>|
| Experimental: non-Scripted Debriefing, High Realism Simulation<br>In this arm, novice instructors were provided the scenario learning objectives WITHOUT A DEBRIEFING SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing WITHOUT USING THE SCRIPT. The hi realism group had the simulator with the compressor turned on, thus activating the functionality of physical findings. | Other: High Physical Realism Simulation<br>* High vs. Low Physical Realism Simulators A pre-programmed infant simulator was used for all simulation sessions. To create high physical realism (HiR), full simulator functions were activated (turned on) including vital sign monitoring, audio feedback, breath sounds, chest rise, heart sounds, palpable pulses, and vocalization. Low physical realism (LoR) groups had the identical simulator but the compressor was turned off, thus eliminating physical findings described above. In addition, the LoR simulator was connected to a monitor, but it only displayed the cardiac rhythm, and not pulse oximetry, respiratory rate, blood pressure, temperature and audio feedback present in the HiR group. All other aspects of the simulated resuscitation environment were standardized for all groups.<br>|
| Experimental: Scripted Debriefing, High Realism Simulation<br>In this arm, novice instructors were provided the scenario learning objectives WITH A DEBRIEFING SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing USING THE SCRIPT. The hi realism group had the simulator with the compressor turned on, thus activating the functionality of physical findings. | Other: Debriefing Script<br>* A debriefing script was designed for novice instructors to facilitate a 20-minute debriefing session. It was developed in iterative steps: (a) review of PALS learning objectives; (b) categorization of script content; (c) development of scripted language; (d) formatting into a cognitive aid and (e) pilot testing script for usability with subsequent edits before implementation in the study. All novice instructors received the scenario 2 weeks prior to the study session. Instructors randomized to scripted debriefing were also given the script with no instruction on how to use it except on the day of the study, to use and follow the script as closely as possible during the debriefing session. All instructors held a clipboard while observing the simulation session; to hold the debriefing script and/or take notes. This allowed for blinding of the video reviewers as to which study arm the team had been randomized. Debriefing sessions were limited to 20-minutes in duration.<br>Other: High Physical Realism Simulation<br>* High vs. Low Physical Realism Simulators A pre-programmed infant simulator was used for all simulation sessions. To create high physical realism (HiR), full simulator functions were activated (turned on) including vital sign monitoring, audio feedback, breath sounds, chest rise, heart sounds, palpable pulses, and vocalization. Low physical realism (LoR) groups had the identical simulator but the compressor was turned off, thus eliminating physical findings described above. In addition, the LoR simulator was connected to a monitor, but it only displayed the cardiac rhythm, and not pulse oximetry, respiratory rate, blood pressure, temperature and audio feedback present in the HiR group. All other aspects of the simulated resuscitation environment were standardized for all groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioural Assessment Tool Score (Percentage 0-100%) | Behavioral Assessment Tool The Behavioral Assessment Tool (BAT) was used to assess the team leader's crisis resource management skills during the pre and post-simulation scenarios. Each behavior is rated on a five-point Likert scale, where a score of one represents poor behavioral performance in the category and a score of five reflects excellent performance. Each behavior is supplement by descriptive anchors for poor (1), average (3) and excellent performance (5). Previous work done by LeFlore et al has focused on establishing reliability and validity of the tool in varying contexts. In a study of nurse practitioner students, data demonstrated a Cronbach's alpha of 0.97 with an intraclass correlation coefficient of 0.84 (p<0.001). In a different study assessing alternative educational models for interdisciplinary student teams, the BAT was used to assess behavioral performance and the Cronbach's alpha was 0.956. | Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Performance Tool Score (Percentage 0-100%) | The Clinical Performance Tool, with 21 individual items, designed for evaluation of Pediatric Advanced Life Support scenarios, was utilized to assess clinical performance of the team. A total score (maximum 42 points) was converted into a percentage (0-100%) for analysis. | Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures | 
| Multiple Choice Test (Knowledge) | For the 20 question test, 15 questions designed to test medical knowledge were chosen from the existing American Heart Association Pediatric Advanced Life Support (PALS) question bank that have undergone rigorous validation, while 5 new questions were developed to assess knowledge of crisis resource management principles. As the study design required a Test A and Test B, stems for the same questions were modified slightly (eg. different age of patient, different vital signs, different history) between the two different tests, but overall content and purpose of questions were structured to be the same. | Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Cardiac, Arrest, Simulation, Debriefing, Realism