About this trial
This study will be a prospective, single-center, randomized controlled trial in a tertiary pediatric emergency department with two parallel groups of voluntary pediatric physicians and nurses. The impact of a mHealth supportive tool will be compared with conventional communication methods on situational awareness, leadership, team communication effectiveness and performance during standardized, simulation-based, pediatric in-hospital cardiac arrest scenario using a high-fidelity manikin. Thirty-six participants will be randomized (1:1). The primary endpoint is the situational awareness score measured with the situation awareness global assessment technique (SAGAT) instrument.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Any physician performing a fellowship in the pediatric emergency department.
Any postgraduate residents pursuing a <5 years residency in pediatrics.
To be registered nurses from the PED.
To have previously completed a standardized 15-min introductory course on the use of the InterFACE tool dispensed by the study investigators.
Disqualifiers
To have not undergone the standardized 15-min introductory course on the use of the InterFACE tool dispensed by the study investigators.
Participation to a simulation in the past month is an exclusion criterion to avoid a recent training effect.
Trial design
Parallel
Treatments tested in this trial
InterFACE (mHealth tool)
DeviceParticipants will be asked to perform consecutively two 20-min highly realistic, scripted CPR scenarios (first: PALS-based scenario, second: ATLS-based scenario) on a high-fidelity WiFi manikin. Within each scenario, 3 separate "freeze" periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and the 2018 ATLS guidelines. Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills. Participants allocated to Arm A will not be allowed to use any other cognitive support.
Conventional methods
Other interventionParticipants will be asked to perform consecutively two 20-min scripted CPR scenarios (PALS and ATLS-based scenario) on a high-fidelity WiFi manikin. Within each scenario, 3 separate "freeze" periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and 2018 ATLS guidelines. Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills. Participants allocated to group B will be allowed to use the PALS pocket reference cards and a conventional calculator, but not any other cognitive support or mHealth tool.
Treatment groups
Trial outcomes
Primary outcomes
Situational awareness
Situational awareness (SA) will be measured using retrospective video review by the SA global assessment technique (SAGAT) instrument for each scenario, both as the score of each SAGAT at an individual level and at the team level (given as the sum of individual SAGAT scores for each team; TSAGAT). The SAGAT responses for categorical variables will be scored as either correct (1) or incorrect (0) by two of the investigators, irrespective of whether they agreed completely with the true answer. For numerical responses, answers will be considered correct based upon a 10% pre-defined tolerance range settled by the research investigators around the true value. The scores will be expressed as percentages in conjunction with absolute n/N values. Higher SA scores will denote higher SA.
Secondary outcomes
Resuscitation team leader evaluation
Leadership will be measured using the 12-item RTLE instrument developed by Grant et al. that encompasses four leadership concepts: (1) the physical and verbal leader's position; (2) communication and delegating skills; (3) ability to assess, adapt and anticipate; and (4) ability to ask for internal and external help. This instrument comprises 12 items rated on a 4-point Likert scale from 0 (not performed) to 3 (performed well) to score leadership and communication skills. A not applicable (N/A) category is also available for those items not relevant to the scenario. For the purpose of this trial, items 1 and 12 will be removed as the leader will be clearly identified from the beginning of the scenario and teams will not be advised to ask for external help. Therefore, the total item score will range from 0 to 30.
Team Emergency Assessment Measure
Teamwork performance will be measured using the 11-item Team Emergency Assessment Measure (TEAM) tool that stands out as the most valid and reliable instrument to use in emergency departments. TEAM comprises 11 items rated on a 5-point Likert scale from 0 (never/hardly) to 4 (always/nearly always), which are summed up into a total item score ranging from 0 to 44. The final score obtained allows to assess the performance of the emergency medical team based on three categories: leadership (items 1 and 2); teamwork (items 3 to 9); and task management (items 10 and 11). Items 8 and 9 relate to SA perception and projection, respectively. Furthermore, the team's overall performance is rated through a twelfth item on a global rating scale of 1 to 10 (higher score denotes better performance).
Medication dosage errors
Errors in drug dose administration (in milligrams) will be measured in each allocation group as a deviation from the 2018 AHA PALS cardiac arrest algorithm. An emergency medication dose administration error is defined as a deviation from the correct weight dose of more than 10%. Errors will be also measured both as the percentage deviation from the amount of delivered drug compared with the correct weight dose as prescribed by the physician and the absolute deviations from that dose. Moreover, defibrillations (in Joules) and the number of shocks will be also measured during the first scenario. For the second scenario, errors in fluid resuscitation volumes (in milliliters) will be measured as a deviation from the 2018 ATLS guidelines.
Time to critical life-saving maneuvers
The elapsed time in seconds between the end of the clinical statement by the study investigator to: (1) cardiac arrest or hypotensive shock recognition; (2) initiation of chest compression; (3) time to each defibrillation attempt; (4) time to administration of intravenous drugs, volume expansion with 0.9% sodium chloride or blood transfusion; and (5) time interval between defibrillation attempts will be measured.
Sponsors and contacts
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Pediatric Clinical Research Platform
Lead sponsor
University Hospital, Geneva
Collaborator
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