Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cardiopulmonary Arrest
  • Pediatric ALL
  • Resuscitation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A prospective, single center, randomized controlled trialMasking: Single (Participant)Masking Description: Blinding to the outcomes will be maintained during recruitment to minimize preparation bias. Allocation concealment will be ensured with an allocation software and will not be released until the participants start the scenario. A post-scenario video review will be done without blinding by two reviewers, but undertaken independently with each blinded to the other's reviews. In the case of disagreement, a third independent evaluator will help reach a consensus. The data analyst will be blinded to group allocation.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

Effective team communication, coordination, and situational awareness by cardiac arrest team members are critical components to deliver optimal cardiopulmonary arrest resuscitation care. But the complexity of care during cardiopulmonary resuscitation (CPR), numerous providers involved, miscommunicat...

Effective team communication, coordination, and situational awareness by cardiac arrest team members are critical components to deliver optimal cardiopulmonary arrest resuscitation care. But the complexity of care during cardiopulmonary resuscitation (CPR), numerous providers involved, miscommunication, and exogenous factors can all contribute to wresting patients care, thus jeopardizing their survival. The aim of this trial is to investigate whether a mHealth supportive tool (the interconnected and focused mobile apps on patient care environment [InterFACE]) developed as a collaborative platform to support CPR providers in real-time and share patient-centered information would increase situational awareness during pediatric CPR and improve team communication and performance. This clinical trial will be a prospective, single-center, randomized controlled trial in a tertiary pediatric emergency department (>33,000 consultations/year) with two parallel groups of voluntary pediatric emergency fellows, residents and nurses. Situational Awareness (SA), leadership, communication skills and team performance will be compared using a shared mHealth supportive tool ("InterFACE", group A) or conventional team interactions (group B) during standardized simulation-based pediatric in-hospital cardiac arrest scenario (p-IHCA) and life-threatening trauma scenarios using a high-fidelity manikin. InterFACE consists of a dual, interconnected mHealth tool composed primarily of a mobile device app, namely "Guiding Pad" (PMID: 32292179), interfaced to a remote large liquid crystal display (LCD) screen installed in the shock room and situated above the patient's head. Thirty-six participants will be randomized 1:1 (each team will comprise six participants, i.e. a total of 6 teams). The teams will be asked to perform consecutively two 20-min highly realistic, scripted CPR scenarios on a high-fidelity WiFi manikin (Laerdal SimBaby, Laerdal Medical, Stavanger, Norway) using either the mHealth tool or conventional methods. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and the 2018 ATLS guidelines. In this simulation-based study, each team member will answer the SAGAT queries specific to their roles. Leadership will be measured with the resuscitation team leader evaluation (RTLE) instrument. Effective teamwork and communication will be measured with the team emergency assessment measure (TEAM) instrument. The SUS instruments will be used to measure the usability of the mHealth tool. For the trauma scenario, the modified non-technical skills scale for trauma (T-NOTECHS) will not be used due to the serious risk of assessment bias with this instrument, as emphasized by the consensus-based standards for the selection of health measurement instruments (COSMIN). Data collection will be carried out by the responsive simulator detectors (Laerdal SimBaby) and the two GoPro video cameras. The set-up of both cameras will be standardized. The recorded videos will be safely stored in duplicate on secured hard-disk drives in a locked room. As all scenarios will be fully video-recorded, all actions, communications and interactions will be recorded and later scored by two raters to allow outcomes analysis and for the calculation of interrater reliability. All actions performed with the app will be automatically saved locally in log files for further analysis. This study offers the major advantage to observe a unique 60-min period per resuscitation team. Therefore, neither follow-up nor retention plans will be necessary. The resuscitation algorithm is highly standardized and deviation from the algorithm is a parameter of interest in this study. Data collection will be carried out using the REDCap database (REDCap, Vanderbilt University, Nashville, TN, USA). This clinical trial will assess the impact of a collaborative mHealth tool to increase situational awareness and effective team communication during in-hospital pediatric resuscitation. As research in this area is scarce, the results generated from this study will be of great importance and may be sufficient to change and improve in-hospital pediatric emergency care practice in an era of communication technologies.

Tracking Information

NCT #
NCT04464603
Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Johan N Siebert, MD Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland