Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-31 @ 3:46 AM
Study NCT ID:
NCT04464603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2020-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a mHealth Supportive Tool on Cardiopulmonary Resuscitation' Situational Awareness
Sponsor:
Pediatric Clinical Research Platform
Organization:
Study Overview
Official Title:
Impact of a Shared Decision-making mHealth Tool on Caregivers' Team Situational Awareness, Communication Effectiveness, and Performance During Pediatric Cardiopulmonary Resuscitation: a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InterFACE
Brief Summary:
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.
Detailed 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, 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: