Impact of a mHealth Supportive Tool on Cardiopulmonary Resuscitation' Situational Awareness (InterFACE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric ALL; Resuscitation; Cardiopulmonary Arrest
• Intervention / Treatment: Device: InterFACE (mHealth tool); Other: Conventional methods

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johan N Siebert, MD; Phone Number: +41 79 553 40 72; Email: Johan.Siebert@hcuge.ch
• Study Contact Backup: Name: Frederic Ehrler, PhD; Email: Frederic.Ehrler@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Geneva Children's Hospital, Geneva University Hospitals
    • Contact: Johan N Siebert, MD; Phone Number: +41 (0)22 372 45 55; Email: Johan.Siebert@hcuge.ch
    • Contact: Frederic Ehrler, PhD; Phone Number: +41 (0)22 372 86 97; Email: Frederic.Ehrler@hcuge.ch
    • Sub-Investigator: Frederic Ehrler, PhD
    • Sub-Investigator: Sergio Manzano, Prof
    • Sub-Investigator: Cyril Sahyoun, MD
    • Sub-Investigator: Oliver Sanchez, MD
    • Sub-Investigator: Delphine S Courvoisier, Prof, PhD
    • Sub-Investigator: Laurence Lacroix, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.
• Participation agreement

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (InterFACE); Participants that will use the mHeath InterFACE tool during the simulation-based pediatric scenario. Each participant will have to do 2 consecutive scenarios (PALS, ATLS).	Device: InterFACE (mHealth tool); Participants 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.
Active Comparator: Arm B (Conventional methods); Participants that will use conventional methods during the simulation-based pediatric scenario. Each participant will have to do 2 consecutive scenarios (PALS, ATLS).	Other: Conventional methods; Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	40 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	40 minutes
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).	40 minutes
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.	40 minutes
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.	40 minutes
System usability scale	Usability testing of the mHealth tool InterFACE will be assessed using the System Usability Scale (SUS) instrument. The SUS instrument consists of a 10-item questionnaire with five response options for each item, based on their level of agreement ranging from 1 (strongly disagree) to 5 (strongly agree). For odd-numbered statements 1, 3, 5, 7, 9 (positively-worded items), the score contribution is equal to the scale position minus 1. For even-numbered statements 2, 4, 6, 8, 10 (negatively-worded items), the score contribution is equal to 5 minus the scale position. Each score contribution will fall within the range of 0 to 4. The participant's scores for each item are then added up together and multiplied by 2.5 to convert the original scores of 0-40 to 0-100.	10 minutes
Team effectiveness	Team effectiveness will be also measured as the time spent by the team to achieve the pre-designed goals set out by the AHA for the PALS course and the American College of Surgeons for the ATLS course.	40 minutes
Stress perceived and satisfaction	A 3-item questionnaire using a 10-point Likert scale will be provided to the participants to measure their perceived stress and satisfaction about the preparation method used during the resuscitation scenario. The questionnaire measures (1) the stress perceived before the scenario starts (On a scale from 1 to 10, how stressed are you now?), (2) the overall stress perceived at the end of the scenario (On a scale of 1 to 10, how stressed [maximum reached] were you during the scenario?), and (3) the satisfaction about the supportive method used during the resuscitation scenario (On a scale of 1 to 10, how satisfied were you with your supported experience?) Scale ranges: from 0 (minimum score) to 10 (maximum score), increments are integers between 0 to 10. For stress, higher values represent a worse score, whereas for satisfaction higher values represent a better score. No subscales will be combined.	10 minutes

Collaborators and Investigators

• Sponsor: Pediatric Clinical Research Platform
• Collaborators: University Hospital, Geneva
• Investigators: Principal Investigator: Johan N Siebert, MD, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland

Publications and helpful links

General Publications

• Siebert JN, Lacroix L, Cantais A, Manzano S, Ehrler F. The Impact of a Tablet App on Adherence to American Heart Association Guidelines During Simulated Pediatric Cardiopulmonary Resuscitation: Randomized Controlled Trial. J Med Internet Res. 2020 May 27;22(5):e17792. doi: 10.2196/17792.
• Ehrler F, Sahyoun C, Manzano S, Sanchez O, Gervaix A, Lovis C, Courvoisier DS, Lacroix L, Siebert JN. Impact of a shared decision-making mHealth tool on caregivers' team situational awareness, communication effectiveness, and performance during pediatric cardiopulmonary resuscitation: study protocol of a cluster randomized controlled trial. Trials. 2021 Apr 13;22(1):277. doi: 10.1186/s13063-021-05170-3.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Biomedical Technology; Mobile applications; Information technologies; Situation Awareness; Teamwork; Leadership
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: InterFACE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be deidentified and the study investigators will house the data locally on secure hard disk drives at the Geneva Children's Hospital. The datasets used or analyzed during the current trial will be available from the corresponding author upon reasonable request. Only deidentified/anonymized data will be shared.
• IPD Sharing Time Frame: Available from 1 month to 10 years after trial publication.
• IPD Sharing Access Criteria: From the corresponding author upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No