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

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ClinicalTrials.gov Identifier: NCT04464603
Recruitment Status : Not yet recruiting
First Posted : July 9, 2020
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
Private foundation of Geneva University Hospitals
Information provided by (Responsible Party):
Johan Siebert, Pediatric Clinical Research Platform

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.

Condition or disease Intervention/treatment Phase
Cardiopulmonary Arrest Pediatric ALL Resuscitation Device: InterFACE (mHealth tool) Other: Conventional methods Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, single center, randomized controlled trial
Masking: 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
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
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CPR

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.





Primary Outcome Measures :
  1. Situational awareness [ Time Frame: 40 minutes ]
    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 Outcome Measures :
  1. Resuscitation team leader evaluation [ Time Frame: 40 minutes ]
    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.

  2. Team Emergency Assessment Measure [ Time Frame: 40 minutes ]
    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).

  3. Medication dosage errors [ Time Frame: 40 minutes ]

    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.


  4. Time to critical life-saving maneuvers [ Time Frame: 40 minutes ]
    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.

  5. System usability scale [ Time Frame: 10 minutes ]
    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.

  6. Team effectiveness [ Time Frame: 40 minutes ]
    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.

  7. Stress perceived and satisfaction [ Time Frame: 10 minutes ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464603


Contacts
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Contact: Johan N Siebert, MD +41 79 553 40 72 Johan.Siebert@hcuge.ch
Contact: Frederic Ehrler, PhD Frederic.Ehrler@hcuge.ch

Locations
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Switzerland
Geneva Children's Hospital, Geneva University Hospitals
Geneva, Switzerland, 1205
Contact: Johan N Siebert, MD    +41 (0)22 372 45 55    Johan.Siebert@hcuge.ch   
Contact: Frederic Ehrler, PhD    +41 (0)22 372 86 97    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         
Sponsors and Collaborators
Pediatric Clinical Research Platform
Private foundation of Geneva University Hospitals
Investigators
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Principal Investigator: Johan N Siebert, MD Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland
Publications:
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Responsible Party: Johan Siebert, MD, Deputy Head, Pediatric Clinical Research Platform
ClinicalTrials.gov Identifier: NCT04464603    
Other Study ID Numbers: InterFACE
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: Available from 1 month to 10 years after trial publication.
Access Criteria: From the corresponding author upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johan Siebert, Pediatric Clinical Research Platform:
Information technologies
Situation Awareness
Teamwork
Leadership
Mobile applications
Biomedical Technology
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases