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Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR

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ClinicalTrials.gov Identifier: NCT03921346
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Geneva Emergency Medical Services, Geneva, Switzerland
Lausanne Emergency Medical Services, Lausanne, Switzerland
Zürich Emergency Medical Services (Schutz & Rettung Sanität), Zürich, Switzerland
Ticino Emergency Medical Services (SALVA Servizio Ambulanza Locarnese e Valli), Ticino, switzerland
Fribourg Emergency Medical Services, Fribourg, Switzerland
Neuchâtel Emergency Medical Services, Neuchâtel, Switzerland
Morges & Aubonne Emergency Medical Services (CSUMA), Morges and Aubonne, Switzerland
Information provided by (Responsible Party):
Johan Siebert, University Hospital, Geneva

Brief Summary:
The study investigators will recruit paramedics in many Emergency Medical Services (EMS) in Switzerland to prepare direct intravenous (IV) emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac arrest scenario. According to randomization, each paramedic will be asked to prepare sequentially 4 IV emergency drugs (epinephrine, midazolam, dextrose 10%, sodium bicarbonate 4.2%) following either their current conventional methods or by the aim of a mobile device app. This app is designed to support drug preparation at pediatric dosages. In a previous multicenter randomized trial with nurses, the investigators reported the ability of this app to significantly reduce in-hospital continuous infusion medication error rates and drug preparation time compared to conventional preparation methods during simulation-based resuscitations. In this trial, the aim was to assess this app during pediatric out-of-hospital cardiopulmonary resuscitation with paramedics.

Condition or disease Intervention/treatment Phase
Cardiopulmonary Arrest Resuscitation Pediatrics Medication Errors Emergency Medical Services Device: Mobile device app (PedAMINES™) 1st drug Device: Mobile device app (PedAMINES™) 2nd drug Device: Mobile device app (PedAMINES™) 3rd drug Device: Mobile device app (PedAMINES™) 4th drug Device: Conventional method 1st drug Device: Conventional method 2nd drug Device: Conventional method 3rd drug Device: Conventional method 4th drug Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, multicenter, randomized, controlled trial
Masking: Single (Participant)
Masking Description: Blinding to the direct IV drugs and doses intended for use will be maintained during recruitment to minimize preparation bias. Allocation concealment will be ensured with an allocation software and not released until the paramedics start the scenario. Study team members will be revealed to the participants just before the scenario starts. Paramedics will be unblinded when the simulated scenario starts. Although the intervention could not be masked, all investigators will remain unaware of the outcomes until all data will be unlocked for analysis at the end of the trial. All scenarios will be video-recorded for later analysis. Post-scenario video review will be done without blinding by two reviewers, but undertaken independently and blinded to each other's reviews. In case of disagreement, a third independent evaluator will help reach a consensus. The data analyst will be blinded to treatment allocation.
Primary Purpose: Treatment
Official Title: A Mobile Device App to Reduce Prehospital Medication Errors and Time to Drug Preparation and Delivery by EMS During Simulated Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized, Controlled Trial
Estimated Study Start Date : September 3, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A (mobile device app)

Paramedics preparing drugs with the help of the mobile device app PedAMINES™.

Each paramedic will have to prepare sequentially 4 direct IV emergency drugs with the help of the mobile device app PedAMINES™.

Device: Mobile device app (PedAMINES™) 1st drug
To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)

Device: Mobile device app (PedAMINES™) 2nd drug
To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)

Device: Mobile device app (PedAMINES™) 3rd drug
To prepare 4 mL/kg dextrose 10%

Device: Mobile device app (PedAMINES™) 4th drug
To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)

Active Comparator: Arm B (conventional preparation method)

Paramedics preparing drugs with the help of conventional method.

Each paramedic will have to prepare sequentially 4 direct IV emergency drugs with the help of conventional method

Device: Conventional method 1st drug
To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)

Device: Conventional method 2nd drug
To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)

Device: Conventional method 3rd drug
To prepare 4 mL/kg dextrose 10%

Device: Conventional method 4th drug
To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)




Primary Outcome Measures :
  1. Medication dosage errors [ Time Frame: 20 minutes ]
    To measure in each allocation group the number and proportion of medication dosage containing errors that occur during the sequence from drug preparation to drug injection. An emergency medication dose administration error is defined as a deviation from the correct weight dose of more than 10%. These 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.


Secondary Outcome Measures :
  1. Time to drug preparation and time to drug delivery [ Time Frame: 20 minutes ]
    Secondary outcome will be the elapsed time in seconds between the oral prescription by the physician and a) time to drug preparation completion and b) time to drug delivery by the participant.

  2. Type of medication errors [ Time Frame: 20 minutes ]
    Error in transcription of the physician's order into the medication dose, wrong choice of drug, wrong vial's initial concentration, wrong air purge out of the syringe before injection, stage of error detection: before or after injection, and aseptic errors will be measured.

  3. Stress perceived and satisfaction [ Time Frame: 20 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 drug preparation period?), and (3) the satisfaction about the preparation method used during the resuscitation scenario (On a scale of 1 to 10, how satisfied were you with your preparation 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.


  4. Stress level measured by heart rate monitoring (smartwatch). [ Time Frame: 20 minutes ]
    The participants' stress level will be assessed by measuring continuously their heart rate using a Polar A360 smartwatch on their wrist during the resuscitation scenario. Mean delta HR values (difference between HR peak values and baseline HR) will be obtained during some small segments of scenario and correlated to the scenario phases and the preparation methods used.

  5. Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire [ Time Frame: 60 minutes ]

    Acceptability and usability testing of the app will be assessed using a 52-item questionnaire based on the unified theory of acceptance and use of technology (UTAUT) model. It's a standardized instrument for measuring the likelihood of success for new technology introductions and helps to understand the drivers of its acceptance.

    The questionnaire has 52 questions distributed in 4 key constructs: 1) performance expectancy, 2) effort expectancy, 3) social influence, and 4) facilitating conditions.

    Each question are based on a Likert-type 5-point scale ranging from 1 = strongly disagree to 5 = strongly agree. Increments are integers between 1 to 5.




Information from the National Library of Medicine

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

Inclusion Criteria:

  • To be paramedic certified
  • To know how to prepare direct IV drugs
  • To have previously completed the 5-minute introductory course to the use of the app PedAMINES™ dispensed by the study investigators
  • Participation agreement

Exclusion Criteria:

  • To have at any time previously used the app PedAMINES™
  • To have not undergone the 5-minute introductory course to the use of the app PedAMINES™

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): NCT03921346


Contacts
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Contact: Johan N Siebert, MD +41 79 553 40 72 Johan.Siebert@hcuge.ch
Contact: Sergio Manzano, MD PD +41 79 553 26 18 Sergio.Manzano@hcuge.ch

Locations
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Switzerland
Geneva Emergency Medical Services (ACE Ambulances) Recruiting
Geneva, Switzerland, 1205
Contact: Xavier Schorno, EMT-P       x.schorno@ace-ambulances.ch   
Sponsors and Collaborators
Pediatric Clinical Research Platform
Geneva Emergency Medical Services, Geneva, Switzerland
Lausanne Emergency Medical Services, Lausanne, Switzerland
Zürich Emergency Medical Services (Schutz & Rettung Sanität), Zürich, Switzerland
Ticino Emergency Medical Services (SALVA Servizio Ambulanza Locarnese e Valli), Ticino, switzerland
Fribourg Emergency Medical Services, Fribourg, Switzerland
Neuchâtel Emergency Medical Services, Neuchâtel, Switzerland
Morges & Aubonne Emergency Medical Services (CSUMA), Morges and Aubonne, Switzerland
Investigators
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Principal Investigator: Johan N Siebert, MD Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland
  Study Documents (Full-Text)

Documents provided by Johan Siebert, University Hospital, Geneva:

Publications:

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Responsible Party: Johan Siebert, MD: Deputy Head, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03921346     History of Changes
Other Study ID Numbers: SNSF_32003B_182374
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
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, University Hospital, Geneva:
Medication errors
Drugs
Pediatrics
Biomedical Technology
Mobile applications
Emergency Medical Services
Additional relevant MeSH terms:
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Heart Arrest
Emergencies
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases