A mobile device app to reduce prehospital medication errors and time to drug preparation and delivery by emergency medical services during simulated pediatric cardiopulmonary resuscitation: study protocol of a multicenter, prospective, randomized controlled trial

Johan N Siebert, Laurie Bloudeau, Frédéric Ehrler, Christophe Combescure, Kevin Haddad, Florence Hugon, Laurent Suppan, Frédérique Rodieux, Christian Lovis, Alain Gervaix, Sergio Manzano, Johan N Siebert, Laurie Bloudeau, Frédéric Ehrler, Christophe Combescure, Kevin Haddad, Florence Hugon, Laurent Suppan, Frédérique Rodieux, Christian Lovis, Alain Gervaix, Sergio Manzano

Abstract

Background: Emergency drug preparation and administration in children is both complex and time-consuming and places this population at a higher risk than adults for medication errors. Moreover, survival and a favorable neurological outcome from cardiopulmonary resuscitation are inversely correlated to drug preparation time. We developed a mobile device application (the pediatric Accurate Medication IN Emergency Situations (PedAMINES) app) as a step-by-step guide for the preparation to delivery of drugs requiring intravenous injection. In a previous multicenter randomized trial, we 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 pediatric resuscitations. This trial aims to evaluate the effectiveness of this app during pediatric out-of-hospital cardiopulmonary resuscitation.

Methods/design: We will conduct a multicenter, prospective, randomized controlled trial to compare the PedAMINES app with conventional calculation methods for the preparation of direct intravenously administered emergency medications during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios using a high-fidelity manikin. One hundred and twenty paramedics will be randomized (1:1) in several emergency medical services located in different regions of Switzerland. Each paramedic will be asked to prepare, sequentially, four intravenously administered emergency medications using either the app or conventional methods. The primary endpoint is the medication error rates. Enrollment will start in mid-2019 and data analysis in late 2019. We anticipate that the intervention will be completed in early 2020 and study results will be submitted in late 2020 for publication (expected in early 2021).

Discussion: This clinical trial will assess the impact of an evidence-based mobile device app to reduce the rate of medication errors, time to drug preparation and time to drug delivery during prehospital 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 prehospital pediatric emergency care practice.

Trial registration: ClinicalTrials.gov, ID: NCT03921346. Registered on 18 April 2019.

Keywords: Biomedical technology; Emergency medical services; Medication errors; Mobile applications; Pediatrics; Pharmaceutical preparations; Resuscitation.

Conflict of interest statement

Geneva University Hospitals are the owners of the app PedAMINES. The app is available on the Google Play Store and the App Store (Apple). All authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Trial flow chart
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials checklist (SPIRIT) Figure
Fig. 3
Fig. 3
Pediatric Accurate Medication IN Emergency Situations (PedAMINES) screenshot. List of bolus intravenously administered (IV) drugs (white boxes) and drugs for continuous infusion (yellow boxes) are selectable in the left margin of the application. The right window shows drugs selected by the paramedic for a child weighing 12 kg. In this screenshot example, epinephrine is being delivered at 0.01 mg/kg (0.1 mL/kg of 0.1 mg/mL concentration). Midazolam 0.1 mg/kg (of 5 mg/mL concentration and 10 mL sodium chloride 0.9%) is selected and ready to be injected, waiting for the nurse’s approval (“delivered?”). The printer logo in the upper right corner indicates that all actions performed by the nurses are sequentially saved in historic files that can be retrieved and printed at any time

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