A Mobile Device App to Reduce Medication Errors and Time to Drug Delivery During Pediatric Cardiopulmonary Resuscitation: Study Protocol of a Multicenter Randomized Controlled Crossover Trial

Johan N Siebert, Frederic Ehrler, Christian Lovis, Christophe Combescure, Kevin Haddad, Alain Gervaix, Sergio Manzano, Johan N Siebert, Frederic Ehrler, Christian Lovis, Christophe Combescure, Kevin Haddad, Alain Gervaix, Sergio Manzano

Abstract

Background: During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusions is complex and time-consuming. The need for individual specific weight-based drug dose calculation and preparation places children at higher risk than adults for medication errors. Following an evidence-based and ergonomic driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. In a prior single center randomized controlled trial, medication errors were reduced from 70% to 0% by using PedAMINES when compared with conventional preparation methods.

Objective: The purpose of this study is to determine whether the use of PedAMINES in both university and smaller hospitals reduces medication dosage errors (primary outcome), time to drug preparation (TDP), and time to drug delivery (TDD) (secondary outcomes) during pediatric CPR when compared with conventional preparation methods.

Methods: This is a multicenter, prospective, randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drug infusion rate table in the preparation of continuous drug infusion. The evaluation setting uses a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin. The study involving 120 certified nurses (sample size) will take place in the resuscitation rooms of 3 tertiary pediatric emergency departments and 3 smaller hospitals. After epinephrine-induced return of spontaneous circulation, nurses will be asked to prepare a continuous infusion of dopamine using either PedAMINES (intervention group) or the infusion table (control group) and then prepare a continuous infusion of norepinephrine by crossing the procedure. The primary outcome is the medication dosage error rate. The secondary outcome is the time in seconds elapsed since the oral prescription by the physician to drug delivery by the nurse in each allocation group. TDD includes TDP. Stress level during the resuscitation scenario will be assessed for each participant by questionnaire and recorded by the heart rate monitor of a fitness watch. The study is formatted according to the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH) and the Reporting Guidelines for Health Care Simulation Research.

Results: Enrollment and data analysis started in March 2017. We anticipate the intervention will be completed in late 2017, and study results will be submitted in early 2018 for publication expected in mid-2018. Results will be reported in line with recommendations from CONSORT-EHEALTH and the Reporting Guidelines for Health Care Simulation Research .

Conclusions: This paper describes the protocol used for a clinical trial assessing the impact of a mobile device app to reduce the rate of medication errors, time to drug preparation, and time to drug delivery during pediatric resuscitation. As research in this area is scarce, results generated from this study will be of great importance and might be sufficient to change and improve the pediatric emergency care practice.

Trial registration: ClinicalTrials.gov NCT03021122; https://ichgcp.net/clinical-trials-registry/NCT03021122 (Archived by WebCite at http://www.webcitation.org/6nfVJ5b4R).

Keywords: biomedical technology; children; emergency; medication errors; pediatrics; pharmaceutical preparations; resuscitation; simulation.

Conflict of interest statement

Conflicts of Interest: JNS, FE, CL, AG, and SM are the owners of the PedAMINES app that will be available in the near future in Google Play and the App Store. The authors therefore declare a direct financial interest to market this app.

©Johan N Siebert, Frederic Ehrler, Christian Lovis, Christophe Combescure, Kevin Haddad, Alain Gervaix, Sergio Manzano. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.08.2017.

Figures

Figure 1
Figure 1
Study design and flowchart per study center.
Figure 2
Figure 2
Calculation of the Composition of Drug Infusions (Syringe Pump). Frank Shann Drug Doses [15].
Figure 3
Figure 3
PedAMINES screenshot.

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