Effect of a Mobile App on Prehospital Medication Errors During Simulated Pediatric Resuscitation: A Randomized Clinical Trial

Abstract

Importance: Medication errors are a leading cause of injury and avoidable harm, affecting millions of people worldwide each year. Children are particularly susceptible to medication errors, but innovative interventions for the prevention of these errors in prehospital emergency care are lacking.

Objective: To assess the efficacy of an evidence-based mobile app in reducing the occurrence of medication errors compared with conventional preparation methods during simulated pediatric out-of-hospital cardiac arrest scenarios.

Design, setting, and participants: This nationwide, open-label, multicenter, randomized clinical trial was conducted at 14 emergency medical services centers in Switzerland from September 3, 2019, to January 21, 2020. The participants were 150 advanced paramedics with drug preparation autonomy. Each participant was exposed to a 20-minute, standardized, fully video-recorded, realistic pediatric out-of-hospital cardiac arrest cardiopulmonary resuscitation scenario concerning an 18-month-old child. Participants were tested on sequential preparations of 4 intravenous emergency drugs of varying degrees of preparation difficulty (epinephrine, midazolam, 10% dextrose, and sodium bicarbonate).

Intervention: Participants were randomized (1:1 ratio) to the support of an app designed to assist with pediatric drug preparation (intervention; n = 74) or to follow conventional drug preparation methods without assistance (control; n = 76).

Main outcomes and measures: The primary outcome was the rate of medication errors, defined as a failure in drug preparation according to predefined, expert consensus-based criteria. Logistic regression models with mixed effects were used to assess the effect of the app on binary outcomes. Secondary outcomes included times to drug preparation and delivery, assessed with linear regression models with mixed effects.

Results: In total, 150 advanced paramedics (mean [SD] age, 35.6 [7.2] years; 101 men [67.3%]; mean [SD] time since paramedic certification, 8.0 [6.2] years) participated in the study and completed 600 drug preparations. Of 304 preparations delivered using the conventional method, 191 (62.8%; 95% CI, 57.1%-68.3%) were associated with medication errors compared with 17 of 296 preparations delivered using the app (5.7%; 95% CI, 3.4%-9.0%). When accounting for repeated measures, with the app, the proportion of medication errors decreased in absolute terms by 66.5% (95% CI, 32.6%-83.8%; P < .001), the mean time to drug preparation decreased by 40 seconds (95% CI, 23-57 seconds; P < .001), and the mean time to drug delivery decreased by 47 seconds (95% CI, 27-66 seconds; P < .001). The risk of medication errors varied across drugs with conventional methods (19.7%-100%) when compared with the app (4.1%-6.8%).

Conclusions and relevance: Compared with conventional methods, the use of a mobile app significantly decreased the rate of medication errors and time to drug delivery for emergency drug preparation in a prehospital setting. Dedicated mobile apps have the potential to improve medication safety and change practices in pediatric emergency medicine.

Trial registration: ClinicalTrials.gov Identifier: NCT03921346.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Siebert reported having pending individual intellectual property rights on the mobile app PedAMINES and, as an employee of Geneva University Hospitals, receiving an indirect institutional reward through its commercialization. Drs Lovis, Gervaix, Ehrler, and Manzano reported having pending individual intellectual property rights on the mobile app PedAMINES and, as employees of Geneva University Hospitals, receiving an indirect institutional reward through its commercialization. No other disclosures were reported.

Figures

Figure 1.. CONSORT Diagram of Study Participation

Figure 2.. Proportions of Drug Doses Within Dose Deviation Set Margins From Prescribed Doses for Each of the 4 Drugs

Curves represent the percentage of preparations (y-axis) with a dose deviation (underdose or overdose) lower than a specified margin when this margin ranged from 0% to 100% of the prescribed dose (x-axis). Dashed horizontal line indicates the percentage of preparations with a dose deviation of 0% in the app group; and vertical dashed lines, dose deviation set margin that should be accepted in the conventional method group to achieve this percentage. For example, in panel A, a dose deviation set margin of 91.7% would categorize 89.2% of epinephrine preparations via the conventional method as acceptable and 100% of epinephrine preparations via the app as acceptable. Thus, for this example, even with a tolerable limit of dose deviation set high at 91.7% of the prescribed dose, 10.8% of errors would still occur with the conventional method.