Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.
Faculty of Medicine, University of Geneva, Geneva, Switzerland.
JAMA Netw Open. 2021 Aug 2;4(8):e2123007. doi: 10.1001/jamanetworkopen.2021.23007.
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.
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).
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).
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.
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%).
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.
ClinicalTrials.gov Identifier: NCT03921346.
用药错误是造成伤害和可避免伤害的一个主要原因，每年影响着全球数百万人。儿童尤其容易发生用药错误，但在院前急救中预防这些错误的创新干预措施却很缺乏。
评估一款基于证据的移动应用程序在减少模拟儿科院外心脏骤停场景中用药错误发生率方面与传统准备方法相比的效果。
设计、地点和参与者：这是一项在瑞士 14 个急救医疗服务中心进行的全国性、开放性、多中心、随机临床试验，时间为 2019 年 9 月 3 日至 2020 年 1 月 21 日。参与者为 150 名具有药物准备自主决策权的高级护理人员。每位参与者都要接受 20 分钟的标准化、全视频记录的、逼真的 18 个月大儿童院外心脏骤停心肺复苏场景。参与者要对 4 种不同准备难度的静脉急救药物（肾上腺素、咪达唑仑、10%葡萄糖和碳酸氢钠）进行连续准备。
参与者被随机（1:1 比例）分为接受设计用于协助儿科药物准备的应用程序支持的干预组（n = 74）或接受没有协助的传统药物准备方法的对照组（n = 76）。
主要结局是用药错误的发生率，定义为根据预先确定的、基于专家共识的标准未能进行药物准备。使用具有混合效应的逻辑回归模型来评估该应用程序对二项结局的影响。次要结局包括药物准备和输送的时间，使用具有混合效应的线性回归模型进行评估。
共有 150 名高级护理人员（平均[标准差]年龄，35.6[7.2]岁；101 名男性[67.3%]；平均[标准差]获得护理人员认证后的时间，8.0[6.2]年）参加了研究，并完成了 600 次药物准备。在使用传统方法进行的 304 次药物准备中，191 次（62.8%；95%置信区间，57.1%-68.3%）与用药错误有关，而在使用应用程序进行的 296 次药物准备中，只有 17 次（5.7%；95%置信区间，3.4%-9.0%）与用药错误有关。当考虑重复测量时，使用该应用程序，用药错误的比例绝对减少了 66.5%（95%置信区间，32.6%-83.8%；P < .001），药物准备时间平均减少了 40 秒（95%置信区间，23-57 秒；P < .001），药物输送时间平均减少了 47 秒（95%置信区间，27-66 秒；P < .001）。与应用程序相比，传统方法的用药错误风险在不同药物之间存在差异（19.7%-100%），而应用程序的风险为（4.1%-6.8%）。
与传统方法相比，在院前环境中使用移动应用程序显著降低了紧急药物准备的用药错误率和药物输送时间。专门的移动应用程序有可能提高用药安全性并改变儿科急救医学的实践。
ClinicalTrials.gov 标识符：NCT03921346。
