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

Children are a vulnerable population with specific medical needs compared to adults. The fast, accurate and safe preparation and administration of intravenously administered (IV) drugs is both complex and time-consuming in pediatric critical situations, such as cardiopulmonary resuscitation (CPR) [1‐4]. Most drugs given intravenously to children are provided in vials originally prepared for the adult population. This leads to the need for a specific, individual, weight-based drug-dose calculation and preparation for each child that varies widely across age groups [3, 5‐9]. This error-prone process and the lower dosing error tolerance of children [10] places them at a high risk for life-threatening medication errors [3, 5, 6, 11]. Despite well-equipped and staffed environments with numerous available safeguards, direct IV medication errors have been reported in up to 41% of cases during simulated in-hospital pediatric resuscitations, 65% of which were incorrect medication dosage, thus making it the most common error [12]. The rate of errors is also important in the high-risk prehospital setting, which is reported as occurring in more than 30% of all pediatric drugs administered, with an error rate for epinephrine dosage alone of more than 60% [13]. In this particular context, initial care has to be delivered quickly by emergency medical services (EMS) in challenging field environments where resources and providers are limited [14]. A single paramedic is often in charge of determining the patient’s weight, choosing the most suitable drug, calculating the drug dose and appropriate volume to inject, and administering it to the patient. However, as paramedics have little exposure to pediatric education during their initial training [15] and, thereafter, to critically ill children during their work hours [16], they have limited opportunities to administer resuscitation drugs at pediatric doses and to improve their skill level.

In resuscitation, time is a critical success criterion. During the first 15 min of pediatric CPR, survival and favorable neurological outcome decrease linearly by 2.1 and 1.2% per min, respectively [17], and rely in part on drug preparation time in both in-hospital [18] or out-of-hospital settings [19]. Among non-shockable pediatric out-of-hospital cardiac arrests, each minute delay to epinephrine delivery is associated with a 9% decrease in survival odds [19, 20]. Regrettably, most patients in the prehospital setting receive epinephrine more than 10 min after EMS arrival [19, 20]. Therefore, the chain of survival critically relies on early out-of-hospital CPR by EMS [21] and on-site administration of emergency drugs without delay [19, 20, 22] before a rapid transfer to pediatric emergency departments (PED) and advanced care. Despite efforts to solve this problem, out-of-hospital preparation and delivery of pediatric emergency drugs remain a worldwide health challenge. The evaluation of new methods to reduce pediatric medication errors is of paramount importance, but research in this area is scarce.

Despite many advances in the emergency medical field in recent years, a suboptimal quality of resuscitation is still common for both adult and pediatric patients [41]. Currently, the hospital survival rate from pediatric in-hospital cardiopulmonary arrest is 36% [41], whereas it is below 10% for pediatric out-of-hospital cardiac arrests [11, 42]. According to the American Heart Association, emergency medication such as epinephrine should be considered in children undergoing pediatric advanced life support [33, 43]. Many critical situations also require the use of drugs or substrates that require a pharmacological intervention to restore vital functions and prevent patients from deteriorating (e.g., anticonvulsive drugs, dextrose, etc.). Although much attention has been paid to in-hospital pediatric emergent medication errors which are present in almost half of all resuscitation cases [12], with significant dose deviation from the prescribed dose reported in up to 16% of the analyzed syringes [35], data regarding EMS-related prehospital medication errors and error prevention strategies are scarce [13]. However, EMS are largely exposed to opportunities for out-of-hospital medication errors, thus severely compromising patient safety. In this setting, children are likely to require immediate care [14] and resources are limited. Prehospital dosing errors affect approximately 56,000 children treated by EMS each year in the USA [6] with drugs administered outside of the proper dose range reported in up to 39.8% of more than 5500 children. Among other drugs [44], epinephrine was shown to have the highest rates of incorrect doses with 60.9% of preparations containing an error and a mean error overdose of 808%. These results are similar to others reporting that paramedics commit dosing errors 49–63% of the time, with miscalculation as a primary cause [6]. The rate of medication errors further increases in critical care environments requiring the administration of several drugs where each may have its own concentration, dose and volume [3]. Disruptive emotional anxiety and exogenous conditions encountered during prehospital pediatric resuscitation, such as challenging field environments, parental stress, and time pressure to prepare the drugs on-site are other factors that potentially add to the complexity of the process and increase the cognitive load [45, 46]. The latter has been shown to be higher and error-prone when a task is uncommon [45, 47, 48]. Paramedics have little exposure to critically ill children and lack experience to administer emergency medications at pediatric doses [49], with minimal opportunities to gain and maintain competence in this skill [13, 15]. Pediatric situations only account for about 7% of EMS calls [16, 50]. It was shown that the delivery of epinephrine to children by EMS in the USA accounted for only 3.6% of the total adult drug administration [49] and this well illustrates the fact that almost 60% of paramedics report their initial education course as deficient in pediatric-specific training [13].

Providing EMS with ready access to a weight-estimation device app and a drug-dosing guide, such as the Broselow-Luten tape (BLT), was shown to lack sufficient accuracy and information to function as a complete resuscitation aid for the prevention of a high rate of prehospital medication errors [51, 52], with epinephrine dosing errors exceeding 60–70% [44]. Even after interventions to train EMS in the use of the BLT and precalculated drug-dosing charts, medication dosing errors remain significant [49]. Underlying causes of errors include incorrect estimation of weight, incorrect use of the BLT, incorrect recall of doses, difficulty with calculations under stress, mg/kg to milligrams to milliliter conversion errors, inaccurate measurement of volumes, and failure to cross-check doses between providers [51].

Therefore, the sole expertise of paramedics helped by conventional methods is not sufficient to ensure the fast and reliable conversion and preparation of pediatric emergency IV medication. Although numerous interventions involving information technologies have been developed to improve the in-hospital security of the medication process [53, 54], there has been no trial evaluating the impact of a mobile app used by EMS to reduce prehospital medication errors, time to drug preparation and time to drug delivery during pediatric resuscitation. As most of the results obtained from simulation-based resuscitation studies agree with those obtained in real-life studies, we are confident that our results could be of great interest for a potential application in real-life situations encountered by EMS.

Our study has some limitations. First, it will be conducted during a resuscitation simulation-based scenario rather than tested in real-life situations. However, high-fidelity simulation is an essential investigative methodology to answer research questions that cannot be answered otherwise during real CPR as the diversity of patients and their diseases make such studies hard to standardize in critical situations [30]. Moreover, standardizing the scenario and the environment will help to avoid effect modifiers by limiting the influence of undesired variables on the outcomes. Second, the 5-min app training will be dispensed just before the scenario. In real life, the interval between training and actual use would probably be months. However, training with the app months before the study would unblind participants to its purpose and could create a preparation bias. Third, multiple dose calculators are available on the web or as smartphone apps, but most are not evidence-based. In our previous multicenter trial [23], the app has been validated as an efficient tool to reduce in-hospital medication errors and delays in pediatric CPR. Its selection as study comparator is, therefore, justified. Finally, the Likert-type questionnaire that will be used to measure stress has not been assessed for validity, internal consistency, reliability or generalizability. Although it cannot objectively measure the stress perceived, it can be used to measure the difference of perceived stress.

In conclusion, and to the best of our knowledge, PedAMINES is the only evidence-based mobile app to assist medical prescriptions for in-hospital pediatric resuscitation with the capacity to reduce medication errors, as well as time to drug delivery during simulated resuscitations. It remains to be determined whether the use of this app by EMS may significantly reduce medication error rates and time to drug preparation in the prehospital setting where paramedics are less exposed to pediatric resuscitation. Although the survival rate has complex and numerous components, every single minute saved in the preparation of emergency medications in the prehospital setting can lead to an increase of 9% in the survival odd [19]. As research in this area is scarce, it is anticipated that the results generated from this study will be of great importance, with the potential to change and improve pediatric prehospital emergency care practice in this vulnerable population and thus increase the survival rate.