Clinical trial NCT03921346: Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR
Official title: A Mobile Device App to Reduce Prehospital Medication Errors and Time to Drug Preparation and Delivery by EMS During Simulated Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Arrest
Resuscitation
Pediatrics
Medication Errors
Emergency Medical Services
Keywords: Medication errors
Drugs
Pediatrics
Biomedical Technology
Mobile applications
Emergency Medical Services
Lead sponsor: Pediatric Clinical Research Platform
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
name: University of Lausanne Hospitals
name: Schutz & Rettung Sanitat
name: Salva Servizio Ambulanza Locarnese e Valli
name: Fribourg Emergency Medical Services, Fribourg, Switzerland
name: Réseau Hospitalier Neuchâtelois
name: Morges & Aubonne Emergency Medical Services (CSUMA), Morges and Aubonne, Switzerland
First posted: 2019-04-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, randomized, controlled trial
Primary purpose: TREATMENT

Brief summary: The study investigators will recruit paramedics in many Emergency Medical Services (EMS) in Switzerland to prepare direct intravenous (IV) emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac arrest scenario. According to randomization, each paramedic will be asked to prepare sequentially 4 IV emergency drugs (epinephrine, midazolam, dextrose 10%, sodium bicarbonate 4.2%) following either their current conventional methods or by the aim of a mobile device app. This app is designed to support drug preparation at pediatric dosages. In a previous multicenter randomized trial with nurses, the investigators 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 resuscitations. In this trial, the aim was to assess this app during pediatric out-of-hospital cardiopulmonary resuscitation with paramedics.

Detailed description: Children represent a vulnerable population with specific medical needs compared to adults. Fast, accurate, and safe preparation and administration of IV drugs is both complex and time consuming in pediatric critical situations, such as cardiopulmonary resuscitation (CPR). Most drugs given IV to children are provided in vials originally prepared for the adult population, which leads to the need for a specific individual, weight-based drug dose calculation and preparation for each child that varies widely across age groups. This error-prone process and the lower dosing error tolerance of children place them at a high risk for life-threatening medication errors. 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, making it the most common error. The rate of errors is also important in the prehospital setting, occurring in more than 30% of all pediatric drugs administered. As paramedics have little exposure to critically ill children, they have limited opportunities to administer resuscitation drugs at pediatric doses and to train this skill.

Moreover, in resuscitation, time is inversely correlated to survival. During the first 15 min of in-hospital pediatric CPR, survival and favorable neurological outcome decrease linearly by 2,1% and 1,2% per min, respectively, and rely in part on drug preparation time either in- or out-of-hospital. Among non-shockable pediatric out-of-hospital cardiac arrests, each minute delay to epinephrine delivery is associated with 9% decrease in the odds of survival. Regrettably, in the prehospital setting, the majority of patients receive epinephrine more than 10 minutes after EMS arrival. The chain of survival therefore critically relies on early out-of-hospital CPR by EMS, and onsite administration of IV emergency drugs without delay before a rapid transfer to pediatric emergency departments and advanced care.

In a previous multicenter, randomized crossover trial, medication errors, time to drug preparation, and time to drug delivery for continuous infusions during simulation-based pediatric in-hospital postcardiac arrest scenarios were significantly reduced by using a mobile device app - the pediatric accurate medication in emergency situations (PedAMINES™) app - designed to help pediatric drug preparation.

The present multicenter trial aims to compare the impact of this app with conventional calculation methods for the preparation of direct IV drugs during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios. The investigators hypothesized that use of the app might extend and scale up the previous multicenter in-hospital observations by similarly reducing occurrence of medication errors and time to drug preparation and delivery when used by paramedics in out-of-hospital settings.

In this trial, the investigators will recruit paramedics in many EMS in Switzerland to prepare direct IV emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac arrest scenario with a high-fidelity WiFi manikin (Laerdal SimBaby). The scenario will take place out-of-hospital in a simulated children's room to increase realism.

On the day of participation after random allocation (1:1 allocation ratio), each participating paramedic will (1) complete a survey collecting data regarding their demographics, care training, and simulation and computer experience, (2) receive a standardized 5-min training session on how to use the app, and (3) be presented the simulation manikin characteristics. The paramedics will then be asked to perform a 20-min highly realistic pediatric CPR scenario on the high-fidelity manikin. Each paramedic will be asked to prepare sequentially 4 intravenous emergency drugs (epinephrine, midazolam, dextrose 10%, sodium bicarbonate 4.2%) following either their current conventional methods or by the aim of the mobile app. The procedure is standardized across all sites to follow the same chronological progression and range of difficulty to ensure each participant is exposed to exactly the same case, with similar challenges in decision making and treatment preparation provided on the same manikin.

All the actions (i.e. primary and secondary outcomes) performed by the paramedics during the scenario will be automatically recorded and stored by the responsive simulator detectors, the app, and by several GoPro Hero 5 Black edition action video cameras worn by the paramedics and placed within the room.

The study will be carried out in accordance with the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH) guidelines and the Reporting Guidelines for Health Care Simulation Research.

This study aims to compare the impact of this app with conventional calculation methods for the preparation of direct IV drugs during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios, were paramedics are little exposed to pediatric CPRs. The investigators hypothesize that use of the app might extend and scale up their previous multicenter in-hospital observations by similarly reducing occurrence of medication errors and time to drug preparation and delivery when used by paramedics in out-of-hospital settings.

Eligibility criteria: Inclusion Criteria:

* To be paramedic certified
* To know how to prepare direct IV drugs
* To have previously completed the 5-minute introductory course to the use of the app PedAMINES™ dispensed by the study investigators
* Participation agreement

Exclusion Criteria:

* To have at any time previously used the app PedAMINES™
* To have not undergone the 5-minute introductory course to the use of the app PedAMINES™

Primary outcomes:
measure: Medication Dosage Errors
timeFrame: 20 minutes
Secondary outcomes:
measure: Time to Drug Preparation and Time to Drug Delivery
timeFrame: 20 minutes
measure: Type of Medication Errors
timeFrame: During each of the 4 drug preparations, an average of 20 minutes per drug preparation.
measure: Perceived Stress
timeFrame: At preintervention and postintervention, a total of 20 minutes will be used to complete the STAI questionnaire.
measure: Stress Level Measured by Heart Rate Monitoring (Smartwatch).
timeFrame: Baseline, recovery, and during each of the 4 drug preparations, a total of 20 minutes per participant will be used to continuously record heart rates on the smartwatch. Maximal HRpeak is the maximum HR across all preparations
measure: Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva Emergency Medical Services (ACE Ambulances)
Study officials:
affiliation: Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland
name: Johan N Siebert, MD
role: PRINCIPAL_INVESTIGATOR
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