Reducing Medication Errors and Time to Drugs Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter RCT

Study Overview
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Brief Summary
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The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them step-by-step from order to delivery of these drugs. Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection. Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD).

Detailed Description
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During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusion is both complex and time-consuming, placing children at higher risk than adults for medication errors. It is well established that CPR duration is inversely correlated to survival, decreasing linearly by 2.1 % per minute, and to decreased risk of neurological sequelae [1]. In this study, the investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin (Laerdal SimJunior™). The scenario will take place in the shock room to increase realism. According to randomization with a 1:1 allocation ratio, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™ (Pediatric Accurate Medication In Emergency Situations). PedAMINES™ is designed to support nurses step-by-step from order to delivery of a wide range of drugs, especially those requiring continuous infusion. PedAMINES™ has already been shown in a single-center simulation-based study to reduce time to vasoactive drug preparation, to delivery and the rate of medication errors [2]. On the day of participation, after obtaining nurse's written informed consent and randomization, nurses will receive a standardized 5-minute training session on how to use the app. Then, the nurses will be asked to perform a standardized 15-minute highly realistic CPR scenario, including post-return of spontaneous circulation (ROSC). After epinephrine-induced ROSC, nurses will be asked to first prepare a continuous infusion of dopamine, using either PedAMINES™ or a conventional method, and then a continuous infusion of norepinephrine by crossing the procedure. Moreover, 2 questionnaires will be given before and after the scenario to ask the nurses about their demographics data, perceived stress and degree of satisfaction. Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection. Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD). All the actions (i.e. primary and secondary outcomes) performed by the nurses during the scenario will be automatically recorded and stored by the responsive simulator detectors, the application and by several video cameras. To avoid assessment bias, two evaluators will then independently review these video recordings. In case of disagreement, a third independent evaluator will help reach a consensus. We aim to determine whether the use of PedAMINES™ might improve the management of acute life-threatening conditions by quickly delivering expertise in vasoactive drugs administration in other hospitals in Switzerland, even in non-university hospitals where nurses (and physicians) are either little or not exposed to pediatric CPRs. We hypothesize that PedAMINES™ might primary reduce medication errors, and secondary reduce delays to drugs preparation and delivery independently of the existing conventional preparation methods or nurses' skills.

Official Title
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Reducing Medication Errors and Time to Vasoactive Drugs Preparation and Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized Controlled Trial

Conditions
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Resuscitation, Pediatrics

Intervention / Treatment
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* Device: PedAMINES™ / Conventional Method
* Device: Conventional Method / PedAMINES™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be nurse certified To know how to prepare intravenous drugs injection. To have previously completed the 5-minute introductory course to the use of PedAMINES dispensed by the investigators of the study. Participation agreement Exclusion Criteria: To have at any time undergone a previous experiment with a cognitive numeric device aimed to help vasoactive drugs preparation. To have not undergone the 5-minute introductory course to the use of PedAMINES.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (PedAMINES™ / Conventional Method)<br>A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of PedAMINES™ first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of a Conventional Method. | Device: PedAMINES™ / Conventional Method<br>* Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design: • PedAMINES™ (Period 1) and then Conventional Method (Period 2)<br>|
| Active Comparator: Arm B (Conventional Method / PedAMINES™)<br>A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of a Conventional Method first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of PedAMINES™. | Device: Conventional Method / PedAMINES™<br>* Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design: • Conventional Method (Period 1) and then PedAMINES™ (Period 2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication dosage errors | To measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection. | On the day of study participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to drug preparation (TDP) and time to drug delivery (TDD) | To measure in each allocation group the elapsed time in seconds between the oral prescription by the physician to drug preparation completion by the nurse (TDP) and to drug delivery (TDD) by the nurse. | On the day of study participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication errors, Resuscitation, Drugs, Pediatrics, Biomedical technology