A Mobile App For Drug Dosage Calculation In The Context Of Pediatric And Adult Resuscitation: A Cross-Over Randomized Controlled Trial
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this study is to investigate whether the use of the EZResus app by physicians and nurses reduces medication errors in simulated adult and pediatric resuscitation scenarios compared to the use of standard protocols. This study is a randomized controlled crossover trial with two groups comparing the use of EZResus app with standard protocol in four simulated resuscitation scenarios. The participants will form resuscitation teams, each including an attending physician and two nurses responsible for the preparation and administration of medications. Each team will conduct one adult and one pediatric resuscitation scenario using the EZResus application, along with one adult and one pediatric resuscitation scenario following standard protocols.The teams will be individually randomized to start the scenarios either with or without the medical application using sealed envelopes. The participants will be recruited from one regional hospital (Haut-Richelieu hospital) and one university hospital (Charles LeMoyne Hospital).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2025
CompletedStudy Start
First participant enrolled
January 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2025
CompletedFirst Posted
Study publicly available on registry
February 3, 2025
CompletedFebruary 3, 2025
January 1, 2025
5 days
January 10, 2025
January 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Drug administration appropriate or not
In this study, the drug administration will be classified as either appropriate or inappropriate, with inappropriate administration being defined by one or more of the following criterias : * the administration of the incorrect medication * the use of an inappropriate route of administration * a prescribed dosage that deviates by more than 10% from the appropriate dose (as defined in the medication tables in appendix) or * an administered dosage that deviates by more than 10% from the prescribed dosage * The omission of a medication considered essential for treatment.
duration of the simulation: 15-25 minutes per scenario
Secondary Outcomes (10)
Drug administration appropriate or not - prescription phase
duration of the simulation: 15-25 minutes per scenario
Drug administration appropriate or not
duration of the simulation: 15-25 minutes per scenario
time to drug prescription
duration of the simulation: 15-25 minutes per scenario
time for drug preparation
duration of the simulation: 15-25 minutes per scenario
time to drug delivery
duration of the simulation: 15-25 minutes per scenario
- +5 more secondary outcomes
Study Arms (2)
Medical calculator application use (EzResus)
EXPERIMENTALParticipants (physicians and nurses) will be allowed to use a medical calculator application called EzResus. They will receive a 5-minute training prior to the simulations. Participants are also allowed to use other ressources, such as local protocols, medication administration guide.
Standard care
ACTIVE COMPARATORParticipants are also allowed to use the ressources they use in their practice, apart from a medical calculator application. They are allowed to use local protocols, medication administration guides, medical mobile apps that don't calculate drug doses.
Interventions
Each team of physician and nurses will participate in 4 scenarios: 2 adult, 2 pediatric. In each scenario, physician and nurses will have a clinical description of the scenario with the age and weight of each patient. The simulations will be conducted at the clinical simulation laboratory at Jean-Marc Lepage Pavilion of the University of Sherbrooke using high-fidelity mannequins. SimMan 3GPus will be used for adult scenarios and SimJunior for pediatric scenarios, both from Laerdal company. Participants will receive a briefing containing key information about the scenario and the patient just before starting the simulation. During the scenarios, the physician is expected to prescribe medications by mentioning the name, the dose and the route of administration of every medication. Moreover, if multiple dilution for a medication is possible, the physician is expected to mention the desired dilution.
Eligibility Criteria
You may qualify if:
- Emergency physicians or emergency nurses working in the resuscitation room and working in one of the two eligible hospital centers.
You may not qualify if:
- Being part of the research team or affiliated in any way with the EZResus team.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Charles-Le Moyne
Greenfield Park, Quebec, J3V 6M6, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Emergency medicine and Pediatric emergency medicine specialist
Study Record Dates
First Submitted
January 10, 2025
First Posted
February 3, 2025
Study Start
January 10, 2025
Primary Completion
January 15, 2025
Study Completion
January 15, 2025
Last Updated
February 3, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
all requested data