NCT06804915

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

5 days

First QC Date

January 10, 2025

Last Update Submit

January 27, 2025

Conditions

Keywords

mobile appsmartphoneresuscitationdrug errors

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)

EXPERIMENTAL

Participants (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.

Behavioral: simulation

Standard care

ACTIVE COMPARATOR

Participants 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.

Behavioral: simulation

Interventions

simulationBEHAVIORAL

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.

Medical calculator application use (EzResus)Standard care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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. Standard protocol is defined as standard care using any resources usually used by professionals, except for medical calculator applications.
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

Locations