Testing of Medication Dosing Software

NCT ID: NCT06129370

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-04-30

Brief Summary

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The goal of this clinical study is to evaluate the clinical efficiency of a medication dosing software in simulated pediatric emergency care. The main questions it aims to answer are:

* Will the time to patient be significantly reduced with the medication dosage software when compared to standard clinical practice?
* Will the time to calculate dosage of medications be significantly reduced with the medication dosage software when compared to standard clinical practice?
* How will users perceive clinical efficiency, ease of use, confidence level of using the medication dosage software when compared to standard clinical practice?
* How will accuracy of medication dose and volume calculations as well as final volume ready for administration using the medication dosage software compared to standard clinical practice?
* Will the time spent calculating medication doses by the second healthcare professional on pediatric non-acute and acute care cases be significantly reduced with the medication dosage software when compared to standard clinical practice?

Participants will be presented pediatric care scenarios and asked to calculate and prepare intravenous medications under two interventions: the medication dosage software and standard clinical practice (Lexicomp and manual calculator).

Detailed Description

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Conditions

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Pediatric Emergency Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Software, then Standard

Participants will use the medication dosage software to calculate and prepare intravenous medications during the initial run through of pediatric case scenarios. Then, they will use standard clinical practice (Lexicomp and manual calculator) during the second run through of pediatric case scenarios.

Group Type EXPERIMENTAL

Standard practice

Intervention Type DEVICE

Lexicomp and manual calculator

Medication dosing software

Intervention Type DEVICE

Medication dosing software

Standard, then Software

Participants will use standard clinical practice (Lexicomp and manual calculator) to calculate and prepare intravenous medications during the initial run through of pediatric case scenarios. Then, they will use the medication dosage software during the second run through of pediatric case scenarios.

Group Type EXPERIMENTAL

Standard practice

Intervention Type DEVICE

Lexicomp and manual calculator

Medication dosing software

Intervention Type DEVICE

Medication dosing software

Interventions

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Standard practice

Lexicomp and manual calculator

Intervention Type DEVICE

Medication dosing software

Medication dosing software

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

-Healthcare professionals who have worked or who are currently working at a healthcare facility and involved in the calculation or preparation of IV medication.

Exclusion Criteria

* Healthcare professionals who cannot read, speak, or understand English or French as the simulations will be conducted in English or French.
* Performance of physically strenuous activity 30 min prior to study.
* Physical limitations that affect performance on required tasks (e.g., inability to place arm cuff on mannequin's arm, inability to handle weight estimation and touchscreen devices).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nura Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2024-10183

Identifier Type: -

Identifier Source: org_study_id

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