NCT06129370

Brief Summary

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).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Status
unknown

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

November 3, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 3, 2023

Last Update Submit

November 8, 2023

Conditions

Pediatric Emergency Medicine

Keywords

SimulationPediatric emergency careHealthcare professionalsMedication errors

Outcome Measures

Primary Outcomes (2)

  • TIme to patient

    Assess the time elapsed from ordering of medication to ready for administration using the medication dosage software compared to the time achieved with standard clinical practice

    Through study completion, up to 3 months

  • Time to calculate

    Assess the time to calculate medication dosage using the medication dosage software compared to standard clinical practice

    Through study completion, up to 3 months

Secondary Outcomes (3)

  • Feedback

    Through study completion, up to 3 months

  • Accuracy

    Through study completion, up to 3 months

  • Time of calculation by second healthcare professional

    Through study completion, up to 3 months

Study Arms (2)

Software, then Standard

EXPERIMENTAL

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.

Device: Standard practiceDevice: Medication dosing software

Standard, then Software

EXPERIMENTAL

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.

Device: Standard practiceDevice: Medication dosing software

Interventions

Standard practiceDEVICE

Lexicomp and manual calculator

Software, then StandardStandard, then Software
Medication dosing softwareDEVICE

Medication dosing software

Software, then StandardStandard, then Software

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 13, 2023

Study Start

December 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

November 13, 2023

Record last verified: 2023-11