Testing of Medication Dosing Software

November 8, 2023 updated by: Nura Medical

Testing of a Medication Dosing Software for Pediatric Emergency Care

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Standard practice
Lexicomp and manual calculator
Device: Medication dosing software
Medication dosing software
Experimental: 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.
Device: Standard practice
Lexicomp and manual calculator
Device: Medication dosing software
Medication dosing software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TIme to patient
Time Frame: Through study completion, up to 3 months
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
Time Frame: Through study completion, up to 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feedback
Time Frame: Through study completion, up to 3 months
time to calculate medication dosage using the medication dosage software compared to standard clinical practice
Through study completion, up to 3 months
Accuracy
Time Frame: Through study completion, up to 3 months
To assess the accuracy of (I) medication dose and volume calculations and (II) final volume ready for administration using the medication dosage software compared to standard clinical practice.
Through study completion, up to 3 months
Time of calculation by second healthcare professional
Time Frame: Through study completion, up to 3 months
To assess the time spent calculating medication dosages by the second healthcare professional.
Through study completion, up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nura Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-10183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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