Testing of Medication Dosing Software

• Sponsor: Nura Medical (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06129370
• Collaborator: (none)
• Enrollment: 12
• Arms: 2
• Anticipated Duration (Months): 4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pediatric Emergency Medicine	Device: Standard practice; Device: Medication dosing software	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Testing of a Medication Dosing Software for Pediatric Emergency Care
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. TIme to patient [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

2. Time to calculate [Through study completion, up to 3 months]

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

Secondary Outcome Measures

1. Feedback [Through study completion, up to 3 months]

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

2. Accuracy [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.

3. Time of calculation by second healthcare professional [Through study completion, up to 3 months]

   To assess the time spent calculating medication dosages by the second healthcare professional.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nura Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nura Medical
• ClinicalTrials.gov Identifier: NCT06129370
• Other Study ID Numbers: 2024-10183
• First Posted: Nov 13, 2023
• Last Update Posted: Nov 13, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nura Medical: Simulation; Pediatric emergency care; Healthcare professionals; Medication errors
• Additional relevant MeSH terms: Emergencies

Study Results

No Results Posted as of Nov 13, 2023