Smartphone Apps for Pediatric Resuscitation

Status Epilepticus Clinical Trial

— SMARTER  

Official title:

Smartphone Medical Applications to Reduce Treatment Dosage Errors in Pediatric Resuscitation; a Randomized Simulation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958605
• Other study ID #: SMARTER1
• Status: Completed
• Phase: N/A
• First received: November 4, 2016
• Last updated: October 4, 2017
• Start date: November 2016
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Medication errors are common in children. Characteristics of errors during critical situations in the Emergency Department are ill-defined and might be more frequent than previously thought. However, optimal strategies to eliminate the risk of prescribing errors remain unknown.

Many smartphone apps have been suggested over the last years with some of them designed to calculate medication dosage for children. The impact of these apps to decrease dosage error has never been evaluated in resuscitation setting.

The aim of the study is to evaluate whether the use of a smartphone application designed to calculate medication doses decreases prescribing errors among residents during pediatric simulated resuscitations.

This will be a crossover-randomized trial using high fidelity simulation among 40 residents rotating in the pediatric emergency department.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Residents (PGY1 to PGY4)

• Completing a rotation in pediatric emergency

Exclusion Criteria:

• Residents who previously participated in this study

Related Conditions & MeSH terms

• Anaphylaxis
• Status Epilepticus

Intervention

Device:
• Smartphone apps
If already own a smartphone application dedicated to calculate medication dosage for children, the participant will be allowed to use his/her own application. Otherwise, the resident will be offered to chose among a list of applications paid by the research team (PediSafe, PediStat, Palm Pedi, Safedose, EZdrip peds). He/she will be instructed to practice with a few time at home before doing the simulations.
• Handbook
Resuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000.

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
St. Justine's Hospital	Canadian Medical Protective Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication error	The primary outcome is the presence of a medication error. An error will be defined as a drug dose varying by more than 20% from the recommended dose or by incorrect route.	During resuscitation
Secondary	Proportion of tenfold error	A tenfold error will be defined as a drug dose varying by a factor of 10 compared to the recommended dose.	During resuscitation
Secondary	Time for prescribing the first medication	Time from the beginning of the simulation and complete prescription (oral or written) of the first medication.	During the simulation (10 minutes)
Secondary	Error in bolus medication	An error in bolus medication will be defined as a drug dose varying by more than 20% from the recommended dose or by incorrect route.	during simulation
Secondary	Error in perfusion medication	An error in perfusion medication will be defined as a drug dose varying by more than 20% from the recommended dose. This can be related to a preparation error or a flow error.	during simulation
Secondary	User satisfaction	Satisfaction of the resident with both tools using a Visual analog scale	2 weeks
Secondary	User confidence	Confidence of the resident while using both tools using a Visual analog scale	2 weeks