Smartphone Apps for Pediatric Resuscitation (SMARTER)

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

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.

Study Overview

• Status: Completed
• Conditions: Anaphylaxis; Status Epilepticus
• Intervention / Treatment: Device: Smartphone apps; Device: Handbook

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1C5
      • CHU Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Residents (PGY1 to PGY4)
• Completing a rotation in pediatric emergency

Exclusion Criteria:

• Residents who previously participated in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartphone; Smartphone application	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.
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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
User satisfaction	Satisfaction of the resident with both tools using a Visual analog scale	2 weeks
User confidence	Confidence of the resident while using both tools using a Visual analog scale	2 weeks

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Collaborators: Canadian Medical Protective Association

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: November 5, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Children; smartphone; resuscitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Neurologic Manifestations; Hypersensitivity; Seizures; Status Epilepticus; Anaphylaxis
• Other Study ID Numbers: SMARTER1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No