SMARTER: Smartphone Apps for Pediatric Resuscitation

Sponsor

St. Justine's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02958605

Collaborator

Canadian Medical Protective Association (Other)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Status Epilepticus Anaphylaxis	Device: Smartphone apps Device: Handbook	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Medication error [During resuscitation]
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.

Secondary Outcome Measures

Proportion of tenfold error [During resuscitation]
A tenfold error will be defined as a drug dose varying by a factor of 10 compared to the recommended dose.
Time for prescribing the first medication [During the simulation (10 minutes)]
Time from the beginning of the simulation and complete prescription (oral or written) of the first medication.
Error in bolus medication [during simulation]
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.
Error in perfusion medication [during simulation]
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.
User satisfaction [2 weeks]
Satisfaction of the resident with both tools using a Visual analog scale
User confidence [2 weeks]
Confidence of the resident while using both tools using a Visual analog scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Residents who previously participated in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Sainte-Justine	Montreal	Quebec	Canada	H3T1C5

Sponsors and Collaborators

St. Justine's Hospital
Canadian Medical Protective Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jocelyn Gravel, Principal investigator, St. Justine's Hospital

ClinicalTrials.gov Identifier:

NCT02958605

Other Study ID Numbers:

SMARTER1

First Posted:

Nov 8, 2016

Last Update Posted:

Oct 6, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Jocelyn Gravel, Principal investigator, St. Justine's Hospital

Children

resuscitation

smartphone

Additional relevant MeSH terms:

Status Epilepticus

Anaphylaxis

Study Results

No Results Posted as of Oct 6, 2017