NCT02958605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

November 4, 2016

Last Update Submit

October 4, 2017

Conditions

Keywords

Childrenresuscitationsmartphone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Proportion of tenfold error

    During resuscitation

  • Time for prescribing the first medication

    During the simulation (10 minutes)

  • Error in bolus medication

    during simulation

  • Error in perfusion medication

    during simulation

  • User satisfaction

    2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Smartphone

EXPERIMENTAL

Smartphone application

Device: Smartphone apps

Handbook

EXPERIMENTAL

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

Interventions

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.

Smartphone
HandbookDEVICE

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.

Handbook

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Residents who previously participated in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Status EpilepticusAnaphylaxis

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

October 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations