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Smartphone Apps for Pediatric Resuscitation (SMARTER)

Primary Purpose

Status Epilepticus, Anaphylaxis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Smartphone apps
Handbook
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Epilepticus focused on measuring Children, resuscitation, smartphone

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Residents who previously participated in this study

Sites / Locations

  • CHU Sainte-Justine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Smartphone

Handbook

Arm Description

Smartphone application

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Time for prescribing the first medication
Time from the beginning of the simulation and complete prescription (oral or written) of the first medication.
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.
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.
User satisfaction
Satisfaction of the resident with both tools using a Visual analog scale
User confidence
Confidence of the resident while using both tools using a Visual analog scale

Full Information

First Posted
November 4, 2016
Last Updated
October 4, 2017
Sponsor
St. Justine's Hospital
Collaborators
Canadian Medical Protective Association
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1. Study Identification

Unique Protocol Identification Number
NCT02958605
Brief Title
Smartphone Apps for Pediatric Resuscitation
Acronym
SMARTER
Official Title
Smartphone Medical Applications to Reduce Treatment Dosage Errors in Pediatric Resuscitation; a Randomized Simulation Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
Collaborators
Canadian Medical Protective Association

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus, Anaphylaxis
Keywords
Children, resuscitation, smartphone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone
Arm Type
Experimental
Arm Description
Smartphone application
Arm Title
Handbook
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Smartphone apps
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Handbook
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication error
Description
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.
Time Frame
During resuscitation
Secondary Outcome Measure Information:
Title
Proportion of tenfold error
Description
A tenfold error will be defined as a drug dose varying by a factor of 10 compared to the recommended dose.
Time Frame
During resuscitation
Title
Time for prescribing the first medication
Description
Time from the beginning of the simulation and complete prescription (oral or written) of the first medication.
Time Frame
During the simulation (10 minutes)
Title
Error in bolus medication
Description
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.
Time Frame
during simulation
Title
Error in perfusion medication
Description
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.
Time Frame
during simulation
Title
User satisfaction
Description
Satisfaction of the resident with both tools using a Visual analog scale
Time Frame
2 weeks
Title
User confidence
Description
Confidence of the resident while using both tools using a Visual analog scale
Time Frame
2 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Residents (PGY1 to PGY4) Completing a rotation in pediatric emergency Exclusion Criteria: Residents who previously participated in this study
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Smartphone Apps for Pediatric Resuscitation

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