NCT03799393

Brief Summary

This study explores the utility of a tablet computer-based, individually-tailored application called Computer Intervention Authoring Software (CIAS) in the Emergency Department for discharge education on proper child car restraint safety. The investigators hypothesize that tablet-based, individually-tailored discharge instructions are more effective than current standard, one-size-fits-all, printed discharge instructions. This is a randomized, controlled, non-blinded trial of of children age 0-21 years old in the Emergency Department. Patients will be randomized to receive either (a) a brief tablet-based questionnaire followed by standard, paper discharge instructions or (b) a brief tablet-based questionnaire followed by the intervention - CIAS, a tablet-based computer program. One week after discharge, participants in both groups will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. These variables will be compared between the control and intervention groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
295

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

1.6 years

First QC Date

December 24, 2018

Last Update Submit

December 7, 2021

Conditions

Keywords

injury preventioncar safetycar seatsbooster seatscar restraints

Outcome Measures

Primary Outcomes (2)

  • Demonstration of age-appropriate car restraint knowledge

    Rate of correct response to a post-intervention follow-up survey question regarding age appropriate car restraint for child in control group vs. intervention group.

    one week after enrollment

  • Change in car restraint knowledge

    Change in rate of correct response pre-intervention vs. post-intervention compared between control group vs. intervention

    one week after enrollment

Secondary Outcomes (6)

  • Actions taken related to car restraints

    one week after enrollment

  • Rate of difference types of actions taken related to car restraints

    one week after enrollment

  • Satisfaction with discharge education - CIAS

    during intervention/enrollment

  • Parental confidence in type of car restraint

    one week after enrollment

  • Parental confidence in car restraint installation

    one week after enrollment

  • +1 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The control group will receive a brief tablet-based questionnaire followed by standard, paper discharge instructions on car safety. Children ≥13 years old and above will answer questions themselves. They will complete a questionnaire on the usefulness of their discharge education. One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint.

Behavioral: Standard Printed Discharge Instructions

Experimental/CIAS Group

EXPERIMENTAL

The Experimental/CIAS Group will receive a brief tablet-based questionnaire followed by the intervention - CIAS, an interactive tablet computer program that gives educational information customized to the patient's age and size. Children ≥13 years old will answer questions and interact with the program themselves. They will complete a questionnaire on the usefulness of their discharge education. One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint.

Behavioral: CIAS (Computer Intervention Authoring Software)

Interventions

This is a digital application that allows families to interact with a tablet computer to receive educational information customized to the patient's age and size. allows authors to develop screening, assessment, and intervention tools for patients without requiring new programming. The CIAS intervention is programmed using tailored branching logic to allow a custom path through the intervention based on the respondent's answers. Delivery of the intervention uses a two-dimensional avatar narrator character that mimics the conversational structure of person-delivered brief interventions.

Experimental/CIAS Group

Patients/families will receive standard, printed discharge instructions. This is a 5 page general document from our Injury Prevention Center that describes appropriate car restraint safety for all age groups, not specific to the child enrolled.

Control Group

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Children age 0-21 years presenting to the children's emergency department for any chief complaint whose parent/guardian owns or has access to a car that the child rides in (or for adolescents 16 years or older, have access to a car themselves).

You may not qualify if:

  • No access to email or a smart phone
  • Adolescents with significant developmental delay
  • Adolescents who are critically injured
  • No parent/guardian present at time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasbro Children's Hospital Emergency Department

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Zhang AY, Leviter J, Baird J, Charles-Chauvet D, Frackiewicz LM, Duffy S, Dessie A. Buckle me up! A randomised controlled trial using a tablet-based emergency department intervention for child car safety education. Inj Prev. 2024 Jul 19;30(4):334-340. doi: 10.1136/ip-2023-044998.

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Susan Duffy, MD, MPH

    Associate Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 24, 2018

First Posted

January 10, 2019

Study Start

August 1, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

December 9, 2021

Record last verified: 2021-12

Locations