Buckle Me Up!: A Digital Emergency Department Discharge Intervention for Child Car Safety

December 7, 2021 updated by: Almaz Dessie, Lifespan

Buckle Me Up!: A Computerized, Individually-Tailored Emergency Department Discharge Intervention for Child Car Restraint Safety Education

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.

Study Overview

Detailed Description

This study explores the utility of a tablet computer-based, individually-tailored technology 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 a convenience sample of 200 children age 0-21 years old who present to the Hasbro Children's Hospital Emergency Department by car and have access to a smartphone and/or email. 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 computer program that allows families to interact with a tablet computer to receive educational information customized to the patient. Children 13 years old and above will answer questions themselves instead of having their parent/guardian answer for them. Both group will be offered information for the Lifespan Injury Prevention Center's Kohl's Car Seat Program. Both groups will complete a questionnaire on the usefulness of their discharge education. 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.

Study Type

Interventional

Enrollment (Actual)

295

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Hasbro Children's Hospital Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group

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.

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.
Experimental: Experimental/CIAS Group

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstration of age-appropriate car restraint knowledge
Time Frame: one week after enrollment
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
Time Frame: one week after enrollment
Change in rate of correct response pre-intervention vs. post-intervention compared between control group vs. intervention
one week after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actions taken related to car restraints
Time Frame: one week after enrollment
Rate of parental self-report of actions taken related to changing use of car restraints on post-intervention follow-up survey. This will be a binary variable (NO action taken vs. YES action taken).
one week after enrollment
Rate of difference types of actions taken related to car restraints
Time Frame: one week after enrollment
Rates of each specific type of actions taken will also be compared between control and intervention groups (e.g. percentage of subjects who purchased a new car restraint device in each group, percentage of patients that had car seat installation checked at a fire department in each group, etc).
one week after enrollment
Satisfaction with discharge education - CIAS
Time Frame: during intervention/enrollment
For intervention group only - parent/patient satisfaction with education given on discharge based on score on Technology Posttrial Impressions Questionnaire. We will examine 13 individual components scored on an ordinal scale 1 to 5 (poor, fair, good, very good, excellent). Mean total score will be calculated.
during intervention/enrollment
Parental confidence in type of car restraint
Time Frame: one week after enrollment

Change in parental confidence that child is in the correct type of car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:

How confident are you that your child is in the right type of car restraint?

1- not at all confident 2- 3- 4- 5- very confident

one week after enrollment
Parental confidence in car restraint installation
Time Frame: one week after enrollment

Change in parental confidence that car restraint is correctly installed, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:

How confident are you that your car restraint is installed correctly?

1- not at all confident 2- 3- 4- 5- very confident

one week after enrollment
Parental confidence in buckling the car restraint
Time Frame: one week after enrollment

Change in parental confidence that the child is correctly buckled in the car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:

How confident are you that your child is correctly buckled into the car restraint?

1- not at all confident 2- 3- 4- 5- very confident

one week after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Susan Duffy, MD, MPH, Associate Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

December 24, 2018

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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