search
Back to results

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

Primary Purpose

Safety Issues, Injuries, Car Accident

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CIAS (Computer Intervention Authoring Software)
Standard Printed Discharge Instructions
Sponsored by
Lifespan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Safety Issues focused on measuring injury prevention, car safety, car seats, booster seats, car restraints

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hasbro Children's Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental/CIAS Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Actions taken related to car restraints
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).
Rate of difference types of actions taken related to car restraints
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).
Satisfaction with discharge education - CIAS
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.
Parental confidence in type of car restraint
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
Parental confidence in car restraint installation
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
Parental confidence in buckling the car restraint
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

Full Information

First Posted
December 24, 2018
Last Updated
December 7, 2021
Sponsor
Lifespan
search

1. Study Identification

Unique Protocol Identification Number
NCT03799393
Brief Title
Buckle Me Up!: A Digital Emergency Department Discharge Intervention for Child Car Safety
Official Title
Buckle Me Up!: A Computerized, Individually-Tailored Emergency Department Discharge Intervention for Child Car Restraint Safety Education
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lifespan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues, Injuries, Car Accident
Keywords
injury prevention, car safety, car seats, booster seats, car restraints

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
295 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental/CIAS Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CIAS (Computer Intervention Authoring Software)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Printed Discharge Instructions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Demonstration of age-appropriate car restraint knowledge
Description
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.
Time Frame
one week after enrollment
Title
Change in car restraint knowledge
Description
Change in rate of correct response pre-intervention vs. post-intervention compared between control group vs. intervention
Time Frame
one week after enrollment
Secondary Outcome Measure Information:
Title
Actions taken related to car restraints
Description
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).
Time Frame
one week after enrollment
Title
Rate of difference types of actions taken related to car restraints
Description
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).
Time Frame
one week after enrollment
Title
Satisfaction with discharge education - CIAS
Description
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.
Time Frame
during intervention/enrollment
Title
Parental confidence in type of car restraint
Description
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
Time Frame
one week after enrollment
Title
Parental confidence in car restraint installation
Description
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
Time Frame
one week after enrollment
Title
Parental confidence in buckling the car restraint
Description
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
Time Frame
one week after enrollment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Duffy, MD, MPH
Organizational Affiliation
Associate Professor
Official's Role
Study Director
Facility Information:
Facility Name
Hasbro Children's Hospital Emergency Department
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs