- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03799393
Buckle Me Up!: A Digital Emergency Department Discharge Intervention for Child Car Safety
Buckle Me Up!: A Computerized, Individually-Tailored Emergency Department Discharge Intervention for Child Car Restraint Safety Education
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Hasbro Children's Hospital Emergency Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Study Director: Susan Duffy, MD, MPH, Associate Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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