Clinical trial NCT03799393: 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
Overall status: COMPLETED
Phase: NA
Conditions: Safety Issues
Injuries
Car Accident
Keywords: injury prevention
car safety
car seats
booster seats
car restraints
Lead sponsor: Lifespan
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 295
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Demonstration of age-appropriate car restraint knowledge
timeFrame: one week after enrollment
measure: Change in car restraint knowledge
timeFrame: one week after enrollment
Secondary outcomes:
measure: Actions taken related to car restraints
timeFrame: one week after enrollment
measure: Rate of difference types of actions taken related to car restraints
timeFrame: one week after enrollment
measure: Satisfaction with discharge education - CIAS
timeFrame: during intervention/enrollment
measure: Parental confidence in type of car restraint
timeFrame: one week after enrollment
measure: Parental confidence in car restraint installation
timeFrame: one week after enrollment
measure: Parental confidence in buckling the car restraint
timeFrame: one week after enrollment
Other outcomes:
Locations:
city: Providence
country: United States
facility: Hasbro Children's Hospital Emergency Department
state: Rhode Island
Study officials:
affiliation: Associate Professor
name: Susan Duffy, MD, MPH
role: STUDY_DIRECTOR
References: