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Completed

NCT Number: NCT03799393

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

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.

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Key information

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasbro Children's Hospital Emergency Department

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CIAS (Computer Intervention Authoring Software)

Behavioral

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.

Standard Printed Discharge Instructions

Behavioral

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 outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Lifespan

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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