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

NCT ID: NCT03799393

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-02-28

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.

Conditions

Safety Issues; Injuries; Car Accident

Keywords

injury prevention; car safety; car seats; booster seats; car restraints

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard Printed Discharge Instructions

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

CIAS (Computer Intervention Authoring Software)

Intervention Type: 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.

Interventions

CIAS (Computer Intervention Authoring Software)

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

Standard Printed Discharge Instructions

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.

Intervention Type: BEHAVIORAL

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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lifespan

OTHER

Sponsor Role: lead

Responsible Party

Almaz Dessie

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Duffy, MD, MPH

Role: STUDY_DIRECTOR

Associate Professor

Locations

Hasbro Children's Hospital Emergency Department

Providence, Rhode Island, United States

Countries

United States

References

Zhang AY, Leviter J, Baird J, Charles-Chauvet D, Frackiewicz LM, Duffy S, Dessie A. Buckle me up! A randomised controlled trial using a tablet-based emergency department intervention for child car safety education. Inj Prev. 2024 Jul 19;30(4):334-340. doi: 10.1136/ip-2023-044998.

Reference Type: DERIVED

PMID: 38302281 (View on PubMed)

Other Identifiers

2012-17

Identifier Type: -

Identifier Source: org_study_id