Safety IssuesNCT03799393
Buckle Me Up!: A Digital Emergency Department Discharge Intervention for Child Car Safety
A study testing CIAS (Computer Intervention Authoring Software) and Standard Printed Discharge Instructions in people with Safety Issues and Injuries, run by Lifespan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Injuries, Car Accident
- What is being tested?
- CIAS (Computer Intervention Authoring Software) and Standard Printed Discharge Instructions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hasbro Children's Hospital Emergency Department
Providence, Rhode Island, 02903
About this study
Official title: Buckle Me Up!: A Computerized, Individually-Tailored Emergency Department Discharge Intervention for Child Car Restraint Safety Education
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.
Read the 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
- Being tested
- CIAS (Computer Intervention Authoring Software), Standard Printed Discharge Instructions
- Keywords
- injury prevention, car safety, car seats, booster seats, car restraints
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIAS (Computer Intervention Authoring Software)Behavioural
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 InstructionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Behavioral: Standard Printed Discharge Instructions |
| Experimental/CIAS Group | Experimental | 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. Receives: Behavioral: CIAS (Computer Intervention Authoring Software) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week after enrollment
Change in car restraint knowledge
Change in rate of correct response pre-intervention vs. post-intervention compared between control group vs. intervention
Measured: one week after enrollment
Secondary outcomes (6)
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).
Measured: one week after enrollment
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).
Measured: one week after enrollment
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.
Measured: during intervention/enrollment
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
Measured: one week after enrollment
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
Measured: one week after enrollment
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
Measured: one week after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Aug 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Almaz Dessie, Lifespan
- Investigators
- Susan Duffy, MD, MPH, Study director, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799393
- Sponsor's protocol ID
- 2012-17
- Status last verified
- Dec 2021
- First submitted
- 24 Dec 2018
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38302281
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buckle Me Up!: A Computerized, Individually-Tailored Emergency Department Discharge Intervention for Child Car Restraint Safety Education
- ClinicalTrials.gov ID
- NCT03799393
- Acronym / sponsor ID
- 2012-17
- Conditions
- Safety Issues, Injuries, Car Accident
- Keywords
- injury prevention, car safety, car seats, booster seats, car restraints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Standard Printed Discharge InstructionsThe 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. |
| Experimental/CIAS Group | Experimental | Behavioral: CIAS (Computer Intervention Authoring Software)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. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Experimental/CIAS Group |
| Standard Printed Discharge InstructionsPatients/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. | Behavioural | Control Group |
Primary outcome
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.
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
6 secondary outcomes
Actions taken related to car restraints
Time frame: one week after enrollment
Rate of difference types of actions taken related to car restraints
Time frame: one week after enrollment
Satisfaction with discharge education - CIAS
Time frame: during intervention/enrollment
Parental confidence in type of car restraint
Time frame: one week after enrollment
Parental confidence in car restraint installation
Time frame: one week after enrollment
Parental confidence in buckling the car restraint
Time frame: one week after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Derived from this study: PubMed 38302281Zhang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Duffy, MD, MPH study director
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIAS (Computer Intervention Authoring Software) and Standard Printed Discharge Instructions in people with Safety Issues and Injuries, run by Lifespan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of age-appropriate car restraint knowledge (time frame: one week after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03799393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.