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临床试验/NCT03799393
NCT03799393已完成不适用

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

Lifespan1 个研究点 分布在 1 个国家目标入组 295 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Lifespan
入组人数
295
试验地点
1
主要终点
Change in car restraint knowledge

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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).

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Standard Printed Discharge Instructions (Behavioral)

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.

干预措施: CIAS (Computer Intervention Authoring Software) (Behavioral)

结局指标

主要结局

Change in car restraint knowledge

时间窗: one week after enrollment

Change in rate of correct response pre-intervention vs. post-intervention compared between control group vs. intervention

Demonstration of age-appropriate car restraint knowledge

时间窗: 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.

次要结局

  • Actions taken related to car restraints(one week after enrollment)
  • Parental confidence in car restraint installation(one week after enrollment)
  • Parental confidence in buckling the car restraint(one week after enrollment)
  • Satisfaction with discharge education - CIAS(during intervention/enrollment)
  • Parental confidence in type of car restraint(one week after enrollment)
  • Rate of difference types of actions taken related to car restraints(one week after enrollment)

研究者

发起方
Lifespan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Almaz Dessie

Principal Investigator

Lifespan

研究点 (1)

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