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CheckED Yourself Study

2018年9月4日 更新者:Taraneh Shafii、Seattle Children's Hospital

CheckED Yourself: Using Emergency Department Screening to Impact Adolescent Risk Behavior

During adolescence, the most common causes of morbidity and mortality are related to risky behaviors. The American Academy of Pediatrics recommends that adolescents be screened for these behaviors during primary care visits, but many adolescents do not receive the recommended risk behavior screening and counseling, in part because they are infrequently seen in primary care. The objective of this study is to evaluate if the electronic health screening tool, which includes an electronic health assessment with integrated personalized feedback, reduces risk behaviors in adolescents seen in the Emergency Department (ED).

研究概览

详细说明

Adolescents and their parents (if participant is under the age of 18 years) will be approached and invited to participate in the study during their Emergency Department (ED) visit. Following consent, adolescents will be randomized to the intervention or control group. A tablet computer will be provided to the participants for use during their baseline assessment in the ED. The CheckED Yourself App will be pre-loaded on the tablet. The CheckED Yourself App (eHA-IPF) is an innovative electronic health screening tool with integrated personalized feedback about risk behaviors. The CheckED Yourself App (eHA-IPF) will be divided into an assessment about risk behaviors and a personalized feedback portion. Participants will be randomized to a control or intervention group at the time of consent. Those in the intervention group will receive both parts of the CheckED Yourself App, while the control group will receive only the assessment with no feedback.

Those in the Intervention arm will complete the health risk behavior assessment and receive integrated personalized feedback from the CheckED Yourself App (eHA-IPF), and those in the control group will complete the health risk behavior assessment only. Participants will complete the questionnaire at some point during their ED visit and prior to discharge.

Follow-up assessments will be completed at 1-day and 3 months post ED visit via an online survey. Reminders for the 1-day and 3-month follow-ups will be sent via email or text message. The 1-day assessment will focus on adolescent-reported motivation to make a health behavior change, the content of the ED visit including what, if any, risk behaviors their ED provider discussed with the participant, and satisfaction with care in the ED. The 3-month assessment will include a re-assessment of risk behaviors.

研究类型

介入性

注册 (预期的)

300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Washington
      • Seattle、Washington、美国、98105
        • 招聘中
        • Seattle Children's Hospital
        • 接触:
        • 首席研究员:
          • Taraneh Shafii, MD, MPH
        • 副研究员:
          • Eileen Klein, MD, MPH
        • 副研究员:
          • Siobhan Thomas-Smith, MD
        • 副研究员:
          • Stephanie Richling, MD
        • 副研究员:
          • Laura Richardson, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

13年 至 18年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 13-18 years of age
  • Ability of patient and parent of patient <18 years old to fluently speak and read English
  • Has email address and/or cell phone

Exclusion Criteria:

  • Inability to independently complete the assessment due to intellectual disability
  • Acute cognitive impairment due to injury and/or intoxication
  • Administration of IV sedation or pain medications during Emergency Department visit
  • Presenting to the Emergency Department due to a psychiatric or mental health complaint
  • Emergency Department visit results in hospital admission

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:放映
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:Control
Participants will complete the electronic health assessment only and will not receive integrated personalized feedback
实验性的:Intervention
Participants will complete the electronic health assessment and will receive integrated personalized feedback
Integrated personalized feedback about self-reported risk behaviors will be generated and shown to participants as they complete their baseline health risk assessment using the CheckED Yourself app. The integrated personalized feedback is based on motivational feedback strategies such as normative feedback (comparison to peer behaviors and age-based health guidelines), increasing knowledge regarding potential consequences of behaviors, and providing practical tips for changing behavior.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Motivation to change
大体时间:We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
To evaluate if adolescents who received integrated personalized feedback had higher levels of motivation to change their risk behaviors post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback
We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
Decreased risk behaviors
大体时间:We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
To evaluate if adolescents who received integrated personalized feedback reported decreased risk behaviors 3 months post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback.
We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
Prevalence of risk behaviors
大体时间:We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
To describe the prevalence of risk behaviors among adolescents who present to the Emergency Department for care.
We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年3月1日

初级完成 (预期的)

2018年10月1日

研究完成 (预期的)

2018年11月30日

研究注册日期

首次提交

2017年10月3日

首先提交符合 QC 标准的

2017年10月3日

首次发布 (实际的)

2017年10月9日

研究记录更新

最后更新发布 (实际的)

2018年9月6日

上次提交的符合 QC 标准的更新

2018年9月4日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 00000365

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

N/A IPD will not be shared

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Integrated personalized feedback的临床试验

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