CheckED Yourself Study

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).

Study Overview

• Status: Unknown
• Conditions: Risk Behavior; Motivation; Adolescent Behavior
• Intervention / Treatment: Behavioral: Integrated personalized feedback

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taraneh Shafii, MD, MPH; Phone Number: 206-987-2028; Email: taraneh.shafii@seattlechildrens.org
• Study Contact Backup: Name: Eileen Klein, MD, MPH; Phone Number: 206-987-2708; Email: eileen.klein@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Contact: Lindsey Johnson; Phone Number: 206-884-1075; Email: lindsey.johnson@seattlechildrens.org
      • Principal Investigator: Taraneh Shafii, MD, MPH
      • Sub-Investigator: Eileen Klein, MD, MPH
      • Sub-Investigator: Siobhan Thomas-Smith, MD
      • Sub-Investigator: Stephanie Richling, MD
      • Sub-Investigator: Laura Richardson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will complete the electronic health assessment only and will not receive integrated personalized feedback
Experimental: Intervention; Participants will complete the electronic health assessment and will receive integrated personalized feedback	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation to change	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	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	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.

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): November 30, 2018

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 00000365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: N/A IPD will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No