Clinical trial NCT03304574: CheckED Yourself Study
Official title: CheckED Yourself: Using Emergency Department Screening to Impact Adolescent Risk Behavior
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Behavior
Risk Behavior
Motivation
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups, a control or intervention group. Those assigned to the control group will complete the electronic health assessment only and will not receive integrated personalized feedback. Those assigned to the intervention group will complete the electronic health assessment and will receive integrated personalized feedback.
Primary purpose: SCREENING

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Motivation to change
timeFrame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
measure: Decreased risk behaviors
timeFrame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
measure: Prevalence of risk behaviors
timeFrame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References: