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CheckED Yourself Study

4 september 2018 uppdaterad av: 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).

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

300

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna, 98105
        • Rekrytering
        • Seattle Children's Hospital
        • Kontakt:
        • Huvudutredare:
          • Taraneh Shafii, MD, MPH
        • Underutredare:
          • Eileen Klein, MD, MPH
        • Underutredare:
          • Siobhan Thomas-Smith, MD
        • Underutredare:
          • Stephanie Richling, MD
        • Underutredare:
          • Laura Richardson, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

13 år till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Undersökning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Control
Participants will complete the electronic health assessment only and will not receive integrated personalized feedback
Experimentell: Intervention
Participants will complete the electronic health assessment and will receive integrated personalized feedback
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Motivation to change
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Seattle Children's Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 mars 2017

Primärt slutförande (Förväntat)

1 oktober 2018

Avslutad studie (Förväntat)

30 november 2018

Studieregistreringsdatum

Först inskickad

3 oktober 2017

Först inskickad som uppfyllde QC-kriterierna

3 oktober 2017

Första postat (Faktisk)

9 oktober 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 september 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 september 2018

Senast verifierad

1 september 2018

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 00000365

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

N/A IPD will not be shared

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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