<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03304574</url>
  </required_header>
  <id_info>
    <org_study_id>00000365</org_study_id>
    <nct_id>NCT03304574</nct_id>
  </id_info>
  <brief_title>CheckED Yourself Study</brief_title>
  <official_title>CheckED Yourself: Using Emergency Department Screening to Impact Adolescent Risk Behavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seattle Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      During adolescence, the most common causes of morbidity and mortality are related to risky&#xD;
      behaviors. The American Academy of Pediatrics recommends that adolescents be screened for&#xD;
      these behaviors during primary care visits, but many adolescents do not receive the&#xD;
      recommended risk behavior screening and counseling, in part because they are infrequently&#xD;
      seen in primary care. The objective of this study is to evaluate if the electronic health&#xD;
      screening tool, which includes an electronic health assessment with integrated personalized&#xD;
      feedback, reduces risk behaviors in adolescents seen in the Emergency Department (ED).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescents and their parents (if participant is under the age of 18 years) will be&#xD;
      approached and invited to participate in the study during their Emergency Department (ED)&#xD;
      visit. Following consent, adolescents will be randomized to the intervention or control&#xD;
      group. A tablet computer will be provided to the participants for use during their baseline&#xD;
      assessment in the ED. The CheckED Yourself App will be pre-loaded on the tablet. The CheckED&#xD;
      Yourself App (eHA-IPF) is an innovative electronic health screening tool with integrated&#xD;
      personalized feedback about risk behaviors. The CheckED Yourself App (eHA-IPF) will be&#xD;
      divided into an assessment about risk behaviors and a personalized feedback portion.&#xD;
      Participants will be randomized to a control or intervention group at the time of consent.&#xD;
      Those in the intervention group will receive both parts of the CheckED Yourself App, while&#xD;
      the control group will receive only the assessment with no feedback.&#xD;
&#xD;
      Those in the Intervention arm will complete the health risk behavior assessment and receive&#xD;
      integrated personalized feedback from the CheckED Yourself App (eHA-IPF), and those in the&#xD;
      control group will complete the health risk behavior assessment only. Participants will&#xD;
      complete the questionnaire at some point during their ED visit and prior to discharge.&#xD;
&#xD;
      Follow-up assessments will be completed at 1-day and 3 months post ED visit via an online&#xD;
      survey. Reminders for the 1-day and 3-month follow-ups will be sent via email or text&#xD;
      message. The 1-day assessment will focus on adolescent-reported motivation to make a health&#xD;
      behavior change, the content of the ED visit including what, if any, risk behaviors their ED&#xD;
      provider discussed with the participant, and satisfaction with care in the ED. The 3-month&#xD;
      assessment will include a re-assessment of risk behaviors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">November 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will be blinded to their group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Motivation to change</measure>
    <time_frame>We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decreased risk behaviors</measure>
    <time_frame>We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of risk behaviors</measure>
    <time_frame>We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.</time_frame>
    <description>To describe the prevalence of risk behaviors among adolescents who present to the Emergency Department for care.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Adolescent Behavior</condition>
  <condition>Risk Behavior</condition>
  <condition>Motivation</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will complete the electronic health assessment only and will not receive integrated personalized feedback</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete the electronic health assessment and will receive integrated personalized feedback</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated personalized feedback</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  13-18 years of age&#xD;
&#xD;
          -  Ability of patient and parent of patient &lt;18 years old to fluently speak and read&#xD;
             English&#xD;
&#xD;
          -  Has email address and/or cell phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to independently complete the assessment due to intellectual disability&#xD;
&#xD;
          -  Acute cognitive impairment due to injury and/or intoxication&#xD;
&#xD;
          -  Administration of IV sedation or pain medications during Emergency Department visit&#xD;
&#xD;
          -  Presenting to the Emergency Department due to a psychiatric or mental health complaint&#xD;
&#xD;
          -  Emergency Department visit results in hospital admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Taraneh Shafii, MD, MPH</last_name>
    <phone>206-987-2028</phone>
    <email>taraneh.shafii@seattlechildrens.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eileen Klein, MD, MPH</last_name>
    <phone>206-987-2708</phone>
    <email>eileen.klein@seattlechildrens.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsey Johnson</last_name>
      <phone>206-884-1075</phone>
      <email>lindsey.johnson@seattlechildrens.org</email>
    </contact>
    <investigator>
      <last_name>Taraneh Shafii, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eileen Klein, MD, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Siobhan Thomas-Smith, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stephanie Richling, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laura Richardson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Taraneh Shafii</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>N/A IPD will not be shared</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03304574
org study id: 00000365
nct id: NCT03304574
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: Single (Participant)
masking description: Participants will be blinded to their group assignment.
measure: Motivation to change
time frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
description: 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
measure: Decreased risk behaviors
time frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
description: 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.
measure: Prevalence of risk behaviors
time frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
description: To describe the prevalence of risk behaviors among adolescents who present to the Emergency Department for care.
arm group label: Control
arm group type: No Intervention
description: Participants will complete the electronic health assessment only and will not receive integrated personalized feedback
arm group label: Intervention
arm group type: Experimental
description: Participants will complete the electronic health assessment and will receive integrated personalized feedback
intervention type: Behavioral
intervention name: Integrated personalized feedback
description: 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.
arm group label: Intervention
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Taraneh Shafii, MD, MPH
phone: 206-987-2028
email: taraneh.shafii@seattlechildrens.org
last name: Eileen Klein, MD, MPH
phone: 206-987-2708
email: eileen.klein@seattlechildrens.org
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Taraneh Shafii
investigator title: Associate Professor
sharing ipd: No
ipd description: N/A IPD will not be shared