<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/NCT02244138</url>
  </required_header>
  <id_info>
    <org_study_id>1308038999</org_study_id>
    <secondary_id>R01HS022681</secondary_id>
    <nct_id>NCT02244138</nct_id>
  </id_info>
  <brief_title>Improving Adolescent Health Outcomes Through Preventive Care Transformation</brief_title>
  <acronym>AdolCHICA</acronym>
  <official_title>Improving Adolescent Health Outcomes Through Preventive Care Transformation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preventive care for adolescents is vitally important for maximizing their health and&#xD;
      well-being. Unfortunately, pediatric primary care frequently fails to meet the preventive&#xD;
      needs of adolescents as demonstrated by poor health outcomes for this population.&#xD;
&#xD;
      In this grant application, the investigators propose to expand an existing computer decision&#xD;
      support system (CDSS) into the investigators adolescent primary care practices for the&#xD;
      purpose of implementing a comprehensive, and developmentally appropriate, screening and&#xD;
      physician decision support process. Prior work completed by the investigators research group&#xD;
      has demonstrated the feasibility of using CDSS to implement and evaluate clinical guidelines.&#xD;
      The investigators seek to positively impact the effectiveness of preventative primary care&#xD;
      visits by applying this previous success to the investigators adolescent practice. The&#xD;
      investigators hypothesize that the implementation of developmentally appropriate universal&#xD;
      screening practices, using tablet technology, and enhanced physician decision support&#xD;
      regarding clinically relevant guidelines for all annual adolescent preventive care visits&#xD;
      will result in better health outcomes, including higher rates of adherence to physician&#xD;
      recommendations and improved patient functioning.&#xD;
&#xD;
      The specific research aims of this proposal are:&#xD;
&#xD;
      Aim 1: Expand and modify an existing CDSS to include an Adolescent Preventive Care Module&#xD;
      comprised of developmentally appropriate screening tools for adolescents aged 11 to 21 years&#xD;
      and tailored evidence-based clinical decision support for physicians.&#xD;
&#xD;
      Aim 2: Evaluate the impact of the Adolescent Preventive Care Module on the identification of&#xD;
      specific mental and physical health problems and treatment outcomes in an adolescent primary&#xD;
      health care setting.&#xD;
&#xD;
      Adolescent primary care issues of interest for this project include sexually transmitted&#xD;
      infection (STI), depression, substance use and Human Papillomavirus (HPV) immunization. The&#xD;
      investigators expect this project to improve the health outcomes of adolescents, guide future&#xD;
      efforts to implement universal screening and CDSS in a variety of primary care settings, and&#xD;
      provide additional evidence to support broad-based electronic screening and computerized&#xD;
      decision support for use in preventive care as a method for improving adolescent health.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>sexually transmitted infection</measure>
    <time_frame>12 months</time_frame>
    <description>diagnosis of sexually transmitted infection by physician as indicated in electronic health record for patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>depression</measure>
    <time_frame>12 months</time_frame>
    <description>diagnosis of depression by physician as indicated in electronic health record for patient</description>
  </secondary_outcome>
  <other_outcome>
    <measure>substance use</measure>
    <time_frame>12 months</time_frame>
    <description>diagnosis of substance use by physician as indicated in electronic health record for patient</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2831</enrollment>
  <condition>Sexually Transmitted Diseases</condition>
  <condition>Depression Diagnosis</condition>
  <condition>Substance Use Disorders</condition>
  <arm_group>
    <arm_group_label>Adolescent CDSS</arm_group_label>
    <description>Implementation clinic site for CDDS</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Adolescent CDSS</intervention_name>
    <description>computer decision support system (CDSS) for health care providers of adolescents in primary care</description>
    <arm_group_label>Adolescent CDSS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adolescent from primary care clinics will be studied&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  11-21 years&#xD;
&#xD;
          -  attending primary care clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>matthew c aalsma, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eskenazi Medical Group</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Matthew Aalsma</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Adolescent</keyword>
  <keyword>Screening</keyword>
  <keyword>Primary Care</keyword>
  <keyword>Computer Decision Support Systems</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sexually Transmitted Diseases</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02244138
org study id: 1308038999
secondary id: R01HS022681
nct id: NCT02244138
lead sponsor: 
collaborator: 
has dmc: No
Preventive care for adolescents is vitally important for maximizing their health and
      well-being. Unfortunately, pediatric primary care frequently fails to meet the preventive
      needs of adolescents as demonstrated by poor health outcomes for this population.

      In this grant application, the investigators propose to expand an existing computer decision
      support system (CDSS) into the investigators adolescent primary care practices for the
      purpose of implementing a comprehensive, and developmentally appropriate, screening and
      physician decision support process. Prior work completed by the investigators research group
      has demonstrated the feasibility of using CDSS to implement and evaluate clinical guidelines.
      The investigators seek to positively impact the effectiveness of preventative primary care
      visits by applying this previous success to the investigators adolescent practice. The
      investigators hypothesize that the implementation of developmentally appropriate universal
      screening practices, using tablet technology, and enhanced physician decision support
      regarding clinically relevant guidelines for all annual adolescent preventive care visits
      will result in better health outcomes, including higher rates of adherence to physician
      recommendations and improved patient functioning.

      The specific research aims of this proposal are:

      Aim 1: Expand and modify an existing CDSS to include an Adolescent Preventive Care Module
      comprised of developmentally appropriate screening tools for adolescents aged 11 to 21 years
      and tailored evidence-based clinical decision support for physicians.

      Aim 2: Evaluate the impact of the Adolescent Preventive Care Module on the identification of
      specific mental and physical health problems and treatment outcomes in an adolescent primary
      health care setting.

      Adolescent primary care issues of interest for this project include sexually transmitted
      infection (STI), depression, substance use and Human Papillomavirus (HPV) immunization. The
      investigators expect this project to improve the health outcomes of adolescents, guide future
      efforts to implement universal screening and CDSS in a variety of primary care settings, and
      provide additional evidence to support broad-based electronic screening and computerized
      decision support for use in preventive care as a method for improving adolescent health.
observational model: Case-Control
time perspective: Prospective
measure: sexually transmitted infection
time frame: 12 months
description: diagnosis of sexually transmitted infection by physician as indicated in electronic health record for patient
measure: depression
time frame: 12 months
description: diagnosis of depression by physician as indicated in electronic health record for patient
measure: substance use
time frame: 12 months
description: diagnosis of substance use by physician as indicated in electronic health record for patient
arm group label: Adolescent CDSS
description: Implementation clinic site for CDDS
intervention type: Behavioral
intervention name: Adolescent CDSS
description: computer decision support system (CDSS) for health care providers of adolescents in primary care
arm group label: Adolescent CDSS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 21 Years
healthy volunteers: No
last name: matthew c aalsma, phd
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Matthew Aalsma
investigator title: Associate Professor
mesh term: Sexually Transmitted Diseases
mesh term: Substance-Related Disorders