<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/NCT01732315</url>
  </required_header>
  <id_info>
    <org_study_id>12-0378</org_study_id>
    <nct_id>NCT01732315</nct_id>
  </id_info>
  <brief_title>Adolescent Vaccination Reminder Study</brief_title>
  <official_title>Adolescent Vaccination Reminders Using Email</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol describes a study about vaccination uptake among adolescents. The purpose of&#xD;
      the study is to determine whether parents who receive email reminders will be more likely to&#xD;
      obtain Tdap (tetanus-diphtheria-acellular pertussis), HPV (human papilloma virus),&#xD;
      meningococcal, and influenza vaccines for their adolescent children than parents who do not&#xD;
      receive email reminders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescents are a reservoir population for a variety of vaccine preventable diseases (VPDs).&#xD;
      Despite this, adolescent vaccination rates lag substantially behind national goals of 80%&#xD;
      coverage for adolescent vaccines set forth by Healthy People 2020. This has been particularly&#xD;
      the case for the vaccines most recently recommended for adolescents, such as the HPV (human&#xD;
      papilloma virus) and seasonal influenza (flu) vaccines; national coverage levels in 2010 for&#xD;
      HPV were 32% (for series completion among females only) and 35% for flu vaccine. Uptake&#xD;
      levels for the two other adolescent-targeted vaccines, Tdap and meningococcal conjugate&#xD;
      (MCV4) vaccines are currently at 69% and 63%, respectively.&#xD;
&#xD;
      A major barrier to increased adolescent vaccination levels is the lack of parental and&#xD;
      provider recognition that an adolescent is due for vaccine doses. For providers, there are&#xD;
      the dual challenges of getting adolescents to come in for annual preventive care visits and&#xD;
      also minimizing &quot;missed opportunities&quot; for vaccination (i.e. clinical interactions with a&#xD;
      patient where a needed vaccine could have been provided but was not). Reminder/recall systems&#xD;
      are one mechanism to help address both of these challenges for providers while also informing&#xD;
      parents about the need for adolescent vaccines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>New immunization doses</measure>
    <time_frame>New immunizations within 60 days of reminder notification</time_frame>
    <description>To examine the effect of email vaccination reminders, new immunization doses of children of parents who receive email vaccination reminders, versus those who do not receive email reminders during the study period will be determined. New doses are those for any of four adolescent vaccines which are administered following the reminder notification, and are subsequently recorded following reminder notifications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Waived immunization doses</measure>
    <time_frame>Waived immunizations within 60 days of reminder notification</time_frame>
    <description>To examine the effect of email vaccination reminders, waived immunization doses of children of parents who receive email vaccination reminders, versus those who do not receive email reminders during the study period will be determined. Waived doses are those for any of four adolescent vaccines for which medical, religious, or philosophical waivers are subsequently recorded following reminder notifications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Historical immunization doses</measure>
    <time_frame>Historical immunizations within 60 days of reminder notification</time_frame>
    <description>To examine the effect of email vaccination reminders, historical immunization doses of children of parents who receive email vaccination reminders, versus those who do not receive email reminders during the study period will be determined. Historical doses are those for any of four adolescent vaccines which are administered prior to the reminder notification and are subsequently recorded following reminder notifications.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3783</enrollment>
  <condition>Adolescent Vaccination Status</condition>
  <arm_group>
    <arm_group_label>Vaccination Email Reminder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of parents in the study will receive email notifications about due/overdue vaccines for their adolescents. Vaccination records will be reviewed to identify adolescent patients in both practices who are newly eligible for a vaccine and/or overdue for a vaccine at the start of every other month. Email notifications will then be sent to the parents of these children.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group of parents in the study will not receive email notifications about due/overdue vaccines for their adolescents.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Email Notification</intervention_name>
    <description>This study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization.</description>
    <arm_group_label>Vaccination Email Reminder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents of adolescents (Ages 11-18) have children who attend one of 4 participating&#xD;
             pediatric practices,&#xD;
&#xD;
          -  Parents are able to read and converse in English,&#xD;
&#xD;
          -  Parents have an active email address that is associated with their child's medical&#xD;
             record,&#xD;
&#xD;
          -  Parents have an adolescent whose medical record can be matched with their MCIR record.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent age &lt;18 years,&#xD;
&#xD;
          -  Parents have an invalid or non-working parent email address,&#xD;
&#xD;
          -  Parents have opted out of email communication,&#xD;
&#xD;
          -  Prisoners,&#xD;
&#xD;
          -  Decisionally challenged participants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Dombkowski, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amanda Dempsey, MD, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>August 13, 2015</last_update_submitted>
  <last_update_submitted_qc>August 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent vaccination</keyword>
  <keyword>Immunization rates</keyword>
  <keyword>Barriers to vaccination</keyword>
  <keyword>Attitudes</keyword>
  <keyword>Intentions</keyword>
  <!-- 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/NCT01732315
org study id: 12-0378
nct id: NCT01732315
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This protocol describes a study about vaccination uptake among adolescents. The purpose of
      the study is to determine whether parents who receive email reminders will be more likely to
      obtain Tdap (tetanus-diphtheria-acellular pertussis), HPV (human papilloma virus),
      meningococcal, and influenza vaccines for their adolescent children than parents who do not
      receive email reminders.
Adolescents are a reservoir population for a variety of vaccine preventable diseases (VPDs).
      Despite this, adolescent vaccination rates lag substantially behind national goals of 80%
      coverage for adolescent vaccines set forth by Healthy People 2020. This has been particularly
      the case for the vaccines most recently recommended for adolescents, such as the HPV (human
      papilloma virus) and seasonal influenza (flu) vaccines; national coverage levels in 2010 for
      HPV were 32% (for series completion among females only) and 35% for flu vaccine. Uptake
      levels for the two other adolescent-targeted vaccines, Tdap and meningococcal conjugate
      (MCV4) vaccines are currently at 69% and 63%, respectively.

      A major barrier to increased adolescent vaccination levels is the lack of parental and
      provider recognition that an adolescent is due for vaccine doses. For providers, there are
      the dual challenges of getting adolescents to come in for annual preventive care visits and
      also minimizing "missed opportunities" for vaccination (i.e. clinical interactions with a
      patient where a needed vaccine could have been provided but was not). Reminder/recall systems
      are one mechanism to help address both of these challenges for providers while also informing
      parents about the need for adolescent vaccines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: New immunization doses
time frame: New immunizations within 60 days of reminder notification
description: To examine the effect of email vaccination reminders, new immunization doses of children of parents who receive email vaccination reminders, versus those who do not receive email reminders during the study period will be determined. New doses are those for any of four adolescent vaccines which are administered following the reminder notification, and are subsequently recorded following reminder notifications.
measure: Waived immunization doses
time frame: Waived immunizations within 60 days of reminder notification
description: To examine the effect of email vaccination reminders, waived immunization doses of children of parents who receive email vaccination reminders, versus those who do not receive email reminders during the study period will be determined. Waived doses are those for any of four adolescent vaccines for which medical, religious, or philosophical waivers are subsequently recorded following reminder notifications.
measure: Historical immunization doses
time frame: Historical immunizations within 60 days of reminder notification
description: To examine the effect of email vaccination reminders, historical immunization doses of children of parents who receive email vaccination reminders, versus those who do not receive email reminders during the study period will be determined. Historical doses are those for any of four adolescent vaccines which are administered prior to the reminder notification and are subsequently recorded following reminder notifications.
arm group label: Vaccination Email Reminder
arm group type: Experimental
description: This group of parents in the study will receive email notifications about due/overdue vaccines for their adolescents. Vaccination records will be reviewed to identify adolescent patients in both practices who are newly eligible for a vaccine and/or overdue for a vaccine at the start of every other month. Email notifications will then be sent to the parents of these children.
arm group label: Usual Care
arm group type: No Intervention
description: This group of parents in the study will not receive email notifications about due/overdue vaccines for their adolescents.
intervention type: Behavioral
intervention name: Email Notification
description: This study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization.
arm group label: Vaccination Email Reminder
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kevin Dombkowski, DrPH
role: Principal Investigator
affiliation: University of Michigan
last name: Amanda Dempsey, MD, PhD, MPH
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor