<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/NCT03246100</url>
  </required_header>
  <id_info>
    <org_study_id>15-0570_2</org_study_id>
    <nct_id>NCT03246100</nct_id>
  </id_info>
  <brief_title>Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates_2nd Trial in Colorado</brief_title>
  <official_title>Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates, 2nd Trial in Colorado</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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>
      This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are&#xD;
      slight changes to methods and a different cohort will be used, thus justifying a 2nd&#xD;
      ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in&#xD;
      Colorado. Each state has it's own ClinicalTrials.gov submission.&#xD;
&#xD;
      Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months,&#xD;
      only about half of children are vaccinated annually leading to substantial influenza disease&#xD;
      in children and spread of disease to adults. A major barrier is that families are not&#xD;
      reminded about the need for their children to receive influenza vaccination. The&#xD;
      investigators will evaluate the impact of patient reminder/recall (R/R) performed by state&#xD;
      immunization information systems to improve influenza vaccination rates by using three&#xD;
      clinical trials in two states. The investigators will assess effectiveness and&#xD;
      cost-effectiveness of: 1) autodialer reminder/recall versus 2) postcard reminder/recall&#xD;
      versus 3) usual care (no R/R) on improving influenza vaccination rates.&#xD;
&#xD;
      The investigators will disseminate the state immunization information system based&#xD;
      reminder/recall system to all states for use for both seasonal and pandemic influenza&#xD;
      vaccinations with the goal of lowering influenza morbidity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Annual epidemics of seasonal influenza cause substantial morbidity and mortality in the U.S.&#xD;
      with high rates of hospitalizations, emergency department and outpatient visits, and medical&#xD;
      costs. Children experience significant morbidity from influenza, and also play a critical&#xD;
      role in spreading infection to adults. Since 2010, the Advisory Committee on Immunization&#xD;
      Practices (ACIP) has recommended influenza vaccination for all children &gt;6 months of age.&#xD;
      However, vaccination rates remain very low-- only 56% of children 2-17 years are vaccinated.&#xD;
      Low rates are a concern for both seasonal influenza and in preparation for pandemic&#xD;
      influenza. One of the nationally recommended strategies for raising childhood influenza&#xD;
      vaccination rates is to use parent reminder/recall (R/R) by phone or mail, which can raise&#xD;
      rates by up to 20 percentage points. However, less than 16% of primary care practices use R/R&#xD;
      despite many studies showing its effectiveness.&#xD;
&#xD;
      Statewide immunization information systems (IISs) now exist in all states to track childhood&#xD;
      vaccinations, but they have not been used for R/R for influenza vaccine because of the lack&#xD;
      of evidence for its effectiveness and lack of a template for IIS-based R/R. The investigators&#xD;
      have united two leading immunization research groups (Denver, CO and Rochester, NY) to assess&#xD;
      the impact of centralized IIS-based influenza vaccine R/R, and to evaluate the effect of two&#xD;
      types of R/R (autodial v. mail R/R) over usual care. The investigators will also develop&#xD;
      tools to aid other states in creating efficient IIS R/R systems for seasonal and possible&#xD;
      pandemic influenza outbreaks.&#xD;
&#xD;
      In Colorado, evaluate the impact of (a) autodialer reminders and (b) mailed messages versus&#xD;
      standard-of-care control on raising influenza vaccination rates among children 6m-17 years of&#xD;
      age.&#xD;
&#xD;
      The investigators propose a 3-arm RCT study design with the following study arms:&#xD;
&#xD;
        1. Standard of care control&#xD;
&#xD;
        2. Autodialer (3 reminders)- with brief education message + practice name + practice phone&#xD;
           #&#xD;
&#xD;
        3. Mailed reminder (3 reminders)-- with brief education message + practice name + practice&#xD;
           phone #&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>Patients will be randomized within practices to one of 3 arms:&#xD;
Standard of care control&#xD;
Autodialer (3 reminders)- with brief education message + practice name + practice phone # (see autodialer scripts)&#xD;
Mailed reminder (3 reminders)-- with brief education message + practice name + practice phone # (see postcards)</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Receipt of at least 1 influenza vaccine according to immunization records in the Immunization Information System (IIS) records in each state</measure>
    <time_frame>6 months</time_frame>
    <description>Based on our prior studies, we currently plan to send up to 3 autodialer or postcards (based on randomization arm) reminders, spaced every 5 weeks, beginning in early October, and ending mid-December 2017. Outcomes are assessed at 6 months using IIS data.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25531</enrollment>
  <condition>Reminder Systems</condition>
  <condition>Influenza Vaccines</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These patients will receive no reminders from the health department and will receive usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Autodialer R/R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autodialer calls (up to 3 reminders)- with brief education message + practice name + practice phone #</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mail R/R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mailed reminder (up to 3 reminders)-- with brief education message + practice name + practice phone #</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reminders</intervention_name>
    <description>Reminders are sent either through autodial or postcards reminding patients to get flu vaccine.</description>
    <arm_group_label>Autodialer R/R</arm_group_label>
    <arm_group_label>Mail R/R</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have record in Colorado Immunization Information System&#xD;
&#xD;
          -  from 6 months through 17 years of age&#xD;
&#xD;
          -  have not received an influenza vaccine by start of trial&#xD;
&#xD;
          -  must be affiliated with one of our 42 randomly selected primary care practices in&#xD;
             Colorado&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those without a record&#xD;
&#xD;
          -  received an influenza vaccine post 9/1/2017&#xD;
&#xD;
          -  not affiliated with an eligible study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allison Kempe, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>June 20, 2019</last_update_submitted>
  <last_update_submitted_qc>June 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>centralized reminder/recall</keyword>
  <keyword>influenza vaccine reminders</keyword>
  <keyword>childhood influenza vaccines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Aggregate results will be prepared for publications at the end of the trial.</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/NCT03246100
org study id: 15-0570_2
nct id: NCT03246100
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are
      slight changes to methods and a different cohort will be used, thus justifying a 2nd
      ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in
      Colorado. Each state has it's own ClinicalTrials.gov submission.

      Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months,
      only about half of children are vaccinated annually leading to substantial influenza disease
      in children and spread of disease to adults. A major barrier is that families are not
      reminded about the need for their children to receive influenza vaccination. The
      investigators will evaluate the impact of patient reminder/recall (R/R) performed by state
      immunization information systems to improve influenza vaccination rates by using three
      clinical trials in two states. The investigators will assess effectiveness and
      cost-effectiveness of: 1) autodialer reminder/recall versus 2) postcard reminder/recall
      versus 3) usual care (no R/R) on improving influenza vaccination rates.

      The investigators will disseminate the state immunization information system based
      reminder/recall system to all states for use for both seasonal and pandemic influenza
      vaccinations with the goal of lowering influenza morbidity.
Annual epidemics of seasonal influenza cause substantial morbidity and mortality in the U.S.
      with high rates of hospitalizations, emergency department and outpatient visits, and medical
      costs. Children experience significant morbidity from influenza, and also play a critical
      role in spreading infection to adults. Since 2010, the Advisory Committee on Immunization
      Practices (ACIP) has recommended influenza vaccination for all children >6 months of age.
      However, vaccination rates remain very low-- only 56% of children 2-17 years are vaccinated.
      Low rates are a concern for both seasonal influenza and in preparation for pandemic
      influenza. One of the nationally recommended strategies for raising childhood influenza
      vaccination rates is to use parent reminder/recall (R/R) by phone or mail, which can raise
      rates by up to 20 percentage points. However, less than 16% of primary care practices use R/R
      despite many studies showing its effectiveness.

      Statewide immunization information systems (IISs) now exist in all states to track childhood
      vaccinations, but they have not been used for R/R for influenza vaccine because of the lack
      of evidence for its effectiveness and lack of a template for IIS-based R/R. The investigators
      have united two leading immunization research groups (Denver, CO and Rochester, NY) to assess
      the impact of centralized IIS-based influenza vaccine R/R, and to evaluate the effect of two
      types of R/R (autodial v. mail R/R) over usual care. The investigators will also develop
      tools to aid other states in creating efficient IIS R/R systems for seasonal and possible
      pandemic influenza outbreaks.

      In Colorado, evaluate the impact of (a) autodialer reminders and (b) mailed messages versus
      standard-of-care control on raising influenza vaccination rates among children 6m-17 years of
      age.

      The investigators propose a 3-arm RCT study design with the following study arms:

        1. Standard of care control

        2. Autodialer (3 reminders)- with brief education message + practice name + practice phone
           #

        3. Mailed reminder (3 reminders)-- with brief education message + practice name + practice
           phone #
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized within practices to one of 3 arms:
Standard of care control
Autodialer (3 reminders)- with brief education message + practice name + practice phone # (see autodialer scripts)
Mailed reminder (3 reminders)-- with brief education message + practice name + practice phone # (see postcards)
primary purpose: Health Services Research
masking: Single (Participant)
measure: Receipt of at least 1 influenza vaccine according to immunization records in the Immunization Information System (IIS) records in each state
time frame: 6 months
description: Based on our prior studies, we currently plan to send up to 3 autodialer or postcards (based on randomization arm) reminders, spaced every 5 weeks, beginning in early October, and ending mid-December 2017. Outcomes are assessed at 6 months using IIS data.
arm group label: Control
arm group type: No Intervention
description: These patients will receive no reminders from the health department and will receive usual care.
arm group label: Autodialer R/R
arm group type: Experimental
description: Autodialer calls (up to 3 reminders)- with brief education message + practice name + practice phone #
arm group label: Mail R/R
arm group type: Experimental
description: Mailed reminder (up to 3 reminders)-- with brief education message + practice name + practice phone #
intervention type: Behavioral
intervention name: Reminders
description: Reminders are sent either through autodial or postcards reminding patients to get flu vaccine.
arm group label: Autodialer R/R
arm group label: Mail R/R
criteria: 
gender: All
minimum age: 6 Months
maximum age: 17 Years
healthy volunteers: No
last name: Allison Kempe, MD, MPH
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No
ipd description: Aggregate results will be prepared for publications at the end of the trial.