<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/NCT03294473</url>
  </required_header>
  <id_info>
    <org_study_id>17-001153</org_study_id>
    <secondary_id>1R01AI114903</secondary_id>
    <secondary_id>17-001153</secondary_id>
    <nct_id>NCT03294473</nct_id>
  </id_info>
  <brief_title>Centralized Reminder Recall - Flu RCT2</brief_title>
  <official_title>Centralized IIS-Based Reminder Recall to Increase Influenza Vaccination Rates in New York State - Second Trial in New York State</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>New York State Department of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</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 related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some&#xD;
      modifications in relation to the intervention arms as well as the use of a different cohort,&#xD;
      thereby justifying the second submission to Clinicaltrials.gov. This trial is taking place in&#xD;
      New York State, through partnership with the New York State Health Department (excluding New&#xD;
      York City), and Colorado. Each state will have it's own Clinicaltrial.gov submission -- this&#xD;
      was decided as some of the intervention components are different enough that separate&#xD;
      registrations were warranted.&#xD;
&#xD;
      Despite U.S. guidelines for influenza vaccination of all children starting at 6 months, only&#xD;
      about half of children are vaccinated annually leading to substantial influenza disease in&#xD;
      children and spread of disease to adults. A major barrier is that families are not reminded&#xD;
      about the need for their children to receive influenza vaccination. The investigators will&#xD;
      evaluate the impact of patient reminder/recall (R/R) performed by state immunization&#xD;
      information systems to improve influenza vaccination rates by using 4 clinical trials (2 per&#xD;
      state) in two different states. The investigators will assess effectiveness and&#xD;
      cost-effectiveness of 1) autodialer R/R 2) text messages R/R 3) mailed postcard R/R as&#xD;
      compared to 4) standard of care control (no R/R).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Annual epidemics of influenza A and B cause substantial morbidity and mortality in the US&#xD;
      with high rates of hospitalizations, emergency department visits, outpatient visits, and&#xD;
      medical costs. Epidemics cause up to 40,000 deaths/year (mostly elderly) and extensive&#xD;
      morbidity among children who play a key role in instigating and expanding epidemics. In&#xD;
      addition, concerns about pandemic influenza heighten the importance of new mechanisms to&#xD;
      rapidly inform the population about influenza and direct efforts for rapid vaccine delivery.&#xD;
&#xD;
      Since 2010, the Advisory Committee on Immunization Practices (ACIP) has recommended influenza&#xD;
      vaccination for all children &gt;6 months of age. However, vaccination rates remain very low.&#xD;
      For the 2012-2013 season, only 56% of children 2-17years were vaccinated. Modeling studies&#xD;
      suggest that as many as 19 million cases of influenza could be prevented if child vaccination&#xD;
      rates were raised to 70% nationally.&#xD;
&#xD;
      The most effective strategy recommended by CDC and the Task Force on Community Preventive&#xD;
      Services for improving childhood influenza vaccination rates is reminder/recall (R/R), sent&#xD;
      by phone or mail, notifying parents of the need to vaccinate their child. We and others have&#xD;
      shown that R/R can improve influenza vaccination rates by up to 20%. However, &lt;16% of&#xD;
      practices use R/R; barriers are practice costs, insufficient staff time and expertise, and&#xD;
      lack of predictability regarding receipt of vaccine supplies.&#xD;
&#xD;
      Statewide immunization information systems (IISs) now exist in all states to track childhood&#xD;
      vaccinations, but they have not been used for influenza vaccine R/R because of lack of&#xD;
      evidence for their effectiveness and a lack of a template for IIS-based R/R. The&#xD;
      investigators have united two leading immunization research groups (Denver, CO and Rochester&#xD;
      (lead by personnel at UCLA), NY) to assess the impact of centralized IIS-based influenza&#xD;
      vaccine R/R and to evaluate the effect of three types of R/R (autodialer, text message and&#xD;
      mail R/R) over usual care. The investigators will also develop tools to aid other states in&#xD;
      creating efficient IIS R/R systems for seasonal and possible pandemic influenza outbreaks.&#xD;
&#xD;
      For this second R/R trial in New York State, the intent is to evaluate the impact of reminder&#xD;
      recalls, in the form of 1) autodialers 2) text messages and 3) postcards versus the standard&#xD;
      of care control group, specifically in relation to raising influenza vaccination rates among&#xD;
      children 6m-17 years of age.&#xD;
&#xD;
      The proposed design of this 4-arm RCT:&#xD;
&#xD;
        1. standard of care control&#xD;
&#xD;
        2. autodialer R/R -- with brief educational messages, practice name and practice phone&#xD;
           number&#xD;
&#xD;
        3. text message R/R-- with brief educational messages, practice name and practice phone&#xD;
           number&#xD;
&#xD;
        4. mailed (postcards) R/R-- with brief educational messages, practice name and practice&#xD;
           phone number&#xD;
&#xD;
      Hypothesis 1: All IIS-C R/R modalities will be more effective than usual care&#xD;
&#xD;
      Hypothesis 2: Text messaging will be more cost-effective than other modalities&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2017</start_date>
  <completion_date type="Actual">May 4, 2018</completion_date>
  <primary_completion_date type="Actual">April 19, 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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome is receipt of influenza vaccine comparing effectiveness of standard of care control to autodialer, text message and postcard R/R</measure>
    <time_frame>6 months</time_frame>
    <description>Based on our prior studies, we plan to send up to 3 autodialer, text messages or postcards (based on randomization) reminders, roughly every 5-6 weeks. This will begin in October 2017 and end in December 2017. Outcomes are assessed at 6 months using IIS data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost of the R/R intervention</measure>
    <time_frame>6 months</time_frame>
    <description>A cost-effectiveness analysis will be conducted to determine which modality of R/R (autodialer, text message or mailed postcard) is the most cost-effective in relation to improving influenza vaccination rates. The cost analysis will also compare autodialer to text, autodialer to postcard, and texting to postcards.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">70190</enrollment>
  <condition>Influenza, Human</condition>
  <condition>Orthomyxoviridae Infections</condition>
  <condition>RNA Virus Infections</condition>
  <condition>Virus Disease</condition>
  <condition>Respiratory Tract Infections</condition>
  <condition>Respiratory Tract Disease</condition>
  <condition>Vaccines</condition>
  <condition>Physiological Effects of Drugs</condition>
  <arm_group>
    <arm_group_label>Autodial R/R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>R/R Autodialers:Participants in this group will receive up to 3 influenza vaccination reminders via telephone call - with a brief educational message + practice name + practice phone number</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Text Message R/R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>R/R Texting: Participants in this group will receive up to 3 influenza vaccination reminders via text message - with a brief educational message + practice name + practice phone number</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Postcard R/R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>R/R Mailed Postcard:Participants in this group will receive up to 3 influenza vaccination reminders via postcard - with a brief educational message + practice name + practice phone number</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will not receive any influenza vaccination reminders</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>R/R - Autodialers</intervention_name>
    <description>Investigators will send out flu vaccine reminder recall notices via autodialer message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).</description>
    <arm_group_label>Autodial R/R</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>R/R - Texting</intervention_name>
    <description>Investigators will send out flu vaccine reminder recall notices via text message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).</description>
    <arm_group_label>Text Message R/R</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>R/R - mailed postcard</intervention_name>
    <description>Investigators will send out flu vaccine reminder recall notices via mailed postcards to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).</description>
    <arm_group_label>Postcard R/R</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a record in the New York State Immunization Information System&#xD;
&#xD;
          -  in need of at least one influenza vaccination at the time of the beginning of the&#xD;
             study&#xD;
&#xD;
          -  affiliated with a participating practice (145 randomly selected)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no record within the New York State Immunization Information System&#xD;
&#xD;
          -  up to date on their influenza vaccination&#xD;
&#xD;
          -  not affiliated with an eligible practice&#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>Peter Szilagyi, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</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>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>June 4, 2019</last_update_submitted>
  <last_update_submitted_qc>June 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Peter G Szilagyi, MD MPH</investigator_full_name>
    <investigator_title>Executive Vice Chair, Clinical Research, UCLA David Geffen School of Medicine, Dept of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>reminder recall (R/R), influenza vaccines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>RNA Virus Infections</mesh_term>
    <mesh_term>Orthomyxoviridae Infections</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Aggregate results will be prepared for publication 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/NCT03294473
org study id: 17-001153
secondary id: 1R01AI114903
secondary id: 17-001153
nct id: NCT03294473
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some
      modifications in relation to the intervention arms as well as the use of a different cohort,
      thereby justifying the second submission to Clinicaltrials.gov. This trial is taking place in
      New York State, through partnership with the New York State Health Department (excluding New
      York City), and Colorado. Each state will have it's own Clinicaltrial.gov submission -- this
      was decided as some of the intervention components are different enough that separate
      registrations were warranted.

      Despite U.S. guidelines for influenza vaccination of all children starting at 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 4 clinical trials (2 per
      state) in two different states. The investigators will assess effectiveness and
      cost-effectiveness of 1) autodialer R/R 2) text messages R/R 3) mailed postcard R/R as
      compared to 4) standard of care control (no R/R).
Annual epidemics of influenza A and B cause substantial morbidity and mortality in the US
      with high rates of hospitalizations, emergency department visits, outpatient visits, and
      medical costs. Epidemics cause up to 40,000 deaths/year (mostly elderly) and extensive
      morbidity among children who play a key role in instigating and expanding epidemics. In
      addition, concerns about pandemic influenza heighten the importance of new mechanisms to
      rapidly inform the population about influenza and direct efforts for rapid vaccine delivery.

      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.
      For the 2012-2013 season, only 56% of children 2-17years were vaccinated. Modeling studies
      suggest that as many as 19 million cases of influenza could be prevented if child vaccination
      rates were raised to 70% nationally.

      The most effective strategy recommended by CDC and the Task Force on Community Preventive
      Services for improving childhood influenza vaccination rates is reminder/recall (R/R), sent
      by phone or mail, notifying parents of the need to vaccinate their child. We and others have
      shown that R/R can improve influenza vaccination rates by up to 20%. However, <16% of
      practices use R/R; barriers are practice costs, insufficient staff time and expertise, and
      lack of predictability regarding receipt of vaccine supplies.

      Statewide immunization information systems (IISs) now exist in all states to track childhood
      vaccinations, but they have not been used for influenza vaccine R/R because of lack of
      evidence for their effectiveness and a lack of a template for IIS-based R/R. The
      investigators have united two leading immunization research groups (Denver, CO and Rochester
      (lead by personnel at UCLA), NY) to assess the impact of centralized IIS-based influenza
      vaccine R/R and to evaluate the effect of three types of R/R (autodialer, text message and
      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.

      For this second R/R trial in New York State, the intent is to evaluate the impact of reminder
      recalls, in the form of 1) autodialers 2) text messages and 3) postcards versus the standard
      of care control group, specifically in relation to raising influenza vaccination rates among
      children 6m-17 years of age.

      The proposed design of this 4-arm RCT:

        1. standard of care control

        2. autodialer R/R -- with brief educational messages, practice name and practice phone
           number

        3. text message R/R-- with brief educational messages, practice name and practice phone
           number

        4. mailed (postcards) R/R-- with brief educational messages, practice name and practice
           phone number

      Hypothesis 1: All IIS-C R/R modalities will be more effective than usual care

      Hypothesis 2: Text messaging will be more cost-effective than other modalities
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: The primary outcome is receipt of influenza vaccine comparing effectiveness of standard of care control to autodialer, text message and postcard R/R
time frame: 6 months
description: Based on our prior studies, we plan to send up to 3 autodialer, text messages or postcards (based on randomization) reminders, roughly every 5-6 weeks. This will begin in October 2017 and end in December 2017. Outcomes are assessed at 6 months using IIS data.
measure: Cost of the R/R intervention
time frame: 6 months
description: A cost-effectiveness analysis will be conducted to determine which modality of R/R (autodialer, text message or mailed postcard) is the most cost-effective in relation to improving influenza vaccination rates. The cost analysis will also compare autodialer to text, autodialer to postcard, and texting to postcards.
arm group label: Autodial R/R
arm group type: Experimental
description: R/R Autodialers:Participants in this group will receive up to 3 influenza vaccination reminders via telephone call - with a brief educational message + practice name + practice phone number
arm group label: Text Message R/R
arm group type: Experimental
description: R/R Texting: Participants in this group will receive up to 3 influenza vaccination reminders via text message - with a brief educational message + practice name + practice phone number
arm group label: Postcard R/R
arm group type: Experimental
description: R/R Mailed Postcard:Participants in this group will receive up to 3 influenza vaccination reminders via postcard - with a brief educational message + practice name + practice phone number
arm group label: Standard of Care Control
arm group type: No Intervention
description: Participants in this group will not receive any influenza vaccination reminders
intervention type: Behavioral
intervention name: R/R - Autodialers
description: Investigators will send out flu vaccine reminder recall notices via autodialer message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
arm group label: Autodial R/R
intervention type: Behavioral
intervention name: R/R - Texting
description: Investigators will send out flu vaccine reminder recall notices via text message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
arm group label: Text Message R/R
intervention type: Behavioral
intervention name: R/R - mailed postcard
description: Investigators will send out flu vaccine reminder recall notices via mailed postcards to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
arm group label: Postcard R/R
criteria: 
gender: All
minimum age: 6 Months
maximum age: 17 Years
healthy volunteers: No
last name: Peter Szilagyi, MD, MPH
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Peter G Szilagyi, MD MPH
investigator title: Executive Vice Chair, Clinical Research, UCLA David Geffen School of Medicine, Dept of Pediatrics
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Virus Diseases
mesh term: Influenza, Human
mesh term: Respiratory Tract Infections
mesh term: RNA Virus Infections
mesh term: Orthomyxoviridae Infections
mesh term: Respiratory Tract Diseases
sharing ipd: No
ipd description: Aggregate results will be prepared for publication at the end of the trial.