<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/NCT03287830</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR4101</org_study_id>
    <secondary_id>R01HD086045-01A1</secondary_id>
    <nct_id>NCT03287830</nct_id>
  </id_info>
  <brief_title>Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine</brief_title>
  <acronym>F2T</acronym>
  <official_title>Flu2Text: A Multi-Site Study Assessing Text Message Reminders for 2nd Dose of Influenza Vaccine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Academy of Pediatrics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</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 multi-site study assesses the impact of text message reminders on the receipt of the&#xD;
      second dose of influenza vaccine, and takes place primarily in practices from the American&#xD;
      Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is to be conducted over the 1st season (September 2017-April 2018) as an&#xD;
      effectiveness trial and the 2nd (September 2018-April 2019) as a replication study. This&#xD;
      approach tests that the intervention effects can be replicated across seasons, during which&#xD;
      the severity and incidence of influenza disease may vary. Eligible parents will have a child&#xD;
      who received his/her first vaccine dose and is in need of 2 doses that season. Current&#xD;
      recommendations require 2 doses for certain children 6 months through 8 years old. Within&#xD;
      each practice site, parents will be randomized to receive either: 1) text message reminders&#xD;
      embedded with influenza vaccine health-literacy promoting information, or 2) usual care.&#xD;
      Randomization is to be stratified by practice site, age (6-23 months, 2-8 years) and language&#xD;
      (Spanish, English).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The care provider, primary statistician and analyst will be blinded to participant status.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year</measure>
    <time_frame>Up to receipt of second dose, an average of 6 months</time_frame>
    <description>Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination</measure>
    <time_frame>Up to 42 days after first dose</time_frame>
    <description>Receipt of second dose influenza vaccine by 42 days after first dose</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2105</enrollment>
  <condition>Influenza</condition>
  <condition>Vaccination</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Text message influenza vaccine reminders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Season 2017-18: Usual care has no text message&#xD;
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text message influenza vaccine reminders</intervention_name>
    <description>Text message reminders for second dose of influenza vaccination</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parenting adult (or legal guardian) of a child that:&#xD;
&#xD;
               -  is between 6 months through 8 years at the time of enrollment (or the age for&#xD;
                  which 2 doses of influenza are recommended should Centers for Disease Control and&#xD;
                  Prevention (CDC) recommendations change)&#xD;
&#xD;
               -  received 1st dose of influenza vaccine within last 7 days&#xD;
&#xD;
               -  receives care at study site&#xD;
&#xD;
               -  needs 2 doses of influenza vaccine that season as determined by their clinician&#xD;
                  at the study site&#xD;
&#xD;
               -  plan to continue to receive care through April 30 of that season (to the best of&#xD;
                  their knowledge) (season 2017-18 only)&#xD;
&#xD;
          -  Ability to speak and read English or Spanish&#xD;
&#xD;
          -  Has a cell phone that has text message capability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parenting adult of a child that:&#xD;
&#xD;
               -  already enrolled in the study in this or the previous season&#xD;
&#xD;
               -  will leave practice before end of season (April 30) (to their best knowledge)&#xD;
                  (2017-18 season only)&#xD;
&#xD;
          -  Was told by a health care provider that child should not get the flu shot again due to&#xD;
             an allergic reaction or anaphylaxis (2017-18 season only)&#xD;
&#xD;
          -  Unable to speak and read English or speak and read Spanish&#xD;
&#xD;
          -  Unable to receive or read text messages on their cell phone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa Stockwell, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alex Fiks, MD, MSCE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American Academy of Pediatrics</name>
      <address>
        <city>Itasca</city>
        <state>Illinois</state>
        <zip>60143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <results_first_submitted>November 28, 2022</results_first_submitted>
  <results_first_submitted_qc>March 12, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 14, 2023</results_first_posted>
  <last_update_submitted>September 3, 2023</last_update_submitted>
  <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Melissa Stockwell</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics and Population and Family Health</investigator_title>
  </responsible_party>
  <keyword>text message</keyword>
  <keyword>Short message service (SMS)</keyword>
  <keyword>mHealth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03287830/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Text message influenza vaccine reminders&#xD;
Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Season 2017-18: Usual care has no text message&#xD;
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1050"/>
                <participants group_id="P2" count="1055"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1044"/>
                <participants group_id="P2" count="1042"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>not meeting inclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Text message influenza vaccine reminders&#xD;
Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Season 2017-18: Usual care has no text message&#xD;
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1044"/>
            <count group_id="B2" value="1042"/>
            <count group_id="B3" value="2086"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>age 6-23 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1044"/>
                    <count group_id="B2" value="1042"/>
                    <count group_id="B3" value="2086"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="966"/>
                    <measurement group_id="B2" value="965"/>
                    <measurement group_id="B3" value="1931"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-8 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1044"/>
                    <count group_id="B2" value="1042"/>
                    <count group_id="B3" value="2086"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1044"/>
                    <count group_id="B2" value="1042"/>
                    <count group_id="B3" value="2086"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="521"/>
                    <measurement group_id="B2" value="492"/>
                    <measurement group_id="B3" value="1013"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="523"/>
                    <measurement group_id="B2" value="550"/>
                    <measurement group_id="B3" value="1073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preferred Language for Texting</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>English</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1044"/>
                    <count group_id="B2" value="1042"/>
                    <count group_id="B3" value="2086"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="966"/>
                    <measurement group_id="B2" value="964"/>
                    <measurement group_id="B3" value="1930"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spanish</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1044"/>
                    <count group_id="B2" value="1042"/>
                    <count group_id="B3" value="2086"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year</title>
        <description>Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year</description>
        <time_frame>Up to receipt of second dose, an average of 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Text message influenza vaccine reminders&#xD;
Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Season 2017-18: Usual care has no text message&#xD;
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year</title>
          <description>Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1044"/>
                <count group_id="O2" value="1042"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="875"/>
                    <measurement group_id="O2" value="843"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination</title>
        <description>Receipt of second dose influenza vaccine by 42 days after first dose</description>
        <time_frame>Up to 42 days after first dose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Text message influenza vaccine reminders&#xD;
Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Season 2017-18: Usual care has no text message&#xD;
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination</title>
          <description>Receipt of second dose influenza vaccine by 42 days after first dose</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1044"/>
                <count group_id="O2" value="1042"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="651"/>
                    <measurement group_id="O2" value="580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Text message influenza vaccine reminders&#xD;
Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Season 2017-18: Usual care has no text message&#xD;
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1044"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1042"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1044"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1042"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1044"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1042"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Melissa Stockwell</name_or_title>
      <organization>Columbia University</organization>
      <phone>2123425732</phone>
      <email>mss2112@cumc.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03287830
org study id: AAAR4101
secondary id: R01HD086045-01A1
nct id: NCT03287830
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This multi-site study assesses the impact of text message reminders on the receipt of the
      second dose of influenza vaccine, and takes place primarily in practices from the American
      Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.
The study is to be conducted over the 1st season (September 2017-April 2018) as an
      effectiveness trial and the 2nd (September 2018-April 2019) as a replication study. This
      approach tests that the intervention effects can be replicated across seasons, during which
      the severity and incidence of influenza disease may vary. Eligible parents will have a child
      who received his/her first vaccine dose and is in need of 2 doses that season. Current
      recommendations require 2 doses for certain children 6 months through 8 years old. Within
      each practice site, parents will be randomized to receive either: 1) text message reminders
      embedded with influenza vaccine health-literacy promoting information, or 2) usual care.
      Randomization is to be stratified by practice site, age (6-23 months, 2-8 years) and language
      (Spanish, English).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: The care provider, primary statistician and analyst will be blinded to participant status.
measure: Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year
time frame: Up to receipt of second dose, an average of 6 months
description: Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year
measure: Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination
time frame: Up to 42 days after first dose
description: Receipt of second dose influenza vaccine by 42 days after first dose
arm group label: Intervention
arm group type: Experimental
description: Text message influenza vaccine reminders
arm group label: Usual care
arm group type: No Intervention
description: Season 2017-18: Usual care has no text message
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.
intervention type: Behavioral
intervention name: Text message influenza vaccine reminders
description: Text message reminders for second dose of influenza vaccination
arm group label: Intervention
criteria: 
gender: All
minimum age: 6 Months
maximum age: 8 Years
healthy volunteers: No
last name: Melissa Stockwell, MD, MPH
role: Principal Investigator
affiliation: Columbia University
last name: Alex Fiks, MD, MSCE
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Melissa Stockwell
investigator title: Associate Professor of Pediatrics and Population and Family Health
mesh term: Influenza, Human
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 