<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/NCT02243774</url>
  </required_header>
  <id_info>
    <org_study_id>2014-P-001821</org_study_id>
    <nct_id>NCT02243774</nct_id>
  </id_info>
  <brief_title>Mail Outreach To Increase Vaccination Acceptance Through Engagement</brief_title>
  <acronym>MOTIVATE</acronym>
  <official_title>Mail Outreach To Increase Vaccination Acceptance Through Engagement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Health and Human Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centers for Medicare and Medicaid Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Social and Behavioral Sciences Team</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <brief_summary>
    <textblock>
      The aim of this study is to determine whether receiving a core letter signed by the Surgeon&#xD;
      General or the Director of the National Vaccine Program that provides only information about&#xD;
      influenza, or a core letter signed by the Surgeon General with an added basic or enhanced&#xD;
      implementation prompt, will increase rates of influenza vaccination among Medicare&#xD;
      beneficiaries when compared to a control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of study participants who receive influenza vaccination</measure>
    <time_frame>4 months</time_frame>
    <description>Primary outcome of interest, determined from administrative claims data, will be the number of beneficiaries in each experimental group who receive an influenza vaccination between the date letter is mailed in September 2014 and January 31, 2015</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">228000</enrollment>
  <condition>Influenza, Human</condition>
  <condition>Influenza</condition>
  <condition>Human Flu</condition>
  <arm_group>
    <arm_group_label>No letter</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals randomized to the control group who will not receive any of the four letters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Core letter signed by Surgeon General</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals randomized to receive only a core letter signed by the Surgeon General</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Core letter signed by Director of the National Vaccine Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals randomized to receive only a core letter signed by the Director of the National Vaccine Program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Core letter signed by Surgeon General + implementation prompt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals randomized to receive a core letter signed by the Surgeon General with an implementation intention prompt added in an appended P.S. tag region below the signature line</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Core letter signed by SG + enhanced implementation prompt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals randomized to receive a core letter signed by the Surgeon General (SG) with an enhanced implementation intention prompt added in an appended P.S. tag region below the signature line</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Core letter signed by Surgeon General</intervention_name>
    <description>The core letter provides information about influenza and the risks associated with it, incorporating a number of behavioral insights. All four letters evaluated in this study will contain the same tops and bodies that are included in the core letter, but the signature and P.S. tag region will differ among the various intervention groups. In this intervention, the core letter is signed by and includes a picture of the Surgeon General. The letter ends after the signature line and the space beneath the signature line is left blank where a P.S. tag region could be appended.</description>
    <arm_group_label>Core letter signed by Surgeon General</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Core letter signed by the Director of the National Vaccine Program</intervention_name>
    <description>The core letter is signed by and includes a picture of the Director of the National Vaccine Program. The letter ends after the signature line and the space beneath the signature line is left blank where a P.S. tag region could be appended.</description>
    <arm_group_label>Core letter signed by Director of the National Vaccine Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Core letter signed by Surgeon General + implementation prompt</intervention_name>
    <description>The core letter is signed by and includes a picture of the Surgeon General. Below the signature line of the core letter, an implementation intention prompt is provided in the P.S. tag region that invites the recipient to write in the day of week, month, day, and time at which he or she plans to get vaccinated.</description>
    <arm_group_label>Core letter signed by Surgeon General + implementation prompt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Core letter signed by SG + enhanced implementation prompt</intervention_name>
    <description>The core letter is signed by and includes a picture of the Surgeon General (SG). Below the signature line of the core letter, an enhanced implementation intention prompt is provided in the P.S. tag region that prompts recipients to &quot;decide now&quot; - by checking one of two boxes - indicating they will or will not get vaccinated. The options use language that highlights the losses incumbent in refusing to vaccinate. In addition, an implementation intention prompt is embedded into the checkbox for indicating a choice to be vaccinated.</description>
    <arm_group_label>Core letter signed by SG + enhanced implementation prompt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Medicare fee-for-service beneficiaries aged 66 and older are eligible for study inclusion.&#xD;
        There will be no additional exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>66 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Niteesh K Choudhry, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital/Harvard Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centers for Medicare &amp; Medicaid Services</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 16, 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>July 9, 2017</last_update_submitted>
  <last_update_submitted_qc>July 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Niteesh K. Choudhry, MD, PhD</investigator_full_name>
    <investigator_title>Associate Professor, Harvard Medical School</investigator_title>
  </responsible_party>
  <keyword>Vaccination</keyword>
  <keyword>Immunization</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <keyword>Prevention &amp; Control</keyword>
  <keyword>Preventive Measures</keyword>
  <keyword>Health Promotion</keyword>
  <keyword>Medicare</keyword>
  <keyword>Intention Prompts</keyword>
  <keyword>Letters</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</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/NCT02243774
org study id: 2014-P-001821
nct id: NCT02243774
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
The aim of this study is to determine whether receiving a core letter signed by the Surgeon
      General or the Director of the National Vaccine Program that provides only information about
      influenza, or a core letter signed by the Surgeon General with an added basic or enhanced
      implementation prompt, will increase rates of influenza vaccination among Medicare
      beneficiaries when compared to a control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of study participants who receive influenza vaccination
time frame: 4 months
description: Primary outcome of interest, determined from administrative claims data, will be the number of beneficiaries in each experimental group who receive an influenza vaccination between the date letter is mailed in September 2014 and January 31, 2015
arm group label: No letter
arm group type: No Intervention
description: Individuals randomized to the control group who will not receive any of the four letters
arm group label: Core letter signed by Surgeon General
arm group type: Experimental
description: Individuals randomized to receive only a core letter signed by the Surgeon General
arm group label: Core letter signed by Director of the National Vaccine Program
arm group type: Experimental
description: Individuals randomized to receive only a core letter signed by the Director of the National Vaccine Program
arm group label: Core letter signed by Surgeon General + implementation prompt
arm group type: Experimental
description: Individuals randomized to receive a core letter signed by the Surgeon General with an implementation intention prompt added in an appended P.S. tag region below the signature line
arm group label: Core letter signed by SG + enhanced implementation prompt
arm group type: Experimental
description: Individuals randomized to receive a core letter signed by the Surgeon General (SG) with an enhanced implementation intention prompt added in an appended P.S. tag region below the signature line
intervention type: Behavioral
intervention name: Core letter signed by Surgeon General
description: The core letter provides information about influenza and the risks associated with it, incorporating a number of behavioral insights. All four letters evaluated in this study will contain the same tops and bodies that are included in the core letter, but the signature and P.S. tag region will differ among the various intervention groups. In this intervention, the core letter is signed by and includes a picture of the Surgeon General. The letter ends after the signature line and the space beneath the signature line is left blank where a P.S. tag region could be appended.
arm group label: Core letter signed by Surgeon General
intervention type: Behavioral
intervention name: Core letter signed by the Director of the National Vaccine Program
description: The core letter is signed by and includes a picture of the Director of the National Vaccine Program. The letter ends after the signature line and the space beneath the signature line is left blank where a P.S. tag region could be appended.
arm group label: Core letter signed by Director of the National Vaccine Program
intervention type: Behavioral
intervention name: Core letter signed by Surgeon General + implementation prompt
description: The core letter is signed by and includes a picture of the Surgeon General. Below the signature line of the core letter, an implementation intention prompt is provided in the P.S. tag region that invites the recipient to write in the day of week, month, day, and time at which he or she plans to get vaccinated.
arm group label: Core letter signed by Surgeon General + implementation prompt
intervention type: Behavioral
intervention name: Core letter signed by SG + enhanced implementation prompt
description: The core letter is signed by and includes a picture of the Surgeon General (SG). Below the signature line of the core letter, an enhanced implementation intention prompt is provided in the P.S. tag region that prompts recipients to "decide now" - by checking one of two boxes - indicating they will or will not get vaccinated. The options use language that highlights the losses incumbent in refusing to vaccinate. In addition, an implementation intention prompt is embedded into the checkbox for indicating a choice to be vaccinated.
arm group label: Core letter signed by SG + enhanced implementation prompt
criteria: 
gender: All
minimum age: 66 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Niteesh K Choudhry, MD, PhD
role: Principal Investigator
affiliation: Brigham and Women's Hospital/Harvard Medical School
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Niteesh K. Choudhry, MD, PhD
investigator title: Associate Professor, Harvard Medical School
mesh term: Influenza, Human