<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/NCT01667354</url>
  </required_header>
  <id_info>
    <org_study_id>250147</org_study_id>
    <nct_id>NCT01667354</nct_id>
  </id_info>
  <brief_title>Vaccine Hesitancy Intervention--Provider (VHIP)</brief_title>
  <acronym>VHIP</acronym>
  <official_title>Vaccine Hesitancy Intervention--Provider (VHIP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington State, Department of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>WithinReach</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kaiser Permanente</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this trial is to test the effectiveness of an intervention to train&#xD;
      primary care physicians to determine if it leads to decreased parental vaccine hesitancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this trial is to test the effectiveness of an intervention to train&#xD;
      primary care physicians to determine if it leads to decreased parental vaccine hesitancy. The&#xD;
      investigators will train primary care teams with an initial training followed by telephone&#xD;
      coaching and follow-up visits, and assess the outcomes of parental vaccine hesitancy&#xD;
      (primary) and physician self-efficacy (secondary) at baseline and 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parental Vaccine Hesitancy Measure</measure>
    <time_frame>Change from Baseline in Parental Hesitancy at 6 months</time_frame>
    <description>The investigators will contact mothers of newborns in study practices and conduct a telephone survey at two time points: baseline and 6 months. Surveys will assess parental hesitancy, parental trust in provider, and other covariates such as perceived social norms, other sources of information about vaccines, and demographic information.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physician Self Efficacy Measure</measure>
    <time_frame>Change from Baseline in Physician Attitudes at 6 months</time_frame>
    <description>Assessed via self-administered surveys of providers in all participating clinics at baseline and 6-months. The investigators will measure physician attitudes, perceived norms, intentions to change behavior, practice characteristics, and physician demographics.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">491</enrollment>
  <condition>Childhood Vaccination</condition>
  <arm_group>
    <arm_group_label>Intervention Clinics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers in intervention clinics will receive a training followed by telephone coaching and follow-up visits for six months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Clinics</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control clinics will receive all intervention materials at the completion of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Academic Detailing</intervention_name>
    <description>The intervention design is based on &quot;academic detailing,&quot; an effective method of changing physician behavior. The aim of the training is effective communication with parents who are hesitant about childhood vaccinations.</description>
    <arm_group_label>Intervention Clinics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Study population:&#xD;
&#xD;
          -  Eligible pediatric and family medicine practices in three counties in Washington&#xD;
             State; King, Pierce and Snohomish Counties.&#xD;
&#xD;
          -  Mothers whose infants will receive care in participating clinics.&#xD;
&#xD;
        Inclusion Clinics:&#xD;
&#xD;
          -  Located in King, Snohomish, Pierce Counties, WA;&#xD;
&#xD;
          -  Family practice clinics;&#xD;
&#xD;
          -  Pediatric practice clinics;&#xD;
&#xD;
          -  Order &gt; 1000 doses of vaccine in 2009 from State of Washington Department of Health.&#xD;
&#xD;
        Exclusion Clinics: Not willing to be randomized.&#xD;
&#xD;
        Inclusion Mothers:&#xD;
&#xD;
          -  Babies born at participating hospitals;&#xD;
&#xD;
          -  Mother can be recruited before discharged post-birth;&#xD;
&#xD;
          -  Mothers declare pediatric care at one of participating clinics;&#xD;
&#xD;
          -  Singleton or twin pregnancies.&#xD;
&#xD;
        Exclusion Mothers:&#xD;
&#xD;
          -  Babies born &lt; 36 weeks gestational age;&#xD;
&#xD;
          -  Known medical vaccine contraindications;&#xD;
&#xD;
          -  Parental age &lt; 18;&#xD;
&#xD;
          -  NICU;&#xD;
&#xD;
          -  Triplet or more;&#xD;
&#xD;
          -  Maternal complications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Grossman, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Group Health Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>March 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parental Childhood Vaccine Hesitancy</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/NCT01667354
org study id: 250147
nct id: NCT01667354
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The primary aim of this trial is to test the effectiveness of an intervention to train
      primary care physicians to determine if it leads to decreased parental vaccine hesitancy.
The primary aim of this trial is to test the effectiveness of an intervention to train
      primary care physicians to determine if it leads to decreased parental vaccine hesitancy. The
      investigators will train primary care teams with an initial training followed by telephone
      coaching and follow-up visits, and assess the outcomes of parental vaccine hesitancy
      (primary) and physician self-efficacy (secondary) at baseline and 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Parental Vaccine Hesitancy Measure
time frame: Change from Baseline in Parental Hesitancy at 6 months
description: The investigators will contact mothers of newborns in study practices and conduct a telephone survey at two time points: baseline and 6 months. Surveys will assess parental hesitancy, parental trust in provider, and other covariates such as perceived social norms, other sources of information about vaccines, and demographic information.
measure: Physician Self Efficacy Measure
time frame: Change from Baseline in Physician Attitudes at 6 months
description: Assessed via self-administered surveys of providers in all participating clinics at baseline and 6-months. The investigators will measure physician attitudes, perceived norms, intentions to change behavior, practice characteristics, and physician demographics.
arm group label: Intervention Clinics
arm group type: Experimental
description: Providers in intervention clinics will receive a training followed by telephone coaching and follow-up visits for six months.
arm group label: Control Clinics
arm group type: No Intervention
description: Control clinics will receive all intervention materials at the completion of the study.
intervention type: Behavioral
intervention name: Academic Detailing
description: The intervention design is based on "academic detailing," an effective method of changing physician behavior. The aim of the training is effective communication with parents who are hesitant about childhood vaccinations.
arm group label: Intervention Clinics
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Grossman, MD, MPH
role: Principal Investigator
affiliation: Kaiser Permanente
facility: 
country: United States
responsible party type: Sponsor