<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/NCT04444518</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00005115</org_study_id>
    <nct_id>NCT04444518</nct_id>
  </id_info>
  <brief_title>Increasing Influenza and Tdap Vaccination of Pregnant Women</brief_title>
  <official_title>The VAX-MOM Study: Increasing Influenza and Tdap Vaccination of Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</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>
      Pregnant women who get influenza are more likely than non-pregnant women to have serious&#xD;
      complications, including hospitalizations, death, preterm labor and premature birth.&#xD;
      Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap&#xD;
      vaccination rates for pregnant women are low nationally. In this study, the investigators&#xD;
      will perform a randomized controlled trial aimed at practice change in obstetricians'&#xD;
      offices, with an overall goal of reducing morbidity and mortality from influenza and&#xD;
      pertussis infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infants under 6 months of age at increased risk of both influenza (flu) and pertussis&#xD;
      disease, and pregnant women risk serious illness and premature labor from flu. The Advisory&#xD;
      Committee on Immunization Practices recommends that women receive a flu vaccine in flu&#xD;
      season, and tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine&#xD;
      during each pregnancy (ideally between 27-36 weeks) to lower the risk for flu and pertussis&#xD;
      disease for themselves and their infants. However, only half of pregnant women in the US&#xD;
      receive a flu and Tdap vaccine, respectively; only 33% of women receive both vaccines. Lack&#xD;
      of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy),&#xD;
      provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of&#xD;
      standing orders and patient reminders) factors. An effective intervention is needed to&#xD;
      improve flu and Tdap vaccination rates for pregnant women. To address these low vaccination&#xD;
      rates the investigators plan to use a clustered RCT (randomizing practices), allocating half&#xD;
      of the participating practice sites within each health system to the VAX-MOM intervention and&#xD;
      the other half to standard of care. The multi-component VAX-MOM intervention will be&#xD;
      comprised of: training in communication, provider prompts, standing orders, and feedback on&#xD;
      vaccination rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 11, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>Change in the rate of influenza vaccination</measure>
    <time_frame>6 months during the 2019-2020 flu season (baseline), compared to 6 months during the 2021-2022 flu season (intervention)</time_frame>
    <description>Average rate of vaccination over 6 months during baseline will be compared with average rate of vaccination over 6 months during intervention, for vaccine eligible patients at participating OB/GYN practice sites. Vaccination status will be obtained from patient electronic health records.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the rate of Tdap vaccination</measure>
    <time_frame>12 month baseline compared to 12 month intervention</time_frame>
    <description>Average rate of vaccination over 12 months during baseline will be compared with average rate of vaccination over 12 months during intervention, for vaccine eligible patients at participating OB/GYN practice sites. Vaccination status will be obtained from patient electronic health records.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients seen in the practices</measure>
    <time_frame>12 months during intervention period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of providers/nurses/staff completing training modules</measure>
    <time_frame>12 months during intervention period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flu and Tdap vaccination rates by insurance group (public vs private)</measure>
    <time_frame>12 months during intervention period</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9903</enrollment>
  <condition>Immunization; Infection</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>VAX-MOM Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VAX-MOM Intervention</intervention_name>
    <description>The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.</description>
    <arm_group_label>VAX-MOM Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard vaccine education and processes provided to patients by obstetric practices.</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients&#xD;
&#xD;
          -  Sex is female&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  identified as being eligible for influenza or Tdap vaccine&#xD;
&#xD;
        Providers&#xD;
&#xD;
          -  any provider, nurse or staff associated with the participating sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients&#xD;
&#xD;
          -  none&#xD;
&#xD;
        Providers&#xD;
&#xD;
          -  none&#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>
  <location>
    <facility>
      <name>El Monte Comprehensive Health Center</name>
      <address>
        <city>El Monte</city>
        <state>California</state>
        <zip>91731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>High Desert Regional Health Center</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93535</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hubert Humphrey Comprehensive Health Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hudson Comprehensive Health Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles County USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MLK Outpatient Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90059</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronald Reagan OB</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Faculty Practice. OBGYN at West Medical</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Monica Faculty Practice</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA OBGYN Nurse-Midwives Clinic</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olive View</name>
      <address>
        <city>Sylmar</city>
        <state>California</state>
        <zip>91342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbor UCLA</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Bay (Torrance)</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Clarita OBGYN</name>
      <address>
        <city>Valencia</city>
        <state>California</state>
        <zip>91355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Lake/Thousand Oaks</name>
      <address>
        <city>Westlake Village</city>
        <state>California</state>
        <zip>91361</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity OBGYN at Brockport</name>
      <address>
        <city>Brockport</city>
        <state>New York</state>
        <zip>14420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clifton Springs Hospital &amp; Clinic</name>
      <address>
        <city>Clifton Springs</city>
        <state>New York</state>
        <zip>14432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finger Lakes Medical Associates OBGYN-Geneva</name>
      <address>
        <city>Geneva</city>
        <state>New York</state>
        <zip>14456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RRH OBGYN at Henrietta</name>
      <address>
        <city>Henrietta</city>
        <state>New York</state>
        <zip>14467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Women's Center at Newark</name>
      <address>
        <city>Newark</city>
        <state>New York</state>
        <zip>14513</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finger Lakes Medical Associates OBGYN-Penn Yan</name>
      <address>
        <city>Penn Yan</city>
        <state>New York</state>
        <zip>14527</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Women's Center at Clinton</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Women's Center at Alexander Park</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community OB</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highland Women's Health</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity OBGYN at West Main</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity OBGYN at Parkway</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity OBGYN at Clinton Crossings</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University OB/GYN</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UR/HH Midwifery</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Practice at Lattimore</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Women's Center at RGH</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strong Perinatal Associates</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity OBGYN at Park Ridge</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity OBGYN at Ridgeway</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Women's Center at Victor</name>
      <address>
        <city>Victor</city>
        <state>New York</state>
        <zip>14564</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Creek Midwifery</name>
      <address>
        <city>Webster</city>
        <state>New York</state>
        <zip>14580</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Cynthia Rand</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>pertussis</keyword>
  <keyword>influenza</keyword>
  <keyword>vaccination</keyword>
  <keyword>prenatal care</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>Yes</sharing_ipd>
    <ipd_description>Data will be shared with investigators upon request as part of a collaboration.</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/NCT04444518
org study id: STUDY00005115
nct id: NCT04444518
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pregnant women who get influenza are more likely than non-pregnant women to have serious
      complications, including hospitalizations, death, preterm labor and premature birth.
      Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap
      vaccination rates for pregnant women are low nationally. In this study, the investigators
      will perform a randomized controlled trial aimed at practice change in obstetricians'
      offices, with an overall goal of reducing morbidity and mortality from influenza and
      pertussis infections.
Infants under 6 months of age at increased risk of both influenza (flu) and pertussis
      disease, and pregnant women risk serious illness and premature labor from flu. The Advisory
      Committee on Immunization Practices recommends that women receive a flu vaccine in flu
      season, and tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine
      during each pregnancy (ideally between 27-36 weeks) to lower the risk for flu and pertussis
      disease for themselves and their infants. However, only half of pregnant women in the US
      receive a flu and Tdap vaccine, respectively; only 33% of women receive both vaccines. Lack
      of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy),
      provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of
      standing orders and patient reminders) factors. An effective intervention is needed to
      improve flu and Tdap vaccination rates for pregnant women. To address these low vaccination
      rates the investigators plan to use a clustered RCT (randomizing practices), allocating half
      of the participating practice sites within each health system to the VAX-MOM intervention and
      the other half to standard of care. The multi-component VAX-MOM intervention will be
      comprised of: training in communication, provider prompts, standing orders, and feedback on
      vaccination rates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in the rate of influenza vaccination
time frame: 6 months during the 2019-2020 flu season (baseline), compared to 6 months during the 2021-2022 flu season (intervention)
description: Average rate of vaccination over 6 months during baseline will be compared with average rate of vaccination over 6 months during intervention, for vaccine eligible patients at participating OB/GYN practice sites. Vaccination status will be obtained from patient electronic health records.
measure: Change in the rate of Tdap vaccination
time frame: 12 month baseline compared to 12 month intervention
description: Average rate of vaccination over 12 months during baseline will be compared with average rate of vaccination over 12 months during intervention, for vaccine eligible patients at participating OB/GYN practice sites. Vaccination status will be obtained from patient electronic health records.
measure: Number of patients seen in the practices
time frame: 12 months during intervention period
measure: Number of providers/nurses/staff completing training modules
time frame: 12 months during intervention period
measure: Flu and Tdap vaccination rates by insurance group (public vs private)
time frame: 12 months during intervention period
arm group label: VAX-MOM Intervention
arm group type: Experimental
arm group label: Standard of Care
arm group type: Active Comparator
intervention type: Behavioral
intervention name: VAX-MOM Intervention
description: The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
arm group label: VAX-MOM Intervention
intervention type: Behavioral
intervention name: Standard of Care
description: Standard vaccine education and processes provided to patients by obstetric practices.
arm group label: Standard of Care
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Cynthia Rand
investigator title: Associate Professor
mesh term: Influenza, Human
sharing ipd: Yes
ipd description: Data will be shared with investigators upon request as part of a collaboration.