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A Comprehensive Pre-Natal Intervention to Increase Vaccine Coverage (P3+): Practice, Provider, Patient Level Interventions (NCT02898688)

National Institute of Allergy and Infectious Diseases (NIAID)
This study will address vaccine uptake both for pregnant women and for their children, through 20 months of age, to test the hypothesis that exposure to the P3+ intervention package will increase the likelihood a pregnant woman gets herself vaccinated against influenza and pertussis before delivery and get her child vaccinated on time. This study builds off of a prior intervention, developed by Emory, at the practice, provider, and patient levels (P3) to develop, implement and evaluate an enhanced intervention (P3+) to improve vaccination uptake among pregnant women, and later, their children.
  • Behavioral: Control Site
    Control sites will continue with their standard practice regarding discussing vaccines with their patients.
    • Practice/provider-Level Control
  • Behavioral: Intervention Site
    Intervention Sites will each assign a Vaccine Champion and will have Assessment, Feedback, Incentives, and eXchange (AFIX) visits. AFIX is a quality improvement program to raise immunization coverage levels, reduce missed opportunities to vaccinate, and improve standards of practices at the provider level. A Continuing Medical Education (CME) module will be given to all providers, covering the recommended maternal vaccinations and how to talk to patients about vaccines. Intervention sites will have access to written materials covering all recommended maternal and infant vaccinations, the diseases they prevent, potential adverse reactions and common patient questions with talking points and references for each topic.
    • Practice/provider-Level Intervention
  • Behavioral: Patient-level Control Group
    Participants randomized the control arm will complete a computer-based questionnaire, on an iPad with a preloaded app. The questionnaire asks about vaccine knowledge, attitudes, and beliefs and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questionnaire includes questions requiring a "yes" or "no" response, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), questions to capture the vaccines participants plan to get for themselves and their children, and open-ended questions.
    • Behavioral: Patient-level Intervention Group
      Participants randomized to the intervention arm will complete a computer-based questionnaire on an iPad with a preloaded app, prior to watching informational videos covering topics on maternal and childhood vaccines. The questionnaire asks about vaccine knowledge, attitudes, beliefs, and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questions require "yes" or "no" responses, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), and open-ended responses. After watching at least one informational video, the participant completes a questionnaire asking about the perceived usefulness of the app, degree of agreement with the vaccine information presented in the video, and ways to make the app more useful to participants.
      Ages eligible for Study
      18 Years to 50 Years
      Genders eligible for Study
      Female
      Accepts Healthy Volunteers
      Accepts Healthy Volunteers
      Inclusion Criteria:
      • Women who are currently pregnant for the first time
      • Up to 26 weeks gestational age
      • Have not previously participated in this study
      • Able to understand and communicate in English
      Exclusion Criteria:
      • Have received influenza and/or pertussis vaccines during the current pregnancy
      This study will address vaccine uptake both for pregnant women and for their children, through 20 months of age, to test the hypothesis that exposure to the P3+ intervention package will increase the likelihood a pregnant woman gets herself vaccinated against influenza and pertussis before delivery and get her child vaccinated on time.

      This study uses a multi-level factorial design which randomizes at both the practice and the patient level. Obstetric practices in Georgia and Colorado will be randomized to be either an intervention practice or a control practice. The women recruited in the practices and enrolled in the study will be randomly assigned to the intervention arm or the control arm.

      Women randomized to the intervention arm will complete a computer-based questionnaire (administered via iPad with a preloaded study app) which asks for their basic demographic and contact information and asks questions about their vaccine knowledge, attitudes, and beliefs. Immediately following the questionnaire, participants will receive the individual level intervention (videos providing information on vaccines) on the same iPad. In order to best answer their questions and not provide information beyond the scope of what the study participants need or want, the videos provided to each participant will be selected based on responses to the survey questions. There are 6 videos: one discusses the dangers of the diseases prevented by vaccines, and the others address specific vaccine concerns (concerns include vaccine ingredients, children receiving simultaneous vaccines (multiple vaccines at one time), and the safety of receiving the tdap or flu vaccine during pregnancy). If the participant does not have any concerns, they will only see the video about dangers of vaccine preventable diseases. Participants expressing concerns in the survey will receive up to two videos addressing those concerns, based on an order of priority determined by the study researchers.

      Women randomized to the control arm will also complete a computer-based questionnaire which includes their personal information and vaccine knowledge, attitudes, and beliefs questions but will then continue to receive usual prenatal care rather than view informational videos.

      All enrolled women complete two follow-up surveys when their children are 30 days and 18 months of age.

      23 locations

      United States (23)
      • CU Center for Midwifery
        recruiting
        Aurora, Colorado, United States, 80045
      • CU Maternal and Fetal Medicine Clinic
        recruiting
        Aurora, Colorado, United States, 80045
      • University Nurse Midwives
        recruiting
        Aurora, Colorado, United States, 80045
      • Boulder Women's Care
        recruiting
        Boulder, Colorado, United States, 80303
      • St. Joe's Midwives
        recruiting
        Denver, Colorado, United States, 80218
      • Partners in Women's Health at Rose
        recruiting
        Denver, Colorado, United States, 80220
      • Rocky Mountain OBGYN
        recruiting
        Denver, Colorado, United States, 80220
      • Colorado Mountain Medical
        recruiting
        Edwards, Colorado, United States, 81632
      • Bella Natural Women's Care
        recruiting
        Englewood, Colorado, United States, 80113
      • Associates in Women's Health
        recruiting
        Golden, Colorado, United States, 80401
      • Women's Health Group Thornton
        recruiting
        Thornton, Colorado, United States, 80229
      • Atlanta Women's Specialists
        recruiting
        Alpharetta, Georgia, United States, 30005
      • Roswell Ob/Gyn
        recruiting
        Alpharetta, Georgia, United States, 30005
      • Athens Midwifery
        recruiting
        Athens, Georgia, United States, 30606
      • Athens Ob-Gyn
        recruiting
        Athens, Georgia, United States, 30606
      • Women's Healthcare Associates of Athens
        recruiting
        Athens, Georgia, United States, 30606
      • Emory Clinic
        recruiting
        Atlanta, Georgia, United States, 30322
      • Riverbend OB/GYN and Counseling
        recruiting
        Atlanta, Georgia, United States, 30342
      • Peachtree Women's Clinic
        recruiting
        Cumming, Georgia, United States, 30041
      • Comprehensive Women's OB/GYN
        recruiting
        Duluth, Georgia, United States, 30096
      • Dunwoody Ob-Gyn
        recruiting
        Dunwoody, Georgia, United States, 30338
      • Atlanta Gynecology & Obstetrics
        recruiting
        Lilburn, Georgia, United States, 30047
      • Women's Medical Center
        recruiting
        Tyrone, Georgia, United States, 30290
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      11 June, 2017
      Updated:
      16 July, 2017
      Participants:
      1896
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