P3+ Intervention Phase
Condition: Vaccination
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Control Site; Intervention Site; Patient-level Control Group; Patient-level Intervention Group
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Control sites will continue with their standard practice regarding discussing vaccines with their patients.; 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.; 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.; 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.
Other intervention name(s): Practice/provider-Level Control; Practice/provider-Level Intervention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Influenza vaccine; Pertussis vaccine; Perinatal vaccination; Infant vaccination