Influenza, Pertussis
Conditions
Keywords
Influenza, Pertussis, Vaccination
Brief summary
The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis vaccine.
Detailed description
The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza vaccine and/or Tdap vaccine before delivery. A secondary research aim assesses whether the comprehensive package improves maternal knowledge, attitudes, and beliefs regarding maternal and infant vaccination. The intervention package will include evidence-based components aimed at the practice-level, provider-level, and patient level and will be tested through a cluster-randomized trial design. The primary outcome measure is influenza vaccine receipt during pregnancy. The secondary outcomes include 1) receipt of pertussis (Tdap) vaccination during pregnancy, and 2) changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination. The primary hypothesis is that implementation of a comprehensive vaccine promotion package in the obstetric setting will increase the likelihood that a pregnant woman receives an influenza and/or pertussis vaccination.
Interventions
BEHAVIORALP3 Vaccine Promotion Package.
P3 stands for Practice, Provider, and Patient level vaccine promotion package. The 5 obstetric practices randomized to the intervention arm will receive this comprehensive influenza and Tdap vaccine promotion package at the beginning of the study. Physicians and staff will be familiarized with each component, and practices will be instructed to implement each component to the best of their ability. The components include: posters, educational brochures, lapel buttons, provider-to-patient talking points, lists of nearby locations offering flu and/or Tdap vaccines (if not offered by the practice), identification of a vaccine champion within the practice, provider and staff training on vaccination during pregnancy, and use of an interactive, tablet-based educational tutorial for patients.
Sponsors
Centers for Disease Control and Prevention
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 18 - 50 * Currently pregnant * Unvaccinated with 2012 - 2013 seasonal influenza vaccine * Unvaccinated with Tdap vaccine during current pregnancy
Exclusion criteria
* Under 18 years of age or over 50 * Not currently pregnant * Previous receipt of 2012 - 2013 seasonal influenza vaccine * Previous receipt of Tdap vaccine during current pregnancy * Does not speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of influenza vaccine during pregnancy | Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment. | Our primary outcome is receipt of a 2012 - 2013 seasonal influenza vaccine during a participant's current pregnancy, before she delivers her child(ren). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of Tdap vaccine during pregnancy | Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment. | A secondary outcome is receipt of a Tdap vaccine during a participant's current pregnancy, before she delivers her child(ren). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination | Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment. | This secondary outcome will be assessed through two surveys: one survey administered at baseline upon enrollment, and another survey administered 2 - 3 months post-partum. |
Countries
United States
Outcome results
None listed