Protecting Pregnant Women From Infectious Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Protecting Pregnant Women From Infectious Diseases: a Cluster Randomized Evaluation of the Comprehensive P3 Intervention Package Within Obstetric Practices in Georgia

Conditions
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Influenza, Pertussis

Intervention / Treatment
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* Behavioral: P3 Vaccine Promotion Package.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P3 Vaccine Promotion Package<br>The 5 obstetric practices randomized to the intervention arm will receive and implement all components of the evidence-based P3 vaccine promotion package at the beginning of the study. | Behavioral: P3 Vaccine Promotion Package.<br>* 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.<br>|
| No Intervention: No P3 vaccine promotion package intervention<br>The 5 obstetric practices randomized to the control arm will not receive the comprehensive vaccine promotion package at the beginning of the study and will instead be instructed to continue their standard of care regarding influenza and Tdap vaccination of pregnant patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of influenza vaccine during pregnancy | Our primary outcome is receipt of a 2012 - 2013 seasonal influenza vaccine during a participant's current pregnancy, before she delivers her child(ren). | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of Tdap vaccine during pregnancy | A secondary outcome is receipt of a Tdap vaccine during a participant's current pregnancy, before she delivers her child(ren). | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Pertussis, Vaccination