Protecting Pregnant Women From Infectious Diseases

Emory University

Status: Completed

Conditions: Influenza; Pertussis

Treatments: Behavioral: P3 Vaccine Promotion Package.

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01761799

IRB00060292

5P01TP000300-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

P3 Vaccine Promotion Package

Experimental group

Description:

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.

Treatment:

Behavioral: P3 Vaccine Promotion Package.

No P3 vaccine promotion package intervention

No Intervention group

Description:

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.