Protecting Pregnant Women From Infectious Diseases

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

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.

Study Overview

• Status: Completed
• Conditions: Pertussis; Influenza
• Intervention / Treatment: Behavioral: P3 Vaccine Promotion Package.

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.

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30606
      • Athens OBGYN
    • Athens, Georgia, United States, 30606
      • Women's Healthcare Associates
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic A, Clifton Road Clinic
    • Bogart, Georgia, United States, 30622
      • Women's Center of Athens
    • Cumming, Georgia, United States, 30041
      • North Pointe OB/GYN
    • Fayetteville, Georgia, United States, 30214
      • Southern Crescent Women's Health Care
    • Macon, Georgia, United States, 31201
      • W.T. Anderson Health Center - MCCG
    • Riverdale, Georgia, United States, 30274
      • New Millennium OB/GYN
    • Riverdale, Georgia, United States, 30274
      • My OB/GYN
    • Statesboro, Georgia, United States, 30458
      • Statesboro OB/GYN Specialists
    • Thomasville, Georgia, United States, 31792
      • Shaw Center for Women's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: P3 Vaccine Promotion Package; 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.; "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.
No Intervention: No P3 vaccine promotion package intervention; 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?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination	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.	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.

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Saad B Omer, MBBS,MPH,PhD, Emory Unversity

Publications and helpful links

General Publications

• Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortes M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Improving influenza and Tdap vaccination during pregnancy: A cluster-randomized trial of a multi-component antenatal vaccine promotion package in late influenza season. Vaccine. 2015 Jul 9;33(30):3571-9. doi: 10.1016/j.vaccine.2015.05.048. Epub 2015 Jun 1.
• Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortes M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Impact of a multi-component antenatal vaccine promotion package on improving knowledge, attitudes and beliefs about influenza and Tdap vaccination during pregnancy. Hum Vaccin Immunother. 2016 Aug 2;12(8):2017-2024. doi: 10.1080/21645515.2015.1127489. Epub 2016 Apr 15.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 7, 2013

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 30, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Influenza; Vaccination; Pertussis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Whooping Cough
• Other Study ID Numbers: IRB00060292; 5P01TP000300-05 (U.S. NIH Grant/Contract)