P3+ Intervention Phase

A Comprehensive Pre-Natal Intervention to Increase Vaccine Coverage (P3+): Practice, Provider, Patient Level Interventions

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.

Study Overview

• Status: Completed
• Conditions: Vaccination
• Intervention / Treatment: Behavioral: Control Site; Behavioral: Patient-level Control Group; Behavioral: Patient-level Intervention Group; Behavioral: Intervention Site

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.

• Study Type: Interventional
• Enrollment (Actual): 2200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • CU Center for Midwifery
    • Aurora, Colorado, United States, 80045
      • CU Maternal and Fetal Medicine Clinic
    • Aurora, Colorado, United States, 80045
      • University Nurse Midwives
    • Boulder, Colorado, United States, 80303
      • Boulder Women's Care
    • Denver, Colorado, United States, 80218
      • St. Joe's Midwives
    • Denver, Colorado, United States, 80220
      • Partners in Women's Health at Rose
    • Denver, Colorado, United States, 80220
      • Rocky Mountain OBGYN
    • Edwards, Colorado, United States, 81632
      • Colorado Mountain Medical
    • Englewood, Colorado, United States, 80113
      • Bella Natural Women's Care
    • Golden, Colorado, United States, 80401
      • Associates in Women's Health
    • Thornton, Colorado, United States, 80229
      • Women's Health Group Thornton
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Atlanta Women's Specialists
    • Alpharetta, Georgia, United States, 30005
      • Roswell Ob/Gyn
    • Athens, Georgia, United States, 30606
      • Athens Midwifery
    • Athens, Georgia, United States, 30606
      • Athens Ob-Gyn
    • Athens, Georgia, United States, 30606
      • Women's Healthcare Associates of Athens
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic
    • Atlanta, Georgia, United States, 30342
      • Riverbend OB/GYN and Counseling
    • Cumming, Georgia, United States, 30041
      • Peachtree Women's Clinic
    • Duluth, Georgia, United States, 30096
      • Comprehensive Women's OB/GYN
    • Dunwoody, Georgia, United States, 30338
      • Dunwoody Ob-Gyn
    • Lilburn, Georgia, United States, 30047
      • Atlanta Gynecology & Obstetrics
    • Tyrone, Georgia, United States, 30290
      • Women's Medical Center

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:

• Have not previously participated in this study
• Currently pregnant
• Up to 26 weeks gestational age
• Able to understand and communicate in English

Exclusion Criteria:

• Have received pertussis vaccine during the current pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Site + Control Patient; The obstetric practice site is randomized to be a control site and the patient is randomized to the control group.	Behavioral: Control Site; Control sites will continue with their standard practice regarding discussing vaccines with their patients.; Other Names: Practice/provider-Level Control; Behavioral: Patient-level Control Group; 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.
Experimental: Control Site + Intervention Patient; The obstetric practice site is randomized to be a control site and the patient is randomized to receive the intervention.	Behavioral: Control Site; Control sites will continue with their standard practice regarding discussing vaccines with their patients.; Other Names: Practice/provider-Level Control; Behavioral: Patient-level Intervention Group; 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.
Experimental: Intervention Site + Control Patient; The obstetric practice site is randomized to be an intervention site and the patient is randomized to the control group.	Behavioral: Patient-level Control Group; 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.; Behavioral: Intervention Site; 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.; Other Names: Practice/provider-Level Intervention
Experimental: Intervention Site + Intervention Patient; The obstetric practice site is randomized to be an intervention site and the patient is randomized to receive the intervention.	Behavioral: Patient-level Intervention Group; 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.; Behavioral: Intervention Site; 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.; Other Names: Practice/provider-Level Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of women receiving influenza vaccination	Whether or not the participant chose to receive the flu vaccine during pregnancy (between the baseline visit and birth of infant) will be compared between study arms	Up to 34 weeks
Number of women receiving pertussis vaccination	Whether or not the participant chose to receive the pertussis vaccine during pregnancy (between the baseline visit and birth of infant) will be compared between study arms	Up to 34 weeks
Timely childhood vaccinations	Childhood vaccination will be assessed as timely uptake of childhood vaccines by calculating average days under-vaccinated. The total number of days under-vaccinated will be divided by the number of vaccines a child should have received, according to the Advisory Committee on Immunization Practices (ACIP) schedule, to give the average number of days under-vaccinated across all recommended vaccines. This can range from 0 to 415 days in the first 20 months of life. The average number of days under-vaccinated will be modeled as a continuous variable, and the distribution of days under-vaccinated will be evaluated, in total and by vaccine where possible, to identify specific patterns of interest for follow-up.	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in maternal vaccine knowledge	Maternal vaccine knowledge will be collected by the app surveys at different time periods, including before receiving the patient-level intervention, immediately after receiving the intervention, and 30 days and 18 months after the birth of the child. The survey questions assessing these outcomes will most often be measured on a Likert scale. Changes in these outcomes over time will be compared between mothers in the different study arms.	Up to 106 weeks (baseline visit until 18 months post delivery)
Changes in maternal vaccine attitudes	Maternal vaccine attitudes will be collected by the app surveys at different time periods, including before receiving the patient-level intervention, immediately after receiving the intervention, and 30 days and 18 months after the birth of the child. The survey questions assessing these outcomes will most often be measured on a Likert scale. Changes in these outcomes over time will be compared between mothers in the different study arms.	Up to 106 weeks (baseline visit until 18 months post delivery)
Changes in maternal vaccine beliefs	Maternal vaccine beliefs will be collected by the app surveys at different time periods, including before receiving the patient-level intervention, immediately after receiving the intervention, and 30 days and 18 months after the birth of the child. The survey questions assessing these outcomes will most often be measured on a Likert scale. Changes in these outcomes over time will be compared between mothers in the different study arms.	Up to 106 weeks (baseline visit until 18 months post delivery)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Daniel Salmon, PhD, MPH, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• Dudley MZ, Limaye RJ, Omer SB, O'Leary ST, Ellingson MK, Spina CI, Brewer SE, Chamberlain AT, Bednarczyk RA, Malik F, Frew PM, Salmon DA. Factors associated with referring close contacts to an app with individually-tailored vaccine information. Vaccine. 2020 Mar 17;38(13):2827-2832. doi: 10.1016/j.vaccine.2020.02.019. Epub 2020 Feb 22.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Actual): July 6, 2020
• Study Completion (Actual): July 6, 2020

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Influenza vaccine; Pertussis vaccine; Perinatal vaccination; Infant vaccination
• Other Study ID Numbers: IRB00090267; 5R01AI110482-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No