P3+ Intervention Phase

Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898688
• Other study ID #: IRB00090267
• Secondary ID: 5R01AI110482-02
• Status: Completed
• Phase: N/A
• Start date: June 12, 2017
• Est. completion date: July 6, 2020

Study information

• Verified date: August 2020
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: July 6, 2020
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaccination

Intervention

Behavioral:
• Control Site
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Atlanta Women's Specialists	Alpharetta	Georgia
United States	Roswell Ob/Gyn	Alpharetta	Georgia
United States	Athens Midwifery	Athens	Georgia
United States	Athens Ob-Gyn	Athens	Georgia
United States	Women's Healthcare Associates of Athens	Athens	Georgia
United States	Emory Clinic	Atlanta	Georgia
United States	Riverbend OB/GYN and Counseling	Atlanta	Georgia
United States	CU Center for Midwifery	Aurora	Colorado
United States	CU Maternal and Fetal Medicine Clinic	Aurora	Colorado
United States	University Nurse Midwives	Aurora	Colorado
United States	Boulder Women's Care	Boulder	Colorado
United States	Peachtree Women's Clinic	Cumming	Georgia
United States	Partners in Women's Health at Rose	Denver	Colorado
United States	Rocky Mountain OBGYN	Denver	Colorado
United States	St. Joe's Midwives	Denver	Colorado
United States	Comprehensive Women's OB/GYN	Duluth	Georgia
United States	Dunwoody Ob-Gyn	Dunwoody	Georgia
United States	Colorado Mountain Medical	Edwards	Colorado
United States	Bella Natural Women's Care	Englewood	Colorado
United States	Associates in Women's Health	Golden	Colorado
United States	Atlanta Gynecology & Obstetrics	Lilburn	Georgia
United States	Women's Health Group Thornton	Thornton	Colorado
United States	Women's Medical Center	Tyrone	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)