P3+ Intervention Phase
A Comprehensive Pre-Natal Intervention to Increase Vaccine Coverage (P3+): Practice, Provider, Patient Level Interventions
2 other identifiers
interventional
2,200
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Typical duration for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2016
CompletedStudy Start
First participant enrolled
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2020
CompletedAugust 5, 2020
August 1, 2020
3.1 years
September 8, 2016
August 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Changes in maternal vaccine knowledge
Up to 106 weeks (baseline visit until 18 months post delivery)
Changes in maternal vaccine attitudes
Up to 106 weeks (baseline visit until 18 months post delivery)
Changes in maternal vaccine beliefs
Up to 106 weeks (baseline visit until 18 months post delivery)
Study Arms (4)
Control Site + Control Patient
OTHERThe obstetric practice site is randomized to be a control site and the patient is randomized to the control group.
Control Site + Intervention Patient
EXPERIMENTALThe obstetric practice site is randomized to be a control site and the patient is randomized to receive the intervention.
Intervention Site + Control Patient
EXPERIMENTALThe obstetric practice site is randomized to be an intervention site and the patient is randomized to the control group.
Intervention Site + Intervention Patient
EXPERIMENTALThe obstetric practice site is randomized to be an intervention site and the patient is randomized to receive the intervention.
Interventions
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Have not previously participated in this study
- Currently pregnant
- Up to 26 weeks gestational age
- Able to understand and communicate in English
You may not qualify if:
- Have received pertussis vaccine during the current pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
CU Center for Midwifery
Aurora, Colorado, 80045, United States
CU Maternal and Fetal Medicine Clinic
Aurora, Colorado, 80045, United States
University Nurse Midwives
Aurora, Colorado, 80045, United States
Boulder Women's Care
Boulder, Colorado, 80303, United States
St. Joe's Midwives
Denver, Colorado, 80218, United States
Partners in Women's Health at Rose
Denver, Colorado, 80220, United States
Rocky Mountain OBGYN
Denver, Colorado, 80220, United States
Colorado Mountain Medical
Edwards, Colorado, 81632, United States
Bella Natural Women's Care
Englewood, Colorado, 80113, United States
Associates in Women's Health
Golden, Colorado, 80401, United States
Women's Health Group Thornton
Thornton, Colorado, 80229, United States
Atlanta Women's Specialists
Alpharetta, Georgia, 30005, United States
Roswell Ob/Gyn
Alpharetta, Georgia, 30005, United States
Athens Midwifery
Athens, Georgia, 30606, United States
Athens Ob-Gyn
Athens, Georgia, 30606, United States
Women's Healthcare Associates of Athens
Athens, Georgia, 30606, United States
Emory Clinic
Atlanta, Georgia, 30322, United States
Riverbend OB/GYN and Counseling
Atlanta, Georgia, 30342, United States
Peachtree Women's Clinic
Cumming, Georgia, 30041, United States
Comprehensive Women's OB/GYN
Duluth, Georgia, 30096, United States
Dunwoody Ob-Gyn
Dunwoody, Georgia, 30338, United States
Atlanta Gynecology & Obstetrics
Lilburn, Georgia, 30047, United States
Women's Medical Center
Tyrone, Georgia, 30290, United States
Related Publications (2)
Dudley MZ, Omer SB, O'Leary ST, Limaye RJ, Ellingson MK, Spina CI, Brewer SE, Bednarczyk RA, Chamberlain AT, Malik F, Frew PM, Church-Balin C, Riley LE, Ault KA, Orenstein WA, Halsey NA, Salmon DA. MomsTalkShots, tailored educational app, improves vaccine attitudes: a randomized controlled trial. BMC Public Health. 2022 Nov 21;22(1):2134. doi: 10.1186/s12889-022-14498-7.
PMID: 36411403DERIVEDDudley 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.
PMID: 32098739DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Bednarczyk, PhD
Emory University
- PRINCIPAL INVESTIGATOR
Daniel Salmon, PhD, MPH
Johns Hopkins Bloomberg School of Public Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 8, 2016
First Posted
September 13, 2016
Study Start
June 12, 2017
Primary Completion
July 6, 2020
Study Completion
July 6, 2020
Last Updated
August 5, 2020
Record last verified: 2020-08