P3+ Intervention Phase
- Conditions
- Vaccination
- Interventions
- Behavioral: Control SiteBehavioral: Intervention SiteBehavioral: Patient-level Intervention GroupBehavioral: Patient-level Control Group
- Registration Number
- NCT02898688
- Lead Sponsor
- Emory University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2200
- Have not previously participated in this study
- Currently pregnant
- Up to 26 weeks gestational age
- Able to understand and communicate in English
- Have received pertussis vaccine during the current pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Control Site + Intervention Patient Patient-level Intervention Group The obstetric practice site is randomized to be a control site and the patient is randomized to receive the intervention. Intervention Site + Control Patient Patient-level Control Group The obstetric practice site is randomized to be an intervention site and the patient is randomized to the control group. Control Site + Control Patient Control Site The obstetric practice site is randomized to be a control site and the patient is randomized to the control group. Intervention Site + Intervention Patient Patient-level Intervention Group The obstetric practice site is randomized to be an intervention site and the patient is randomized to receive the intervention. Control Site + Control Patient Patient-level Control Group The obstetric practice site is randomized to be a control site and the patient is randomized to the control group. Intervention Site + Control Patient Intervention Site The obstetric practice site is randomized to be an intervention site and the patient is randomized to the control group. Intervention Site + Intervention Patient Intervention Site The obstetric practice site is randomized to be an intervention site and the patient is randomized to receive the intervention. Control Site + Intervention Patient Control Site The obstetric practice site is randomized to be a control site and the patient is randomized to receive the intervention.
- Primary Outcome Measures
Name Time Method Number of women receiving pertussis vaccination Up to 34 weeks 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
Number of women receiving influenza vaccination Up to 34 weeks 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
Timely childhood vaccinations 20 months 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.
- Secondary Outcome Measures
Name Time Method Changes in maternal vaccine attitudes Up to 106 weeks (baseline visit until 18 months post delivery) 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.
Changes in maternal vaccine beliefs Up to 106 weeks (baseline visit until 18 months post delivery) 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.
Changes in maternal vaccine knowledge Up to 106 weeks (baseline visit until 18 months post delivery) 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.
Trial Locations
- Locations (23)
Athens Ob-Gyn
🇺🇸Athens, Georgia, United States
Women's Healthcare Associates of Athens
🇺🇸Athens, Georgia, United States
CU Maternal and Fetal Medicine Clinic
🇺🇸Aurora, Colorado, United States
University Nurse Midwives
🇺🇸Aurora, Colorado, United States
St. Joe's Midwives
🇺🇸Denver, Colorado, United States
Emory Clinic
🇺🇸Atlanta, Georgia, United States
Dunwoody Ob-Gyn
🇺🇸Dunwoody, Georgia, United States
Comprehensive Women's OB/GYN
🇺🇸Duluth, Georgia, United States
Boulder Women's Care
🇺🇸Boulder, Colorado, United States
Women's Medical Center
🇺🇸Tyrone, Georgia, United States
CU Center for Midwifery
🇺🇸Aurora, Colorado, United States
Partners in Women's Health at Rose
🇺🇸Denver, Colorado, United States
Rocky Mountain OBGYN
🇺🇸Denver, Colorado, United States
Bella Natural Women's Care
🇺🇸Englewood, Colorado, United States
Colorado Mountain Medical
🇺🇸Edwards, Colorado, United States
Associates in Women's Health
🇺🇸Golden, Colorado, United States
Women's Health Group Thornton
🇺🇸Thornton, Colorado, United States
Atlanta Women's Specialists
🇺🇸Alpharetta, Georgia, United States
Athens Midwifery
🇺🇸Athens, Georgia, United States
Roswell Ob/Gyn
🇺🇸Alpharetta, Georgia, United States
Peachtree Women's Clinic
🇺🇸Cumming, Georgia, United States
Atlanta Gynecology & Obstetrics
🇺🇸Lilburn, Georgia, United States
Riverbend OB/GYN and Counseling
🇺🇸Atlanta, Georgia, United States