Clinical trial NCT02898688: P3+ Intervention Phase
Official title: A Comprehensive Pre-Natal Intervention to Increase Vaccine Coverage (P3+): Practice, Provider, Patient Level Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Keywords: Influenza vaccine
Pertussis vaccine
Perinatal vaccination
Infant vaccination
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-09-13
Enrollment: 2200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of women receiving influenza vaccination
timeFrame: Up to 34 weeks
measure: Number of women receiving pertussis vaccination
timeFrame: Up to 34 weeks
measure: Timely childhood vaccinations
timeFrame: 20 months
Secondary outcomes:
measure: Changes in maternal vaccine knowledge
timeFrame: Up to 106 weeks (baseline visit until 18 months post delivery)
measure: Changes in maternal vaccine attitudes
timeFrame: Up to 106 weeks (baseline visit until 18 months post delivery)
measure: Changes in maternal vaccine beliefs
timeFrame: Up to 106 weeks (baseline visit until 18 months post delivery)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: CU Center for Midwifery
state: Colorado
city: Aurora
country: United States
facility: CU Maternal and Fetal Medicine Clinic
state: Colorado
city: Aurora
country: United States
facility: University Nurse Midwives
state: Colorado
city: Boulder
country: United States
facility: Boulder Women's Care
state: Colorado
city: Denver
country: United States
facility: St. Joe's Midwives
state: Colorado
city: Denver
country: United States
facility: Partners in Women's Health at Rose
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain OBGYN
state: Colorado
city: Edwards
country: United States
facility: Colorado Mountain Medical
state: Colorado
city: Englewood
country: United States
facility: Bella Natural Women's Care
state: Colorado
city: Golden
country: United States
facility: Associates in Women's Health
state: Colorado
city: Thornton
country: United States
facility: Women's Health Group Thornton
state: Colorado
city: Alpharetta
country: United States
facility: Atlanta Women's Specialists
state: Georgia
city: Alpharetta
country: United States
facility: Roswell Ob/Gyn
state: Georgia
city: Athens
country: United States
facility: Athens Midwifery
state: Georgia
city: Athens
country: United States
facility: Athens Ob-Gyn
state: Georgia
city: Athens
country: United States
facility: Women's Healthcare Associates of Athens
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Riverbend OB/GYN and Counseling
state: Georgia
city: Cumming
country: United States
facility: Peachtree Women's Clinic
state: Georgia
city: Duluth
country: United States
facility: Comprehensive Women's OB/GYN
state: Georgia
city: Dunwoody
country: United States
facility: Dunwoody Ob-Gyn
state: Georgia
city: Lilburn
country: United States
facility: Atlanta Gynecology & Obstetrics
state: Georgia
city: Tyrone
country: United States
facility: Women's Medical Center
state: Georgia
Study officials:
affiliation: Emory University
name: Robert Bednarczyk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Daniel Salmon, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.