P3+ Intervention Phase

NACompletedINTERVENTIONAL
Enrollment

2,200

Participants

Timeline

Start Date

June 12, 2017

Primary Completion Date

July 6, 2020

Study Completion Date

July 6, 2020

Conditions
Vaccination
Interventions
BEHAVIORAL

Control Site

Control sites will continue with their standard practice regarding discussing vaccines with their patients.

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.

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

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."

Trial Locations (23)

30005

Atlanta Women's Specialists, Alpharetta

Roswell Ob/Gyn, Alpharetta

30041

Peachtree Women's Clinic, Cumming

30047

Atlanta Gynecology & Obstetrics, Lilburn

30096

Comprehensive Women's OB/GYN, Duluth

30290

Women's Medical Center, Tyrone

30322

Emory Clinic, Atlanta

30338

Dunwoody Ob-Gyn, Dunwoody

30342

Riverbend OB/GYN and Counseling, Atlanta

30606

Athens Midwifery, Athens

Athens Ob-Gyn, Athens

Women's Healthcare Associates of Athens, Athens

80045

CU Center for Midwifery, Aurora

CU Maternal and Fetal Medicine Clinic, Aurora

University Nurse Midwives, Aurora

80113

Bella Natural Women's Care, Englewood

80218

St. Joe's Midwives, Denver

80220

Partners in Women's Health at Rose, Denver

Rocky Mountain OBGYN, Denver

80229

Women's Health Group Thornton, Thornton

80303

Boulder Women's Care, Boulder

80401

Associates in Women's Health, Golden

81632

Colorado Mountain Medical, Edwards

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Emory University

OTHER

NCT02898688 - P3+ Intervention Phase | Biotech Hunter | Biotech Hunter