Increasing Influenza and Tdap Vaccination of Pregnant Women

The VAX-MOM Study: Increasing Influenza and Tdap Vaccination of Pregnant Women

Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related; Immunization; Infection
• Intervention / Treatment: Behavioral: VAX-MOM Intervention; Behavioral: Standard of Care

Detailed Description

Infants under 6 months of age at increased risk of both influenza (flu) and pertussis disease, and pregnant women risk serious illness and premature labor from flu. The Advisory Committee on Immunization Practices recommends that women receive a flu vaccine in flu season, and tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine during each pregnancy (ideally between 27-36 weeks) to lower the risk for flu and pertussis disease for themselves and their infants. However, only half of pregnant women in the US receive a flu and Tdap vaccine, respectively; only 33% of women receive both vaccines. Lack of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy), provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of standing orders and patient reminders) factors. An effective intervention is needed to improve flu and Tdap vaccination rates for pregnant women. To address these low vaccination rates the investigators plan to use a clustered RCT (randomizing practices), allocating half of the participating practice sites within each health system to the VAX-MOM intervention and the other half to standard of care. The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

• Study Type: Interventional
• Enrollment (Actual): 9903
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • El Monte, California, United States, 91731
      • El Monte Comprehensive Health Center
    • Lancaster, California, United States, 93535
      • High Desert Regional Health Center
    • Los Angeles, California, United States, 90003
      • Hubert Humphrey Comprehensive Health Center
    • Los Angeles, California, United States, 90007
      • Hudson Comprehensive Health Center
    • Los Angeles, California, United States, 90033
      • Los Angeles County USC Medical Center
    • Los Angeles, California, United States, 90059
      • MLK Outpatient Center
    • Los Angeles, California, United States, 90095
      • Ronald Reagan OB
    • Los Angeles, California, United States, 90095
      • UCLA Faculty Practice. OBGYN at West Medical
    • Santa Monica, California, United States, 90404
      • Santa Monica Faculty Practice
    • Santa Monica, California, United States, 90404
      • UCLA OBGYN Nurse-Midwives Clinic
    • Sylmar, California, United States, 91342
      • Olive View
    • Torrance, California, United States, 90502
      • Harbor UCLA
    • Torrance, California, United States, 90503
      • South Bay (Torrance)
    • Valencia, California, United States, 91355
      • Santa Clarita OBGYN
    • Westlake Village, California, United States, 91361
      • West Lake/Thousand Oaks
  • New York
    • Brockport, New York, United States, 14420
      • Unity OBGYN at Brockport
    • Clifton Springs, New York, United States, 14432
      • Clifton Springs Hospital & Clinic
    • Geneva, New York, United States, 14456
      • Finger Lakes Medical Associates OBGYN-Geneva
    • Henrietta, New York, United States, 14467
      • RRH OBGYN at Henrietta
    • Newark, New York, United States, 14513
      • The Women's Center at Newark
    • Penn Yan, New York, United States, 14527
      • Finger Lakes Medical Associates OBGYN-Penn Yan
    • Rochester, New York, United States, 14605
      • The Women's Center at Clinton
    • Rochester, New York, United States, 14607
      • The Women's Center at Alexander Park
    • Rochester, New York, United States, 14609
      • Community OB
    • Rochester, New York, United States, 14609
      • Highland Women's Health
    • Rochester, New York, United States, 14611
      • Unity OBGYN at West Main
    • Rochester, New York, United States, 14612
      • Unity OBGYN at Parkway
    • Rochester, New York, United States, 14618
      • Unity OBGYN at Clinton Crossings
    • Rochester, New York, United States, 14620
      • University OB/GYN
    • Rochester, New York, United States, 14620
      • UR/HH Midwifery
    • Rochester, New York, United States, 14620
      • Women's Health Practice at Lattimore
    • Rochester, New York, United States, 14621
      • The Women's Center at RGH
    • Rochester, New York, United States, 14623
      • Strong Perinatal Associates
    • Rochester, New York, United States, 14626
      • Unity OBGYN at Park Ridge
    • Rochester, New York, United States, 14626
      • Unity OBGYN at Ridgeway
    • Victor, New York, United States, 14564
      • The Women's Center at Victor
    • Webster, New York, United States, 14580
      • Bay Creek Midwifery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Patients

• Sex is female
• Pregnant
• identified as being eligible for influenza or Tdap vaccine

Providers

• any provider, nurse or staff associated with the participating sites

Exclusion Criteria:

Patients

• none

Providers

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	Behavioral: Standard of Care; Standard vaccine education and processes provided to patients by obstetric practices.
Experimental: VAX-MOM Intervention	Behavioral: VAX-MOM Intervention; The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the rate of influenza vaccination	Average rate of vaccination over 6 months during baseline will be compared with average rate of vaccination over 6 months during intervention, for vaccine eligible patients at participating OB/GYN practice sites. Vaccination status will be obtained from patient electronic health records.	6 months during the 2019-2020 flu season (baseline), compared to 6 months during the 2021-2022 flu season (intervention)
Change in the rate of Tdap vaccination	Average rate of vaccination over 12 months during baseline will be compared with average rate of vaccination over 12 months during intervention, for vaccine eligible patients at participating OB/GYN practice sites. Vaccination status will be obtained from patient electronic health records.	12 month baseline compared to 12 month intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients seen in the practices	12 months during intervention period
Number of providers/nurses/staff completing training modules	12 months during intervention period
Flu and Tdap vaccination rates by insurance group (public vs private)	12 months during intervention period

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: University of California, Los Angeles; Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: influenza; vaccination; pertussis; prenatal care
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: STUDY00005115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with investigators upon request as part of a collaboration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No