Increasing Influenza and Tdap Vaccination of Pregnant Women

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04444518
• Other study ID #: STUDY00005115
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9903
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Immunization; Infection
• Influenza, Human
• Pregnancy Related

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.
• Standard of Care
Standard vaccine education and processes provided to patients by obstetric practices.

Locations

Country	Name	City	State
United States	Unity OBGYN at Brockport	Brockport	New York
United States	Clifton Springs Hospital & Clinic	Clifton Springs	New York
United States	El Monte Comprehensive Health Center	El Monte	California
United States	Finger Lakes Medical Associates OBGYN-Geneva	Geneva	New York
United States	RRH OBGYN at Henrietta	Henrietta	New York
United States	High Desert Regional Health Center	Lancaster	California
United States	Hubert Humphrey Comprehensive Health Center	Los Angeles	California
United States	Hudson Comprehensive Health Center	Los Angeles	California
United States	Los Angeles County USC Medical Center	Los Angeles	California
United States	MLK Outpatient Center	Los Angeles	California
United States	Ronald Reagan OB	Los Angeles	California
United States	UCLA Faculty Practice. OBGYN at West Medical	Los Angeles	California
United States	The Women's Center at Newark	Newark	New York
United States	Finger Lakes Medical Associates OBGYN-Penn Yan	Penn Yan	New York
United States	Community OB	Rochester	New York
United States	Highland Women's Health	Rochester	New York
United States	Strong Perinatal Associates	Rochester	New York
United States	The Women's Center at Alexander Park	Rochester	New York
United States	The Women's Center at Clinton	Rochester	New York
United States	The Women's Center at RGH	Rochester	New York
United States	Unity OBGYN at Clinton Crossings	Rochester	New York
United States	Unity OBGYN at Park Ridge	Rochester	New York
United States	Unity OBGYN at Parkway	Rochester	New York
United States	Unity OBGYN at Ridgeway	Rochester	New York
United States	Unity OBGYN at West Main	Rochester	New York
United States	University OB/GYN	Rochester	New York
United States	UR/HH Midwifery	Rochester	New York
United States	Women's Health Practice at Lattimore	Rochester	New York
United States	Santa Monica Faculty Practice	Santa Monica	California
United States	UCLA OBGYN Nurse-Midwives Clinic	Santa Monica	California
United States	Olive View	Sylmar	California
United States	Harbor UCLA	Torrance	California
United States	South Bay (Torrance)	Torrance	California
United States	Santa Clarita OBGYN	Valencia	California
United States	The Women's Center at Victor	Victor	New York
United States	Bay Creek Midwifery	Webster	New York
United States	West Lake/Thousand Oaks	Westlake Village	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	Centers for Disease Control and Prevention, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Number of patients seen in the practices		12 months during intervention period
Secondary	Number of providers/nurses/staff completing training modules		12 months during intervention period
Secondary	Flu and Tdap vaccination rates by insurance group (public vs private)		12 months during intervention period