Increasing Influenza and Tdap Vaccination of Pregnant Women
Primary Purpose
Immunization; Infection, Pregnancy Related
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VAX-MOM Intervention
Standard of Care
Sponsored by
About this trial
This is an interventional health services research trial for Immunization; Infection focused on measuring pertussis, influenza, vaccination, prenatal care
Eligibility Criteria
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
Sites / Locations
- El Monte Comprehensive Health Center
- High Desert Regional Health Center
- Hubert Humphrey Comprehensive Health Center
- Hudson Comprehensive Health Center
- Los Angeles County USC Medical Center
- MLK Outpatient Center
- Ronald Reagan OB
- UCLA Faculty Practice. OBGYN at West Medical
- Santa Monica Faculty Practice
- UCLA OBGYN Nurse-Midwives Clinic
- Olive View
- Harbor UCLA
- South Bay (Torrance)
- Santa Clarita OBGYN
- West Lake/Thousand Oaks
- Unity OBGYN at Brockport
- Clifton Springs Hospital & Clinic
- Finger Lakes Medical Associates OBGYN-Geneva
- RRH OBGYN at Henrietta
- The Women's Center at Newark
- Finger Lakes Medical Associates OBGYN-Penn Yan
- The Women's Center at Clinton
- The Women's Center at Alexander Park
- Community OB
- Highland Women's Health
- Unity OBGYN at West Main
- Unity OBGYN at Parkway
- Unity OBGYN at Clinton Crossings
- University OB/GYN
- UR/HH Midwifery
- Women's Health Practice at Lattimore
- The Women's Center at RGH
- Strong Perinatal Associates
- Unity OBGYN at Park Ridge
- Unity OBGYN at Ridgeway
- The Women's Center at Victor
- Bay Creek Midwifery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VAX-MOM Intervention
Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Number of patients seen in the practices
Number of providers/nurses/staff completing training modules
Flu and Tdap vaccination rates by insurance group (public vs private)
Full Information
NCT ID
NCT04444518
First Posted
June 19, 2020
Last Updated
August 31, 2023
Sponsor
University of Rochester
Collaborators
Centers for Disease Control and Prevention, University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT04444518
Brief Title
Increasing Influenza and Tdap Vaccination of Pregnant Women
Official Title
The VAX-MOM Study: Increasing Influenza and Tdap Vaccination of Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Centers for Disease Control and Prevention, University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunization; Infection, Pregnancy Related
Keywords
pertussis, influenza, vaccination, prenatal care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9903 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VAX-MOM Intervention
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
VAX-MOM Intervention
Intervention Description
The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
Standard vaccine education and processes provided to patients by obstetric practices.
Primary Outcome Measure Information:
Title
Change in the rate of influenza vaccination
Description
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.
Time Frame
6 months during the 2019-2020 flu season (baseline), compared to 6 months during the 2021-2022 flu season (intervention)
Title
Change in the rate of Tdap vaccination
Description
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.
Time Frame
12 month baseline compared to 12 month intervention
Secondary Outcome Measure Information:
Title
Number of patients seen in the practices
Time Frame
12 months during intervention period
Title
Number of providers/nurses/staff completing training modules
Time Frame
12 months during intervention period
Title
Flu and Tdap vaccination rates by insurance group (public vs private)
Time Frame
12 months during intervention period
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
El Monte Comprehensive Health Center
City
El Monte
State/Province
California
ZIP/Postal Code
91731
Country
United States
Facility Name
High Desert Regional Health Center
City
Lancaster
State/Province
California
ZIP/Postal Code
93535
Country
United States
Facility Name
Hubert Humphrey Comprehensive Health Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90003
Country
United States
Facility Name
Hudson Comprehensive Health Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
Facility Name
Los Angeles County USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
MLK Outpatient Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
Ronald Reagan OB
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Faculty Practice. OBGYN at West Medical
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Santa Monica Faculty Practice
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCLA OBGYN Nurse-Midwives Clinic
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Olive View
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Harbor UCLA
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
South Bay (Torrance)
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Santa Clarita OBGYN
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
Facility Name
West Lake/Thousand Oaks
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Unity OBGYN at Brockport
City
Brockport
State/Province
New York
ZIP/Postal Code
14420
Country
United States
Facility Name
Clifton Springs Hospital & Clinic
City
Clifton Springs
State/Province
New York
ZIP/Postal Code
14432
Country
United States
Facility Name
Finger Lakes Medical Associates OBGYN-Geneva
City
Geneva
State/Province
New York
ZIP/Postal Code
14456
Country
United States
Facility Name
RRH OBGYN at Henrietta
City
Henrietta
State/Province
New York
ZIP/Postal Code
14467
Country
United States
Facility Name
The Women's Center at Newark
City
Newark
State/Province
New York
ZIP/Postal Code
14513
Country
United States
Facility Name
Finger Lakes Medical Associates OBGYN-Penn Yan
City
Penn Yan
State/Province
New York
ZIP/Postal Code
14527
Country
United States
Facility Name
The Women's Center at Clinton
City
Rochester
State/Province
New York
ZIP/Postal Code
14605
Country
United States
Facility Name
The Women's Center at Alexander Park
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
Facility Name
Community OB
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Highland Women's Health
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Unity OBGYN at West Main
City
Rochester
State/Province
New York
ZIP/Postal Code
14611
Country
United States
Facility Name
Unity OBGYN at Parkway
City
Rochester
State/Province
New York
ZIP/Postal Code
14612
Country
United States
Facility Name
Unity OBGYN at Clinton Crossings
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
University OB/GYN
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
UR/HH Midwifery
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Women's Health Practice at Lattimore
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
The Women's Center at RGH
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Strong Perinatal Associates
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Unity OBGYN at Park Ridge
City
Rochester
State/Province
New York
ZIP/Postal Code
14626
Country
United States
Facility Name
Unity OBGYN at Ridgeway
City
Rochester
State/Province
New York
ZIP/Postal Code
14626
Country
United States
Facility Name
The Women's Center at Victor
City
Victor
State/Province
New York
ZIP/Postal Code
14564
Country
United States
Facility Name
Bay Creek Midwifery
City
Webster
State/Province
New York
ZIP/Postal Code
14580
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with investigators upon request as part of a collaboration.
Learn more about this trial
Increasing Influenza and Tdap Vaccination of Pregnant Women
We'll reach out to this number within 24 hrs