Increasing Influenza and Tdap Vaccination of Pregnant Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Immunization; Infection, Pregnancy Related

Intervention / Treatment
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* Behavioral: VAX-MOM Intervention
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pertussis, influenza, vaccination, prenatal care