Immunization; Infection, Pregnancy Related
Conditions
Keywords
pertussis, influenza, vaccination, prenatal care
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.
Interventions
BEHAVIORALVAX-MOM Intervention
The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
BEHAVIORALStandard of Care
Standard vaccine education and processes provided to patients by obstetric practices.
Sponsors
Centers for Disease Control and Prevention
University of California, Los Angeles
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Influenza Vaccination | 10/1/2021-6/30/2022 (intervention flu season) | Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records. |
| Rate of Tdap Vaccination | 7/1/2021 - 6/30/2022 (intervention period) | Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VAX-MOM Intervention 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. | 5,992 |
| Standard of Care Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices. | 6,768 |
| Total | 12,760 |
Baseline characteristics
| Characteristic | VAX-MOM Intervention | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 129 Participants | 118 Participants | 247 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5837 Participants | 6637 Participants | 12474 Participants |
| Race/Ethnicity, Customized Asian | 430 Participants | 526 Participants | 956 Participants |
| Race/Ethnicity, Customized Black | 694 Participants | 1266 Participants | 1960 Participants |
| Race/Ethnicity, Customized Hispanic | 547 Participants | 721 Participants | 1268 Participants |
| Race/Ethnicity, Customized Unknown | 2490 Participants | 2239 Participants | 4729 Participants |
| Race/Ethnicity, Customized White | 1831 Participants | 2016 Participants | 3847 Participants |
| Region of Enrollment United States | 5992 participants | 6768 participants | 12760 participants |
| Sex: Female, Male Female | 5992 Participants | 6768 Participants | 12760 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Rate of Influenza Vaccination
Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.
Time frame: 10/1/2021-6/30/2022 (intervention flu season)
Population: Pregnant during flu season
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VAX-MOM Intervention | Rate of Influenza Vaccination | 2382 participants |
| Standard of Care | Rate of Influenza Vaccination | 2496 participants |
Primary
Rate of Tdap Vaccination
Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.
Time frame: 7/1/2021 - 6/30/2022 (intervention period)
Population: Pregnant individuals during study period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VAX-MOM Intervention | Rate of Tdap Vaccination | 4532 participants |
| Standard of Care | Rate of Tdap Vaccination | 5452 participants |