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Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake

Assessment, Feedback, Incentive, Exchange (AFIX-OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04678271
Acronym
AFIX-OB
Enrollment
202
Registered
2020-12-21
Start date
2021-07-01
Completion date
2023-01-31
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Whooping Cough

Keywords

Pregnancy, Vaccination, Vaccine Acceptance, Influenza, Pertussis, Tdap

Brief summary

The purpose of this study is to evaluate the AFIX-OB model to determine its impact on the change in flu and pertussis (Tdap) uptake, provider knowledge, attitudes and beliefs, and patient knowledge, attitudes and beliefs regarding maternal vaccination. The structure of the model and quality improvement interventions are guided by theory including the elaboration likelihood model and P3 model. These quality improvement measures will be implemented in OB clinics within the Yale New Haven Health System.

Interventions

BEHAVIORALAFIX-OB Quality Improvement Package

Practices randomized to the intervention arm will be provided with a package of core and supplemental quality improvement interventions to choose from so that the most effective combination for their practice is implemented. Each practice will be required to implement a tablet-based educational app for patients, and evidence based online educational module for providers, standing order protocol, and a reminder/recall protocol. They can then choose to also use flyers and posters in their waiting rooms, standardized talking points for maternal immunization for the providers, educational content for the practice website, and laminated and highlighted CDC Vaccine Information Sheets. The recruited patients and providers at the practice will be given a baseline and follow-up survey to assess their knowledge, attitudes, and beliefs towards maternal immunization.

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Between 18-50 years of age * Currently pregnant and gestational age \<26 weeks

Exclusion criteria

* Already enrolled in the study

Design outcomes

Primary

MeasureTime frameDescription
Change in Maternal Influenza UptakeBaseline and one year after implementationImmunization rates for each practice will be collected through JDAT or a random chart review.
Change in Maternal Tdap UptakeBaseline and one year after implementationImmunization rates for each practice will be collected through JDAT or a random chart review.

Secondary

MeasureTime frameDescription
Change in Patient Vaccine AttitudesBaseline and one year after implementationData on patient attitudes regarding vaccines will be collected from enrolled participants at the beginning of the study and following the implementation of the intervention via a 10-15 minute survey.
Change in Patient Vaccine BeliefsBaseline and one year after implementationData on patient beliefs regarding vaccines will be collected from enrolled participants at the beginning of the study and following the implementation of the intervention via a 10-15 minute survey.
Change in Patient Vaccine KnowledgeBaseline and one year after implementationData on patient knowledge regarding vaccines will be collected from enrolled participants at the beginning of the study and following the implementation of the intervention via a 10-15 minute survey.
Change in Provider Vaccine AttitudesBaseline and one year after implementationProviders in both study arms will complete baseline and follow-up surveys pre-and post-intervention.
Change in Provider Vaccine BeliefsBaseline and one year after implementationProviders in both study arms will complete baseline and follow-up surveys pre-and post-intervention.
Change in Provider Vaccine KnowledgeBaseline and one year after implementationProviders in both study arms will complete baseline and follow-up surveys pre-and post-intervention.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026