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

Study Overview
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Brief Summary
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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.

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

Conditions
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Influenza, Whooping Cough

Intervention / Treatment
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* Behavioral: AFIX-OB Quality Improvement Package


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18-50 years of age Currently pregnant and gestational age <26 weeks Exclusion Criteria: Already enrolled in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AFIX-OB Intervention Arm<br>Practices randomized to this arm will choose from a suite of quality improvement interventions that address patient, provider, and practice-level factors relating to maternal vaccination. | Behavioral: AFIX-OB Quality Improvement Package<br>* 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.<br>|
| No Intervention: Control Arm<br>Practices randomized to this arm will continue to provide their normal standard of care to pregnant patients at their practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Maternal Influenza Uptake | Immunization rates for each practice will be collected through JDAT or a random chart review. | Baseline and one year after implementation | 
| Change in Maternal Tdap Uptake | Immunization rates for each practice will be collected through JDAT or a random chart review. | Baseline and one year after implementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Vaccine Knowledge | Data 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. | Baseline and one year after implementation | 
| Change in Provider Vaccine Knowledge | Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention. | Baseline and one year after implementation | 
| Change in Patient Vaccine Attitudes | Data 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. | Baseline and one year after implementation | 
| Change in Patient Vaccine Beliefs | Data 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. | Baseline and one year after implementation | 
| Change in Provider Vaccine Beliefs | Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention. | Baseline and one year after implementation | 
| Change in Provider Vaccine Attitudes | Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention. | Baseline and one year after implementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Vaccination, Vaccine Acceptance, Influenza, Pertussis, Tdap