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

Not Applicable

Completed

• Conditions: Influenza; Whooping Cough
• Interventions: Behavioral: AFIX-OB Quality Improvement Package

• Registration Number: NCT04678271
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-21
• Study Start: 2021-07-01
• Primary Completion: 2022-09-30
• Study Completion: 2023-01-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 202

Inclusion Criteria

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

Read More

Exclusion Criteria

• Already enrolled in the study

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AFIX-OB Intervention Arm	AFIX-OB Quality Improvement Package	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.

Primary Outcome Measures

Name	Time	Method
Change in Maternal Influenza Uptake	Baseline and one year after implementation	Immunization rates for each practice will be collected through JDAT or a random chart review.
Change in Maternal Tdap Uptake	Baseline and one year after implementation	Immunization rates for each practice will be collected through JDAT or a random chart review.

Secondary Outcome Measures

Name	Time	Method
Change in Provider Vaccine Knowledge	Baseline and one year after implementation	Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.
Change in Patient Vaccine Attitudes	Baseline and one year after implementation	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.
Change in Provider Vaccine Beliefs	Baseline and one year after implementation	Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.
Change in Provider Vaccine Attitudes	Baseline and one year after implementation	Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.
Change in Patient Vaccine Beliefs	Baseline and one year after implementation	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.
Change in Patient Vaccine Knowledge	Baseline and one year after implementation	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.

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States