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

September 18, 2023 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06512
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Already enrolled in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AFIX-OB Intervention Arm
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
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.
No Intervention: Control Arm
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?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000027357
  • 1U01IP001110-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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