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Completed

NCT Number: NCT04678271

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.

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Key information

Conditions

Influenza Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Gram-Negative Bacterial Infections Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Whooping Cough

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Already enrolled in the study

Treatment and study plan

AFIX-OB Quality Improvement Package

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Acronym: AFIX-OB

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 21, 2020
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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