Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake (AFIX-OB)
Primary Purpose
Influenza, Whooping Cough
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AFIX-OB Quality Improvement Package
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Pregnancy, Vaccination, Vaccine Acceptance, Influenza, Pertussis, Tdap
Eligibility Criteria
Inclusion Criteria:
- Between 18-50 years of age
- Currently pregnant and gestational age <26 weeks
Exclusion Criteria:
- Already enrolled in the study
Sites / Locations
- Yale New Haven Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AFIX-OB Intervention Arm
Control Arm
Arm Description
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.
Practices randomized to this arm will continue to provide their normal standard of care to pregnant patients at their practice.
Outcomes
Primary Outcome Measures
Change in Maternal Influenza Uptake
Immunization rates for each practice will be collected through JDAT or a random chart review.
Change in Maternal Tdap Uptake
Immunization rates for each practice will be collected through JDAT or a random chart review.
Secondary Outcome Measures
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.
Change in Provider Vaccine Knowledge
Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.
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.
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.
Change in Provider Vaccine Beliefs
Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.
Change in Provider Vaccine Attitudes
Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.
Full Information
NCT ID
NCT04678271
First Posted
December 16, 2020
Last Updated
September 18, 2023
Sponsor
Yale University
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04678271
Brief Title
Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake
Acronym
AFIX-OB
Official Title
Assessment, Feedback, Incentive, Exchange (AFIX-OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Whooping Cough
Keywords
Pregnancy, Vaccination, Vaccine Acceptance, Influenza, Pertussis, Tdap
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AFIX-OB Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Practices randomized to this arm will continue to provide their normal standard of care to pregnant patients at their practice.
Intervention Type
Behavioral
Intervention Name(s)
AFIX-OB Quality Improvement Package
Intervention Description
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 Outcome Measure Information:
Title
Change in Maternal Influenza Uptake
Description
Immunization rates for each practice will be collected through JDAT or a random chart review.
Time Frame
Baseline and one year after implementation
Title
Change in Maternal Tdap Uptake
Description
Immunization rates for each practice will be collected through JDAT or a random chart review.
Time Frame
Baseline and one year after implementation
Secondary Outcome Measure Information:
Title
Change in Patient Vaccine Knowledge
Description
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.
Time Frame
Baseline and one year after implementation
Title
Change in Provider Vaccine Knowledge
Description
Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.
Time Frame
Baseline and one year after implementation
Title
Change in Patient Vaccine Attitudes
Description
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.
Time Frame
Baseline and one year after implementation
Title
Change in Patient Vaccine Beliefs
Description
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.
Time Frame
Baseline and one year after implementation
Title
Change in Provider Vaccine Beliefs
Description
Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.
Time Frame
Baseline and one year after implementation
Title
Change in Provider Vaccine Attitudes
Description
Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.
Time Frame
Baseline and one year after implementation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between 18-50 years of age
Currently pregnant and gestational age <26 weeks
Exclusion Criteria:
Already enrolled in the study
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06512
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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10437765
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Yuen CY, Tarrant M. Determinants of uptake of influenza vaccination among pregnant women - a systematic review. Vaccine. 2014 Aug 6;32(36):4602-13. doi: 10.1016/j.vaccine.2014.06.067. Epub 2014 Jul 2.
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Citation
Myers KL. Predictors of maternal vaccination in the United States: An integrative review of the literature. Vaccine. 2016 Jul 25;34(34):3942-9. doi: 10.1016/j.vaccine.2016.06.042. Epub 2016 Jun 18.
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Citation
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Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake
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