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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
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Pregnancy, Vaccination, Vaccine Acceptance, Influenza, Pertussis, Tdap

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
December 16, 2020
Last Updated
September 18, 2023
Sponsor
Yale University
Collaborators
Centers for Disease Control and Prevention
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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:
PubMed Identifier
10437765
Citation
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Results Reference
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26044495
Citation
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Results Reference
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PubMed Identifier
10186655
Citation
Dini EF, Chaney M, Moolenaar RL, LeBaron CW. Information as intervention: how Georgia used vaccination coverage data to double public sector vaccination coverage in seven years. J Public Health Manag Pract. 1996 Winter;2(1):45-9. doi: 10.1097/00124784-199600210-00008.
Results Reference
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PubMed Identifier
9949744
Citation
Fairbrother G, Hanson KL, Friedman S, Butts GC. The impact of physician bonuses, enhanced fees, and feedback on childhood immunization coverage rates. Am J Public Health. 1999 Feb;89(2):171-5. doi: 10.2105/ajph.89.2.171.
Results Reference
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PubMed Identifier
30503657
Citation
Frew PM, Murden R, Mehta CC, Chamberlain AT, Hinman AR, Nowak G, Mendel J, Aikin A, Randall LA, Hargreaves AL, Omer SB, Orenstein WA, Bednarczyk RA. Development of a US trust measure to assess and monitor parental confidence in the vaccine system. Vaccine. 2019 Jan 7;37(2):325-332. doi: 10.1016/j.vaccine.2018.09.043. Epub 2018 Nov 30.
Results Reference
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PubMed Identifier
30260946
Citation
Kahn KE, Black CL, Ding H, Williams WW, Lu PJ, Fiebelkorn AP, Havers F, D'Angelo DV, Ball S, Fink RV, Devlin R. Influenza and Tdap Vaccination Coverage Among Pregnant Women - United States, April 2018. MMWR Morb Mortal Wkly Rep. 2018 Sep 28;67(38):1055-1059. doi: 10.15585/mmwr.mm6738a3.
Results Reference
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PubMed Identifier
24996123
Citation
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.
Results Reference
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PubMed Identifier
27317458
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.
Results Reference
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PubMed Identifier
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Citation
Ellingson MK, Dudley MZ, Limaye RJ, Salmon DA, O'Leary ST, Omer SB. Enhancing uptake of influenza maternal vaccine. Expert Rev Vaccines. 2019 Feb;18(2):191-204. doi: 10.1080/14760584.2019.1562907. Epub 2019 Jan 28.
Results Reference
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Citation
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Results Reference
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Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake

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