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

Influenza Clinical Trial

— AFIX-OB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678271
• Other study ID #: 2000027357
• Secondary ID: 1U01IP001110-01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: September 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: January 31, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Between 18-50 years of age

• Currently pregnant and gestational age <26 weeks

Exclusion Criteria:

• Already enrolled in the study

Related Conditions & MeSH terms

• Influenza
• Whooping Cough

Intervention

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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (10)

Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortes M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Improving influenza and Tdap vaccination during pregnancy: A cluster-randomized trial of a multi-component antenatal vaccine promotion package in late influenza season. Vaccine. 2015 Jul 9;33(30):3571-9. doi: 10.1016/j.vaccine.2015.05.048. Epub 2015 Jun 1. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

LeBaron CW, Mercer JT, Massoudi MS, Dini E, Stevenson J, Fischer WM, Loy H, Quick LS, Warming JC, Tormey P, DesVignes-Kendrick M. Changes in clinic vaccination coverage after institution of measurement and feedback in 4 states and 2 cities. Arch Pediatr Adolesc Med. 1999 Aug;153(8):879-86. doi: 10.1001/archpedi.153.8.879. — View 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. — View Citation

O'Leary ST, Pyrzanowski J, Brewer SE, Dickinson LM, Dempsey AF. Evidence-based vaccination strategies in obstetrics and gynecology settings: Current practices and methods for assessment. Hum Vaccin Immunother. 2016 Apr 2;12(4):866-71. doi: 10.1080/21645515.2015.1130194. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Maternal Influenza Uptake	Immunization rates for each practice will be collected through JDAT or a random chart review.	Baseline and one year after implementation
Primary	Change in Maternal Tdap Uptake	Immunization rates for each practice will be collected through JDAT or a random chart review.	Baseline and one year after implementation
Secondary	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.	Baseline and one year after implementation
Secondary	Change in Provider Vaccine Knowledge	Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.	Baseline and one year after implementation
Secondary	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.	Baseline and one year after implementation
Secondary	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.	Baseline and one year after implementation
Secondary	Change in Provider Vaccine Beliefs	Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.	Baseline and one year after implementation
Secondary	Change in Provider Vaccine Attitudes	Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.	Baseline and one year after implementation