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

NCT04678271 | Completed

• 2 other identifiers: 20000273571U01IP001110-01
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Whooping Cough

Keywords

Pregnancy; Vaccination; Vaccine Acceptance; Influenza; Pertussis; Tdap

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Change in Patient Vaccine Knowledge

  Baseline and one year after implementation

• Change in Provider Vaccine Knowledge

  Baseline and one year after implementation

• Change in Patient Vaccine Attitudes

  Baseline and one year after implementation

• Change in Patient Vaccine Beliefs

  Baseline and one year after implementation

• Change in Provider Vaccine Beliefs

  Baseline and one year after implementation

Study Arms (2)

AFIX-OB Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

Practices randomized to this arm will continue to provide their normal standard of care to pregnant patients at their practice.

Interventions

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.

AFIX-OB Intervention Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Already enrolled in the study

Sponsors & Collaborators

• Yale University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location

Related Publications (10)

• 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.

  PMID: 10437765 BACKGROUND

• 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.

  PMID: 26044495 BACKGROUND

• 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.

  PMID: 10186655 BACKGROUND

• 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.

  PMID: 9949744 BACKGROUND

• 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.

  PMID: 30503657 BACKGROUND

• 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.

  PMID: 30260946 BACKGROUND

• 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.

  PMID: 24996123 BACKGROUND

• 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.

  PMID: 27317458 BACKGROUND

• 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.

  PMID: 30587042 BACKGROUND

• 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.

  PMID: 26829978 BACKGROUND

MeSH Terms

Conditions

Influenza, Human; Whooping Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: July 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: January 31, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)