AzTrials
AzTrials

InfluenzaAFIX-OBNCT04678271

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

A study testing AFIX-OB Quality Improvement Package in people with Influenza and Whooping Cough, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Influenza, Whooping Cough
What is being tested?
AFIX-OB Quality Improvement Package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 siteUnited States
Study dates
1 Jul 2021to 31 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Already enrolled in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale New Haven Hospital

    New Haven, Connecticut, 06512

Other trials in United States

About this study

Official title: 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.

Being tested
AFIX-OB Quality Improvement Package
Keywords
Pregnancy, Vaccination, Vaccine Acceptance, Influenza, Pertussis, Tdap
Medical subject headings
Influenza, Human, Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AFIX-OB Quality Improvement PackageBehavioural

    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.

Study groups in NCT04678271
Study groupRoleWhat they receive
AFIX-OB Intervention ArmExperimentalPractices 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.
Receives: Behavioral: AFIX-OB Quality Improvement Package
Control ArmNo interventionPractices randomized to this arm will continue to provide their normal standard of care to pregnant patients at their practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Maternal Influenza Uptake

    Immunization rates for each practice will be collected through JDAT or a random chart review.

    Measured: Baseline and one year after implementation

  2. Change in Maternal Tdap Uptake

    Immunization rates for each practice will be collected through JDAT or a random chart review.

    Measured: Baseline and one year after implementation

Secondary outcomes (6)

  1. 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.

    Measured: Baseline and one year after implementation

  2. Change in Provider Vaccine Knowledge

    Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.

    Measured: Baseline and one year after implementation

  3. 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.

    Measured: Baseline and one year after implementation

  4. 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.

    Measured: Baseline and one year after implementation

  5. Change in Provider Vaccine Beliefs

    Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.

    Measured: Baseline and one year after implementation

  6. Change in Provider Vaccine Attitudes

    Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention.

    Measured: Baseline and one year after implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2020
  2. Study start1 Jul 2021
  3. Primary completion30 Sep 2022
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04678271
Sponsor's protocol ID
2000027357
Other IDs
1U01IP001110-01
Acronym
AFIX-OB
Status last verified
Sep 2023
First submitted
16 Dec 2020
Last updated
21 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10437765

  • 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.

    PubMed 26044495

  • 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.

    PubMed 10186655

  • 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.

    PubMed 9949744

  • 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.

    PubMed 30503657

  • 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.

    PubMed 30260946

  • 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.

    PubMed 24996123

  • 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.

    PubMed 27317458

  • 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.

    PubMed 30587042

  • 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.

    PubMed 26829978

Questions about this trial

What is this clinical trial studying?

A study testing AFIX-OB Quality Improvement Package in people with Influenza and Whooping Cough, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Maternal Influenza Uptake (time frame: Baseline and one year after implementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04678271, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
AFIX-OB Clinical Trial NCT04678271 | AzTrials