Clinical trial NCT04678271: Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake
Official title: Assessment, Feedback, Incentive, Exchange (AFIX-OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Whooping Cough
Keywords: Pregnancy
Vaccination
Vaccine Acceptance
Influenza
Pertussis
Tdap
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-12-21
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Already enrolled in the study

Primary outcomes:
measure: Change in Maternal Influenza Uptake
timeFrame: Baseline and one year after implementation
measure: Change in Maternal Tdap Uptake
timeFrame: Baseline and one year after implementation
Secondary outcomes:
measure: Change in Patient Vaccine Knowledge
timeFrame: Baseline and one year after implementation
measure: Change in Provider Vaccine Knowledge
timeFrame: Baseline and one year after implementation
measure: Change in Patient Vaccine Attitudes
timeFrame: Baseline and one year after implementation
measure: Change in Patient Vaccine Beliefs
timeFrame: Baseline and one year after implementation
measure: Change in Provider Vaccine Beliefs
timeFrame: Baseline and one year after implementation
measure: Change in Provider Vaccine Attitudes
timeFrame: Baseline and one year after implementation
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
References:
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