Improving Vaccinations for Young Children (IVY)

Vaccination Refusal Clinical Trial

— IVY  

Official title:

Improving Vaccinations for Young Children (IVY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203277
• Other study ID #: 190032
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: May 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The IVY project focuses on improving combination 10 vaccine rates for Tennessee children through an educational and quality improvement intervention rolled out through a stepped-wedge cluster randomized trial.

Description:

The proposed work seeks to improve Combination 10 vaccination rates for Tennessee children at 2 years of age through the development and implementation of a new program, Improving Vaccination for Young Children (IVY). Through a collaboration with the Cumberland Pediatrics Foundation (CPF), a non-profit company focused on improving health care services for Tennessee's children, investigators plan to adapt and disseminate existing CoVER educational materials for community pediatric providers and clinical staff, and develop and implement targeted quality improvement (QI) initiatives.

A.3. Specific Objectives:

1. Design interactive web-based modules individualized for two groups (pediatric providers and pediatric clinical staff) to educate on key vaccine topics. Modules will include information related to 1) diseases vaccines are targeting, including influenza 2) vaccine contraindications, common misconceptions, and vaccine safety, 3) communication techniques, 4) vaccine schedules and catch up rules, and 5) exemptions, school requirements, and practice dismissal.

2. Design an in-person QI coaching session incorporating key drivers for improved vaccination rates. The session will be developed using the 4Pillars™ Practice Transformation Program (4Pillars™) and will include introduction of 1) acute visits for vaccine catch up, 2) team-based care practices, 3) standing vaccination record review and vaccination orders, and 4) reminder/recall systems.

3. Implement educational modules and QI coaching session at specific time points within the context of a stepped wedge cluster randomized trial (SW-CRT). Combination 10 [(Combo 10)] vaccine rates will be collected monthly from the Electronic Health Record (EHR) of recruited practices for eligible children turning 2 years of age. Vaccine rates will be compared between practices monthly within the SW-CRT design. Rates will also be evaluated by practice over time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pediatric clinics

• serving children at minimum up to age 2

• located in Tennessee

Exclusion Criteria:

-none

Related Conditions & MeSH terms

• Vaccination Refusal

Intervention

Other:
• IVY
a combination of practice education and quality improvement interventions

Locations

Country	Name	City	State
United States	Sarah E Williams	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combination 10 vaccination rates in 2 year old children	The primary outcome is individual patient-level receipt of all vaccinations [Combo 10 (binary, yes/no)] for children turning 2 years of age in prior month.	Assessing change in combination 10 vaccination rates in 2 year old children up to 12 months
Secondary	Combination 3 vaccination rates in 2 year old children	The primary outcome is individual patient-level receipt of all vaccinations [Combo 3 (binary, yes/no)] for children turning 2 years of age	Assessing change in combination 3 vaccination rates in 2 year old children up to 12 months
Secondary	Additional sub analyses of combination 10 vaccination rates (excluding flu vaccine) in 2 year old children	We will adjust our data and analyze combo 10 vaccination rates minus influenza vaccine.	Assessing change in combination 10 vaccination (excluding flu vaccine) rates in 2 year old children up to 12 months
Secondary	Additional sub analyses of combination 10 vaccination rates in 2 year old children adjusting for proportion of practice who complete educational training	We will determine proportion of the practice who completed the educational training and conduct a dose analysis.	Assessing how "dose" of educational training affects change in combination 10 vaccination rates in 2 year old children up to 12 months
Secondary	Additional sub analyses of combination 10 vaccination rates in 2 year old children adjusting for whether practice represents a community or academic population	We will adjust for the bivariate variable of community versus academic population within our analysis model. Community practices are those that are recruited by our partner Cumberland Pediatric Foundation and academic practices are those directly affiliated with Vanderbilt.	Assessing change in combination 10 vaccination rates in 2 year old children up to 12 months, adjusting for educational "dose"