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Completed

NCT Number: NCT04203277

Improving Vaccinations for Young Children (IVY)

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.

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Key information

Conditions

Vaccination Refusal Behavior Health Behavior Treatment Adherence and Compliance Treatment Refusal

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sarah E Williams

Nashville, Tennessee, 37232, United States

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pediatric clinics
  • serving children at minimum up to age 2
  • located in Tennessee

Exclusion criteria

-none

Treatment and study plan

IVY

Other

a combination of practice education and quality improvement interventions

Primary outcomes

  1. Combination 10 vaccination rates in 2 year old children

    Time frame: Assessing change in combination 10 vaccination rates in 2 year old children up to 12 months

    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.

Secondary outcomes

  1. Combination 3 vaccination rates in 2 year old children

    Time frame: Assessing change in combination 3 vaccination rates in 2 year old children up to 12 months

    The primary outcome is individual patient-level receipt of all vaccinations [Combo 3 (binary, yes/no)] for children turning 2 years of age

  2. Additional sub analyses of combination 10 vaccination rates (excluding flu vaccine) in 2 year old children

    Time frame: Assessing change in combination 10 vaccination (excluding flu vaccine) rates in 2 year old children up to 12 months

    We will adjust our data and analyze combo 10 vaccination rates minus influenza vaccine.

  3. Additional sub analyses of combination 10 vaccination rates in 2 year old children adjusting for proportion of practice who complete educational training

    Time frame: Assessing how "dose" of educational training affects change in combination 10 vaccination rates in 2 year old children up to 12 months

    We will determine proportion of the practice who completed the educational training and conduct a dose analysis.

  4. Additional sub analyses of combination 10 vaccination rates in 2 year old children adjusting for whether practice represents a community or academic population

    Time frame: Assessing change in combination 10 vaccination rates in 2 year old children up to 12 months, adjusting for educational "dose"

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: IVY

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2019
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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