Improving Vaccinations for Young Children (IVY) (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.

Study Overview

• Status: Completed
• Conditions: Vaccination Refusal
• Intervention / Treatment: Other: IVY

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Sarah E Williams

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Step Wedge Randomized Group 1; Includes two pediatric practices randomized to the first step of the step-wedge randomized trial	Other: IVY; a combination of practice education and quality improvement interventions
Experimental: Step Wedge Randomized Group 2; Includes two pediatric practices randomized to the second step of the step-wedge randomized trial	Other: IVY; a combination of practice education and quality improvement interventions
Experimental: Step Wedge Randomized Group 3; Includes two pediatric practices randomized to the third step of the step-wedge randomized trial	Other: IVY; a combination of practice education and quality improvement interventions
Experimental: Step Wedge Randomized Group 4; Includes two pediatric practices randomized to the fourth step of the step-wedge randomized trial	Other: IVY; a combination of practice education and quality improvement interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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"

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Sarah E Williams, MD, MPH, Vanderbilt University

Publications and helpful links

General Publications

• Williams SE, Adams LE, Sommer EC. Improving Vaccination for Young Children (IVY): A Stepped-Wedge Cluster Randomized Trial. Acad Pediatr. 2021 Sep-Oct;21(7):1151-1160. doi: 10.1016/j.acap.2021.06.001. Epub 2021 Jun 10.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: vaccine uptake, timely vaccination
• Other Study ID Numbers: 190032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No