Improving Vaccinations for Young Children (IVY)

NCT04203277 | Completed

• 1 other identifier: 190032
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaccination Refusal

Keywords

vaccine uptake, timely vaccination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Combination 3 vaccination rates in 2 year old children

  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

  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

  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

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

Study Arms (4)

Step Wedge Randomized Group 1

EXPERIMENTAL

Includes two pediatric practices randomized to the first step of the step-wedge randomized trial

Other: IVY

Step Wedge Randomized Group 2

EXPERIMENTAL

Includes two pediatric practices randomized to the second step of the step-wedge randomized trial

Other: IVY

Step Wedge Randomized Group 3

EXPERIMENTAL

Includes two pediatric practices randomized to the third step of the step-wedge randomized trial

Other: IVY

Step Wedge Randomized Group 4

EXPERIMENTAL

Includes two pediatric practices randomized to the fourth step of the step-wedge randomized trial

Other: IVY

Interventions

IVY OTHER

a combination of practice education and quality improvement interventions

Step Wedge Randomized Group 1; Step Wedge Randomized Group 2; Step Wedge Randomized Group 3; Step Wedge Randomized Group 4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Sarah E Williams

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 34118498 DERIVED

MeSH Terms

Conditions

Vaccination Refusal

Condition Hierarchy (Ancestors)

Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sarah E Williams, MD, MPH

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: Intervention effectiveness on improving vaccination rates will be evaluated using a SW-CRT. 36 Eight practices (clusters) will eventually be randomized to receive the IVY intervention over a 13-month study period. Patients are clustered within practices, and outcomes will be assessed on cross-sectional samples of individuals at each practice at 13 discrete, monthly time points. There will be a baseline block of two months where all practices will be in the control group (Figure 3). Following this, two practices will be randomly assigned to receive the intervention (Group 1). Two months after initiation of IVY in Group 1, two practices will be randomly assigned to receive the intervention in Group 2. This will be continued for 4 total Groups. There will be a five-month block after implementing IVY in all practices where data will continue to be collected after all have been assigned to receive the intervention.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 18, 2019
• Study Start: April 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)