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临床试验/NCT04203277
NCT04203277已完成不适用

Improving Vaccinations for Young Children (IVY)

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Combination 10 vaccination rates in 2 year old children

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

Step Wedge Randomized Group 1

Experimental

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

干预措施: IVY (Other)

Step Wedge Randomized Group 2

Experimental

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

干预措施: IVY (Other)

Step Wedge Randomized Group 3

Experimental

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

干预措施: IVY (Other)

Step Wedge Randomized Group 4

Experimental

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

干预措施: IVY (Other)

结局指标

主要结局

Combination 10 vaccination rates in 2 year old children

时间窗: 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.

次要结局

  • 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")
  • 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 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 (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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Williams

Assistant Professor of Pediatrics

Vanderbilt University Medical Center

研究点 (2)

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