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临床试验/NCT01557621
NCT01557621已完成不适用

Center for Research in Implementation Science and Prevention (CRISP): Project 1: Comparative Effectiveness Trial of Two Reminder/Recall Methods to Increase Immunization Rates in Young Children

University of Colorado, Denver4 个研究点 分布在 1 个国家目标入组 68,000 人开始时间: 2012年9月最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
68,000
试验地点
4
主要终点
1) Change in up-to-date rates for 19- to 35-month-olds (who needed an immunization at baseline) in collaborative population-based counties compared to practice-based intervention counties

研究概览

简要总结

The purpose of this study is to determine if a collaborative centralized population-based reminder/recall intervention is more effective than a traditional practice-based reminder/recall intervention at increasing immunizations among young children.

详细描述

The study proposed is of immense importance in directing future methodology for bringing children who have not received needed immunizations up to date. The proposed study builds on the success of a previous trial and incorporates data from providers and patients to further improve the intervention. In this study the investigators aim to increase the effectiveness, cost effectiveness, and acceptability to practices and families of population-based R/R by introducing a strong private-public collaboration and maximizing health information technologies that allow practices to interface with Colorado's Immunization Services System (CIIS). Two real-world approaches will be compared: one approach will provide primary care practices the tools to conduct recall and educational interventions. In the other approach, population-based centralized recall by the state immunization registry will be conducted in collaboration with practices. Determining which of these methods is most effective in reaching the most children and comparing the cost of each will provide data critical in guiding future national efforts to assure that children entering school are fully vaccinated. Because the trial will be conducted at the level of both urban and rural counties throughout the state and will include all types of providers, the investigators expect our findings to be nationally generalizable.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
19 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 19-35 months at time of recall
  • has an address in a specified study county listed in the state immunization registry
  • child is in need of at least one immunization at time of study

排除标准

  • Opted out of the Colorado Immunization Information System (CIIS)
  • child is up-to-date on all immunizations

结局指标

主要结局

1) Change in up-to-date rates for 19- to 35-month-olds (who needed an immunization at baseline) in collaborative population-based counties compared to practice-based intervention counties

时间窗: every 6 months for 2 years

The definition of up-to-date is based on the national Advisory Committee on Immunization Practices(ACIP)recommended series of antigens (4:3:1:3:3:1:3) to be received by the age of 19-20 months. Three different cohorts of children aged 19-35 months will be assessed across the 3 year study period. Outcomes from each cohort will be assessed 6 months post-intervention.

2) Change in percent of children (who needed an immunization at baseline) who received any additional vaccines in each type of intervention county.

时间窗: every 6 months for two years

Number (percent) of children who received ANY vaccination within the 6 month intervention period.

次要结局

  • Cost Analysis of Collaborative Population-based Recall versus Practice-based Recall(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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