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临床试验/NCT02165722
NCT02165722已完成不适用

An Enhanced 4 Pillars Toolkit for Increasing Adolescent Immunization: A Randomized Controlled Cluster Trial in Pediatrics and Family Medicine

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2013年9月最近更新:
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
22
试验地点
2
主要终点
Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age

研究概览

简要总结

The purpose of this study is to test whether or not the 4 Pillars Immunization Toolkit increases adolescent vaccination rates, particularly influenza and human papillomavirus (HPV) but also tetanus, diphtheria and pertussis (Tdap), and meningococcal conjugate (MCV) vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to national guidelines. The investigators will conduct a randomized cluster trial of this toolkit in diverse primary care practices with electronic medical records (EMRs).

详细描述

This intervention is a stratified randomized cluster trial in about 22 diverse primary care practices. These practices will be randomly assigned to be intervention or control sites to test this 4 Pillars Immunization Toolkit intervention package of evidence-based techniques tailored to their practice structure and culture; the specialties are split between pediatric and family medicine practices.

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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

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • For clinical sites: inclusion criterion includes
  • an appropriate adolescent population: e.g., adolescents aged 11 to 17 years
  • currently using an EMR
  • having and keeping immunization data within a EMR or registry.

排除标准

  • For clinical sites: the exclusion criteria is consistent SOP use for the vaccines being studied or known much higher than average immunization rates.

研究组 & 干预措施

Intervention: Toolkit

Experimental

4 Pillars Toolkit

干预措施: 4 Pillars Toolkit (Behavioral)

No Intervention: Standard practice

No Intervention

11 Clinical Practices [control sites]

结局指标

主要结局

Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age

时间窗: Baseline period to post-intervention

Change in cumulative vaccination rates from baseline to end of year 1 for HPV series initiation (e.g., receipt of first dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.

Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age

时间窗: Baseline period to post-intervention

Change in cumulative vaccination rates from baseline to end of year 1 for HPV series completion (e.g., receipt of third dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.

次要结局

未报告次要终点

研究者

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

Richard Zimmerman

Professor

University of Pittsburgh

研究点 (2)

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