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临床试验/NCT01390363
NCT01390363已完成不适用

Adolescent Immunization Recall Systems: A Randomized Controlled Trial

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2010年5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
420
试验地点
1
主要终点
receipt of vaccine of interest at 28 days

研究概览

简要总结

The purpose of this study is to determine whether contacting the parents of adolescents overdue for routine vaccines or contacting both the parents AND adolescents overdue to routine vaccines improves immunization rates as compared to usual care.

详细描述

This randomized controlled trial is a 3-armed study designed to evaluate an immunization recall system in adolescents. In the control arm (Group 1), the adolescents will receive usual care, in which they will primarily receive immunizations at annual physical exams, or as recommended by providers at urgent care visits. In one intervention arm (Group 2), the parent/guardian will receive a telephone call informing them that the adolescent is overdue for one or more immunizations (conjugated Neisseria meningitidis (MCV4) vaccine, tetanus-diphtheria-pertussis (Tdap) booster, and/or the second varicella (VZV) vaccine). In the second intervention arm (Group 3), both the parent/guardian and the adolescent will receive a telephone call informing them that the adolescent is overdue for one or more immunizations. Immunization rates will be compared between the 3 groups at a four week and a twelve month follow up period.

研究设计

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

入排标准

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

入选标准

  • at least 13 years of age and under 18 years of age
  • had a billing code for an annual physical exam in the past 3 years at the Adolescent/Young Adult Medical Practice at Children's Hospital Boston
  • immunization record shows one of the following: no tetanus containing vaccine in the previous 5 years; no MCV4 vaccine; and/or has received the 1st VZV vaccine but not the 2nd VZV vaccine and has no documented history of the chicken pox

排除标准

  • immunization record shows no vaccines or only influenza vaccines
  • sibling enrolled in the study
  • in the custody of the Department of Youth Services
  • in the custody of the Department of Child and Family Services

研究组 & 干预措施

control

No Intervention

This study arm will receive usual clinical care, but no specific intervention will be made to inform the parent or adolescent that the adolescents is overdue for a routine vaccine.

Parent Only Group

Experimental

Parent Only Phone Call

干预措施: Parent Only Phone Call (Other)

Parent and Adolescent Group

Experimental

Parent and Adolescent Phone Call

干预措施: Parent and Adolescent Phone Call (Other)

结局指标

主要结局

receipt of vaccine of interest at 28 days

时间窗: 28 days

Vaccination records are assessed 28 days after the intervention to see if Tdap, MCV4, or the 2nd VZV vaccine were administered.

次要结局

  • receipt of other vaccines at 1 year(1 year)
  • receipt of prior vaccines at 28 days(28 days)
  • receipt of prior vaccines at 1 year(1 year)
  • receipt of vaccine of interest at 1 year(1 year)
  • receipt of other vaccines at 28 days(28 days)

研究者

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

Kathryn S. Brigham

Fellow

Boston Children's Hospital

研究点 (1)

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