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临床试验/NCT02924467
NCT02924467已完成不适用

Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates in New York State

University of California, Los Angeles0 个研究点目标入组 100,000 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100,000
主要终点
Number of subjects receiving influenza vaccine

研究概览

简要总结

Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months, only about half of children are vaccinated annually, leading to substantial influenza disease in children and spread of disease to adults. A major barrier is that families are not reminded about the need for their children to receive influenza vaccination. The investigators will evaluate the impact of patient reminder/recall performed by state immunization information systems to improve influenza vaccination rates by using three clinical trials in two states. The investigators will assess effectiveness and cost-effectiveness of phone reminder/recall on improving influenza vaccination rates. The investigators will disseminate the state immunization information system-based reminder/recall system to all states for use for seasonal and pandemic influenza vaccinations with the goal of lowering influenza morbidity.

详细描述

Annual epidemics of influenza A and B cause substantial morbidity and mortality in the US with high rates of hospitalizations, emergency department visits, outpatient visits, and medical costs. Children experience significant morbidity from influenza and also play a key role in instigating and expanding epidemics. In addition, concerns about pandemic influenza heighten the importance of new mechanisms to rapidly inform the population about influenza and direct efforts for rapid vaccine delivery.

Since 2010, the Advisory Committee on Immunization Practices (ACIP) has recommended influenza vaccination for all children >6 months of age. However, vaccination rates remain very low. For the 2012-2013 season, only 56% of children 2-17y were vaccinated. Modeling studies suggest that as many as 19 million cases of influenza could be prevented if child vaccination rates were raised to 70% nationally. The most effective strategy recommended by CDC and the Task Force on Community Preventive Services for improving childhood influenza vaccination rates is reminder/recall (R/R), sent by phone or mail, notifying parents of the need to vaccinate their child. The published literature suggests R/R can improve influenza vaccination rates. However, few practices use R/R; barriers are practice costs, insufficient staff time and expertise, and lack of predictability regarding receipt of vaccine supplies.

Statewide immunization information systems (IISs) now exist in all states to track vaccinations. They have not yet been used for influenza vaccine R/R because of lack of evidence for their effectiveness and a lack of a template for IIS-based reminder/recall. The investigators have united two leading immunization research groups (Denver, CO and Rochester, NY) to assess the impact of centralized IIS-based influenza vaccine reminder/recall, and to evaluate the effect of intensity of recall (1 v. 2. v. 3 reminders) over usual care. The investigators will also develop tools to aid other states in creating efficient IIS reminder/recall systems. The investigators will also develop tools to aid other states in creating efficient IIS reminder/recall systems for seasonal and possible pandemic influenza outbreaks.

The study has four aims:

Aim 1 is to develop the protocols, clinical decision support, and message content for state IISs to conduct reminder/recall for influenza vaccinations.

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
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • A record in the New York State Immunization Information System
  • In need of at least one influenza vaccination at time of study
  • Affiliated with a participating practice

排除标准

  • Up to date on influenza vaccine

结局指标

主要结局

Number of subjects receiving influenza vaccine

时间窗: 6 months

The primary outcome is receipt of influenza vaccine by children receiving zero notices compared to those receiving 1,2, or 3 notices.

次要结局

  • Number of subjects receiving influenza vaccine based on demographic subgroups(6 months)
  • Number of subjects <9 years of age that will receive an additional vaccine(1 month)

研究者

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

Peter G Szilagyi, MD MPH

Principal Investigator

University of California, Los Angeles

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