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临床试验/NCT02761551
NCT02761551已完成不适用

Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates: Colorado

University of Colorado, Denver0 个研究点目标入组 56,549 人开始时间: 2016年9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
56,549
主要终点
Number of subjects receiving influenza vaccine based on zero notices versus those receiving 1, 2 or 3 notices.

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 (R/R) 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 both seasonal and pandemic influenza vaccinations with the goal of lowering influenza morbidity.

详细描述

Annual epidemics of seasonal influenza cause substantial morbidity and mortality in the U.S. with high rates of hospitalizations, emergency department and outpatient visits, and medical costs. Children experience significant morbidity from influenza, and also play a critical role in spreading infection to adults. 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-- only 56% of children 2-17 years are vaccinated. Low rates are a concern for both seasonal influenza and in preparation for pandemic influenza. One of the nationally recommended strategies for raising childhood influenza vaccination rates is to use parent reminder/recall (R/R) by phone or mail, which can raise rates by up to 20 percentage points. However, less than 16% of primary care practices use R/R despite many studies showing its effectiveness.

Statewide immunization information systems (IISs) now exist in all states to track childhood vaccinations, but they have not been used for R/R for influenza vaccine because of the lack of evidence for its effectiveness and lack of a template for IIS-based R/R. The investigators have united two leading immunization research groups (Denver, CO and Rochester, NY) to assess the impact of centralized IIS-based influenza vaccine R/R, 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 R/R systems for seasonal and possible pandemic influenza outbreaks.

This 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.

Aim 2 is to conduct a pragmatic trial, with randomization at the level of the patient within practices randomly selected to be proportionate to each state, to compare: 1) effectiveness and cost-effectiveness of centralized R/R of different intensity (1 vs. 2 vs. 3 messages) and usual care (0 messages) and 2) effectiveness and cost-effectiveness of R/R in specified subgroups (family medicine vs pediatric provider, rural vs urban, age of child) on receipt of influenza vaccination.

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 Colorado Immunization Information System,
  • In need of at least one influenza vaccination at time of study,
  • Affiliated with a participating practice, or
  • Randomly selected among unaffiliated patients.

排除标准

  • Opted out of participating in CIIS, or
  • Are up-to-date on influenza vaccine

研究组 & 干预措施

Usual Care

No Intervention

Patients in this group will not receive any reminders for influenza vaccine.

1 notice

Experimental

Patients in this group will receive one reminder for influenza vaccine across the 2016 influenza season.

干预措施: Reminder notifications via autodialer (Behavioral)

2 notices

Experimental

Patients in this group will receive up to two reminders for influenza vaccine across the 2016 season.

干预措施: Reminder notifications via autodialer (Behavioral)

3 notices

Experimental

Patients in this group will receive up to three reminders for influenza vaccine across the 2016 season.

干预措施: Reminder notifications via autodialer (Behavioral)

结局指标

主要结局

Number of subjects receiving influenza vaccine based on zero notices versus those receiving 1, 2 or 3 notices.

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

研究者

申办方类型
Other
责任方
Sponsor

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