Centralized IIS-Based Reminder-Recall to Increase Influenza Vaccination Rates

 描述(申请人提供)：季节性流感的年度流行在美国造成相当大的发病率和死亡率，住院率、急诊科和门诊就诊率以及医疗费用都很高。儿童患流感的发病率很高，在将感染传播给成年人方面也发挥了关键作用。自2010年以来，免疫实践咨询委员会(ACIP)建议所有6个月大的儿童接种流感疫苗。然而，疫苗接种率仍然很低--只有56%的2-17岁儿童接种了疫苗。低发病率是季节性流感和准备应对大流行性流感的一个令人担忧的问题。国家推荐的提高儿童流感疫苗接种率的策略之一是通过电话或邮件使用家长提醒/召回(R/R)，这可以将接种率提高高达20个百分点。然而，尽管许多研究表明了R/R的有效性，但只有不到16%的初级保健实践使用R/R。全州范围的免疫信息系统(IISS)现在所有州都有用来跟踪儿童疫苗接种，但它们还没有用于流感疫苗的R/R，因为缺乏证据证明它的有效性，并且缺乏基于IIS的R/R模板。我们已经联合了两个领先的免疫研究小组(科罗拉多州丹佛和纽约州罗切斯特)，以评估集中的基于IIS的流感疫苗R/R的影响，并评估邮寄R/R通过较便宜的电话R/R的附加值。我们还将开发工具，帮助其他州创建有效的IIS R/R系统，以应对季节性和可能的大流行流感爆发。我们的研究有四个目标。目标1是为国家IISS制定规程、临床决策支持和信息内容，以进行流感疫苗的提醒/召回。目的2a是比较集中式IIS自动拨号器(电话)R/R和标准护理控制，以评估IIS R/R对疫苗接种率的影响。我们将在两个不同的疫苗接种提供系统的州(CO和NY)使用整群随机实用试验，并将应用RE-AIM框架来评估IIS R/R的覆盖范围、有效性/成本效益、采用和实施。这项RCT将涉及来自60个实践的66,000名6-17岁儿童，使我们能够评估IIS R/R对整个人口和亚群的影响。Aim 2b将在上述随机对照试验中使用嵌套随机对照试验，以比较基于IIS的R/R对儿童实践的影响与基于IIS的R/R对实践的影响，以及其他社区疫苗接种站点Aim 3将评估自动拨号器故障(错误号码，没有电话)的邮寄R/R的额外好处(和成本)。为此，我们将使用双臂随机对照试验，将练习中的儿童随机分为自动拨号器-单独拨号器与组合自动拨号器+邮寄R/R。这项随机对照试验将涉及来自60个练习的33,000名儿童。目标4(传播目标)将为季节性和大流行性流感的国家基于IIS的流感疫苗R/R开发工具包，并与主要利益攸关方合作制定可持续发展计划。到研究结束时，我们将有一个可行和具有成本效益的模式，以提高儿童季节性或可能的大流行性流感疫苗接种率，以预防流感。我们将向所有州传播IIS模式。

 DESCRIPTION (provided by applicant): Annual epidemics of seasonal influenza cause substantial morbidity and mortality in the US 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. We 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 added value of mailed R/R over the less-expensive phone R/R. We will also develop tools to aid other states in creating efficient IIS R/R systems for seasonal and possible pandemic influenza outbreaks. Our 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 2a is to compare centralized IIS autodialer (phone) R/R to standard of care control to assess the impact of IIS R/R on vaccination rates. We will use a cluster- randomized pragmatic trial in two states (CO and NY) that vary in vaccination delivery systems and will apply the RE-AIM framework to evaluate the reach, effectiveness/cost-effectiveness, adoption and implementation of IIS R/R. This RCT will involve 66,000 children 6m-17yrs from 60 practices, allowing us to assess the impact of IIS R/R on the entire population and on subgroups. Aim 2b will use a nested RCT within the above RCT to compare the impact of IIS-based R/R to the child's practice versus IIS-based R/R to the practice plus other community vaccination sites Aim 3 will evaluate the added benefit (and costs) of mailed R/R for autodialer failures (wrong number, no phone). For this aim we will use a 2-arm RCT, randomizing children within practices to autodialer-alone versus combined autodialer + mailed R/R. This RCT will involve 33,000 children from 60 practices. Aim 4 (dissemination aim) will develop a toolkit for state IIS-based influenza vaccine R/R for seasonal and pandemic influenza, and work with key stakeholders on a sustainability plan. By the end of the study we will have a feasible and cost-effective model to raise child seasonal or possibly pandemic influenza vaccination rates to prevent influenza. We will disseminate the IIS model to all states.