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

 描述（由申请方提供）：在美国，季节性流感的年度流行导致大量发病率和死亡率，住院率、急诊和门诊就诊率以及医疗费用都很高。儿童经历流感的显著发病率，并且在将感染传播给成人方面也起着关键作用。自2010年以来，免疫实践咨询委员会（ACIP）建议所有6个月以上的儿童接种流感疫苗。然而，疫苗接种率仍然很低，2-17岁儿童中只有56%接种了疫苗。低发病率是季节性流感和大流行性流感的一个问题。提高儿童流感疫苗接种率的国家推荐策略之一是通过电话或邮件使用父母提醒/召回（R/R），这可以将接种率提高20个百分点。然而，尽管许多研究表明其有效性，但只有不到16%的初级保健实践使用R/R。目前，所有州都有全州范围的免疫信息系统（IIS）来跟踪儿童疫苗接种情况，但由于缺乏证据证明其有效性，也缺乏基于IIS的R/R模板，因此尚未将其用于流感疫苗的R/R。我们联合了两个领先的免疫研究小组（科罗拉多州丹佛市和纽约州罗切斯特市），以评估基于IIS的流感疫苗集中R/R的影响，并评估邮寄R/R相对于较便宜的电话R/R的附加值。我们还将开发工具，帮助其他州建立有效的IIS R/R系统，以应对季节性和可能的大流行性流感爆发。我们的研究有四个目标。目标1是为州IIS制定方案、临床决策支持和信息内容，以进行流感疫苗接种的提醒/召回。目的2a是比较集中式IIS自动拨号器（电话）R/R与标准护理对照，以评估IIS R/R对疫苗接种率的影响。我们将在两个州（CO和NY）进行一项分组随机化实用试验，这两个州的疫苗接种系统不同，并将应用RE-AIM框架来评价IIS R/R的覆盖范围、有效性/成本效益、采用和实施。这项随机对照试验将涉及来自60个实践的66，000名6 m-17岁儿童，使我们能够评估IIS R/R对整个人群和亚组的影响。目标2b将在上述随机对照试验中使用嵌套随机对照试验，比较基于IIS的R/R对儿童实践的影响，以及基于IIS的R/R对实践和其他社区疫苗接种点的影响。目标3将评估邮寄R/R对自动拨号失败（错误号码，没有电话）的额外益处（和成本）。为此，我们将使用一项2组RCT，将实践中的儿童随机分为单独自动拨号器组和联合自动拨号器+邮寄R/R组。这项随机对照试验将涉及来自60个诊所的33 000名儿童。目标4（传播目标）将开发一个工具包，用于季节性和大流行性流感的基于国家免疫系统的流感疫苗R/R，并与关键利益攸关方合作制定可持续性计划。到研究结束时，我们将有一个可行的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。我们将向所有州推广IIS模型。

 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.