NIA AD/ADRD Health Care Systems Research Collaboratory

新冠肺炎疫情对熟练护理机构的居民和工人造成了不成比例的影响， 这也是几十年来美国主权财富基金面临的最大挑战。SNF医护人员也经常 面临感染病毒风险的弱势群体。因此，对居民和工人的普遍检测 是遏制病毒传播的关键管理方法。新冠肺炎放大了长久以来的健康 少数族裔SNF居民之间在护理质量和结果方面的差异。公平的SARS-CoV-2检测 战略在缩小这种差距方面发挥着关键作用。这项提案的首要目标是 利用NIA嵌入的务实AD/ADRD临床试验(IMPACT)合作实验室的基础 成立Impact-新冠肺炎(Impact-C)，致力于开发和评估SARS-CoV-2 在高度脆弱的SNF居民和工人中测试策略。目标是：1)建立 Impact-C的基础设施；2)描述SARS-CoV-2检测中的差异，并确定居民、设施和 与新冠肺炎爆发和结果相关的政策特征；3)让关键利益攸关方参与 制定对文化敏感的SARS-CoV-2检测策略；以及4)设计和实施SARS-CoV-2群集式随机对照试验- 嵌入SNF卫生系统的CoV-2检测策略。所有数据将与RADx-UP共享 协调和数据收集中心。的组织、管理和专业知识组件 Impact-C将包括：领导力、监管结构、传播和调查人员。Impact-C也将 利用Impact的数据共享协作，其中包括11家国家公司，这些公司共同拥有 1,000 SNF，并使用通用电子病历(EMR)平台。我们已经建立了 安全、定期地从该财团接收日常电子病历和新冠肺炎数据并将其链接的基础设施 到联邦医疗保险索赔和最低数据集评估。利用这个丰富和有代表性的数据库，我们将 建立一系列模型，为SARS-CoV-2检测政策提供信息，并预测疫情。此外，我们 将利用Impact的资源来发展一支多元化的、积极参与的利益相关者小组，他们将确定 非典冠状病毒-2检测的障碍，开发解决方案，并为未来检测的发展提供信息 将在分组研究中进行测试的战略(目标4)。我们设计了一个由120-150个设施组成的集群RCT来 比较新颖的护理点检测和常规护理对新冠肺炎感染率的影响。这个 新冠肺炎大流行正在迅速演变，我们拥有专业知识来修改拟议的试验， 测试技术的进步，改善了在SNF中进行护理点测试的机会，利益相关者 建议和区域政策。最终，Impact-C将迅速而严格地 进行疫苗试验。总而言之，Impact-C将建立基础设施和专业知识来开发和 评估对具有同情心和文化敏感性的SNF的SARS-CoV-2检测策略，但在 同时，它们足够灵活，足以应对测试模式和疫苗开发方面的快速进步。

The COVID-19 pandemic has disproportionately affected skilled nursing facilities’ (SNF) residents and workers, and it is the biggest challenge U.S. SNFs have faced in decades. SNF healthcare workers are also often disadvantaged persons at risk for contracting the virus. Thus, universal testing of residents and workers has been a key management approach to containing viral spread. COVID-19 has magnified long-standing health disparities in the quality and outcomes of care among minority SNF residents. Equitable SARS-CoV-2 testing strategies have a critical role to play in mitigating such disparities. This proposal’s overarching goal is to leverage the foundation of the NIA IMbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory to establish IMPACT-COVID-19 (IMPACT-C) which will be dedicated to developing and evaluating SARS-CoV-2 testing strategies among highly vulnerable SNF residents and workers. The Aims are to: 1) Establish the infrastructure of IMPACT-C; 2) Describe disparities in SARS-CoV-2 testing, and identify resident, facility and policy characteristics associated with COVID-19 outbreaks and outcomes; 3) Engage key stakeholders to develop culturally sensitive SARS-CoV-2 testing strategies; and 4) Design and conduct cluster RCTs of SARS- CoV-2 testing strategies embedded in SNF heath systems. All data will be shared with the RADx-UP Coordination and Data Collection Center. The organizational, administrative, and expertise components for IMPACT-C will include: leadership, regulatory structures, dissemination, and investigators. IMPACT-C will also leverage IMPACT’s Data Sharing Collaborative that includes 11 national companies that collectively own over 1,000 SNFs and use a common electronic medical record (EMR) platform. We have already established the infrastructure to securely and regularly receive daily EMR and COVID-19 data from this consortium and link it to Medicare claims and Minimum Data Set assessments. Using this rich and representative database, we will conduct a series of models to inform policies on SARS-CoV-2 testing and to forecast outbreaks. Further, we will leverage IMPACT’s resources to develop a diverse and engaged group of stakeholders who will identify barriers to SARS-CoV-2 testing in SNFs, develop solutions, and inform the development of future testing strategies to be tested in a cluster RCT (Aim 4). We have designed a cluster RCT of 120-150 facilities to compare the effect of novel, point-of-care testing versus usual care on the rate of COVID-19 infections. The COVID-19 pandemic is rapidly evolving, and we have the expertise to modify the proposed trial based on advances in testing technology, improved access to point-of-care testing in SNFs, stakeholder recommendations, and regional policies. Ultimately, IMPACT-C will be well-poised to rapidly and rigorously conduct a vaccine trial. In summary, IMPACT-C will establish the infrastructure and expertise to develop and evaluate SARS-CoV-2 testing strategies for SNFs that are compassionate and culturally sensitive, but at the same time, are nimble enough to respond to rapid advances in testing modalities and vaccine development.