NIA AD/ADRD Health Care Systems Research Collaboratory

COVID-19大流行对熟练护理设施（SNF）的居民和工人造成了不成比例的影响， 这是美国SNF几十年来面临的最大挑战。SNF的医护人员也经常 有感染病毒风险的弱势群体。因此，居民和工人的普遍测试 是遏制病毒传播的关键管理方法。COVID-19放大了长期存在的健康状况 少数民族SNF居民的护理质量和结果存在差异。公平的SARS-CoV-2检测 战略在缩小这种差距方面可发挥关键作用。该提案的总体目标是 利用NIA嵌入式实用AD/ADRD临床试验（IMPACT）合作实验室的基础， 建立IMPACT-COVID-19（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测试中的差异，并确定居民，设施和 与COVID-19疫情和结果相关的政策特征; 3）让关键利益相关者参与， 制定文化敏感的SARS-CoV-2检测策略;和4）设计和进行SARS-CoV-2的集群随机对照试验 CoV-2测试策略嵌入SNF健康系统。所有数据将与RADx-UP共享 协调和数据收集中心。组织、行政和专业知识组成部分， IMPACT-C将包括：领导、监管结构、传播和调查人员。IMPACT-C还将 利用IMPACT的数据共享合作，其中包括11个国家的公司，共同拥有超过 1，000个SNF，并使用通用电子病历（EMR）平台。我们已经建立了 基础设施，以安全和定期地接收来自该联盟的每日EMR和COVID-19数据，并将其 医疗保险索赔和最小数据集评估。利用这一丰富而有代表性的数据库，我们将 开展一系列模型，为SARS-CoV-2检测政策提供信息，并预测疫情。我们还 将利用IMPACT的资源，发展一个多元化的利益相关者群体， 在SNF中进行SARS-CoV-2测试的障碍，制定解决方案，并为未来测试的发展提供信息 在一个随机对照试验集群中测试的策略（目标4）。我们设计了一个120-150个设施的集群RCT， 比较新型即时检测与常规护理对COVID-19感染率的影响。的 COVID-19大流行正在迅速发展，我们拥有专业知识，可以根据以下情况修改拟议的试验 检测技术的进步，改善SNF中的即时检测，利益相关者 建议和区域政策。最终，IMPACT-C将能够快速、严格地 进行疫苗试验。总之，IMPACT-C将建立基础设施和专门知识， 评估SARS-CoV-2检测策略的SNF是同情和文化敏感，但在 与此同时，它们也足够灵活，能够对测试模式和疫苗开发方面的迅速进步作出反应。

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.