NIA AD/ADRD Health Care Systems Research Collaboratory

COVID-19大流行对熟练护理机构（SNF）的居民和工作人员造成了不成比例的影响，

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.