Improved Testing for COVID-19 in Skilled Nursing Facilities: IMPACT-C

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 oftendisadvantaged persons at risk for contracting the virus. Thus, universal testing of residents and workers hasbeen a key management approach to containing viral spread. COVID-19 has magnified long-standing healthdisparities in the quality and outcomes of care among minority SNF residents. Equitable SARS-CoV-2 testingstrategies have a critical role to play in mitigating such disparities. This proposal's overarching goal is toleverage the foundation of the NIA IMbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory toestablish IMPACT-COVID-19 (IMPACT-C) which will be dedicated to developing and evaluating SARS-CoV-2testing strategies among highly vulnerable SNF residents and workers. The Aims are to: 1) Establish theinfrastructure of IMPACT-C; 2) Describe disparities in SARS-CoV-2 testing, and identify resident, facility andpolicy characteristics associated with COVID-19 outbreaks and outcomes; 3) Engage key stakeholders todevelop 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-UPCoordination and Data Collection Center. The organizational, administrative, and expertise components forIMPACT-C will include: leadership, regulatory structures, dissemination, and investigators. IMPACT-C will alsoleverage IMPACT's Data Sharing Collaborative that includes 11 national companies that collectively own over1,000 SNFs and use a common electronic medical record (EMR) platform. We have already established theinfrastructure to securely and regularly receive daily EMR and COVID-19 data from this consortium and link itto Medicare claims and Minimum Data Set assessments. Using this rich and representative database, we willconduct a series of models to inform policies on SARS-CoV-2 testing and to forecast outbreaks. Further, wewill leverage IMPACT's resources to develop a diverse and engaged group of stakeholders who will identifybarriers to SARS-CoV-2 testing in SNFs, develop solutions, and inform the development of future testingstrategies to be tested in a cluster RCT (Aim 4). We have designed a cluster RCT of 120-150 facilities tocompare the effect of novel, point-of-care testing versus usual care on the rate of COVID-19 infections. TheCOVID-19 pandemic is rapidly evolving, and we have the expertise to modify the proposed trial based onadvances in testing technology, improved access to point-of-care testing in SNFs, stakeholderrecommendations, and regional policies. Ultimately, IMPACT-C will be well-poised to rapidly and rigorouslyconduct a vaccine trial. In summary, IMPACT-C will establish the infrastructure and expertise to develop andevaluate SARS-CoV-2 testing strategies for SNFs that are compassionate and culturally sensitive, but at thesame time, are nimble enough to respond to rapid advances in testing modalities and vaccine development.