Impact of the COVID-19 pandemic on patient outcomes, telehealth care delivery, and treatment for unhealthy alcohol use in vulnerable patients with advanced liver disease across two healthcare systems

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PROJECT SUMMARY (SUPPLEMENT) This administrative supplement application is to request additional funds in order to comply with NOT-AA-19-020, “Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).” As stated in the Notice, the NIAAA requires NIAAA-funded studies that include human subjects to submit de- identified data into the NIAAADA, a NIAAA data repository hosted and managed by the NIMH Data Archive (NDA), in order to increase value to research through widespread data sharing. The goal of this supplement request is to ensure budgetary support to fulfill the requirements of the NDA. The data to be submitted through this supplement will include parent study data relevant to the care of patients with advanced chronic liver disease (CLD) during the COVID-19 pandemic within hepatology practices in two health systems, a public safety net system and Veterans Affairs healthcare systems. In the parent study we will: 1) evaluate the impact of the COVID-19 pandemic on clinical outcomes of vulnerable patients with advanced CLD receiving care in hepatology practices, in a natural experiment; 2) Evaluate patient-reported experiences with use of telemedicine in response to the pandemic to deliver hepatology specialty care in those with advanced CLD; and 3) Conduct a randomized controlled trial evaluating the efficacy and feasibility of a stepped alcohol treatment using telemedicine on unhealthy alcohol use in patients with alcohol-related CLD receiving care in hepatology practices, compared with usual care. Data from the completion of these study objectives will be included in the data archiving to be supported by this administrative supplement.