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

COVID-19 大流行对两个医疗系统中晚期肝病弱势患者的患者治疗结果、远程医疗保健服务以及不健康饮酒治疗的影响

• 批准号: 10476764
• 负责人: Mandana Khalili
• 金额: $ 0.5万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10476764
• 关键词: Address; Administrative Supplement; Alcohol consumption; Alcohols; Anxiety; Award; COVID-19 pandemic; Caring; Client satisfaction; Clinic; Clinical; Data; Ensure; Funding; Goals; Health system; Healthcare Systems; Hepatology; Informed Consent; Intervention; Liver diseases; Measurement; Measures; Mental Depression; National Institute of Mental Health; National Institute on Alcohol Abuse and Alcoholism; Natural experiment; Outcome; Parents; Patient Care; Patient-Focused Outcomes; Patients; Policies; Procedures; Quality of life; Randomized; Randomized Controlled Trials; Regulation; Reporting; Research; Research Project Grants; Research Subjects; Resolution; Schedule; Site; Surveys; System; Telemedicine; Telephone; Time; United States Department of Veterans Affairs; Validation; alcohol abuse therapy; alcohol misuse; archive data; base; care delivery; chronic liver disease; cost; cost estimate; data archive; data de-identification; data repository; data sharing; data submission; efficacy evaluation; experience; health literacy; health service use; human subject; medical specialties; pandemic disease; patient population; prospective; response; safety net; telehealth; tool; treatment as usual; two-arm study

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.

项目概要（附件） 这份行政补充申请是为了要求额外的资金，以符合 NOT-AA-19-020，“NIAAA人类受试者赠款研究数据共享政策通知 由国家酒精滥用和酒精中毒研究所（NIAAA）资助。所报 注意，NIAAA要求NIAAA资助的研究，其中包括人类受试者提交去- 将识别的数据输入NIAAADA，NIAAA数据存储库由NIMH托管和管理 数据存档（NDA），通过广泛的数据共享增加研究价值。 这一补充请求的目的是确保预算支助，以满足 NDA。通过本补充文件提交的数据将包括母研究数据 与COVID-19期间晚期慢性肝病（CLD）患者的护理相关 在两个卫生系统、一个公共安全网系统和 退伍军人事务部医疗系统。在母研究中，我们将：1）评估 COVID-19大流行对接受晚期CLD治疗的脆弱患者的临床结局的影响 在自然实验中，在肝病学实践中护理; 2）评估患者报告的经验 利用远程医疗应对大流行病， 晚期CLD患者; 3）进行随机对照试验，评估疗效 使用远程医疗对不健康的酒精使用进行分步酒精治疗的可行性 接受肝病治疗的酒精相关CLD患者，与常规治疗相比 在乎完成这些研究目标的数据将纳入数据存档中， 支持这一行政补充。