SARS-COV-2 Screening in Dialysis Facilities: Building an Optimal Strategy to Protect High Risk Populations

透析设施中的 SARS-COV-2 筛查：制定保护高危人群的最佳策略

• 批准号: 10447527
• 负责人: Shuchi Anand
• 金额: $ 116.65万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-11 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10447527
• 关键词: 2019-nCoV; Address; Affect; Awareness; Black Populations; Black race; COVID-19; COVID-19 mortality; COVID-19 pandemic; COVID-19 patient; COVID-19 screening; COVID-19 surveillance; COVID-19 testing; COVID-19 treatment; COVID-19 vaccination; Caring; Cessation of life; Clinical; Clinical assessments; Clinical effectiveness; Collaborations; Common Data Element; Communities; County; Data; Dialysis procedure; Dose; Early identification; Early treatment; Economically Deprived Population; Educational Materials; Electronic Health Record; End stage renal failure; Exposure to; Family member; Formulation; Frequencies; General Population; Goals; Health; Health care facility; Hemodialysis; Hepatitis B; Hispanic Populations; Hospitalization; Immune response; Immunoglobulin G; Impairment; Indoor environment; Infection; Influenza; Intervention; Kidney; Laboratories; Measures; Modification; Monoclonal Antibodies; Morbidity - disease rate; Neighborhoods; Outcome; Patient risk; Patients; Policies; Population; Positioning Attribute; Poverty; Pragmatic clinical trial; Prevalence; Prevention; Provider; Public Health; RADx Underserved Populations; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Risk; Risk Factors; SARS-CoV-2 infection; Seroprevalences; Serum Albumin; Severities; Social Workers; Subgroup; Surface; Surveys; Symptoms; Testing; Therapeutic; Time; Travel; Vaccinated; Vaccination; Vaccines; Virus Diseases; Vulnerable Populations; Work; base; breakthrough infection; comorbidity; coronavirus disease; disadvantaged background; disparity reduction; effectiveness evaluation; ethnic minority population; experience; high risk; high risk population; industry partner; infection rate; medical vulnerability; mortality; pandemic disease; primary outcome; racial and ethnic; racial minority; randomized trial; receptor binding; response; risk mitigation; screening; secondary outcome; seroconversion; sociodemographics; symptomatic COVID-19; testing uptake; transmission process; treatment center; trial comparing; unvaccinated; uptake; vaccine acceptance; vaccine effectiveness

PROJECT ABSTRACT Patients receiving dialysis are one of the highest risk groups for serious illness with SARS-CoV-2 infection. In addition to the inherent risks of travel to and dialysis within indoor facilities, patients receiving dialysis are more likely to be older, non-white, from disadvantaged backgrounds, and have impaired immune responses to viral infections and vaccinations. Universal testing offered at hemodialysis facilities could shield this vulnerable population from exposure, enable early identification and treatment for those affected, and reduce transmission to other patients and family members. In our preliminary work, we created an academic-industry partnership with the third largest dialysis provider in the US (US Renal Care) and a central commercial laboratory (Ascend Clinical). We evaluated SARS-CoV-2 seroprevalence, response to infection and vaccination, and vaccine acceptability among patients receiving dialysis. We now propose to build on this partnership to implement and compare two test-based universal screening strategies in dialysis facilities, and to assess vaccine effectiveness. In a pragmatic cluster randomized controlled trial, we will randomize 62 US Renal Care facilities with an estimated 2480 patients to static versus dynamic universal screening testing strategies. Static universal screening will involve offering patients SARS-CoV-2 screening tests every two weeks; the dynamic universal screening strategy will vary the frequency of testing from once every week to once every four weeks, depending on community COVID-19 case rates. We hypothesize that patients dialyzing at facilities randomized to a dynamic testing frequency responsive to community case rates will have higher test acceptability (primary outcome), experience lower rates of COVID-19 death and hospitalization, and report better experience-of-care metrics. Since patients receiving dialysis achieve suboptimal rates of seroconversion post influenza, hepatitis B, and COVID-19 vaccination, we will embed an assessment of the clinical effectiveness of COVID-19 vaccination within the framework of this pragmatic intervention. We will determine rates of asymptomatic and symptomatic SARS-CoV-2 infection in vaccinated versus unvaccinated patients, and risk factors for vaccine breakthrough, specifically whether longer duration of ESKD and absent or diminished semi-quantitative receptor binding domain IgG response one-year post vaccination increase risk for breakthrough infection. Our network will be well-positioned to rapidly generate data on the acceptability and benefits of test-based screening, and will inform policies for SARS-CoV-2 prevention including potential modification of vaccine dosing and/or formulations. The objectives of our work align with the goals of the RADx-UP initiative. In collaboration with a major community stakeholder serving this medically vulnerable population, we will address two issues of utmost public health concern—universal screening strategies and vaccine assessments—and reduce risks for SARS-CoV-2 infection, morbidity, and mortality in patients receiving dialysis.

项目摘要 接受透析的患者是严重疾病感染SARS-CoV-2的高危人群之一。在……里面 除了前往室内设施和在室内进行透析的固有风险外，接受透析的患者更多 可能是年龄较大的非白人，来自弱势背景，对病毒的免疫反应受损 感染和接种疫苗。血液透析设施提供的普遍检测可以保护这些脆弱的人 防止人口暴露，使受影响的人能够及早识别和治疗，并减少传播 传给其他病人和家属。在我们的前期工作中，我们建立了学术和行业合作伙伴关系 拥有美国第三大透析提供商(US Renal Care)和一个中央商业实验室(Ascend 临床)。我们评估了SARS-CoV-2的血清阳性率、对感染和接种疫苗的反应以及疫苗 接受透析的患者的可接受性。我们现在建议在这一伙伴关系的基础上实施和 比较透析设施中两种基于测试的普遍筛查策略，并评估疫苗 有效性。在一项务实的整群随机对照试验中，我们将随机选择62家美国肾脏护理机构 估计有2480名患者采用静态与动态普遍筛查测试策略。静态万能 筛查将包括每两周为患者提供SARS-CoV-2筛查测试；动态普遍 筛查策略将改变检测频率，从每周一次到每四周一次， 视社区新冠肺炎发案率而定。我们假设在设施中进行透析的患者是随机的 响应社区案例的动态测试频率将具有更高的测试可接受性(主要 结果)，体验更低的新冠肺炎死亡率和住院率，并报告更好的护理体验 指标。由于接受透析的患者在流感、肝炎后的血清转换率低于最佳水平 B和新冠肺炎接种，我们将嵌入新冠肺炎的临床效果评估 在这一务实干预的框架内接种疫苗。我们将确定无症状和 接种疫苗与未接种疫苗的患者中有症状的SARS-CoV-2感染及其危险因素 突破性进展，特别是ESKD持续时间是否更长，以及缺席或减少的半定量 免疫后一年的受体结合区免疫球蛋白反应增加突破性感染的风险。我们的 网络将处于有利地位，能够快速生成关于基于测试的可接受性和优势的数据 筛查，并将为预防SARS-CoV-2的政策提供信息，包括可能修改疫苗 剂量和/或配方。我们的工作目标与RADx-UP倡议的目标一致。在……里面 与服务于这些医疗弱势群体的主要社区利益相关者合作，我们将解决 两个最大的公共卫生问题--普遍筛查战略和疫苗评估--以及 降低接受透析患者感染SARS-CoV-2的风险、发病率和死亡率。