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: 10549372
• 负责人: Shuchi Anand
• 金额: $ 115.24万
• 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 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10549372
• 关键词: 2019-nCoV; 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; Electronics; End stage renal failure; Exclusion; Exposure to; Family member; Formulation; Frequencies; General Population; Goals; Health care facility; Health protection; Hemodialysis; Hepatitis B; Hispanic Populations; Hospitalization; Immune response; Immunoglobulin G; Impairment; Indoor environment; Infection; Influenza; Kidney; Laboratories; Learning; Measures; Modification; Monoclonal Antibodies; Morbidity - disease rate; Neighborhoods; Outcome; Patients; Policies; Population; Positioning Attribute; Poverty; Pragmatic clinical trial; Prevalence; Prevention; Provider; Public Health; RADx Underserved Populations; Randomized; Randomized, Controlled Trials; Reaction Time; Reporting; Risk; Risk Factors; Risk Reduction; SARS-CoV-2 infection; Seroprevalences; Serum Albumin; Severities; Social Workers; Subgroup; Surface; Surveys; Symptoms; Tablets; Testing; Therapeutic; Time; Travel; Vaccinated; Vaccination; Vaccines; Virus Diseases; Vulnerable Populations; Work; breakthrough infection; comorbidity; coronavirus disease; disadvantaged background; disparity reduction; effectiveness evaluation; ethnic minority; ethnic minority population; experience; high risk; high risk population; industry partner; infection rate; medical vulnerability; mortality; mortality risk; pandemic disease; pragmatic intervention; primary outcome; racial minority; racial minority population; randomized trial; randomized, clinical trials; receptor binding; response; risk mitigation; screening; secondary outcome; seroconversion; sociodemographics; symptomatic COVID-19; testing uptake; transmission process; treatment center; 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 接受透析的患者是患有SARS-COV-2感染的严重疾病的最高风险组之一。在 除了继承室内设施内前往和透析风险，接受透析的患者更多 可能年龄年龄较大，非白人，背景受到干扰，并且免疫血液受损 感染和疫苗接种。血液透析设施提供的通用测试可能会屏蔽这个脆弱的 受到暴露的人口，为受影响者提供早期识别和治疗，并减少传播 给其他患者和家人。在我们的初步工作中，我们建立了一个学术行业伙伴关系 美国（美国肾脏护理）和中央商业实验室（Ascend）拥有第三大透析提供商 临床）。我们评估了SARS-COV-2血清阳性，对感染和疫苗的反应以及疫苗 接受透析的患者的可接受性。我们现在建议以这种合作伙伴关系来实施和 比较透析设施中的两种基于测试的通用筛查策略，并评估疫苗 效力。在务实的群集随机对照试验中，我们将随机对62个美国肾脏护理设施进行随机化 估计有2480名患者与动态通用筛查测试策略相比。静态通用 筛查将涉及每两周为患者提供SARS-COV-2筛查测试；动态通用 筛查策略将从每周一次的测试频率变化到每四周一次 取决于社区COVID-19案率。我们假设患者在随机的设施中透析 对于响应社区病例率的动态测试频率将具有更高的测试可接受性（主要的 结果），经历较低的Covid-19死亡和住院率，并报告更好的护理经验 指标。由于接受透析的患者达到了血清转化后的次优率，因此肝炎 B和COVID-19疫苗接种，我们将嵌入COVID-19的临床有效性的评估 在这种务实干预的框架内疫苗接种。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，以及疫苗的危险因素 突破，特别是ESKD的持续时间更长，半定量 疫苗接种后一年的受体结合结构域IgG反应增加了突破感染的风险。我们的 网络将有充分的位置，以快速生成有关基于测试的可接受性和好处的数据 筛查，并将为预防SARS-COV-2的政策提供信息，包括潜在的疫苗修饰 剂量和/或公式。我们工作的目标与Radx-Up计划的目标保持一致。在 与为这一医学脆弱人群服务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关注问题的问题 - 截筛选策略和疫苗评估，以及 降低接受透析患者的SARS-COV-2感染，发病率和死亡率的风险。

项目成果

Feasibility and Acceptability of SARS-CoV-2 Screening among Patients Receiving Hemodialysis: A Pilot Study.

接受血液透析的患者中 SARS-CoV-2 筛查的可行性和可接受性：一项试点研究。

• DOI: 10.2215/cjn.0000000000000137
• 发表时间: 2023
• 期刊: Clinical journal of the American Society of Nephrology : CJASN
• 作者: Anand,Shuchi;Montez-Rath,Maria;Varkila,Meri;Yu,Xue;Block,Martha;Brillhart,Stephanie;Leppink,Amanda;Hunsader,Patti;Owens,DouglasK;Chertow,GlennM;Parsonnet,Julie;Block,GeoffreyA
• 通讯作者: Block,GeoffreyA

Use of Wastewater Metrics to Track COVID-19 in the US.

• DOI: 10.1001/jamanetworkopen.2023.25591
• 发表时间: 2023-07-03
• 期刊: JAMA network open
• 影响因子: 13.8