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临床试验/NCT05225298
NCT05225298已完成不适用

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

Stanford University2 个研究点 分布在 1 个国家目标入组 2,389 人开始时间: 2023年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,389
试验地点
2
主要终点
Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered

研究概览

简要总结

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 this pragmatic cluster randomized controlled trial as part of NIH RADx-UP Consortium, 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • An established US Renal Care in-center hemodialysis facility located in a county with at least two US Renal Care facilities
  • Facility governing board (Medical Director, Facility Manager, Social Worker and Charge Nurses) willingness to participate Patient
  • Treatment at US Renal Care in-center hemodialysis facility
  • Age ≥ 18 years

排除标准

  • Unwillingness to share anonymized clinical (electronic health record) or serum samples drawn during routine dialysis care (i.e., without an additional needlestick). If a patient declines offered testing he/she will still be part of the analyses as long as he/she is willing to share clinical data
  • Dementia or cognitive impairment, with inability to comprehend 'opting out' of participation

研究组 & 干预措施

Static frequency

Active Comparator

Test based screening for SARS-CoV-2 every two weeks

干预措施: Offering SARS-CoV-2 test (Behavioral)

Dynamic frequency

Active Comparator

Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates

干预措施: Offering SARS-CoV-2 test (Behavioral)

结局指标

主要结局

Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered

时间窗: 3 months

次要结局

  • Deaths(4 months)
  • Hospitalizations(4 months)
  • Change in Facility Scores on In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shuchi Anand

Associate Professor

Stanford University

研究点 (2)

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