SARS-COV-2 Screening in Dialysis Facilities

Not Applicable

Completed

• Conditions: SARS-CoV-2 Acute Respiratory Disease; Dialysis; Complications; End-stage Renal Disease
• Interventions: Behavioral: Offering SARS-CoV-2 test

• Registration Number: NCT05225298
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-04
• Study Start: 2023-02-06
• Primary Completion: 2023-08-01
• Study Completion: 2023-10-01
• Results First Submitted: 2024-08-04
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Results First Posted: 2024-10-30
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2389

Inclusion Criteria

• Facility

  • 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

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Exclusion Criteria

• Patient

  • 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Static frequency	Offering SARS-CoV-2 test	Test based screening for SARS-CoV-2 every two weeks
Dynamic frequency	Offering SARS-CoV-2 test	Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates

Primary Outcome Measures

Name	Time	Method
Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered	3 months

Secondary Outcome Measures

Name	Time	Method
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	this survey is administered annually at each dialysis facility dialysis facility (based on Centers for Medicare Services regulation)

Trial Locations

Locations (1)

US Renal Care; 🇺🇸 Plano, Texas, United States