SARS-COV-2 Screening in Dialysis Facilities

Study Overview
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Brief Summary
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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.

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

Conditions
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End-stage Renal Disease, SARS-CoV-2 Acute Respiratory Disease, Dialysis; Complications

Intervention / Treatment
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* Behavioral: Offering SARS-CoV-2 test


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Static frequency<br>Test based screening for SARS-CoV-2 every two weeks | Behavioral: Offering SARS-CoV-2 test<br>* A pragmatic cluster (facility-level) randomized clinical trial, comparing test-based screening performed at a static (every two weeks) frequency versus a dynamic frequency (ranging from once a week to once every four weeks) anchored to county COVID-19 case rates<br>|
| Active Comparator: Dynamic frequency<br>Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates | Behavioral: Offering SARS-CoV-2 test<br>* A pragmatic cluster (facility-level) randomized clinical trial, comparing test-based screening performed at a static (every two weeks) frequency versus a dynamic frequency (ranging from once a week to once every four weeks) anchored to county COVID-19 case rates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test acceptance rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deaths |  | 2 years | 
| Hospitalizations |  | 2 years | 
| Change in facility scores on In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey | this survey is administered annually at each dialysis facility dialysis facility (based on Centers for Medicare Services regulation) | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Underserved communities, RADx-UP