SARS-COV-2 Screening in Dialysis Facilities

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Acute Respiratory Disease; End-stage Renal Disease; Dialysis; Complications
• Intervention / Treatment: Behavioral: Offering SARS-CoV-2 test

• Study Type: Interventional
• Enrollment (Actual): 2389
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75024
      • US Renal Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Static frequency; Test based screening for SARS-CoV-2 every two weeks	Behavioral: Offering SARS-CoV-2 test; 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
Active Comparator: Dynamic frequency; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deaths		4 months
Hospitalizations		4 months
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)	4 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Julie Parsonnet, MD, Stanford University; Principal Investigator: Shuchi Anand, MD, Stanford University; Principal Investigator: Glenn Chertow, MD, Stanford University; Study Director: Geoff Block, MD, US Renal Care

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Screening; Underserved communities; RADx-UP
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Respiratory Tract Diseases; Kidney Failure, Chronic; Respiration Disorders
• Other Study ID Numbers: 64616; U01AI169477 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data will be shared with NIH Radx-UP data repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No