SARS-COV-2 Screening in Dialysis Facilities

• Sponsor: Stanford University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05225298
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
• Enrollment: 2,480
• Arms: 2
• Anticipated Duration (Months): 41

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End-stage Renal Disease; SARS-CoV-2 Acute Respiratory Disease; Dialysis; Complications	Behavioral: Offering SARS-CoV-2 test	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: SARS-COV-2 Screening in Dialysis Facilities: Building an Optimal Strategy to Protect High Risk Populations
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Aug 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Test acceptance rate [3 months]

Secondary Outcome Measures

1. Deaths [2 years]

2. Hospitalizations [2 years]

3. Change in facility scores on In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey [18 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Stanford University
• National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

• Principal Investigator: Shuchi Anand, MD, Stanford University
• Principal Investigator: Julie Parsonnet, MD, Stanford University
• Principal Investigator: Glenn Chertow, MD, Stanford University
• Study Director: Geoff Block, MD, US Renal Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shuchi Anand, Assistant Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT05225298
• Other Study ID Numbers: 64616
• First Posted: Feb 4, 2022
• Last Update Posted: Feb 4, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Shuchi Anand, Assistant Professor, Stanford University: Screening; Underserved communities; RADx-UP
• Additional relevant MeSH terms: Respiration Disorders; Respiratory Tract Diseases; Kidney Failure, Chronic

Study Results

No Results Posted as of Feb 4, 2022