SARS-COV-2 Screening in Dialysis Facilities

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225298
• Other study ID #: 64616
• Secondary ID: U01AI169477
• Status: Completed
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2389
• Est. completion date: October 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dialysis; Complications
• End-stage Renal Disease
• Kidney Failure, Chronic
• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease

Intervention

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

Locations

Country	Name	City	State
United States	US Renal Care	Plano	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test acceptance rate		3 months
Secondary	Deaths		2 years
Secondary	Hospitalizations		2 years
Secondary	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