SARS-COV-2 Screening in Dialysis Facilities

NCT05225298 | Completed Results DMC

• 2 other identifiers: 64616U01AI169477
• Study Type: interventional
• Target: 2,389
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Screening; Underserved communities; RADx-UP

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered

  3 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Static frequency

ACTIVE COMPARATOR

Test based screening for SARS-CoV-2 every two weeks

Behavioral: Offering SARS-CoV-2 test

Dynamic frequency

ACTIVE COMPARATOR

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

Interventions

Offering SARS-CoV-2 test BEHAVIORAL

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

Dynamic frequency; Static frequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

US Renal Care

Plano, Texas, 75024, United States

Location

Related Publications (2)

• Montez-Rath M, Varkila M, Yu X, Brillhart S, Morgan C, Leppink A, Block MS, Mehta S, Hunsader P, Fountaine A, Subramanian N, Dittrich M, Owens DK, Chertow GM, Parsonnet J, Anand S, Block GA. Acceptance of SARS-CoV-2 Surveillance Testing Among Patients Receiving Dialysis: A Cluster Randomized Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434159. doi: 10.1001/jamanetworkopen.2024.34159.

  PMID: 39298171 DERIVED

• Anand S, Montez-Rath M, Varkila M, Yu X, Block M, Brillhart S, Leppink A, Hunsader P, Owens DK, Chertow GM, Parsonnet J, Block GA. Feasibility and Acceptability of SARS-CoV-2 Screening among Patients Receiving Hemodialysis: A Pilot Study. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):930-932. doi: 10.2215/CJN.0000000000000137. Epub 2023 Apr 24. No abstract available.

  PMID: 36976655 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Shuchi Anand, MD, MS
• Organization: Stanford University

sanand2@stanford.edu

650-725-2207

Study Officials

• Shuchi Anand, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Julie Parsonnet, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Glenn Chertow, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Geoff Block, MD

  US Renal Care

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 4, 2022
• Study Start: February 6, 2023
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 30, 2024
• Results First Posted: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (1)