SARS-COV-2 Screening in Dialysis Facilities

NCT ID: NCT05225298

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2389 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2023-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Static frequency

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

Group Type: ACTIVE_COMPARATOR

Offering SARS-CoV-2 test

Intervention Type: 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

Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates

Group Type: ACTIVE_COMPARATOR

Offering SARS-CoV-2 test

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Shuchi Anand

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuchi Anand, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Julie Parsonnet, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Glenn Chertow, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Geoff Block, MD

Role: STUDY_DIRECTOR

US Renal Care

Locations

US Renal Care

Plano, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39298171 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36976655 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U01AI169477

Identifier Type: NIH

Identifier Source: secondary_id

View Link

64616

Identifier Type: -

Identifier Source: org_study_id