SARS-COV-2 Screening in Dialysis Facilities

Stanford University

Status: Completed

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

Treatments: Behavioral: Offering SARS-CoV-2 test

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05225298

64616

U01AI169477 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 2,389 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,389 participants in 2 patient groups

Static frequency

Active Comparator group

Description:

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

Treatment:

Behavioral: Offering SARS-CoV-2 test

Dynamic frequency

Active Comparator group

Description:

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

Treatment:

Behavioral: Offering SARS-CoV-2 test