SARS-COV-2 Screening in Dialysis Facilities

Not Recruiting

Trial ID: NCT05225298

Purpose

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.

Official Title

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

Stanford Investigator(s)

Julie Parsonnet
Julie Parsonnet

George DeForest Barnett Professor of Medicine and Professor of Epidemiology and Population Health

Glenn M. Chertow
Glenn M. Chertow

Norman S. Coplon/Satellite Healthcare Professor of Medicine and Professor, by courtesy, of Epidemiology and Population Health and of Health Policy

Shuchi Anand
Shuchi Anand

Associate Professor of Medicine (Nephrology)

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

Intervention(s):

behavioral: Offering SARS-CoV-2 test

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shuchi Anand, MD
6507252207