SARS-COV-2 Screening in Dialysis Facilities

Trial ID or NCT#

NCT05225298

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Julie Parsonnet
Julie Parsonnet
Infectious disease doctor
George DeForest Barnett Professor of Medicine and Professor of Epidemiology and Population Health
Glenn M. Chertow
Glenn M. Chertow
Nephrologist
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
Nephrologist
Associate Professor of Medicine (Nephrology)

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Contact

Shuchi Anand, MD
6507252207