Clinical trial NCT05225298: SARS-COV-2 Screening in Dialysis Facilities
Official title: SARS-COV-2 Screening in Dialysis Facilities: Building an Optimal Strategy to Protect High Risk Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
SARS-CoV-2 Acute Respiratory Disease
Dialysis; Complications
Keywords: Screening
Underserved communities
RADx-UP
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-02-04
Enrollment: 2389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered
timeFrame: 3 months
Secondary outcomes:
measure: Deaths
timeFrame: 4 months
measure: Hospitalizations
timeFrame: 4 months
measure: Change in Facility Scores on In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey
timeFrame: 4 months
Other outcomes:
Locations:
city: Plano
country: United States
facility: US Renal Care
state: Texas
Study officials:
affiliation: Stanford University
name: Shuchi Anand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Julie Parsonnet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Glenn Chertow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: US Renal Care
name: Geoff Block, MD
role: STUDY_DIRECTOR
References: