Dialysis; Complications, End-stage Renal Disease, SARS-CoV-2 Acute Respiratory Disease
Conditions
Keywords
Screening, Underserved communities, RADx-UP
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.
Interventions
BEHAVIORALOffering 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
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations | 4 months | — |
| Deaths | 4 months | — |
| Change in Facility Scores on In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey | 4 months | this survey is administered annually at each dialysis facility dialysis facility (based on Centers for Medicare Services regulation) |
Countries
United States
Participant flow
Recruitment details
Patients were offered tests over a period of 3 months then entered a 1-month follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| Static Frequency Test based screening for SARS-CoV-2 every two weeks | 1,069 |
| Static Frequency Test based screening for SARS-CoV-2 every two weeks | 28 |
| 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 | 1,320 |
| 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 | 29 |
| Total | 2,446 |
Baseline characteristics
| Characteristic | Total | Dynamic Frequency | Static Frequency |
|---|---|---|---|
| Age, Continuous | 64 years | 65 years | 63 years |
| Diabetes | 1603 Participants | 883 Participants | 720 Participants |
| Facility Region Midwest | 10 Facilities | 5 Facilities | 5 Facilities |
| Facility Region Northeast | 8 Facilities | 4 Facilities | 4 Facilities |
| Facility Region South | 27 Facilities | 14 Facilities | 13 Facilities |
| Facility Region West | 12 Facilities | 6 Facilities | 6 Facilities |
| Race/Ethnicity, Customized American Indian | 138 Participants | 66 Participants | 72 Participants |
| Race/Ethnicity, Customized Asian | 60 Participants | 34 Participants | 26 Participants |
| Race/Ethnicity, Customized Black | 885 Participants | 490 Participants | 395 Participants |
| Race/Ethnicity, Customized Hispanic | 338 Participants | 173 Participants | 165 Participants |
| Race/Ethnicity, Customized Missing | 17 Participants | 13 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 75 Participants | 49 Participants | 26 Participants |
| Race/Ethnicity, Customized White | 876 Participants | 495 Participants | 381 Participants |
| Region of Enrollment United States | 2389 Participants | 1320 Participants | 1069 Participants |
| Sex: Female, Male Female | 1048 Participants | 570 Participants | 478 Participants |
| Sex: Female, Male Male | 1341 Participants | 750 Participants | 591 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 31 / 1,069 | 41 / 1,320 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered
Time frame: 3 months
Population: All participants who started in the Participant Flow
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Static Frequency | Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered | 509 Tests |
| Dynamic Frequency | Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered | 475 Tests |
p-value: 0.9log binomial model
Secondary
Change in Facility Scores on In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey
this survey is administered annually at each dialysis facility dialysis facility (based on Centers for Medicare Services regulation)
Time frame: 4 months
Population: Data were not collected for this outcome measure
Secondary
Deaths
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Static Frequency | Deaths | 31 Participants |
| Dynamic Frequency | Deaths | 41 Participants |
p-value: 0.94log binomial model
Secondary
Hospitalizations
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Static Frequency | Hospitalizations | 310 Participants |
| Dynamic Frequency | Hospitalizations | 444 Participants |
p-value: 0.053log binomial model