SARS-COV-2 Screening in Dialysis Facilities: Building an Optimal Strategy to Protect High Risk Populations
Phase: NA
Conditions: End-stage Renal Disease, SARS-CoV-2 Acute Respiratory Disease, Dialysis; Complications
Sponsor: Stanford University

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Study name: SARS-COV-2 Screening in Dialysis Facilities: Building an Optimal Strategy 
to Protect High Risk Populations 
 
NIH NIMHD grant Number: 1U01AI169477 
 
 
Institutions 
US Renal Care 
Ascend Clinical Laboratory 
Stanford University 
 
Principal investigators: Shuchi Anand, Julie Parsonnet, Glenn M Chertow 
Clinicaltrials.gov number: NCT05225298 
Stanford eprotocol number: 64616 
Advarra eprotocol number: Pro00061393 
 
 
Protocol generation date: April 4, 2022 
Revision: June 26, 2023 
Prior Revision dates: June 20, 2022; November 18, 2022 
 
 
 

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Table of Contents 
PROTOCOL OVERVIEW ............................................................................................................. 4 
 
BACKGROUND .................................................................................................................. 5 
2.1 
Patients receiving dialysis are an underserved, medically vulnerable population ... 5 
2.2 
Patients receiving dialysis face high risk for death & hospitalization from COVID-
19 
5 
2.3 
Even after vaccination, patients receiving dialysis will contend with prolonged 
risks due to impaired immune responses ................................................................................ 6 
2.4 
Universal screening of high-risk clustered populations will simplify screening 
protocols, prevent transmission, and identify early disease for rapid treatment with 
monoclonal antibodies............................................................................................................... 6 
 
TRIAL OBJECTIVES ........................................................................................................ 7 
3.1 
To identify a highly acceptable SARS-CoV-2 testing strategy in dialysis facilities . 7 
3.2 
To evaluate effectiveness of the SARS-CoV-2 testing strategies in patients 
receiving dialysis ........................................................................................................................ 7 
3.3 
Determine risk factors for serious illness with COVID-19 among patients receiving 
dialysis ........................................................................................................................................ 7 
 
STUDY ORGANIZATION ................................................................................................. 7 
4.1 
Collaborating Institutions.............................................................................................. 7 
4.2 
Role of RADx-UP ........................................................................................................... 9 
 
STUDY DESIGN................................................................................................................. 9 
5.1 
Study Overview .............................................................................................................. 9 
5.2 
Sampling Procedures ................................................................................................... 10 
5.3 
Governing Body Review .............................................................................................. 11 
5.4 
Inclusion/Exclusion Criteria ........................................................................................ 11 
5.5 
Sample Size ................................................................................................................... 11 
5.6 
Static Testing Frequency ............................................................................................. 12 
5.7 
Dynamic Testing Frequency ........................................................................................ 12 
5.8 
Test Characteristics ...................................................................................................... 13 
5.9 
Adherence ..................................................................................................................... 13 
5.10 Outcomes ....................................................................................................................... 14 
5.11 Pilot Phase ..................................................................................................................... 14 
 
PARTICIPANT ENROLLMENT..................................................................................... 15 

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6.1 
Rationale for Waiver of Informed Consent ............................................................... 16 
6.1.1 
The intervention involves no more than minimal risk ........................................................................... 16 
6.1.2 
The waiver or alteration will not adversely affect the rights and welfare of the participants ................ 16 
6.1.3 
The research could not practicably be carried out without the requested waiver or alteration .............. 17 
6.1.4 
For research using identifiable private information or identifiable biospecimens, the research could not 
practicably be carried out without using such information or biospecimens in an identifiable format ............... 17 
6.1.5 
Whenever appropriate, the participants or legally authorized representatives will be provided with 
additional pertinent information after participation ............................................................................................ 18 
6.2 
Rationale for Waiver of HIPAA ................................................................................. 18 
6.2.1 
The researchers require access to the PHI to conduct the research. ....................................................... 18 
6.2.2 
The research cannot be practically conducted without the waiver ......................................................... 18 
6.2.3 
The use or disclosure of PHI will carry minimal risks ........................................................................... 19 
 
TRIAL IMPLEMENTATION .......................................................................................... 19 
7.1 
Governing Board Review ............................................................................................. 19 
7.2 
RADx-UP Survey .......................................................................................................... 19 
7.3 
Randomization .............................................................................................................. 20 
7.4 
Intervention: SARS-CoV-2 Testing ............................................................................ 20 
7.5 
Testing at Ascend Clinical Laboratory ...................................................................... 20 
7.6 
Test Results ................................................................................................................... 21 
7.7 
Data Collection ............................................................................................................. 21 
7.8 
Data Confidentiality Procedures ................................................................................. 22 
7.8.1 
RADx-UP Common Data Elements Survey .......................................................................................... 22 
7.8.2 
Limited PHI Electronic health record .................................................................................................... 22 
7.9 
Data extraction and transfer procedures ................................................................... 23 
7.9.1 
RADx-UP Survey .................................................................................................................................. 23 
7.9.2 
Limited PHI Data ................................................................................................................................... 23 
7.10 Statistical Analysis Plan ............................................................................................... 23 
 
DATA AND SAFETY MONITORING ............................................................................ 23 
9.0   EXIT SURVEY   
 
 
 
 
 
 
 
 
        25 
 REFERENCES ................................................................................................................. 25 
 APPENDIX ....................................................................................................................... 30 
 
 
 

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PROTOCOL OVERVIEW 
In this study we plan to offer SARS-CoV-2 screening tests at up to 62 selected US Renal Care 
dialysis in order to: reduce transmission, and detect early cases and prevent serious illness. This 
clinical trial is part of the NIH Rapid Acceleration of Diagnostics- Underserved Populations 
(NIH-RADx-UP) initiative (https://radx-up.org/about/), whose goal is to improve access to 
COVID-19 testing in underserved communities. Patients receiving dialysis have an 8-fold higher 
risk for hospitalization and 15-fold higher risk for death from COVID-19 compared with the 
general population.  Patients receiving dialysis also disproportionately belong to racial/ethnic 
minority and economically disadvantaged groups. Thus the goals of this project are to increase 
availability of highly sensitive and specific testing for SARS-CoV-2 infection in a medically 
vulnerable and disadvantaged population.   
Approach: This is a pragmatic cluster (facility-level) randomized clinical trial to test the patient 
level acceptability of two strategies for offering test-based screening  at the dialysis facility. We 
will be offering anterior nares, rtPCR tests at a static frequency (arm 1) versus a dynamic 
frequency anchored to county COVID-19 spread (arm 2). After a pilot in four facilities, we plan 
to scale up the study to up to 62 dialysis facilities within US Renal Care. Ascend Clinical 
Laboratory will provide testing supplies, process testing, and return results to facilities. Abbott 
Molecular will provide supplies for the Alinity m SARS-CoV-2 rtPCR assay (approved under 
FDA EUA) at discounted costs. Stanford University will lead study design, data analysis, and 
dissemination of results.  
Arm 1—Static frequency: selected facilities will offer testing once every two weeks to all 
patients coming to dialysis  
Arm 2—Dynamic frequency: selected facilities will offer testing to all patients coming to 
dialysis once a week if county COVID-19 spread is high, once every two weeks if county 
COVID-19 spread is low or moderate, and once a month if COVID-19 spread is minimal or 
eliminated.  
Intervention time frame: 3 months  
We will assess the following outcomes: 
1 Patient level test acceptability (primary outcome)  
2 Facility level Deaths 
3 Facility level Hospitalization  
The overall goal is to identify a highly acceptable universal testing strategy for patients receiving 
dialysis and prevent serious complications from SARS-CoV-2 by identifying cases early.   
 
 

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 BACKGROUND 
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.  
2.1 
Patients receiving dialysis are an underserved, medically vulnerable 
population   
The average patient on dialysis in the US is between 65-74 years old and has advanced diabetes 
causing kidney failure(1). Among patients on hemodialysis, 47% have diabetes as the primary 
cause ESKD, 62% have cardiovascular disease, and 32% have heart failure. Patients receiving 
dialysis are also disproportionately from racial/ethnic minority groups(1, 2). One striking piece 
of data encapsulates the disproportionate burden of ESKD on minority populations: 12% of 
persons in the US self-identify as Black; in contrast, 30% of patients on dialysis are Black. 
Thirty-five percent of patients on dialysis in the US live in poor neighborhoods (i.e., 
neighborhoods with 20% of persons living below the federal poverty line)(3). In a seminal 
analysis, Volkova et al.(4) determined that persons living in poor neighborhoods had 3 to 5-fold 
higher likelihood of incident ESKD (compared with neighborhoods with < 5% of persons living 
below the poverty line), with larger risks experienced by Blacks compared with whites.  
Requirement for in-center visits to complete dialysis can amplify the risk for SARS-CoV-2 
transmission within the facility and in the community(5). Patients wear masks but may need to 
take them off to ingest prescribed medications and nutritional supplements; they have 
interactions in lobbies with friends on dialysis, often their only social interaction of the day. As 
with the rest of the US population, 40% of patients receiving dialysis with SARS-CoV-2 
infection may be asymptomatic(6), potentiating the risk for transmission. Corbett et al.(5) report 
from the UK that dialysis facility characteristics such as distance between dialysis chairs, waiting 
room size, and staff symptomatic illness all correlated with facility COVID-19 cases. In the 
context of the COVID-19 pandemic this setup is a worst case scenario: a highly comorbid, 
elderly and socially disadvantaged population, with impaired immune responses and frailty, 
sharing small indoor spaces for prolonged periods.(7, 8)  
2.2 
Patients receiving dialysis face high risk for death & hospitalization from 
COVID-19 
Centers for Medicare & Medicaid Services (CMS) data indicate that patients receiving dialysis 
have the highest rate of COVID-19 hospitalizations among susceptible groups, 8-fold higher than 
population average(9). Early on in the pandemic, nearly one third of patients who were 
hospitalized with COVID-19 in New York(10) died. Despite improvements in treatment, a 
nationwide analysis continues to estimate mortality rates exceeding 20%(11), and CMS data 
continue to report high numbers of excess deaths. In addition to the innate factors of older age, 
comorbidity, and clustering, there has been also “renal-ism” in use of treatments(12, 13). For 

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example, remedesivir—an early promising therapy—was considered ‘contra-indicated’ in 
ESKD, although any concerns for a theoretical risk from its carrier had been previously 
debunked(14, 15).  
2.3 
Even after vaccination, patients receiving dialysis will contend with 
prolonged risks due to impaired immune responses   
Experts predict recurrent ‘outbreaks’ of COVID-19 extending into 2025 if infection or 
vaccination does not result in sustained immunity (16-20). Boosters, and requirements thereof for 
subsets of the population are as-yet uncertain, but it is becoming clear that a sizeable portion of 
patients on dialysis (21-23), patients on immunosuppression(24), and other subgroups(25) have 
impaired responses to vaccination. Prior data on vaccination in the dialysis population 
corroborates emerging data(26, 27). In multiple prospective studies of Hepatitis B, only 60-70% 
of vaccinated patients receiving dialysis mounted a sufficient response and, of these, 40% lost 
immunity within 1-3 years(28, 29).  In influenza studies, one focused on H1N1 strain alone(30) 
and one(31) on trivalent vaccine including H1N1 strain, 57% and 46% of patients receiving 
dialysis mounted sufficient titers to be considered immune to H1N1 at 4 weeks, compared with 
90% or more of healthy volunteers. Patients receiving dialysis will likely face excess risk for 
COVID-19 despite vaccination just as they do for influenza(32) despite universal influenza 
vaccination protocols in dialysis facilities. 
2.4 
Universal screening of high-risk clustered populations will simplify 
screening protocols, prevent transmission, and identify early disease for 
rapid treatment with monoclonal antibodies.  
Current non-standard testing protocols across and within dialysis facilities lead to considerable 
uncertainty and may miss or delay diagnoses at the cost of patients’ lives. Evidence from other 
settings suggests that universal screening in a clustered population dramatically improves the 
detection rate. For example, a universal screening protocol implemented in 11 nursing home 
facilities led to a 3-fold higher detection of SARS-CoV-2(33) (34, 35). Similar data (of only two 
secondary transmissions) were reported from a boarding school implementing universal rtPCR 
testing(36). Thus, universal screening has the potential to save lives in high-risk, clustered 
populations.  
Since dialysis facilities are staffed by ably trained nurses, technicians, dieticians, and social 
workers, dialysis facilities can also serve as a conduit for the provision of primary health care to 
patients receiving dialysis and for mitigation of risks for SARS-CoV-2. Many foundational 
primary care interventions, including vaccines, diabetic foot checks, and social support 
assessments, occur at the dialysis facility, which many patients consider as their ‘medical home.’ 
Facilities are partnered with central laboratories, with processes in place for rapid specimen 
shipment and results return in the electronic medical record. Most importantly facilities stock 
monoclonal antibodies. Data from patients treated with bamalanivimab at US Renal Care suggest 
dramatic improvements in requirement for hospitalization: hospitalization rate was 15% among 
40 patients receiving the antibody, compared with 57% among patients on dialysis with COVID-
19 matched for age, sex, self-reported race, and diabetes status(37). The two other large dialysis 
organizations reported <10% hospitalization rate post bamlanivimab administration(37).   

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Mina and Anderson present a framework for selecting and applying testing strategies based on 
the health scenario. Patients on dialysis require testing for both “personal health” (given their 
high vulnerability) and “public health” (given the risk for transmission) indications(38).  
 TRIAL OBJECTIVES 
3.1 
To identify a highly acceptable SARS-CoV-2 testing strategy in dialysis 
facilities 
The primary objective of this study is to offer SARS-CoV-2 testing to an underserved 
population. We hypothesize that the community COVID-19 case rate will be associated with test 
acceptability. We will test this hypothesis by offering testing either at a static (every two weeks) 
frequency (arm 1) or offering testing at a dynamic frequency tied to community COVID-19 
rates. Among the two arms, we will assess differences in:  
 
1) Primary outcome (assessed during the three-month period of the intervention): Proportion 
of offered tests accepted: # of times individuals respond yes / total # of times individuals 
are asked to perform the test during the 3-month period of the intervention  
3.2 
To evaluate effectiveness of the SARS-CoV-2 testing strategies in patients 
receiving dialysis 
We will evaluate the clinical effectiveness of the two testing strategies by reporting and 
comparing:  
Secondary outcomes (assessed up to one-month post completion of intervention):  
2) Hospitalizations  
3) Deaths  
3.3 
Determine risk factors for serious illness with COVID-19 among patients 
receiving dialysis   
By following outcomes of participants who are diagnosed with COVID-19 during the study, we 
will be able to determine risk factors for serious illness requiring hospitalization. This will 
further enable identification of the subgroup requiring aggressive and early therapy with 
antivirals or monoclonal antibodies.  
 STUDY ORGANIZATION 
4.1 
Collaborating Institutions 
Key investigators are outlines in below figure. Three organizations will work integrally: study 
design input will come from Stanford, followed by patient-facing implementation at US Renal 
Care facilities with laboratory support from Ascend Clinical Laboratory. Stanford University 
investigators are physicians, epidemiologists, health policy experts, statisticians, and clinical 
trialists who are well qualified to design and implement the proposed study, with established 

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processes for ethical conduct of research, handling protected health information (PHI), and study 
analysis. US Renal Care is a for profit dialysis network with over 350+ nationwide dialysis 
facilities, and actively participates in multiple clinical trials and epidemiology studies to advance 
the health care of patients receiving dialysis.  Finally Ascend Clinical is a CLIA-certified, high 
throughput clinical laboratory specializing in testing for patients receiving dialysis; this 
laboratory processes more than 2 million tests per month.   
US Renal Care and Ascend Clinical will transfer data with limited protected health information 
(PHI) to Stanford University. Stanford University investigators will be responsible for data 
preparation, analysis, and transfer to NIH RADx-UP. The “Rapid Acceleration for Diagnostics 
Program (RADx) Institutional Certification” for studies using data generated for the RADx 
program, is located in the Appendix. In addition, Abbott Molecular will discount the anterior 
nares rtPCR testing kits and associated supplies (Alinity m SARS-CoV-2 assay).  
 
 

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4.2 
Role of RADx-UP 
The NIH RADx-UP consortium (https://radx-up.org/about/) is funded by the NIH National 
Institute on Minority Health and Health Disparities. The goal of the consortium is to engage 
community and academic partnerships to expand availability of SARS-CoV-2 testing in 
underserved communities. As of January 2022, there are over 100 projects occurring throughout 
the country.  As part of the consortia, participating institutions are required to collect and share 
data on a set of “Common Data Elements”: https://radx-up.org/learning-resources/cdes/.  
Furthermore, studies receive support in terms of translation, materials to enhance test uptake, and 
logistical support for procuring tests.  
 
 STUDY DESIGN 
5.1 
Study Overview 
We plan a pragmatic cluster randomized clinical trial at the dialysis facility-level. We will 
compare rtPCR SARS-CoV-2 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 among patient dialyzing at up to 62 facilities within US Renal Care 
(Figure 1). This design builds on a recently supported NIDDK initiative – the pragmatic facility-
based cluster randomized trial. The Time to reduce Mortality in End-stage Kidney Disease 
(TiME) trial (https://jasn.asnjournals.org/content/30/5/890/tab-article-info) showcased the ability 
of dialysis facilities to provide accurate and complete clinical data for exposures and outcomes 
(death and hospitalizations), the willingness of >99% of patients to participate in and share 
clinical data using an 'opt out' consent, and feasibility of implementation without on-site research 
staff.  

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Anterior nares rtPCR SARS-CoV-2 tests will be offered to all patients in the  selected facilities 
(at a frequency decided by the randomization procedure). Patients may decline tests at any time 
during the 3-month study period. We will record test acceptance (primary outcome of the study). 
If a participant accepts the test, results will be relayed back to the patient and the facility within 
48 hours. Patients with positive tests will be cared for as per standard facility procedures: 
asymptomatic persons will be advised to quarantine and will be isolated during dialysis to 
prevent further transmission, and symptomatic persons will be considered for antiviral therapy or 
referral to higher level of care based on the most updated Centers for Disease Control and 
Prevention guidelines. 
After study completion, in addition to clinical data from the electronic health record, responses to 
the In-Center Hemodialysis Consumer Assessment of Healthcare (ICH CAHPS) of patients 
dialyzing at participating facilities will be tracked. Since participants are familiar with this 
survey and it is mandated to be implemented biannually, its use fits within the pragmatic 
framework of the trial.  
5.2 
Sampling Procedures  
We will narrow the sampling frame to counties with at least two US Renal Care facilities. We 
will then select the paired facilities for randomization, oversampling by 30%. Sampling from 
Standard 
practice: test in 
facility as feasible 
or refer for test 
symptomatic 
patients
Static universal testing* 
every 2 weeks in facility
Primary Outcome:
Test acceptability
Dynamic universal testing* 
in facility
Level of Community Transmission^
Facility-level 
randomization
Test every 4 weeks
Test every 2 weeks
Test every week
Secondary Outcomes:
1)
Death 
2)
Hospitalizations
Figure 1. Study overview 
 

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counties with at least two US Renal Care facilities ensures balance in socio-demographics of 
randomized facilities without sacrificing geographic diversity. 
5.3 
Governing Body Review  
All dialysis facilities have a CMS mandated governing body responsible for facility-level 
operations. The governing body typically includes the medical director (nephrologist), facility 
manager, and members of the nursing or social work teams. This governing body meets monthly 
to review facility data. Among the selected facilities, we will review study goals and procedures 
for the selected facilities’ governing bodies. The governing body can request to opt out of the 
study.  
 
  
5.4 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
For 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 willingness to participate 
Patient 
• Treatment at US Renal Care in-center hemodialysis facility 
• Age ≥18 years 
Exclusion Criteria 
Patient 
• Unwillingness to share limited PHI clinical data using the electronic health record (EHR). 
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 
5.5 
Sample Size   
We performed power calculations for the primary outcome of test acceptability. Briefly, we 
followed formulas given by Donner and Klar (2000) for the design of cluster randomized trials 
comparing probabilities for two groups with an adjustment for the clustered design (Variance 

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Inflation Factor) by dialysis facility. Assuming a type I error of 𝛼𝛼= 0.05, 80% power (𝛽𝛽= 0.2), 
a test acceptability proportion equal to 0.4 in the static arm and 0.65 in the dynamic arm – 
corresponding to a 25% absolute difference, a high degree of correlation between patients within 
the same facility (Interclass correlation coefficient, ICC=0.5), and that we will be able to recruit 
~40 patients per facility (median number of patients per facility at US Renal), we will require 
2480 patients from 31 facilities per intervention arm. The assumed ICC reflects the belief that we 
will observe a high dependence among individuals within a cluster accepting to do the test, i.e., 
test acceptability is likely related, through the neighborhood composition, for individuals within 
the facility. With this sample size we will be able to detect a difference of at least 25% for 
acceptability rates in the static arm ranging from 10% to 60%.  
 
5.6 
Static Testing Frequency  
In discussion with the US Renal Care medical officers regarding feasibility of integrating 
universal testing into routine clinical care, and given that test acceptability is our chief outcome 
of interest, we will offer patients dialyzing in the facilities randomized to the static arm rtPCR 
testing once every two weeks.    
5.7 
Dynamic Testing Frequency 
Facilities randomized to the dynamic arm will offer dialyzing patients rtPCR testing according to 
an adaptive testing strategy based on current estimates of community COVID-19 transmission. 
We anticipate that community transmission and risk of COVID-19 will evolve over the lifetime 
of this trial. Wastewater SARS-CoV-2 RNA loads can be used to detect COVID-19 incidence 
rates as low as 1 per 100 000 persons and have been demonstrated to correlate with clinical case 
data during the COVID-19 pandemic (Wolfe 2021, Karthikeyan 2021, Graham 2021, Huisman 
2022). We will combine disease surveillance estimates based on wastewater samples with 
community surveillance data from the CDC to monitor current epidemic trends at the county 
level and guide testing strategy assignment in real time.  
Using data from the preceding week, we will establish testing frequency for each facility for a 
period of four weeks. Facilities with high, medium, and low evidence of community COVID-19 
transmission will be assigned to once weekly, once every two weeks, and once every four weeks 
testing respectively. After each four-week intervention period, facilities will be assigned a new 
testing strategy based on the current county level of COVID-19 transmission. 
The data that will inform the facility assignment to testing strategies will be:  
1)  SARS-CoV-2 RNA wastewater percentile levels 
Or  
2) Number of new cases per 100,000 persons 
Or 
3) Number of hospitalizations per 100,000 persons 

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High, medium and low evidence of community COVID-19 transmission will be determined by 
pre-defined thresholds in these indicators (Table 1). If indicators suggest different transmission 
levels, the highest level is selected, with facilities falling into the highest frequency of testing 
when any one of the indicator criteria are met.  
If at any given time during the trial, 95% of facilities do not meet criteria for high frequency 
testing then facilities will be assigned to testing frequency strategies using trial-wide tertiles of 
current COVID-19 incidence. 
 
 
 
Table 1. Thresholds for levels of community COVID-19 risk by indicator 
 
 
Wastewater 
 
Clinical indicators 
 
Community Risk 
Level 
Viral percentile levela  
 
New COVID-
19 casesb 
 
New COVID-19 
hospitalizationsb 
 
Low 
< 20 % 
 
<50 
 
<10 
 
Moderate 
20–59 % 
 
50–199 
 
NA 
 
High 
≥ 60 % 
 
≥200 
 
≥10 
 
a SARS-CoV-2 RNA wastewater levels with respect to local historical range 
b Total number per 100 000 persons in the past 7 days 
 
 
5.8 
Test Characteristics 
The Abbott Alinity m SARS-CoV-2 real time rtPCR test has FDA EUA approval for testing 
symptomatic and asymptomatic individuals using nasal, nasopharyngeal and oropharyngeal 
swabs, with a positive and negative agreement rate of 100% and level of detection 100 virus 
copies/mL(42). The test has been independently validated(43).  
5.9 
Adherence  
Stanford University investigators can monitor intervention adherence in a non-obtrusive manner 
at each dialysis facility, both in terms of the number and frequency of rtPCR tests performed, by 
regularly reviewing all dialysis visits and rtPCR test data recorded in the electronic health 
system. Based on this information, Stanford University investigators can generate reports about 
performance of participating facilities. These reports will be provided to the dialysis provider 
organization research teams who, in turn, can communicate with clinical leadership at the 

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dialysis facilities. The Stanford University investigators can additionally generate reports 
comparing adherence rates between participating dialysis units, which can be reviewed at 
monthly dialysis unit quality improvement meetings. 
COVID-19 surveillance testing, as well as other COVID-19 safety protocols, are part of standard 
practice at all dialysis units. Accordingly, members of the multi-disciplinary care teams in 
dialysis units are trained to pay close attention to adherence these protocols. The multi-
disciplinary teams will be encouraged to review adherence to rtPCR testing protocols 1) during 
routine monthly multidisciplinary care rounds, 2) during routine monthly quality improvement 
meetings, or 3) through direct communication from the trial project managers to the dialysis unit 
clinical leadership. To encourage adherence at an individual patient-level at units randomized to 
both static and dynamic testing interventions, informational materials about the trial, the risks of 
COVID-19 for patients receiving dialysis, and methods to prevent COVID-19 transmission, will 
be provided. In addition, at dynamic intervention units, current data about county-level COVID-
19 community transmission will be provided to both trial participants and clinical staff. Treating 
nephrologists will be encouraged to discuss the importance of rtPCR testing for SARS-CoV-2 as 
a method to prevent transmission with trial participants and clinical staff. 
5.10 
Outcomes  
The primary outcome is test acceptability, i.e., the proportion of tests accepted from the total 
number of tests offered. Statistical analyses will account for multiple observations per patient 
and clustering by dialysis facility.  
Secondary outcomes include time to death or hospitalization. Patients on dialysis experience the 
highest rates of hospitalization across all CMS at-risk beneficiaries’ group(9), and among the 
highest death rates of patients hospitalized with COVID-19. We posit that by early identification 
of infected persons and by reducing transmission of SARS-CoV-2 we will reduce overall 
hospitalizations and death among patients receiving dialysis. Hospitalizations and deaths can be 
ascertained from dialysis facility records since they are mandated for tracking at monthly Quality 
Assessment and Performance Improvement Meetings. Thus we will use the US Renal Care 
electronic health record to ascertain dates, and admission and discharge diagnoses for 
hospitalizations. We will use the electronic health record to track dates and cause of death as 
applicable.     
5.11 
Pilot Phase  
We plan a pilot phase of the study for 4 US Renal Facilities; thus in total 66 facilities are 
anticipated to be participating in the study. Using mixed methods including patient and personnel 
interviews, and review of preliminary data, the pilot will assess: 1) facility personnel preference 
for one of two workflows for SARS-CoV-2 testing, 2) preliminary data on test acceptability and 
reasons for test refusal, and 3) patient feedback on patient facing documents. In discussion with 
US Renal Care Chief and Associate Chief Medical Officers, the two workflows to be tested in 
pilot phase would be offering test to all facility patients on a designated day of week, or selecting 
dialysis shifts throughout a weeklong period during which to offer tests. Preliminary data on test 
acceptability will inform estimates for test acceptability and material requirement. Patient 

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feedback on patient facing documents will allow us to generate patient-friendly materials that 
will improve patient comprehension and engagement.  
 PARTICIPANT ENROLLMENT 
In this cluster randomized trial, potential participants will be patients dialyzing at selected US 
Renal Care facilities. In considering informed consent for our study, there are three major 
components (Figure 2):  
 
1. A survey of RADx-UP Common Data Elements which covers topics related to COVID-
19 pandemic and its effects on the health and wellbeing of underserved populations. This 
survey is mandated by the NIH RADx-UP consortium. Participants are requested to share 
identifiable information as part of this survey.  
2. Offer of a SARS-CoV-2 screening test (i.e., the intervention) at a frequency dictated by 
facility randomization assignment 
3. The sharing of limited PHI clinical electronic health record data with the study team to 
assess outcomes  
 
There will be 2 research information sheets associated with the study: Research Information 
Sheet – Trial will cover the overall study design and all three components (Appendix A). 
Research Information Sheet – Survey will be specifically shared prior to the electronic RADx-
UP survey (Appendix B).   
Following the precedent of the pragmatic TiME trial, which was conducted under waiver of 
consent (see Dember et al JASN May 2019, 30 5 890-903; DOI: 
https://doi.org/10.1681/ASN.2018090945), we request waiver of consent for components 2&3. 
The detailed TiME trial rationale for waiving consent is attached to this IRB application. The 
TiME trial showcased the willingness of patients to share clinical data for the purposes of 
research, as >99% of enrolled patients allowed data sharing.  

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6.1 
Rationale for Waiver of Informed Consent 
 
6.1.1 
The intervention involves no more than minimal risk 
All three components of the study are considered no more than minimal risk because:  
i) the intervention consists of a SARS-CoV-2 screening test offered at varying frequency, 
which is being routinely administered in many settings in the United States (including in 
hospitals, schools, offices and airports) as well as in many other countries, without 
informed consent. Patients may opt out of taking the offered test at any time. 
ii)  There are minimal to no safety concerns related to SARS-CoV-2 screening tests. The 
selected SARS-CoV-2 screening tests (the Abbott Alinity rtPCR test) has a positive and 
negative agreement rate of 100% and level of detection 100 virus copies/mL. Thus, we 
expect minimal false positive or false negative result rates.  
iii) The NIH mandated RADx-UP survey is a validated instrument currently employed across 
more than 100 sites with well-established and embedded processes for secure data 
acquisition, transfer and storage. Since this patient-facing survey does request PHI 
including name, address, medical record number as available, it will be accompanied by a 
clear research information sheet identifying the PHI data components in simple language. 
The research sheet will also explain to the patient how identifiable information will be 
stored and managed separately from anonymized data, and clearly explains in simple 
terms the processes for privacy protection.  
iv) Electronic health record data obtained from US Renal Care will be anonymized with a 
limited PHI obtained zip code of dialysis facility, dates of SARS-CoV-2 testing, dates of 
COVID-19 diagnosis, hospitalization, deaths, or transfers of care. This limited PHI will 
have low risk for traceability back to individual participants.  Patients will have the 
opportunity to ‘opt out’ of sharing any clinical data by simply informing a designated 
member of their care team likely to be the dialysis nurse at any point during the study. 
Working with the US Renal Care clinical research coordinator, any patients deemed by 
dialysis facility social workers to lack capacity for ‘opt out’ consent will be eliminated 
from the dataset.  Any patients requesting to opt out will also be eliminated from the 
dataset.  
 
6.1.2 
The waiver or alteration will not adversely affect the rights and welfare of 
the participants 
All patients already dialyzing at selected facilities will receive Research Information Sheet – 
Trial explaining the study aims and design, including information about opting out of testing and 
anonymized data sharing. Patients initiating dialysis treatment at a participating facility during 
the time period of the study will be provided with the Research Information Sheet – Trial at the 
time they start dialysis. The screening tests will be offered without any mandate to the 
participant. Patients will be provided with an opportunity to opt out of electronic health record 
data sharing. No changes will be made to current dialysis facility standards of care around the 
COVID-19 pandemic. 
 

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6.1.3 
The research could not practicably be carried out without the requested 
waiver or alteration 
Because the randomized facility selection will be determined before patients are enrolled, a 
requirement for patient-level informed consent would severely compromise the generalizability 
and assessment of primary outcome of the trial. Patients who provide informed consent to 
proceed within the trial will have a much higher likelihood of test acceptance—the primary 
outcome—and will not be representative of the overall dialysis population. Thus, information 
gleaned from such a study will not be informative of the real-world effect of offering SARS-
CoV-2 test-based screening in dialysis facilities. 
Furthermore, to generate information valid nationally and enriched with information from the 
underserved populations, we plan to enroll up to 62 facilities throughout the US Renal Care 
Network, including those in remote areas (e.g., Alaska). We also plan a short and synchronous 
time period—3 months—in order to rapidly generate data relevant to the ongoing public health 
emergency related to the COVID-19 pandemic. We cannot practically have available study 
personnel for informed consent across all selected facilities, covering all potential patient 
interface times (typically 5 am- 9 pm, 7 days a week).     
Two research information sheets--one for the overall trial, one tied to the specific electronic 
survey--will be distributed and will cover the typical elements of the informed consent. 
Requiring signed consent will make this minimal risk study infeasible. 
 
6.1.4 
For research using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using such 
information or biospecimens in an identifiable format 
For participants who opt to take the NIH RADx-UP Common Data Elements survey, they will 
be requested to share following PHI elements:  
• Name 
• Date of birth 
• Address, including zip code 
• Email  
• Medical record number   
• COVID-19 dates as applicable 
The RADx-UP initiative is making a concerted effort to reach underserved populations and 
wants to be able to ascertain identifiable information so as to allow linkage of data to other NIH, 
CMS and claims databases. Furthermore, another aim of gathering this identifiable information is 
to enable RADx-UP to reach back out to these participants as additional opportunities for 
interventions arise.     
Additionally, Stanford University will receive the following limited PHI elements from the 
electronic health record on all patients in the participating facilities.    

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• Patient residence zipcode  
• Dates of SARS-CoV-2 screening tests offered and resulted  
• Dates of COVID-19 vaccination  
• COVID-19 dates  
• Dialysis facility USRC ID and zip code 
• Hospitalizations, dates and admission and discharge diagnosis as applicable 
• Death, dates and cause as applicable 
• Transfer out of facility date as applicable  
This limited PHI dataset is required to track test results, facilitate appropriate care, and enable 
assessment of key secondary outcomes (cases, hospitalizations, and deaths). This outcome 
assessment will help to generate a model for surveillance of COVID-19 and other infectious 
diseases among patients receiving in center dialysis. 
 
6.1.5 
Whenever appropriate, the participants or legally authorized representatives 
will be provided with additional pertinent information after participation 
Participating facilities will be informed of the study results as soon as they become 
Available, so that patients may be informed. Furthermore, a major objective of the study is to 
ensure feasibility, generalizability, and scalability, in close partnership with US Renal Care. We 
plan to identify an optimal testing frequency at dialysis facilities that will enable reduction in 
transmission and early identification of COVID-19. The results of this study will thus directly 
inform policy for SARS-CoV-2 screening in dialysis facilities nationwide. 
6.2 
Rationale for Waiver of HIPAA  
 
6.2.1 
The researchers require access to the PHI to conduct the research.  
The RADx-UP Common Data Elements survey PHI elements are a mandated element of the 
grant. They will allow linkage of patient information to other databases and enable the NIH to 
recontact the underserved population should opportunities for additional interventions arise (e.g., 
among participants expressing vaccine hesitancy). Participants will receive detailed information 
about data protection for their identifiable health information, including that these data will be 
kept in a separate repository hosted only at the RADx-UP CDCC and the initial project site 
(Stanford University). Stanford University also requires limited PHI data from patients at the 
selected facilities in order to assess key secondary outcomes (detected cases, deaths, and 
hospitalizations) that will factor into determining the effectiveness of the intervention. We will 
offer patients the option to ‘opt out’ of inclusion in this limited PHI dataset, although we expect 
few will take this option based on the precedence of the TiME trial.  
 
6.2.2 
The research cannot be practically conducted without the waiver 
This pragmatic intervention will be implemented across up to 62 facilities over a short time 
frame. The goal is to develop a scalable system that can be integrated within clinical care. For 

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both reasons delivery of HIPAA authorization via trained research personnel trained is not 
practical for the purposes of this research.    
 
6.2.3 
The use or disclosure of PHI will carry minimal risks   
Given the track record thus far of managing over 100 projects securely through the RADx-UP 
consortium, the risk for loss of privacy for participating in the RADx-UP survey will be 
minimized to the greatest extent feasible. Furthermore, the RADx-UP data coordinating center 
has developed processes for separating identifiable information and anonymizing the remaining 
data so as to enable wider use while minimizing risks to patient privacy. Finally the RADx-UP 
Common Data Elements survey is an ‘opt in’ process, thus patients can chose not to participate 
or provide protected health information as they take the survey.   
The risks for participants for the opt out electronic health record data sharing process are low 
since data shared with Stanford University will not be traceable back to the participant.  
 
 TRIAL IMPLEMENTATION  
Below we outline trial implementation according to anticipated chronological timeline.  
7.1 
 Governing Board Review  
All dialysis facilities have a CMS mandated governing board responsible for facility-level 
operations. The governing body typically includes the medical director (nephrologist), facility 
manager, and members of the nursing or social work teams. This governing body meets monthly 
to review facility data on census, hospitalizations, regulatory reviews etc. Among the selected 
facilities, we will review study goals and procedures for the selected facilities. The governing 
body can request to opt out of the study.  
7.2 
RADx-UP Survey   
Among participating facilities, Research Information Sheet – Trial will be provided to all 
patients dialyzing at the facility, and to new patients during their admission process to the 
facility. Patient facing flyers, in English and Spanish, will be posted throughout the facility, 
advertising the opportunity for participation in the RADx-UP Common Data Elements survey 
(Appendix C). For patients expressing interest, they will be able to follow a web address on their 
smart phone or use the facility iPAD to access the survey. The survey will begin with Research 
Information Sheet – Survey, and among those proceeding, we expect a ~30-minute survey 
(Appendix X for Common Data Elements Survey). Data from this survey will be stored on 
Stanford University’s PHI secure servers, accessible to Stanford PIs, analysts and statisticians 
only. Data will be downloaded, cleaned, and submitted to the NIH RADx-UP Data Coordinating 
Center (see Section X, Data management) 

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7.3 
Randomization 
We will sort US Renal Care facility ID numbers by location and facility size. Within US census 
region (Northeast, Midwest, South, and West) and facility size strata (< median or >=median 
size), we will randomly select two facilities per county, oversampling by 30%.  
7.4 
Intervention: SARS-CoV-2 Testing  
Facilities will be randomized to dynamic versus static frequency testing. As standard of care, 
each patient is individually checked in for each dialysis treatment, with weight and vitals 
assessment prior to dialysis. On the day of the test, as patients are checking in, facility staff will 
screen each patient for current health status, as per the current standard routine procedures.  
As part of the intervention, each patient will then be offered the anterior nares SARS-CoV-2 test, 
and his or her response recorded. If the patient agrees to the test, facility staff will use the 
following PPE surgical face mask, gloves, gown and eye protection. He/she will perform the 
anterior nares test following CDC guidelines (https://www.cdc.gov/coronavirus/2019-
nCoV/lab/guidelines-clinical-specimens.html) for anterior nares swab:  
Anterior nasal specimen (performed by a healthcare provider or the patient after reviewing and 
following the collection instructions): 
• 
Insert the entire collection tip of the swab provided (usually ½ to ¾ of an inch, or 1 to 1.5 
cm) inside the nostril. 
• 
Firmly sample the nasal wall by rotating the swab in a circular path against the nasal wall 
at least 4 times. 
• 
Take approximately 15 seconds to collect the specimen. Be sure to collect any nasal 
drainage that may be present on the swab. 
• 
Repeat in the other nostril using the same swab. 
• 
Place swab, tip first, into the transport tube provided. 
Staff will then follow standard procedures including labeling and batch shipment to Ascend 
Clinical Laboratory at the end of the day. The intervention of testing will be offered for a period 
of three months.     
7.5 
Testing at Ascend Clinical Laboratory  
Patients receiving in-center dialysis have monthly laboratory testing performed, while 
undergoing dialysis and without requiring needlestick/phlebotomy. The monthly laboratory tests 
are standard of care and inform dialysis prescription and medication changes (e.g., hemoglobin 
informing use of erythropoietin stimulating agents). Ascend Clinical Laboratory 
(http://clinical.aclab.com/about-us/) is a fully accredited, CLIA certified laboratory with a 
throughput of more than 2 million tests per month. Ascend Clinical serves as the contract central 
laboratory for US Renal Care for these tests, as well as for the symptomatic in-facility anterior 
nares rtPCR testing that is already in place at US Renal Care. The two partners have established 
processes for sample collection, shipment and electronic health record communication for release 

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of health results. Ascend Clinical will ship sample collection kits to selected facilities. US Renal 
Care staff will follow standard procedures for collection, labeling and shipment back to Ascend 
Clinical Laboratory. Results will be released into the electronic health record system with an 
expected time frame of < 48 hours (i.e., prior to the return of the patient to the facility for 
dialysis).  
7.6 
Test Results  
Standard processes for notification of facilities of ‘critical results’ are already in place, due to the 
extant clinical partnership between US Renal Care and Ascend Clinical Laboratory. As part of 
this study, any positive SARS-CoV-2 will be designated as critical results. Critical results require 
Ascend Clinical Laboratory staff to make at least two attempts to reach a treating RN to inform 
them of the results. As a failsafe, a project manager hired specifically to work on this project will 
be informed if RN cannot be reached, and will reach out to both the patient and the treating 
physician. In addition positive test results are reported to the local Department of Public Health 
as well.  Triage to higher level of care will occur following existing facility protocols and CDC 
guidelines as necessary.  
7.7 
Data Collection  
In addition to data that patients may choose to provide as part of the RADx-UP Common Data 
Elements survey, we will track the following data from the electronic health record (PHI is 
accompanied by asterixis)  
Patient Clinical data:  
• Age 
• Sex 
• Self-reported race/ethnicity 
• Comorbidities (e.g., diabetes, heart failure, primary cause of ESKD, history of kidney 
transplant) 
• Medications  
• Body mass index  
• Vaccination status   
• Dialysis-related characteristics: vascular access, treatment length, treatment frequency, 
average ultrafiltration rate; number of years on dialysis   
• Patient residence zip code * 
• Dates of  SARS-CoV-2 screening tests offered and resulted * 
• Results of SARS-CoV-2 screening tests * 
• Dates of COVID-19 vaccination * 
• COVID-19 dates * 
• Hospitalizations, dates and admission and discharge diagnosis as applicable* 
• Death, dates and cause as applicable* 
• Transfer out of facility date as applicable*  

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Patient laboratory data:  
• Albumin 
• Hemoglobin  
• Sodium 
• Potassium 
• Phosphorous 
• Kt/Vurea an index of dialysis efficiency 
• Hepatitis B semi quantitative titers  
• SARS-CoV-2 S1RBD semi-quantitative IgG, as available  
The following facility level data will be collected: 
Facility data (US Renal):  
• Facility % of patients with hemodialysis catheters as vascular access 
• Zip code  
• Covered area  
• Number of dialysis chairs  
7.8 
Data Confidentiality Procedures 
 
7.8.1 
RADx-UP Common Data Elements Survey  
Redcap survey data will be transferred from Stanford University to the RADx-UP 
Data Coordinating Center (Duke Clinical Research Institute), who will store data in 
two separate files, one hosting all identifiable information and one with anonymized 
data. These data will stay in a password-protected secure electronic system and only 
staff responsible for maintaining the security of data at Stanford University and the 
RADx-UP DCC will be able to access this information. If applicable these data will be 
linked with Centers for Medicare and Medicaid Services claims data to enable 
further research into outcomes. If the participant permits, these data will also be 
used to contact the participant for future research. 
 
7.8.2 
Limited PHI Electronic health record 
Each patient at a selected dialysis facility will be assigned a unique (random) research 
identification number. This ID number will be associated with all participant data 
that are collected, entered, and analyzed for the study. If a patient is identified by the 
social workers as unable to participate in opt out consent and/or if he/she selects to 
opt out of the limited PHI data sharing, he/she will not receive this research ID 
number. If the opt out selection occurs during the trial, the research ID will be 
eliminated from future data sharing processes. 
The link between participants’ names and study ID numbers will be kept in a separate electronic 
file on secure US Renal Care servers. US Renal Care will ensure that all data prepared for 
analysis are anonymized, prior to transfer to Stanford University Investigators.  

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7.9 
Data extraction and transfer procedures 
 
For the purposes of this study data will be collected using two methods: a) by RADx-UP survey 
and b) through limited PHI data extraction from electronic health records. 
 
7.9.1 
RADx-UP Survey 
Electronic survey data will be rendered remotely from the study sites via the Stanford University 
School of Medicine REDcap platform, which is a highly secure online survey and database 
management system. Data will be downloaded from REDcap at regular intervals for analysis 
onto password protected computers and saved on PHIsafe, HIPAA secure, encrypted Stanford 
University School of Medicine servers. A log (saved in REDcap) will be maintained to track 
when, and by whom data are entered as well as downloaded for analysis (including what data are 
downloaded and for what specific purpose). Only study staff at Stanford University will have 
download access. Study staff will subsequently clean and upload the data to RADx-UP Data 
Coordinating Center (Duke Clinical Research Institute) servers. 
 
7.9.2 
Limited PHI Data 
We will work with US Renal Care health management systems to identify the relevant data fields 
in the electronic health record (data elements specified under 6.7.). Patients participating in the 
study will be identified using their research identification number. US Renal Care will collate the 
selected data fields for each research ID from the electronic health record, and transfer 
anonymized data to Stanford University using a secure data pipeline set up by Stanford 
University investigators. Only study staff at Stanford University will have access to the data. 
7.10 
Statistical Analysis Plan 
 
We will compare the proportion of the total number of times individuals accept performing the 
test (# of times individuals respond yes / total # of times individuals are asked to perform the 
test) in the static versus dynamic testing frequency arms. We will use a log-binomial model 
predicting the probability of acceptability (Y) from intervention arm applying a generalized 
estimating equation (GEE) approach to take into account the clustering by dialysis facility and 
the multiple observations per patient. A similar method will be used for estimating the effect of 
the intervention on the outcome of death or hospitalization. Alternatively, we will use a frailty 
model which allows for a survival analysis of heterogeneous populations due to the clustering 
within facilities and multiple observations for each individual(46).  
 DATA AND SAFETY MONITORING 
We do not anticipate serious complications from the implementation of this pragmatic study.  
We identified the following potential risks: loss of privacy and possibility of a false positive or 
negative result. We have significant experience and will put in place rigorous processes for 
protecting patient-level identifiable health information, including by:  
1) using HIPAA and PHI secure electronic platform to undertake the RADx-UP Common 
Data Elements, eliminating the need for paper forms   

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2) storing and transferring data on HIPAA and PHI secure servers  
3) separating PHI containing files from other anonymized data, and rendering strict 
password protection on PHI containing files   
The possibility of a false positive or negative result is minimized by use of rtPCR testing, which 
is the best available testing technology.  Another important protocol we will put in place for 
patient safety is to ensure appropriate notification and triage of positive results. Standard 
processes for a potentially time sensitive test result already exist, due to the extant clinical 
partnership between Ascend Clinical Laboratory and US Renal Care, in which Ascend Clinical 
Laboratory notifies facilities about positive results. All positive results will be returned as 
‘critical’ results, which under standard processes require that Ascend Clinical Coordinators make 
at least two attempt to reach dialysis facility RNs to relay results. As a failsafe the US Renal 
Care project manager will be notified if dialysis facility RN cannot be reached.  After a pilot 
phase implementation, these workflows will be reviewed and revised by study PIs, the US Renal 
Care Associate Medical Officer, Ascend Clinical Chief Operating Officer, and the US Renal 
Care project manager.    
Prior to the start of the study, we will form a Data Safety and Monitoring Board consisting of 
faculty with nephrology, health policy, and clinical trial expertise. This DSMB will review 
patient facing materials, study procedures including procedures for notification to patient and 
facility of a positive result, and data extraction and transfer processes. The Board will meet after 
the pilot phase and review preliminary data and workflow on these parameters and meet 
regularly during the 3-month trial intervention period to review interim data on numbers of 
positive results and outcomes related to positive results.   
In summary, Acknowledging the disproportionate toll of the COVD-19 pandemic among patients 
receiving dialysis and the urgent need for preventive measures, our entire multi-disciplinary 
study team is committed to collaborating with each other and with the RADx-UP Consortium to 
implement a practical, scalable intervention that increases test availability to our medically 
vulnerable population of patients receiving dialysis.  
 
 
 
 
 
 
 
 

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 EXIT SURVEY 
 
In order to assess the feasibility and acceptability of this pragmatic trial on a facility level, 
we plan to implement an Exit survey (see Attachment labeled “Exit survey”) 
 
The survey will be sent electronically to facility managers,  care coordinators and social workers 
of the 62 selected facilities participating in the trial. The survey will be anonymous. Participants 
will be asked to label their facility name, but will not be asked to identify themselves or their 
roles. Following our prior protocols (see Garcia et al. JASN 2020 J Am Soc Nephrol. 2021 
Jul;32(7):1575-1581. doi: 10.1681/ASN.2021010104) where we implemented a nationwide 
survey of COVID19 vaccine acceptability, we will provide detailed information about the goals 
of the survey, and privacy protections prior to start of the survey. Participants will be assumed to 
have given consent if they proceed with the survey after reviewing this information.  
 
We will administer the survey as a link or QR code embedded in an email communication sent 
from US Renal Care staff. Data will be hosted on HIPPA-protected servers at Stanford 
University; all analyses will conducted within this HIPPA-secure environment as well.   
 
 
 
 

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11.0 APPENDIX 
  

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