Allocation System for Changes in Equity in kidNey Transplantation (ASCENT) Study
Phase: NA
Conditions: Kidney Disorders
Sponsor: Emory University

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IRB00081580                                                                                                                   Version 08/25/2017 
 
 
 
Evaluation of Racial Disparities in Access to Kidney Transplantation 
in the New National 
Kidney Allocation Policy (Aim 2) 
 
 
 
IRB#00081580 
 
 
 
 
 
 
 
 
 
 
 
Evaluation of Racial Disparities in Access to Kidney Transplantation 
in the New National 
Kidney Allocation Policy (Aim 2) 
 
 
 
 
 
Protocol Dated Aug 25th 2017 
 
 
 
 
 NCT02879812 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Title: Evaluation of Racial Disparities in Access to Kidney Transplantation in the New National 
Kidney Allocation Policy (Aim 2) 
 
Investigators: Rachel E Patzer, Cam Escoffery, David Howard, Stephen Pastan, Laura Plantinga, Nicole 
Turgeon, Rebecca Zhang, Janice Lea, Sumit Mohan 
 
C.4. Specific Aim 2. To evaluate the impact of a systems-level approach to providing tailored 
transplant performance feedback and education about the kidney allocation policy, we will 
conduct a multicomponent, clinical effectiveness-implementation study among 750 US dialysis 
facilities with racial disparities in waitlisting. Based on our preliminary data and access to national 
data on dialysis facility performance in waitlisting and transplant, we anticipate that increasing 
provider knowledge about the allocation policy within facilities that have racial disparities in 
waitlisting will reduce national disparities in access to the waiting list. 
 
INTRODUCTION AND BACKGROUND 
 
The public health burden of kidney failure in the United States is substantial, with more than 600,000 end-
stage renal disease (ESRD) patients. There are two main treatments for kidney disease – dialysis or 
kidney transplantation. A complex, multi-tiered national system regulates kidney disease care, 
reimbursement,and transplantation, creating barriers to overcoming the significant racial disparities that 
exist in transplantation, the most effective treatment for ESRD. The federal Organ Procurement and 
Transplantation Network of the United Network for Organ Sharing oversees the allocation of all deceased 
donor organs in the US, and on Dec. 4, 2014, a major change to the allocation policy was implemented 
that is expected to impact racial disparities in transplantation access. We propose to study the impact of 
the natural experiment offered by enactment of this new kidney allocation policy on reducing disparities in 
the key steps of referral for transplant evaluation, waitlisting, and transplantation, each of which have 
complexities for measurement at the local and national level. Based on national data that we have used 
to develop a systems-level practice, we will disseminate a systems-level practice of providing feedback to 
dialysis centers about their transplant performance to improve overall waitlisting rates and decrease 
disparities in kidney transplantation. 
 
Within the Southeastern US, where access to kidney transplantation is the lowest and racial and 
socioeconomic disparities in transplant access are the most substantial, we will work with our 
Dissemination Advisory Board, which includes relevant stakeholders within the kidney health care 
system, to finalize intervention materials (Objective 1) and then disseminate dialysis facility-specific 
performance feedback reports as part of a multicomponent intervention (educational videos for staff and 
patients; webinar for staff) using a clinical effectiveness-implementation study50 design among a national 
sample of 1500 dialysis facilities with racial disparities in waitlisting access (Objective 2). Key outcomes 
will include 1-year disparity reduction in dialysis facility-level waitlisting (primary outcome), and change in 
knowledge, intent to refer for transplant, communication to patients, and staff training about the allocation 
policy (secondary outcomes). 
 
The purpose of Aim 2 is to test a systems-level approach to disseminate a multicomponent intervention 
consisting of tailored, facility-specific performance report that will reflect a facilities performance (with 
respect to transplant and racial disparities in waitlisting) in the era of the new national kidney allocation 
policy and educational materials targeting dialysis facility Medical Directors, staff, and patients. We will 
implement a multicomponent intervention to ~1500 dialysis facilities in all 18 ESRD Network regions 
across the US to extend the influence of the national allocation policy in reducing disparities in early steps 
in kidney transplant access. In Objective 2, we will conduct a pragmatic, clinical effectiveness-
implementation study50, which will not only test the effectiveness of this approach, but even if the 
approach is not effective in reducing disparities, providing important information through implementation 
will still occur. The rationale for this design is based on several evidence-based criteria.45 In this study, 
there is strong face validity for both clinical and implementation activities, based on experts from our 
Coalition. There is a strong base of indirect evidence, defined as clinical effectiveness data from a 
different but associated population, through a Cochrane Review of performance feedback reports51 and 

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through our prior work that used a performance feedback report as a major component of an intervention 
among GA dialysis facilities in the RaDIANT study, where we found that disparities in referral were 
reduced 36% over 9 months among the intervention vs. control facilities.31 Feedback reports to dialysis 
facilities are minimal risk quality improvement activities that are routinely delivered to facilities in ESRD 
Networks, where similar reports have been used as a main component of the intervention in the national 
Fistula First Breakthrough Initiative,50 for increasing influenza and pneumococcal vaccination among 
ESRD patients within facilities,42 and for reducing racial disparities in kidney transplant referral.30 Finally, 
there is a strong implementation momentum of material related to the kidney allocation system, since it 
started in December 2014, and there are many potential ESRD patients who could benefit from this 
policy; a total of 74,443 current ESRD patients (of which nearly half are AA) have been on dialysis for 
more than 5 years and would likely have short wait times if referred for transplant evaluation now.26 
Because evidence also suggests that performance feedback reports are more effective when combined 
with a multicomponent intervention strategy,52 including both verbal and written communications, we will 
combine the report with educational videos (~5 minutes) for staff and patients and an educational webinar 
for dialysis facility staff. While our intervention efforts will primarily target Medical Directors, the leaders of 
the dialysis facility, educational material and outcomes will assess whether the Medical Directors 
disseminated information about the new kidney allocation policy and transplant information to dialysis 
facility staff and ESRD patients.  
 
Objective 1 – To develop a dissemination and feedback report as part of a multicomponent intervention 
for US dialysis facilities.  
 
STUDY DESIGN AND METHODS 
 
Dissemination Advisory Board - Partnering stakeholders will play a key role in the dissemination of this 
research. In Year 1 (Q1), a Dissemination Advisory Board will be convened among the study Co-Is, 
regional members of the Southeastern Kidney Transplant Coalition, and other national partners, including 
the National Kidney Foundation, the American Association of Kidney Patients, dialysis facility social 
workers and staff, ESRD patients, researchers, and key policy partners including ESRD Network 6 
leadership and staff, members from the National ESRD Network Board (Dr. Pastan), and a representative 
from the UNOS kidney committee (Turgeon). Several Medical Directors, nephrologists, and social 
workers from dialysis facilities will also be included (see Letters of Support). Under the direction of 
Stephen Pastan (Co-I; Chair of Southeastern Kidney Transplant Coalition) and the PI (Patzer), 
stakeholder feedback about the incentives or barriers that exist will ensure that dialysis facilities 
understand the new kidney allocation policy and communicate information to facility staff and ESRD 
patients to encourage improved access to kidney transplantation. The volunteer Dissemination Advisory 
Board will meet on a virtual basis monthly for 4 months to develop communication pieces for use in 
formative testing (e.g., feedback reports, webinar) and to draft surveys to measure secondary study 
outcomes; they will finalize intervention materials following formative evaluation (described below).  
 
Multicomponent Intervention. Similar to our prior dialysis facility-level interventions30,42,44, the 
multicomponent intervention will consist of the feedback report as well as a ~45-minute educational 
webinar for dialysis facility Medical Directors and staff and a separate ~5-minute educational video for 
patients and staff.  
Performance Feedback Reports. Performance feedback reports are defined as “a summary of clinical 
performance of health care over a specified period of time aimed at providing information to health 
professionals to allow them to assess and adjust their performance.”51 As in our prior work,30 a 
performance feedback report will be developed by the Dissemination Advisory Board using evidence-
based approaches31,42 and then provided to facility Medical Directors for pretesting. We expect the report 
to emphasize the most relevant information about the new kidney allocation policy for dialysis facilities, 
including tailored, facility-specific information (from publicly available, national Dialysis Facility Report 
data that we have previously used in research analyses29 and for facility-specific reports30) on the mean 
time on dialysis for patients in that facility, since transplant eligible-patients with longer dialysis may be 
more likely receive a transplant faster, compared to those with shorter dialysis time. In addition, the report 
will emphasize transplant access performance measures, such as waitlisting and transplantation, 

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including the magnitude of racial disparity, detailing when a facility is performing below the national or 
regional average. Evidence-based strategies will be used for the communication piece.45 For example, 
one figure may emphasize simple communication about the kidney allocation policy, whereas another 
report may emphasize benchmarking to compare how the facility compares to other facilities in that state 
or ESRD Network region. One figure may emphasize information about racial disparity in transplant 
access and show the proportion of AA patients within the facility with corresponding transplant access 
measures. Based on 108 comparisons from 70 studies in a Cochrane Review, feedback performance 
reports are most effective when they include an action plan.51 This report will offer consistent messaging 
regarding action plans (e.g., educating patients about transplant). Individualized reports will be emailed to 
facility staff as described below, but will also be made available for download on the same website as the 
educational videos and webinars.  
Educational Video for Staff & Patients –The Dissemination Advisory Board will develop a short 
educational video targeted to dialysis facility staff (nephrologists, nurses, & social workers) that describes 
the new kidney allocation policy and how it impacts dialysis facilities, as well as a video targeted to 
patients within facilities to explain in plain language (6th-8th grade level) the transplant process and 
allocation policy. These videos will be hosted on a website and usage tracked. We (Patzer, Turgeon, 
Pastan, Escoffery) have prior experience making videos for patients and staff  
Educational Webinar for Medical Directors and Facility Staff – Dr. Turgeon (a UNOS representative) 
has agreed to participate in the Advisory Board and on the educational webinar about the kidney 
allocation policy. Content will be approved by the Dissemination Advisory Board and targeted to Medical 
Directors and facility staff. We (Patzer, Pastan, Krisher) have experience developing content and hosting 
webinars for dialysis facility staff (n=12 webinars in 2014 alone) with 81% attendance 
(http://www.esrdnetwork6.org/improving-care/transplant.html). The webinar materials will also be hosted 
on a website for study participants to access. 
 
Formative Evaluation of Intervention Materials – Formative evaluation is a rigorous assessment 
process designed to identify potential influences on the progress and effectiveness of implementation 
efforts to optimize the potential for success of the intervention.50 The purpose of formative testing in our 
study is to conduct a rigorous assessment approach to refine, improve, tailor and adapt the intervention to 
our relevant target population (Medical Directors) prior to the effectiveness-implementation study. In Year 
2, Q1-Q2, we will conduct in-person, formative testing of the dissemination materials in n=6 of the >600 
dialysis facilities in ESRD Network 6 to ensure that the materials developed incorporate the most 
persuasive content and most effective way to communicate information to the target population of dialysis 
facility Medical Directors (nephrologists). Following informed consent, Medical Directors will be surveyed 
about their kidney allocation policy knowledge and whether they have made any efforts to communicate 
information about the changes to the kidney allocation policy to nephrologists, staff, and ESRD patients in 
their facilities. Next, we will give the draft performance feedback report to Medical Directors and ask them 
to view the educational videos within 1 week, and then follow up with structured interviews among 
Medical Directors and staff to assess whether there were any missing educational domains from the 
feedback report to try to identify any gaps in understanding about the kidney allocation policy and how the 
policy influences their facility or ESRD patient population. For example, we will ask whether there are any 
remaining questions about the kidney allocation policy, what incentives they need to educate their staff, 
and their opinions about what other information might help to influence transplant access among different 
patient populations (e.g., AA patients, females, patients with low SES, etc.). Draft questions for this 
formative evaluation and draft surveys that that will be pretested and then used in the effectiveness-
implementation study are included in the Social Research section of IRB. We will assess how long facility 
Medical Directors estimate it would take to educate staff about the kidney allocation policy to ensure 3 
months is adequate time to measure outcomes. Medical Directors will be offered gift card incentives for 
participation in the structured interviews and surveys. 
 
 
Objective 2 - To evaluate the clinical effectiveness and feasibility of implementing a feedback report to 
dialysis facilities with racial disparities in waitlisting access.  
 

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We will test the effectiveness and implementation of the performance feedback report among ~1500 
dialysis facilities in 18 ESRD Networks across the US to examine whether this dissemination intervention 
improves facility waitlisting performance. Facilities will be randomized to the intervention or usual care. 
The intervention group will receive a performance feedback report, educational videos, and the webinar, 
while the usual care comparison group will receive an educational pamphlet from UNOS. We expect to 
survey Medical Directors at baseline and at 3 months (exact time will depend on formative testing) to 
assess changes in secondary outcomes.  
 
PARTICIPANT SELECTION 
 
Recruitment of Dialysis Facilities – Executive Directors of all 18 ESRD Networks were contacted and 
invited to participate in this study, and all 18 US ESRD Networks, representing 50 states (and 3 
territories)have committed support in participation. All ESRD Networks have a requirement to focus on 
disparity reduction in the quality improvement projects among dialysis facilities, and transplant referral is 
also a priority area in the 2015 CMS ESRD Network Statement of Work and is expected to be of 
continued importance.32 To encourage participation of ESRD Networks across the nation, we will develop 
annual transplant performance reports with tailored feedback detailing Network’s performance in 
waitlisting and transplantation with respect to other Networks, as well as some of the key features that will 
be included in the facility-specific reports to encourage participation.  
 
Eligibility Criteria and Description of Potential Study Population – Facilities with at least n=11 
patients (at least 4 AA patients) in their facility with a waitlisting disparity will be eligible for participation, 
since measured outcomes focus on disparity reduction and facilities with small proportions of AA or a 
small number of patients may be difficult to classify as a disparity facility. Of the facilities in the 18 ESRD 
Networks, n=1529 dialysis facilities had a racial disparity in waitlisting in 2014. Demographics of 
participating facilities with a racial disparity in waitlisting are: AA (42.3%) and 53.0% white; mean age 61.7 
years; 65.5% unemployed, 11.4% Medicaid insurance; and 25.8% of patients waitlisted, and mean 
number of staff / facility 17.7. We expect ~1% of facilities will close in 1 year or there may be an 
improvement in racial disparities (from 2011) once we start the study, thus we expect a minimum of 
N=750 facilities will participate. 
 
STUDY DESIGN AND METHODS 
 
Study Procedures – Because there may be significant heterogeneity in dialysis facilities and patient and 
staff populations across the 18 participating ESRD Networks, we will randomize dialysis facilities that 
were not included in formative testing within each ESRD Network region to either the multicomponent 
intervention (feedback report, webinar, and videos) or comparison group (usual care plus UNOS 
educational brochure). At baseline (Year 2, Q3-Q4), all eligible dialysis facility Medical Directors in both 
the intervention and control group will receive an email from their ESRD Network Executive Director a 
web-based survey (HIPAA-compliant surveymonkey) with informed consent. For those who consent to 
participate (in reporting secondary outcome measures), baseline surveys will then be administered. 
Within one week of this email (or immediately after for those that complete a baseline survey), all facility 
Medical Directors from participating facilities will be emailed a UNOS pamphlet and instructed to share 
with staff; intervention facilities will be emailed facility-specific performance feedback report and videos, 
and information about the educational webinar. At 3 months, all facility Medical Directors who consented 
to participate will be emailed follow-up surveys by their respective ESRD Network Executive Director to 
assess secondary outcomes. Our prior work has shown >90% response rates by Medical Directors when 
surveys are mailed directly from the ESRD Network.53 Medical Directors will be offered an electronic gift 
card incentive ($10) for participation.  
 
Effectiveness Measure Outcomes – To test the effectiveness of this intervention, several outcomes will 
be assessed via surveys and surveillance data. Waitlisting data from 1 year post-intervention will be 
assessed using nationally available Dialysis Facility Report surveillance data in order to assess disparity 
reduction at the facility level. Follow-up surveys will be emailed to all Medical Directors at 3 months to test 
change in knowledge about the kidney allocation policy and whether Medical Directors have implemented 

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any staff training regarding the allocation policy within their dialysis facility, what methods the facility has 
used to educate ESRD patients about the kidney allocation policy, and whether the policy influenced 
facility Medical Directors’ intent to refer more patients for transplantation.  
 
Measures are described below. Surveys will be pilot tested in formative phases and finalized with 
approval by the Dissemination Advisory Board. 
 
1) Change in Waitlisting Disparity (Primary Outcome) – We will calculate facility racial disparity in 
waitlisting one year prior and post-intervention as the difference between the proportion of AA vs. whites 
waitlisted.  
2) Change in Knowledge about the Kidney Allocation System (Secondary Outcome) – We will 
survey Medical Directors using a 20-question scale measuring knowledge about the kidney allocation 
system, and general transplant knowledge, based on a validated scale we have used among dialysis staff 
and patients.54  
3) Change in Staff Training about Kidney Transplant and the Allocation System (Secondary 
Outcome) – We will assess at baseline whether Medical Directors have trained their staff about 
transplantation and/or the details of the kidney allocation policy. We will ask whether the Medical Director 
provided training about transplant or the kidney allocation policy in the prior 3 months after intervention 
delivery, and information about training (e.g., did they hold a training session, send an email, watch video 
presentations, etc.). Details about trainings will be collected to inform best practices for staff training for 
future scale-up.  
4) Evidence of Communication to Patients (Secondary Outcome) – To ensure that dialysis facility 
Medical Directors communicate information about the kidney allocation system to their staff and patients, 
we will track the educational video website usage by asking users to input user type, facility name, and 
location. This will allow us to track intervention dose and usage statistics such as number of uses by 
facility, time in application, etc. We have previously tracked other mobile educational initiatives through 
Google Analytics with success.55 
5) Change in Intent to Refer Patients to Kidney Transplantation (Secondary Outcome) – We will 
assess the current referral practices of facilities by surveying Medical Director about the estimated 
proportion of patients interested, eligible, and referred for transplant in their facility at baseline and at 3 
months post- intervention. We will ask questions about the estimated % of patients referred for transplant 
by specific patient characteristics (e.g. age, 
race/ethnicity, SES, time on dialysis, etc). A 
similar survey has been used in our Network in 
the past53 and will be finalized by the 
Dissemination Advisory Board in objective 1. 
Obtaining actual referral data is only possible 
for ESRD Network 6 dialysis facilities. 
However, our prior analyses examining dialysis 
staff-reported referrals and actual referrals to 
transplant centers show high correlation 
(r=0.79; p<0.01).  
Implementation effect measures: We will use 
an adaptation of the RE-AIM (Reach, 
Effectiveness, Adoption, Implementation, and 
Maintenance) framework38 for evaluating the 
public health impact of this health policy 
change.45 This framework builds upon the 
conceptual models of Rogers56 and Green and 
Krueter57 in this hybrid effectiveness-implementation study. A description of each of these measures and 
how they are applied to evaluating the successful implementation of a policy intervention are described in 
the table above. Effectiveness and Adoption measures are described in detail above. Implementation will 
be assessed by calculating a composite measure, or ‘crude implementation index’ for each facility as the 
sum of each secondary outcome (dichotomized at the median). We will conduct qualitative analyses of 
select dialysis facility providers that were successful intervention implementers (n=5) and non-

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implementers (n=5). At 1 year via phone interviews. These providers will be selected among the providers 
who completed the follow-up survey and already provided consent for the intervention. Phone interviews 
will be recorded and transcribed to help us better understand how to improve the intervention for the 
future. Providers who participate in the interview will be given $30 gift cards as an incentive. 
 
Other Measures. To explore potential moderators of the effectiveness of this system-level intervention, 
we will examine facility characteristics (region, facility size, profit status, etc), characteristics of patients in 
facilities (e.g., race, SES, comorbidities, etc), and neighborhood characteristics. We will include process 
measures for the intervention (receipt of intervention and self-report) to evaluate utility, value, satisfaction 
and reactions to intervention materials to ensure optimal future dissemination of interventions to other US 
dialysis facilities. 
 
STATISTICAL ANALYSES 
We will evaluate our main outcome of change in AA vs. white racial disparity reduction in waitlisting in the 
year post-intervention compared to the year prior to the intervention among the intervention vs. control 
facilities (intent to treat) using generalized linear models48 to account for potential correlation of facilities 
within Networks. Secondary analyses will examine facility- and patient-level modifiers of the intervention. 
Change in each of the secondary outcomes will be examined. We hypothesize that increasing provider 
knowledge about the allocation policy in facilities with racial disparities will reduce waitlisting disparities. 
Follow-up interviews will be transcribed verbatim and a codebook will be developed for qualitative 
analysis. Thematic analysis of key facilitators and barriers will be conducted to inform practice change.51 
 
Sample Size and Power. With 18 ESRD Networks participating (representing 1500 dialysis facilities with 
a waitlisting disparity), we estimate a minimum of ~375 facilities (average of 70 patients/facility) in each 
control/intervention group (total N=750), after accounting for ~1% loss from facilities that may close in the 
1-year evaluation and yearly fluctuation in waitlisting disparity. This will achieve 80% power (at α=0.05) to 
detect a difference of 10% in the waitlisting disparity ratio (%AA waitlisted/%white waitlisted) in the 
intervention vs. control group at 1 year, assuming the same disparity ratio (0.6) by group at baseline and 
an intraclass correlation coefficient of 0.06 among patients in a facility (based on RaDIANT). We found a 
36% disparity reduction in the RaDIANT study after 9 months31; thus we expect that a 10% effect within 1-
year is achievable.  
 
 
DATA AND SAFETY MONITORING PLAN (DSMP) - A Dissemination Advisory Board (comprised of 
members of the SEKTC, and regional and national partners in the kidney transplant community) will be 
responsible for finalizing interventional material including performance feedback reports, webinars, and 
educational videos;  See DSMB section in eIRB 81580.