Creating a Patient-centered Report Card for Solid Organ Transplant Candidates
Phase: NA
Conditions: Transplants
Sponsor: Ajay Israni, MD

PROTOCOL TITLE: HSR # 16-4130 Testing a Patient-Centered Report Card for Solid Organ 
Transplant C-candidates Among Kidney Transplant Candidates
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PROTOCOL COVER PAGE
Protocol Title
Creating a Patient Centered Report Card for Solid Organ 
Transplant Candidates
Principal 
Investigator/Faculty 
Advisor
Name: Ajay Israni 
Nephrologist, Hennepin Healthcare
President, Hennepin Healthcare Research Institute 
Professor of Medicine
Adjunct Faculty School of Public Health,
University of Minnesota.
Telephone Number: 612-873-6988
Email Address:  Ajay.Israni@hcmed.org
Scientific 
Assessment
Nationally-based, federal funding organizations
Version 
Number/Date:
Version 2
Version Date: 5/9/2022

PROTOCOL TITLE: HSR # 16-4130 Testing a Patient-Centered Report Card for Solid Organ 
Transplant C-candidates Among Kidney Transplant Candidates
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REVISION HISTORY
Revision #
Version Date
Summary of Changes
Consent Change?
Version 2
05/03/22
Add 97 subjects to the protocol 
that were already recruited for 
interview, focus groups and 
usability testing. This along with 
the 50 subjects that can be 
enrolled in the trial at HCMC, 
brings the total maximum 
enrollment to 147.
No

PROTOCOL TITLE: HSR # 16-4130 Testing a Patient-Centered Report Card for Solid Organ 
Transplant C-candidates Among Kidney Transplant Candidates
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Table of Contents
1.0
Objectives
7
2.0
Background
7
3.0
Study Endpoints/Events/Outcomes
9
4.0
Study Intervention(s)/Interaction(s)
9
5.0
Procedures Involved
10
6.0
Data Banking
12
7.0
Sharing of Results with Participants
12
8.0
Study Duration
12
9.0
Study Population
13
10.0
Vulnerable Populations
13
11.0
Number of Participants
15
12.0
Recruitment Methods
16
13.0
Withdrawal of Participants
18
14.0
Risks to Participants
18
15.0
Incomplete Disclosure or Deception
19
16.0
Potential Benefits to Participants
19
17.0
Statistical Considerations
19
18.0
Health Information and Privacy Compliance
21
19.0
Confidentiality
25
20.0
Provisions to Monitor the Data to Ensure the Safety of Participants
25
21.0
Compensation for Research-Related Injury
25
22.0
Consent Process
25
23.0
Setting
26
24.0
Multi-Site Research
26
25.0
Coordinating Center Research
27
26.0
Resources Available
27
27.0
References
27

PROTOCOL TITLE: HSR # 16-4130 Testing a Patient-Centered Report Card for Solid Organ 
Transplant C-candidates Among Kidney Transplant Candidates
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ABBREVIATIONS/DEFINITIONS ABBREVIATIONS/DEFINITIONS 
 
•
EMR              Electronic Medical Record 
•
HHS  
Hennepin Healthcare System
•
HHRI
Hennepin Healthcare Research Institute
•
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
•
IRB 
  
Institutional review board 
•
ITS2               Internal Transcribed Spacer 2 
•
PI 
 
Principal Investigator 
•
PHI 
 
Protected Health Information 
•
SRTR  
Scientific Registry of Transplant Recipients 
•
UMN              University of Minnesota 
•
FDA                  Food and Drug Administration
•
RCT                  Randomized Controlled Trials
•
OPTN               Organ Procurement and Transplantation Network
•
AHRQ              Agency for Healthcare Research and Quality 
•
USRDS             United State Renal Data System 
•
BMT                 Bone Marrow Transplant
•
ICS                   Informatics Consulting Services
•
ISRS                 International Standard on Related Services 
•
CTSI                Clinical and Translation Science Institute 
•
FWA                Federal wide Assurance
•
HSCT               Hematopoietic Stem Cell Transplant
•
ITT                   Intention-to-treat
•
IE                     Information Exchange 
•

PROTOCOL TITLE: HSR # 16-4130 Testing a Patient-Centered Report Card for Solid Organ 
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1.0  Objectives
1.1 Purpose:
Evaluate the effectiveness of the patient-centered SRTR report card among kidney 
transplant candidates. A randomized controlled trial (RCT) of all transplant candidates 
evaluated at the Hennepin Healthcare System (HHS) transplant centers will be 
conducted. One group with be shown the existing SRTR report cards and then the 
new patient-centered report cards (funded by AHRQ) on the web. The new patient-
centered report cards were developed with feedback from the general public, local 
transplant candidates, their family members and national transplant recipients. The 
feedback was collected using data from emails and phone calls received by SRTR, 
Amazon Mechanical Turk randomized surveys, interviews and focus groups and 
subsequent usability testing of functioning prototypes with local candidates. (n=97 for 
subjects in interviews and focus groups and usability testing). 
2.0 Background
2.1 Significance of Research Question/Purpose: 
On average, every 10 minutes someone is added to the organ transplant waiting list 
(1). Previous studies have shown that kidney transplant is a more effective treatment 
than dialysis (2). For patients with end-stage liver, heart, or lung disease, life is often 
not sustainable without a transplant. However, on average, every day 79 patients 
undergo transplant but 18 others die waiting (1). Mortality on the waiting list remains 
high. Thus, transplant is cost effective (3-8). Chronic comorbid conditions are 
increasingly common (9). Most transplant candidates have end-stage organ failure 
due to a variety of chronic diseases, and thus represent a priority AHRQ population. 
Figure 1: Adjusted adult graft survival hazard ratios for kidney, heart, liver, and lung 
transplant centers, from publicly available SRTR report cards.

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Transplant C-candidates Among Kidney Transplant Candidates
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2.2 Preliminary Data: Our preliminary data and other data suggest room for improvement 
in quality and efficiency of care. Using SRTR’s publically available PSRs, we described 
the variation in risk-adjusted hazard ratios for allograft failure at 1-year post 
transplant for all solid organ transplant centers (Figure 1). Allograft failure was 
defined as return to dialysis, transplant, or death.  We also surveyed all kidney 
transplant centers in the US and showed considerable variation in the structure and 
process of care (10). The PI and collaborators have shown that the structure and 
process of care plays a role in patient adherence to immunosuppressive medications 
(11). Others have shown variation in aggressiveness of liver transplant centers (12, 
13). 
2.3
Relevance to proposed work
 
 : Variation in post-transplant outcomes and in risk 
tolerance at transplant centers is not known to all patients. Informing patients of 
their choices through our innovative study can improve their chances of undergoing 
transplant and improve post-transplant outcomes.
Dissemination of a new website and a printout of SRTR report cards that will be 
functional even after the proposed project is completed: The proposed project will 
deliver a new website and printouts of the SRTR report cards, which SRTR will use to 
provide information to the public about each transplant center in the country. Since 
this project is being carried out by Dr. Israni, SRTR Medical Director (PI on this 
proposal), the final website will likely be adopted for use by SRTR. SRTR and OPTN 
lack the qualitative and design collaborators and easy access to transplant 
candidates needed to carry out the project. Therefore, the project team will develop 
and evaluate patient-centered SRTR report cards that will effectively communicate 
comparative information to transplant candidates on their alternatives when 
choosing transplant centers. 
In the future, SRTR staff can also inform patients and their family members about 
the new patient-friendly website. The SRTR website will prominently display a link 
for patients and their family members. This website currently receives more than 
100,000 hits annually and the most common hits are to the section that displays the 
report cards. 
Potential for the proposed project to improve outcomes: We will change the 
paradigm for how patients choose a transplant center by using report cards tailored 
to an individual’s clinical profile, thereby improving a broad set of patient-centered 
outcomes, effectively navigating the system of transplant centers with varying 
candidate acceptance criteria, creating greater satisfaction with the center selection 
process, and resulting in potentially better post-transplant outcomes. Transplant 
candidates could use the website to refer themselves directly to centers with better 
outcomes, thereby becoming empowered. Candidates who are turned down at one 
center could use the report card to find other centers more likely to transplant 
patients like them. Such public information is also likely to change transplant center 
behavior (14-16). Centers currently unwilling to transplant high-risk candidates could 
see patients choosing a nearby center that does transplant such candidates. This 

PROTOCOL TITLE: HSR # 16-4130 Testing a Patient-Centered Report Card for Solid Organ 
Transplant C-candidates Among Kidney Transplant Candidates
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could motivate a risk-averse center to review its practices and potentially accept 
more high-risk candidates. Thus, the patient-centered report cards can provide 
incentives to improve access to transplantation.
3.0 Study Endpoints/Events/Outcomes
3.1
Primary Endpoint/Event/Outcome: The primary outcomes are two separate 
assessments of the comprehension of the report card. To assess comprehension, the 
correct response to the following type of question will be assessed, “Which of the 
following transplant centers have the most experience with transplanting candidates 
over age 70?” There will be one correct answer; respondents will be told to assume 
they are in a specific zip code or state and are over age 70 and then asked to choose 
one of the several transplant center report cards shown or respond “Don’t know.” 
Another example of the question used to assess comprehension will be used, 
“Which of the following transplant centers have the most experience with 
transplanting candidates with body mass index (BMI) over 40?” There will be one 
correct answer; respondents will be told to assume they are in a specific zip code or 
state and have a BMI over 40 and then asked to choose one of the several transplant 
center report cards shown or respond “Don’t know.” Similar measures used 
previously by Dr. Hibbard, to determine the best way to present report cards to the 
general public (17). We will also determine comprehension of key concepts in the 
reports, to identify participants’ ability to determine whether a center performs 
transplants on “patients like me.” 
3.2
Secondary Endpoint(s)/Event(s)/Outcome(s): Perceived value of information will be 
determined via patient responses to the following question, “How useful is the 
information in the report card in helping you choose a transplant center for you or 
your family?” Response choices to the questions will be based on a 5-point Likert-
type scale (Example: 1 = not at all useful to 5 = very useful). We will also measure 
satisfaction with decision-making and decisional conflict using the effective decision 
subscale of the Ottawa Decisional Conflict Scale, which has been validated in 
multiple studies (18-21). 
These questions will be written on cards if the intervention is conducted face-to-
face. If conducted via HIPPA compliant zoom call, the questions will be placed in the 
chat box for the subject to refer to them during the intervention.
4.0 Study Intervention(s)/Interaction(s)
4.1
Description: 
Before the intervention, the study design with use of hypothetical scenarios will be 
explained to the participant. The concept of randomization will be also be explained. 
The participants will be asked a few questions to assess their understanding of the 
study design, specifically the hypothetical nature of the scenarios. We will also 
assess whether they understand the concept of being randomized to see one 

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Transplant C-candidates Among Kidney Transplant Candidates
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website first and then the other. Only those participants that understand the study 
design will be invited to participate in the intervention and will be randomized. For 
subjects that are randomized, a survey will be administered verbally to collect 
demographic information and information about their kidney disease and 
comorbidities. The functional health literacy and numeracy assessment and health 
status questionnaire will be completed. Subjects will be stratified by the transplant 
center site and then block randomized. One group will be shown the existing SRTR 
website with its existing SRTR report cards and then the website with the new 
patient-centered AHRQ report cards for kidney transplants. The other group will be 
shown the two websites in opposite order. Each participant will have at most 30 
minutes to view each of the websites. After viewing each website, responses to the 
intervention will be collected. Sessions where participants are reviewing the 
websites will be recorded using Zoom. Figure 2 shows the study design whereby 
subjects will be block randomized once to one of the four groups consisting of 18 
subjects each. At the end of the study, the patients will have access to both the 
websites.
The study interventions can be administered in person on a laptop. During the 
COVID-19 pandemic, the intervention can be administered remotely via email and 
zoom. The link to the websites will be sent via encrypted email and the intervention 
will be recorded via zoom. The recordings for subjects at Hennepin Healthcare will 
be stored on computers at that site.
If participant does not have your own electronic device or internet, the study will 
send the participant a study iPad with internet that participant can use for the 
intervention and then to send back to the study team. We will provide detailed 
instructions on how to use the iPad and Zoom application. The study will also pay for 
a FedEx pick up from the participants’ home to return the iPad to the study team 
after the completion of the intervention.

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Figure 2: Study Design of the Randomized Trial.
5.0
Procedures Involved
5.1
Study Design: This aim will entail an RCT of kidney transplant candidates at HHS 
transplant centers to evaluate the new report card. 
5.2
Study Procedures: The study entails assessing knowledge and perceived value of 
information along with measure of satisfaction with decision-making and decisional 
conflict. Open-ended questions that provide feedback on the sites will also be 
collected at the end of the study procedures. This study involves one study visit, 
approximately 90 minutes in length, to review the two report card websites. This 
study visit will be done in person or online using Zoom. 
The first 5 participants at each site will be enrolled in a vanguard study to optimize 
the study design. If no change in study design is required, these subjects will be 
analyzed in the main study.
For consented patients who will be participating in the study remotely, the study 
team will contact patients via email to confirm the patient’s email address. If 
participants do have their own electronic device with good internet connection, the 
study team will send a Zoom link for the Zoom testing session to check patient 
technology and ability to share their screen.
If a participant is willing to participate but has any issues with internet connection 
or/and missing or inadequate electronic device, the study team will send the 
participant a study iPad with internet that participant can use for the intervention 
Then subject will see SRTR
website. (30 min)
Primary Outcome: Which 
of the following transplant 
centers have the most 
experience with 
transplanting candidates 
over age 70? 
Then subject will see 
SRTR website. (30 min)
Primary Outcome: Which 
of the following transplant 
centers have the most 
experience with 
transplanting candidates 
with BMI over 40? 
36 subjects per organ type randomized to see 
AHRQ website first. 
36 Subjects per organ type  randomized to see SRTR 
website first
18 subjects (30 min)
Primary Outcome: 
Which of the following 
transplant centers have 
the most experience with 
transplanting candidates 
over age 70? 
18 subjects (30 min)
Primary Outcome: Which 
of the following transplant 
centers have the most 
experience with 
transplanting candidates 
with BMI over 40? 
18 subjects  (30 min)
Primary Outcome: 
Which of the following 
transplant centers have 
the most experience with 
transplanting candidates 
over age 70? 
18 subjects (30 min)
Primary Outcome: Which 
of the following transplant 
centers have the most 
experience with 
transplanting candidates 
with BMI over 40? 
Then subject will see 
AHRQ website. (30 min)
Primary Outcome: 
Which of the following 
transplant centers have 
the most experience with 
transplanting candidates 
with BMI over 40? 
Then subject will see 
AHRQ website. (30 min)
Primary Outcome: Which 
of the following transplant 
centers have the most 
experience with 
transplanting candidates 
over age 70? 
Study Design

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Transplant C-candidates Among Kidney Transplant Candidates
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and then to send back to the study team. We will provide detailed instructions on 
how to use the iPad and Zoom application. The study will also pay for a FedEx pick 
up from the participants’ home to return the iPad to the study team after the 
completion of the intervention.
When the clinical coordinator confirms good technology connection (through 
patient personal electronic device or study iPad). The study coordinator will 
schedule a 90 minute Zoom study visit. A sample script for the day of this study visit 
is attached.
If a participant prefers a face to-face study visit and this is allowed based on local 
site guidelines, the study intervention can be administered in the clinic. A study 
coordinator will help patients to work on study's iPad and record the Zoom session 
of the visit.
We estimate that the total time for the study visit will be around 90 min. After 
viewing each website, responses to the intervention will be collected.
5.3
Follow-Up: Data that will be collected includes demographic information, 
information regarding participants’ kidney disease and other comorbidities, and the 
recordings of the study sessions during which participants evaluate the two report 
card websites. Following the study intervention, there is no follow up for this study. 
5.4
Individually Identifiable Health Information: This study will involve use of individually 
identifiable health information. All subjects will sign a HIPAA authorization form 
separate from the consent form. 
6.0 Data Banking
6.1
Storage and Access: The identifiers for all Hennepin Healthcare subjects will be 
stored at Hennepin Healthcare. The recordings will be banked for future use for 5 
years after the study is completed and stored at the respective sites. The PI and the 
study team will have access to the de-identified data and the recordings. 
6.2
Data: The identifiers collected with the initial survey will be destroyed at the end of 
the study. 
6.3
Release/Sharing: 
Data will only be accessed by researchers involved in this study and designated lab 
personnel. The Principal Investigators, will be responsible for the confidentiality of 
banked data. 
7.0 Sharing of Results with Participants
N/A – No assessments are performed that may be shared with participants. 
8.0 Study Duration 
8.1    Each participant will be enrolled in the study and the duration anticipated to enroll 
all study participants is two years. The duration anticipated to complete all study 
procedures and data analysis is seven years.

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9.0 Study Population
9.1
Inclusion Criteria: All adults seeking a kidney transplant are eligible for the RCT. We 
will focus on recruiting kidney waitlist candidates. 
9.2
Exclusion criteria are inability to speak or understand English, visual impairment, and 
inability to give consent. All vulnerable populations except for those listed in the 
table titled vulnerable populations, will be excluded. 
9.3 Screening:  Screening will be done by viewing potential participants’ information in   
their electronic medical record (Epic). The research coordinator at Hennepin 
Healthcare will have access to Epic at HHS and File MakerPro. Within Epic, 
researchers will first look at a potential subjects ‘Patient Type’ to determine if the he 
or she has opted in or opted out of research. 
If the patient has opted in to research, preliminary screening will take place before 
initial approach. 
If the patient has opted out of research, the researcher will not contact the patient via 
mail for recruitment. If the opt-out patient has an appointment at HHS, they may be 
approached in-clinic, by the treatment team, per clinic guidelines.
Patients will be approached either in-person, by mail (followed up via a phone call) or 
by encrypted email if the study is first presented by the care team and the patient 
wishes to learn more about the study (see section 12.1).  Allowing for these 
approaches for recruitment enables us to reach more than just the newly waitlisted 
patients (those who are in for appointments more frequently) and ensures a wider net 
of patient availability. 
Before the intervention, the study design with use of hypothetical scenarios will be 
explained. The concept of randomization will be also be explained. The participants 
will be asked a few questions to assess their understanding of the study design, 
specifically the hypothetical nature of the scenarios. One such sample question is: In 
one of the scenarios being tested, a 71 year old candidate is looking to find a 
transplant center that transplants patients like him or her. So how old is the person 
that is looking for information about transplant centers? “
We will also assess whether they understand the concept of being randomized to see 
one website first and then the other. The participants will be asked a question to 
assess their understanding of the randomization process. One such sample question is: 
Can you tell me how it will be decided which patients in this study get to see the SRTR 
website first and which will get to see the AHRQ website first? 
Only those participants that understand the study design as denoted by giving the 
correct answers to the screening questions will be invited to participate in the 
intervention and will be randomized.
10.0 Vulnerable Populations

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10.1
Vulnerable Populations:
Vulnerable Population
Population / Group
Identify whether any of the 
following populations will be 
targeted, included (not necessarily 
targeted) or excluded from 
participation in the study. 
Children
Excluded from Participation
Pregnant women/fetuses/neonates
Excluded from Participation
Prisoners
Excluded from Participation
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders
Excluded from Participation
Non-English speakers
Excluded from Participation
Those unable to read (illiterate)
Excluded from Participation
Employees of the researcher
Excluded from Participation
Students of the researcher
Excluded from Participation
Undervalued or disenfranchised 
social group
Included/Allowed to Participate
Active members of the military 
(service members), DoD personnel 
(including civilian employees)
Included/Allowed to Participate

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Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc.
Excluded from Participation
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare.
Excluded from Participation
Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments.
Excluded from Participation
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior).
Excluded from Participation
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
influence consent to research or 
decision to continue in research.
Excluded from Participation
            10.2 Additional Safeguards: 
This is a study that is open to all kidney transplant candidates who fit study 
inclusion/exclusion criteria.  All vulnerable populations except for those listed in the 
table above will be excluded.
11.0 Number of Participants
11.1 Number of Participants to be Consented
The table shows the required sample size for ranges of detectable differences and     
within-person correlation. 
Correlation
 
0.0
0.1
0.2
0.3
0.4
0.
5
0.6
0.20
107
98
89
79
67
56
45

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Detectable 
0.22
90
82
76
66
56
47
38
Difference
0.24
76
71
64
55
48
40
33
0.25
70
66
59
51
44
37
*
0.26
66
61
55
48
41
34
*
0.28
57
53
46
41
35
30
*
0.30
51
45
41
36
32
27
*
On the conservative side, we will power the study to detect a proportional difference as 
small as 25% and therefore plan to enroll at 72 subjects for each organ trial. Recruitment 
will continue until this desired sample size is achieved. Given the low-risk nature of this 
project, there will be no stoppage rules based on interim analysis for recruitment.
This 72 is in addition to the 130 subjects enrolled in the interviews and focus groups and 
usability testing. Thus the total enrollment will be 130 + 72= 202. The 97 subjects already 
enrolled along with the 50 subjects that can be enrolled in the trial at HCMC, brings the 
total maximum enrollment to 147 at HCMC.
12.0 Recruitment Methods
12.1 Recruitment Process:
The research coordinators will screen kidney transplant candidates at HHS until an 
appropriate number have agreed to participate. Patients may be recruited a number 
of ways:

Patient direct contact at the Hennepin Healthcare transplant clinic or 
hospital - the study coordinator will ascertain an appropriate time to 
introduce the study to the patient during a standard of care visit and ask if 
they are interested and willing to participate in the study. If they agree to 
learn more, the investigator or study team member will close the door and in 
the presence of family (if requested), begin the consent process. 

By mail – alternately, eligible patients will be sent an invitation letter along 
with consent materials by mail. The invitation letter will state that they are 
being invited to the study because they are a transplant candidate at the 
Hennepin Healthcare. A study coordinator will then contact the patient by 
phone to introduce the study and ask if they are interested and willing to 
participate after allowing time for the invitation letter to arrive. Patients will 
be instructed to sign and return the consent materials by mail if they wish to 
participate in the study.

Electronically if waiver of consent not provided by IRB- Patients may be 
consented electronically using an e-consent platform (REDcap HHRI) with an 
accompanying phone call or video feed to conduct the consent conversation. 
The subject will review the e-consent in detail and have the chance to ask 
questions. Study personnel will then ask the subject questions to ensure that 

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they understand the information presented in the consent discussion using a 
teach back method. 

By care team - If allowed by local sites, care team members may ask 
potential participants if they are interested in learning more about this study 
by email. If so, the study team may send potential participants the study 
invitation letter by encrypted email.
The research coordinator will keep a log of all participants who do not meet 
eligibility criteria and why. The coordinator will assess whether the participant has a 
smartphone, tablet or computer through which the participant can access the 
websites being studied. 
Patients who agree to participate in the study will be consented and randomized. All 
participants will read, sign, and date a consent form before undergoing any study 
procedures. A copy of the signed consent form will be given to the participant. 
Patients who are consented by mail will not be considered as enrolled in the study 
until the study team has received their signed consent form. The consent process 
will be ongoing until recruitment goals are met.
12.2 Source of Participants: 
The sites for the RCT include HHS. Participants will be recruited from the adult 
kidney transplant candidate.
12.3 Identification of Potential Participants: 
Potential participants will be recruited based on information from their medical 
record—they must be kidney transplant candidates with either evaluations or 
waitlisted at the HHS. All potential patients under the care of the Hennepin 
Healthcare use an EMR that will be accessed to screen for adult patients. During the 
chart review, patients meeting exclusion criteria will be excluded. All potential 
transplant candidate participants are patients of the Hennepin Healthcare. 
All members of the research team have access to Epic. The research team will run a 
report for potential participants who meet inclusion/exclusion criteria for the study. 
An eligibility report may be generated by FileMaker and EPIC that have similar 
information for kidney transplant candidates.
The study coordinators will create a patient list to evaluate possible participants 
against inclusion and exclusion criteria. Coordinators will exclude patients who have 
declined to participate in research, unless this study is presented by the care team 
and the patient wishes to learn more about the study.
While preparing invitation letters, the study team may review the list to determine if 
some potential participants are coming into clinic for routine care. If a potential 
participant is coming into clinic for routine care, the study team may approach the 
potential participant in clinic.

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12.4 Recruitment Materials: 
An IRB-approved recruitment letter will be sent to potential participants recruited 
via mail. An IRB-approved phone script will also be used to contact potential 
participants after the recruitment letter is sent. No recruitment materials (other 
than the IRB-approved consent form) will be used for potential participants 
recruited in person.
12.5 Payment: Participants will receive a $40 Target e-gift card or check for their 
participation. Parking costs will be covered for patients participating in the in-person 
study visits.
13.0 Withdrawal of Participants
13.1 Withdrawal Circumstances:
If a subject is unable or unwilling to complete the study tasks (interventional 
testing), they may be withdrawn from the study without their consent.
13.2 Withdrawal Procedures: 
If a subject withdraws their consent, study staff will no longer use or disclose their 
health information.  However, information already collected cannot be retrieved or 
destroyed and may be used as part of the study.
13.3  Termination Procedures: 
The study may terminate early and at any time for administrative reasons.  In the 
event that this occurs, the IRB will be notified of this decision. 
14.0 Risks to Participants
14.1 Foreseeable Risks: Foreseeable risks to participants include loss of confidentiality of 
their responses, as collected during the RCT. The likelihood of the loss of 
confidentiality will be low because of the research processes detailed below.
Participants will be sent a link via encrypted email to the websites being studied (the 
intervention occurs via Zoom). The websites are available to the public. When the 
intervention is done remotely the participant will share their screen with the 
research coordinator using a password protected video conference service such as 
Zoom. Participants will be instructed to shut down all other programs and pages so 
as not to accidently share other information on their computer with the research 
coordinator. The coordinator will take notes on which pages of the website are 
viewed and how long participants took to respond to the questions posed. The 
responses to survey questions and knowledge questions will be recorded by the 
coordinator on paper that only has the unique study code and no personal 
identifiers. Thus, no names will be attached to the surveys,—they will be labeled 
only with the unique study code.  The identifiers for the respective subjects will be 
kept separately. The Zoom conference call will be recorded (audio and video), and 
stored on a HHRI computer or server.

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The randomized clinical trial participants will be instructed not to use their full 
names since the intervention will be recorded. The recordings will be used to 
determine whether the study procedure was followed correctly.  For example, the 
recordings will be reviewed to ensure that there were no prompts given 
inadvertently to the participant to help the participant get the correct answer. The 
recordings will also be reviewed to determine locations in the websites that were 
difficult for the participant to navigate.
14.2 Reproduction Risks: N/A
14.3 Risks to Others: N/A
15.0 Incomplete Disclosure or Deception
15.1 Incomplete Disclosure or Deception: N/A
16.0 Potential Benefits to Participants
16.1 Potential Benefits:
 Despite the availability of best medical care, patients with end-stage disease have 
difficulty finding transplant centers that transplant patients like them. The cost of 
caring for these end-stage disease patients is high and transplantation is cost-
effective and life-saving. Participation in the study confers no direct benefit to the 
study subjects. 
Understanding the needs of transplant candidates and creating a patient friendly 
website that allows them to find transplant centers that transplant patients like 
them, will be useful for all future transplant candidates. This study could improve 
access to transplantation and potentially improve outcomes post transplantation. 
Given the lack of direct benefit to study participants, it is important to recognize that 
the risks are also minimal, the major risk being loss of confidentiality. The safeguards 
planned will minimize this risk.
17.0 Statistical Considerations
17.1 Data Analysis Plan: 
Before initiating outcome analyses, we will perform exploratory analysis to examine 
frequency distributions for all baseline variables, with particular attention to variable 
ranges and skewness. We will examine group comparability at baseline between the 
two RCT arms to assess whether randomization succeeded in creating equivalent 
groups. These analyses will help determine potential need to incorporate additional 
covariates in later analyses using propensity-based methods (22-25). Relevant 
baseline measures include socio-demographic factors, health literacy and numeracy 
assessment, and baseline survey information. 
17.2 Power Analysis: The table shows the required sample size for ranges of detectable 
differences and within-person correlation. 

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Correlation
 
0.0
0.1
0.2
0.3
0.4
0.
5
0.6
0.20
107
98
89
79
67
56
45
Detectable 
0.22
90
82
76
66
56
47
38
Difference
0.24
76
71
64
55
48
40
33
0.25
70
66
59
51
44
37
*
0.26
66
61
55
48
41
34
*
0.28
57
53
46
41
35
30
*
0.30
51
45
41
36
32
27
*
On the conservative side, we will power the study to detect a proportional 
difference as small as 25% and therefore plan to enroll at 72 subjects. Recruitment 
will continue until this desired sample size is achieved.
17.3
Statistical Analysis: 
The primary analysis will be based on the conservative “intention-to-treat” (ITT) 
approach. We will use a chi-square test and logistic regressions for analyzing primary 
and secondary measures. A sensitivity analysis will be conducted excluding subjects 
that did not enter the correct hypothetical information into the website. The 
research coordinator will record the amount of time subjects spend with each 
website and the webpages viewed by each subjects and that information will be 
analyzed for descriptive analysis. Other subset analysis will be conducted but 
presented as ad hoc analysis. 
17.4
Data Integrity: 
The PI is responsible for the integrity of the data for this study. The study recordings 
will be used to determine whether the study procedure was followed correctly.  For 
example, the recordings will be reviewed to ensure that there were no prompts 
given inadvertently to the participant to help the participant get the correct answer
The recordings will be stored. If the recordings are presented in publications and 
presentations, the presented recordings will focus on the website that subjects are 
navigating but without the subject’s voice and face being shown. These recordings 
can highlight strengths and weaknesses of the websites in order to motivate future 
improvements to the web site. 
18.0 Health Information and Privacy Compliance
Individually Identifiable Health Information: 

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Under the HIPAA Privacy Rule, research studies are permitted to use and disclose protected 
health information with the authorization of the research participants, or without individual 
authorization in limited circumstances. Outside of that none of this information will be released 
outside of the covered entity.
18.1
Select which of the following is applicable to your research:
☐ My research does not require access to individual health information and 
therefore assert HIPAA does not apply. 
☒ I am requesting that all research participants’ sign a HIPCO approved HIPAA
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization), only if IRB does not 
grant waiver of consent.
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research.
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the U 
of M stand-alone HIPAA Authorization.  Note: External IRB must be serving as the 
privacy board for this option.
18.2
Identify the source of Private Health Information you will be using for your 
research (Check all that apply) 
☐ I will use the Informatics Consulting Services (ICS) available through CTSI (also 
referred to as the University's Information Exchange (IE) or data shelter) to pull 
records for me
☒ I will collect information directly from research participants.
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT (Hematopoietic 
Stem Cell Transplant) database.
☒ I will pull records directly from EPIC.
☐ I will retrieve record directly from axiUm / MiPACS
☐ I will receive data from the Center for Medicare/Medicaid Services 
☐ I will receive a limited data set from another institution 
18.3
Explain how you will ensure that only records of patients who have agreed to have 
their information used for research will be reviewed. 

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Please see pertinent recruitment and screening sections above. Within EPIC, 
research team members will first look at a potential participant’s “Patient Type” to 
determine if he or she has opted in or opted out of research. If the potential 
participant has not opted out of research, preliminary screening will take place 
prior to the research team approaching the potential participant. If a potential 
participant has opted out of research, the research team will not look into the 
chart and will not be able to do preliminary screening. Instead, the researcher will 
approach the potential participant in person to ascertain interest in the study. If 
the potential participant expresses interest in the study, the researcher will inform 
the potential participant that his or her medical record will be reviewed to 
determine eligibility and ask for the potential participant’s permission to view his 
or her medical record for this purpose.
18.4
Approximate number of records required for review: 
There are approximately 300 kidney transplant candidates on the waiting list at at 
HHS. The records of these candidates will be screened to enroll 50 of the 72 subjects 
in the RCT. 
18.5
Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes
☐ This research involves record review only. There will be no communication with 
research participants.
☐ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment. 
☒ Communication with patients will take place in-person, via phone, video 
conference calls, through mail, and encrypted email. Email communication will 
be used to share initial details about the study (if the patient is approached by a 
care team member and would like to hear from the study team via email), the 
Zoom session information, and to provide patient compensation following their 
study session if they prefer to be compensated by email. 
18.6
Access to participants:
Investigators have permissible access to patient records via EPIC and their treating 
relationship with the patients.  Research team members have EPIC access via NERS 
and will only access records and PHI as outlined in the protocol above.
18.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply). 
☐ In the data shelter of the Information Exchange (IE) 
☐ Store
☐ Analyze
☐ Share

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☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database 
☐ Store
☐ Analyze
☐ Share
☒ In REDCap (recap.ahc.umn.edu) 
☒ Store
☒ Analyze
☒ Share
☐ In Qualtrics (qualtrics.umn.edu)
☐ Store
☐ Analyze
☐ Share
☐ In OnCore (oncore.umn.edu) 
☐ Store
☐ Analyze
☐ Share
☐ In the University’s Box Secure Storage (box.umn.edu) for M-Health patients
☐ Store
☒ Analyze
☒ Share
☒ Store
☒ Analyze
☒ Share
☐ In an AHC-IS supported desktop or laptop. 
Provide UMN device numbers of all devices:
☐ Store
☐ Analyze
☐ Share
☒ Other: 
Data will be maintained in paper, digital, and audio formats. De-identified data 
collected on paper will be transferred to a database stored on a secure server at 
Hennepin Healthcare Research Institute (HHRI). Paper data will be stored in filing 
cabinets in the researchers' locked offices. All computers require users to log-in with 
usernames and passwords.
Only the investigators have permissible access to the study records. Consents will be 
kept in a locked drawer in a secure room that requires keypad access.
No names will attach to the surveys, audits or tapes; they will be labeled only with 
the unique code. At the end of the study, we will delete the zoom recordings.
Indicate if  data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet computer 
such as an iPad or a smartphone (iPhone or Android devices) that you have not 
already identified in the preceding questions
☐I will use a server not previously listed to collect/download research data
☒I will use a desktop or laptop not previously listed HHS location for HHS patients
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed 

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☐I will use a mobile device such as an tablet or smartphone not previously listed
18.8 Consultants. Vendors. Third Parties. Not applicable 
18.9 Links to identifiable data: 
None . 
18.10 Sharing of Data with Research Team Members: Data will be shared within the 
University of Minnesota’s Box.
18.11 Storage and Disposal of Paper Documents: Any paper documents generated at the 
HHS sites will be stored on-site in the research offices HHS.  The office space is 
secured by key-card or door-code access only.  All study documents will be stored 
through the required length of storage outlined by the study protocol and grant 
materials. Likewise, M-Health documents will be stored on M-Health site.
19.0 Confidentiality
19.1 Data Security:
 Data will be maintained in paper, digital, and audio formats. Electronic data from 
the de-identified paper forms will be stored on a secure server at HHRI. All servers 
have encryption and require users to log-in with usernames and passwords.  Paper 
data will be stored in filing cabinets in the researchers' locked offices. Electronic 
locations for data storage, analysis and sharing: HHRI secure server.
20.0 Provisions to Monitor the Data to Ensure the Safety of Participants
20.1 Data Integrity Monitoring.
This is a minimal risk project, collecting quantitative and qualitative data from 
interviews. The principal investigator will be responsible for overseeing the data 
integrity throughout the project.
20.2 Data Safety Monitoring. N/A – this research involves no more than minimal risk
21.0 Compensation for Research-Related Injury
21.1 Compensation for Research-Related Injury: N/A - minimal risk.
21.2  Contract Language: N/A
22.0 Consent Process
22.1 Consent Process (when consent will be obtained): 
Potential participants will be approached either in clinic, via mailing followed by a 
phone call from study personnel, or encrypted email (see section 12.1).  At the time 
of approach, participants will be given a consent form for review. Patients will be 
consented either in person, by phone, or electronically using REDCap HHRI. 

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Participants consented by phone will mail their signed consent form back to the 
study team. Participants will be given a copy of the consent form for their records. 
All potential participants will be given time to think about the study information 
presented to them.  They will be encouraged to ask questions and discuss the study 
with individuals other than the study personnel.  Subjects will have adequate time to 
review the consent form and ask questions before signing the consent form.  
Subjects will be informed of the voluntary nature of the study. The individual 
presenting the study will stress the fact that the subject’s care and/or relationships 
with the HHS will not be affected by the subject’s decision to participate or not to 
participate.
22.2 Waiver or Alteration of Consent Process (when consent will not be obtained, 
required information will not be disclosed, or the research involves deception): N/A 
22.3 Waiver of Written/Signed Documentation of Consent (when written/signed consent 
will not be obtained):  NA
22.4 Non-English Speaking Participants: N/A 
22.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of 
age): N/A
22.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: N/A
22.7 Adults Unable to Consent: N/A
23.0 Setting
23.1 Research Sites: 
The research will take place locally at the HHS.  Subjects will be recruited from the 
Hennepin Healthcare Clinic.
23.2 International Research: N/A 
23.3 Community Based Participatory Research: N/A 
24.0 Multi-Site Research
24.1 Study-Wide Number of Participants: 
This study is performed at HHS. This site will enroll kidney transplant candidates as 
subjects for the RCT. 
24.2 Study-Wide Recruitment Methods: N/A 
24.3 Study-Wide Recruitment Materials: N/A
24.4 Communication Among Sites: N/A

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24.5 Communication to Sites: N/A 
25.0 Coordinating Center Research
             HHS is Coordinating Center for this research study.
25.1 Role: The data coordinating center will be involved in receiving de-identified data 
from each of the sites and doing the final analysis. 
25.2 Responsibilities: The data coordinating center will hold regular calls with the 
coordinators at each site to ensure that proper procedures are used. During these 
calls, the coordinating center will ensure that the most current version of the 
protocol is being followed and that amendments to the protocol are communicated 
to all centers. 
25.3 Oversight: Provide each participating center FWA number with OHRP (if the research 
is federally funded). The protocol events at HHS will be reported to the IRB at   HHS. 
25.4 Collection and Management of Data: The data will be collected in a central data 
collection tool such as RedCap with no identifiers. The identifiers will be maintained 
at the individual study site only. The de-identified data will be used for analysis.
26.0 Resources Available
26.1 Resources Available: 
To assist with this study, the study will utilize services from Hennepin Healthcare 
Research Institute. 
HHS will provide regulatory and clinical coordinator support for the study for 
subjects enrolled at HHS. 
27.0 References
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Kryworuchko J, Stacey D, Bennett C, Graham I. Appraisal of primary outcome measures 
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Little R, Rubin D. Statistical Analysis with Missing Data. New York, NY: Wiley; 2002.
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Rubin D. Multiple Imputation for Non-Response in Surveys. New York: John Wiley & 
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Little R. Survey Nonresponse Adjustments for Estimates of Means. Int Stat Rev. 
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D'Agostino RB Jr. Propensity score methods for bias reduction in the comparison of a 
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