Improving Shared Decision-Making and Access to Non-Dialytic Treatment for People With Kidney Disease (The ExPAND Trial)
Phase: NA
Conditions: Chronic Kidney Disease
Sponsor: George Washington University

 
 
 
 
 
Expanding and Promoting Alternative Care 
and Knowledge in Decision-Making: The 
ExPAND Study (Improving Shared Decision-
Making and Access to Non-Dialytic 
Treatment for People with Kidney Disease) 
Protocol Number 
NCR235148 
Principal Investigator 
Dr. Dale Lupu 
Sponsor 
PCORI 
 
Protocol Version 
2 June 2025 
Version 8 
 
 
 
Confidentiality Statement: 
This document is confidential and proprietary to George Washington University and its affiliates. Acceptance of this 
document constitutes agreement by the recipient that no unpublished information contained herein will be 
reproduced, published, or otherwise disseminated or disclosed without prior written approval of George Washington 
University or its affiliates, except that this document may be disclosed in any medium to appropriate clinical 
investigators, Institutional Review Boards, and others directly involved in the clinical investigation that is the subject of 
this information under the condition that they keep the information strictly confidential. 
 
 

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Study Personnel 
Principal Investigator 
Dr. Dale Lupu 
George Washington University 
Email: dlupu@gwu.edu 
  
  
Alvin Moss 
George Washington University 
West Virginia University 
Email: amoss@hsc.wvu.edu 
  
Investigator 
Adam Ciarleglio 
George Washington University 
Email: aciarleglio@gwu.edu 
  
  
Christine Corbett 
George Washington University 
George Washington University 
Email: christine.corbett@gwu.edu 
  
  
Fergus Caskey 
University of Bristol 
Email: fergus.caskey@bristol.ac.uk 
  
 
Lucy Selman 
University of Bristol 
Email: lucy.selman@bristol.ac.uk 
 
 
David Rush 
Email: info4drush@gmail.com 
Other Study Personnel with Research 
Duties: 
Matthew Ryan 
George Washington University 
Email: m.ryan@gwu.edu 
  
  
Kelly Shipley 
George Washington University 
Email: k.shipley@gwu.edu 
  
  
Elizabeth Anderson 
George Washington University 
Email: lizbanderson@gmail.com 
  

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Annette Aldous 
George Washington University 
Email: aaldous@gwu.edu 
  
  
Joshua Mannix 
George Washington University 
Email: joshuajmannix@gwu.edu 
  
 
Chloe Shaw 
University of Bristol 
Email: chloe.shaw@bristol.ac.uk 
 
 
  
Miranda Johnson 
George Washington University 
Email: miranda.johnson@gwmail.gwu.edu 
  
 
Katherine Duberg 
George Washington University 
Email: k.duberg@gwmail.gwu.edu 
 
 
 
 
 

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SYNOPSIS 
Primary Objective 
The primary objective of this study is to compare two health system-based approaches for 
offering kidney failure treatment options to older patients with kidney failure, to ensure they 
are actively involved in a shared decision making (SDM) process covering a full range of 
choices and have meaningful access to that full range of choices, including standard in-
center or home dialysis (SIHD) and alternative treatment plans (ATPs): active medical care 
without dialysis (AMCWD), time-limited trial of dialysis (TLT), palliative dialysis, and deciding 
not to decide (DND). 
 
 
Aim 1: Compare the effectiveness of two approaches: 1) improved kidney disease education 
(KDE) and SDM or 2) improved KDE and SDM plus the creation of a kidney supportive care 
program in a) increasing proportion of patients choosing ATP and b) reducing patient 
decisional conflict.  
 
Secondary Objectives (if applicable) 
Aim 2: Compare the patient and family experience of an ATP between Approach 1 and 
Approach 2, with particular emphasis on TLT and AMCWD in terms of quality of life, services 
used, and end-of-life (EOL) experience through medical record review and interviews with a 

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sample of bereaved family members. Aim 2a will focus on experience while patients are 
receiving an ATP (several months to several years). Aim 2b will describe the EOL 
experience. 
Aim 3: In order to evaluate implementation of each intervention (Approaches 1 and 2), the 
ExPAND research team will cooperate with a separate tandem evaluation conducted by an 
independent evaluation team based at NORC. The implementation evaluation is a mixed-
methods design based on the expanded Reach, Effectiveness, Adoption, Implementation, 
Maintenance (RE-AIM) framework. The implementation evaluation will consist of staff 
surveys, interviews, and site visits conducted by the NORC evaluation team. Regulatory 
oversight of AIM 3 will be handled by the NORC IRB. 
 
General Design Description 
This will be a repeated, cross-sectional stepped wedge cluster randomized trial (SW-CRT) 
with randomization at the nephrology clinic level. Clinics are randomly assigned to one of 
three sequences. Each sequence consists of four 10-month time periods during which 
patients are accrued and followed for study outcomes. To minimize contamination in the 
primary analysis, we will exclude patients recruited during the 4 months before each 
sequence moves to Approach 2 (see white squares in the table below). These patients will be 
included in a sensitivity analysis. In the 4th study period, accrual of new patients will stop at 
10 months, allowing a closing 4-month follow-up period to collect primary outcomes at the 
end of the study. All practice sites begin by implementing Approach 1 (Educate and Engage). 
Practice sites then add Approach 2 (Kidney Supportive Care Program) at the assigned period 
based on their sequence. We have prepared for 15% drop-out of sites, leaving 21sites in the 
final analysis sample.  
 
 
Patients will receive the intervention based on the approach (condition) in which the site is 
enrolled at the time of accrual. When a practice site begins implementation of Approach 2, 
referral to the kidney supportive care program for patients considering ATPs will become 

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standard care at that site. All patients still alive who chose ATPs in prior periods will be 
offered the option of receiving care from the newly organized supportive care program.  
There are several advantages to a SW-CRT design vs. standard cluster-randomized trial. 
First, SW-CRT gives every practice the opportunity to implement both approaches, which is 
something that the physician practice leaders have told us they value. Second, SW-CRT 
means that from the patient perspective, they will be receiving the standard care delivered by 
the practice site at any given time, and there is no need for patients to opt in or out of a trial to 
receive this improved access to best practice care. 
In addition to the primary SW-CRT comparing the two intervention approaches, we will do a 
pre-post comparison of primary outcomes, comparing clinic practices at baseline with each of 
the interventions. 
 
Primary Outcome Variables 
Co-primary outcomes: 
• 
Proportion of patients 65 years and older who choose alternative treatment plans 
(ATP) 
• 
Decisional conflict score 4 months after decision initiated 
Secondary  and Exploratory Outcome Variables (if applicable) 
• 
Know-CKD score: assessment of patient knowledge about chronic kidney disease 
(CKD) and treatments 4 months after decision initiated 
• 
Patient experience of shared decision-making as on SDM Q-9 and COLLABORATE 
scales 4 months after decision initiated 
• 
Patient reported decision regret 9 months after decision initiated 
• 
Advance care planning documentation in chart 4 months after index visit 
• 
End of life intensity of treatment (ATP patients) 
• 
Unplanned start of dialysis in last 30 days of life (ATP patients) 
• 
Advance care planning at end of life for patients who die 
Additional secondary and exploratory outcomes detailed further in section 5.2.2 
Number of Participants 
Table 6.1.1 Number of Participants 

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Population 
Description 
N 
1. Patients of the 
nephrology practices 
(Aims 1 and 2) 
Patients 65+ years old with 
eGFR less than 30. Within this 
population, patients are 
grouped according to their 
treatment choice (within first 
10 months). 
 
2,948 
• 
Choose dialysis: 2,240 
• 
Choose ATP: 560  
• 
Lack decision-making 
capacity: 147 
2. Family/care partners 
of ATP patients (Aim 2) 
Sample of family members 
and care partners of patients 
who choose an ATP 
 
35 
• 
Longitudinal 
Interviews: 15 
• 
Bereavement 
interviews: 20 
3. Employees of the 
nephrology practices 
(Aim 3) 
Administrators/leaders (n = 
50), other clinicians and staff 
(including doctors, advanced 
practice provider (APP)s, 
nurses, social workers, 
dieticians, palliative care 
specialists, and staff, n = 90) 
 
140 
• 
Administrators: 50 
• 
Other employees: 90 
 
 
Visit Schedule Table (Optional) 
 
Synopsis Table 1. Schedule of Study Activities 
 
Time 
 
Activity 
 
Population 

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Screening 
(approx. weekly) 
 
Research coordinator (RC) reviews 
upcoming appointments to identify 
eligible patients. 
 
All 
 
Post-screening 
 
RC notifies treating 
nephrologist/APP of plans to enroll 
patient at upcoming visit. 
 
All eligible 
 
Time 0 / Index visit 
 
Eligible patients enrolled in study 
for chart monitoring. 
 
All eligible 
 
Time 0 / Index visit 
 
Under a practice protocol for 
ExPAND including a provider 
standing order, patient is referred 
to kidney disease education (KDE). 
Provider introduces topic of 
treatment decision. 
 
All eligible 
 
Time 0 / Index visit 
 
RC consents patient for surveys 
and administers first Decision 
Conflict Survey: DCS-1 
 
Survey eligible 
(Has decision-making 
capacity and speaks 
English or Spanish.) 
 
4 months after Time 0 
 
RC administers DCS-2 
 
Survey eligible 
 
4 months after Time 0 
 
Chart audit of advance care 
planning documentation 
 
All eligible 

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4 months after Time 0 
RC reviews chart, records current 
treatment preference and other 
outcomes 
 
All eligible 
 
9 months after Time 0 
 
RC administers DCS-3 
 
Survey eligible 
 
10 months after Time 
0 
 
RC reviews chart for missing 
outcomes, records current 
treatment preference, and enters 
Aim 1 completion status for patient 
(completed all study activities; 
followed for 10 months but did not 
complete all activities; died, lost to 
follow-up) 
 
All eligible 
 
After treatment 
decision 
 
RC begins monthly chart audit of 
ATP patient. 
 
ATP patients 
 
After treatment 
decision 
 
RC requests permission from ATP 
patient and/or care partner to share 
contact information with external 
research team, (addendum to 
previous informed consent form). 
 
ATP patients who 
participated in DCS 
surveys and their 
family/care partners 
 
Every 4 months after 
treatment decision 
 
ExPAND Research Team 
interviewers conduct longitudinal 
interviews 
 
Sample of ATP 
patients and 
family/care partners 
 
 
 

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3 Months after ATP 
patient death 
RC conducts end-of-life chart audit ATP patients who died 
during study 
 
4 Months after ATP 
patient death 
 ExPAND Research Team 
interviewers conduct bereavement 
interviews 
 
Sample of family/care 
partners of ATP 
patients who died 
during study 
Study Flow Chart (Optional) 
See Flowchart of Study Activities and Outcomes (Appendix) for schematic flow of Aim 1 and 
Aim 2 activities and outcomes. 
 
 
 
 
 
 
 
 
 
 
 

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ABBREVIATIONS 
Abbreviation 
Explanation 
AE 
Adverse Event 
AMCWD 
active medical care without dialysis 
APP 
advanced practice provider 
ATP 
alternative treatment plan 
DCS 
Decisional Conflict Scale 
DND 
deciding not to decide, measured here as not making a treatment 
decision within the 10 ½ month follow-up period 
DSMB 
Data Safety Monitoring Board 
ED 
emergency department 
EOL 
end-of-life 
ICC 
intraclass correlation 
IRB 
Institutional Review Board 
NKF 
National Kidney Foundation 
NP 
nurse practitioner 
PDA 
patient decision aid 
RC  
research coordinator 
RE-AIM 
Reach, Effectiveness, Adoption, Implementation, Maintenance 

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REDCap 
Research Electronic Data Capture 
SAE 
Serious Adverse Event 
SIHD 
standard in-center or home dialysis 
SW 
stepped wedge 
SW-CRT 
stepped wedge cluster randomized trial 
TLT 
time-limited trial of dialysis 
 
 

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Table of Contents 
SYNOPSIS ............................................................................................................................ 4 
ABBREVIATIONS ................................................................................................................ 11 
1. Statement of Compliance ................................................................................................. 17 
2. Background ...................................................................................................................... 18 
3. Rationale/Significance ...................................................................................................... 20 
3.1 Problem Statement ..................................................................................................... 20 
3.2 Purpose of Study/Potential Impact .............................................................................. 20 
3.3 Potential Risks and Benefits ....................................................................................... 21 
3.3.1 Potential Risks ...................................................................................................... 21 
3.3.2 Potential Benefits .................................................................................................. 22 
4. Study Objectives .............................................................................................................. 23 
4.1 Hypothesis .................................................................................................................. 23 
4.2 Primary Objective ........................................................................................................ 23 
4.3 Secondary Objectives (if applicable) ........................................................................... 24 
5. Study Design .................................................................................................................... 25 
5.1 General Design Description ........................................................................................ 25 
5.2 Outcome Variables ..................................................................................................... 26 
5.2.1 Primary Outcome Variables .................................................................................. 26 
5.2.2 Secondary and Exploratory Outcome Variables (if applicable) .............................. 26 
6. Study Population .............................................................................................................. 33 
6.1 Study Population ......................................................................................................... 33 
6.1.1 Number of Participants ......................................................................................... 33 
6.1.2 Eligibility Criteria/Vulnerable Populations .............................................................. 34 
7. Methods ........................................................................................................................... 36 
7.1 Intervention ................................................................................................................. 36 

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7.1.1 Description of Intervention .................................................................................... 36 
7.1.2 Method of Assignment/Randomization .................................................................. 37 
7.1.3 Selection of Instruments/Outcome Measures ........................................................ 37 
7.1.4 Intervention Administration ................................................................................... 40 
7.1.5 Reaction Management .......................................................................................... 41 
7.2 Assessments .............................................................................................................. 42 
7.2.1 Efficacy ................................................................................................................. 42 
7.2.2 Safety/Pregnancy-related Procedure .................................................................... 42 
7.2.3 Adverse Events Definition and Reporting .............................................................. 42 
7.2.4 Pharmacokinetics (if applicable) ........................................................................... 44 
7.2.5 Biomarkers (if applicable) ..................................................................................... 44 
7.3 Study Procedures ....................................................................................................... 44 
7.3.1 Study Schedule .................................................................................................... 44 
7.3.2 Informed Consent ................................................................................................. 46 
7.3.3 Screening ............................................................................................................. 48 
7.3.4 Recruitment, Enrollment and Retention ................................................................ 48 
7.3.5 Study Visits ........................................................................................................... 51 
7.3.6 End of Study and Follow Up ................................................................................. 51 
7.3.7 Removal of Subjects ............................................................................................. 51 
7.4 Statistical Method ........................................................................................................ 51 
7.4.1 Statistical Design .................................................................................................. 51 
7.4.2 Sample Size Considerations ................................................................................. 53 
7.4.3 Planned Analyses ................................................................................................. 60 
7.4.3.1 Primary Analyses ............................................................................................... 60 
7.4.3.2 Secondary Objectives Analyses, if applicable ....... Error! Bookmark not defined. 
7.4.3.3 Analysis of Subject Characteristics .................................................................... 62 
7.4.3.4 Interim Analysis (if applicable) ........................................................................... 62 

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7.4.3.5 Health economic evaluation, if applicable .......................................................... 62 
7.4.3.6 Other ................................................................................................................. 62 
7.4.4 Subsets and Covariates ........................................................................................ 62 
7.4.5 Handling of Missing Data ...................................................................................... 63 
8. Trial Administration .......................................................................................................... 64 
8.1 Ethical Considerations: Informed Consent/Assent and HIPAA Authorization ............... 64 
8.2 Institutional Review Board (IRB) Review ..................................................................... 65 
8.3 Subject Privacy, Confidentiality & Data Management .................................................. 66 
8.4 Deviations/Unanticipated Problems ............................................................................ 67 
8.5 Data Collection ........................................................................................................... 68 
8.6 Data Quality Assurance .............................................................................................. 70 
8.7 Study Records ............................................................................................................ 70 
8.8 Access to Source ........................................................................................................ 71 
8.9 Data or Specimen Storage/Security ............................................................................ 71 
8.10 Retention of Records ................................................................................................ 72 
8.11 Study Monitoring ....................................................................................................... 72 
8.12 Data Safety Monitoring Plan...................................................................................... 72 
8.13 Study Modification ..................................................................................................... 73 
8.14 Study Discontinuation ............................................................................................... 73 
8.15 Study Completion ...................................................................................................... 73 
8.16 Conflict of Interest Management Plan ....................................................................... 74 
8.17 Funding Source......................................................................................................... 74 
8.18 Publication Plan ........................................................................................................ 74 
LIST OF TABLES ................................................................................................................. 76 
LIST OF CHARTS ................................................................................................................ 77 
REFERENCES .................................................................................................................... 78 
SUMMARY OF CHANGES ..................................................... Error! Bookmark not defined. 

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APPENDICES ...................................................................................................................... 83 
 
 
 

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1. Statement of Compliance 
This document is a protocol for a human research study. The purpose of this protocol is to 
ensure that this study is to be conducted according to the Common Rule at 45CFR46 (human 
subjects) and other applicable government regulations and Institutional research policies and 
procedures. 
 
 

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2. Background 
Why this project is needed: 
Over 130,000 patients with kidney failure start dialysis annually (1) . Older patients constitute 
the fastest growing segment (1) . Those who are frail or have other serious medical conditions 
may not live any longer with dialysis than without it (2) . US healthcare policy has created a 
powerful "dialysis default," where virtually all patients with kidney failure who do not receive a 
transplant are treated with a standard dialysis regimen in a dialysis center regardless of whether 
it will help them live any longer or better. About 20% of patients regret the decision to start 
dialysis, yet non-dialysis alternatives are rarely offered to them (3) . Most report they were 
unaware they had a choice about kidney failure treatment. Many older patients with kidney 
disease value independence over staying alive longer. Not aware of their patients' values, most 
nephrologists do not offer alternatives to standard dialysis such as active medical care without 
dialysis (AMCWD), a time-limited trial of dialysis (TLT), palliative dialysis, or deciding not to 
decide (DND) until a later date. 
 
 
Similarly, these options, which we have collectively labeled alternative treatment plan (ATP)s, 
are rarely included in kidney disease education (KDE) sessions for patients funded by Medicare. 
Other countries—notably Australia, Canada, and the United Kingdom—have found that about 
15% of older patients with kidney failure prefer AMCWD (4) .  They have created programs 
within their healthcare systems that integrate primary palliative care into care for patients who 
choose an ATP. These programs report excellent outcomes in terms of patient quality of life, 
care according to patient's wishes, and patient survival on average for over a year. They have 

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shown it is possible to avoid complications at the end of life such as patients who wanted 
AMCWD being started on dialysis because their symptoms were not well managed. These 
programs provide an extra layer of support and prepare patients and families for when the 
patient's kidney failure worsens. 
Shared decision-making is recognized as the preferred approach to implementing patient-
centered care and assuring that patients receive treatment that matches their goals. For over a 
decade, shared decision-making (SDM) has been recommended by nephrology professional 
societies before initiating dialysis (5). Despite the recommendation and preference for SDM (6) 
(7) of people with advanced chronic kidney disease (CKD), it remains poorly implemented, and 
observers have noted a "powerful [dialysis] default option with few perceived alternatives." (8) 
There is an urgent need for strategies to increase adoption and implementation of SDM in 
nephrology practices and elsewhere in healthcare systems where CKD patients receive care. 
 
 

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3. Rationale/Significance 
3.1 Problem Statement 
For older patients with advanced CKD and comorbidities, frailty, and/or dementia, dialysis may 
not provide a survival advantage for them once they have reached end-stage kidney failure. In 
the United States in contrast to other countries including Australia, Canada, and the United 
Kingdom, there are not well-established programs to care for these patients if they choose NOT 
to start dialysis. The problem to be addressed in this project is how best to implement a kidney 
supportive care program that will 1) fully inform patients of all their treatment options including 
in-center and home dialysis, kidney transplantation, a time-limited trial of dialysis, palliative 
dialysis, deciding not to decide about dialysis till a later date, and AMCWD; and 2) provide an 
infrastructure to support patients who choose an alternative to in-center or home dialysis and 
kidney transplantation that will manage their symptoms, conduct advance care planning with 
them, refer them to hospice as appropriate, and support them in a symptom crisis so that they 
have the options to stay at home or be treated in an inpatient hospice as an alternative to going 
to a hospital emergency department (ED). 
3.2 Purpose of Study/Potential Impact 
Using a comparative effectiveness approach, the purpose of this study is to determine, in real-
world nephrology practices, whether 1) KDE using a shared decision-making approach and 
patient decision aids alone OR 2) improved KDE plus the creation of a kidney supportive care 
program is the most feasible and effective way to educate and provide alternative treatment 
plans to older patients with kidney failure, including those who do NOT want standard in-center 
or home dialysis. Although we hope to see a shift from in-center hemodialysis to home dialysis 
consistent with recently implemented federal value-based care initiatives, and although we 
expect that the intervention may contribute to such a shift, this study will evaluate change in the 
proportion of the less commonly offered alternate treatments (AMCWD, TLT, palliative dialysis, 
and DND). The choice of this outcome reflects the specific goals of the project as well as the 
need to avoid confounding by secular trends in the take-up of home dialysis. 
The potential impact of this study is immense. Patients with advanced chronic kidney disease 
75 years of age and older are the age group with the highest incidence and prevalence of 
patients on dialysis. Dialysis is a labor-intensive and expensive life-prolonging intervention. 
Once fully informed, approximately 15-20% of older patients with advanced chronic kidney 
disease in other countries choose a non-dialysis option for their kidney failure treatment. There 
is a paucity of data on the number of such patients who make this decision in this country, but it 
is thought that it is only about 1-3%. If one of the approaches in this study proves effective and 
acceptable to patients and the number in this country increases to a number comparable to 
other countries, 15,000 or more patients each year in the US could benefit from a non-dialysis 
treatment approach according to their wishes. 

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It is important to note that we are NOT trying to compare the experience or outcomes of ATP to 
the experience or outcomes of hemodialysis. Such descriptive comparisons already exist in the 
evidence base, especially for AMCWD. (9)  (10)  (11)  (12)  (13)  These cited comparison 
studies provide evidence for the rationale for making ATP more widely available to the subset of 
patients who might not do well with dialysis and who might want and benefit from AMCWD, 
since the quality and quantity of life outcomes are non-inferior for older, frail patients. This 
evidence base has been criticized because few of the studies involved randomization, but such 
a randomized trial comparing patients who choose to prepare for dialysis to those who prepare 
for AMCWD is currently underway in the United Kingdom (14) . We have designed a trial whose 
primary aim is to test HOW best to increase SDM and access to ATP's. A second aim is to 
provide a comprehensive description of patient and family experience during ATP. 
3.3 Potential Risks and Benefits 
3.3.1 Potential Risks 
Patients: Because this study is implementing recommended best practices in the care of older 
patients with advanced chronic kidney disease, there are no anticipated major risks associated 
with it. Clinicians will employ recommended communication approaches and ask for permission 
to provide information about the patient's kidney disease and possible treatment options before 
doing so. Nonetheless, some patients might experience distress once informed that they have 
advanced chronic kidney disease if they were not previously aware of it. This distress is 
comparable to that experienced by patients in routine clinical practice who receive bad news. 
This study may differ from standard care in that patients might become better informed and 
more aware of the range of treatment options they have. Also, in taking the Decisional Conflict 
Scale and other surveys, they might realize more clearly that they don't know 1) what are the 
benefits of treatment that matter most to them, 2) what risks and side effects are most 
troublesome to them, and 3) overall, what treatment option is best for them. Interviewers will be 
trained to watch for indications of emotional distress and will be trained in how to respond 
calmly and empathetically. If the situation persists or worsens, the interview will be terminated, 
and the incident will be reported within 24 hours to the patient's treating clinician, who will 
develop a plan for supporting the patient including referral for further mental health services, as 
indicated.  
Care partners and clinic employees: The main risk to these participants is loss of confidentiality 
of research data. Specific steps to minimize these risks are described in section 8.3. 
Before data collection starts, all research personnel will be required to undertake appropriate 
training in the conduct of human subjects research, such as Collaborative Institutional Training 
Initiative (CITI) or Association of Clinical Research Professionals (ACRP) coursework. All staff 
will complete a training program developed by the study PIs. This training will include modules 
covering: 1) study overview, 2) recruitment procedures, 3) study arm procedures, 4) collection 
and management of study data, and 5) adverse event reporting and managing emergencies. 
The trial will be registered on ClinicalTrials.gov and Advarra will be the Central IRB (IRB of 

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record). Participant recruitment will begin at each site only after that site's clinical trials office (or 
equivalent) has approved the study materials containing IRB-approved protocol, surveys, and 
data collection instruments.  
3.3.2 Potential Benefits 
Because this study mirrors recommended best clinical practices such as the use of shared 
decision-making, patient decision aids, and kidney supportive care to address unmet palliative 
care needs in the population of older patients with advanced chronic kidney disease, the 
investigators believe that there will be significant benefits for the participants. These include 
being aware that they have a choice about treatment to make, being fully informed of all 
treatment options, participating as co-equals in treatment decisions and in the development of a 
treatment plan, being offered the opportunity to participate in advance care planning, being 
routinely assessed for symptoms and being treated for them, and being referred to palliative 
care and/or hospice in a timely manner as appropriate. 
 
 

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4. Study Objectives 
4.1 Hypothesis 
Primary hypothesis: Approach 1 (Educate and Engage) will be less effective than Approach 2 
(Provide Primary Palliative Care) in a) increasing proportion of patients choosing ATP and b) 
reducing patient decisional conflict. Subgroup hypothesis: The difference in primary outcomes 
(selection of ATP and decisional conflict) will be more pronounced for older/frailer patients and 
for patients with heart disease. 
4.2 Primary Objective 
The primary objective of this study is to compare two health system-based approaches for 
offering kidney failure treatment options to older patients with kidney failure, to ensure they are 
actively involved in a shared decision making (SDM) process covering a full range of choices 
and have meaningful access to that full range of choices, including standard in-center or home 
dialysis (SIHD) and alternative treatment plans (ATPs): active medical care without dialysis 
(AMCWD), time-limited trial of dialysis (TLT), palliative dialysis, and deciding not to decide 
(DND). 
 
 
Aim 1: Compare the effectiveness of two approaches: 1) improved kidney disease education 
(KDE) and SDM or 2) improved KDE and SDM plus the creation of a kidney supportive care 
program in a) increasing proportion of patients choosing ATP and b) reducing patient decisional 
conflict.  

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4.3 Secondary Objectives (if applicable) 
Aim 2: Compare the patient and family experience of an ATP between Approach 1 and 
Approach 2, with particular emphasis on TLT and AMCWD in terms of quality of life, services 
used, and end-of-life (EOL) experience through medical record review and interviews with a 
sample of bereaved family members. Aim 2a will focus on experience while patients are 
receiving an ATP (several months to several years). Aim 2b will describe the EOL experience. 
Aim 3: In order to evaluate implementation of each intervention (Approaches 1 and 2), the 
ExPAND research team will cooperate with a separate tandem evaluation conducted by an 
independent evaluation team based at NORC. The implementation evaluation is a mixed-
methods design based on the expanded Reach, Effectiveness, Adoption, Implementation, 
Maintenance (RE-AIM) framework. The implementation evaluation will consist of staff surveys, 
interviews, and site visits conducted by the NORC evaluation team. Regulatory oversight of AIM 
3 will be handled by the NORC IRB. 
 
 
 

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5. Study Design 
5.1 General Design Description 
This will be a repeated, cross-sectional stepped wedge cluster randomized trial (SW-CRT) with 
randomization at the nephrology clinic level. Clinics are randomly assigned to one of three 
sequences. Each sequence consists of four 10-month time periods during which patients are 
accrued and followed for study outcomes. To minimize contamination in the primary analysis, 
we will exclude patients recruited during the 4 months before each sequence moves to 
Approach 2 (see white squares in the table below). These patients will be included in a 
sensitivity analysis. In the 4th study period, accrual of new patients will stop during a 4-month 
follow-up period (to collect primary outcomes) at the end of the study. All practice sites begin by 
implementing Approach 1 (Educate and Engage). Practice sites then add Approach 2 (Kidney 
Supportive Care Program) at the assigned period based on their sequence. We have prepared 
for 15% drop-out of sites, leaving 24 sites in the final analysis sample.  
 
 
Patients will receive the intervention based on the approach (condition) in which the site is 
enrolled at the time of accrual. When a practice site begins implementation of Approach 2, 
referral to the kidney supportive care program for patients considering ATPs will become 
standard care at that site. All patients still alive who chose ATPs in prior periods will be offered 
the option of receiving care from the newly organized supportive care program.  
There are several advantages to a SW-CRT design vs. standard cluster-randomized trial. First, 
SW-CRT gives every practice the opportunity to implement both approaches, which is 
something that the physician practice leaders have told us they value. Second, SW-CRT means 
that from the patient perspective, they will be receiving the standard care delivered by the 
practice site at any given time, and there is no need for patients to opt in or out of a trial to 
receive this improved access to best practice care. 
In addition to the primary SW-CRT comparing the two intervention approaches, we will do a pre-
post comparison of primary outcomes, comparing clinic practices at baseline with each of the 
interventions. 

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5.2 Outcome Variables 
5.2.1 Primary Outcome Variables 
Table 5.2.1 Primary Outcomes 
 
Primary Outcomes  
 
Name of 
outcome 
 
Specific 
measure 
 
Timepoints 
 
Power 
(effect size) 
(E* 
 
N 
 
Aim 1: Effectiveness - compare 2 approaches to offering ATP 
 
Proportion of 
patients 
choosing ATP* 
 
 
 
Month 4 (return 
nephrology visit) 
 
.96 
(medium) 
 
2,800 
 
Decisional 
conflict score at 
return 
nephrology visit 
 
Decisional 
Conflict Scale 
(Month 4 score, 
adjusted for 
baseline score) 
 
Month 0 
(covariate) 
Month 4 (return 
nephrology 
visit; outcome) 
Month 9 
(exploratory) 
 
.89 
(medium) 
 
780 
* ATP: alternative treatment plan, including active medical care without dialysis (AMCWD), time-
limited trial of dialysis (TLT), palliative dialysis, and deciding not to decide (DND). DND is 
defined as not making a treatment decision within the 10 ½ month follow-up period. 
 
5.2.2 Secondary and Exploratory Outcome Variables (if applicable) 

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Table 5.2.2.A Secondary Outcomes for Aim 1 
 
Secondary Outcomes  
 
Name of 
outcome 
 
Specific 
measure to be 
used 
 
Timepoints 
 
Power 
(effect size) (a) 
 
N 
 
Aim 1: Effectiveness - compare 2 approaches to offering ATP 
 
Knowledge about 
CKD and 
treatments at 
return 
nephrology visit 
 
Know-CKD 
(Month 4 score, 
adjusted for 
baseline score) 
 
Month 0 
(covariate) 
Month 4 (return 
nephrology 
visit; outcome) 
Month 9 
(exploratory) 
 
.89 
(medium) 
 
780 
 
Patient-reported 
experience of 
SDM 
 
SDM-Q-9 
 
Month 4  
 
.83 
(medium) 
 
780 
 
Patient-reported 
experience of 
SDM 
 
CollaboRATE 
 
Month 4  
 
.83 
(medium) 
 
780 
 
 
 
 
 

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Patient reported 
decision regret 
Modification of 
dialysis decision 
regret: Do you 
regret your 
decision to start 
(treatment 
selected) 
Month 9 
.84 
 (b)  (large) 
780 
 
Advance care 
planning (ACP) 
documentation 
 
Complete ACP 
measure (Three 
elements present 
in chart: a 
surrogate, a 
goals of care 
discussion, and 
either an 
accessible 
advance 
directive or 
medical order 
such as POLST 
or DNR.) 
 
Month 4 
 
.99 
(medium) 
 
2,800 
 
Table 5.2.2.B Secondary Outcomes for Aims 2 and 3 
 
Aim 2a: Descriptive - experience during ATP  
 
Proportion of 
AMCWD patients 
who change to 
dialysis at any 
time  
 
Proportion of 
patients who 
initially choose 
AMCWD who 
subsequently 
switch to dialysis 
(standard in-
 
At study end or 
patient death 
 
.79 (large) (b)  
 
280 

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(Primary for Aim 
2) 
center 
hemodialysis, 
home dialysis, 
TLT, or 
palliative). 
 
Proportion of 
ATP patients 
who "crash" into 
dialysis 
 
Proportion of 
patients who 
initially chose an 
ATP who have 
unplanned 
dialysis start: 
defined as 
starting dialysis 
urgently in the 
hospital during 
an unscheduled 
admission. (See 
examples below.) 
 
At study end or 
patient death 
 
 
560 
 
Planned Admission for Dialysis Start. Example: Patient with congestive heart failure (or other 
condition such as hypotension that could increase the risk of dialysis) and ESKD who is 
admitted as a precaution to monitor cardiac status during the first or several sessions of 
hemodialysis. Because dialysis is planned, the patient has a "permanent" access, an 
arteriovenous fistula, an arteriovenous graft, or a tunneled cuffed catheter. 
________________________________________ 
 
Unplanned Admission for Dialysis Start. Example: Patient with advanced CKD who does 
routine lab work for next nephrology appointment and labs reveal one or more of the following: 
life-threateningly high potassium, very low CO2, and/or BUN is very high (>75 mg/dL), OR 
patient has symptomatic uremia or volume overload with dyspnea/hypoxia. Patient is 
requested to go to the Emergency Department or is a direct admit to the hospital. Patient will 
need a temporary (non-tunneled) dialysis catheter for urgent start hemodialysis.  
 
 

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Aim 2b: EOL experience during ATP 
 
EOL intensity 
scale 
 
Measure based 
on 
hospitalization, 
ICU admission, 
intensive 
procedures 
during last 30 
days of life and 
death in hospital. 
 
Chart review 3 
months after 
death 
 
 
173 
 
AMCWD & DND 
patients who 
initiate dialysis in 
the last month of 
life 
 
Proportion of 
AMCWD & DND 
patients who die 
who used 
dialysis in last 30 
days of life. 
 
Sensitivity 
analysis - also 
examine change 
to dialysis 60 
days and 90 
days before 
death. 
 
Chart review 3 
months after 
death 
 
 
173 
 
Advance care 
planning (ACP) 
documentation 
 
Complete ACP 
(same measure 
as in Aim 1, but 
performed over 
different time 
period.) 
 
Chart review 3 
months after 
death 
 
 
173 
 

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Table 5.2.2.C Exploratory Outcomes 
 
Name of Outcome 
 
Specific measure to 
be used 
 
Timepoints 
 
N 
 
Aim 1: Effectiveness - compare 2 approaches to offering ATP 
 
Decisional conflict 
scale subscale scores 
 
Decisional Conflict 
Scale 
(Month 4 score, 
adjusted for baseline 
score) 
 
Month 0 (covariate) 
Month 4 (return 
nephrology visit; 
outcome) 
Month 9 (exploratory) 
 
780 
 
Aim 2a: Descriptive - experience during ATP 
 
Patient reports of their 
experience of an ATP 
 
 
Open-ended 
qualitative questions 
about their 
experience 
One item (Part A) 
from the McGill 
Quality of Life 
Questionnaire 
 
 
Reported by sample 
of patients in 
longitudinal cohort 
every 4 months 
 
40 
 
Care partner reports 
of their experience 
 
Open-ended 
qualitative questions 
 
Reported by sample 
of care partners in 
 
15 

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caring for patients 
who have selected an 
ATP 
about their 
experience = 
One item (Part A) 
from the McGill 
Quality of Life 
Questionnaire 
longitudinal cohort 
every 4 months 
 
Aim 2b: EOL experience 
 
Hospice Use 
 
Proportion of deaths 
with hospice care, 
length of use of 
hospice 
 
Chart review after 
death 
 
173 
 
Care partner reports 
of their experience of 
end-of-life care 
 
 
Open-ended 
qualitative questions 
about their 
experience 
 
 
Family members/care 
partners approached 
4 months after patient 
death 
 
20 
 
 
 

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6. Study Population 
6.1 Study Population 
Study Population 1: Patients at participating clinics 
Patients at participating CKD clinics who are 65+ years old and have eGFRs < 30. These 
patients are at the point in their disease course when they should make a decision about 
treatment for kidney failure. 
Study Population 2: Family and care partners of patients who choose ATPs 
To learn about family/care partner perceptions of the healthcare received by patients who 
choose an ATP, we will survey/interview a sample of family members and care partners a) 
throughout care and b) after patient's death. 
Study Population 3: Employees of participating clinics 
Employees who participate in the training to deliver the interventions will be asked to complete 
surveys measuring the impact of the training. 
6.1.1 Number of Participants 
Table 6.1.1 Number of Participants 
Population 
Description 
N 
1. Patients of the nephrology 
practices (Aims 1 and 2) 
Patients 65+ years old with 
eGFR less than 30. Within 
this population, patients are 
grouped according to their 
treatment choice (within first 
10 months). 
 
2,948 
• 
Choose dialysis: 2,240 
• 
Choose ATP: 560  
• 
Lack decision-making 
capacity: 147 
2. Family/care partners of 
ATP patients (Aim 2) 
Sample of family members 
and care partners of patients 
who choose an ATP 
 
35 
• 
Longitudinal 
Interviews: 15 
• 
Bereavement 
interviews: 20 

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3. Employees of the 
nephrology practices (Aim 3) 
Administrators/leaders (n = 
50), other clinicians and staff 
(including doctors, advanced 
practice provider (APP)s, 
nurses, social workers, 
dieticians, palliative care 
specialists, and staff, n = 90) 
 
140 
• 
Administrators: 50 
• 
Other employees: 90 
 
 
6.1.2 Eligibility Criteria/Vulnerable Populations 
Study Population 1: Person with CKD, cared for at participating clinic 
Inclusion Criteria (screened by research coordinator):    
• 
Age 65 years or older 
• 
Most recent eGFR <30 at time of screening AND meets practice site criteria for KDE referral 
• 
Treatment naïve (no dialysis or kidney transplant prior to enrollment) 
Exclusion Criteria (assessed by treating nephrologist, APP, or other clinician): 
• 
The patient is a transplant candidate. 
• 
The current decrease in eGFR is thought to be due to an acute event. 
• 
Education and initiation of shared decision-making process are not yet indicated for the 
patient, (per practice protocol and/or provider’s judgment). 
o The patient will continue to be screened to see if their kidney function falls to the 
point where education and shared-decision making are indicated. 
o Note that patients who lack decision-making capacity should be enrolled when they 
would otherwise be eligible. 
Note: patients who lack decision-making capacity should be enrolled, when otherwise eligible, 
but they will be excluded from the primary analysis. Outcomes for this group will be described 
separately. 
All patients who meet the criteria above should be enrolled in the study. Additional exclusions 
apply for patients recruited for surveys and interviews: 
• 
Insufficient decision-making capacity 
• 
Non-English and non-Spanish speaking 

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• 
Treating nephrologist/APP opts patient out (for example, if contraindicated for patient's 
health) 
 
Study Population 2: Family member or care partner of patient in Study Population 1 
Inclusion Criteria:    
• 
Family member or care partner of Population 1 patient who has  a) chosen an alternative 
treatment plan and b) consented to the decision conflict surveys. 
• 
18+ years old 
• 
English or Spanish speaking 
• 
Cognitively able to participate in surveys/interviews 
Study Population 3: Administrator, clinical provider, or staff at participating chronic kidney 
disease clinic 
Inclusion Criteria: 
• 
Currently practicing or employed at participating clinic 
Employees are a vulnerable population. The intervention is at the clinic level, and supervisors at 
each site will decide which employees will be asked to participate in training and 
implementation. Participation in the evaluation of the training and interventions is voluntary, as 
described below. 
In order to evaluate effectiveness of the training to implement the interventions and for quality 
improvement purposes, we will survey staff before and after the training. Participation in surveys 
will be voluntary, and employees will not be subject to firing or any other punitive action if they 
do not participate. We will not disclose which employees participate. In reporting aggregate 
results to the clinic sites, we will exclude results that would make it easy to identify participants 
(e.g., results for dieticians at Clinic A (n=1)); however, it may be possible in some cases for 
other staff members to infer participation. 
 
 

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7. Methods 
7.1 Intervention 
7.1.1 Description of Intervention 
Intervention Approach 1 — Educate & Engage: This is a bundle of three components to 
improve SDM. Other than these activities aimed at decision-making, patients receive standard 
CKD care, which rarely offers what is provided under Approach 2 (care coordination, case 
management, active symptom management, and advance care planning). The components of 
Approach 1 are: 
1. Practice sites encourage patients to engage with a formal KDE program using the 
National Kidney Foundation (NKF) Council of Advanced Practice Providers curriculum 
enriched by the investigators to include an expanded and balanced presentation of TLT, 
palliative dialysis, and AMCWD. The project will train the educators providing the KDE in 
best practices for engaging patients and families and for culturally sensitive and inclusive 
delivery of KDE. Under a practice protocol for ExPAND including a provider standing 
order, all eligible patients will be referred to KDE unless opted out by provider. 
2. Practice sites use evidence-based decision aids that include unbiased presentations of 
ATP options. These will be vetted by the project with input from advisory group to assure 
cultural inclusivity. 
3. Current CKD teams (nephrologists, APPs, nurses, social workers, and kidney educators) 
receive training in communication skills using the Ask-Tell-Ask approach and the 9 
elements of SDM. SDM best practices include using unbiased language to describe all 
options and using decision aids. 
Intervention Approach 2 — Provide primary palliative care to patients choosing ATP: In 
this comparator, practice sites implement a new systematic kidney supportive care program to 
manage and coordinate additional services for patients choosing ATP. In addition to the 
Approach 1 bundle of education and engagement activities, practice sites set up and offer a 
systematic program integrating primary palliative care to support patients and their families who 
choose any ATP regimen. This program closely follows patients on ATP treatment regimens 
and implements care coordination, symptom management, advance care planning, and 
psychosocial support. The project team will assist the CKD practice site in building a program 
based on the Pathways Project AMMWD toolkit (https://go.gwu.edu/ammwd), which integrates 
palliative care into routine CKD patient care. The original toolkit will be expanded to include 
support for other ATPs. Practice sites will designate a lead clinician (usually a nurse 
practitioner) and will be encouraged to expand the staff of the primary palliative care program to 
include social worker and dietician. Practices will forge a relationship with at least one 
community palliative care and hospice organization so that these services can help to support 
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program include regular care coordination, frequent patient contact not normally deployed in 
CKD practices (such as biweekly to monthly symptom check calls), systematic advance care 
planning, care management, symptom assessment and management, attention to psychosocial 
and family concerns, early involvement of specialty palliative care/hospice, and anticipatory 
guidance with a plan in advance of a symptom crisis. Patients considering ATP are referred to 
this team for initial consultation. If they choose an ATP, they are followed by the team in addition 
to usual services provided by their nephrologist. 
7.1.2 Method of Assignment/Randomization 
Randomization will be performed at the clinic (practice site) level. The study coordinator will 
randomly assign (using a random number generator) each clinic to one of the three sequences. 
The assigned sequence determines when the clinic moves from Approach 1 to Approach 2. 
Patients will receive the intervention based on the approach (condition) in which the site is 
enrolled at the time of accrual. When a practice site begins implementation of Approach 2, 
referral of patients who choose ATP to the supportive care clinic will become standard care at 
that site. All patients still alive who chose ATP during prior periods will be offered the option of 
receiving care from the newly organized supportive care program. Ethics require offering 
existing ATP patients the new care option once it is implemented. 
7.1.3 Selection of Instruments/Outcome Measures 
Table 7.1.3  Instruments and Surveys 
 
Instrument 
 
Measures 
 
Items 
 
Completed by* 
 
Decisional Conflict 
Scale (DCS) — 
Statement Format: 
16 item 5 response 
(15)  
 
Decisional conflict 
 
16 
 
All 
 
Know-CKD (16)  
 
Knowledge about 
kidney failure 
 
12 
 
All 
 
 
Readiness 
 
1 
 
All 

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Stage of Decision 
Making: 1 item (17)  
 
The 9-item Shared 
Decision Making 
Questionnaire (SDM-
Q-9) (18)  
 
SDM 
 
9 
 
All 
 
CollaboRATE (19)  
 
SDM 
 
3 
 
All 
 
Dialysis decision 
regret (modified): “Do 
you regret your 
treatment 
decision?” (5 point 
Likert scale from 1 to 
5, with 1 being “no 
regret at all” and 5 
being “a lot of 
regret”) (3)  
 
Decision regret 
 
1 
 
All 
 
McGill Quality of Life 
Questionnaire – Part 
A (20)  
 
Quality of life 
 
16 
 
Patients and care 
partners in 
longitudinal 
qualitative interviews 
Staff Training 
Evaluation Surveys 
(One per training 
session) 
Self-Reported 
Confidence in 
Learning Objectives 
Varies 10-15 
Employees 
*Population definitions: All = all survey-eligible patients who consent; Longitudinal = ATP 
patients, family members, or care partners who participate in the longitudinal surveys; Bereaved 

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= bereaved family members or care partners of ATP patients who die during the study; 
Employees = nephrology practice employees. 
 
ExPAND End of Life Intensity Score for People with CKD (Adapted from Wong, O'Hare, 
2012 (22) ):  
 
Intensity of Care During the Final Month (30 days) of Life 
 
Measure 
 
Points 
 
Notes 
 
Any hospital admission 
 
1 
 
  
 
Total days hospitalized > 14 
days 
 
1 
 
Cut-off from Earle, 2004 (23)  
 
Any intensive care unit 
admission 
 
1 
 
  
 
Total days in ICU >= 4 
 
1 
 
Wong mean was 3.5 for 
dialysis patients 
 
Any intensive procedure 
 
1 
 
Mechanical ventilation, CPR, 
or feeding tube 
 
Death in hospital 
 
1 
 
  

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Total 
 
6 
 
  
 
Complete advance care planning measure: This multi-component measure was successfully 
used in the Pathways Project (24) . Trained auditors use a checklist to ascertain the presence 
and quality of documentation for each of the following elements: designated surrogate decision- 
maker, narrative discussion of goals of care, an accessible advance directive, and a medical 
order such as a do-not- resuscitate (DNR) or orders for life- sustaining treatment (e.g. POLST or 
MOLST). Complete ACP documentation requires three elements: a surrogate, a goals of care 
discussion, and either an accessible advance directive or medical order. 
7.1.4 Intervention Administration 
The intervention will be administered by clinicians (nephrologists, APPs, nurses, social workers, 
and kidney disease educators) at the participating nephrology centers according to the schedule 
specified by the stepped wedge design. At each clinic, all eligible patients will receive the 
intervention being used by the clinic at the time of treatment. 
Training and support 
Approach 1: Clinicians administering the intervention receive training in communication skills 
using the Ask-Tell-Ask approach and the 9 elements of SDM. SDM best practices include using 
unbiased language to describe all options and using decision aids. Training will use learning 
methodologies including small group case discussion, recorded role plays with standardized 
patients, and video observation of SDM and critique. Our goal is to train at least 50% of existing 
CKD practice staff (including nephrologists). 
Approach 2: The project team will assist the CKD practice sites in building a kidney supportive 
care program based on the Pathways Project AMMWD toolkit (https://go.gwu.edu/ammwd), 
which integrates palliative care into routine CKD patient care. Practice sites will designate a lead 
clinician (usually a nurse practitioner (NP)) and will be encouraged to expand the staff of the 
primary palliative care program to include social worker and dietician. Practices will forge a 
relationship with at least one community palliative care and hospice organization so that these 
services can help to support patients and families in their ATP care.  
There can be considerable turnover of staff in nephrology practices for reasons beyond the 
influence of the research project. If there is staff turnover at clinical sites, especially the 
champion nephrologist, nurse practitioner or research coordinator, we will orient and train their 
successor. If staff such as research coordinator changes, we will re-train the replacement staff 
in study processes. If key clinical staff, such as champion nephrologist or NP leaves, we will 
attempt to orient a new champion at the site. We will provide the new champion with one-to-one 
orientation and training in the intervention and the study processes. The most critical problem 

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will be if the lead staff person running the ATP program leaves, it may take time for the site to 
recruit a replacement ATP clinician. If this were to happen, we might have to pause accrual at 
that site until the ATP clinic and approach 2 could be restarted with sufficient staffing resources 
at the clinic. 
Core Functions/Form 
To accommodate local adaptations, we will be using an implementation science framework 
called Core Functions and Forms. This format allows flexibility in the "forms" (specific methods) 
sites may use in order to fulfill the core "functions" of the intervention. The central research team 
(including patient advisors), together with key collaborators at the clinic sites, will finalize and 
develop a document describing the core (required) functions of the intervention, including 
functions for 1) provider discussions with patients that incorporate shared decision making and 
an ask-tell-ask approach, 2) patient kidney disease education (KDE), 3) patient decision aid 
(PDA)s, and 4) the palliative care program of Approach 2. 
7.1.5 Reaction Management 
Patient reactions 
Because of the nature of this minimal risk study, no physical harms are expected. It is possible 
that patients might suffer psychological distress. Some patients may become emotionally upset 
when thinking about their disease progression or the decisions they are making about their 
treatment. In standard CKD patient care, patients also need to make decisions about what 
treatment they want. This study may differ from standard care in that patients might become 
better informed and more aware of the range of treatment options they have. Also, in taking the 
Decisional Conflict Scale (DCS) and other surveys, they might realize more clearly that they 
don't know 1) what are the benefits of treatment that matter most to them, 2) what risks and side 
effects are most troublesome to them, and 3) overall, what treatment option is best for them.  
Interviewers will be trained to watch for indications of emotional distress and will be trained in 
how to respond calmly and empathetically. If the situation persists or worsens, the interview will 
be terminated, and the incident will be reported within 24 hours to the patient's treating clinician, 
who will develop a plan for supporting the patient including referral for further mental health 
services, as indicated.  
Nephrology practice-level reactions: 
As the intervention occurs at an organizational level, it is possible, although highly unlikely, that 
the intervention could create undesirable impacts for the staff. The most plausible would be 
higher than usual staff turnover due to changes in work processes due to the intervention. If an 
organization experiences staff turnover that the organizational leadership judges is related to 
the study intervention, the organizational leadership will report this to the Co-PI's. This will be 
discussed with the Clinical Site Council and the Data Safety Monitoring Board (DSMB) for 
potential adjustments to the intervention implementation. 

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7.2 Assessments 
 7.2.1 Efficacy 
The efficacy of the two intervention approaches will be compared using the measures below. 
See 7.1.3 for more information about survey instruments. 
Aim 1 - All Patients 
Primary 
• 
Chart review: Proportion of patients who choose an ATP, as reported in the medical 
record. 
• 
Survey: Decisional Conflict Scale  
Secondary 
• 
Survey: Know-CKD 
• 
Survey: SDM-Q-9  
• 
Survey: CollaboRATE  
• 
Question: Dialysis decision regret (modified):  Do you regret your treatment decision? (5 
point Likert scale from 1 to 5, with 1 being “no regret at all” and 5 being “a lot of regret”) 
• 
Chart review: Proportion of patients with advance care planning documented in the 
medical record. 
7.2.2 Safety/Pregnancy-related Procedure 
NA 
7.2.3 Adverse Events Definition and Reporting 
No serious adverse events related to this minimal risk study are anticipated. However, to be 
comprehensive in our monitoring of adverse events, we have developed detailed policies and 
processes for monitoring and reporting adverse events. The key feature is distinguishing 
between adverse events that may be related to the study interventions from adverse events that 
are likely to happen in the study population but are unrelated to the study interventions. Local 
site PI's will assess all serious events and all unexpected events to determine whether or not 
they are related to study participation. Specific reporting timetables for reporting events are 
detailed in the appendix. 
Definitions 
Adverse Event (AE): Any untoward or unfavorable medical occurrence in a human subject, 
including any abnormal sign, symptom, or disease, temporally associated with the subject's 
participation in the research, whether or not considered related to the subject's participation in 

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the research (modified from the definition of adverse events in the 1996 International 
Conference on Harmonization E-6 Guidelines for Good Clinical Practice). AEs encompass both 
physical and psychological harms. AEs are assessed in terms of seriousness, expectedness, 
and relatedness. 
Serious adverse event (SAE): An AE that meets any of the following conditions: 
• 
results in death 
• 
is life-threatening (actually, not hypothetically) 
• 
requires inpatient hospitalization or prolongation of existing hospitalization 
• 
results in persistent or significant disability/incapacity 
• 
Other 'important medical events' may also be considered serious if they jeopardize the 
participant or require an intervention to prevent one of the above consequences. 
Unexpected Adverse Event: An AE is "unexpected" when its nature, severity or frequency is 
inconsistent with risk information previously reviewed and approved by the IRB in the context of 
the study population. 
Related Adverse Event: An AE is "possibly related" to the research procedures if, in the opinion 
of the investigator, the research procedures may have caused the harm. 
ExPAND study expected AEs 
Unrelated AEs: Due to the nature of advanced CKD and its treatment, especially in multi-morbid 
frail older people, SAEs would be expected to occur frequently throughout the course of the 
disease. These expected SAEs include: 
• 
Abnormal electrolyte and hematological laboratory results that can be explained directly 
or indirectly by their advanced CKD or comorbidities 
• 
Hospital admissions — elective and emergency — that can be explained directly or 
indirectly by their advanced CKD or comorbidities 
• 
Hospice admissions — planned and emergency — that can be explained directly or 
indirectly by their advanced CKD or comorbidities 
• 
Infections and cardiovascular events, including fluid overload and swelling, that can be 
explained directly or indirectly by their advanced CKD or comorbidities 
• 
Commencement of dialysis 
• 
Death that can be explained directly or indirectly by their advanced CKD or comorbidities 
Study-related AEs: Because of the nature of this minimal risk study, no physical harms are 
expected. It is possible that patients might suffer psychological distress. Some patients may 

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become emotionally upset when thinking about their disease progression or the decisions they 
are making about their treatment. In standard CKD patient care, patients also need to make 
decisions about what treatment they want. This study may differ from standard care in that 
patients might become better informed and more aware of the range of treatment options they 
have. Also, in taking the DCS and other surveys, they might realize more clearly that they don't 
know 1) what are the benefits of treatment that matter most to them, 2) what risks and side 
effects are most troublesome to them, and 3) overall, what treatment option is best for them. 
Interviewers will be trained to watch for indications of emotional distress and will be trained in 
how to respond, (see 7.1.5). 
More details can be found in the document ExPAND Adverse Event Reporting Guidelines 
(Appendix). 
AE Reporting 
The Site Principal Investigator will assess the severity, expectedness, and relatedness of the 
AE, which will be reported accordingly. 
Prompt reporting: The Site Principal Investigator will report the following events to the study 
Principal Investigator within 24 hours of becoming aware of the event. The study Principal 
Investigator will report the AE to the Institutional Review Board (IRB) within 48 hours of 
becoming aware of the event. 
• 
SAEs, that are study-related (related to the research procedures) 
• 
AEs (whether serious or not) that are both unexpected and study-related 
Other reporting: All study-related adverse events will be recorded in Research Electronic Data 
Capture (REDCap )by the research coordinator (RC )(date, description, severity, expectedness, 
relatedness, and management/remediation of AE). The central data management team will 
assemble a list and summary of AEs, which will be reported to the IRB, DSMB, study sponsor, 
and site principal investigators as part of periodic reporting. 
7.2.4 Pharmacokinetics (if applicable) 
NA 
7.2.5 Biomarkers (if applicable) 
NA 
7.3 Study Procedures 
7.3.1 Study Schedule 
Baseline chart audit: 

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Prior to the beginning of the intervention (Approach 1), or as soon as possible thereafter, local 
RC will conduct a retrospective chart audit to assess key outcomes at baseline. Section 8.5 
describes the methodology and data to be collected. 
Intervention (Approaches 1 and 2) - All eligible patients: 
1. Local RC screens patients with upcoming appointments for eligibility and identifies 
candidates.  
2. RC notifies treating nephrologist/APP, who determines final eligibility. They plan for research 
activities at patient visit, potentially including discussion about treatment options, referral to KDE 
and/or recruitment for decision conflict surveys (DCS).  
3. Enrollment Visit = Time 0. 
• 
When an eligible patient attends initial visit, the patient is enrolled. With HIPAA waiver of 
authorization and a waiver of consent, RC will monitor chart outcomes for all enrolled 
patients. 
• 
Clinician assesses patient frailty and decision-making capacity. 
• 
Clinician initiates discussion about treatment decision and/or refers patient to KDE. 
• 
RC approaches survey-eligible patients (English/Spanish speaking with decision-making 
capacity). For patients who provide written informed consent, administer first survey 
(DCS-1). (May be administered up to 2 months later but not after post-enrollment KDE, if 
attended. May be administered in person or remotely.) 
4. Four months after Time 0, RC administers DCS-2 in person or remotely. (May be up to 2 
months early or 2 months late, preferably after 2nd visit with provider). 
5. Four months after Time 0, RC reviews chart, records current treatment preference and other 
outcomes. (May be up to 2 months early or 2 months late, preferably after 2nd visit with 
provider). 
6. Four months after Time 0, RC completes chart audit of advance care planning. (May be up to 
2 months early or 2 months late, preferably after 2nd visit with provider). 
9. Nine months after Time 0, RC administers DCS-3 in person or remotely. (May be up to 2 
months early or 2 months late.) 
7. Ten months after Time 0, RC reviews chart for missing outcomes (e.g. treatment decision) 
and enters Aim 1 completion status for patient (completed all study activities; followed for 10 
months but did not complete all activities; died, lost to follow-up). 
Patients who choose ATP: 

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1. After patient chooses an ATP, RC submits monthly report for each patient via REDCap. This 
report includes clinic visits, change in treatment plans, dialysis, hospitalizations, and death. 
2. RC approaches patients who consented to DCS and, where available, care partners. 
Requests permission to share contact information with ExPAND research team interviewers for 
longitudinal and bereavement interviews. For patients and care partners who assent, RC adds 
addendum to ICF, and enters contact information into REDCap. 
3. Purposeful sample of ATP patients and care partners selected to participate in longitudinal 
series of interviews. ExPAND research team interviewers contact selected subjects, provide 
information about the interviews, and invite them to participate. For participants who agree, they 
schedule and administer the interviews, starting with verbal consent. The interviewer will send 
thank-you cards upon completion of each longitudinal interview. Follow-up interviews are 
conducted every 4 months until study end or patient death. 
4. If ATP patient dies, RC reports data on end-of-life service intensity and ACP documentation 
at end of life. 
Bereaved family members or care partners: 
If ATP patient dies, and family/care partner has previously assented to be contacted, ExPAND 
research team interviewer sends a bereavement card to family/care partner. Four month after 
patient death, interviewer follows up with family/care partner and invites them to participate in 
bereavement interview.  
Clinic staff: 
1. Clinic staff who participate in training activities complete pre-and post-test survey at 
beginning and end of training. 
See Flowchart of Study Activities and Outcomes (Appendix) for schematic flow of Aim 1 and 
Aim 2 activities. 
 
7.3.2 Informed Consent 
Multiple consent processes will be employed, depending on subject population and study 
activity. In general, 
• 
for chart reviews, we will ask the IRB to approve a HIPAA waiver of authorization and 
waiver of consent 
• 
for surveys conducted by the local RC, we will obtain written informed consent or 
eConsent 

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• 
for surveys/interviews conducted remotely by the central research team (external to the 
site), we will obtain verbal consent and ask the IRB to approve a HIPAA waiver of 
documentation of consent 
Patients: 
Chart audits: We will ask the IRB to approve a HIPAA waiver of consent in order to conduct 
chart audits to gather data on treatment choice, health service utilization, and advance care 
planning for all patients meeting inclusion/exclusion criteria. 
Decisional conflict surveys (administered by site RC): the site RC will approach eligible patients, 
explain the study, and obtain written informed consent to participate in the three DCS surveys. 
Ideally, the initial approach and consent will be in person but if needed, the RC may conduct 
these activities by phone, email, or US mail. The consent may be remote (e.g., US mail) or 
electronic. We have implemented an eConsent process in REDCap. Alternatively, patients may 
sign a paper copy of the consent form, scan it, and email it to the RC. Sites may also use their 
own Advarra-approved eConsent mechanisms. See Informed Consent Form for Patient DCS 
Survey, Recruitment Letter/Email to Patients for DCS Survey, eConsent REDCap Script  
(Appendix). 
ATP Patients, family members, and care partners:  
Longitudinal and bereavement interviews (conducted by ExPAND Research Team interviewers; 
waiver of documentation of consent): After patients choose an alternative treatment plan (ATP), 
the RC will approach those patients who have previously consented to the DCS surveys at a 
clinic visit, along with their care partners, where available. The RC will provide a patient/care 
partner information sheet about the interviews and ask for permission to share contact 
information (for the patient and/or family/care partners) with the external research team for this 
purpose. If the patient and/or care partner assents, the RC will collect the contact information 
and share it with the central research team. Assent will be documented as an addendum to the 
ICF for the DCS surveys. The patient/care partner will be reminded that only a sample of 
patients/care partners who provide contact information will be contacted. See Patient and Care 
Partner Information Sheet for Aim 2 Interviews, Addendum to Patient ICF — Contact Info 
(Appendix). 
Subsequently, if the patient or care partner is selected for longitudinal interviews or 
bereavement interview, ExPAND Team interviewers will contact the participant (patient or 
family/care partner) to invite them to participate. The process and interview content will be 
described, and any participant questions will be answered. For willing participants, an interview 
will be scheduled. At the beginning of the telephone or video call, the consent language will be 
read by the interviewer over the phone and verbal consent will be obtained both before and after 
the interview recording starts. A copy of the consent will be mailed to the participant if they wish 
to provide their street address or email. A thank-you card will be sent to the interview participant 
upon completion of the interview either via email or U.S. mail.  

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7.3.3 Screening 
On a regular (e.g., weekly or biweekly) basis, an RC at each clinic will review the medical record 
of patients with upcoming clinic visits to identify eligible candidates. For eligible patients, the RC 
will notify the treating nephrologist/APP, who will determine final eligibility based on exclusion 
criteria. They will plan for research activities at the upcoming patient visit, potentially including 
discussion about treatment options, referral to KDE and/or recruitment for decision conflict 
surveys.  
Patients who meet the eligibility criteria and attend the planned visit will be automatically 
enrolled for EHR data collection. We will seek a HIPAA waiver of authorization and a waiver of 
consent for this. EHR data will be collected for all patients who meet the primary eligibility 
criteria, including patients who lack decision-making capacity or do not speak English or 
Spanish. 
7.3.4 Recruitment, Enrollment and Retention 
Patients, family members and care partners 
Intervention: Trial enrollment and randomization are at the site level. All patients at each site 
receive the intervention based on the approach in which the site is enrolled at the time. 
Chart review: With a HIPAA waiver of authorization and a waiver of consent, the utilization 
outcomes will be collected on all eligible patients, with little missing data expected. 
Participant level recruitment is applicable to patient and care partner reported outcomes 
collected via surveys and interviews as described below. 
Decisional conflict surveys (DCS): The site RC will approach survey-eligible patients for the 
DCS at the enrollment visit or shortly thereafter. (May be up to 2 months later but not after post-
enrollment KDE, if attended.) All eligible patients should be invited to take the surveys, including 
those who make a treatment decision at the enrollment visit and regardless of KDE referral 
status. For this co-primary outcome, we believe that the administration of the short (10-20 
minute) survey on site during clinic visits will maximize participation rates. Ideally, the RC will 
approach eligible patients, explain the study, obtain written informed consent, and then 
immediately administer the survey. If needed, the RC may approach the patients by phone or 
email to obtain consent and administer the survey. We will pay an incentive for completion of 
DCS on the following schedule: $50 on completion of the first 2 surveys, additional $25 on 
completion of 3rd survey. We estimate that 35% of eligible patients will consent and 26% will 
complete the survey at all three time points. If the response rate is higher than expected, we will 
introduce random sampling to determine which patients are invited to participate. 
Longitudinal and bereavement interviews (ATP patients/family/care partners): After patients 
choose an ATP, the RC will approach those patients who have previously consented to the DCS 

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surveys at a clinic visit, along with their care partners, where available. The RC will provide a 
patient/care partner information sheet about the interviews and ask for permission to share 
contact information (for the patient and/or family/care partners) with the external research team 
for this purpose. A patient may provide assent for his or ger own contact information even if the 
care partner chooses not to, and vice versa. If the patient and/or care partner assents, the RC 
will collect the contact information and share it with the central research team. Assent will be 
documented as an addendum to the ICF for the DCS surveys. The patient/care partner will be 
reminded that only a sample of patients/care partners who provide contact information will be 
contacted. See Patient and Care Partner Information Sheet for Aim 2 Interviews (Appendix). 
Subsequently, if the patient or family/care partner is selected for longitudinal interviews, or if the 
patient dies, the ExPAND Team interviewers will contact the participant (patient or family/care 
partner) to invite them to participate. The process and interview content will be described, and 
any participant questions will be answered. For willing participants, an interview will be 
scheduled. At the beginning of the telephone or video call, the consent language will be read by 
the interviewer over the phone and verbal consent will be obtained both before and after the 
interview recording starts. A copy of the consent will be mailed to the participant if they wish to 
provide their street address or email. Participants will be paid $50 for each interview. We expect 
some drop out for the longitudinal interviews. Bereavement interviews are given only once. 
Response rates 
Although we will strive for higher response rates, we based our power calculations for the 
patient-reported outcomes on conservative projections of response rates. This conservative 
estimate aligns with our prior experience seeking to survey dialysis patients during the 
Pathways Project. This estimate is also consistent with the national response rate for the 
Consumer Assessment of Healthcare Providers and Systems In-Center Hemodialysis Survey 
(ICH CAHPS). The ICH CAHPS survey response rate, based on average response rates for all 
survey periods that have been completed as of Feb 2020, showed an expected response rate of 
28% for mail only responses, 24% for telephone only responses, and 33% for mixed mode (mail 
and telephone). 
To strengthen our response rate, we will incorporate evidence-based best practices for patient 
surveys, especially for vulnerable patients. Three key components that will be integrated into the 
survey instruments are brevity, clarity, and consistency. Keeping surveys short helps reduce 
burden and increase participation. An additional best practice we will employ is to offer multiple 
modality options such as in person, telephone, online. We will provide information about the 
study in multiple formats such as posters, flyers, and postcards. Finally, we will offer the surveys 
in English and Spanish. 
The key to recruitment of patients will be at least one committed RC at each clinical site. The 
RC will be research personnel employed by the site who will have responsibility for 1) screening 
medical records and appointment lists to identify persons who meet the eligibility criteria for the 
study, 2) approaching eligible patients to explain the study and obtain their consent to 

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participate in the survey portion of the study, 3) administer the DCS surveys, 4) approach ATP 
patients and care partners to obtain permission to share contact information with the central 
research team, and 5) facilitate payment of incentives to participating patients.  
We will pre-test these processes at one site. We expect to refine the recruitment process based 
on the pre-test experience and on input from the site planning group and National Advisory 
Council. 
Clinical sites 
Study Site Selection: The organizations providing the study sites were selected because their 
organizational leadership is invested in improving kidney supportive care, is willing to deliver the 
interventions, has sufficient research infrastructure, and has sufficient number of CKD patients. 
These organizations manage over 70,000 patients with kidney disease at more than 70 offices 
and satellite practice sites, of which 28 sites will participate in the project (to allow for site drop-
out over course of the study to attain a final analysis sample of 24 sites.) These nephrology 
organizations are "real world" settings operating under the regulatory and financial conditions 
and constraints typical for nephrology clinical practice, which will bolster generalizability of the 
results. The patient population served across all sites includes rural, suburban, and urban 
populations, patients from diverse races and ethnicities, and a wide range of economic 
circumstances. The organizations identified the specific participating sites based on size (at 
least 1,000 CKD patients), staffing levels, presence of a nephrologist or NP "champion" to be 
lead at the site, and availability of research infrastructure. 
One of the key ways we will retain clinical sites is to meaningfully engage their leadership in the 
project. One mechanism for engagement will be a Clinical Site Council of the participating 
practices. Each practice site will designate a representative to serve on the council, which will 
provide input especially into questions around adaptation of the interventions for implementation 
based on local conditions. The council will consult with the investigators on barriers and 
problems that arise during the project as well as identify innovations in practice that facilitated 
implementation through incorporation in routine workflows. 
It is possible that sites will drop out of the study over the five years for reasons beyond the 
control of the research project, such as sale of the practice, closure of offices, or other major 
reorganizations. We have prepared for 15% dropout by recruiting more sites than needed for 
final analysis sample. We think it highly unlikely that site attrition will exceed 15%, since the 
nephrology organizations we are partnering with are stable practices, with deep track records in 
clinical care as well as renal research. 
Clinical staff participants 
The intervention is at the clinic level, and supervisors at each clinic will decide which employees 
will be asked to participate in training and implementation. Recruitment applies to feedback 
provided by employees to the research team via surveys. Members from the ExPAND team will 

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provide an online link for the training evaluation survey, and reminders including the survey link 
will be emailed to participants.  
Avoiding undue influence or coercion in recruitment: 
Patients: Patients, family members, and care partners will be informed that participation is 
voluntary and that all patients, regardless of their participation status, will continue to receive 
standard care. They will be informed that they may stop participating at any time without 
penalty. Research staff will not provide final lists of participants to the nephrology center 
providers or staff. In some cases, research staff may include nurses who have had human 
subjects research training. Otherwise, in general, the people delivering patient care will not be 
aware of whether an individual patient participated.  
Staff: The intervention is at the clinic level, and supervisors at each clinic will decide which 
employees will be asked to attend training and participate in implementation. Participation in the 
evaluation of the training is voluntary. Participants will be informed that their employment will not 
be affected in any way by their participation status and that they may stop participating at any 
time without penalty. In summary reports to sites, we will not identify study participants; 
however, due to the small sample sizes, it is possible that participant identities may be inferred 
in some cases. 
7.3.5 Study Visits 
See section 7.3.1 for study schedule. 
7.3.6 End of Study and Follow Up 
Enrollment of patients into the study will stop on February 29, 2028.  
Follow-up of patients, including bereavement interviews of family members/care partners will 
stop on June 30, 2028. 
7.3.7 Removal of Subjects 
No subjects will be removed from the EHR data collection (with HIPAA waiver) unless it is 
determined that they were added in error, i.e., they did not meet the eligibility criteria. 
Consented participants who request to be withdrawn from the study in writing will be removed 
for purposes of further data collection, but data already collected may be used. We will not 
publish any quotations or individual-level data for these participants. 
Consented participants who drop out or are lost to follow-up will not be removed from the study 
and data collected may be used. 
7.4 Statistical Method 
7.4.1 Statistical Design 
UPDATES: 

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1. The statistical design and power calculations described below were based on earlier 
sample size projections (N = 2,800) based on 21 clinics in the final analysis sample. We 
now anticipate having approximately 24 clinics; however, we still aim to enroll an 
analysis sample of N = 2,800. The additional sites provide us with a buffer, which we 
believe is prudent given the high risk of attrition in these types of studies and the limited 
information available upon which to base our estimates of enrollment rates. 
2. We originally planned to perform advance care planning chart audits on a random 
sample of enrolled patients (n = 264) as described in this section. For simplicity, we now 
plan to perform the chart audit for all enrolled patients. 
3. We originally planned to have WVU interviewers conduct a separate telephone interview 
of a sample of patients. We have now decided to include the shared decision-making 
questions that were going to be part of the telephone interview (SQM-Q-9, 
CollaboRATE) into the second DCS survey and the decision regret question into DCS-3. 
4. The question regarding decisional regret in DCS-3 was changed from a yes/no question 
to a 5 point Likert scale with 1 being “no regret at all” and 5 being “a lot of regret”. 
Effectiveness (Aim 1) 
To compare which mode of improving SDM and access to ATP is more effective, we will use a 
repeated cross-sectional stepped wedge (SW) design with randomization at the practice site 
level. Each clinic will be randomly assigned to one of three sequences. Each sequence consists 
of four 10-month time periods during which patients are accrued and followed for study 
outcomes. To minimize contamination in the primary analysis, we will exclude patients recruited 
during the 4 months before each sequence moves to Approach 2 (see white squares in Figure 
5.1). These patients will be included in a sensitivity analysis. In the 4th study period, accrual of 
new patients will stop at 10 months, allowing a closing 4-month follow-up period to collect 
primary outcomes at the end of the study, (see Figure 5.1). All practice sites begin by 
implementing Approach 1 (Educate and Engage). Practice sites then add Approach 2 (Kidney 
Supportive Care Program) at the assigned period based on their sequence. With 24 clinics 
participating, we have prepared for 15% drop-out of sites, leaving 21 sites in the final analysis 
sample. Patients will receive the intervention based on the approach (condition) in which the site 
is enrolled at the time of accrual. When a practice site begins implementation of Approach 2, 
referral to the supportive care clinic will become standard care at that site. All patients still alive 
who chose ATP in the prior period will be offered the option of receiving care from the newly 
organized supportive care program. Ethics require offering existing ATP patients the new care 
option once it is implemented, even though this may greatly reduce the number of patients who 
die during Approach 1 care, thereby limiting our ability to compare Approach 1 and Approach 2 
on EOL outcomes (Aim 2b).  
There are several advantages to a cluster randomized stepped wedge (SW) design vs. standard 
cluster randomized trial. First, SW gives every practice the opportunity to implement both 

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approaches, which is something that the physician practice leaders have told us they value. 
Second, SW means that from the patient perspective, they will be receiving the standard care 
delivered by the practice site at that time, and there is no need for patients to opt in or out of a 
trial to receive this improved access to best practice care. 
Prior to implementation of Approach 1, we will measure the proportion of patients who choose 
each treatment option. We will also retroactively assess hospital EOL utilization and proportion 
of ATP patients who begin dialysis within 30 days of death.  
Patient and family/care partner experience using ATP (Aim 2) 
To describe the patient/family experience of ATP care through the end of life, we will monitor 
utilization patterns for all ATP patients and conduct chart audits at end of life, survey a subset of 
ATP patients periodically throughout the course of care, and interview bereaved family 
members. A panel of patients who have chosen an ATP and family members/care partners will 
be interviewed every 4 months to develop a description of experience over time. A sample of 
bereaved family members/care partners will be interviewed 4 months after a patient's death. 
Mixed methods, including thematic analysis, will be used to explore themes about quality of life 
during receipt of ATP, concordance of end-of-life experience with patient goals, family/care 
partner experience of caregiving and at EOL, and utilization patterns, especially change to other 
treatment modes and hospitalizations. 
Exploratory comparison of patients who receive EOL care in Approach 1 vs Approach 2 will be 
conducted, especially through qualitative themes emerging during interviews. The study may 
not have sufficient power to detect differences in the quantitative measures because the number 
of patients receiving Approach 1 who are projected to die is expected to be small. Nevertheless, 
the qualitative interviews will reveal themes that illuminate the effects of the two approaches. 
We expect that Approach 2, which provides more care management and more advance care 
planning, will lead to lower EOL intensity scores, fewer initiations of standard dialysis within 30 
days of death, and care more concordant with known patient wishes as reported by family. (See 
Flowchart of Study Activities and Outcomes (Appendix) for schematic flow of Aim 2 clinical 
processes and data collection points.) 
7.4.2 Sample Size Considerations 
UPDATE: See Section 7.4.1 for changes made since the power calculations below were 
performed. 
Sample Size and Power (Aims 1 and 2) 
Detailed assumptions for sample size targets are shown in the table below. Sample sizes will 
vary by outcome, e.g., medical record derived outcomes should be available for all eligible 
patients, while survey-based outcomes will need to exclude patients who do not consent to 
complete the surveys. Aim 2 outcomes are only relevant to patients choosing ATP. Because the 
two approaches are delivered under SW design and the number of accruable eligible patients at 

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each practice site during the study period are largely beyond the control of the study, the choice 
of the number of participating practice sites is key for planning adequate power. 
Table 7.4.2.A Assumptions for Sample Size and Power Projections 
 
Assumption 
 
Rationale/Data 
Source/Calculation 
 
Resulting N 
 
AIM 1: Impact of approaches on patient treatment decisions 
 
21 practice sites; 2,000 
patients average per clinic 
 
Data from first 13 practice 
sites agreeing to participate 
 2,000*21 practice sites = 
44,000 patients 
 
44,000 CKD patients, all 
stages, all ages 
 
Annually, 117 patients per 
practice reach eGFR <= 20 
(75 patients new to practice 
site + 42 moving from stage 3 
or early stage 4) 
 
Data from first 13 practice 
sites agreeing to participate 
 117*21*(32/12) months = 
6,552 patients (rounded to 
6,550) 
 
6,550 patients reach eGFR 
<=20 during 32 months of 
recruiting 
 
-    60% of patients with eGFR 
<20 are age 65+ 
-    75% of age 65+ are not 
transplant recipients 
-    95% of non-transplant 
have decision-making 
capacity. 
 
Data from first 13 practice 
sites and US Renal Data 
System website 
 6,550*0.60*0.75*0.95 = 
2,800 patients 
 
2,800 patients added to 
study for EHR data 
collection (1,400 per 
approach) 
 
 
 

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-    35% of patients consent to 
Decisional Conflict survey 
offered onsite at 1st office 
visit. 
-    75% of these complete 
2nd survey at 2nd office visit. 
Prior experience of team, 
including My Way project 
(40% response rate of 
patients approached for 
participation) 
2,800*.35*.75=735 
participants 
735 for Aim 1 Decisional 
Conflict survey (367 each 
approach) 
 
Target n is 300. Includes 
oversample to obtain 
sufficient numbers of Black 
and Hispanic patient 
responses. 
 
The detectable effect sizes 
range from medium to large.  
 
300 telephone survey 
responses. (150 each 
approach) 
 
Randomly sample patient 
deciders for chart audit 
 
99% power to detect a 
difference of 35% vs. 10%, 
alpha = .05, estimated rates 
based on My Way project 
experience. 
 
264 chart audits 
(132 each approach) 
 
 AIM 2: Patient and family experience during ATP care and at end of life 
 
# patients who will choose 
ATP: 
Approach 1: 5% AMCWD, 0% 
TLT or palliative dialysis, 5% 
DND = 10% ATP. 
(SIHD = 10% home dialysis, 
80% in-center dialysis) 
Approach 2: 15% AMCWD, 
5% TLT, 5% palliative 
dialysis, 5% DND = 30% ATP. 
 
Approach 1: Expert opinion 
Approach 2: Canadian, 
Australian, UK experience: 
20% of older patients choose 
AMCWD. We have assumed 
a lower rate as the Approach 
2 programs may need time to 
get established and gain the 
trust of providers and 
patients. 
 
560 patients choose ATP 
(AMCWD, TLT, palliative 
dialysis, DND) 
Approach 1: 140 patients 
Approach 2: 420 patients 

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(SIHD = 15% home dialysis, 
55% in-center dialysis) 
1,400*0.10 = 140 patients 
added in Approach 1 
1,400*0.30 = 420 patients 
added in Approach 2 
 
# patients who switch back to 
dialysis 
 
Expert opinion. Canadian, 
Australian, UK experience — 
very few AMCWD patients 
switch to dialysis. 
 
560 for denominator (all ATP) 
 
Randomly sample ATP 
patients to invite for 
qualitative interviews. 25% 
will agree to interview. 
 
Prior experience of team, 
including My Way project and 
Pathways project. Difficult to 
reach patients for phone 
interview; many patients too 
tired or sick for phone 
interview. 
 
About 40 patients will be 
interviewed 
 
25% of ATP patients 
anticipated will die yearly (.02 
person/month) 
 
This is more conservative 
than actual experience in 
Australian and Canadian 
programs to allow for 
possibility that patients will be 
choosing ATP earlier in 
disease progression and thus 
living longer 
 
173 deaths* ( 
(Approach 1: 35 
Approach 2: 138) 
 
Contact family member/care 
partner for all ATP patients 
who die. Will not have contact 
information for some 
proportion. 25% will agree to 
interview. 
 
Survey data will be examined 
for missing items, and any 
patterns will be reported 
qualitatively and be used to 
qualify the interpretation of 
findings, e.g., "families under 
 
About 20 family 
members/care partners may 
be reachable and agree to 
interview. Complete one 
bereavement interview per 
family member/care partner. 

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more apparent stress were 
less likely to complete certain 
of the quality-of-life items. 
 
* The number of deaths was calculated for each period using a 25% annual mortality rate and 
the number of ATP patients alive (under each approach) at the beginning of the period. Note 
that some patients accrued under Approach 1 will die under Approach 2. 
A series of stepped wedge (SW) power analyses were conducted, where the following 
parameters were varied: number of clusters, steps, periods, within-cluster intraclass correlation 
(ICC)s, effect sizes, the expected number of patients with usable data at each cluster-period, 
and desired power. Besides power, the following were considered: a greater number of practice 
sites allows 1) confidence in generalizability of findings, 2) more opportunity to explore site/ 
population characteristics associated with approach differences in outcomes, and 3) more 
precise estimates of effect sizes which are essential for policy decisions. Consequently, the 
optimal design was 21 practice sites, 3 sequences, each stepping 7 practices from Approach 1 
to Approach 2 after a 4-month transition. This would entail 4 periods, each with 6 or 10 months 
of patient accrual. The last period has 6 months of accrual to allow complete 4-month follow-
ups. (See Figure 5.1.)  Although the power analyses and design assume 21 practice sites, we 
have recruited 24 practice sites (plus 2 more for pilot testing) as allowance for practice sites who 
might drop out for unforeseen reasons.  
Table 7.4.2.B Power for Comparing Approach 1 and Approach 2 Outcomes 
 
# 
 
Outcome 
 
n 
 
Effect Size, Power 
 
# 
 
Outcome 
 
n 
 
Smaller Effect 
 
Medium Effect 
 
Larger Effect 
 
Aim 1 (all patients making treatment decision) 
 
1 
 
Proportion 
of patients 
choosing 
ATP 
 
2,800 
 
P1=.10, P2=.15 
Power = .46 
 
P1=.10, P2=.20 
Power = .96 
 
P1=.10, P2=.25 
Power = .99 

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2 
 
Decisional 
conflict 
score at 
return 
nephrology 
visit 
 
735 
 
d=.20 
Power = .40 
 
d=.35 
Power = .89 
 
d=.50 
Power = .99 
 
3, 4 
 
Patient-
reported 
experience 
of SDM 
(SDM-Q-9, 
CollaboRA
TE) 
 
300 
 
d=.40 
Power =.65 
 
d=.50 
Power =.83 
 
d=.60 
Power =.94 
 
5 
 
Patient 
reported 
decision 
regret 
(proportion 
regretting 
decision) 
 
300 
 
P1=.25, P2=.15 
Power = .26 
 
P1=.25, P2=.10 
Power = .54 
 
P1=.25, P2=.05 
Power = .84 
 
6 
 
Advance 
care 
planning 
documentat
ion 
 
2,800 
 
P1=10., P2=.15 
Power = .57 
 
P1=10, P2=.25 
Power = .99 
 
P1=.10, P2=.35 
Power = .99 
 
Aim 2a (only includes patients initially choosing ATP) 
 
 
 
 
 
 

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7 
Proportion 
of ATP 
patients 
who 
change to 
dialysis <1 
month 
before 
death 
n1=140, 
n2=420 
P1=.40, P2=.30 
Power = .26 
P1=.40, P2=.25 
Power = .52 
P1=.40, P2=.20 
Power = .79 
 
8 
 
Advance 
care 
planning 
documentat
ion 
 
n1=140, 
n2=420 
 
P1=.10, P2=.30 
Power = .88 
 
P1=.10, P2=.35 
Power = .96 
 
P1=.10, P2=.40 
Power = .99 
Notes. P1, P2 are proportions choosing the outcome for Approach 1 and 2, respectively. Where 
unequal n's are expected under the 2 approaches, n1 andn2 are number of patients expected 
under each Approach 1 and 2, respectively; otherwise, the n's are expected to be equal.  d is 
Cohen's d (standardized effect size). 
Table 7.4.2.B summarizes minimum sample size expectations and power estimates for key 
outcomes. Actual power will be lowered by unequal sample sizes per practice site but increased 
if more than 21 practice sites remain in the study. The total sample size of 2,800 for Outcome 1 
is based on data from the first 13 sites agreeing to participate, as described in Table 7.4.2.A. 
The survey-based sample size (Outcome 2) is much lower because patient consent and 
availability is required, and the telephone survey (Outcomes 3, 4, 5) will be based on a pre-
planned sampled subset of the surveyed sample. Power calculations used R package 
swCRTdesign version 3.3. (28)  ICCs currently listed in the CLOUD Bank (29) for SW studies in 
health care settings average about .03, and therefore a slightly more conservative ICC=.05 was 
incorporated into calculations. Alpha (two-sided) is set at .025 for the 2 co-primary Aim 1 
outcomes, and at .05 for the remaining outcomes. 
For Outcome 1, an increase from 10% choosing an ATP under Approach 1 to 20% under 
Approach 2 would be substantial enough to be considered important (30) (31) and we believe 
an increase to 25% or 30% is highly plausible. This is based on personal communication with 
US nephrologists regarding the present number of CKD patients wanting AMCWD and on 
reports from AMCWD programs in the UK, Australia, and Canada. (32) (33) (34) The moderate 
effect (change from 10% to 20% choosing ATP) is detectable with .96 power. 

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For Outcomes 2, 3, and 4, the standardized effect sizes detectable with .80 or higher power 
range from about .35 to .60 in magnitude. Power calculations for those outcomes assume a pre-
post r=.50, which increases power. (35)  Power for Outcome 5 (decision regret) will be weaker, 
only reaching power >.80 if the there is a very large difference between the 2 approaches. For 
Outcome 6 (ACP documentation) power should be excellent (.99) for detecting plausible 
differences based on experience from the My Way study, where the rates were 4% at baseline, 
18% in the enhanced control and 33% among CKD patients who received ACP coaching. (36)  
For the Aim2a Outcome 7, although we expect a large effect of Approach 2 in reducing change 
to dialysis 1 month before death (detectable with power of .79), a more modest effect would 
have weak power. Therefore, a non-significant result would need to be interpreted cautiously, 
with an emphasis on descriptive statistics and confidence intervals. For Outcome 8, (ACP 
documentation), we are assuming stronger Approach 2 effects in this population of patients 
choosing an ATP, and therefore statistical power should be excellent. 
7.4.3 Planned Analyses 
7.4.3.1 Primary Analyses 
Aim 1 and 2 
For all primary outcomes as well as most secondary quantitative outcomes, statistical 
hypotheses concern the contrast between patients accrued under Approach 1 and 2. The intent-
to-treat principle will be followed for all primary outcomes. Treatment choice, unless otherwise 
defined, refers to the treatment preference recorded 4 months (+/- 2 months) after enrollment. 
Differences between the two approaches will be tested through a generalized linear mixed effect 
model, which can accommodate the random cluster effects inherent to the SW design and 
handle outcomes that are binary, normally distributed, etc. Analyses will include age and gender 
as fixed effect covariates, and cluster as a random effect. For the survey-based outcomes, the 
Decisional Conflict Score assessed at the first nephrology visit will also be included as a 
covariate. The telephone survey analyses (Outcomes 3, 4, and 5), which involve data from a 
stratified sample of patients by race, will include race as a covariate and a test of effect 
modification through inclusion of a Race x Approach interaction term. Racial/ethnicity categories 
will be decided based on observed frequencies in the survey. In SW designs, time is a potential 
confounder but is expected to be minimal. 
Sensitivity Analysis: For the deciding not to decide (DND) treatment choice, we will not be able 
to reliably distinguish between a conscious shared decision to postpone deciding and simply not 
deciding. Therefore, we define DND as not making a treatment choice within the 10 ½ months 
of follow-up. To measure the impact of including this population among patients who choose an 
ATP, we will conduct a sensitivity analysis excluding patients who do not make a treatment 
decision within the 10 ½ months of follow-up. 
Heterogeneity of Treatment Effects: It is hypothesized that for Outcomes 1 and 2, there will be a 
more pronounced effect for patients who are over age 80, frail, or have heart disease. Although 

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pre-specified tests are described here, they will be interpreted as secondary analyses because 
of uncertainties regarding power. As a pre-specified analysis, this will be tested by adding 
Approach x Age Group, Approach x Frailty Group, and Approach x Heart Disease Group terms 
to the regression model, which would also include the main effect variables (age group, frail 
group, and heart disease group as indicator variables). Because these subgroups are likely to 
have considerable overlap leading to possibly high multicollinearity of variables, the 3 interaction 
terms will first be tested together as a set with an omnibus test. A significant p-value result (< 
.05) would be followed by testing the regression coefficients for each of the separate terms (with 
significance at p<.05), which would determine, say, whether the heart disease group was more 
affected by Approach 2 after controlling for the other interaction effects. For Outcomes 3, 4, and 
5, an Approach x Race term will be included in those models. For Outcome 1, as an exploratory 
analysis, heterogeneity in approach effect across clinics will be tested through inclusion of a Site 
x Approach interaction random effect. Practice site differences in Approach effects will also be 
examined through descriptive and graphical methods. Any strong patterns observed will then be 
compared with known characteristics of each practice site to gather plausible explanations of 
any important Approach effect differences among the clinics. Currently, this is the only 
exploratory interaction test planned. If any later heterogeneity tests are conducted, these will be 
tested through an interaction term added to the model; however, any publication describing 
those results will state clearly that these are exploratory and therefore those results are highly 
tentative. 
Preliminary analyses: Internal consistency reliability will be assessed for scale scores. Because 
the SW design partly confounds treatment and time, we will examine de-identified patient 
demographic and diagnostic trends across the study period to identify any that may confound or 
limit study interpretation. For example, shifts in outcomes under either study condition may 
occur due to secular external trends, new legislation or rules, etc., as well as changes due to 
greater staff experience. As an indicator of secular trends, we will monitor the proportion of older 
adults (80+ years) starting dialysis in the national data reported annually by the USRDS and 
include this information in the interpretation of results. Missing data. For the outcome of 
choosing ATP, data will be available for all participants via chart audit. Survey-based outcomes 
will only be available for participants who consent and complete the survey. This may introduce 
a selection bias, e.g., if participants under Approach 2 feel more motivated to complete the 
survey. A preliminary analysis will therefore examine whether there is a difference in study 
participation rate between the 2 study conditions. If there is an important difference, then the 
survey-based results will be subjected to sensitivity analyses to identify whether the conclusions 
would differ under various reasonable missing data scenarios. Practice dropout. If any practice 
sites drop out of study participation after randomization, a judgment will be made by the PI as to 
whether any patient study data collected from patients by those sites can reasonably be 
considered missing completely at random, and therefore included in the analysis, or whether it 
likely represents an important bias (e.g., a practice site largely non-adherent on staff education 
required for the study) and will be excluded from analysis, or whether to do a sensitivity analysis 
on the effect of that practice site's data on study results. 

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Exploratory analyses: Although a primary outcome is choosing any ATP, the range of specific 
ATPs or standard dialysis options chosen will be examined descriptively. For example, one of 
the approaches may lead to greater or less use of home dialysis as a sub-type of SIHD. Other 
analyses will examine practice site characteristics as predictors of outcomes as a multi-level 
model e.g., stronger Approach 2 effects for clinics with higher staff/patient ratios. 
7.4.3.2 Analysis of Subject Characteristics 
Subject characteristics (e.g., age, gender, race, etc.) will be collected, summarized, and 
regularly reported (overall and by site) at DSMB meetings. Subject characteristics will be 
reported in all publications.  
7.4.3.3 Interim Analysis (if applicable) 
No interim analysis of outcomes is planned as the interventions pose minimal risk. 
7.4.3.4 Health economic evaluation, if applicable 
NA  
7.4.3.5 Other 
NA 
7.4.4 Subsets and Covariates 
Subgroups of patient population (older patients (≥ 65 years) with stage 4 or 5 CKD (eGFR < 30) 
being cared for at a participating practice site): 
• 
Patients who are frail, based on the Clinical Frailty Scale (39)  
• 
Patients who are 80+ years old 
• 
Patients with heart disease:  ICD-10 I20-I52 
• 
(Exploratory only) Patients with diabetes 
• 
(Exploratory only) Black patients 
• 
(Exploratory only) Hispanic patients 
• 
(Exploratory only) socioeconomic status, based on zip code 
The following covariates will be included in models for the outcomes specified: 
• 
Age (in models for all Outcomes) 
• 
Gender (in models for all Outcomes) 
• 
Decisional Conflict Score (in models for survey Outcomes) 
• 
Race (in models for Outcomes 3, 4, 5) 

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7.4.5 Handling of Missing Data 
Missing data. For the outcome of choosing ATP, data will be available for all participants via 
chart audit. Survey-based outcomes will only be available for participants who consent and 
complete the survey. This may introduce a selection bias, e.g., if participants under Approach 2 
feel more motivated to complete the survey. A preliminary analysis will therefore examine 
whether there is a difference in study participation rate between the 2 study conditions. If there 
is an important difference, then the survey-based results will be subjected to sensitivity analyses 
to identify whether the conclusions would differ under various reasonable missing data 
scenarios. 
Practice site dropout. If any practice sites drop out of study participation after randomization, a 
judgment will be made by the PI as to whether any patient study data collected from patients by 
those sites can reasonably be considered missing completely at random, and therefore included 
in the analysis, or whether it likely represents an important bias (e.g., a practice site largely non-
adherent on staff education required for the study) and will be excluded from analysis, or 
whether to do a sensitivity analysis on the effect of that practice site's data on study results. 
 
 

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8. Trial Administration 
8.1 Ethical Considerations: Informed Consent/Assent and HIPAA Authorization 
This is benign behavioral intervention and a minimal risk study. 
HIPAA waiver of authorization and waiver of consent 
To answer the research questions (effect of interventions on number of patients who attend 
kidney disease education, choose alternative treatment plans, have advance care planning 
documentations in the chart), we need to have the information for all eligible patients. Obtaining 
informed consent would introduce selection bias and reduce power to evaluate the effects of the 
intervention. It might also undermine our ability to evaluate the effect of the intervention on 
subgroups (race, comorbidities, etc.). With a HIPAA waiver of authorization and waiver of 
consent, we will collect data from the medical record that are protected (PHI), but not highly 
sensitive. Most of the information we will collect will be completely deidentified, but we need to 
collect dates of services to reliably keep track of time intervals and of which services take place 
under each intervention approach. Because some patients will be followed as the clinic moves 
from Approach 1 to Approach 2, we need to measure the duration of exposure to each 
approach, and to know whether certain activities occurred during the baseline period, Approach 
1, or Approach 2. We will not collect date of birth but will collect year of age to be able to 
evaluate whether effects differ by age. We will also collect provider name (to evaluate reach of 
intervention), zip code as a means to assess the impact of social determinants of health and 
whether we see disparities by zip code. Non-PHI to be collected include demographic 
information, clinical information (e.g., comorbidities), kidney failure treatment decision, and 
healthcare utilization (clinic visits, hospital visits, etc.) 
We expect that the waiver will not directly affect the participants in any way. No research data 
will be added to the patients' permanent medical records. The data collected will be used only 
for the purposes of the research, and we will take appropriate measures to minimize the 
potential for a breach of confidentiality (8.3, 8.9). We will destroy the identifiable information and 
code link when this research and any approved follow-up research are complete, as described 
in section 8.10.  
Information collected with consent 
After providing informed consent, some patients will participate in surveys and interviews. 
Recruiting and consenting procedures, including measures taken to avoid coercion, are 
described in sections 7.3.2 and 7.3.4. When describing the study to patients, we will use general 
language without specific descriptions of the differences between the two intervention 
approaches. The reason is to avoid introducing bias by influencing treatment decisions or 
perceptions about care that are reported in patient-reported outcomes (surveys and interviews). 
For example, a patient in Approach 1 who might otherwise consider AMCWD, who learned that 
other clinics were providing a kidney supportive care program while their own clinic was not, 

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might conclude that they would not receive adequate support and decide to choose dialysis 
after all; or the same patient might have negative perceptions about the care they received if 
they imagined that patients in the other approach were receiving better care. 
HIPAA waiver of documentation of consent 
To reduce the burden on site RCs, some surveys and interviews will be administered remotely 
by ExPAND Team interviewers . For these interviews, the site RC will obtain permission from 
patients and/or family members/care partners to share their contact information with the 
research team outside the local clinic. With patient/care partner permission, this contact 
information will be stored in REDCap and made available to the remote interviewers. The 
remote interviewers will be responsible for describing the research procedures and verbally 
consenting the patients, as described in sections 7.3.2 and 7.3.4. We will request a HIPAA 
waiver of documentation of consent for these activities. The reason we ask for waiver of 
documentation of consent is to reduce the burden on the local RC (to obtain consent) or on the 
participant (to return a signed consent form in the mail). It will also facilitate maximal 
participation, which will provide more statistical power and reduce selection bias.  
Payments to participants 
Participants (patients and family members/care partners) will receive the following payments for 
participation in surveys and interviews: 
• 
Decision conflict survey ($50 after second survey, $25 after third survey) 
• 
Longitudinal interviews ($50 per interview) 
• 
Bereavement interviews ($50 per interview) 
As part of consent, patients may choose to receive the payment in the form of a debit card, 
electronic wire transfer, or paper check delivered via US mail. We believe these amounts will 
express our appreciation and provide an incentive to participate while not being so significant as 
to be coercive. 
Family members/care partners who participate in a longitudinal or bereavement interview will 
receive a gift card upon completion. During the interview, the family member/care partner may 
choose to receive the gift card either via email or US mail.  
8.2 Institutional Review Board (IRB) Review 
Central IRB / IRB of Record 
Advarra will serve as the Central IRB (also known as the IRB of Record).  
The protocol will be submitted to the Central IRB for review and approval. Approval of the 
protocol must be obtained before initiating any research activity. Any modification to the protocol 
will be approved by the Central IRB before implementation.  

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Continuing review requests will be submitted to the Central IRB annually, and a study closure 
report will be submitted after all research activities have been completed. 
Other study events (e.g., data breaches, protocol deviations) will be reported as described in 
this protocol and per the Central IRB's policies. 
Relying Institutions 
Each participating practice will formally cede their IRB review to the Central IRB using a fully 
executed reliance agreement (known as an IRB authorization agreement or IAA). 
Study documents approved by the Central IRB, including initial and modified protocols, consent 
forms, and others, will be sent to the relying institutions per Central IRB protocol. Reports and 
other communications with the Central IRB will be reported to relying institutions, if relevant. 
 
8.3 Subject Privacy, Confidentiality & Data Management 
Protection of data confidentiality: 
We will maintain all standard processes for maintaining data in a secure manner:  
• 
Identifiable data will be stored only in secure REDCap research database at GWU or 
other secure platform approved for regulated data (e.g., GW Box). (A copy of site-
specific study data may be housed securely at each participating site.) 
• 
Access to the secure database will be limited to specified research staff. 
• 
 All enrolled patients will be assigned a unique study identification number. All data 
collected will be identified only by these study identification numbers. Where it is 
necessary to collect direct identifiers (e.g., for contact and payment of survey 
participants), these will be kept in separate databases from other data collected. A site-
specific link between each study identification number and participant name will be kept 
in a password-protected file on a password protected computer at each participating site. 
• 
Research personnel at the clinical sites may temporarily use paper documents for 
participant tracking and data collection. Data will be transcribed to REDCap in a timely 
manner. Paper documents will be secured in a locked cabinet at the clinical site until 
they are no longer needed. Then they will be shredded. 
• 
Only completely de-identified data will be provided to others outside the study team as 
needed for data analysis. 
• 
 No medical records or protected health information (collected for the patient participants 
only) shall be re-disclosed, unless required by law. 

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• 
Data and code links will be destroyed after the period for maintaining data has elapsed, 
in accordance with this protocol and Central IRB's policies, (see section 8.10). 
Oversight of research personnel to maintain research participant protection and rights: 
For GWU and all subaward organizations, all research personnel will have up to date training in 
the conduct of human subjects research, such as Collaborative Institutional Training Initiative 
(CITI) or Association of Clinical Research Professionals (ACRP) coursework. Research 
personnel will meet either the GW IRB requirements for training, or the requirements of their 
home institution. 
At clinical sites (participating nephrology practices), RCs (aka "study coordinators") employed 
by the sites will have responsibility for 1) screening medical records to identify persons who 
meet the eligibility criteria for the study, 2) conducting chart reviews to obtain data on treatment 
decision, advance care planning and service utilization (e.g. hospitalizations at end of life), 3) 
entering study data into REDCap, 4) maintaining a code link, 5) approaching eligible patients to 
explain the study and obtain their consent to participate in the survey portion of the study, 6) 
administering the DCS surveys, 7)  providing contact information to ExPAND Team interviewers 
of patients who give permission, and 8) facilitating incentive payments to participating patients. 
We will also provide project specific videoconference training for the site research personnel on 
the study protocol, best practices for involving patients from diverse backgrounds, and best 
practices for maintaining privacy, confidentiality and protection of research participants and data 
collected. 
For personnel involved in the study in roles other than research (for instance, nurse practitioners 
who lead the kidney supportive care clinics) but do not obtain data from the chart or from 
patients for research purposes, we will provide an overview of research ethics and procedures 
as part of the orientation to the overall project. Clinical personnel who provide information to 
patients about the clinical services being studied under each approach are not considered to be 
engaging in research and will not be tracked as to whether they have appropriate training in the 
conduct of human research. We will also clearly delineate between patient assent processes 
(giving assent to provide contact information to the research team) — for which research 
training is not required — and consent processes (being informed about risks and benefits, 
asking questions, and providing consent to use data). Consent will only be obtained by 
personnel who have appropriate research training. 
8.4 Deviations/Unanticipated Problems 
Protocol Deviations 
This is a minimal risk study, and we do not expect protocol deviations to impact participant 
safety. In the unlikely event that a protocol deviation occurs that may impact participant safety, it 
will be reported to the IRB and the DSMB within 48 hours of the Principal Investigator becoming 
aware of the event. Other protocol deviations will be logged and reported to the IRB and DSMB 
as part of periodic reports and continuing review requests. The log will be maintained by the 

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Project Manager and will include date, description of deviation, impact on participants, and 
remediation actions. Examples of protocol deviations that could occur in this study are: 
• 
Enrollment of an ineligible participant 
• 
Failure to obtain informed consent 
• 
Data collection outside study windows 
• 
Mishandled data 
Unanticipated problems 
Unanticipated problems are defined as any incident, experience, or outcome that meets all of 
the following criteria: 
• 
Unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the IRB-approved research protocol and informed 
consent document; and (b) the characteristics of the participant population being studied 
• 
Related or possibly related to participation in the research. Possibly related means there 
is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research 
• 
Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously known 
or recognized 
Unanticipated problems will be reported to the IRB and the DSMB within 48 hours of the 
Principal Investigator becoming aware of the problem. They will be logged by the Project 
Manager, as for protocol deviations, and included in periodic reporting to the IRB, DSMB, and 
PCORI. 
8.5 Data Collection 
Code link and separate storage of data 
To better ensure confidentiality, patient research data will be stored in several separate secure 
REDCap databases: 
1. The first database will contain patient PHI and other information collected from the 
medical record under a HIPAA waiver of authorization and a waiver of consent. This 
database will include indirect identifiers, as described in section 8.1. 
2. The second database will contain patient survey data. No identifying information will be 
stored in this database. 
3. The third database will contain information needed by the Advarra payment system to 
pay participant incentives. This includes direct identifiers. 

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4. The fourth database will contain patient/family/care partner contact information for use in 
administration of remote surveys and interviews. 
5. The fifth database will contain data from the ExPAND Research Team interviewers. This 
includes interview completion status, interviewer/interviewee information, and date of the 
interview. 
All enrolled patients will be assigned a unique study identification number. All data collected will 
be identified only by these study identification numbers, which will be used to link patient and 
care partner data between the REDCap databases. A site-specific link between each study 
identification number and participant name will be kept in a password-protected file on a 
password protected computer at each participating site. (More information about secure 
management of the code link and data can be found in sections 8.3, 8.9, and 8.10.) 
Collection of patient and care-partner information 
See section 7.3 for study procedures including schedule of study activities. 
• 
Chart audit and participant tracking data (with indirect patient identifiers, mainly dates) 
will be entered by site RC directly into REDCap database 1.  
• 
DCS survey data (completely deidentified) will be entered into a REDCap database 2 by 
the RC or directly by the patient (for patients who choose to take the survey 
electronically).  
• 
Information needed for payment of patient incentives (including direct identifiers) will be 
entered by site RC directly into REDCap database 3. 
• 
Patient/family/care partner contact information will be entered by the RC into REDCap 
database 4, to keep identifying information separate from deidentified survey responses 
and partially deidentified medical record data. 
• 
For the ATP patient and family/care partner telephone interviews, the ExPAND Team 
interviewers will enter information pertaining to interview completion status into REDCap 
database 5.  
• 
All recordings and transcripts of the longitudinal and bereavement interviews will be kept 
in the GW Box.  
• 
De-identified interview transcripts will be imported to GWU’s NVivo for thematic analysis. 
Alternatively, the RC may use paper documents temporarily for participant tracking and data 
collection. In that case, data will be transcribed to GW Box in a timely manner. Paper 
documents will be secured in a locked cabinet at the clinical site until they are no longer needed 
and then shredded. 
Collection of clinic employee information 

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• 
Employee survey data will be stored on GW Box or other platform approved for 
regulated data by GWU.  
Collection of baseline chart audit data 
Prior to the beginning of the intervention (Approach 1), or as soon as possible thereafter, local 
RC will conduct a retrospective chart audit to assess key outcomes at baseline (prior to 
intervention Approach 1). Patients seen in the clinic between 1/1/2023 and 1/31/2024 will be 
retrospectively screened for study eligibility using the same criteria as for the main study. The 
charts of eligible patients will be reviewed from the date of eligibility to six months later. The 
following outcomes will be recorded: referral to KDE (y/n, eGFR at referral), attendance at KDE 
(y/n), advance care planning documentation (y/n), treatment decision (choice), start of 
treatment, if applicable (y/n, treatment, number of days after eligibility), death or loss to follow-
up (number of days after eligibility). For patients who chose an alternative treatment plan, the 
follow-up period will be through July 31, 2024 for the following addition outcomes: death 
(number of days after eligibility), place of death, dialysis start (number of days after eligibility, 
setting). In addition to the outcomes data, the RC will record the patient's age, gender, race, 
ethnicity, whether the patient has decision-making capacity, and the most recent eGFR at the 
time of eligibility. All data will be completely deidentified: ages > 90 years will be recorded as 90, 
and all dates will be reported as the number of days from becoming eligible. Deidentified data 
will be entered into REDCap. 
8.6 Data Quality Assurance 
With the use of video-conferencing and instructional documents, site RCs will be trained in 
study protocol and data collection procedures. In addition, the data management team will 
correspond regularly with site RCs to answer questions and solve problems. 
Data will be entered into REDCap, which has built-in mechanisms to minimize typos, encourage 
data entry in the correct format, flag missing data, and apply customized data quality checking 
in real time. Data will be regularly monitored by the data management team using human 
assessment as well as customized software to check for missing, improperly formed, or 
implausible data in the context of the study. Data quality reports will be sent regularly to the data 
collection personnel at the clinical sites, who will work with the data management team to 
correct missing and erroneous data. 
8.7 Study Records 
The following study records will be maintained by the ExPAND Project Manager 
• 
Regulatory documents (IRB applications and approvals, approved documents) 
• 
Reports to the funder (PCORI) 
• 
Reports to and from the DSMB 

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• 
Study protocol 
The following study records will be maintained by the RC at each clinical site 
• 
Consent forms 
• 
Code link 
The following study records will be maintained in REDCap or on GW Box by the ExPAND data 
management team 
• 
Case report forms 
• 
Patient data collected from the medical record 
• 
Patient contact and payment information (with permission) 
• 
Survey responses (with written or verbal consent) 
• 
Interview completion status (REDCap) 
• 
Interview recordings and transcripts (GW Box) 
8.8 Access to Source 
Data will be collected from four sources: 
1. Patient medical record: collected by site RC and entered into REDCap 
2. Patient surveys 
a. DCS survey responses collected by RC and entered into REDCap, or entered 
directly by participant (if taking the survey electronically) 
3. Employee surveys 
a. Surveys: responses entered directly into REDCap or U.S. mailed to central data 
management team 
4. Semi-structured interviews: recorded by interviewers, transcribed, and stored securely 
on GW Box or another GWU-approved platform approved for regulated data 
8.9 Data or Specimen Storage/Security 
Most study data will be stored on a GWU-approved REDCap server. REDCap (Research 
Electronic Data CAPture) is a mature, secure, web-based application for building and managing 
online surveys and databases. Security measures include both electronic (encryption) and 
physical (monitored, restricted access) measures. It is the database platform of choice for all 
NIH Clinical and Translational Science Award (CTSA) awarded institutions and for other 

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institutions who want to collect and store health-related research data securely. REDCap is 
HIPAA compliant. 
Some study data, including semi-structured interview data, may be stored on another platform 
that has been approved by GWU for regulated data, such as the password-protected GW Box. 
See section 8.3 for other information on how we will maintain data security and confidentiality. 
8.10 Retention of Records 
After this study, we would like to do a follow-up study to see what happens with patients' health 
for up to 5 years after the end of the current study. If we obtain funding and approval for the 
follow-up study, we will retain the study records (listed in 8.7) until the completion of the follow-
up study, including data analysis and dissemination of results. 
At the completion of the follow-up study, or sooner if no follow-up study is done, we will 
completely deidentify the study patient data and add the deidentified data to a shared data 
repository, as required by PCORI. The code links at each participating nephrology practice site 
will then be destroyed (electronic records deleted).  At the completion of the follow-up study, the 
clinic staff data will not be shared to the data repository and will be destroyed.   
After completion of the studies, deidentified data, consent forms, and research records will be 
maintained for the period required by the Central IRB. Consents documents will then be 
shredded. 
8.11 Study Monitoring 
Ongoing study progress is reported at least annually to the ExPAND Clinical Site Council, 
ExPAND National Advisory Council, ExPAND Data Safety and Monitoring Board, the Central 
IRB, and PCORI. 
Mandatory reporting to PCORI occurs at least quarterly for pre-specified study milestones. 
Enrollment reports are submitted to PCORI monthly. 
8.12 Data Safety Monitoring Plan 
The study will empanel a Data and Safety Monitoring Board (DSMB) to act in an advisory 
capacity to the PIs and to evaluate the progress of the study, including periodic assessments of 
data quality and timeliness, participant recruitment, accrual and retention, participant risk versus 
benefit, performance of trial sites, and other factors that can affect study outcomes. The DSMB 
will make recommendations to the PIs concerning the continuation, modification, or conclusion 
of the trial. 
The DSMB will have multidisciplinary representation, including physicians from relevant medical 
specialties, biostatisticians, ethicists, clinical trialists, patients, and a person expert in racial and 
ethnic inequities in healthcare. The DSMB members shall be free of significant conflicts of 
interest (i.e., financial, intellectual, professional, or regulatory). A DSMB Charter for the study 

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2 June 2025 - Version 8 
 
will be developed by the study team and approved by the DSMB members. Further details are 
in the attached DSMB Charter and Data Safety Monitoring Plan (Appendix).  
The DSMB will meet in person or by Zoom: 
• 
 prior to recruitment to review and approve the study protocol 
• 
every 12 months, at a minimum, to review study progress 
• 
after the end of data collection 
The Principal Investigators will attend these meetings, and minutes and any recommendations 
will be documented. The DSMB will review enrollment and attrition rates and advise the PIs on 
any potential risks as well as on any risk mitigation plans. The DSMB recommendations will be 
discussed with the PIs. All data will be reviewed for protocol adherence, including a data 
verification check that the appropriate outcome measures are given at the appropriate time 
points. 
8.13 Study Modification 
Any modification to the protocol will be approved by the Central IRB before implementation. The 
IRB-approved revised protocol and other revised documents will be sent to the relying 
institutions per Central IRB protocol.  
Modifications which increase risk for participants (not anticipated) will be brought to the Data 
Safety Monitoring Board for review. 
Any major changes in overall research plan (as contrasted to changes in procedures) will be 
submitted to PCORI for approval. 
8.14 Study Discontinuation 
Any decision about study discontinuation will be made in conjunction with the DSMB. 
8.15 Study Completion 
After the last patient is enrolled for EHR data collection (with HIPAA waiver), chart data will be 
collected for up to six months. During this time, final surveys and interviews will be collected. 
The data will then be analyzed, and the results reported to participants (unless they opted out 
during consent), stakeholders, and the public, via conferences and peer-reviewed journals. We 
have found that dissemination can take up to two years or more. 
Study data, including data stored at GWU and code links maintained at each site, will be 
retained, shared (deidentified data only), and eventually destroyed as described in section 8.10. 
At this point, final reports will be made to the IRB and DSMB, and the study will be closed. 

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8.16 Conflict of Interest Management Plan 
The independence of this study from any actual or perceived influence, such as by the dialysis 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the 
design, conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. 
Furthermore, persons who have a perceived conflict of interest will be required to have such 
conflicts managed in a way that is appropriate to their participation in the trial. The study 
leadership in conjunction with the appropriate conflict of interest review committee has 
established policies and procedures for all study group members to disclose all conflicts of 
interest and will establish a mechanism for the management of all reported dualities of interest. 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or 
financial gain greater than the minimum allowable by their institution, etc.) must have the conflict 
reviewed following the procedure outlined in the George Washington University Conflict of 
Interest Policies. A conflict management plan will be established according to GW policy and 
reviewed by appropriate Dean and approved by the study sponsor prior to participation in this 
study.  All investigators will follow the applicable conflict of interest policies. As needed, the PI's 
will consult with the GW Office of Ethics, Compliance, and Risk for guidance on any conflict of 
interest issues. 
8.17 Funding Source 
This study is funded through a contract from the Patient Centered Outcomes Research Institute 
(PCORI).  
Contract title: Expanding Patient Choice in Kidney Failure Treatment, Contract #: IHS-2022C2-
27678 
8.18 Publication Plan 
Abstracts for Scientific Meetings of Professional Societies 
1. Abstracts will be submitted to annual scientific meeting of the American Society of 
Nephrology and the spring clinical meeting of the National Kidney Foundation 
2. Abstracts with palliative medicine outcomes will be submitted to the annual assembly of 
the American Academy of Hospice and Palliative Medicine 
3. Abstracts will be submitted to the annual American Nephrology Nurses Association 
National Symposium 
Possible papers resulting from unique research challenges of ExPAND 
1. Effectiveness of implementation science approach of creating a core function/form 
matrix and intervention table to facilitate flexible multisite trial with multiple nephrology 
practices. (Appropriate for Kidney360 Innovative Technology and Methodology article 
type.) 

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2. Process with stakeholder input for 1) choice of patient-centered, patient-friendly Kidney 
Disease Education and patient decision aid for shared decision-making; and 2) 
recruitment approach to increase patient KDE participation-appropriate for Medical 
Decision Making or Patient Education and Counseling. (If patient recruitment for KDE is 
substantially higher than previously reported, then it could be appropriate for CJASN or 
AJKD.) 
3. Communication skills training to increase SDM-Q-9 scores of ExPAND participants. (If 
successful, appropriate for CJASN, AJKD, Kidney360, Kidney Medicine, Medical 
Decision Making or Patient Education and Counseling.) 
4. Role of nurses or social workers in implementing shared decision-making for nephrology 
practices and delivering KDE and presenting patient decision aids. (Nephrology Nursing 
Journal or the Journal of Nephrology Social Work) 
Main Papers with Results 
1. Results paper comparing number/percentage of patients choosing ATP and decisional 
conflict, SDM-Q-9, and CollaboRATE scores in approach 1 vs approach 2. (Appropriate 
for CJASN or AJKD. If really successful, could be appropriate for Ann Intern Med or 
JAMA Intern Med.) 
2. Separate paper analyzing ATP selections (to our knowledge, no one has studied the 
extent to which patients choose a time-limited trial or deciding not to decide when 
explicitly informed of possibility. (Depending on strength of results potentially appropriate 
for CJASN, AJKD, Kidney 360 or Kidney Medicine.) 
3. Possible brief communication article type on stability of preference paper comparing 
approach 1 to approach 2 regarding planned and unplanned dialysis starts. (Depending 
on strength of results, could be appropriate for CJASN, AJKD, Kidney 360 or Kidney 
Medicine.) 
Final Report to PCORI 
 
 
 

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LIST OF TABLES 
Title 
Section 
Synopsis Table 1. Schedule of Study 
Activities 
Visit Schedule Table (Optional) 
Table 5.2.1 Primary Outcomes 
5.2.1 Primary Outcome Variables 
Table 5.2.2.A Secondary Outcomes for Aim 
1 
5.2.2 Secondary and Exploratory Outcome 
Variables (if applicable) 
Table 5.2.2.B Secondary Outcomes for 
Aims 2 and 3 
5.2.2 Secondary and Exploratory Outcome 
Variables (if applicable) 
Table 6.1.1 Number of Participants 
6.1.1 Number of Participants 
Table 7.1.3 Validated Instruments 
7.1.3 Selection of Instruments/Outcome 
Measures 
Table 7.4.2.A Assumptions for Sample Size 
and Power Projections 
7.4.2 Sample Size Considerations 
Table 7.4.2.B Power for Comparing 
Approach 1 and Approach 2 Outcomes 
7.4.2 Sample Size Considerations 
 
 

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LIST OF CHARTS 
Title 
Section 
Stepped Wedge Design 
5.1 General Design Description 
Alternative Treatment Plans 
2 Background 
Two Approaches to Offering ATP 
4.2 Primary Objective 
 
 

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APPENDICES 
# 
Title 
Section 
Topic 
1 
Flowchart of Study Activities 
and Outcomes 
Synopsis 
Study Flow Chart 
(Optional) 
2 
ExPAND Adverse Event 
Reporting Guidelines 
7 Methods 
7.2.3 Adverse Events 
Definition and 
Reporting 
3 
Informed Consent Form for 
Patient DCS Survey 
7 Methods 
7.3.2 Informed 
Consent 
4 
Recruitment Letter/Email to 
Patients for DCS Survey 
7 Methods 
7.3.2 Informed 
Consent 
5 
eConsent REDCap Script  
7 Methods 
7.3.2 Informed 
Consent 
6 
Patient and Care Partner 
Information Sheet for Aim 2 
Interviews 
7 Methods 
7.3.2 Informed 
Consent 
7 
Addendum to Patient ICF – 
Contact Info 
7 Methods 
7.3.2 Informed 
Consent 
8 
Data Safety Monitoring Plan 
8 Trial 
Administration 
8.12 Data Safety 
Monitoring Plan 
9 
DSMB Charter 
8 Trial 
Administration 
8.12 Data Safety 
Monitoring Plan 
 

 
 
 
 
 
 
 
 
Appendix 1 
Flowchart of Study Activities and Outcomes 
 
 

 
 

 
  

 
 
 

 
 
 
 
Appendix 2 
ExPAND Adverse Event Reporting

 
 
 
 
 
 
ExPAND Working Instructions: 
Adverse Event and Serious Adverse Event Reporting 
Version 3.0 – 11/1/2024 
 
 
 
 
 
 
 
 
 
 
 
Amendment History 
 
 
Version no. 
Date issued 
Details of changes made 
1.0 
9/20/2023 
2.0 
3/22/2024 
Prompt reporting requirement changed from unexpected or 
related SAE to unexpected and related SAE. 
3.0 
11/2/2024 
Reporting requirement changed from reporting all AEs in REDCap 
to reporting only AEs related to the intervention or research 
procedures. 
• 
This document must be kept within the Site Investigator File 
• 
Updates will be sent to centers periodically 

 
 
 
 
1. Safety reporting overview 
No serious adverse events related to this minimal risk study are anticipated. However, to be 
comprehensive in our monitoring of adverse events, we have developed detailed policies and 
processes for monitoring and reporting adverse events. The key feature is distinguishing between 
adverse events that may be related to the study interventions from adverse events that are likely 
to happen in the study population but are unrelated to the study interventions. Local site PI’s will 
assess all serious events and all unexpected events to determine whether or not they are related to 
study participation.  
Due to the nature of advanced CKD and its treatment, especially in multi-morbid frail older people, 
SAEs would be expected to occur frequently throughout the course of the disease. These expected 
SAEs include: 
• 
Abnormal electrolyte and hematological laboratory results that can be explained directly or 
indirectly by their advanced CKD 
• 
Hospital admissions – elective and emergency – that can be explained directly or indirectly 
by their advanced CKD or comorbidities 
• 
Hospice admissions – planned and emergency – that can be explained directly or indirectly 
by their advanced CKD or comorbidities 
• 
Infections and cardiovascular events, including fluid overload and swelling, that can be 
explained directly or indirectly by their advanced CKD or comorbidities 
• 
Commencement of dialysis 
• 
Death that can be explained directly or indirectly by their advanced CKD or comorbidities 
Given the high frequency of SAEs expected, the ExPAND trial utilizes the following risk-adapted safety 
reporting approach. 
Prompt Reporting: These AEs must be reported on the AE form to the Principal Investigator within 
24 hours of when the site becomes aware of the event: 
 
• 
SAEs categorized as causally related to the intervention or research procedures.  
• 
AEs (whether serious or not) categorized as unexpected and causally related to the 
intervention or research procedures. 
Other Reporting: These will be regularly reviewed by the study team, the IRB, the Data Safety 
Monitoring Board, and the sponsor. 
 
• 
All AEs (whether serious or not) categorized as causally related to the intervention or research 
procedures should be reported in REDCap. 
 
2. Definitions 
Adverse Event (AE) 
Any untoward medical occurrence in a participant, including occurrences which are not necessarily 
caused by or related to the intervention or to participation in research. AEs include both physical and 
psychological harms. 
 

 
 
 
 
Serious Adverse Event (SAE) 
A serious adverse event is any untoward medical occurrence that: 
• 
results in death 
• 
is life-threatening (actually, not hypothetically) 
• 
requires inpatient hospitalization or prolongation of existing hospitalization 
• 
results in persistent or significant disability/incapacity 
Other ‘important medical events’ may also be considered serious if they jeopardize the participant 
or require an intervention to prevent one of the above consequences. 
 
3.  Collection and classification of AE data 
Sites are requested to conduct an assessment of whether hospitalizations, deaths, and other AEs 
are expected and of whether they are causally related to the study procedures or treatment. These 
assessments need to be conducted by site PI. Guidance on conducting these assessments is 
provided in the remainder of this document. 
Information on AEs and SAEs categorized as causally related to the intervention or research procedures 
should be reported in REDCap. This includes: 
• 
Hospitalizations 
• 
Deaths 
• 
Other AEs 
Within REDCap, sites should document their assessment of the event’s expectedness and of its 
relatedness (to the study procedures or treatment). 
Related events 
 
Events are related if they resulted from administration of any of the procedures required by the 
ExPAND protocol. Relationship is described using the following categories: 
• 
Definitely related 
• 
Probably related 
• 
Possibly related 
• 
Unlikely to be related 
• 
Not related 
Events that are expected to occur in people with advanced CKD (see below) may be categorized as 
“Not related” to the research procedures unless there is reason to believe otherwise. 
Expected events 
 
Events are expected if they are listed in the protocol (7.2.3) as an expected AE. 
Appendix 1 sets out a more detailed breakdown of events that are expected to occur in people with 
advanced CKD to assist in the classification of whether an event is expected. 
This list is not meant to be exhaustive, but rather illustrative of the types of events that are 
expected. If an event is not listed in Appendix 1, please seek advice from the trial team and principal 
investigator before a decision is made. 
 

 
 
 
 
4. What events need prompt reporting as an AE or SAE? 
 
 
 
All other research-related AEs are collected in the REDCap database.  
Due to the benign nature of the study, study-related and unexpected SAEs are likely to be rare. An 
example would be psychological harm or distress related to participation in the trial, for example as 
a result of decision conflict, resulting in hospitalization or death. 
 
5. Reporting procedures for promptly reportable AEs 
 
• 
AEs occurring from the time of consent until 30 days after the end of the trial must be 
reported 
• 
Central trial team must be notified within 24 hours of site being made aware 
• 
Document the AE in REDCap 
• 
Send an email to the study Principal Investigator and Study Manager notifying them of the 
event and providing the study ID of the patient. 
• 
Email (marked URGENT) to: Dale Lupu (dlupu@gwu.edu) and Matthew Ryan 
(m.ryan@gwu.edu) 
• 
Receipt will be confirmed. Please follow up for confirmation if not received. 
• 
Any change of condition or other follow-up information relating to a previously 
reported AE should be documented in REDCap as soon as available. Study 
Principal Investigator and Study Manager should be notified. 
• 
Events must be followed up until the event has resolved or a final outcome has 
been reached. 
• Any inpatient stay in hospital or death classified as definitely, probably, or possibly 
related to the intervention or the research procedures. 
• Any AE classified as definitely, probably, or possibly related and unexpected. 

 
 
 
 
Appendix 1. An illustrative list of events that would be considered as expected SAEs due 
to advanced CKD and common comorbidities 
 
Death or admission to hospital related to: 
 
Cardiac/Cardiovascular 
Diagnoses 
Hypertension 
Angina 
Chest pain, MI ruled out 
Acute myocardial infarction (MI) 
Cardiac arrest/sudden death 
Congestive heart failure 
Cardiomyopathy 
Valvular heart disease 
Atrial fibrillation 
Other arrhythmia 
Pericarditis &/or tamponade 
Hypotension 
Procedures 
Cardiac catheterization 
Coronary angioplasty 
Coronary bypass graft (CABG) 
Valve repair or replacement 
Cardioversion 
Cardiac defibrillator placement 
Pacemaker placed 
Pericardial procedure 
CKD and Dialysis-Related† 
Diagnoses 
Hyperkalemia 
Fluid overload 
PD peritonitis† 
Peritoneal catheter 
complication† 
Procedures 
Extra dialysis treatment† 
Peritoneal catheter insertion/ 
removal† 
Endocrine/Metabolic 
Diagnoses 
Hyperparathyroidism 
Diabetes complication (e.g., 
DKA) 
Thyroid disease 
Hypercalcemia 
Hypothyroidism 
Procedures 
Parathyroidectomy 
Eye, Ear, Nose, Throat 
Diagnoses 
Diabetic retinopathy 
Cataract 
Glaucoma 
Blindness 
Epistaxis 
Procedures 
Retinal laser surgery 
Cataract extraction 
Gastrointestinal 
Diagnoses 
GI bleed 
Gastritis/Peptic ulcer disease 
Gastroenteritis 
Abdominal pain 
Diarrhea 
Bowel obstruction 
Diverticulitis 
Malnutrition/cachexia 
Nausea/vomiting 
Other 
Procedures 
OGD (upper GI endoscopy) 
ERCP 
Colonoscopy 
Gastric surgery 
Hernia repair 
Colectomy/colon surgery 
Appendectomy 
Parenteral nutrition 
Health investigation 
Procedures 
Diagnostic Tests unrelated to 
the HD/ HDF process 
Hematologic 
Diagnoses 
Anemia 
Infectious Diseases 
Diagnoses 
Pneumonia 
Liver, Biliary, Pancreas 
Diagnoses 
Viral hepatitis 

 
 
 
 
Procedures 
Blood transfusion 
Bone marrow biopsy 
Septicemia 
Endocarditis 
AIDS/HIV 
Urinary Tract Infection 
Wound Infection 
Abscess 
Meningitis 
Cellulitis/soft tissue infection 
Osteomyelitis 
Viral infection 
Fungal infection 
Fever or chills, source unknown 
Procedures 
Abscess Drainage 
Liver Failure 
Ascites 
Pancreatitis 
Gall bladder disease 
Procedures 
Liver biopsy 
Liver surgery 
Gall bladder surgery 
Pancreas surgery 
Musculoskeletal 
Diagnoses 
Carpal tunnel syndrome 
Dialysis amyloidosis (B2- 
microglobulin deposition) 
Infectious arthritis 
Procedures 
Carpal tunnel release (surgical) 
Neoplastic/Cancer 
Diagnoses 
Benign tumor 
Cancer, non-metastatic 
Cancer, metastatic 
Multiple myeloma 
Lymphoma/leukemia 
Procedures 
Surgical resection 
Chemotherapy 
Radiation therapy 
Neurologic/Cerebrovascular 
Diagnoses 
Seizure 
Dementia 
Mental status change/ 
confusion 
TIA 
Stroke (CVA) – hemorrhagic 
Stroke (CVA) – ischemic 
Stroke (CVA) – type unknown 
Subdural hematoma 
Procedures 
Carotid revascularization 
Carotid endarterectomy 
Evacuation of hematoma 
Obstetric/Gynecologic/Breast 
Diagnoses 
Abnormal bleeding 
Breast disease 
Other 
Procedures 
Breast Biopsy 
Hysterectomy 
Orthopedic 
Diagnoses 
Hip Fracture 
Other fracture 
Herniated intervertebral disk 
Other 
Procedures 
Fracture repair 
Hip replacement 
Other joint replacement 
Psychiatric/Mental Health 
Diagnoses 
Depression * 
Suicide attempt * 
anxiety disorder * 
Alcohol abuse 
Substance abuse 
Psychosis 
Pulmonary 
Diagnoses 
Chronic Obstructive Pulmonary 
Disease 
Asthma 
Bronchitis 
Pneumonia 
Hemoptysis 
Pleural effusion 
Pulmonary oedema 
Respiratory Failure/ Arrest 
Shortness of breath 
Skin 
Diagnoses 
Psoriasis 
Cellulitis/Skin infection 
Calciphylaxis 
Rash 
Social/Rehabilitation 
Diagnoses 
Placement issues 
Failure to thrive 
Fall 
Rehabilitation 
Hospice/palliative care 
 

 
 
Pulmonary embolism 
Procedures 
Ventilator-assisted breathing 
Bronchoscopy 
Thoracentesis 
Transplant-Related 
Diagnoses 
Transplant evaluation 
Other 
Procedures 
Kidney transplant 
Transplant nephrectomy 
Trauma/Injury 
Diagnoses 
Death 
Other 
Procedures 
Laparotomy 
Skin graft 
Urologic 
Diagnoses 
Hematuria 
Renal cysts 
Kidney stone 
Other 
Procedures 
Cystoscopy 
Prostate surgery 
Nephrectomy 
Vascular 
Diagnoses 
Claudication/Rest pain 
Ulcer of extremity 
Gangrene 
Aortic aneurysm 
Deep vein thrombosis 
Other 
Procedures 
Angiogram 
Arterial bypass surgery 
Amputation 
Aortic aneurysm repair 
Wound debridement 
Vascular Access 
Diagnoses 
Clotted access† 
Infected access† 
Aneurysm† 
Failing access† 
Access 
bleeding† 
Other 
Procedures 
Salvage 
procedure† 
Revision 
procedure† 
New access creation† 
Access removal† 
Catheter placement† 
Other/Miscellaneous 
Diagnoses 
Drug reaction/allergy 
* Unless thought to be related to participation in the trial. 
† Dialysis related

 
 
 
 
Appendix 3 
Informed Consent Form for Patient DCS Survey 

  
 
 
 
 
             
 
Patient-Centered Outcomes Research Institute (PCORI) 
Page 1 of 8  
 
«PiFullName» 
Advarra IRB Approved Version 16 May 2024 
Revised «PIApprovalDate» 
 
Informed Consent for Participation in a Research Study 
For Patients 
Sponsor / Study 
Title: 
Patient-Centered Outcomes Research Institute 
(PCORI) / “Expanding and Promoting 
Alternative Care and Knowledge in Decision-
Making: The ExPAND Study (Improving 
Shared Decision-Making and Access to Non-
Dialytic Treatment for People with Kidney 
Disease)” 
 
Principal 
Investigator: 
 
«PiFullName» 
 
Telephone: 
 
«IcfPhoneNumber» 
 
Address: 
«PiLocations» 
 
 
Key Information 
We invite you to take part in a research study. About 20-30 kidney care 
offices across the United States are taking part. Around 3000 participants 
are expected to be enrolled. The purpose of this study is to find better ways 
for providers and patients with kidney disease to make decisions about 
treatment. As part of this study, our office is enhancing discussions about 
options for treating advanced kidney disease. To help us learn how patients 
feel about these enhanced discussions, we invite you to complete three 
short surveys, one now and two later. The surveys ask how clear you are 
about your treatment choices, how you feel about your decision, and your 
conversations with your provider. The total amount of time you will spend is 
about 30-45 minutes over the next nine months. Taking part in these 
surveys is voluntary, which means it is your choice. Your treatment will be 
the same either way. 
 
 

  
 
 
 
 
             
 
Patient-Centered Outcomes Research Institute (PCORI) 
Page 2 of 8  
 
«PiFullName» 
Advarra IRB Approved Version 16 May 2024 
Revised «PIApprovalDate» 
 
The main reason you might choose to volunteer for these surveys is to help 
us learn how to provide better care for people with chronic kidney disease. 
 
The reasons you might choose not to take part are you might by too busy, 
or you might feel uncomfortable answering the survey questions. You may 
skip any questions you do not want to answer. We will make every effort to 
keep your information confidential, but we cannot guarantee this. Later in 
this form, we describe the ways we keep your information safe. 
 
You can get more information about this study by contacting the study 
investigator using the contact information on the first page of this form. 
 
What is this study about? 
The purpose of this research program is to find better ways for kidney care 
providers and patients to make healthcare decisions together. We want to 
know how to explain all of the treatments so that patients can make 
decisions based on what is most important to them. 
 
Patients have choices about what to do when their kidneys are no longer 
working well. The offices in this study are training their staff members in 
better ways to help all patients make these choices. The staff members are 
learning: 
 
• To give information about all the choices. 
• To ask patients about what is important to them. 
• To support patients in the choices they make.  
 
If you take part in the surveys, you will: 
 
• Take a short survey today about your decision about your future 
kidney treatment and your conversations with your provider. The 
survey will take about 10-20 minutes. 
• Take the survey again in about 4 months. You can choose to do this 
follow-up survey in person, on the telephone, or online. 
• Take the survey again about 9 months from now. Again, you can 
choose how you want to take the survey. 

  
 
 
 
 
             
 
Patient-Centered Outcomes Research Institute (PCORI) 
Page 3 of 8  
 
«PiFullName» 
Advarra IRB Approved Version 16 May 2024 
Revised «PIApprovalDate» 
 
 
The total amount of time you will spend on these surveys is about 30-45 
minutes. You may skip any of the survey questions, and you may stop 
taking part in this study at any time.  
 
We will gather some limited and de-identified information about your health 
and the healthcare services you receive from the kidney office’s electronic 
medical record. This shortens the time you would need to spend taking the 
survey because we can get some basic information from the medical 
record (such as your age, sex, whether you have been in the hospital 
recently, and when you last visited your kidney doctor) rather than asking 
you additional questions.  
 
What are the costs? 
There will be no charge to you for your participation in this study. 
 
Will I get paid for taking part? 
«Compensation» 
 
You will receive payments after the second and third short surveys as a 
thank you. After the second survey, the payment will be $50. After the third 
survey, the payment will be $25. The total amount you will receive is $75.  
 
The research team will use a system called Advarra (formerly known as 
FORTE) Participant Payments to manage payments to research 
participants. The system offers 3 payment options: 
 
1. 
Reloadable debit/credit card. With this option, funds are available on 
the same business day. There may be some restrictions on the use of the 
card. You can see these in the cardholder agreement. 
2. 
Electronic deposit into your bank account. If you choose this method, 
we will email you a link where you will provide your bank account 
information. If all the information is provided correctly, the funds are 
available within 3 business days.  
3. 
Paper check mailed to you. If you choose this method, we will email 
you a link where you will provide your mailing address. If all your 

  
 
 
 
 
             
 
Patient-Centered Outcomes Research Institute (PCORI) 
Page 4 of 8  
 
«PiFullName» 
Advarra IRB Approved Version 16 May 2024 
Revised «PIApprovalDate» 
 
information is entered correctly, a paper check takes 3 days to process plus 
delivery time. 
 
All three options require the collection of your name and date of birth. If you 
choose payment option 2 or 3, you will need to provide your email address 
to the research team. 
 
If you choose a reloadable card, Advarra Participant Payments may share 
information about the card or the purchases you make. They would only do 
this for the reasons below:  
 
• Where it is needed for completing transactions, 
• To verify the existence and condition of the card for a third party, 
such as a merchant, 
• To follow government agency, court order, or other legal or 
administrative reporting requirements,  
• If you consent by giving us your written permission, 
• To our employees, auditors, affiliates, service providers, or attorneys 
as needed, or  
• To fulfill our obligations under the card holder agreement (provided 
separately). 
 
What are the risks of taking part? 
You might feel uncomfortable answering the survey questions. You may 
skip any questions you do not want to answer. We will make every effort to 
keep your information confidential, but we cannot guarantee this. Later in 
this form, we describe the ways we keep your information safe. 
 
What are the benefits of taking part? 
It is possible that answering the survey questions might help you think 
about your decision. You may also learn more about kidney disease. We 
hope that other people with kidney disease will benefit in the future. This 
could happen if kidney care teams learn better ways of helping patients 
make decisions based on what is important to them in their care. 
 

  
 
 
 
 
             
 
Patient-Centered Outcomes Research Institute (PCORI) 
Page 5 of 8  
 
«PiFullName» 
Advarra IRB Approved Version 16 May 2024 
Revised «PIApprovalDate» 
 
Will my answers be kept private? 
Only the research team or people who are required to review the study will 
have access to your information. Your kidney care team will not see your 
answers.  
 
We will keep your information on a secure, password protected computer. 
Any personally identifiable information collected will be coded using a 
unique study ID. The coded lists are only accessible to the research 
coordinator at your kidney doctor’s office. The information that has your 
personally identifiable information will be kept separately from the rest of 
your data. 
 
After this study, we would like to do a follow-up study to see how you are 
doing after the end of this study. We may keep your information for the 
follow-up study. At the end of the follow-up study, or sooner if no follow-up 
study is done, we will remove any information that could be used to identify 
you. Then, your de-identified study data may be shared on data 
repositories for future research studies. While every effort will be made to 
protect the confidentiality of your information, absolute confidentiality 
cannot be guaranteed. 
 
How will the findings of this study be shared? 
A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not 
include information that can identify you. At most, the website will include a 
summary of the results. You can search this website at any time. 
  
We plan to report the findings of this research study in journals and at 
scientific meetings. It can take several years to publish the final results. 
You will not be named or identified. 
  
During the study, we plan to send you a newsletter about how the study is 
going. These may come out once or twice a year. At the end of the study, 
we will provide you a summary of the main findings. Later in this form, you 
can tell us whether you want to receive this information. 
  

  
 
 
 
 
             
 
Patient-Centered Outcomes Research Institute (PCORI) 
Page 6 of 8  
 
«PiFullName» 
Advarra IRB Approved Version 16 May 2024 
Revised «PIApprovalDate» 
 
Whom to contact about this study 
During the study, if you have questions, concerns or complaints about the 
study such as: 
 
• Payment or compensation for being in the study, if any; 
• Your responsibilities as a research participant; 
• Eligibility to participate in the study; 
• The Investigator’s or study site’s decision to withdraw you from 
participation; 
 
Please contact the Investigator at the telephone number listed on the 
first page of this consent document.  
 
An institutional review board (IRB) is an independent committee 
established to help protect the rights of research participants. If you have 
any questions about your rights as a research participant, contact: 
 
• By mail: 
Study Subject Adviser 
Advarra IRB 
6100 Merriweather Dr., Suite 600 
Columbia, MD 21044 
• or call toll free:    877-992-4724 
• or by email:          adviser@advarra.com 
 
Please reference the following number when contacting the Study Subject 
Adviser: Pro00078064. 
 
New findings 
Any new important information that is discovered during the study and 
which may influence your willingness to continue participation in the study 
will be provided to you. 
 
Alternatives to participation 
This research study is for research purposes only. The only alternative is to 
not participate in this study. 

  
 
 
 
 
             
 
Patient-Centered Outcomes Research Institute (PCORI) 
Page 7 of 8  
 
«PiFullName» 
Advarra IRB Approved Version 16 May 2024 
Revised «PIApprovalDate» 
 
 
Voluntary participation / Withdrawal  
Your decision to participate in this study is voluntary. You may choose to 
not participate or you may withdraw from the study for any reason without 
penalty or loss of benefits to which you are otherwise entitled and without 
any effect on your future medical care. However, please note that any 
information collected up to the point of your withdrawal will not be removed 
from the study. 
 
The Investigator or the sponsor can stop your participation at any time 
without your consent for the following reasons: 
 
• If you fail to follow directions for participating in the study; 
• If it is discovered that you do not meet the study requirements; 
• If the study is canceled; or  
• For administrative reasons. 
 
Signature 
By signing below, you agree that the above information has been explained 
to you and you have had the chance to ask questions. Your signature 
documents your permission to take part in this research.  
 
 
 
 
_______________________________  
 
 
 
 
 
Printed name of participant 
 
_______________________________  
 
____________  
Signature of participant 
 
 
 
 
 
Date 
 
Check one payment method: 
 Reloadable debit/credit card 
 Electronic deposit into my bank account 
 Paper check delivered by US mail 
 
Check one: 
 I do not want to receive newsletters and other information about the 
study.  

  
 
 
 
 
             
 
Patient-Centered Outcomes Research Institute (PCORI) 
Page 8 of 8  
 
«PiFullName» 
Advarra IRB Approved Version 16 May 2024 
Revised «PIApprovalDate» 
 
 I give my permission for you to send me emails with newsletters and 
other information about the study. 
 
_______________________________  
 
____________  
Signature of participant 
 
 
 
 
 
Date 
 
WITNESS SIGNATURE FOR SUBJECTS WHO CANNOT READ  
The study participant has indicated that he/she is unable to read. The 
consent document has been read to the participant by a member of the 
study staff, discussed with the participant by a member of the study staff, 
and the participant has been given an opportunity to ask questions of the 
study staff.   
 
 
________________________________________ 
Printed Name of Impartial Witness  
 
 
________________________________________  
___________ 
Signature of Impartial Witness 
 
 
 
 
Date  
 
 
Please keep a copy of this form in case you want to read it again. 

 
 
 
 
Appendix 4 
Recruitment Letter/Email to Patients for DCS 
Survey

 
 
 
ExPAND Project Patient Survey Information Email - Version: 9/18//2024 
 
Dear _______ 
 
At <clinic name>, we always look for ways to improve our care. Research is one way we 
do this. We have joined with a team of researchers for a study. It is called ExPAND. This 
letter is to tell you about it.  
We are testing ways to talk about treatments for kidney disease. We want patients to 
understand all their choices. Also, we want to listen to what matters most to patients. The 
goal is to help patients make decisions they feel good about. 
We invite you to be a part of this study. We ask you to take a short survey now and two 
more times over the next few months. Each survey takes about 10-20 minutes. They are 
about the decision for the type of treatment you want for kidney disease. We will pay you 
$75 for the three surveys.   
We have attached a form to this <letter/email>. We encourage you to read it. Please think 
about whether you would like to take part. You may want to discuss it with family or friends. 
If you have questions, we will be happy to answer them. Call or email <RC name> at 
<phone number> or <email address>. 
 
What will happen next? 
The research coordinator will call you. <She/he> will answer any questions you have. If 
you would like to take part, <she/he> will ask you how you want to answer the survey 
questions. You can answer them on the phone. Or <she/he> can send you an email link. 
You can click on the link and answer the questions.  
You do not have to take part in ExPAND. You will receive the same care either way. If you 
do not want the research coordinator to call you, let us know. You can call our office 
<phone number> or reply to this email.  
Thank you for reading about the ExPAND study. It is our pleasure to provide your kidney 
care.  
 
Sincerely, 
<signature>

 
 
 
 
 
Appendix 5 
eConsent REDCap Script

Confidential 
09-10-2024 
projectredcap.org 
 
 
Page 1 
Informed Consent for Participation in a Research Study 
This form gives you important information you need to know about the ExPAND study before you decide if 
you want to take part. The research coordinator will talk to you about the study and answer all of your 
questions. 
We encourage you to discuss this study with your family and anyone else you trust before making your 
decision. It's important that you have as much information as you need and that all your questions are 
answered. 
 
 
This is a placeholder for the content of the informed consent for participation in a 
research study for patients. 
The electronic ICF(s) will be a complete and exact copy of the current, site- 
specific, IRB approved study consent document(s) and will be updated to match 
IRB-approved revisions. 

Confidential 
09-10-2024 
projectredcap.org 
 
 
 
 
First name of adult participant 
 
 
Last name of the adult participant 
 
 
Check one payment method: 
Reloadable debit/credit card 
Electronic deposit into my bank account 
Paper check delivered by US mail 
 
Enter email address: 
 
Advarra will send you an email at this address to 
set up payment. 
 
Do you want to receive newsletters about the study? 
 I do not want to receive newsletters and 
other Check one: 
 
information about the study. 
 I give my permission for you to send me 
emails with newsletters and other information 
about the study. 
 
Please enter the identification code provided to 
you by the research coordinator: 
 
 
Electronic signature of participant 
 
Please type your full name: 
(For example, Mary Smith) 
 
Date and time of 
signature 
 
 
(Click the 'NOW' button to enter the time and 
date automatically) 
 
 
AFFIDAVIT OF PERSON OBTAINING CONSENT: 
I certify that I have explained to the above individual the nature and purpose of the study, possible risks, 
and potential benefits associated with participation in this study. 
I have answered any questions that have been raised. 
 
Name of the person obtaining consent: 
 
 
CKD clinic (office) where patient seen: 
Clinic A 
Clinic B 
 
 

Confidential 
09-10-2024 
projectredcap.org 
 
 
 
 
 
Electronic signature of the person obtaining 
consent. Please type your full name in the box to 
the right. 
Date and time of 
signature: 
 
 
(Click the 'NOW' button to enter the time and 
date automatically) 

 
 
 
 
Appendix 6 
Patient and Care Partner Information Sheet 
for Aim 2 Interviews

 
 
 
Information Sheet for Patient and Care Partner Interviews 
 
 
Thank you for being a part of the ExPAND research study! 
 
We are trying to improve the way providers support patients in making 
healthcare decisions.  
 
As part of the study, we would like to interview a small group of patients 
and their care partners. A care partner is a close friend or family member 
who is involved with the patient’s healthcare. It may be the person who 
brings the patient to the clinic. We want to learn how patients and care 
partners feel about the healthcare they have received.  
 
With your permission, we would like to provide your contact information 
to interviewers from the ExPAND Research Team. If you are selected, 
they will contact you to tell you more. 
 
What is the purpose of the interviews? 
We want to learn about the experiences of patients who choose a 
treatment plan that is not standard dialysis. We also want to learn about 
the experiences of the people who are close to them. The treatment plan 
could be active medical care (conservative care). It could also be a time-
limited trial or waiting a while to decide. We want to understand patient 
and care partner views and experiences of health and healthcare after 
the treatment decision. 
 
Will we interview everyone? 
No. The study will last about 4 years. We expect over 500 patients to 
choose an alternative treatment plan. We will interview about 40 patients 
and about 35 care partners. 
 
How will we choose people to interview? 
We will invite a few people from each of the kidney care practices in the 
study. We will choose people of different ethnicities and cultural 
backgrounds. We want all the patients and care partners in the study to 
be represented. 

 
 
 
Why are we interviewing care partners? 
Care partners are closely involved in the patient’s healthcare. We want 
to learn how they are affected by the patient’s experience. If a patient 
passes away during the study, we would like to talk to their care partners 
about how things went at the end of life and how they are doing now. 
 
What if a patient doesn’t have a care partner? Or if their care 
partner does not want to give permission? 
We will interview some patients without care partners. We will also 
interview some care partners without patients. Patients and care 
partners can each choose whether to share their own contact 
information.  
 
What will the interviews be like? 
The interviewers will talk to participants on the phone. Some people will 
be asked to take part in a single interview. Others will be invited to take 
part in a few interviews. Each interview will last about 40 minutes. The 
questions will be about the health and healthcare experiences of the 
patient and the care partner.  
 
How much will people be paid for taking part? 
Patients and care partners will receive $50 for each interview.  
 
If you are selected, when will you be contacted? 
You may be contacted at any time during the study. The study will last for 
about 4 years. 
 
If you are selected, do you have to take part? 
No. If you are selected to take part, the interviewers will contact you. 
They will provide more information. Then you can choose whether you 
want to take part.  
 

 
 
 
 
Appendix 7 
Addendum to Patient ICF – Contact Info

Sponsor Name / Protocol Number Sponsor Protocol Number 
Page 1 of 5 
 
Advarra Template Version 05.27.22 
 
MULTI-SITE PROTOCOL FOOTER 
«PiFullName» 
Advarra IRB Approved Version e.g., 6 Sep 2024 
Revised «PIApprovalDate» 
 
 
 
 
 
 
 
INFORMED CONSENT FORM ADDENDUM 
 
PERMISSION TO SHARE CONTACT INFORMATION 
 
Sponsor / Study 
Title: 
  
Sponsor Name / “Protocol Title” 
 
Protocol Number: 
 
Protocol Number 
 
Principal 
Investigator: 
(Study Doctor) 
 
«PiFullName» 
 
Telephone: 
 
«IcfPhoneNumber» 
 
Address: 
«PiLocations» 
 
 
 
Purpose of this Addendum. 
When you joined this research study, you signed an Informed Consent Form. You 
agreed to take a series of three short surveys. This addendum contains information 
about an extra study activity. We would like to interview a small group of patients and 
their care partners. We want to learn about their healthcare experiences over time.  
 
Please read this form carefully. Ask the study staff as many questions as you would like. 
They can explain words or information you do not understand. Everything in the consent 
form you signed before still applies to this study. 
 
We are not asking you to take part in the new study activity right now. We are just 
asking for your permission to share your contact information. If you give us permission, 
we will share it with the interviewers. The interviewers are from the ExPAND Research 
Team. If you are selected to take part, they will contact you and provide more 
information.  
 
New Study Activity. 
We would like to interview a small group of patients and their care partners. We want to 
learn about their healthcare experiences over time. The interviewers are from the 
ExPAND Research Team. We are asking for your permission to share your contact 
information with them. If you do, they may contact you later to provide more information. 
 
What is the purpose of the interviews? 
We want to learn about the experiences of patients who choose a treatment plan that is 
not standard dialysis. We also want to learn about the experiences of the people who 

Sponsor Name / Protocol Number Sponsor Protocol Number 
Page 2 of 5 
 
Advarra Template Version 05.27.22 
 
MULTI-SITE PROTOCOL FOOTER 
«PiFullName» 
Advarra IRB Approved Version e.g., 6 Sep 2024 
Revised «PIApprovalDate» 
 
 
 
 
 
 
 
are close to them. The treatment plan could be active medical care (conservative care). 
It could also be a time-limited trial or waiting a while to decide. We want to understand 
patient and care partner views and experiences of health and healthcare after the 
treatment decision.  
 
Will we interview everyone? 
No. The study will last about 4 years. We expect over 500 patients to choose an 
alternative treatment plan. We will interview about 40 patients and about 35 care 
partners. 
 
Why are we interviewing care partners? 
Care partners are closely involved in the patient’s healthcare. We want to learn how 
they are affected by the patient’s experience. If a patient passes away during the study, 
we would like to talk to their care partners about how things went at the end of life and 
how they are doing now. 
 
What if a patient doesn’t have a care partner? Or if their care partner does not 
want to give permission? 
We will interview some patients without care partners. We will also interview some care 
partners without patients. Patients and care partners can each choose whether to share 
their own contact information.  
 
If you are selected, when will you be contacted? 
You may be contacted at any time during the study. The study will last for about 4 
years. 
 
If you are selected, do you have to take part? 
No. If you are selected to take part, the interviewers will contact you. They will provide 
more information. Then you can choose whether you want to take part. 
 
Whom to contact about this study 
During the study, if you have questions, concerns, or complaints about the study such 
as: 
 
• Payment or compensation for being in the study, if any; 
• Your responsibilities as a research participant; 
• Eligibility to participate in the study; 
• The Investigator’s or study site’s decision to withdraw you from participation; 
 
Please contact the Investigator at the telephone number listed on the first page of 
this document.  
 

S p o n s or N a m e  / Pr ot o c ol N u m b er S p o n s or Pr ot o c ol N u m b er  
P a g e 3  of 5  
 
A dv arr a T e m pl at e V ersi o n 0 5. 2 7. 2 2  
 
M U L TI -SI T E P R O T O C O L F O O T E R  
« Pi F ull N a m e »  
A d v arr a I R B A p pr o v e d V er si o n e. g., 6 S e p  2 0 2 4  
R e vi s e d « PI A p pr o v al D at e »  
 
 
 
 
 
 
 
A n i n stit uti o n al r e vi e w b o ar d (I R B) i s a n i n d e p e n d e nt c o m mitt e e e st a bli s h e d t o h el p 
pr ot e ct t h e ri g ht s of r e s e ar c h p arti ci p a nt s. If y o u h a v e a n y q u e sti o n s a b o ut y o ur ri g ht s 
a s a r e s e ar c h p arti ci p a nt, c o nt a ct:  
 
•   B y m ail : 
St u d y S u bj e ct A d vi s er  
A d v arr a I R B  
6 1 0 0 M erri w e at h er Dr., S uit e 6 0 0  
C ol u m bi a, M D 2 1 0 4 4  
•  or c all t oll fr e e:    8 7 7 -9 9 2 -4 7 2 4  
•  or b y e m ail :          a d vi s er @ a d v arr a. c o m  
 
Pl e a s e r ef er e n c e t h e f oll o wi n g n u m b er w h e n c o nt a cti n g t h e St u d y S u bj e ct A d vi s er: 
Pr o 0 0 0 7 8 0 6 4 . 
 
 
C O N T A C T I N F O R M A TI O N F O R P A TI E N T  
If y o u ar e s el e ct e d t o t a k e p art i n t h e st u d y, i nt er vi e w er s fr o m t h e E x P A N D R e s e ar c h 
T e a m will  u s e t h e i nf or m ati o n y o u pr o vi d e b el o w t o c o nt a ct y o u. T h e y will o nl y u s e t h e 
i nf or m ati o n t o s c h e d ul e a n d c o n d u ct t h e i nt er vi e w s a n d t o s e n d r e mi n d er s a b o ut t h e 
i nt er vi e w s. T h e y will n ot s h ar e t h e i nf or m ati o n wit h a n y o n e el s e.  
 
H o w m a y t h e y c o nt a ct y o u ? C h e c k all t h e a p pl y:  
 
 H o m e a d dr e s s: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
                               
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 E m ail a d dr e s s: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 P h o n e n u m b er: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
M a y t h e y s e n d t e xt m e s s a g e s f or r e mi n d er s a n d t o i d e ntif y t h e m s el v e s b ef or e t h e y c all ?  
 Y e s     N o         P h o n e n u m b er f or t e xt m e s s a g e s: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
M a y t h e y l e a v e v oi c e m e s s a g e s ?  
 N o m e s s a g e s     S h ort m e s s a g e s      M e s s a g e s i n cl u di n g pri v at e i nf or m ati o n  
 
B e st ti m e s t o c all: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 

S p o n s or N a m e  / Pr ot o c ol N u m b er S p o n s or Pr ot o c ol N u m b er  
P a g e 4  of 5  
 
A dv arr a T e m pl at e V ersi o n 0 5. 2 7. 2 2  
 
M U L TI -SI T E P R O T O C O L F O O T E R  
« Pi F ull N a m e »  
A d v arr a I R B A p pr o v e d V er si o n e. g., 6 S e p  2 0 2 4  
R e vi s e d « PI A p pr o v al D at e »  
 
 
 
 
 
 
 
 
P A TI E N T A S S E N T S T A T E M E N T  
I h a v e r e a d t hi s A d d e n d u m, a n d it s c o nt e nt s h a v e b e e n e x pl ai n e d. I gi v e p er mi s si o n f or 
m y c o nt a ct i nf or m ati o n t o b e s h ar e d f or t h e p ur p o s e s li st e d a b o v e. I u n d er st a n d t h at I 
m a y or m a y n ot b e c o nt a ct e d at s o m e p oi nt d uri n g t h e st u d y. If I a m c o nt a ct e d, I c a n 
d e ci d e w h et h er I w a nt t o t a k e p art i n i nt er vi e w s at t h at ti m e. I will r e c ei v e a si g n e d c o p y 
of t hi s A d d e n d u m f or m y r e c or d s.  
 
I a m n ot gi vi n g u p a n y of m y l e g al ri g ht s b y si g ni n g t hi s f or m. N ot hi n g i n t hi s f or m i s 
i nt e n d e d t o c h a n g e a p pli c a bl e f e d er al, st at e, or l o c al l a w s. 
 
 
 
  
 
_ _ _ _/ _ _ _ _/ _ _ _ _  
Si g n at ur e of R e s e ar c h S u bj e ct  
  
 
D at e  
 
 
 
Pri nt e d N a m e of R e s e ar c h S u bj e ct  
 
 
 
C O N T A C T I N F O R M A TI O N F O R C A R E P A R T N E R  
If y o u ar e s el e ct e d t o t a k e p art i n t h e st u d y, i nt er vi e w er s fr o m t h e E x P A N D R e s e ar c h 
T e a m will u s e t h e i nf or m ati o n y o u pr o vi d e b el o w t o c o nt a ct y o u. T h e y will o nl y u s e t h e 
i nf or m ati o n t o s c h e d ul e a n d c o n d u ct t h e i nt er vi e w s a n d t o s e n d r e mi n d er s a b o ut t h e 
i nt er vi e w s. T h e y will n ot s h ar e t h e i nf or m ati o n wit h a n y o n e el s e.  
 
N a m e of c ar e p art n er : _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
R el ati o n s hi p t o p ati e nt: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
H o w m a y t h e y c o nt a ct y o u ? C h e c k all t h e a p pl y:  
 
 H o m e a d dr e s s: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
                                 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 E m ail a d dr e s s: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 P h o n e n u m b er: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
M a y t h e y s e n d t e xt m e s s a g e s f or r e mi n d er s a n d t o i d e ntif y t h e m s el v e s b ef or e t h e y c all ?    
 Y e s     N o         P h o n e n u m b er f or t e xt m e s s a g e s: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
M a y t h e y l e a v e v oi c e m e s s a g e s ?  
 N o m e s s a g e s     S h ort m e s s a g e s      M e s s a g e s i n cl u di n g pri v at e i nf or m ati o n  

Sponsor Name / Protocol Number Sponsor Protocol Number 
Page 5 of 5 
 
Advarra Template Version 05.27.22 
 
MULTI-SITE PROTOCOL FOOTER 
«PiFullName» 
Advarra IRB Approved Version e.g., 6 Sep 2024 
Revised «PIApprovalDate» 
 
 
 
 
 
 
 
 
Best times to call:-
______________________________________________________________________ 
______________________________________________________________________ 
______________________________________________________________________ 
 
 
 
CARE PARTNER ASSENT STATEMENT 
I have read this Addendum, and its contents have been explained. I give permission for 
my contact information to be shared for the purposes listed above. I understand that I 
may or may not be contacted at some point during the study. If I am contacted, I can 
decide whether I want to take part in interviews at that time. I will receive a signed copy 
of this Addendum for my records.  
 
I am not giving up any of my legal rights by signing this form. Nothing in this form is 
intended to change applicable federal, state, or local laws. 
 
 
 
 
 
 
____/____/____ 
Signature of Care Partner 
 
 
Date 
 
 
 
Printed Name of Care Partner      
 
 

 
 
 
 
Appendix 8 
Data Safety Monitoring Plan

 
 
 
7 
Data Safety and Monitoring Plan 
 
Study Title: Improving Shared Decision-Making and Access to Non-Dialytic Treatment for 
People with Kidney Disease (the ExPAND study) 
 
Sponsor: Patient-Centered Outcomes Research Institute (PCORI) 
 
Contract Number: IHS-2022C2-2678 
 
Principal Investigator: Dale E. Lupu, PhD, MPH, Alvin H. Moss, MD, FACP, FAAHPM  
 
Site Investigator: Dale E. Lupu, PhD, MPH 
 
Institutions: George Washington University, West Virginia University 
 
Version 2 – 11-01-24 
Submitted to PCORI for Approval 
Approved by the DSMB 
 
 
 

 
 
 
8 
 
 
Brief Description of Interventions 
 
The interventions being studied are Approach 1: Educate and Engage and Approach 2: Educate 
and Engage + Kidney Supportive Care in older patients with advanced chronic kidney disease. 
Approach 1 provides kidney disease education covering both dialysis and non-dialysis options 
in an unbiased way using a shared decision-making (SDM) approach and patient decision aids 
while Approach 2 includes these as well as the creation of a kidney supportive care program for 
patients who choose alternative (non-dialysis) treatment plans (ATPs).  
 
Specific Aims 
 
Aim 1. Compare the effectiveness of two approaches: 1) improved kidney disease education 
(KDE) and SDM or 2) improved KDE and SDM plus the creation of a kidney supportive care 
program in a) increasing proportion of patients choosing ATP and b) reducing patient decisional 
conflict.  
 
Aim 2. Compare the patient and family/care partner experience of an ATP between Approach 1 
and Approach 2, with particular emphasis on TLT and AMCWD in terms of quality of life, 
services used, and end-of-life experience through medical record review and interviews with a 
sample of bereaved family members/care partners. Aim 2a will focus on experience while 
patients are receiving an ATP (several months to several years). Aim 2b will describe the end-
of-life experience.  
 
Aim 3. In order to evaluate implementation of each intervention (Approaches 1 and 2), the 
ExPAND research team will cooperate with a separate tandem evaluation conducted by an 
independent evaluation team based at NORC. The implementation evaluation is a mixed-
methods design based on the expanded Reach, Effectiveness, Adoption, Implementation, 
Maintenance (RE-AIM) framework. The implementation evaluation will consist of staff surveys, 
interviews, and site visits conducted by the NORC evaluation team. Regulatory oversight of AIM 
3 will be handled by the NORC IRB. 
 
Brief Description of Project Design 
 
This will be a repeated cross-sectional stepped wedge cluster-randomized trial (SW-CRT) with 
randomization at the nephrology clinic level. Twenty-five clinics will be randomly assigned to 
one of three sequences. Each sequence consists of four 10-month time periods during which 
patients are accrued and followed for study outcomes. To minimize contamination in the primary 
analysis, we will exclude patients recruited during the 4 months before each sequence moves to 

 
 
 
9 
Approach 2. These patients will be included in a sensitivity analysis. In the 4th study period, 
accrual of new patients will stop at 10 months, allowing a closing 4-month follow-up period to 
collect primary outcomes at the end of the study.. All practices begin by implementing Approach 
1 (Educate and Engage). Practices then "step" into Approach 2 (Kidney Supportive Care 
Program) at the assigned time based on their sequence. We have prepared for 15% drop-out of 
sites, leaving 21 sites in the final analysis sample. We expect to recruit approximately 2800 
patients (1400 under Approach 1 and 1400 under Approach 2). Patients at least 65 years and 
with eGFR recently having dropped below 30 will be included in the study. 
 
We will also recruit 35 family members/care partners of patients who chose ATP to be 
interviewed about their experiences.  
 
 
 

 
 
 
10
Table of Contents 
1.0 
PARTICIPANTS SAFETY ............................................................................................... 11 
1.1. 
Potential Risks and Benefits for Participants ...................................................................... 11 
1.1.1. 
Potential risk and protections against risks ....................................................................................... 11 
1.1.2. 
Potential benefits .............................................................................................................................. 13 
2.0 
ADVERSE EVENT AND SERIOUS ADVERSE EVENT COLLECTION AND REPORTING ......... 13 
2.1. 
AE/SAE definitions and expected events ............................................................................ 14 
2.2. 
AE/SAE Documentation and Reporting .............................................................................. 15 
3.0 
DATA AND SAFETY MONITORING .............................................................................. 16 
3.1. 
Frequency of Data and Safety Monitoring .......................................................................... 16 
APPENDICES ........................................................................................................................ 18 
Appendix 1. Adverse Event Log ..................................................................................................... 19 
Appendix 2. ExPAND Adverse Event Reporting Instructions ................... Error! Bookmark not defined. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
11
1.0 
PARTICIPANTS SAFETY 
 
This study includes three types of participants: patient participants, care partner participants, 
and nephrology clinic employee participants. Any mention of medical information below only 
applies to the patient participants. Caregiver participants and clinic employee participants are 
not the target of the intervention, and the study team will not be collecting any sensitive 
information about them. 
 
1.1. 
Potential Risks and Benefits for Participants 
 
1.1.1. Potential risk and protections against risks  
 
Patients: Because this study is implementing recommended best practices in the care of older 
patients with advanced chronic kidney disease, there are no anticipated major risks associated 
with it. Clinicians will employ recommended communication approaches and ask for permission 
to provide information about the patient's kidney disease and possible treatment options before 
doing so. Nonetheless, some patients might experience distress once informed that they have 
advanced chronic kidney disease if they were not previously aware of it. This distress is 
comparable to that experienced by patients in routine clinical practice who receive bad news. 
This study may differ from standard care in that patients might become better informed and 
more aware of the range of treatment options they have. Also, in taking the Decisional Conflict 
Scale and other surveys, they might realize more clearly that they don't know 1) what are the 
benefits of treatment that matter most to them, 2) what risks and side effects are most 
troublesome to them, and 3) overall, what treatment option is best for them. Interviewers will be 
trained to watch for indications of emotional distress and will be trained in how to respond 
calmly and empathetically. If the situation persists or worsens, the interview will be terminated, 
and the incident will be reported within 24 hours to the patient's treating clinician, who will 
develop a plan for supporting the patient including referral for further mental health services, as 
indicated.  
 
Care partners and clinic employees: The main risk to these participants is loss of confidentiality 
of research data. Specific steps to minimize these risks are described below. 
 
 

 
 
 
12
Before data collection starts, all study personnel will be required to undertake appropriate 
Collaborative Institutional Training Initiative (CITI) coursework, including Human Subjects 
Research and Health Information Privacy and Security training. All staff will complete an IRB 
approved training program developed by the study PIs. This training will include modules 
covering: (1) study overview, (2) recruitment procedures, (3) study arm procedures, (4) 
collection and management of study data, and (5) adverse event reporting and managing 
emergencies. The trial will be registered on ClinicalTrials.gov and the George Washington 
University (GWU) IRB will be the IRB of record. Participant recruitment will begin at each site 
only after that site’s clinical trials office (or equivalent) has approved the study materials 
containing IRB-approved protocol, surveys, and data collection instruments. The following 
sections provide a detailed overview of our specific efforts to minimize risks including risks to 
privacy and confidentiality: 
 
1) The majority of patient and care partner participant information collected for this project 
will be stored in a GW REDCap database, GW Box, or other GWU platform approved for 
regulated data. An additional copy of the site-specific study data may be housed 
securely at each participating site.  
2) Patient chart data collected from the EMR under a HIPAA waiver of consent will only be 
shared with CITI-trained researchers from GWU, and will be stored securely at GWU as 
described above.  
3) All enrolled patients will be assigned a unique study identification number. All data 
collected will be identified only by these study identification numbers. This will minimize 
risks regarding breach of confidentiality with respect to the study data. A site-specific link 
between each study identification number and participant name will be kept in a 
password-protected file on a password-protected computer at each participating site. 
4) Before any patient is invited to participate in surveys or interviews, the patient’s treating 
nephrologist or advance practitioner will have the opportunity to opt-out the patient. 
Reasons for exclusion include insufficient decision-making capacity, lack of proficiency 
with English or Spanish language, anticipated loss to follow-up, or if otherwise contra-
indicated for the patient’s health. The research assistant may also opt-out a patient if 
similar information is available in the EMR.  
5) Printed forms with identifiable participant data, e.g., signed consent forms, will be stored 
in separate file folders in locked filing cabinets at each clinic site. 
6) No medical records or protected health information (collected for the patient participants 
only) shall be re-disclosed, unless required by law. 
7) After completion of the study, the completely deidentified research data from this project 
will be deposited with the digital repository, the Patient-Centered Outcomes Data 
Repository (PCODR), of the Inter-university Consortium for Political and Social 
Research (ICPSR), University of Michigan to ensure that the research community has 
long-term access to the data. This is required by PCORI and included in consent forms. 

 
 
 
13
 
Avoiding undue influence or coercion in recruitment: 
 
Patients and care partners: Information from the electronic medical record (EMR) will be 
collected on all eligible patients with a HIPAA waiver of consent. Participation in surveys 
and interviews is voluntary. Patients, family members, and care partners will be informed 
that participation is voluntary and that all patients, regardless of their participation status, 
will continue to receive standard care. They will be informed that they may stop 
participating at any time without penalty. Research staff will not provide final lists of 
participants to the nephrology center providers or staff. Therefore, in general, the people 
delivering patient care will not be aware of whether an individual patient or care partner 
participated. 
 
Clinic employees: The intervention is at the clinic level, and supervisors at each clinic will decide 
which employees will be asked to attend training and participate in implementation. Participation 
in the evaluation of the training is voluntary. Participants will be informed that their employment 
will not be affected in any way by their participation status and that they may stop participating 
at any time without penalty. In summary reports to sites, participants will not be identified; 
however, due to the small sample sizes, it is possible that participant identities may be inferred 
in some cases. 
 
1.1.2.Potential benefits 
 
Because this study mirrors recommended best clinical practices such as the use of shared 
decision-making, patient decision aids, and kidney supportive care to address unmet palliative 
care needs in the population of older patients with advanced chronic kidney disease, the 
investigators believe that there will be significant benefits for the participants. These include 
being aware that they have a choice about treatment to make, being fully informed of all 
treatment options, participating as a co-equal in treatment decisions and the development of a 
treatment plan, being offered the opportunity to participate in advance care planning, being 
routinely assessed for symptoms and being treated for them, and being referred to palliative 
care and/or hospice in a timely manner as appropriate. 
 
2.0 
ADVERSE EVENT AND SERIOUS ADVERSE EVENT COLLECTION 
AND REPORTING 
 
No serious adverse events related to this minimal risk study are anticipated. However, to be 
comprehensive in our monitoring of adverse events, we have developed detailed policies and 
processes for monitoring and reporting adverse events. The key feature is distinguishing 

 
 
 
14
between adverse events that may be related to the study interventions from adverse events that 
are likely to happen in the study population but are unrelated to the study interventions. Local 
site PI’s will assess all serious events and all unexpected events to determine whether or not 
they are related to study participation. Specific reporting timetables for reporting events are 
detailed in the appendix. 
 
2.1. 
AE/SAE definitions and expected events 
 
Adverse Event (AE): Any untoward or unfavorable medical occurrence in a human subject, 
including any abnormal sign, symptom, or disease, temporally associated with the subject's 
participation in the research, whether or not considered related to the subject's participation in 
the research (modified from the definition of adverse events in the 1996 International 
Conference on Harmonization E-6 Guidelines for Good Clinical Practice). AEs encompass both 
physical and psychological harms. AEs are assessed in terms of seriousness, expectedness, 
and relatedness. 
 
Serious Adverse Event (SAE): An AE that meets any of the following conditions: 
• 
results in death 
• 
is life-threatening (actually, not hypothetically) 
• 
requires inpatient hospitalization or prolongation of existing hospitalization 
• 
results in persistent or significant disability/incapacity 
• 
Other 'important medical events' may also be considered serious if they jeopardize the 
participant or require an intervention to prevent one of the above consequences. 
 
Related Adverse Event: An AE is "possibly related" to the research procedures if, in the opinion 
of the investigator, the research procedures may have caused the harm. 
 
Unexpected Adverse Event: An AE is "unexpected" when its nature, severity or frequency is 
inconsistent with risk information previously reviewed and approved by the IRB in the context of 
the study population. 
 
Expected SAEs: Due to the nature of advanced CKD and its treatment, especially in multi-
morbid frail older people, SAEs would be expected to occur frequently throughout the course of 
the disease. These expected SAEs include: 
 
 

 
 
 
15
• 
Abnormal electrolyte and hematological laboratory results that can be explained directly 
or indirectly by their advanced CKD or comorbidities 
• 
Hospital admissions — elective and emergency — that can be explained directly or 
indirectly by their advanced CKD or comorbidities 
• 
Hospice admissions — planned and emergency — that can be explained directly or 
indirectly by their advanced CKD or comorbidities 
• 
Infections and cardiovascular events including fluid overload and swelling that can be 
explained directly or indirectly by their advanced CKD or comorbidities 
• 
Commencement of dialysis 
• 
Death that can be explained directly or indirectly by their advanced CKD or comorbidities 
 
Expected study-related AEs: Because of the nature of this minimal risk study, no physical harms 
are expected. It is possible that patients might suffer psychological distress. Some patients may 
become emotionally upset when thinking about their disease progression or the decisions they 
are making about their treatment. In standard CKD patient care, patients also need to make 
decisions about what treatment they want. This study may differ from standard care in that 
patients might become better informed and more aware of the range of treatment options they 
have. Also, in taking the Decisional Conflict Scale and other surveys, they might realize more 
clearly that they don't know 1) what are the benefits of treatment that matter most to them, 2) 
what risks and side effects are most troublesome to them, and 3) overall, what treatment option 
is best for them. Interviewers will be trained to watch for indications of emotional distress and 
will be trained in how to respond (see 7.1.5 of the study protocol). 
 
2.2. 
AE/SAE Documentation and Reporting 
 
Detailed guidance will be provided to the Site Principal Investigator and research coordinator 
about AE/SAE reporting (see Appendix 2). The Site Principal Investigator will assess the 
severity, expectedness, and relatedness of the AE, which will be reported accordingly. 
 
Prompt reporting: The Site Principal Investigator will report the following events to the study 
Principal Investigator within 24 hours of becoming aware of the event. The study Principal 
Investigator will report the AE to the Institutional Review Board (IRB) within 48 hours of 
becoming aware of the event. 
• 
SAEs that are causally related to the research procedures 
• 
AEs, including SAEs, that are both unexpected and causally related to the research 
 
 

 
 
 
16
Other reporting: All adverse events categorized as related to the research procedures will be 
recorded in Research Electronic Data Capture (REDCap) by the research coordinator (date, 
description, severity, expectedness, relatedness, and management/remediation of AE). The 
central data management team will assemble a list and summary of AEs, which will be reported 
to the IRB, DSMB, study sponsor, and site principal investigators as part of periodic reporting. 
 
3.0 
DATA AND SAFETY MONITORING 
 
Data quality: The site research coordinator, under the supervision of the site PI, is responsible 
for ensuring the accuracy, completeness, legibility, and timeliness of the data reported. 
Participant tracking and survey data will be entered directly into electronic case report forms in 
REDCap, and clinical data will be entered directly from the source documents (EMR) into 
REDCap. REDCap includes password protection and internal quality checks, such as automatic 
range checks, to identify data that appear inconsistent, incomplete, or inaccurate. Data will be 
regularly monitored by the data management team using human assessment as well as 
customized software to check for missing, improperly formed, or implausible data in the context 
of the study. Data quality reports will be sent regularly to the data collection personnel at the 
clinical sites, who will work with the data management team to correct missing and erroneous 
data.  
 
The study will empanel a Data and Safety Monitoring Board (DSMB) to act in an advisory 
capacity to the PIs and to evaluate the progress of the study, including periodic assessments of 
data quality and timeliness, participant recruitment, accrual and retention, participant risk versus 
benefit, performance of trial sites, and other factors that can affect study outcomes. The DSMB 
will make recommendations to the PIs concerning the continuation, modification, or conclusion 
of the trial. 
 
3.1. 
Frequency of Data and Safety Monitoring  
 
A Data and Safety Monitoring Board (DSMB) will be appointed to provide additional oversight of 
the trial and will meet prior to recruitment to review the study protocol and at the end of data 
collection. The PIs will attend these meetings, with minutes and any recommendations 
documented. The DSMB will consist of nine members, including geriatric nephrologists, a health 
equity specialist, biostatisticians, a CKD patient, a CKD patient’s family member, a nurse 
practitioner, and an ethicist. A DSMB Charter for the study will be developed by the study team 
and approved by the DSMB members. The DSMB will then meet by Zoom to review study 
progress at minimum, every 12 months throughout the project. The DSMB will review enrollment 
and attrition rates and advise the PIs on any potential risks as well as on any risk mitigation 
plans. The DSMB recommendations will be discussed with the PIs. All data will be reviewed for 

 
 
 
17
protocol adherence, including a data verification check that the appropriate outcome measures 
are given at the appropriate time points. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
18
 
 
APPENDICES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
19
Appendix 1. Adverse Event Log 
 
Adverse Event Type 
Relatedness to Study 
Intervention 
Relationship 
 
 
Expected 
 
 
SAE 
Outcome of Event  
1. Emergency room 
visit 
2. Hospital admission 
3. Other medical 
emergency 
4. Other medical event 
(non-emergency) 
5. Psychological 
6. Death 
7. Hospice admission 
8. Other 
1 = Definitely 
related 
2 = Possibly 
related 
3 = Not related 
1 = Yes 
2 = No 
1 = Yes 
2 = No 
 
1 = Resolved, 
 
2 = AE still present- 
no treatment 
 
3 = AE still present- 
being treated 
 
4 = Unknown 
5 = Death 
6 = Other 
 
Participant 
Study ID 
 
Age  Sex 
Adverse 
Event 
(Description) 
Advers
e Event  
Type 
Start 
Date 
Relatedness 
to Study 
Intervention 
Expected 
SAE Response/ 
Remediation 
(Description) 
Outcome  
of Event 
PI 
Initials 
 &  
Date 
 
 
 
 
 

ExPAND Working Instructions: AE and SAE reporting, v3.0, 11/1/2024 
Page 1 of 
 
 
 
 
Appendix 2. ExPAND Working Instructions: Adverse Event and Serious Adverse Event 
Reporting 
 
 
 
 
ExPAND Working Instructions: 
Adverse Event and Serious Adverse Event Reporting 
Version 3.0 – 11/1/2024 
 
 
 
 
 
 
 
 
 
 
 
Amendment History 
 
 
Version no. 
Date issued 
Details of changes made 
1.0 
9/20/2023 
2.0 
3/22/2024 
Prompt reporting requirement changed from unexpected or 
related SAE to unexpected and related SAE. 
3.0 
11/2/2024 
Reporting requirement changed from reporting all AEs in REDCap 
to reporting only AEs related to the intervention or research 
procedures. 
• 
This document must be kept within the Site Investigator File 
• 
Updates will be sent to centers periodically 

ExPAND Working Instructions: AE and SAE reporting, v3.0, 11/1/2024 
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6. Safety reporting overview 
No serious adverse events related to this minimal risk study are anticipated. However, to be 
comprehensive in our monitoring of adverse events, we have developed detailed policies and 
processes for monitoring and reporting adverse events. The key feature is distinguishing between 
adverse events that may be related to the study interventions from adverse events that are likely 
to happen in the study population but are unrelated to the study interventions. Local site PI’s will 
assess all serious events and all unexpected events to determine whether or not they are related to 
study participation.  
Due to the nature of advanced CKD and its treatment, especially in multi-morbid frail older people, 
SAEs would be expected to occur frequently throughout the course of the disease. These expected 
SAEs include: 
• 
Abnormal electrolyte and hematological laboratory results that can be explained directly or 
indirectly by their advanced CKD 
• 
Hospital admissions – elective and emergency – that can be explained directly or indirectly 
by their advanced CKD or comorbidities 
• 
Hospice admissions – planned and emergency – that can be explained directly or indirectly 
by their advanced CKD or comorbidities 
• 
Infections and cardiovascular events, including fluid overload and swelling, that can be 
explained directly or indirectly by their advanced CKD or comorbidities 
• 
Commencement of dialysis 
• 
Death that can be explained directly or indirectly by their advanced CKD or comorbidities 
Given the high frequency of SAEs expected, the ExPAND trial utilizes the following risk-adapted safety 
reporting approach. 
Prompt Reporting: These AEs must be reported on the AE form to the Principal Investigator within 
24 hours of when the site becomes aware of the event: 
 
• 
SAEs categorized as causally related to the intervention or research procedures.  
• 
AEs (whether serious or not) categorized as unexpected and causally related to the 
intervention or research procedures. 
Other Reporting: These will be regularly reviewed by the study team, the IRB, the Data Safety 
Monitoring Board, and the sponsor. 
 
• 
All AEs (whether serious or not) categorized as causally related to the intervention or research 
procedures should be reported in REDCap. 
 
 
7. Definitions 
Adverse Event (AE) 
Any untoward medical occurrence in a participant, including occurrences which are not necessarily 
caused by or related to the intervention or to participation in research. AEs include both physical and 
psychological harms. 
 
Serious Adverse Event (SAE) 
A serious adverse event is any untoward medical occurrence that: 
• 
results in death 
• 
is life-threatening (actually, not hypothetically) 
• 
requires inpatient hospitalization or prolongation of existing hospitalization 
• 
results in persistent or significant disability/incapacity 
Other ‘important medical events’ may also be considered serious if they jeopardize the participant 

ExPAND Working Instructions: AE and SAE reporting, v3.0, 11/1/2024 
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or require an intervention to prevent one of the above consequences. 
 
8.  Collection and classification of AE data 
Sites are requested to conduct an assessment of whether hospitalizations, deaths, and other AEs 
are expected and of whether they are causally related to the study procedures or treatment. These 
assessments need to be conducted by site PI. Guidance on conducting these assessments is 
provided in the remainder of this document. 
Information on AEs and SAEs categorized as causally related to the intervention or research procedures 
should be reported in REDCap. This includes: 
• 
Hospitalizations 
• 
Deaths 
• 
Other AEs 
Within REDCap, sites should document their assessment of the event’s expectedness and of its 
relatedness (to the study procedures or treatment). 
Related events 
 
Events are related if they resulted from administration of any of the procedures required by the 
ExPAND protocol. Relationship is described using the following categories: 
• 
Definitely related 
• 
Probably related 
• 
Possibly related 
• 
Unlikely to be related 
• 
Not related 
Events that are expected to occur in people with advanced CKD (see below) may be categorized as 
“Not related” to the research procedures unless there is reason to believe otherwise. 
Expected events 
 
Events are expected if they are listed in the protocol (7.2.3) as an expected AE. 
Appendix 1 sets out a more detailed breakdown of events that are expected to occur in people with 
advanced CKD to assist in the classification of whether an event is expected. 
This list is not meant to be exhaustive, but rather illustrative of the types of events that are 
expected. If an event is not listed in Appendix 1, please seek advice from the trial team and principal 
investigator before a decision is made. 
 
9. What events need prompt reporting as an AE or SAE? 
 
 
 
All other research-related AEs are collected in the REDCap database.  
Due to the benign nature of the study, study-related and unexpected SAEs are likely to be rare. An 
example would be psychological harm or distress related to participation in the trial, for example as 
a result of decision conflict, resulting in hospitalization or death. 
 
10. Reporting procedures for promptly reportable AEs 
 
• 
AEs occurring from the time of consent until 30 days after the end of the trial must be 
• Any inpatient stay in hospital or death classified as definitely, probably, or possibly 
related to the intervention or the research procedures. 
• Any AE classified as definitely, probably, or possibly related and unexpected. 

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reported 
• 
Central trial team must be notified within 24 hours of site being made aware 
• 
Document the AE in REDCap 
• 
Send an email to the study Principal Investigator and Study Manager notifying them of the 
event and providing the study ID of the patient. 
• 
Email (marked URGENT) to: Dale Lupu (dlupu@gwu.edu) and Matthew Ryan 
(m.ryan@gwu.edu) 
• 
Receipt will be confirmed. Please follow up for confirmation if not received. 
• 
Any change of condition or other follow-up information relating to a previously 
reported AE should be documented in REDCap as soon as available. Study 
Principal Investigator and Study Manager should be notified. 
• 
Events must be followed up until the event has resolved or a final outcome has 
been reached. 

ExPAND Working Instructions: AE and SAE reporting, v3.0, 11/1/2024 
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Appendix 1. An illustrative list of events that would be considered as expected SAEs due 
to advanced CKD and common comorbidities 
 
Death or admission to hospital related to: 
 
Cardiac/Cardiovascular 
Diagnoses 
Hypertension 
Angina 
Chest pain, MI ruled out 
Acute myocardial infarction (MI) 
Cardiac arrest/sudden death 
Congestive heart failure 
Cardiomyopathy 
Valvular heart disease 
Atrial fibrillation 
Other arrhythmia 
Pericarditis &/or tamponade 
Hypotension 
Procedures 
Cardiac catheterization 
Coronary angioplasty 
Coronary bypass graft (CABG) 
Valve repair or replacement 
Cardioversion 
Cardiac defibrillator placement 
Pacemaker placed 
Pericardial procedure 
CKD and Dialysis-Related† 
Diagnoses 
Hyperkalemia 
Fluid overload 
PD peritonitis† 
Peritoneal catheter 
complication† 
Procedures 
Extra dialysis treatment† 
Peritoneal catheter insertion/ 
removal† 
Endocrine/Metabolic 
Diagnoses 
Hyperparathyroidism 
Diabetes complication (e.g., 
DKA) 
Thyroid disease 
Hypercalcemia 
Hypothyroidism 
Procedures 
Parathyroidectomy 
Eye, Ear, Nose, Throat 
Diagnoses 
Diabetic retinopathy 
Cataract 
Glaucoma 
Blindness 
Epistaxis 
Procedures 
Retinal laser surgery 
Cataract extraction 
Gastrointestinal 
Diagnoses 
GI bleed 
Gastritis/Peptic ulcer disease 
Gastroenteritis 
Abdominal pain 
Diarrhea 
Bowel obstruction 
Diverticulitis 
Malnutrition/cachexia 
Nausea/vomiting 
Other 
Procedures 
OGD (upper GI endoscopy) 
ERCP 
Colonoscopy 
Gastric surgery 
Hernia repair 
Colectomy/colon surgery 
Appendectomy 
Parenteral nutrition 
Health investigation 
Procedures 
Diagnostic Tests unrelated to 
the HD/ HDF process 

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Hematologic 
Diagnoses 
Anemia 
Infectious Diseases 
Diagnoses 
Pneumonia 
Liver, Biliary, Pancreas 
Diagnoses 
Viral hepatitis 
Procedures 
Blood transfusion 
Bone marrow biopsy 
Septicemia 
Endocarditis 
AIDS/HIV 
Urinary Tract Infection 
Wound Infection 
Abscess 
Meningitis 
Cellulitis/soft tissue infection 
Osteomyelitis 
Viral infection 
Fungal infection 
Fever or chills, source unknown 
Procedures 
Abscess Drainage 
Liver Failure 
Ascites 
Pancreatitis 
Gall bladder disease 
Procedures 
Liver biopsy 
Liver surgery 
Gall bladder surgery 
Pancreas surgery 
Musculoskeletal 
Diagnoses 
Carpal tunnel syndrome 
Dialysis amyloidosis (B2- 
microglobulin deposition) 
Infectious arthritis 
Procedures 
Carpal tunnel release (surgical) 
Neoplastic/Cancer 
Diagnoses 
Benign tumor 
Cancer, non-metastatic 
Cancer, metastatic 
Multiple myeloma 
Lymphoma/leukemia 
Procedures 
Surgical resection 
Chemotherapy 
Radiation therapy 
Neurologic/Cerebrovascular 
Diagnoses 
Seizure 
Dementia 
Mental status change/ 
confusion 
TIA 
Stroke (CVA) – hemorrhagic 
Stroke (CVA) – ischemic 
Stroke (CVA) – type unknown 
Subdural hematoma 
Procedures 
Carotid revascularization 
Carotid endarterectomy 
Evacuation of hematoma 
Obstetric/Gynecologic/Breast 
Diagnoses 
Abnormal bleeding 
Breast disease 
Other 
Procedures 
Breast Biopsy 
Hysterectomy 
Orthopedic 
Diagnoses 
Hip Fracture 
Other fracture 
Herniated intervertebral disk 
Other 
Procedures 
Fracture repair 
Hip replacement 
Other joint replacement 
Psychiatric/Mental Health 
Diagnoses 
Depression * 
Suicide attempt * 
anxiety disorder * 
Alcohol abuse 
Substance abuse 
Psychosis 

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Pulmonary 
Diagnoses 
Chronic Obstructive Pulmonary 
Disease 
Asthma 
Bronchitis 
Pneumonia 
Hemoptysis 
Pleural effusion 
Pulmonary oedema 
Respiratory Failure/ Arrest 
Shortness of breath 
Skin 
Diagnoses 
Psoriasis 
Cellulitis/Skin infection 
Calciphylaxis 
Rash 
Social/Rehabilitation 
Diagnoses 
Placement issues 
Failure to thrive 
Fall 
Rehabilitation 
Hospice/palliative care 

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Pulmonary embolism 
Procedures 
Ventilator-assisted breathing 
Bronchoscopy 
Thoracentesis 
Transplant-Related 
Diagnoses 
Transplant evaluation 
Other 
Procedures 
Kidney transplant 
Transplant nephrectomy 
Trauma/Injury 
Diagnoses 
Death 
Other 
Procedures 
Laparotomy 
Skin graft 
Urologic 
Diagnoses 
Hematuria 
Renal cysts 
Kidney stone 
Other 
Procedures 
Cystoscopy 
Prostate surgery 
Nephrectomy 
Vascular 
Diagnoses 
Claudication/Rest pain 
Ulcer of extremity 
Gangrene 
Aortic aneurysm 
Deep vein thrombosis 
Other 
Procedures 
Angiogram 
Arterial bypass surgery 
Amputation 
Aortic aneurysm repair 
Wound debridement 
Vascular Access 
Diagnoses 
Clotted access† 
Infected access† 
Aneurysm† 
Failing access† 
Access 
bleeding† 
Other 
Procedures 
Salvage 
procedure† 
Revision 
procedure† 
New access creation† 
Access removal† 
Catheter placement† 
Other/Miscellaneous 
Diagnoses 
Drug reaction/allergy 
* Unless thought to be related to participation in the trial. 
† Dialysis related 
 

 
 
 
 
Appendix 9 
DSMB Charter

 
Version 1.0 February 12, 2024 – Approved by DSMB 
 
Page 1 of 8 
Data Safety and Monitoring Board (DSMB) Charter 
 
Study Title: Improving Shared Decision-Making and Access to Non-Dialytic Treatment for 
People with Kidney Disease (the ExPAND* study) 
 
Sponsor: Patient-Centered Outcomes Research Institute (PCORI) 
 
Contract Number: IHS-2022C2-2678 
 
Principal Investigators: Dale E. Lupu, PhD, MPH, Alvin H. Moss, MD, FACP, FAAHPM 
 
Site Principal Investigators: Dale E. Lupu, PhD, MPH 
 
Institutions:  George Washington University, West Virginia University 
 
 
 
Version 1.0 February 12, 2024 – Approved by DSMB  
 
 
*Expanding and Promoting Alternative Care and Knowledge in Dialysis Care (EXPAND) Trial 
 
 
 
 
 

 
Version 1.0 February 12, 2024 – Approved by DSMB 
 
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Table of Contents 
Abbreviations 
3 
DSMB Responsibilities 
4 
Membership 
5 
Meetings 
5 
Meeting Format 
5 
Meeting Agendas 
6 
Meeting Materials 
6 
Meeting Minutes 
7 
Reports from the DSMB 
7 
Confidentiality 
7 
Conflicts of Interest 
7 
 
 
 
 
 

 
Version 1.0 February 12, 2024 – Approved by DSMB 
 
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Abbreviations 
 
COI 
Conflicts of Interest 
DSMB 
Data Safety and Monitoring Board 
DSMP 
Data Safety and Monitoring Plan 
ExPAND 
Improving Shared Decision-Making and Access to Non-Dialytic Treatment for 
People with Kidney Disease Study 
IRB 
Institutional Review Board 
PCORI 
Patient-Centered Outcomes Research Institute 
PO 
Program Officer 
 
 
 
 

 
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The Data and Safety Monitoring Board (DSMB) will act in an advisory capacity to the Patient-
Centered Outcomes Research Institute (PCORI) to monitor participant safety, data quality and 
study progress of “Improving Shared Decision-Making and Access to Non-Dialytic Treatment for 
People with Kidney Disease (the ExPAND study)”, contract number IHS-2022C2-2678 by PI 
Dale Lupu (George Washington University). 
 
DSMB Responsibilities 
The DSMB responsibilities are to:  
 
At the initial meeting, 
 
● Review the entire IRB-approved study protocol, regarding data/participant safety 
including recruitment, randomization, intervention, data management, quality control and 
analysis and the informed consent documents. 
 
● Recommend changes to the protocol related to data/participant safety and the informed 
consent forms, when applicable. 
 
● Identify the relevant data parameters (including those related to adverse events (AEs), 
serious AEs (SAEs) and unanticipated problems (UPs)) and the format of the information 
to be regularly reported. 
 
● Recommend participant recruitment be initiated after receipt of a satisfactory protocol. If 
the need for modifications to the protocol, consent forms, Data Safety and Monitoring 
Plan (DSMP) or any other study document is indicated by the DSMB, the DSMB will 
postpone its recommendation for the initiation of participant recruitment until after the 
receipt of a satisfactory revised protocol(s) or other study documents. 
 
During the study meetings, 
 
● Review masked (if masking is feasible) and unmasked data. These data can be related 
to safety, recruitment, randomization, retention, protocol adherence, trial operations, 
data completeness, form completion, intervention effects on primary endpoints, gender 
and minority inclusion.  
 
● Identify needs for additional data relevant to safety issues and request these data from 
the study investigators.  
 
● Propose additional analyses.  
● At each meeting, consider the rationale for continuation of the study, with respect to 
progress of recruitment, randomization, retention, protocol adherence, data 
management, safety issues, and outcome data (if relevant) and make a recommendation 
for or against the trial's continuation.  

 
Version 1.0 February 12, 2024 – Approved by DSMB 
 
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● Review and make recommendations on proposed protocol changes, and/or new 
protocols proposed during the trial. The DSMB may recommend to PCORI to appoint a 
blinded working group of the DSMB to review the proposed protocol changes and make 
recommendations to PCORI on whether to approve the requests. 
● Provide advice on issues regarding data discrepancies found by the data auditing 
system or other sources. 
● DSMB members with expertise in a particular area may be asked to contribute their 
thoughts regarding the conduct of the ExPAND trial (e.g. asked Review manuscripts of 
trial results if requested). 
The DSMB will discharge itself from its duties when the study is complete. 
Membership 
The DSMB consists of nine members that have been appointed by the study investigators.  
Members are completely independent of the study investigators and have no financial, scientific 
or other conflict of interest with the trial. The DSMB members and their expertise are as follows: 
● Geriatric Nephrologist: Ann O’Hare, MD  
● Geriatric Nephrologist: Vanita Jassal, MD 
● Health Equity Nephrologist: Vanessa Grubbs, MD  
● Biostatistician: Denise Esserman, PhD  
● Biostatistician: Jonathan Yabes, PhD 
● Patient: Patrick Gee 
● Nurse Practitioner: Suzanne Ward, NP 
● Ethicist: Donna Chen, MD, MPH 
● Patient Family Member: Melissa Tolzien  
Dr. Ann O’Hare will serve as the Chairperson and is responsible for facilitating the meetings, 
reviewing the first draft of the meeting notes and any decision making in the case of a tie vote. 
The Chair will act as the official contact for the DSMB. At each DSMB meeting, the Chairperson 
will prepare a formal summary of the DSMB’s recommendations regarding continuation or 
termination of the study as well as any other changes requested by the DSMB.  The GWU 
School of Nursing will provide the logistical management and support for the DSMB.  

 
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Meetings 
Meeting Format 
Meetings of the DSMB will be held at a minimum every 12 months after the protocol is approved 
by the DSMB, including: 1) prior to data collection to approve the study protocol and 2) within 
three months of the completion of data collection. An emergency meeting of the DSMB may be 
called at any time by the DSMB Chair, should participant safety questions or other unanticipated 
problems arise. 
A quorum will require 5 DSMB members including the chair and a statistician.  Meetings will be 
held in-person, by telephone conference, or a combination of the two. 
DSMB meetings will consist of open, closed, and optional executive sessions, all closed to the 
public because discussions may address confidential participant data.  
The open session is attended by study PIs, key staff members, including the study 
biostatistician, and DSMB members. Discussions at these sessions focus on the review of the 
aggregate study data, conduct and progress of the study, including participant accrual, protocol 
compliance, and problems encountered. Data by treatment group are not presented in the open 
session.  
The closed session will be attended by the DSMB members and the unblinded study 
biostatistician. The primary objective of the closed sessions is to review safety-related 
outcomes, adverse events and serious adverse events data by study group, and recommend 
any safety-related protocol changes required to the study team.  
If necessary, an executive session may be requested by the DSMB and will be attended only 
by voting DSMB members. 
Meeting Agenda 
The DSMB Chair or the Principal Investigators will prepare the meeting agenda that usually 
includes the following: 
1. Welcome and introduction – study team and DSMB members  
2. Open session (review study protocol and its amendments, consent form, open study 
report, etc.) - study team and DSMB members 
3. Closed session (review closed session report, including unmasked safety data, etc.) – 
DSMB members, study team if invited 
4. Executive session (optional, upon DSMB request) – DSMB members, PCORI staff if 
invited 

 
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5. Debriefing (optional, upon DSMB request, time permitting) - study team and DSMB 
members 
The DSMB may modify its processes and procedures at any time as needed. 
Meeting Materials  
DSMB interim report templates developed by the study staff for both the open and closed 
sessions and plans for interim analyses will be reviewed and either approved at the initial DSMB 
meeting or changes requested. Upon DSMB request, reports could be modified at any time 
during the study. 
Part 1 - Open Session Reports. Open session reports will include administrative reports that 
describe participants (screened, enrolled, completed), fidelity to study procedures, as well as 
baseline characteristics of the study population that is not grouped by treatment. Other general 
information on study status may also be presented. Listings of adverse events and serious 
adverse events, and unanticipated problems will also be presented (also not grouped by 
treatment). See DSMB Report Template. 
Part 2 – Closed Session Reports. Closed session reports will present the same information 
but additionally summarized by treatment group.  The Closed Session Report is considered 
confidential and should be destroyed at the conclusion of the meeting. 
Meeting Minutes 
The minutes will be taken by the DSMB support staff. Minutes will be circulated to all DSMB 
members for approval.  
 
Reports from the DSMB 
The DSMB Chair will prepare the report based on the meeting minutes from the open session 
and any recommendations from the closed and executive session and circulate the report to the 
DSMB members for feedback and revision. After DSMB review and approval of the minutes, the 
DSMB chair will forward the report to the study PIs.  
The report will contain the recommendations for continuation or modification of the study. As 
stated above, each meeting must include a recommendation to continue the study made by a 
formal DSMB majority or unanimous vote. Should the DSMB decide to issue a termination 
recommendation, the full vote of the DSMB is required. In the event of a split vote, majority vote 
will rule, and a minority report should be appended. The DSMB Chair provides the tie-breaking 
vote in the event of a 50-50 split vote. 

 
Version 1.0 February 12, 2024 – Approved by DSMB 
 
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A recommendation to terminate the study may be made by the DSMB at any time by majority 
vote. If this recommendation was made during the DSMB’s Executive session, the Chair should 
notify PCORI immediately by telephone and email.  
The study PIs will ensure that a summary of recommendations based on the report is sent to all 
participating Institutional Review Boards (IRBs) after each DSMB meeting. 
Confidentiality  
All materials, discussions and proceedings of the DSMB are completely confidential. Members 
and other participants in DSMB meetings are expected to maintain confidentiality.  
Conflicts of Interest 
Each member of the DSMB will complete a COI form before attending the first DSMB meeting. 
The DSMB Chair will be responsible for deciding whether any disclosed COIs materially affect 
their objectivity on the DSMB. Members of the DSMB will be responsible for notifying the DSMB 
Chair of any changes in conflicts of interest. Members will be polled at the beginning of each 
DSMB meeting to disclose whether status has changed. Members of the DSMB who develop 
potential or significant perceived conflicts of interest will be asked to resign from the DSMB.