Enhancing the Cardiovascular Safety of Hemodialysis Care: A Cluster-Randomized, Comparative Effectiveness Trial of Multimodal Provider Education and Patient Activation Interventions (Dialysafe)
Phase: NA
Conditions: Kidney Failure, End Stage Renal Disease, Hypotension, Cardiovascular Diseases, Patient Safety
Sponsor: University of Michigan

 
 
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Enhancing the Cardiovascular Safety of Hemodialysis Care: a Cluster-Randomized, 
Comparative Effectiveness Trial of Multimodal Provider Education and Patient Activation 
Interventions (Dialysafe) 
 
Principal Investigator: 
Tiffany Veinot, MLS, PhD  
Associate Dean for Faculty 
Professor of Information and of Health Behavior and Health Education 
University of Michigan 
 
Co-PI 
Rajiv Saran, MBBS, MD, MS 
Associate Director, U-M Epidemiology and Cost Center (UM-KECC) 
Professor of Internal Medicine, Nephrology 
University of Michigan 
 
Supported by: Patient-Centered Outcomes Research Institute (PCORI), research award IHS-
1503-27848 
Study Intervention Provided by: Developed by research team 
Other Identifying Numbers: HUM00125305 
IND/IDE Sponsor: N/A 
 
Protocol Amendments: 
(Any modifications to the protocol should be annotated on the coversheet or in an appendix.  
The annotation should note the exact words that are changed, the location in the protocol the 
date the modification was approved, and the date it became effective.) 
 
STATEMENT OF COMPLIANCE 
The study will be carried out in accordance with Good Clinical Practice (GCP) as required by the 
following: 
 
● United States (US) Code of Federal Regulations (CFR) applicable to clinical studies 
(45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312) 
● PCORI Terms of Award 
● University of Michigan Institutional Review Board (UM IRB-MED) regulations 
 
All key personnel (all individuals responsible for the design and conduct of this study) have 
completed Human Subjects Protection Training. 
 
 
 

 
 
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SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable US federal regulations. 
 
Site Investigator:* 
 
Signed: 
 
Date: 
 
 
Name 
Title 
 
 
 
* The protocol should be signed by the clinical site investigator who is responsible for the day to 
day study implementation at his/her specific clinical site; i.e., if Investigational New Drug (IND) 
study, the individual who signs the Form FDA 1572. 

 
 
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TABLE OF CONTENTS 
Table of Contents 
STATEMENT OF COMPLIANCE .................................................................................... 1 
SIGNATURE PAGE ........................................................................................................ 2 
TABLE OF CONTENTS .................................................................................................. 3 
LIST OF ABBREVIATIONS ............................................................................................. 6 
PROTOCOL SUMMARY ................................................................................................. 7 
1 
Key Roles ........................................................................................................... 10 
2 
Introduction: Background Information and Scientific Rationale .......................... 11 
2.1 
Background Information .............................................................................. 11 
2.2 
Rationale ..................................................................................................... 18 
2.3 
Risks and Benefits ....................................................................................... 22 
3 
Objectives ........................................................................................................... 23 
3.1 
Study Objectives ......................................................................................... 23 
3.2 
Study Outcome Measures ........................................................................... 24 
4 
Study Design ...................................................................................................... 28 
4.1 
Description and Justification of Study Design .............................................. 28 
4.2 
Substudies (if applicable) ............................................................................ 41 
5 
Study Enrollment and Withdrawal ....................................................................... 41 
5.1 
Subject Inclusion Criteria ............................................................................. 41 
5.2 
Subject Exclusion Criteria............................................................................ 41 
5.3 
Strategies for Recruitment and Retention ................................................... 41 
5.4 
Treatment Assignment Procedures ............................................................. 44 
6 
Study Intervention/Investigational Product ......................................................... 46 
6.1 
Study Product Descriptions ......................................................................... 46 
6.2 
Dosage, Preparation and Administration of Study Intervention/Investigational 
Product ................................................................................................................... 48 
6.3 
Modification of Study Intervention/Investigational Product for a Subject ..... 48 
6.4 
Accountability Procedures for the Study Intervention/Investigational 
Product(s) .............................................................................................................. 48 

 
 
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6.5 
Assessment of Subject Compliance with Study Intervention/Investigational 
Product ................................................................................................................... 49 
6.6 
Concomitant Medications/Treatments ......................................................... 50 
7 
Study Schedule .................................................................................................. 50 
7.1 
Screening .................................................................................................... 51 
7.2 
Enrollment/Baseline .................................................................................... 52 
7.3 
Follow-up ..................................................................................................... 55 
7.4 
Final Study Visit ........................................................................................... 55 
7.5 
Early Termination Visit................................................................................. 55 
7.6 
Unscheduled Visit ........................................................................................ 55 
8 
Study Procedures/Evaluations ............................................................................ 55 
8.1 
Clinical Evaluations ..................................................................................... 55 
8.2 
Laboratory Evaluations ................................................................................ 55 
9. 
Assessment of Safety ......................................................................................... 56 
9.1 
Specification of Safety Parameters ............................................................. 56 
9.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters ............................................................................................................ 56 
9.3 
Reporting Procedures ................................................................................. 56 
9.4 
Type and Duration of Follow-up of Subjects after Adverse Events .............. 59 
9.5 
Halting Rules ............................................................................................... 59 
9.6 
Safety Oversight .......................................................................................... 59 
10 
Clinical Monitoring ............................................................................................ 59 
10.1 
Site Monitoring Plan .................................................................................... 59 
11 
Statistical Considerations ................................................................................. 64 
11.1 
Study Hypotheses ....................................................................................... 64 
11.2 
Sample Size Considerations ....................................................................... 64 
11.3 
Planned Interim Analyses (if applicable)...................................................... 69 
11.4 
Final Analysis Plan ...................................................................................... 69 
12 
Source Documents and Access to Source Data/Documents ........................... 77 
13 
Quality Control and Quality Assurance ............................................................ 82 
14 
Ethics/Protection of Human Subjects ............................................................... 82 

 
 
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14.1 
Ethical Standard .......................................................................................... 82 
14.2 
Institutional Review Board ........................................................................... 83 
14.3 
Informed Consent Process .......................................................................... 83 
14.4 
Exclusion of Women, Minorities, and Children (Special Populations) ......... 86 
14.5 
Subject Confidentiality ................................................................................. 86 
14.6 
Study Discontinuation .................................................................................. 90 
14.7 
Future Use of Stored Specimens ................................................................ 90 
15 
Data Handling and Record Keeping ................................................................. 90 
15.1 
Data Management Responsibilities ............................................................. 94 
15.2 
Data Capture Methods ................................................................................ 95 
15.3 
Types of Data .............................................................................................. 95 
15.4 
Timing/Reports ............................................................................................ 95 
15.5 
Study Records Retention............................................................................. 95 
15.6 
Protocol Deviations ..................................................................................... 95 
16 
Publication Policy ............................................................................................. 96 
17 
Literature References ....................................................................................... 97 
SUPPLEMENTS/APPENDICES ................................................................................. 105 
 

 
 
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LIST OF ABBREVIATIONS 
 
CKD: Chronic Kidney Disease characterized by a gradual loss of kidney function over time 
(source: NKF). CKD occurs in 5 stages, with stage 1 being kidney damage with normal kidney 
function and stage 5 meaning kidney failure (or ESRD).  
 
ESRD: End State Renal Disease is CKD stage 5, in which the kidneys no longer work on their 
own. People with ESRD require dialysis or a kidney transplant to survive. All patients in the 
study will be receiving hemodialysis therapy for ESRD. 
 
FMCNA: Fresenius Medical Care of North America (FMCNA) is a large dialysis organization 
with over 2,000 dialysis facilities in the United States. FMCNA is a primary partner in the project 
under a facility services agreement that will be executed shortly. FMCNA is represented on both 
the Advisory Committee and Steering Committee. The intervention will take place in FMCNA 
clinics across the US, and is the source of data as outlined in the enclosed documents. 
http://fmcna.com/ 
 
IDH: Intradialytic Hypotension, or when a person experiences low blood pressure during a 
dialysis session. 
 
IDWG: Interdialytic Weight Gain refers to weight that patients gain between dialysis sessions 
due to fluid accumulation. Because kidney failure leads to the body not being able to remove 
fluid efficiently, most weight gain between sessions is caused by fluid retention. Dialysis 
removes this excess fluid, with a goal of achieving a patient’s ideal “dry weight.” 
 
KECC: The University of Michigan Kidney Epidemiology and Cost Center is located in the 
School of Public Health. It will house all of the data in the study.  Executive UM-KECC faculty 
Rajiv Saran is Co-PI on the project. http://kecc.sph.umich.edu/  
 
 
NKF: The National Kidney Foundation is a partner in the project. Their peer mentoring program 
will be adapted for the patient side of the intervention. NKF is represented in both the Advisory 
Committee and the Steering Committee. https://www.kidney.org/ 
 
 
 
 
 

 
 
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PROTOCOL SUMMARY 
 
Title: 
Enhancing the Cardiovascular Safety of Hemodialysis Care: a 
Cluster-Randomized, Comparative Effectiveness Trial of 
Multimodal Provider Education and Patient Activation 
Interventions 
Précis: 
This project is a pragmatic, cluster-randomized comparative 
effectiveness trial through education of patients and healthcare 
providers, and the use of a checklist to heighten attention to 
patient clinical factors. The study compares a healthcare 
provider-focused to a patient-focused intervention in 20 
hemodialysis facilities that are all part of the same parent 
organization. Facilities will be randomized in a 2x2 factorial 
design, such that 5 sites will receive the patient education 
intervention, 5 sites will receive the facility training and 
checklist intervention, 5 sites will receive both interventions, 
and 5 sites will receive neither intervention. The CRCT will 
compare the effectiveness of the two interventions for 
improving the primary outcome of HD session stability, 
operationalized as intradialytic hypotension (IDH). This 
outcome will be monitored for 12 weeks prior to the 
intervention, for 24 weeks during the intervention period and 
for 12 weeks after the intervention period (Aim 1). The 
interventions will also be assessed in terms of their effects on 
secondary outcomes, including patient symptoms, fluid 
adherence, dialysis adherence, quality of life, hospitalizations 
and mortality (Aim 2). We will also identify factors associated 
with successful implementation of the Dialysafe interventions, 
and ways in which implementation may influence intervention 
effectiveness (Aim 3).  
Objectives: 
 
We will compare two interventions to improve the 
cardiovascular/hemodynamic stability of HD care by pursuing 
the following specific aims: 
 
● Aim 1 Conduct a cluster-randomized controlled trial 
(CRCT) to test and compare the effects of the above HD 
facility-level interventions on the primary outcome of 
dialysis session stability over an intervention period of 24 
weeks and a post-intervention follow-up period of 12 
weeks. 
● Aim 2 Test and compare the effects of the two HD facility-
level interventions on secondary patient-centered clinical 
outcomes, including: patient symptoms, fluid adherence, 
dialysis adherence, quality of life, hospitalizations and 
mortality over the same timeframe. 

 
 
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● Aim 3 Identify factors associated with successful 
implementation of the interventions, and ways in which 
implementation may influence intervention effectiveness. 
Population: 
1,200-1,440 patients, ages 21 and older, receiving in-center 
hemodialysis for chronic kidney disease 
Phase: 
IV 
Number of Sites: 
20 
Study Duration: 
21 months 
Subject Participation 
Duration: 
48 weeks/11 months 
Description of Agent or 
Intervention: 
Patient Intervention: 
● 5 Educational Modules and Peer Mentoring Sessions 
delivered to patients via tablet computer 
Provider Intervention: 
● 2 training sessions delivered to facility staff via online 
learning system 
● 2 training sessions delivered to facility staff via online 
training sessions 
● 1 training session delivered online for physicians, nurse 
practitioners and physician assistants 
● 1 4-item checklist to be completed by facility nurse 
during every dialysis session  
Estimated Time to 
Complete Enrollment: 
17 months 
 

 
 
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*Schematic of Study Design: 
 
Treatment assignments will be as follows: 
 
2 by 2 Factorial Design with Facility and Patient Sample Sizes - # Facilities (# 
Patients) 
 
Patient Activation Intervention 
Total 
Provider Education  
Yes  
No 
 
Yes 
5 (300) 
5 (300) 
10 (600) 
No 
5 (300) 
5 (300) 
10 (600) 
Total 
10 (600) 
10 (600) 
20 (1,200) 
 
The sequence of activities in each study facility is as follows: 
 
 
 

 
 
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1 
KEY ROLES 
 
For questions regarding this protocol, contact Tiffany Veinot at 734-615-8281 or 
tveinot@umich.edu. 
Individuals: 
Principal Investigator:  Tiffany Veinot, MLS, PhD  
Associate Dean for Faculty 
Professor of Information and of Health Behavior and Health 
Education 
University of Michigan 
 
Co-PI 
Rajiv Saran, MBBS, MD, MS 
Associate Director, U-M Epidemiology and Cost Center (UM-
KECC) 
Professor of Internal Medicine, Nephrology 
University of Michigan 
 
Site-PI 
Dinesh Chatoth, MD 
Associate Chief Medical Officer 
Fresenius Medical Care North America  
 
 
Medical Monitor or Behavioral Scientist: N/A 
 
 
Institutions: 
Fresenius Medical Care Holdings, Inc. d/b/a 
Fresenius Medical Care North America 
920 Winter St 
Waltham, MA 
Contact Person: Alicia Zerkle 
678-932-5515 
Fax: 781-810-7896alicia.zerkle@freseniusmedicalcare.com 
Optional: 
Subcontractors: 
 
National Kidney Foundation 
30 E 33rd St #3 
New York, NY 
Contact Person: Jennifer Martin 
212-889-2210 
jenniferm@kidney.org 
 
University of California, Irvine 
Department of Informatics 
6095 Donald Bren Hall 

 
 
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Irvine, CA 
Contact Person: Kai Zheng 
kai.zheng@uci.edu 
 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
2.1 
BACKGROUND INFORMATION 
2.1.1 NAME AND DESCRIPTION OF STUDY INTERVENTIONS: 
 
I. 
Provider Education Intervention 
 
Dialysafe IDH Checklist 
Audience: Nurses, Patient Care Technicians (PCTs) 
File Title: Provider Intervention (section 44 of IRB application) 
A checklist application will be presented on provided tablet computers to nursing staff and PCTs 
at all clinics in the provider intervention arm. The checklist aims to identify patients at increased 
risk of intradialytic hypotension (IDH); it is to be completed by a nurse for each patient’s dialysis 
treatment with verbal or documentation input from the PCT as indicated. The checklist has 4 
items that may be associated with increased IDH risk: two pertaining to the past five treatments, 
and two regarding the date of the current session. The checklist is designed to focus nurse 
attention on clinical criteria related to IDH risk that change frequently. If any at-risk indication is 
selected in the checklist, a list of potential interventions to help prevent IDH will appear on the 
next screen of the checklist application. 
 
See attached Checklist Application Overview.  
 
Dialysafe Staff Training, part 1 of 4 
Audience: Nurses, Patient Care Technicians, Dietitians, and Social Workers 
File Title: Provider Intervention (section 44 of IRB application) 
Staff training will begin by explaining the Dialysafe project goals and study design. Staff will 
refresh their knowledge on consequences of Intradialytic Hypotension (IDH) and the key role of 
fluid accumulation in the development of IDH. They will also identify their clinic’s study group 
into which their clinic was randomized and training requirements related to their assigned study 
group. Finally, the role and responsibilities for each patient care staff member will be clearly 
defined.  
  
Dialysafe Staff Training, part 2 of 4 
Audience: Nurses, Patient Care Technicians, Dietitians, and Social Workers 
File Title: Provider Intervention (section 44 of IRB application) 
During part 2, staff will consider the most vulnerable points in time for cardiovascular instability, 
which includes intradialytic hypotension (IDH). The training will review principles of weight and 
blood pressure measurement per existing FMCNA policy, including orthostatic blood pressure to 
evaluate fluid volume status and risk for IDH. The audience will be introduced to how the nurse 
will use the Dialysafe IDH prevention checklist to systematically evaluate every patient for IDH 
risk early in the session. If patients are found to be at risk for IDH, nurses are encouraged to 
choose from a list displayed on the checklist of possible actions to prevent IDH. If the patient’s 

 
 
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fluid removal goal is decreased as a result, nurses are encouraged to contact the physician if 
indicated by the nurse’s assessment to discuss the possibility of following FMCNA policy to add 
extra time to that session or add an extra session to achieve fluid balance per the physician’s 
order. 
 
Dialysafe Staff Training, part 3 or 4 
Audience: Nurses, Patient Care Technicians, Dietitians, and Social Workers 
File Title: Provider Intervention (section 44 of IRB application) 
Part 3 begins with staff reflecting on their experience with the Dialysafe IDH prevention 
checklist. They will also review actions for increasing cardiovascular stability and assessing 
need for additional actions for patients at higher risk of intradialytic hypotension (IDH). Finally, 
staff will review their role in IDH prevention through important actions like regular review of 
estimated dry weight. They will consider times when they might discuss with the physician if it is 
appropriate to extend treatment time or add an additional day of treatment, and when they 
should consider steps such as additional medication review beyond the usual standard 
medication review or cool dialysate per physician order for higher risk patients to prevent IDH. 
 
Dialysafe Staff Training, part 4 of 4 
Audience: Nurses, Patient Care Technicians, Dietitians, and Social Workers 
File Title: Provider Intervention (section 44 of IRB application) 
Fifteen multiple-choice questions to measure learning of the material covered in parts 1-3. 
 
See attached Staff training modules. 
 
Dialysafe condensed Provider training for physicians, NPs and PAs 
Audience: Physicians, nurse practitioners, and physician assistants 
File Title: Provider Intervention (section 44 of IRB application) 
This training begins by introducing the Dialysafe study goals and design. Advanced practitioners 
will review the purpose of the Dialysafe IDH prevention checklist used by nurses for evaluating 
patients’ risk for Intradialytic Hypotension (IDH). They will review their role in the Dialysafe 
Study by reviewing potential treatment changes that the nurse may discuss with the provider, 
based on systematic patient assessment and IDH risk. 
 
See attached Physician, NP and PA training modules.  
 
II. 
Patient Activation Intervention 
 
Dialysafe Patient Activation Intervention: An Overview 
Audience: Dialysis Patients Enrolled in the Intervention 
File Title: Patient Education Sessions 1-5 (section 44 of IRB application) 
The patient activation intervention occurs over the course of five sessions. These sessions will 
be digitally available on tablets shipped to patients for use at home, and are designed to be 
reviewed by patients at a time that is convenient for them. All content was created through the 
partnership between University of Michigan and National Kidney Foundation. Each session will 
be scheduled to occur roughly one week apart from one another, though patients will have the 
opportunity to complete their sessions on a compressed schedule in as little time as one week, 
pending patient and peer mentor availability.  While each session is focused on a different 
aspect of preventing intradialytic hypotension, they all follow the same format: 
 
Informational Slides 

 
 
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File Title: Patient Education Sessions 1-5 (section 44 of IRB application) 
Content on slides provide patient education as part of the session. These slide decks will be 
transformed into video with voiceover for ease of patient accessibility, including patient visibility 
of the text of the slides and voiceover content.  
Quiz 
File Title: Patient Education Sessions 1-5 (section 44 of IRB application) 
After viewing the informational slides, an optional quiz will allow patients to test their knowledge. 
Correct answers will be displayed after the quiz is submitted, but “passing” the quiz will not be 
required. 
Patient Story Videos 
See section 31 of IRB application. 
Several patients told their stories to Dialysafe study coordinators through webcast. These 
stories were divided into short (less than 5 minute) videos relevant to each session topic. Each 
session contains 1-4 patient story videos, which can be viewed after the main educational 
content is reviewed.  
Goal Setting Module 
File Title: Patient Education Sessions 1-5 (section 44 of IRB application) 
After viewing each session, patients will be directed to a goal setting module. This will ask a set 
of questions to help the patient select a S.M.A.R.T. goal for behavior change (specific, 
measurable, attainable, realistic, and timely) for the IDH prevention-related material they 
viewed. 
Supplementary PDF Resources 
File Title: Patient Education Sessions 1-5 (section 44 of IRB application) 
Additional resources will be available for patients interested in more information related to the 
content they watched in each session. These resources include NKF handouts, tracking forms, 
and suggested apps for supporting dialysis patients in a healthy lifestyle. 
Peer Mentoring Discussion Guide 
File Title: Patient Education Sessions 1-5 (section 44 of IRB application) 
Each session includes this guide to support mentors as they review session content and 
S.M.A.R.T. goals with their mentee during a 20-60 minute video call. Each guide includes 
probing questions to help the mentee think through the material and goal, as well as, 
encouraging statements for the mentor to choose from. To encourage patients, peer mentors 
will also role model positive behavior change where applicable. 
Action Plan 
File Title: Patient Education Sessions 1-5 (section 44 of IRB application) 
After each mentoring session, the mentor will complete this summary of the session and email it 
to the mentee as a reference. This summary includes patient identified goal and values, patient 
stated action plan, identified barriers and steps to overcome barriers, and patient identified 
support system. 
 
Individual sessions focus on five areas related to IDH prevention, as follows: 
 
Patient Education Session 1: Getting Enough Dialysis 
Module 1 covers how dialysis helps patients feel better by removing fluid and preventing fluid 
overload. Target behaviors for this module are attending regularly-prescribed hemodialysis 
sessions and remaining at the treatment for the full prescribed length of the session; also, 
helping the patient to understand benefits of attending lengthened or supplemental hemodialysis 

 
 
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sessions as needed. Session 1 also includes a value-setting module, in which patients will 
select values that will help them set goals for the rest of the intervention.  
 
Patient Education Session 2: Feeling Better with Less Salt/Sodium 
Module 2 covers why people on dialysis need a low-sodium diet. Slides display high sodium 
foods to avoid and low sodium foods to choose, as well as reading a food label. Target 
behaviors for this module are maintaining a diet that is low in sodium so as to reduce thirst and 
fluid retention; reading food labels to assess sodium content; and tracking sodium intake. 
 
Patient Education Session 3: Making Fluid Restrictions Work for You 
Module 3 covers why people on dialysis need to limit fluid intake. Slides offer ways to decrease 
thirst and strategies to keep track of fluid intake. Target behaviors for this module are 
maintaining a level of fluid intake that will optimize interdialytic weight gain; tracking fluid intake; 
becoming aware of usual interdialytic weight gain; discussing symptoms of fluid overload with 
the dialysis team; and discussing the possible need for a longer or extra sessions with the 
dialysis team if experiencing fluid overload symptoms. 
 
Patient Education Session 4: Feeling Better on Dialysis and Having Easier Sessions 
Module 4 covers strategies to prevent low blood pressure and other symptoms of fluid removal. 
Patients learn what to do if symptoms occur, steps to correct low blood pressure, and why it is 
helpful to check blood pressure at home. Target behaviors for this session include recognizing 
their symptoms of IDH, reporting symptoms to staff; tracking blood pressures at home; tracking 
and reporting episodes of IDH to their healthcare team; and notifying staff of changes in weight. 
 
Patient Education Session 5: Getting More Involved in Your Care 
Module 5 covers the patient’s role and responsibilities as a member of the healthcare team. 
Patients also review the roles and responsibilities of the other dialysis team members. Target 
behaviors for this session include actively participating in decisions with providers regarding 
fluid removal targets, ultrafiltration rates, and treatment times. Also, patients should ask 
questions of their dialysis team relevant to session stability, share concerns related to health 
and care, as well as emotional well-being, with the dialysis team, and share with clinicians 
symptoms, ER trips, medication changes, and upcoming procedures. 
 
See attached Patient activation intervention materials, including Patient Story Videos (by peer 
mentoring session; uploaded separately in IRB application per instructions) and content from 
five peer mentoring sessions (Overview, Educational Module Peer Mentoring Discussion Guide, 
Quiz, Goal Setting Module, Supplemental Materials). 
 
See attached Peer Mentor Training Materials: videos and slide sets by session. 
2.1.2 PRIOR STUDIES RELEVANT TO THE TRIAL: 
 
I. 
Checklists and team training for prevention of treatment complications: 
Patient safety interventions are typically “multifactorial and complex,”1 built from several 
interacting components.2 Thus the provider education intervention, which aims to prevent a 
common complication of hemodialysis, will include a checklist, education, team training, and 
procedures for intervention implementation. A recent Agency for Healthcare Research and 
Quality (AHRQ)-sponsored systematic review concluded that checklists are a strongly 
encouraged strategy for the improvement of healthcare quality and safety.3 Furthermore, a 2014 

 
 
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systematic review of use of checklists in surgery showed a 37% relative risk reduction and 
number-needed-to-treat of 27 for surgical complications. Another systematic review specifically 
of implementation of World Health Organization checklists showed a 41% relative risk reduction 
for surgical complications.4 Checklists can prevent errors and improve care quality.5 Checklists 
codify and support organizational routines,6 and are compatible with hemodialysis care because 
they reduce cognitive effort in complex, tiring and stressful work situations.7 Co-PI Saran’s 
experience with an infection control trial in hemodialysis care using checklists, 8, 9 and a recent 
Canadian pilot project underscore the suitability of checklists for hemodialysis care.10 
Successful checklist implementation is facilitated by educational sessions and ongoing 
support.11  
 
As for team training, the aforementioned AHRQ systematic review encourages team training for 
improvement of healthcare quality and safety.3 A systematic review of this approach across 
industries found a moderate effect size (ρ = 0.39) between training and team performance (work 
quality, quantity, accuracy, efficiency and effectiveness).12 A 2014 review of team training in 
healthcare also concluded that there is moderate-to-high quality evidence that team training can 
positively affect team performance and patient outcomes.13  Furthermore, the review concluded 
that the intervention approach planned in our study, team training combined with tools such as 
checklists, had the largest effect sizes in relation to team effectiveness.13 One notable study 
cited in that review found that there was a large (50%) reduction in patient mortality at Veteran’s 
Health Administration facilities that received a surgical team training intervention compared to 
those facilities that did not receive the training.14 
 
II. 
Peer-based interventions for behavior change 
Our intervention uses peer mentoring, which has proven successful in health behavior change 
interventions.15-17 Research by an advisory member of our team, the National Kidney 
Foundation of Michigan, showed the effectiveness of peer mentoring in hemodialysis patients 
for initiating advanced directives and registering for non-kidney organ donation.18-20 Peer 
mentoring also proved successful in populations similar to hemodialysis patients, including older 
adults21 and people with a vulnerable health status,22-24 including cardiovascular disease.25 The 
approach can be effective for health disparity populations such as African Americans and 
Hispanics,26 two groups overrepresented in the hemodialysis patient population.27 While not 
previously applied to patient involvement in dialysis session stability, it can provide the 
education, support and motivational enhancement that has been missing from patient safety 
involvement initiatives.28-30 
 
A systematic review of peer-based interventions showed a pooled small-to-moderate effect size 
on health behavior,22 and a systematic review of telephone-based peer support in particular 
found a pooled significant improvement (Standardized Mean Difference=0.19) in self-
management behavior among patients with vascular diseases.31 Furthermore, a recent 
telephone peer mentoring randomized controlled trial with a similar patient population found a 
moderate effect size on health outcomes. Specifically, average HbA1c levels fell from 9.8% to 
8.7%, while it fell by 0.01% in the control group.23  
2.1.3 CLINICAL AND EPIDEMIOLOGICAL BACKGROUND TO STUDY: 
 
Chronic kidney disease (CKD) was the tenth leading cause of death in the United States (US) in 
2020.1   The most advanced stages of CKD often lead to end-stage renal disease (ESRD), 
when dialysis or transplantation is required to stay alive. In 2019, 492,096 Americans (61.1% of 

 
 
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ESRD patients) received outpatient, facility-based hemodialysis (HD), while 239,413 (29.7%) 
had a kidney transplant and 74,518 (9.2%) were on peritoneal dialysis or home hemodialysis.2  
The ESRD patient population increased by 34.5% since 2009, with 114,432 starting HD in 
2019.2  Transplants may not be an option for many HD patients due to health status and limited 
organ supply.2  The leading causes of ESRD in the US are diabetes and hypertension;2  hence, 
most ESRD patients have multiple chronic conditions, particularly cardiovascular (CV) disease. 
For example, 40% of dialysis patients have had heart failure.4 Sudden cardiac death, the 
leading cause of death in HD patients, accounts for death in up to one-quarter of this 
population.5 The annual mortality rate is 17.5%, with half from cardiovascular (CV) causes.2  HD 
patients also suffer low quality of life,6 and considerable pain, fatigue, social restrictions, and 
distress.7-10 There is significant public expenditure on ESRD care: Medicare funds the majority 
of US ESRD care, spending $51 billion in 2019, or 7.2% of its budget.2   
 
 
Hemodialysis session instability is an important source of cardiovascular harm and patient 
suffering.  
Most hemodialysis patients receive therapy sessions thrice weekly, typically for 12 hours per 
week. The stability of sessions varies, with an average of 20% becoming unstable—most 
commonly from intradialytic hypotension (IDH); this affects half of all hemodialysis 
patients.45-48 IDH may prompt cramping, dizziness, vomiting, fainting, and fatigue.40, 49, 50 
Serious unstable sessions lead to hospitalization or even death on days in which dialysis 
was received 51-53.  The chief cause of unstable hemodialysis sessions is rapid removal of 
large volumes of fluid; this is driven by both patient-level and facility-level factors.48 Indeed, 
there are wide facility-level variations in IDH rates after controlling for patient 
characteristics,48 20% of the variation in IDH is predicted at the patient level.54 
 
Hemodialysis session instability is associated with repetitive and cumulative cardiovascular and 
other organ system injury.55-57 Large volumes of fluid (3 liters or more) may be removed at 
higher than desired ultrafiltration rates during a typical HD session due in part to high 
interdialytic weight gains. In the face of pre-existing diminished cardiovascular reserves, this 
may result in HD instability and repeated myocardial hypoperfusion with resultant wall-
motion abnormalities, an event called “myocardial stunning”.55-57 Emerging evidence shows 
it may be responsible for injury resulting from hypoperfusion in other microcirculatory beds, 
including in the central nervous system (e.g., repetitive neurological injury leading to 
cognitive dysfunction).58  
 
The most common form of hemodialysis session instability, IDH, predicts low quality of life, 
hospitalization and mortality.47, 59 Our team60 and others17, 18 have shown that a care process 
directly linkable to IDH onset, the ultrafiltration rate (i.e. rate of fluid removal) greater than10 
ml/h/kg bodyweight, is linked to elevated mortality risk. Of note, the FMCNA UFR goal is <13 
ml/kg/hr. We have also shown that the thrice-weekly schedule paradigm is associated with 
significantly higher mortality earlier in the week, potentially due to the long interdialytic 
interval over the weekend, which leads to a greater need for fluid removal early in the 
week.61 Negative symptoms may result in session shortening by patients or providers.62 A 
national survey found that 90% of hemodialysis providers had witnessed sessions stopped 
due to patient status in the three months prior.63 

 
 
17 |      Version Draft 7.0  December 2023 
 
2.1.4 IMPORTANCE OF THE STUDY: 
 
While improvements in care procedures and enhanced patient involvement in safety may 
improve hemodialysis session stability, this has not been systematically addressed. 
Hemodialysis session instability is preventable in some cases. Session stability is 
determined by the interplay of multiple factors, many of which are modifiable. At a patient 
level, these include patient decisions regarding sodium and fluid consumption, timing of 
antihypertensive medication and of eating, and skipping or shortening sessions.64 Moreover, 
because early intervention in an IDH episode is important to prevent worsening, patients can 
notify providers of related symptoms, such as nausea, vomiting, dizziness or muscle 
cramping, facilitating prompt provider-based interventions such as placing the patient in 
Trendelenburg position.65 Clinician practice patterns influencing session stability include the 
physician’s decisions regarding the patient’s target post dialysis weight and prescribed 
treatment time, and how often these are revisited. Modifiable within-session decisions made 
primarily by nurses and technicians include assessment of fluid status and setting a patient’s 
ultrafiltration rate (rate of fluid removal).66 Physician decisions such as session length, 
thresholds for ultrafiltration rates and consideration toward adding an extra session per 
week for specific patients are also potentially modifiable factors. 
 
To provide a better foundation for decisions about volume management, a 2014 consensus 
statement from Medical Directors of US hemodialysis facilities called for trials of methods for 
improving patient fluid management67; we address this call in our proposed research.  
 
Preventing treatment complications has been a nationwide priority since publication of a key 
Institute of Medicine (IOM) report more than a decade ago,68 although the majority of 
progress has been in inpatient settings. For example, advances in the field3 include 
successful implementation of strategies to decrease central-line associated bloodstream 
infections, 69-71 use of checklists to improve surgical safety 72 and workflow “bundles” that 
decrease healthcare-associated infections.73 As a reflection of this predominant inpatient 
focus, a 2011 systematic review (SR) concluded that no interventions to prevent treatment 
complications have been credibly shown to improve safety in outpatient settings.74 Our 
proposed study is designed to fill this critical gap in knowledge by testing interventions that 
have been successful in inpatient settings and chronic disease care within an outpatient 
hemodialysis context.  
 
National and international stakeholder organizations have advocated for greater patient 
involvement in the prevention of treatment complications and healthcare provider errors.68, 75-
77 It is argued that patients should be engaged in this since they are present at every 
treatment, can provide important information, and are motivated to reduce risk of harm.78 
However, a 2013 systematic review found knowledge gaps in patient involvement in the 
prevention of treatment complications and errors, and thus prioritized research in this area.78 
No studies to date have examined the potential for patient involvement in dialysis session 
stability.75, 78 Patient involvement is particularly promising in the context of hemodialysis 
because patients already make daily decisions such as how much sodium and fluid to 
consume and whether to shorten or skip hemodialysis sessions. Patients often make 
appropriate and well-informed decisions, but some may make choices without realizing the 
corresponding implications for dialysis session stability. 
 
Our research aims to improve care and outcomes in the outpatient hemodialysis healthcare 
sector. There are over 7,982 outpatient hemodialysis facilities in the US in 2019, the majority 

 
 
18 |      Version Draft 7.0  December 2023 
 
(approximately 89%) of which are freestanding facilities.27 A smaller proportion of outpatient 
hemodialysis care is delivered in hospital-based dialysis units (approximately 7%), with the 
remainder in other settings.  
 
The cardiovascular stability of hemodialysis is vitally important to patients. IDH is linked to 
negative symptoms such as cramping, dizziness, vomiting, fainting, and fatigue,40, 49, 50, 79 
and increased risk of other outcomes important to patients including cardiovascular 
disease,80 hospitalization81 and mortality.82-84 IDH is a top-10 priority outcome (of 33 ranked) 
for dialysis patients.85 Patients express concern about the receipt of insufficient dialysis 
and/or administration of fluids in cases of IDH.79  
 
The enhancement of the cardiovascular/hemodynamic stability of hemodialysis is a critical 
concern for clinicians as they become increasingly aware of the complications of 
hemodialysis session instability,65, 86 and hear vociferous calls for reform in fluid 
management practices in hemodialysis care.87-90 The consensus statement from Medical 
Directors of US dialysis facilities reflects the significant concern among clinicians.67 With a 
lack of clear guidance, approaches to cardiovascular/hemodynamic stability in dialysis care 
are variable. Indeed, there are also wide facility-level variations in IDH rates, demonstrating 
the ability for practice patterns to influence cardiovascular session stability. For instance, 
IDH prevalence varied between 11.1 and 25.8% in a study of 13 US facilities.91 Facility was 
also a significant predictor of IDH with odds ratios between 0.608 and 1.468 after 
adjustment for patient characteristics.  
 
Our evidence-based approach contends that to prevent unstable hemodialysis sessions, fluid 
management must be at the forefront of typical care practices. In line with a growing body of 
evidence, we support gentle adjustment of post-hemodialysis target weights and 
consideration for longer treatment time prescriptions when appropriate, regular assessment 
of patient fluid/volume status, lower ultrafiltration rates (preferably < 10-12ml/kg/hour), and 
early intervention if a patient begins to show signs or symptoms of low blood pressure. We 
do so while continuing to emphasize lower interdialytic weight gain and a low-sodium diet to 
reduce thirst and thus fluid intake.60, 92-96 To facilitate this fluid management-focused 
practice, our intervention translates successful interventions from inpatient and chronic 
disease care settings, respectively, to the outpatient hemodialysis context. 
2.2 
RATIONALE 
2.2.1 JUSTIFICATION OF BEHAVIORAL INTERVENTION METHODS 
 
As Figure 1 shows, we have two facility-level interventions, one focusing on the HD provider 
care team, and one on patients. Both are posited to directly influence the cardiovascular stability 
of hemodialysis. See section 2.1.B for summaries of evidence regarding the effectiveness of 
checklists, team training, and peer mentoring in inpatient settings and chronic disease care.  
 
With regard to specific behavioral intervention methods, Figure 1 illustrates how the 
interventions will address the cardiovascular stability of hemodialysis. Two theoretical 
approaches with strong empirical support in evidence-based interventions have guided 
development of the conceptual model.  
 
 

 
 
19 |      Version Draft 7.0  December 2023 
 
 
 
 
 
 
 
I. 
Patient Activation Intervention 
 
Socio-cognitive theory (SCT), 97-99 is the key framework underlying the patient intervention. SCT 
emphasizes the predictive power of self-efficacy, or confidence in one’s ability to perform an 
action, in the likelihood of performing that action. SCT has informed successful peer-based 
chronic disease interventions.100, 101 Further, peer mentors will use motivational interviewing 
(MI)102 principles that involve encouragement, exploration of feelings and personalized goal 
setting. MI is robust across clinical contexts,103-108 including peer mentoring focused on behavior 
change.19, 20 After influencing motivation and self-efficacy, we posit that the intervention will 
influence patient session instability prevention behavior, which will in turn influence fluid and HD 
adherence, both which predict HD session stability. As Figure 1 shows, we posit a direct 
relationship between patients’ behavioral involvement in session instability prevention activities 
and HD session stability. As Figure 1 shows, for patients, the behavioral outcomes (involvement 
in instability prevention activities) to be encouraged as part of the intervention (as well as post-
intervention) include: 
Figure 1 

 
 
20 |      Version Draft 7.0  December 2023 
 
 
i. 
maintaining a diet that is low in sodium so as to reduce thirst and fluid retention;  
ii. 
maintaining a level of fluid intake that will lead to optimizing interdialytic weight gain, thereby 
resulting in a reduced need for excessive fluid removal during hemodialysis (fluid 
adherence);  
iii. 
attending regularly-prescribed hemodialysis sessions and remaining at the treatment for the 
full prescribed length (dialysis session adherence);  
iv. 
on an as-needed or continual basis, understand the importance of be agreeable to attending 
lengthened or supplemental hemodialysis sessions so as to ensure that treatments can be 
conducted at a lower ultrafiltration rate (<13 ml/kg/hour) (i.e., attention to session 
length/treatment time and ultrafiltration rate); 
v. 
actively participating in decision-making with their physicians and nurses regarding fluid 
removal targets (and achievement of appropriate post-hemodialysis target weight) and 
treatment times, with a goal of maximizing their cardiovascular stability; and  
vi. 
recognizing and reporting their symptoms of dialysis session instability / intradialytic 
hypotension (IDH) (e.g., dizziness, cramping, etc.) as soon as they begin to occur and 
promptly notifying facility staff so that appropriate interventions can be implemented (e.g., 
placing the patient in the Trendelenburg position) early.    
 
The intervention extends the peer mentoring program offered by the National Kidney 
Foundation (NKF), a patient-driven organization on our team. Peer Mentors are trained ESRD 
patients who volunteer to support other patients. Mentors can speak from experience about the 
challenges of life on hemodialysis; thus patients often view mentors as credible and accessible 
information sources.100, 109-111 Mentors can role model health behavior change as they share 
their experiences.110  
 
II. 
Provider Education Intervention 
The provider intervention is informed by the Theory of Planned Behavior (TPB), commonly used 
in practice change interventions for clinicians,112, 113 including patient safety checklist 
adoption.114 The TPB provides a model for predicting behavior based on behavioral 
intentions.115, 116 In the TPB, three belief-based constructs predict intention: (1) attitude toward 
the behavior; (2) subjective norms, i.e., the level of social pressure the person experiences to 
perform it; and (3) perceived behavioral control (PBC), i.e., how easy the person thinks it 
would be to do. In a meta-analysis of healthcare providers behavior studies, there was a 
frequency-weighted mean correlation between TPB constructs and intention of R2 = 0.59, and 
between intentions and behavior of R2 = 0.31.113 The model posits that changes PBC and 
behavioral intentions will change providers’ fluid management practice patterns, which will in 
turn reduce rates of dialysis session instability (Figure 1). The behavioral outcomes (fluid 
management practice patterns) to be encouraged among providers are also depicted on Figure 
1. They include:  
 
vii. 
revisiting patients’ fluid removal targets and treatment time; 
viii. 
involving patients in decisions regarding their fluid removal targets and treatment time; 
ix. 
focusing more on patients who are having difficulties with IDH so as to address these 
problems; and 
x. 
assessing patients’ fluid volume status. 
 

 
 
21 |      Version Draft 7.0  December 2023 
 
Various frontline staff members are engaged with the checklist intervention. While the checklist 
will be completed by the nurse, the checklist is designed as a tool to coordinate the involvement 
of multiple team members (please see attachment for full checklist content). For example, the 
checklist may involve obtaining information from the PCT for a data point which they typically 
gather (“Drop in SBP >=20 mmHg from sitting to standing?”) and will involve obtaining 
information from the patient (“Pt says he or she had symptoms of low BP?”) Furthermore, if 
implemented, the treatment considerations mentioned on the decision support component of the 
checklist also spark engagement with other staff members for their implementation. For 
example, the actions “place patient in modified Trendelenburg position,” and “more frequent BP 
measurement” will typically be implemented by PCTs. The dietitian (and often the nurse) is 
engaged with the following treatment consideration: “Reinforce dietary salt and fluid limits - seek 
dietitian input.” The social worker may also be engaged with the following action: “Stay on full 
prescribed time; do not miss treatments.” Physicians are also engaged with the following 
treatment consideration: “Review medications that affect blood pressure & consult MD as 
needed.”  
2.2.2 SELECTION OF STUDY POPULATION 
 
To accomplish rapid dissemination, and in keeping with the comparative effectiveness 
paradigm, this is a pragmatic trial; thus the effectiveness of the interventions will be assessed 
under the usual conditions in which they will be applied.117 The trial will take place as part of 
routine hemodialysis care, with low-intensity patient follow-up and use of outcome data already 
gathered routinely by facilities.118 Pragmatic intervention studies are most suited to support for 
healthcare-related decision making.117 
 
Facility inclusion criteria include: (1) outpatient HD facilities, (2) at least 70 adult patients (≥>=21 
years of age) who are permanent patients at the study facility (i.e., not from an outside clinic to 
receive isolation at the study facility or a visitor), (3) not involved in other Frenova research, (4) 
facilities with two to five stars in CMS’s Dialysis Facility Compare; (5) not in immediate jeopardy 
in previous two years; (6) not a facility in which the entire facility has been designated for 
isolation of patients with suspected or confirmed COVID-19; and (7) not a Kaiser Permanente 
facility. Dialysis facility staff will not be subjects in the research. These criteria were chosen to: 
protect the sample size (at least 70 adult patients), will not have its attention and resources 
devoted to other matters rather than the study (involvement in other research, one-star facilities, 
immediate jeopardy), and will not have a high proportion of patients suspected of having, or 
diagnosed with, COVID-19. Kaiser Permanente facilities are also excluded due to their 
additional administrative requirements. Randomization was stratified based on region (Midwest, 
Northeast, Southeast, Southwest), and the socio-economic status of the facility’s geographic 
area neighborhood (determined by the poverty rate in the county in which the facility is located; 
these were stratified into low/medium/high poverty levels) to account for potential differences in 
facilities. 
 
We aim to include all non-vulnerable in-center patients at participating dialysis facilities. The trial 
is designed so as not to exclude anyone, including women and minorities to the extent they are 
represented at the dialysis facilities from the ages of 21 and older. We will only exclude 
vulnerable patients: those under 21 years of age; prisoners; those with a cognitive barrier (poor 
cognition or cognitive impairment); those deemed vulnerable by the Clinical Manager, Medical 
Director, and/or Social Worker (see Table 3: Screening for Patient Vulnerable Status), and 
those who are unable to comprehend the patient information sheet due to lack of facility in 

 
 
22 |      Version Draft 7.0  December 2023 
 
English or Spanish. This will counter selection bias by ensuring that participants are 
representative of the full spectrum at a given facility. Selection bias is a risk in a peer mentoring 
intervention for a seriously ill population because patients who are comparatively less sick, and 
more motivated to manage their health actively, may be more likely to participate. The difficulty 
with such selection bias is that the study participants could be part of a subgroup of people who 
may have improved on their own, without the intervention. Therefore, improvements in 
outcomes may be erroneously attributed to the intervention. Our planned approach minimizes 
the likelihood of such mistaken conclusions. With regard to peer mentoring only, we will 
randomly select patients who are not vulnerable or have not opted out of the study in 
succession, until approximately a maximum of 30 patients in a facility finish peer mentoring (with 
partial data on at least 6 patients who start but do not finish). That is, every time a patient 
declines to participate, we will choose another patient randomly until the enrollment target is 
reached. Due to limited availability of peer mentors fluent in languages other than English, only 
English-speaking patients will be offered peer mentoring. 
2.2.3 STUDY HYPOTHESIS 
 
Our main study hypothesis is that hemodialysis session stability will significantly improve with 
either multimodal provider education or patient activation interventions, and that multimodal 
provider education will show a larger improvement. This hypothesis is based on our expectation 
that some hemodialysis patients might refuse or be unable to participate in peer mentoring, 
potentially leading to greater penetration of the provider intervention. We will test this main 
hypothesis and explore this potential explanation of any differential improvement as part of our 
planned sensitivity, mediation and moderation analyses. 
2.3 
RISKS AND BENEFITS 
2.3.1 
Potential Risks 
 
This study has low risk to patients. The study uses current, accepted ways to prevent low blood 
pressure during dialysis. There is a very low risk that any patient’s health data could be seen by 
people other than the research team. Sensitive patient information, such as medical information 
and medical history, will be collected as part of the study. Medical history includes conditions 
such as diabetes, high blood pressure, Hepatitis B or C, history of substance use, and mental 
health. The study is not collecting information about HIV or AIDS. However, there is a small risk 
that a diagnosis of HIV or AIDS will be included in the study data (see next paragraph). The 
study will collect information about COVID-19 diagnoses to examine the condition as a possible 
rival explanation for primary and secondary outcomes, and to account for patient absences from 
their home facility (e.g., in the context of dialysis adherence measures as a secondary 
outcome). All study data will be linked to a patient identifier and the researchers will make no 
attempt to link the information collected as part of the study to a patient’s name or identity. 
Every effort will be made to keep patient information private. There are no known risks to the 
broader public or community. 
 
As noted in the Data Elements List, FMCNA will provide medical diagnoses and the associated 
ICD codes extracted from the EHR. Information on co-morbidities will be extracted from the 
patient diagnosis section of the medical record. HIV/AIDS diagnoses will be excluded on the 

 
 
23 |      Version Draft 7.0  December 2023 
 
basis of ICD9 and ICD10 codes provided by University of Michigan, with the list updated 
annually before October of each year. Although the risk of disclosure of HIV/AIDS diagnoses is 
minimal using this process, inadvertent disclosure may occur if this approach fails to identify all 
potential HIV/AIDS related diagnoses or if conditions associated with HIV/AIDS are included in 
the limited data set. In the event of inadvertent disclosure, such information will have been 
delivered to UM-KECC within a limited data set and will not be linked to any direct patient 
identifiers by the University of Michigan nor will it be included in any analyses. The patient 
information sheet will also include a statement regarding risk of disclosure of HIV/AIDS status. 
Additionally, sensitive diagnoses such as Hepatitis B, substance use, and mental health will be 
included in the limited data sets. The patient diagnoses will include additional diagnoses not 
included in the primary analysis, UM-KECC will restrict the diagnoses to medical co-morbidities 
of interest, including COVID-19. 
 
 
2.3.2 
Known Potential Benefits 
 
If the research is beneficial, describe in detail any physical, psychological, social, legal, 
economic, or any other benefits to subjects that the PI foresees.  
Note: Payment to subjects, whether as an inducement to participate or as compensation for 
pain and inconvenience, is not considered a “benefit.” 
Study results will determine whether a provider education or a patient activation intervention can 
reduce the occurrence of a common complication of hemodialysis, intradialytic hypotension. 
This will inform hemodialysis care providers on whether to pursue these provider-focused or 
patient-focused interventions, both, or neither. People on hemodialysis will also have 
information to help them decide whether to become engaged in dialysis session stability, and 
the intervention will help them learn how to do so. 
 
Peer-based healthcare approaches as trials have shown benefits in health outcomes23, 119-121 
and behavior15-17—including complex health behaviors such as diet change.23, 24 Therefore, 
through an innovative application of peer mentoring, we aim to support the cardiovascular 
stability of hemodialysis by helping patients become more actively engaged in treatment and 
self-care decisions that affect their cardiovascular well-being. We will address patients’ lack of 
information to help them meaningfully participate in cardiovascular stability-related decisions 
such as fluid removal targets, session length and frequency. Our preliminary studies showed 
that some patients already try to influence their treatment targets and speed so as to reduce 
distressing symptoms, and that ESRD patients share strategies for making hemodialysis more 
tolerable.122 
3 
OBJECTIVES 
3.1 
STUDY OBJECTIVES 
We will compare two interventions to improve the cardiovascular/hemodynamic stability of HD 
care by pursuing the following specific aims: 
 

 
 
24 |      Version Draft 7.0  December 2023 
 
● Aim 1 Conduct a cluster-randomized controlled trial (CRCT) to test and compare the effects 
of the above HD facility-level interventions on the primary outcome of dialysis session 
stability over an intervention period of 24 weeks and a post-intervention follow-up period of 
12 weeks. 
● Aim 2 Test and compare the effects of the two HD facility-level interventions on secondary 
patient-centered clinical outcomes, including: patient symptoms, fluid adherence, dialysis 
adherence, quality of life, hospitalizations and mortality over the same timeframe. 
● Aim 3 Identify factors associated with successful implementation of the interventions, and 
ways in which implementation may influence intervention effectiveness. 
3.2 
STUDY OUTCOME MEASURES 
3.2.1 
Primary Outcome Measures 
 
Dialysis session stability (primary outcome, Aim 1).  
We define a dialysis session as unstable based on direct blood pressure measures that are 
routinely gathered during hemodialysis care. Secondary measures of the primary outcome 
include: (1) additional direct blood pressure measures; and (2) hospitalization or death on day in 
which dialysis was received.  
 
Primary measure. The primary indicator of IDH based on direct blood measures after session 
start will be sitting Systolic blood pressure (SBP) falling below 100 mmHg (using lowest SBP 
during session) if starting SBP ≥100. 
 
Secondary measures of primary outcome. Secondary measures of IDH based on direct blood 
pressure measures will include: the lowest (minimum) valid SBP below 100 mmHg during the 
session if starting SBP is ≥100, the number of SBP measurements <100 mmHg (using raw 
blood pressure measures, time of blood pressure measure, and starting SBP) if starting SBP is 
≥100, and whether the sitting SBP falls below 90 mmHg (using lowest SBP during session) if 
starting SBP ≥100. 
 
Hospitalization or death on a day in which dialysis was received will be determined based on 
matching the date of cardiovascular or fluid-related hospitalization or death with the date/time of 
the administered dialysis session, and assessing the hospital discharge diagnosis or primary 
cause of death based on FMCNA records.  
 
Justification of primary outcome. Our primary outcome is hemodialysis session stability, defined 
as intradialytic hypotension (IDH). The primary indicator of IDH based on direct blood measures 
after session start will be sitting Systolic blood pressure (SBP) falling below 100 mmHg (using 
lowest SBP during session) if starting SBP ≥100. A fall of Systolic BP to less than 100mmHg 
signals a clinically important event during dialysis, with a higher probability of (patient-reported) 
symptoms123 which equates to overtly suboptimal patient experience during dialysis. For 
example, in Meredith’s 2015 study an SBP <100 mmHg and/or reduction in SBP of 20% of 
baseline were the thresholds that maximized the probability that a session would result in an 
intervention (which typically occurs in response to symptoms).123 Furthermore, the threshold of 
SBP<100mmHg was also shown to be detrimental both by Flythe et al.82 and Chou et al.84 
Furthermore, intervention at this threshold, even when asymptomatic, has the potential to 
prevent repetitive multi-organ tissue ischemia (e.g., a recent pilot study that studied cerebral 

 
 
25 |      Version Draft 7.0  December 2023 
 
ischemia using noninvasive monitoring during hemodialysis).124 Intervention at this SBP level is 
also likely prevent further decline to dangerously low levels of SBP<90mmHg.81, 82 
3.2.2 
Secondary Outcome Measures 
 
Secondary Outcomes (Aim 2): 
Fluid adherence. Interdialytic weight gain, a fluid intake measure, predicts stability; it is 
routinely recorded by facilities at each session.  
Dialysis adherence. Data regarding dialysis adherence125 are routinely collected by all 
hemodialysis facilities at each session. We will use three measures: number of minutes of 
prescribed dialysis time missed per week, number of missed sessions per week and total 
missed session time. 
Patient symptoms. We will create a Patient Symptom Burden measure combining: symptom 
frequency and severity for each of the following symptoms that are often indicative of IDH, if 
they occur during or after the dialysis session (not pre-dialysis): nausea, vomiting, abdominal 
pain, dizziness, muscle cramps, headache, chest pain, shortness of breath, palpitations, 
diaphoresis, and blurred vision (as listed in the digital Chairside symptom module that is 
completed every session by the nurse.  Symptoms listed on the KDQOL survey (see below) will 
be added to the patient symptom burden measure to supplement the scores obtained from the 
symptom module. We will also calculate the proportion of sessions with each symptom using 
date and time of session. 
 
The nurse does a nursing assessment of the patient at each dialysis session and records 
symptoms (which are by definition reported by the patient) in the Chairside documentation 
system using structured fields and free text fields as needed. The structured fields include 
options for the nurse to record the location, duration, and severity of the symptom (including 
cramping) based on patient complaints. Symptom frequency and severity will be stated by the 
patient and recorded by the nurse during the assessment. 
 
Additionally, after consultation with FMCNA’s patient advisory committee and our patient 
partners, we have created a survey question to assess recovery time that builds on past 
research. 126  
 
The patient recovery time measure is based on a question to be posed by the patient care 
technician or nurse on a weekly basis (not occasionally). This question, which will appear in the 
Chairside documentation system as part of the intake screen, is as follows: 
 
After your last dialysis session, how long did it take you to recover enough to do the 
things you normally do on a non-dialysis day? 
a. 
Within minutes 
b. 
By the time I returned home 
c. 
After a short nap (30 minutes or less) 
d. 
After a long nap (over 30 minutes) 
e. 
By bed time 
f. 
By the next morning 
g. 
Before the next scheduled dialysis session 
h. 
Did not recover before the next scheduled dialysis session 
i. 
Patient unable or declined to answer 
 

 
 
26 |      Version Draft 7.0  December 2023 
 
Furthermore, the Chairside system will require completion of this question once a week before 
the staff member begins the dialysis session. The patient care technicians and nurses will be 
trained prior to study start to record these data.  
 
Responses to this variable will also be used as a secondary outcome for patient symptoms, 
alone and in combination with the patient symptom burden measure described above. This 
question will be asked once per week of every patient in the study.  
 
Quality of life. Quality of life is a patient-reported outcomes, which is “any report of the status of 
a patient's health condition that comes directly from the patient, without interpretation of the 
patient's response by a clinician or anyone else.”127 PRO instruments can be interviewer-
administered, self-administered, computer-administered or interactively administered.127 We will 
use the 36-item Kidney Disease Quality of Life (KDQOLTM-36 Version 1) ,128, 129 which has good 
internal consistency based on alpha scores.129 This instrument is required annually for US 
hemodialysis patients.130 The quality of life survey, the Kidney Disease Quality of Life 
(KDQOLTM-36 Version 1), is intended to be completed on at least an annual basis. KDQOL 
results will be provided twice for each patient from surveys available as follows: 1) The latest 
survey within 12 months prior to the start of the study intervention and 2) the earliest survey 
within 12 months after the start of the intervention. As is current procedure at FMCNA, the 
measure of quality of life is based on a self-administered survey by providing a paper copy to 
the patient to complete during treatment or at home. If a patient needs assistance, the Social 
Worker will assist patients during treatment or via phone in completion of the survey as needed 
or desired.  
 
Hospitalization. These data will be gathered from FMCNA records for all patients. 
Hospitalizations within the study period will be calculated. Secondary analyses of this outcome 
will assess hospitalizations by cause using hospital discharge diagnosis (e.g., fluid-related or 
cardiovascular causes, COVID-19), number of hospitalizations per patient, and length of 
hospitalization. 
 
Mortality. These data will be gathered from FMCNA patient records. 
3.2.3 
Behavioral Outcomes (Behavior Change Measures) 
 
Patient session instability prevention behavior. Once per week, the patient care technician 
or nurse will also record data regarding patient participation in their fluid removal goals for a 
specific session. The question, which has already been incorporated into FMCNA’s Chairside 
documentation system for study purposes, is as follows: 
 
“Did the patient make a request today regarding their fluid removal goal? 
o 
No 
o 
Yes, requested more than the recommended fluid removal goal 
o 
Yes, requested less than the recommended fluid removal goal” 
 
Using these data, we will create a patient-level measure of instability prevention behavior that 
sums the number of requests regarding fluid removal made by each patient, along with 
weighting based on the appropriateness of the request. Appropriateness of the patient request 
will be determined based on the “direction of patient request” combined with assessment of 
clinical factors.  

 
 
27 |      Version Draft 7.0  December 2023 
 
 
Fluid practice patterns measure. We will create a patient-level measure of fluid management 
practice patterns that combines the frequency of the following behaviors: (1) Number of times a 
patient’s post-dialysis target weight was changed, (2) patient average treatment time delivered, 
(3) patient average session ultrafiltration rate, (4) number of changes in number and categories 
of BP medications patient is taking,  (5) use of cool dialysate (based on average dialysate 
temperature for the session), and (6) whether the patient switched to home dialysis (peritoneal 
dialysis or home hemodialysis, using treatment modality change) during study period. These are 
practices that could change as a result of the interventions that may explain intervention effects 
in the primary and secondary outcomes. 
3.2.4 Importance of secondary outcomes, and their role in the analysis and interpretation of 
study results 
 
We will analyze the impact of the interventions on each of the secondary outcomes; thus, the 
effectiveness of the interventions will be assessed in relation to both the primary and the 
secondary outcomes. The study has the following patient-centered secondary outcomes: 
 
Interdialytic weight gain. Interdialytic weight gain, a measure of fluid gains between dialysis 
sessions, which is measured every session. This outcome is important to patients as high fluid 
gains are linked to unpleasant symptoms such as bloating and shortness of breath.131 High fluid 
gains are associated with fluid overload, which is a leading cause of hospitalization in dialysis 
patients.132, 133 High fluid gains are also associated with mortality risk, particularly from 
cardiovascular causes.134, 135 Interdialytic weight gain is a top-20 priority outcome (of 33 ranked) 
for dialysis patients.85 
 
Patient symptoms during the dialysis session based on patient reports of their physical 
experiences and sensations. This is a priority outcome for patients.136 This is further justified 
since HD patients are burdened by negative symptoms. Patients report severe fatigue in 50% of 
HD sessions, and cramping in 30%.40 
 
Patient symptoms after the session in the form of recovery time, which represents both post-
dialysis fatigue and functioning. More than 40% of patients feel that they have not fully 
recovered even after returning home after HD.40 As an indicator of both fatigue/energy and 
dialysis-free time, this is one of the most important outcomes to hemodialysis patients (1st and 
4th of 33 ranked), and more important to patients than healthcare providers.85, 137 
 
Health-related quality of life, a patient-reported outcome which will be measured before and 
after the intervention which has been provided as a key example of a patient-centered outcome 
by PCORI.138 HRQOL is a longer-term measure that reflects symptom patterns and other key 
life dimensions including physical functioning, emotional well-being, pain, and energy levels.139 
The human suffering represented by low HRQOL predicts outcomes that matter to patients, 
including hospitalizations140 and mortality.140, 141 
 
Hospitalizations, which represent a period of heightened symptoms and lost functioning among 
patients; patients describe hospitalizations as extremely distressing, and hospitalizations are a 
top-21 priority outcome for dialysis patients (of 33 ranked).85 
 

 
 
28 |      Version Draft 7.0  December 2023 
 
Mortality, which has been provided as a key example of a patient-centered outcome by 
PCORI.138 
4 
STUDY DESIGN 
4.1 
Description and Justification of Study Design 
I. 
Cluster-Randomized Controlled Trial 
 
The study is a cluster randomized controlled trial. The cluster-randomized controlled trial 
design142 is most appropriate to our goal of improving health care systems—that is, routine 
dialysis care. A cluster-randomized controlled trial design is needed because the interventions 
are, by nature, facility-level strategies. For example, team-based provider education and 
checklist implementation are geared towards all care team members in hemodialysis facilities. 
Similarly, peer mentoring is ultimately meant to be offered to a randomly-selected group of 
patients within a hemodialysis facility. See attached Script for UM Study Coordinator to use 
when calling patients to offer them Peer Mentoring. 
 
Furthermore, a cluster-randomized controlled trial design is most appropriate for optimizing 
pragmatic trial designs, of which our trial is an example.143 Finally, a cluster-randomized 
controlled trial design minimizes the potential problem of contamination.144 We considered 
contamination likely given the nature of the interventions: it would be difficult for trained 
providers who are accustomed to using checklists to change their practice patterns depending 
on the patient to whom they are providing care. Moreover, peer mentoring will be given to 
patients based on their home facility. Because hemodialysis is typically administered in a shared 
location, patients might learn about others’ peer mentoring interactions through conversation, 
which could be seen as a design problem. Accordingly, individual patients not randomized to 
receive peer mentoring could indirectly receive aspects of it through changes in other patients’ 
attitudes and/or behavior. However, this effect could actually become an advantage within a 
cluster-randomized controlled trial, because patients who do not directly receive the intervention 
could nonetheless benefit from it via passive exposure. 
 
II. 
Factorial Design 
 
Our 2X2 factorial design trial is a comparative effectiveness trial that is uniquely positioned to 
answer multiple treatment comparison questions (see below), including “What is the 
comparative effectiveness of patient mentoring versus provider education?”  
 
This design is a superior choice in our circumstance to a simple two-arm trial design (i.e., 
provider education vs. patient activation intervention only) because it provides a control group 
for testing each intervention. An aim of the project is to translate effective interventions from 
other settings into the setting of outpatient hemodialysis care. Therefore, there is an inherent 
need to validate the effectiveness of both interventions in this new environment and patient 
population (see treatment comparison questions i and ii below), while also comparing their 
relative magnitudes of effect (see treatment comparison question iii below) and their potentially 
synergistic or antagonistic effects (see treatment comparison question iv below). If we were to 
conduct a simple two-arm trial (provider education vs. patient activation only), we would only be 
able to answer treatment comparison question iii below. 
 

 
 
29 |      Version Draft 7.0  December 2023 
 
Table 1 - 2 by 2 Factorial Design with Facility and Patient Sample Sizes - # 
Facilities (# Patients) 
 
Patient Activation Intervention 
Total 
Provider Education  
Yes (N2) 
No 
 
Yes (N1) 
A - 5 (300) 
B - 5 (300) 
10 (600) 
No 
C - 5 (300) 
D - 5 (300) 
10 (600) 
Total 
10 (600) 
10 (600) 
20 (1,200) 
 
 
Therefore, we have designed a trial to answer the following four treatment comparison 
questions (see Table 1): 
 
i.Provider education vs. no provider education (assumes no interaction between 
interventions) 
a. 
Cells ((A+B) vs. (C+D)) – F test comparison 
 
ii.Peer mentoring vs. no peer mentoring (assumes no interaction between interventions) 
a. 
Cells ((A+C) vs. (B+D)) – F test comparison 
 
Note that all data are re-used in the comparisons for i and ii.  This shows a key advantage of the 
2x2 design: it allows testing two interventions for the “price of one”.  Furthermore, if an 
interaction is seen (question iv below), then the effect of one intervention can be estimated at 
each level of the other intervention. 
 
iii.Comparative effectiveness of provider education alone vs. peer mentoring alone  
a. 
Cell B vs. C – F test comparison. The head-to-head comparison of the 
magnitude of effect for the two interventions is actually comparing only the 
interventions alone, in the absence of the other ones.  
 
One problem with limiting the focus of this trial to only this comparison (as in a simple two-arm 
trial) is that if the two interventions were found to be equally effective, there would be no way to 
determine whether either represented an improvement over standard care. Without a control 
group, changes in the intervention groups compared to baseline could be attributed to secular 
trends. Because we have a control group in our design, we can rule out (or confirm) secular 
trends; therefore, when paired with tests i and ii above, we are able to determine simultaneously 
that one intervention is both: 1) better (or not) than standard care, and 2) equivalent (or not) to 
the other intervention. 
 
iv.Are there synergistic or antagonistic effects between the provider education and peer 
mentoring interventions? 
a. 
The purpose of this test is to determine whether the effect of one 
intervention differs depending on the presence of the other intervention. The test 
compares: 
● [Cells ((A-C) – (B-D))] – F test comparison to examine the effects of provider 
education intervention with and without the presence of the patient activation 
intervention.  
o 
This is equivalent to ((A-B) – (C-D)), which examines the patient 
activation intervention with or without provider education. 
 
This interaction test will provide power to detect strong synergistic or antagonistic effects.   

 
 
30 |      Version Draft 7.0  December 2023 
 
The use of factorial designs in clinical trials is widely accepted, and is discussed, for example, in 
a well-known book on clinical trials.145 Two particular advantages of factorial designs mentioned 
in this book are the gain in efficiency (the ability to test two treatments using the same number 
of subjects ordinarily used to test a single treatment) and the ability to test for interaction 
between treatments. This statistically efficient approach is valuable for health care interventions, 
where rigorous evaluation is typically expensive.146    
 
One wrinkle in the analysis of factorial designs is that interaction effects must be assumed to be 
null in order to test the main effects, but interaction effects are often of interest and are generally 
tested.  Much has been written about this issue in the statistical literature; in practice, main 
effects are presented in the absence of a (statistically or clinically) significant interaction.  When 
a statistically and clinically significant interaction is present, then the effect of each intervention 
is presented in the presence and absence of the other. Note that no other design can even test 
the presence of an interaction, so the simplicity gained by other analyses is at the cost of 
ignoring the possibility of interaction.    
 
After the 12-week baseline period we plan to track outcomes for 36 weeks (24-week 
intervention period and 12-week post-intervention period). The parallel design with a 24-week 
intervention period, in assessing a post-intervention follow-up period, will generate valuable 
information related to the extent to which the intervention can sustain effects beyond an 
intensive implementation period. This meets the need for longer-term effectiveness studies of 
patient safety checklists,147 This will also help clinics to understand an optimal schedule for 
intervention implementation. 
 
III. 
Trial phase 
 
The study is designed to be a cluster-randomized, pragmatic comparative effectiveness trial. As 
such, the trial will take place as part of routine HD care, with low-intensity patient follow-up and 
use of outcome data already gathered routinely by facilities.118 As such, this trial leverages 
unobtrusive existing electronic health record data to collect data regarding outcomes with the 
addition of two new data collection items to be collected through the electronic health record.148 
 
IV. 
Multi-center trial 
 
The study will take place in 20 outpatient hemodialysis facilities operated by FMCNA. FMCNA 
has provided one site Principal Investigator for the complete study, since all sites are part of the 
same organization. All data from each of these facilities will be provided by FMCNA through its 
central corporate data warehouse, which aggregates data across FMCNA’s digital 
documentation system. FMCNA will submit an IRB Authorization Agreement to cede IRB review 
and oversight to the University of Michigan.  
 
V. 
Study Arms 
 
There are four study arms: (1) patient activation intervention only; (2) provider education 
intervention only; (3) both patient activation and provider education interventions; and (3) no 
intervention. 
 
Table 1 - 2 by 2 Factorial Design with Facility and Approximate Patient Sample 
Sizes - # Facilities (# Patients) 
 
Patient Activation Intervention 
Total 

 
 
31 |      Version Draft 7.0  December 2023 
 
Provider Education  
Yes  
No 
 
Yes 
5 (300) 
5 (300) 
10 (600) 
No 
5 (300) 
5 (300) 
10 (600) 
Total 
10 (600) 
10 (600) 
28 (1,200) 
 
VI. 
Participant Enrollment and Participation 
 
In this protocol, enrollment refers to the period in which patients are given a patient information 
sheet and given the opportunity to opt out of having their data used as part of the study, and 
from being offered peer mentoring. See the attached patient information sheet and patient 
information sheet distribution script. Detailed procedures are provided in the Opt Out Process 
Attachment. The approximate time to complete initial participant enrollment will be one month 
per study facility, followed by a period in which new patients who enter the study facilities will be 
enrolled in the study (i.e., given a patient information sheet and given an opportunity to opt out) 
until 8 weeks prior to the end of the intervention period. Patients who enter the facility 1-7 weeks 
before the intervention period ends will not be enrolled since this would not give patients enough 
time to participate in the patient activation intervention if randomly-selected to do so (assuming 
time for opting out, offering peer mentoring, intake, matching, and scheduling five sessions was 
meant to happen approximately weekly). As shown in Table 2 below, the enrollment period will 
be approximately 4.5 months in all facilities, with two facility groups taking 7.5 months due to 
staggering of enrollment and intervention delivery over the holidays. 
 
 
Table 2 - Patient Enrollment and Participation Summary 
 
Patient Enrollment 
Patient Participation 
Facilit
ies/Im
pleme
ntatio
n 
Group 
Initial 
Enrollm
ent 
Start 
(Estima
ted) 
Initial 
Enrollm
ent 
Ends 
(Estima
ted) 
New 
patients 
enrolled 
until  
(Estima
ted) 
Total 
Enrollm
ent 
Period 
Data 
Collection 
Begins 
(Estimate
d) 
 
Data 
Collecti
on 
Ends 
(Estima
ted) 
Total 
Data 
Collect
ion 
Period 
per 
Facility 
1-4 
(Grou
p 1) 
 
January 
1, 2023 
January 
31, 2023 
May 
2022 
4.5 
months 
October 1, 
2022 
(Retrospec
tive) 
Septem
ber 30, 
2023 
11 
months 
5-8 
(Grou
p 2) 
Februar
y 1, 
2023 
Februar
y 28, 
2023 
June 
2023 
4.5 
months 
November 
1, 2022 
(Retrospec
tive) 
October 
31, 2023 
11 
months 
9-12 
(Grou
p 3) 
October 
1, 2023 
January 
31, 2024 
May 
2024 
7.5 
months 
(stagger
ed over 
holidays
) 
July 1, 
2023 
(Retrospec
tive) 
Septem
ber 30, 
2024 
12  
months 
13-16 
(Grou
p 4) 
October 
1, 2023 
January 
31, 2024 
May 
2024 
7.5 
months 
July 1, 
2023 
Septem
ber 30, 
2024 
12  
months 

 
 
32 |      Version Draft 7.0  December 2023 
 
(stagger
ed over 
holidays
) 
(Retrospec
tive) 
17-20 
(Grou
p 5) 
Februar
y 1, 
2024 
Februar
y 28, 
2024 
June 
2024 
4.5 
months 
November 
1, 2023 
(Retrospec
tive) 
October 
31, 2024 
11 
months 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VII. 
Trial Periods 
 
As Table 2 shows, implementation of the trial study facilities is staggered such that four 
facilities, each randomized to one of the treatment arms, begin the trial simultaneously. Each 
such set of four facilities is referred to as an “implementation group.” There are a total of five 
implementation groups, such that group one begins the trial first, and group five is the last to 
launch. Each facility participates for 11 months, during which patient data is collected for the 
trial. This 11-month period includes: (1) a 12-week baseline data collection period; (2) a 24-
week intervention period; and (3) a 12-week follow-up period. 
 
The “phased introduction/implementation” strategy adopted in this study is an established 
approach to clinical trial design that is warranted in situations in which there are “practical, 
logistical or financial constraints that mean the intervention can only be implemented in 
stages.”149 Accordingly, one of the main drivers that justify the staggered recruitment and 
rollout for our trial is logistical feasibility. In addition, our planned patient involvement 
approaches will benefit from a staggered implementation structure. We do not believe that 
this will pose difficulties in our analyses since our trial design accounts for the temporal 
variability introduced by staggered implementation. 
 
VIII. 
Intervention Description 
 
Patient Activation Intervention 
 
The patient activation intervention occurs over the course of five sessions. These sessions will 
be digitally available on tablets provided to participating dialysis clinics. All content was created 
through the partnership between University of Michigan and National Kidney Foundation. While 
each session, scheduled to occur roughly one week apart from one another, is focused on a 
different aspect of preventing intradialytic hypotension, they all follow the same format: 
 
● Informational Slides 
● Quiz 
● Patient Story Videos 
● Goal Setting Module 
● Supplementary PDF Resources 
● Peer Mentoring Discussion Guide 
● Action Plan 
 

 
 
33 |      Version Draft 7.0  December 2023 
 
The topics of these five sessions are as follows: 
 
● Session 1: Getting Enough Dialysis 
● Session 2: Feeling Better with Less Salt/Sodium 
● Session 3: Making Fluid Restrictions Work for You 
● Session 4: Feeling Better on Dialysis and Having Easier Sessions 
● Session 5: Getting More Involved in Your Care 
 
We now provide more information about the peer mentoring program. 
 
Peer mentoring model. NKFs telephone/videoconference-based peer mentoring model for 
ESRD patients is flexible and compatible with rigorous HD schedules. The mentor’s previous 
role was to provide social support to other patients; this is expanded in the intervention to 
include teaching and motivation with appropriate training and multimedia support. Peer 
mentoring sessions will incorporate behavior change techniques drawn from SCT,150 including 
providing information about CV complications related to HD, teaching skills, encouragement, 
and role modeling (Figure 1). To enhance motivation, mentors will use MI techniques, including 
exploration of feelings and personalized goal setting. Peer Mentor Selection. Peer Mentors 
must: (1) have dialysis experience, and (2) not have an active substance use disorder, disorders 
with psychotic features, or suicidal ideation.151  
 
Peer mentor-mentee matching. Mentees will undergo an intake procedure with NKF staff to 
understand the patient’s characteristics, interests, illness experiences/challenges; these data 
will be used to match compatible mentors with them. 
 
Peer mentor training. The training manual is adapted from NKF’s existing curriculum in 
consultation with peer mentors and the Advisory Committee. There will be multiple training 
cycles over the course of the project. Training will be nine hours long, divided into six 
teleconference based sessions lasting 90 minutes each. Training will include information on (1) 
the role of the peer mentor, (2) CV stability, (3) listening and communication skills, including MI 
techniques, (4) sharing experiences and strategies; (5) confidentiality and boundaries, and (5) 
program protocol/logistics such as using multimedia tools, intervention fidelity and record-
keeping (see Figure 1). Peer mentors will be trained to refer patients with obvious symptoms of 
depression or other mental health issues to NKF staff. Trainers for the peer mentor program 
training will consist of NKF staff and peer mentors; they will receive recorded training on 
motivational interviewing (MI) from Dr. Kenneth Resnicow, a leading expert on MI. To ensure 
mentors have gained needed skills, each mentor will be assessed during role plays. The fidelity 
of training sessions will be tracked with the use of checklists. 
 
Peer mentor supervision/support. Mentors will receive ongoing support via monthly phone calls 
from NKF staff. An e-community will be available to peer mentors, developed with input from the 
focus groups. Within the e-community, peer mentors will have access to a communication tool 
with which to speak with one another, records of their progress, and educational materials. The 
e-community will be developed using Basecamp, a collaboration platform already used by NKF 
volunteers and staff. No patient data will be entered into Basecamp.   
 
Peer mentor motivation and burnout prevention. Current demographics and interest levels in the 
NKF program shed predictive insight into the future engagement of Dialysafe peer mentors. 

 
 
34 |      Version Draft 7.0  December 2023 
 
Reflecting on NKF statistics from June 2018, we are encouraged by the likelihood of high peer 
mentor motivation and low mentor burnout.  
 
Of all of National Kidney Foundation’s currently trained peer mentors, 56% have hemodialysis 
experience. As participation in Dialysafe requires that peer mentors to have this experience, we 
have looked further into this population in order to assess the time generally spent in clinics for 
their own hemodialysis treatment. Importantly, of the peer mentors with hemodialysis 
experience, only 17% are currently undergoing dialysis treatment. The remaining 83% have 
been on hemodialysis previously, but currently have a working kidney transplant or another 
modality that does not require in-center treatment. Thus, less than 10% of all NKF peer mentors 
are currently visiting a dialysis clinic for hemodialysis therapy.  Not only are few peer mentors 
currently undergoing hemodialysis, but the team has also found reassurance in the overall 
engagement and interest in the NKF peer mentoring program. As of June 2018, there were five 
times more applicants to be peer mentors than could be trained and active in the program. This 
means that for every peer mentor in the NKF program, five have applied in hopes of joining the 
program soon. 
 
Answers to application questions also provide insight into the dedication of those who want to 
be peer mentors. A look into application responses provides virtually endless descriptions 
behind applicant motivations. When asked, “why do you want to become a peer mentor?” real 
example answers include “hopes of lessening [other patients’] fears and improving their lives,” “I 
never felt like I had anyone to talk to and I know others must feel the same,” and, “I learned a 
long time ago that a few kind words can go a long way.” A majority of applicants mention that 
they want to share their experience. As one applicant said, “There is so much to be said for 
someone who has been through it all... and I have been through it ALL.” It is apparent that 
potential mentors are highly motivated to help other patients.  
 
As an additional source of motivation, the study has incentives. Patients who join the peer 
mentoring program will receive a blanket after completing their first peer mentoring sessions. 
Patients frequently bring blankets to their dialysis sessions, so this incentive may also generate 
interest in the program among other patients (see “Mentee Blanket Note” for the letter that will 
be enclosed with the blanket). Further, a proportion of the total project budget is allocated to a 
subcontract with the National Kidney Foundation (NKF). This subcontract budget includes 
stipends for peer mentors at a level of compensation deemed fair, $100 per patient with whom a 
mentor completes all five mentoring sessions, or a prorated amount based on the number of 
sessions completed, paid upon completion of the peer mentoring sessions with each patient. 
Peer mentoring satisfaction surveys, $15 per person. (See attached documents: Peer Mentee 
Satisfaction Survey and Peer Mentor Satisfaction Survey). NKF will administer these incentives. 
The study will also provide mentees with a payment of $120 for the completion of the full peer 
mentoring program, with payment on a per-session basis at an escalating rate ($10 for session 
1, $15 for session 2, $20 for session 3, $25 for session 4, and $50 for session 5 and completion 
of the final peer mentoring satisfaction survey). Participants may only receive incentives upon 
completion of each task. These incentives are offered to compensate for the time spent on the 
intervention, in order to show that the patient’s time is valued. 
 
The ratio of peer mentors to mentees will also aid in preventing peer mentor burnout, 
particularly among any mentors currently undergoing in-center hemodialysis therapy. As 
described in the project budget, the National Kidney Foundation will train a minimum of 150 
peer mentors in the Dialysafe program. In each of the 10 clinics where peer mentoring will be 
offered, we estimate that up to 30 patients will receive at least one peer mentoring session and 

 
 
35 |      Version Draft 7.0  December 2023 
 
up to 22 will complete all 5 sessions, totaling 300 mentees over the course of the study. A 
maximum of 30 will finish peer mentoring in each clinic with peer mentoring. This results in a 
ratio of slightly less than three mentees per mentor over the course of the complete study. Note 
that this number is variable and driven by the peer mentor: some may only want to mentor one 
patient, and some may be very involved and want to mentor more than three. In both cases, this 
ratio allows the peer mentor to accept the number of mentees that they wish without pressure of 
taking on more mentees than their schedule allows. In the case that most mentors prefer only 
one mentee, more peer mentors can be trained, as the study has allocated for the training of up 
to 300 peer mentors. 
Family involvement. We have created information sheets for family caregivers that describe 
peer mentoring and detail what caregivers can do to support patients’ 
cardiovascular/hemodynamic stability (e.g., ensuring patients’ access to low-sodium foods). 
Family members will receive the information sheet in one of three ways: 
 
1) Inclusion in a mailing from NKF, if patients indicate they want materials from NKF mailed to 
them 
2) Email from the peer mentoring management system to patient's email 
3) Available for review on the peer mentor management system at any time; patients can email 
forward it from the application to anyone they wish 
 
Management of peer mentoring program. NKF will hire a full-time Project Coordinator, who will 
be responsible for overall management of the peer mentoring program, including working with 
the University of Michigan to develop a system to track and manage the mentors and mentees. 
The system will be similar to that which NKF is already using for its existing Peer mentoring 
program (with some updates for this project), which includes an online platform created for the 
program. The online platform tracks program participants (mentors/mentees), sends alerts 
about actions that need to be taken by the NKF Project Coordinator on an ongoing basis, and 
automates scheduling of calls between mentors and mentees. NKF will also hire a Project 
Assistant to ensure that they have adequate staff support for the training, matching and 
supervision of peer mentors as part of the project. 
 
The NKF Project Coordinator and the NKF Project Assistant will communicate with all 
potential/actual mentors and mentees throughout the course of the project on an ongoing basis, 
utilizing the online platform described above to automate reminders and communications when 
possible. The Project Coordinator will work with the University of Michigan to develop the online 
platform and ensure that it meets the needs of the project. The online community will also be a 
moderated environment in which mentors can access project-related materials and support one 
another and problem-solve together as they mentor patients as part of the project. This online 
community is part of our plan for facilitating ongoing learning and feedback among peer 
mentors. 
 
Emergency procedures (See attachment entitled: Dialysafe Peer Mentor Emergency 
Procedures). In the case that a patient has a medical emergency during a peer mentor session, 
the peer mentor will encourage the patient to call for/get the attention of a clinic nurse. The peer 
mentor will then end the videoconference; that is, the peer mentor will not continue the Dialysafe 
project-related discussion once an incident has occurred. The peer mentor will report any 
incomplete session discussions through the peer mentor view of the Dialysafe peer mentor 
management system (PMMS), which will be visible to the Peer Mentoring Program Coordinator 
at the National Kidney Foundation. Interrupted sessions will be rescheduled, if possible.  
 

 
 
36 |      Version Draft 7.0  December 2023 
 
In the case that a patient indicates that they may be of danger to themselves or others, peer 
mentors are obligated to share this information with the Peer Mentoring Program Coordinator at 
the National Kidney Foundation. Should the program coordinator not be available, there will be 
a backup coordinator who can be contacted. While peer mentors must keep strict confidentiality 
with all mentees, the peer mentor training will explicitly state that this rule does not apply to 
suicidal or homicidal ideation. Mentors who have reason to believe that a mentee is suicidal or 
homicidal will inform the mentee that they are concerned about them and cannot keep what was 
shared confidential. The peer mentor will then contact the Peer Mentoring Program Coordinator 
by email or phone. This will then be followed up by the Peer Mentoring Program Coordinator, 
who will communicate directly with the mentee about whom the concern was expressed. The 
mentee will be assessed for suicidal/homicidal ideations and their intentions/plan, as well as an 
assessment of the patient’s support system in place at the time. The mentee will be referred 
back to their clinic social worker as well. The program coordinator will also be responsible for 
notifying the clinic manager or designated appointee at the dialysis facility, who in turn will notify 
the attending physician responsible for the care of the patient. 
 
Role of patients post intervention. At each study facility, the trial includes a baseline 12-week 
period of data collection, a 24-week intervention phase, and a 12-week post-intervention phase. 
Data collection in each facility will conclude at the end of the post-intervention phase. Therefore, 
there is no explicit ‘non-intervention phase’ after study completion, i.e., we do not envisage 
active patient involvement in study activities after the 24-week trial implementation concludes at 
the participating facilities. However, the University of Michigan or NKF will make efforts to 
recognize and appreciate patients’ involvement in the trial after it is officially over in their facility. 
Specifically, patients who completed the patient activation intervention will be awarded a 
certificate of recognition for their participation. The University of Michigan will also provide 
opportunities for patients to follow the study as it progresses. At the end of the intervention in 
their facility, patient participants will be given access to a study Web site 
(https://dialysafe.si.umich.edu/) that will provide updates about the trial’s progress. 
 
Finally, at the end of data collection in each study facility, facilities will be verbally encouraged, 
using positive messages, by study staff to continue the behaviors that they have learned as part 
of the intervention, if they find them helpful. There is also an important role for patients to play in 
the longer-term dissemination and implementation of study results. First, patient representatives 
on the Steering Committee will be given an opportunity to co-present findings at meetings and 
conferences, and to serve as co-authors on manuscripts. Second, our project includes a 
dissemination partner, the 5-Diamond Patient Safety program. The program is a national 
initiative that includes 12 regional dialysis care quality improvement networks; each of these 
networks involves dialysis patients in liaison and/or advisory roles. Thus if the trial shows 
positive results from the interventions, 5-Diamond will engage its participating networks, which 
involve patients, in dissemination of the intervention to hemodialysis facilities across the 
country. Furthermore, our implementation partner, the National Kidney Foundation, is a national, 
patient-driven organization that is interested in wider implementation of the patient activation 
intervention if study results are positive. 
 
Provider Education Intervention 
 
The provider education intervention has two main components: (1) a checklist that aims to 
identify patients at elevated risk of intradialytic hypotension (IDH); and (2) team training. 
 
Team training.  

 
 
37 |      Version Draft 7.0  December 2023 
 
The team training has several components. Staff in the facility (nurses, patient care technicians, 
dietitians and social workers) will receive: 
 
● 2 training sessions delivered to facility staff via online learning system  
● 2 training sessions delivered to facility staff via videoconference (facility earns 5-
Diamond credit for this training) 
 
Physicians, nurse practitioners and physician assistants, who typically round in multiple 
facilities, will be offered: 
 
● 1 training session delivered online 
 
For the live videoconference training, our intervention will follow the 5-Diamond Patient Safety 
Program format, including slides, speaker notes, tools and resources. The 5-Diamond program 
includes a choice of several modules which facilities who wish to obtain 5-Diamond Status can 
complete, of which our completed training will be one after the trial implementation in the 20 
study facilities is complete. Our training module will follow the 5-Diamond format of slides, which 
includes facility engagement, procedures for implementation of the education and attendance 
sheets. Additionally, self-learning modules delivered through the existing FMCNA LMS 
(Learning Management System) will be used to expand upon the current 5-Diamond format; this 
expansion has already been approved by 5-Diamond. In order to receive 5-Diamond 
certification, facilities must complete 4 training modules, earning a “diamond” for the two  
completed synchronous modules. Facilities that choose to implement our module will earn a 
“diamond” towards their 5-Diamond certification.  
 
In line with the aforementioned evidence, the staff training will be implemented on a team basis 
within the facilities. The training itself will involve a mixture of material for presentation, 
discussion and online modules to complete independently. The training will be implemented by 
the University of Michigan Project Coordinator(s). A “Study Champion,” ideally a Clinic Manager 
or Staff Nurse, will attend a train-the-trainer session with other Study Champions prior to 
intervention start at their sites. At the training sessions, there will be facilitated discussions 
regarding checklist implementation so that the facility staff can evaluate how to make checklist 
implementation fit into their workflows   
 
Checklist. A checklist application will be presented on provided tablet computers to nursing staff 
at all clinics in the provider intervention arm. The checklist aims to be completed by a nurse for 
each patient’s dialysis treatment. The checklist promotes: (1) systematic identification of 
patients who may be at increased risk of having IDH; and (2) considerations for preventive 
interventions to reduce IDH rates in hemodialysis clinics. To accomplish these aims, the 
checklist is designed to enhance: (1) critical thinking regarding factors which place patients at 
risk for IDH; and (2) increased focus on IDH prevention in routine hemodialysis care. The 
checklist has two main parts: (1) four questions to be answered with “yes,” “no,” or “data not 
available;” and (2) A list of potential treatment considerations for interventions, which are 
presented as reminders/prompts if any of the answers to the questions are “yes”. In line with the 
value of team training for patient safety,152 training will be provided to the care team, and to 
individuals through a self-study online curriculum. This holds promise for stimulating both 
collective ownership and for influencing providers’ subjective norms. 
 
The checklist will be made available as an application on an Android tablet computer; the tablet 
computer, with the checklist application preloaded, will be provided to clinics as part of the 

 
 
38 |      Version Draft 7.0  December 2023 
 
study. The tablet computer will be placed in a protective case that can withstand cleaning with 
bleach and facility staff will follow existing policies for disinfection. The checklist will not identify 
the patient or the staff member, but it will automatically log the facility, date, time, items 
displayed, and items clicked on a HIPAA-compliant server. The tablet will not need to be 
connected to the Internet to function; it will synchronize with the remote server when the Internet 
is available. If any screen other than the home screen is idle for more than 2 minutes, the 
system will revert to the home screen, which contains a blank checklist. 
 
IX. 
Randomization and Stratification 
 
To be in the study, facilities have been randomly selected. Randomization was stratified based 
on region, and the socio-economic status of the facility’s geographic area neighborhood 
(determined by the poverty rate in the county in which the facility is located; these were stratified 
into low/medium/high poverty levels) to account for potential differences in facilities. 
 
The 20 HD facilities will be randomized to the four intervention combinations of the 2x2 factorial 
design, assigning 5 facilities to each of the 4 combinations (both provider education and patient 
activation using peer mentoring; provider education alone; patient activation alone; and neither 
intervention). Facilities will be stratified by geographic region and possibly socio-economic 
status to ensure treatment balance on those factors.   
 
X. 
Primary and Secondary Outcomes 
 
 
● Primary Outcome:  
o Dialysis session stability (Intradialytic hypotension) 
● Secondary outcomes: 
o Fluid adherence (Interdialytic Weight Gain) 
o Dialysis adherence 
o Patient symptoms 
o Quality of Life 
o Hospitalization 
o Mortality 
● Behavioral Outcomes 
o Patient Involvement in Dialysis Session Stability 
o Fluid Management Practice Patterns Measure (Providers) 
 
XI. Data Collection Methods 
 
Please refer to the attachment entitled “Data Elements List” for a detailed list. 
 
a) Data for the following outcomes are gathered as part of the standard workflow at 
hemodialysis facilities, and will be electronically transferred from FMCNA to UM’s Kidney 
Epidemiology and Cost Center for analyses: 
● Intradialytic hypotension (primary outcome) 
● Interdialytic weight gain 
● Patient symptoms during the dialysis session based on patient reports of their physical 
experiences and sensations, recorded in the digital Chairside documentation system  
● Health-related quality of life 

 
 
39 |      Version Draft 7.0  December 2023 
 
● Hospitalizations  
● Fluid practice patterns measure components: post-dialysis target weights, treatment time 
delivered, ultrafiltration rate, patient medications, use of cool dialysate  
● Mortality 
● Change in treatment modality for a patient 
The FKC ID1 and FKC ID2 unique patient identifiers will be used to link data clinical patient and 
session data, and data from peer mentoring received from the peer mentoring management 
system (PMMS). 
 
3) Data for the following outcome is not part of the standard workflow at hemodialysis facilities, 
but will gathered electronically (via 2 questions added to the FMCNA Chairside 
application) by staff as part of the routine workflow while facilities are in the study (these 
data will also be electronically transferred): 
● Patient symptoms after the session in the form of recovery time 
● Patient fluid removal goal requests 
 
Dialysis session and patient electronic health record-based data will be transferred by FMCNA 
to the UM-KECC on a scheduled basis using a unique random identifier for each patient that is 
generated by FMCNA (FKC ID1). Peer mentoring records will be generated in a report with the 
University of Michigan School of Information-managed Peer Mentoring Management System; 
this report will be sent to FMCNA using FKC ID2, second a unique patient ID given to each 
patient for the purposes of peer mentoring only. The report will include FKC ID2 along with peer 
mentoring data. FMCNA will then replace each patient’s FKC ID2 with FKC ID1 in the peer 
mentoring dataset, and send it to UM-KECC for analyses (please see attached document 
entitled, Data relinking process). 
UM-KECC has an extensive data security infrastructure to ensure secure data transfer and 
storage. Codebooks will be generated to document the data set and calculated scales.  
 
4) Intervention implementation data will be gathered and shared at the facility level. This 
includes data on training completion, checklist completion, and patient intervention completion. 
Data collected on intervention implementation will be gathered from study tools as follows: 
 
● Checklist Completion Data will be gathered via a tablet computer, and completion data 
will be stored on a database on a secure, HIPAA-compliant server at the University of 
Michigan Medical School (identifiable by a Facility ID) and then transferred to a secure 
research server at the University of Michigan School of Information (UMSI). Data will 
then be used to calculate completion rates by facility using a program such as SPSS or 
Excel. Checklist completion metrics by facility will be transferred to UM-KECC for 
analysis (e.g., checklist completion rate by facility over specific time points; proportion of 
checklist sessions in which patients are identified as being at risk of IDH; and prevalence 
of reasons why patients were identified as being at risk of IDH). See the attached Staff 
Incentive Plan for Checklist and Study Completion for incentives tied to  monthly 
checklist completion and the completion of the entire study. 
● Live videoconference Training Attendance Records by facility and staff role (staff names 
will not be provided) will be emailed from the Clinical Manager to the University of 
Michigan Study Coordinator, via an FMCNA email account and then transferred to an 
Excel or Word document (identifiable by a Facility ID) and stored on a secure research 
server at the University of Michigan School of Information (UMSI). Training completion 
metrics by facility will be transferred to UM-KECC for analyses (e.g., proportion of staff 

 
 
40 |      Version Draft 7.0  December 2023 
 
by role who completed each training session, tracked by facility; average proportion of 
training elements completed; proportion of training sessions in which all training 
elements completed). 
● Learning Management System online Training Records, will be provided by FMCNA to 
UMSI by facility and staff role (staff names will not be provided) by placing these records 
in SharePoint, a secure computing environment to share research data with UMSI). Data 
from SharePoint will be stored on a secure research server hosted by Fresenius Medical 
Care (FMCNA). UMSI staff will be granted limited access to SharePoint by FMCNA and 
will sign an attestation indicating that they understand the security procedures and 
limitations of SharePoint (see section 44, “FMC SharePoint use by External Partners 
Attestation”). Training completion metrics by facility will be transferred to UM-KECC for 
analyses (e.g., proportion of staff by role who completed each training session, tracked 
by facility; average proportion of training elements completed; proportion of training 
sessions in which all training elements completed). 
● Patient Intervention Completion Data – Tablet-based Educational Modules. Data will be 
gathered regarding patient interactions with the digital educational modules. Data will be 
stored on the PMMS stored on secure, HIPAA-compliant server at the University of 
Michigan Medical School. These data will be analyzed at the UM School of Information. 
Metrics include: average number of mentoring sessions completed per patient; patient 
retention rates across all five peer mentoring sessions; average peer mentoring session 
length; education module completion rates by topic and section; quiz completion rates; 
average time spent on each educational module section; average proportion of peer 
mentoring session components completed by session; proportion of peer mentoring 
sessions in which all session components completed; and mentor-specific peer 
mentoring completion rates. In addition to analysis by UM, these data may be used  by 
NKF for training and supporting mentors. 
 
XI. Centralization of Study 
 
All data analyses for Aims 1 and 2 will take place at UM-KECC. Dialysis session and patient 
electronic health record-based data will be transferred by FMCNA on a scheduled basis to UM-
KECC using a unique random FKC ID 1 for each patient. UM-KECC has an extensive data 
security infrastructure to ensure secure data transfer and storage. Codebooks will be generated 
to document the data set and calculated scales.  
 
Data will be transmitted electronically to UM-KECC via secure password-protected file transfer 
protocols. Fidelity data regarding checklists will be retrieved from data entered via tablets, and 
online training data will be securely made available to UM-KECC, and placed in a database at 
UM-KECC. 
 
Aim 3 analyses will take place at the UM School of Information, under the direction of the 
study’s Principal Investigator. 
 
XI. 
Interim Analysis Plans 
 
The study team will produce interim analyses every year of the trial implementation period, or as 
requested by the DSMB. We currently anticipate reporting annually to the DSMB blinded data 
on IDH and mortality rates in each treatment arm. The study has no stopping rules. 
 

 
 
41 |      Version Draft 7.0  December 2023 
 
XII. 
Structure for Safety Oversight 
 
The study will have a Data and Safety Monitoring Board (DSMB). 
4.2 
SUBSTUDIES (IF APPLICABLE) 
 
N/A 
5 
STUDY ENROLLMENT AND WITHDRAWAL 
The sample size for the overall study will be 20 outpatient hemodialysis clinics with 
approximately 1,200-1,440 patients in total. For the peer mentoring intervention, sample size will 
be 30 patients at each of 10 clinics randomized to receive the peer mentoring (n=300).  
 
5.1 
SUBJECT INCLUSION CRITERIA 
We aim to include all non-vulnerable in-center patients at the 20 participating hemodialysis 
facilities. The trial is designed so as not to exclude anyone, including women and minorities to 
the extent they are represented at the dialysis facilities from the ages of 21 and older.  
 
5.2 
SUBJECT EXCLUSION CRITERIA 
We will only exclude those who have opted out of the study and vulnerable patients: those 
under 21 years of age, prisoners, those with poor cognition or cognitive impairment, and those 
deemed vulnerable based on cognitive impairment by the Clinical Manager, Medical Director, 
and/or Social Worker (see Table 3: Screening for Patient Vulnerable Status), and those who are 
unable to comprehend the patient information sheet due to lack of facility in English or Spanish 
(patients whose primary spoken language is not English or Spanish). Due to limited availability 
of peer mentors fluent in languages other than English, only English-speaking patients will be 
offered peer mentoring. 
5.3 
STRATEGIES FOR RECRUITMENT AND RETENTION 
In order to recruit facilities, the FMCNA Project Manager has approached/will approach regional 
management (regional vice presidents, RVPs) at FMCNA to educate them regarding the study 
process. After screening of facilities by FMCNA based on inclusion criteria and random 
selection by UM from the pool of eligible facilities, these RVPs were/will be approached and 
their approval sought, on a voluntary basis. At that time, RVPs have assessed/will assess 
whether facilities were/are adequately staffed to participate in the study and have 
considered/will consider the level of staff effort required in the context of other ongoing FMCNA 
and CMS initiatives. RVPs have management authority over their regional clinics and were/will 
be able to facilitate clinic recruitment. The RVP or the FMCNA Project Manager has 
approached/will approach the medical director of the randomly-selected facilities, and each 
facility’s management body (called Governing Body) will approve study participation. 
 

 
 
42 |      Version Draft 7.0  December 2023 
 
If a facility declines to participate, we will approach the next randomly-selected facility until the 
recruitment goal for the region is reached. Once recruited, facilities will also be randomized into 
study arms. If a facility drops out of the trial, the UM team will select another eligible facility to 
participate in the trial according to the clinic inclusion criteria and recruitment process used for 
the initial clinics. 
 
We plan to include all non-vulnerable patients at participating dialysis facilities who do not opt 
out of the study. The study population of patients enrolled in this trial will be representative of 
the general adult hemodialysis population in the United States with respect to age and health 
status (e.g., typically with multiple comorbid conditions, including diabetes, hypertension, and 
cardiovascular disease). Our target subject sample is approximately 1,200-1,440 patients 
across the 20 facilities will be enrolled in the study (see attached Performance Site Listing).  It is 
anticipated that there will be more than adequate representation by minorities as these are 
typically over represented in the dialysis population and also because of the geographic 
diversity of participating sites (e.g., Michigan, Ohio, California, Alabama, Massachusetts and 
Connecticut). Health care providers will not be study subjects. 
 
As is described in this IRB application, we are seeking Institutional Review Board approval for a 
waiver of consent and waiver of HIPAA authorization based on the study’s minimal risk to 
patients. There will be an opt out process for the Dialysafe Study to meet ethical obligations to 
patients, including respect for patient decision-making and a patient-centered approach to 
research. Thus, each patient will have the opportunity to opt out of having their data used in 
the study, and from being offered peer mentoring if their facility is randomized to the 
intervention and if they are randomly selected to be offered an opportunity to participate 
in the patient activation intervention. The University of Michigan is responsible for the opt out 
process for patients, although it will be implemented by FMCNA staff. Under the direction of, 
and with remote support from, a UM study coordinator, each patient will be given an information 
sheet by FMCNA staff, using a script to be approved by the IRB. The UM study coordinator will 
be available for further explanation of the study and to answer questions, and will monitor and 
check messages at, the toll-free number included in the patient information sheet. Facility staff 
will record that each patient has received the information sheet, and if they have verbalized a 
decision to opt out of the study. The information sheet will also provide a 1-800 telephone 
number to call in order to learn more about the study and opt out of the study if desired (see 
attached Help Line scripts). Any patient opt outs received through the toll-free number while the 
UM coordinator is off-site will be securely transferred to FMCNA. A master list will be maintained 
of all patients informed about the study, and those who have opted out. One week will pass to 
allow patients an opportunity to opt out before starting the study. Thereafter, patients may opt 
out at any time. Enrolled (patients who do not opt out) will have study data shared with UM-
KECC along with the FKC ID1 unique identifier. If patients do not opt out, no further action is 
required from patients to have their data used in the study.  
 
A randomly-selected subset of patients in facilities randomized to the patient activation 
intervention arm will be offered the opportunity to participate in the intervention. A list of patients 
who have not opted out of the study will be provided by FMCNA to UM School of Information 
staff in a secure computing environment, SharePoint. This list will include only the information 
needed to contact patients (first/last name, sex, clinic name/clinic ID, treatment day/shift, 
primary/alternate phone). Patients who are randomly selected will be contacted by a UM Study 
Coordinator on a non-dialysis day by phone to offer them the opportunity to participate using a 
designated script. If the UM Study Coordinator cannot reach the patient after 5 calls, they will 
ask the Study Champion to follow up with the patient to gauge interest. In the event that a 

 
 
43 |      Version Draft 7.0  December 2023 
 
patient is interested in joining the peer mentoring program but does not have regular access to a 
phone to contact UMSI study staff and/or NKF, a pre-paid cell phone will be provided for the 
patient to use. The phone will be shipped to the patient’s home address with a limited number of 
minutes pre-loaded for their use. At the end of the study, the phone may be discarded, or the 
patient may choose to purchase more minutes and retain the phone as a personal device. The 
pre-paid phone is not considered an incentive because it will not be preloaded with enough 
minutes to be used for personal use. The estimated value of the phone without minutes is $25. 
Neither study nor clinic staff will have the ability to track the phone’s use after it has been 
activated by the patient.  
Patients may also be contacted by a “patient advocate,” a current in-center dialysis patient who 
will be identified by their clinic staff as a potential advocate for the peer mentoring program who 
is already enrolled in the peer mentoring program. As in the Operations Committees, clinic staff 
will identify potential advocates. UMSI staff will contact potential patient advocates using the 
contact information they have for the peer mentoring program, and invite them to be a patient 
advocate, emphasizing that the role is voluntary. If an individual agrees to be a patient 
advocate, UMSI study staff will ask clinic staff to provide the patient with the Patient Advocate 
Agreement (See “Patient Advocate Agreement” document) for signature, provide a copy of the 
signed agreement to the patient advocate, and upload the signed document to a secure 
Sharepoint. UMSI study staff will conduct a 15 minute phone call with advocates to describe 
their role and answer any questions or concerns. (See "Patient Advocate Discussions” 
document for advocate training plan.) Patient advocates may discuss their experience in the 
peer mentoring program with other patients in their clinic,  participate in “lobby days” as 
approved and facilitated by their local clinic staff, and direct any interested patients to contact 
the UMSI study staff to learn more about joining the peer mentoring program. Patient advocates 
will not consent any patients for the peer mentoring program (see “Patient Advocate 
Discussions” document for the scope of the patient advocate role; see “Peer Mentor Program 
Flyer” for handout in clinic). Up to three Patient Advocates may be recruited for each shift in the 
clinic. Data for patients who agree to participate in the patient activation intervention will be 
entered into the HIPAA-compliant, web-based peer mentoring management system for intake 
by the National Kidney Foundation. Those who refuse will be recorded on the patient list located 
in the FMCNA SharePoint environment (see attached document, HIPAA Compliance of 
Dialysafe Tools). 
 
Retention of participants in patient activation intervention. While participant retention is 
an issue in virtually any trial, dialysis patients are likely to experience fatigue, pain and other 
symptoms; thus there is a greater than average risk of patients not completing the intervention. 
In the two aforementioned published studies regarding peer mentoring and coaching for 
hemodialysis patients, participant retention rates were 85.7% for the 2-4 month study and 100% 
for the 10-week study, respectively. 18, 153 Another study involving one-to-one peer support to 
people with diabetes had a 75.7% retention rate for a study that was 8-12 months long. 154 
Notably, all of the aforementioned studies were more demanding than ours in terms of numbers 
of sessions with patients (8-30 sessions). Therefore, based on these prior studies, but 
recognizing the uncertainties of the COVID-19 pandemic, we estimate a retention rate of at least 
73% for the peer mentoring intervention. In summary: if 60 patients in a facility are offered peer 
mentoring, we predict that approximately 30 of them will agree to receive peer mentoring; of 
these patients, at least 22 will complete the entire intervention. Under this circumstance, an 
additional 8 will thus complete part of the intervention. 
In order to achieve our estimated retention rate of 65-75% for the complete intervention, 
and in keeping with published research,155 our study team will use a combination of retention 
strategies. The following general evidence-based retention strategies will be used in 

 
 
44 |      Version Draft 7.0  December 2023 
 
combination: patient/community involvement;156 offering participant incentives;156 using a 
participant-tracking database157; using systematic methods for participant contact and 
scheduling of peer mentoring appointments;156 issuing reminders prior to appointments;156; 
interpersonal skill training for project staff;157 monitoring retention;156 and monitoring satisfaction 
with the study158 via the planned peer mentoring survey.  
Furthermore, we will follow best practices for retaining older and seriously ill study 
participants including: demonstrating care for participants by sending birthday or holiday 
cards;158 flexibility in scheduling and dividing up peer mentoring sessions over time158; 
facilitating home-based participation in the study;158 developing a protocol for managing missed 
follow-ups;158 and keeping response burden for patient data collection very low.159 
5.4 
TREATMENT ASSIGNMENT PROCEDURES 
5.4.1 
Randomization Procedures 
 
The 20 hemodialysis facilities will be randomized to the four intervention combinations of the 
2x2 factorial design, assigning 5 facilities to each of the 4 combinations (both provider education 
and patient activation using peer mentoring; provider education alone; patient activation alone; 
and neither intervention). Facilities will be stratified by geographic region and socio-economic 
status to ensure treatment balance on those factors.   
 
With regard to peer mentoring only, we will randomly select patients who are not vulnerable and 
have not opted out of the study in succession, until approximately 30 English-speaking patients 
in a facility accept peer mentoring. Patient randomization will be stratified by treatment shift. 
Every time a patient declines to participate, we will choose another patient randomly until the 
enrollment target is reached. Patients entering a facility randomized to the patient activation 
intervention during weeks 1-18 of the 24-week intervention period will be added to the list of 
patients eligible for peer mentoring from which patients are randomly selected for peer 
mentoring. We anticipate that 15-20% of patients in the study facilities will be replaced by new 
patients during the 11-month study period due to mortality, change in ESRD treatment modality 
(e.g., a kidney transplant), or changing facilities. 
5.4.2 
Blinding Procedures 
 
Study participants and facilities will not be blinded to treatment status. However, during the 
initial analyses, study analysts will be blinded to treatment status in that they will not know which 
facilities are in which intervention group. Each intervention group will be given a non-identifying 
code, and each facility assigned to one of those codes (e.g., group A, group B, group C) while a 
list of facilities by treatment status is kept separate during the analyses. Analyses will then be 
conducted using intervention group codes that do not reveal which intervention in which a 
facility is participating. Supplementary as-treated analyses cannot practicably be completed in a 
blinded fashion due to heterogeneity of measures (e.g., number of peer mentoring sessions 
completed by a patient). 
5.4.3 
Reasons for Withdrawal 
 
Because ours is an educational intervention with support from the dialysis facility’s parent 
organization, we expect facility attrition to be very low. Nevertheless, if facilities do drop out 

 
 
45 |      Version Draft 7.0  December 2023 
 
during the intervention phase, they will be replaced and the intervention will take place at a new 
facility. A facility would need to be replaced if: 1) they request to leave the study; or 2) 75% of 
the staff do not complete at least 90 minutes of the training within the first 14-16 weeks of the 
intervention period. 
 
As for missing outcome data for facilities in the study, data for our primary outcome as well as 
two secondary outcomes (fluid adherence/Interdialytic weight gain and dialysis session 
adherence) are gathered at the dialysis session level, using data that are automatically gathered 
when treatment is delivered.   
 
With IRB waiver of consent and waiver of HIPAA authorization with an opt out process, we 
expect that we will not have significant attrition due to patient withdrawal since interventions will 
be provided at the facility-wide level.  Attrition may be seen in the patient activation (peer 
mentoring) intervention if patients choose not to participate in the peer mentoring program or if 
patients drop-out after starting the program.  
 
A final type of attrition may be the possibility of missing data due to patients not completing the 
self-reported quality of life (KDQOL) survey or the patient symptom question regarding recovery 
time. For example, some participants may refuse to answer certain questions or may miss 
follow-up surveys. Where possible, we will note reasons for missing data by triangulating data 
sources to determine whether a patient has moved to another facility, or in accordance with two 
of our outcomes, been hospitalized or die. Although every effort will be made to collect these 
data, some missing surveys are still likely, particularly among those in ill health. We do not 
expect missing surveys to be associated with study arm, but missingness itself can be analyzed 
for treatment differences as a tertiary outcome measure.  The sample in each cross-section will 
include living patients only, so death will not be a problem as it would be in a longitudinal QOL 
study.  We believe that this approach, along with our conservative assumptions regarding 
sessions needed as described previously, will largely prevent missing data for our primary 
outcome, as well as two secondary ones. Death will be tracked as an outcome, although the 
trial is not powered to assess this as a primary outcome. Data on subjects who leave the study 
site, will be used until their time of departure from the study. In other words, we will not track 
data for patients after they transfer to a non-study facility. 
  
We will compare the characteristics of those with missing data to those without missing data, to 
test whether characteristics are similar between the groups. In addition to complete case 
analyses, we will use state-of-the-art statistical methods such as likelihood approaches and 
multiple imputation to deal with missing data.160 These sensitivity analyses will assess the 
robustness of the results to missing data.  
5.4.4 
Handling of Withdrawals 
 
If facilities do drop out during the intervention phase, they will be replaced and the intervention 
will take place at a new facility. A facility would need to be replaced if: 1) they request to leave 
the study; or 2) 75% of the staff do not complete at least 90 minutes of training within the first 
14-16 weeks of the intervention period.  Data will be retained for facilities that withdraw from the 
study, unless they explicitly request that the data not be used. It is important to note that 
patients who drop out of the patient activation intervention will not be dropped from the overall 
study unless requested, and collection of outcome measures will continue. Data will be retained 
for patients who opt out of the study after the initial opt out period up until the decision to opt 

 
 
46 |      Version Draft 7.0  December 2023 
 
out, unless otherwise requested by the patient. Any attrition (lack of participation in the patient 
activation intervention) could contribute to a reduced estimate of treatment effect in analyses 
using the intent-to-treat principle; this reduction in estimated treatment effect would 
appropriately reflect the expected effect of this intervention in the general dialysis population. 
5.4.5 
Termination of Study  
 
There are no stopping rules for the study. 
 
6 
STUDY INTERVENTION/INVESTIGATIONAL PRODUCT 
6.1 
STUDY PRODUCT DESCRIPTIONS 
6.1.1 
Multimodal Provider Education Intervention 
 
The staff training will be implemented on a team basis within the facilities and will include 
instruction on how to use a tablet-based IDH prevention checklist during the assessment of 
every patient. The online training itself will involve a mixture of material for presentation, 
discussion and online modules to complete independently. The training will be implemented by 
the University of Michigan Project Coordinator(s). A “Study Champion,” ideally a Clinic Manager 
or Staff Nurse, will attend a train-the-trainer session with other Study Champions prior to 
intervention start at their sites. At the training sessions, there will be facilitated discussions 
regarding checklist implementation so that the facility staff can evaluate how to make checklist 
implementation fit into their workflows. The checklist is designed to enhance: (1) critical thinking 
regarding factors which place patients at risk for IDH; and (2) increased focus on IDH prevention 
in routine hemodialysis care. The checklist has two main parts: (1) four questions to be 
answered with “yes,” “no,” or “data not available;” and (2) A list of potential treatment 
considerations for interventions, which are presented as reminders/prompts if any of the 
answers to the questions are “yes”. In line with the value of team training for patient safety,152 
training will be provided to the care team, and to individuals through a self-study online 
curriculum. This holds promise for stimulating both collective ownership and for influencing 
providers’ subjective norms. 
 
The checklist will be made available as an application on an Android tablet computer; the tablet 
computer, with the checklist application preloaded, will be provided to clinics as part of the 
study. The checklist will not identify the patient or the staff member, but it will automatically log 
the facility, date, time, items displayed, and items clicked on a HIPAA-compliant server.  
6.1.2 
Patient Activation Intervention 
 
We will extend the peer mentoring program offered by the National Kidney Foundation (NKF). 
Peer Mentors are trained ESRD patients who volunteer to support other patients. Mentors can 
speak from experience about the challenges of life on hemodialysis; thus patients often view 
mentors as credible and accessible information sources.100, 109-111 Mentors can role model health 
behavior change as they share their experiences.110  
 

 
 
47 |      Version Draft 7.0  December 2023 
 
Peer mentoring model. NKFs telephone-based peer mentoring model for ESRD patients is 
flexible and compatible with rigorous hemodialysis schedules. The mentor’s current role is to 
provide social support to other patients; this will be expanded in the intervention to include 
teaching and motivation with appropriate training and multimedia support. Peer mentoring 
sessions will incorporate behavior change techniques drawn from SCT,150 including providing 
information about cardiovascular complications related to hemodialysis, teaching skills, 
encouragement, and role modeling (Figure 1). To enhance motivation, mentors will use MI 
techniques, including exploration of feelings and personalized goal setting. Peer Mentor 
Selection. Peer Mentors must: (1) have dialysis experience, and (2) not have an active 
substance use disorder, disorders with psychotic features, or suicidal ideation.151  
 
Peer mentor-mentee matching. Mentees will undergo an intake procedure with NKF staff to 
understand the patient’s characteristics, interests, illness experiences/challenges; these data 
will be used to match compatible mentors with them. 
 
Peer mentor training. The training manual has been adapted from NKF’s existing curriculum in 
consultation with peer mentors and the Advisory Committee. There will be multiple training 
cycles over the course of the project. Training will be seven hours long, divided into 10 self-
paced training modules, with one live, virtual training session for role plays and mentor skill 
assessment. Training will include information on (1) the role of the peer mentor, (2) 
cardiovascular stability, (3) listening and communication skills, including MI techniques, (4) 
sharing experiences and strategies; (5) confidentiality and boundaries, and (5) program 
protocol/logistics such as using multimedia tools, intervention fidelity and record-keeping (see 
Figure 1). Peer mentors will be trained to refer patients with obvious symptoms of depression or 
other mental health issues to NKF staff. Trainers for the peer mentor program training will 
consist of NKF staff and peer mentors; they will receive training on motivational interviewing. To 
ensure mentors have gained needed skills, each mentor will be assessed during role plays. The 
fidelity of training sessions will be tracked with the use of checklists. 
 
Peer mentors will receive human subjects training using Harvard Catalyst's Community Partner 
Human Subjects Training, as suggested by UM IRBMED. We have been granted permission to 
modify the training in the following ways: 
 
1) All materials will be delivered through Canvas, the online learning tool used for coursework at 
the University of Michigan 
2) Prior to the first live seminar training, all peer mentors will be enrolled in a "class" using their 
personal email addresses 
3) The educational slide deck will be divided into thematic sections and made into short videos 
with voice over 
4) Each video will be accompanied by the quiz. This quiz will contain the part of Harvard 
Catalyst's suggested assessment that relates its respective training section. Some questions 
may be modified to make them more relevant to the Dialysafe project. The quiz may be re-taken 
in the case of wrong answers.  
5) Study staff will monitor activity on the Canvas page to ensure that each mentor watches each 
video and completes every quiz. Those who complete every section of the video/quiz course will 
receive a certificate of completion.  
6) The first live seminar will include a discussion section regarding the training, including 
examples tailored to study-specific scenarios, edited from the last portion of the catalyst training. 
 
Harvard Catalyst will receive attribution credit on all materials.  

 
 
48 |      Version Draft 7.0  December 2023 
 
 
6.2 
DOSAGE, PREPARATION AND ADMINISTRATION OF STUDY 
INTERVENTION/INVESTIGATIONAL PRODUCT 
6.2.1 
Dosage, Preparation and Administration of Study Intervention/Investigational 
Product – Multimodal Provider Education Intervention 
 
The University of Michigan study coordinator(s) will present online training for each 
hemodialysis clinic randomized to receive the multimodal provider intervention . This will be two 
separate 60-minute online training sessions with all available patient care staff. Any dialysis staff 
members who are unavailable for training will be provided with the slides to review. All dialysis 
staff members will complete a computerized introductory training before the online sessions and 
a computerized quiz to assess learning after the online sessions are complete; these will be 
delivered via the FMCNA or University of Michigan Learning Management System (for facilities 
affiliated with UM). Staff participation is expected to be 75% for the first and fourth parts of 
training, and 75% attendance at the online training in parts 2 and 3. Up to 25% of staff may 
complete independent review of the slides for the third and fourth parts of the training. 
Therefore, 100% of facility staff will ultimately complete parts 2 and 3 of the training. Staff are 
also expected to pass the multiple choice quiz with 80% or greater. Use of the tablet-based 
checklist is intended to be used during the initial assessment for every dialysis session during 
the 24-week intervention period. 
6.2.2 
Dosage, Preparation and Administration of Study Intervention/Investigational 
Product – Patient Activation Intervention 
 
Hemodialysis patients enrolled in the patient activation intervention will complete five 
computerized learning modules followed by a video conference call with their peer mentor to 
discuss content and goal setting. All learning modules and video conference calls will take place 
on a tablet computer in the patient’s home or skilled nursing facility. The schedule for learning 
modules and peer mentor sessions will be created and maintained by the National Kidney 
Foundation.  
 
6.3 
MODIFICATION OF STUDY INTERVENTION/INVESTIGATIONAL PRODUCT FOR A 
SUBJECT 
N/A 
6.4 
ACCOUNTABILITY PROCEDURES FOR THE STUDY INTERVENTION/INVESTIGATIONAL 
PRODUCT(S) 
Tablet computers for both multimodal provider intervention and the patient activation 
intervention will be configured by the study team. Tablet computers for the provider intervention 
will be shipped to each dialysis center; tablet computers for the patient activation will be shipped 
directly to the patient’s home or skilled nursing facility by the study team. Facilities will be able to 
keep the tablet computers and charging stations at the end of the study period.  

 
 
49 |      Version Draft 7.0  December 2023 
 
In the event that a patient is interested in joining the peer mentoring program but does not have 
regular access to a phone to contact UMSI study staff and/or NKF, a pre-paid cell phone will be 
provided for the patient to use. The phone will be shipped to the patient’s home address with a 
limited number of minutes pre-loaded for their use. At the end of the study, the phone may be 
discarded, or the patient may choose to purchase more minutes and retain the phone as a 
personal device. The pre-paid phone is not considered an incentive because it will not be 
preloaded with enough minutes to be used for personal use. The estimated value of the phone 
without minutes is $25. Neither study nor clinic staff will have the ability to track the phone’s use 
after it has been activated by the patient. 
 
In the event that a patient has joined the peer mentoring program but is unable to connect their 
tablet to a secure and reliable internet connection, we will send a mobile hotspot. The mobile 
hotspot will be returned at the completion of the peer mentoring program along with the tablet. 
6.5 
ASSESSMENT OF SUBJECT COMPLIANCE WITH STUDY 
INTERVENTION/INVESTIGATIONAL PRODUCT  
Intervention fidelity tracking methods will include data automatically collected as part of digital 
interventions, as well as checklists manually completed by UM and National Kidney Foundation 
Study Coordinators and peer mentors. These data collection methods include: 
 
● Checklist completion, which includes date/time-stamped records of each checklist 
completion session, logins to identify the facility at which it was completed, and records 
of buttons clicked and screens displayed.  
● Patient Intervention completion, which includes records of completed peer mentoring 
sessions by patient login, with date, time, session length, and the number of people 
present at the session. Additionally, it will record patient views of specific content on the 
tablet-based peer mentoring education, as well as length of time spent viewing each part 
of the content.  
● Peer Mentoring Fidelity. Peer mentors will use a checklist to record their coverage of all 
required content as part of each mentoring session. The checklist will include items such 
as whether the patient understands the benefits of getting enough dialysis, and whether 
the peer mentor has encouraged the patient towards reaching a behavioral goal.  
● Staff Training Fidelity. UM Study Coordinators will use a checklist to record their 
coverage of all required content as part of each online, staff-delivered training session, 
and record attendance by role at the sessions. FMCNA’s learning management system 
(LMS) will also produce reports for each facility regarding the number of staff in each 
role who have completed two LMS training sessions. Similarly, FMCNA staff will provide 
this information to UM Study Coordinators for the online sessions via UM Study 
Coordinators’ FMCNA email accounts. 
● Patient Technology Training Fidelity. Patient who join the peer mentoring program will be 
offered a “tech training call” to ensure that they are comfortable with the study-provided 
tablet. UM study staff will use a checklist (see “Dialysafe_pt_tablet_training_plan”) to 
record items discussed during the training call, including: how to navigate the tablet and 
website, any major issues or questions, the start and stop time of the call, the date of the 
call, and the name of the UMSI staff member providing training. No identifying patient 
information will be recorded. 
● Patient Technology Training Recruitment Records. UM study staff will track the number 
of patients receiving peer mentoring who accept or decline a tech training call. Whether 
training was accepted or refused, the reason for refusal (as applicable), and whether 

 
 
50 |      Version Draft 7.0  December 2023 
 
training was completed and/or rescheduled will be recorded. (See “tech calls” log.) No 
identifying patient information will be recorded. 
● Tracking Technical Support. UM study staff will log questions received from calls to the 
study 1-800 number, and/or emails from clinic staff. The question, whether it was solved, 
and the type of participant making the inquiry (clinic staff/patient/peer mentor) will be 
recorded along with the time, date and name of the UMSI study staff addressing the 
question. (See “tech calls” log.) No identifying patient information will be recorded. 
 
We will use the captured fidelity data to create and track the following metrics: 
 
● Staff Checklist 
o Checklist completion rate by facility over specific time points (number of 
completed checklists / number of patient sessions (for patients included in the 
study) calculated over a given time period (e.g., a month) 
o Proportion of checklist sessions in which patients are identified as being at risk of 
IDH 
o Prevalence of  reasons why patients were identified as being at risk of IDH 
● Staff Training 
o Proportion of staff by role who completed each training session, tracked by 
facility 
o Average proportion of training elements completed 
o Proportion of training sessions in which all training elements completed 
● Patient Intervention 
o Average number of mentoring sessions completed per patient 
o Patient retention rates across all five peer mentoring sessions 
o Average peer mentoring session length 
o Education module completion rates by topic and section  
o Quiz completion rates 
o Average time spent on each educational module section 
o Average proportion of peer mentoring session components completed by session 
o Proportion of peer mentoring sessions in which all session components 
completed 
o Mentor-specific peer mentoring completion rates – for use by NKF in training and 
supporting mentors 
6.6 
CONCOMITANT MEDICATIONS/TREATMENTS 
N/A 
7 
STUDY SCHEDULE 
The active intervention will begin in sets of four clinics at a time, each randomized to one of four 
treatments. See Schedule of Events in Appendix A for staggered roll out dates. The study 
coordinator will contact each clinic manager by phone -7 to -4 months from data collection start. 
The Study Coordinator helpline will be available during the preparation and enrollment periods, 
one month prior to data collection, in order to assist with patient or clinic questions. The study 
coordinator will schedule digital meetings for each provider education clinic in intervention 
weeks 1-3 to conduct the first online training and in weeks 4-6 to conduct the second online 

 
 
51 |      Version Draft 7.0  December 2023 
 
training. Study coordinator(s) will be available by phone for questions or concerns throughout 
the study. See the Schedule of Events for an overview of the study schedule. 
 
The patient activation intervention should take 5-6 weeks on average to complete. We anticipate 
staggered participation of patients in the patient activation intervention due to limits on the 
number of tablet computers and the number of peer mentors.  
7.1 
SCREENING 
To ensure national representation, a list of 60 candidate regions covering the Midwest, 
Northeast, Southeast and Southwest were generated. From these areas, all eligible facilities 
are returned from the FMCNA corporate data warehouse with a query applying the following 
eligibility criteria: (1) outpatient HD facilities, (2) at least 70 adult patients (≥>=21 years of 
age), (3) not involved in other Frenova research, (4) facilities with two to five stars in CMS’s 
Dialysis Facility Compare; (5) not in immediate jeopardy in previous two years, (6) not a 
facility in which the entire facility has been designated for isolation of patients with 
suspected or confirmed COVID-19, and (7) not a Kaiser facility. A list of facilities within 
candidate regions meeting criteria 1-7 will be generated. Facility randomization procedures 
will then performed on this list.  
 
Patients within clinics will be screened for vulnerable status. Patients will be screened in two ways 
per Table 3 below: 1) By the FMCNA Custom Reporting and Data Analytics group team for 
electronically available criteria, and 2) by the local clinic team (Clinical Manager, Medical 
Director, Social Worker) for criteria not electronically available. 
 
Table 3 – Screening for Patient Vulnerable Status 
 
Criteria 
Determined 
Electronically 
Determined by 
Local Clinic Team 
Exclusion Criteria 
Age <21 years old 
√ 
 
Transient Patients 
√ 
 
Acute Renal Failure 
√ 
 
Prisoner 
 
√ 
Cognitive Barrier (poor cognition or cognitive impairment) 
 
 
Patients who were excluded from the most recent KDQOL on basis 
of poor cognition (determined by social worker) 
√ 
 
Per the judgement of the Clinical Manager, Medical Director, and 
Social Worker, with consultation with the Medical Attending as 
needed, regarding: Cognitive impairment. As needed, the Social 
Worker may utilize existing policy for Cognitive Functioning 
Assessment that utilizes the Montreal Cognitive Assessment-Basic 
tool. 
 
√ 
Patient is unable to comprehend the patient information sheet due 
to lack of facility in English or Spanish (patients whose primary 
spoken language is not English or Spanish) 
 
√ 
 

 
 
52 |      Version Draft 7.0  December 2023 
 
Those deemed vulnerable per above will not be included in the study. All other patients will be 
given the opportunity to opt out of the study if desired. 
7.2 
ENROLLMENT/BASELINE 
Details for the opt-out process can be found in the attached Opt out process document. The 
initial patient opt out process is planned to last up to 4 weeks, with patients being given 1 week 
to opt out after receiving the Patient Information Sheet (PIS). All clinics will have the 12-week 
baseline data collected retrospectively. The estimated timeline for the staggered rollout of the 
study for the 20 clinics will begin with the first clinic opt out process in January 2023, and the 
last clinic post intervention data collection period ending in October 2024. We do not anticipate 
monitoring for changes in facility or participant eligibility during the course of the study. 
 
The Patient Information Sheet (PIS) will be distributed to all patients during a hemodialysis 
session by an FMCNA study facility staff member. The Staff member will use wording similar to 
this script when giving the information sheet to the patients. 
 
"This sheet tells you about a study from the University of Michigan that Fresenius 
Medical Care and our Medical Director have approved for our clinic. The goal of the 
study is to help patients feel better by taking steps to prevent low blood pressures during 
dialysis. All patients in the clinic will be in the study. However, after you review the 
details on this sheet you can choose to opt out of the use of your data by letting me 
know or by calling the toll-free number on the last page. You can also get more 
information about the study by calling the toll-free number.” 
 
 
The Dialysafe PIS will inform the patient about the Dialysafe Study data collection, provider 
intervention, follow-up period, and that the patient may be called about optional peer mentoring 
if the clinic is randomized to receive peer mentoring. The PIS will indicate that opting out means 
that the patient’s data will not be shared, the Chairside questions will not be asked of him/her, 
and the patient will not be called to be offered peer mentoring.  However, all patients in the 10 
clinics randomized to the Provider Intervention will still receive the Provider Intervention 
because it is a facility-level intervention that will be applied to all ESRD patients. Refer to Table 
4 for how opting out applies to the four types of study groups. If a patient opts out after data 
collection has started, the patient will be removed from data transfers from the date of opt out 
forward; 5 working days are allowed to process the opt out and discontinue the Chairside study 
questions. 
 
Table 4  - Effect of Opting Out of Dialysafe According to Study Group 
Study Group 
# of Clinics 
Effect of Opting Out1 
Control Group 
5 
● No data collection about that patient 
● No Chairside study questions asked of that patient 
Provider Intervention 
Only (staff education 
and IDH checklist) 
5 
● No data collection about that patient 
● No Chairside study questions asked of that patient 
● Provider Intervention still applies, regardless of opt 
out 
Peer Mentoring Only 
5 
● No data collection about that patient 
● No Chairside study questions asked of that patient 
● Patient will not be called and offered Peer Mentoring 

 
 
53 |      Version Draft 7.0  December 2023 
 
Peer Mentoring + 
Provider Education 
(staff education and 
IDH checklist) 
5 
● No data collection about that patient 
● No Chairside study questions asked of that patient 
● Patient will not be called and offered Peer Mentoring 
● Provider Intervention still applies, regardless of opt 
out 
1If a patient opts out after data collection has started, the patient will be removed from data 
transfers from the date of opt out forward; 5 working days are allowed to process the opt out 
and discontinue the Chairside study questions. 
 
After the initial opt out process, new patients (new to dialysis and new to the clinic) who enter 
the clinic will be offered opt out whose date of entering the clinic is >=8 weeks prior to the end of 
the intervention period. However, to minimize staff time used to distribute the PIS, the PIS 
distribution will occur every 2 months to capture new patients who have been in the clinic for 
>=30 days.  
 
Patient participation in the study will be recorded in the form of an “ancillary order” in the 
patient’s electronic health record at FMCNA (called “eCC”). The Dialysafe Ancillary Order in 
eCC will be entered on all Dialysafe study patients who are eligible and do not opt out. The data 
entered in this Order will be retrieved by the FMCNA Custom Reporting and Data Analytics 
group team to identify study patient start and stop dates for the purpose of study data extraction. 
The Order will trigger two new Chairside questions programmed for the study to appear weekly 
as specified in the Order between the start and stop dates.  The date on which the patient was 
given the patient information sheet will also be recorded in the Ancillary Order. 
 
For recruitment into the Dialysafe Peer Mentoring Program, FMCNA staff will provide a card to 
patients in their clinic advising if they have been randomly selected to be offered peer 
mentoring, and letting them know to expect a call from UM staff to offer them peer mentoring. 
The card encourages them to pick up the phone when UM staff call (see “Peer Mentor 
Reminder Cards”). In the event that clinic staff identifies a patient as interested in learning about 
the peer mentoring program, but without regular access to a personal phone, UMSI study staff 
will mail a pre-paid phone to that patient. The phone may be used to reach UMSI study staff and 
NKF for the purpose of joining the peer mentoring program. UM staff will call patients up to 10 
times to offer them peer mentoring, after which the patient will be listed as “could not be 
reached.” Each patient who cannot be reached or refuses will be replaced by the next randomly-
selected patient (see “Recruitment and Retention Procedure Final”). Patient advocates within 
the clinics may discuss the peer mentoring program with patients who are willing to talk with 
them while waiting for treatment in the lobby or during a clinic-wide “lobby day” (if applicable).    
 
University of Michigan Study Coordinator will use words similar to this script when calling 
patients to offer them peer mentoring. 
 
“I’m calling to talk about a research study being done at your dialysis clinic. You should have 
received an information sheet about this study at your clinic. The study is being done by the 
University of Michigan, working with Fresenius Medical Care and the National Kidney 
Foundation. The goal of this study is to reduce the risk of low blood pressures during your 
treatments. As part of the study, we are now calling patients to offer a peer mentor program. I’d 
like to tell you more about this program- is that okay?” ... (If yes, continue…If no, thank the 
patient and end the call).  
 
The goal of the peer mentoring program is to help patients feel better by coaching them on ways 

 
 
54 |      Version Draft 7.0  December 2023 
 
to prevent low pressure during treatment.  A peer mentor is someone who has been on dialysis 
and is trained and supervised by the National Kidney Foundation. If you choose to be in the 
program, you will be scheduled for five sessions with a peer mentor. The sessions will take 
place over 5-12 weeks. These will be done by using a computer tablet, which is like an iPad, 
that will be shipped to your house.  You will be taught how to use the tablet so that you can 
watch a learning module before each peer mentor session. A learning module is like a set of 
slides with information viewed on the tablet’s screen, and includes videos that shows you 
information while a voice reads the screen. The content of the modules is designed to provide 
you with ways to help you prevent and manage low blood pressures during your treatments. 
Each module will last about 1 hour and after each module, you will be asked to set a goal for 
your health. After the second time you meet with your peer mentor, we will send you a blanket 
from the University of Michigan. Additionally, you will receive an increasing stipend for every 
module that you complete.  You will receive $10 for completing the first module, $15 for 
completing the second, $20 for completing the third, $25 for completing the forth, and $50 for 
completing the fifth module and Peer Mentee Satisfaction Survey.  These incentives total $120 
for the completion of the entire program.  It is possible that some of the topics discussed with 
your peer mentor or in the goal setting part of the educational modules could make you feel 
uncomfortable. It is your choice whether to answer any question or discuss any topic. You can 
skip questions or discussion topics if you wish. You will be connected with your peer mentor for 
a live video-chat to go over what you watched and how you are doing with your goals based on 
what days and times work for you and your matched Peer Mentor. The topics you will discuss 
will include getting enough dialysis, using less salt, fluid limits, feeling better during treatments, 
and getting more involved in your care. All of your learning modules and talking to your peer 
mentor will take place in the comfort of your own home. The program and use of the tablet will 
be provided for you at no cost.  At the end of the program, we do ask that you ship the provided 
tablet back to the University of Michigan.  We will provide the required shipping materials and 
postage by mail so that participating in this program involves no cost to you.  You need to know 
that if you join the peer mentor program, information about you and your peer mentor sessions 
will be entered into a database by the University of Michigan study staff and will be shared with 
your peer mentor and the National Kidney Foundation. This information will include your first 
and last name, gender, clinic name and ID, treatment day and shift, phone numbers, the dates 
when you start and stop the program, and how many sessions you completed. It may also 
include other information you share with your peer mentor such as the goals and personal 
values you identify as part of the program. The peer mentor sessions will not be recorded. After 
the program is over, the data will be sent to the University of Michigan Kidney Epidemiology & 
Cost Center to be analyzed, but only a code number will be used to identify your data. Your 
name and identity will be kept confidential. At the end of the peer mentoring program, you will 
also be asked to complete a survey that will ask your experiences and opinions about the peer 
mentoring program. As previously mentioned, by completing this survey, you will receive the full 
stipend amount of $120 for finishing the entire program.  
 
Joining the peer mentor program is voluntary and you can withdraw at any time. If you withdraw, 
your data will be used for the study only up to the time you withdraw. Do you have any 
questions I can answer? Would you like to sign up for the peer mentor program?” 
 
Once a patient asks to be signed up for peer mentoring, their name and contact information will 
be shared with National Kidney Foundation who will match them with a mentor. They will also 
be offered the option of setting up a phone or web conference call with a UM study coordinator 
to learn how to use the Android tablet. 

 
 
55 |      Version Draft 7.0  December 2023 
 
7.3 
FOLLOW-UP  
If patients miss two peer mentoring sessions in a row and have not responded to other program 
communications, UM staff will contact their clinic in an attempt to reach them to determine if 
they want to continue in the program (see "Recruitment and Retention Procedure Final”). 
 
Study outcomes will be monitored in all facilities for 12 weeks after the 24-week intervention 
period. The same routinely-collected data from FMCNA will be collected during this period. This 
is a pragmatic clinical trial and therefore no special follow-up will occur as a result of the study. 
7.4 
FINAL STUDY VISIT 
N/A 
7.5 
EARLY TERMINATION VISIT 
N/A 
7.6 
UNSCHEDULED VISIT  
N/A 
8 
STUDY PROCEDURES/EVALUATIONS 
8.1 
CLINICAL EVALUATIONS 
Routine dialysis care will continue throughout the study but may be influenced by the provider 
intervention training and IDH checklist, and by the peer mentoring if patients begin to engage 
more in fluid management. Please refer to previous section on interventions regarding the 
provider training, IDH Checklist and peer mentoring. Data from FMCNA are routinely gathered 
as part of this routine care. The only change to the usual clinical evaluation is that two 
aforementioned extra questions will appear in the Chairside documentation system once per 
week during the study period: (1) the question about patients’ post-dialysis recovery time; and 
(2) the question in which the FMCNA staff member records whether the patient made a request 
that day about their fluid removal goal. 
8.2 
LABORATORY EVALUATIONS 
8.2.1 
Clinical Laboratory Evaluations 
 
Routine dialysis care will continue throughout the study. No changes to usual laboratory 
evaluations are expected. 
8.2.2 
Special Assays or Procedures 
 
N/A 

 
 
56 |      Version Draft 7.0  December 2023 
 
8.2.3 
Specimen Preparation, Handling, and Shipping 
8.2.3.1 
Instructions for Specimen Preparation, Handling, and Storage 
N/A 
8.2.3.2 
Specimen Shipment 
N/A 
9. 
ASSESSMENT OF SAFETY 
9.1 
SPECIFICATION OF SAFETY PARAMETERS 
Intradialytic hypotension is the primary study outcome. 
9.2 
METHODS AND TIMING FOR ASSESSING, RECORDING, AND ANALYZING SAFETY 
PARAMETERS 
9.2.1 
Adverse Events 
 
This study has low risk to patients. The study uses current, accepted ways to reduce low blood 
pressure during dialysis. 
9.2.2 
Expected Adverse Reactions 
 
There are no expected adverse reactions to the interventions. 
9.2.3 
Serious Adverse Events 
 
This study has low risk to patients. The study uses current, accepted ways to reduce low blood 
pressure during dialysis. 
9.2.4 
Unanticipated Problems 
 
This study has low risk to patients. The study uses current, accepted ways to reduce low blood 
pressure during dialysis.  
9.2.5 
Procedures to be Followed in the Event of Abnormal Laboratory Test Values or 
Abnormal Clinical Findings 
 
This study has low risk to patients. The study uses current, accepted ways to reduce low blood 
pressure during dialysis. 
9.3 
REPORTING PROCEDURES 
Adverse events (AEs) other than potential breach of confidentiality will not be systematically 
collected since this is an educational intervention that provides content on current, accepted 

 
 
57 |      Version Draft 7.0  December 2023 
 
ways to reduce low blood pressure during dialysis. Thus the risk profile for such approaches is 
well known, and the risk to patients is very low.  
Non-confidentiality-related AEs will also not be systematically tracked since the hemodialysis 
patient is very ill at baseline. Most patients have multiple chronic diseases, including 
cardiovascular disease. Approximately 15-20% of hemodialysis patients die per year and the 
patient population has an average of two hospitalizations per patient year. The primary 
outcome, intradialytic hypotension (IDH), occurs in 20% of hemodialysis sessions in the United 
States. More than 50% of patients experience symptoms during or shortly after hemodialysis. 
These data (mortality, hospitalizations, IDH, and symptoms) are tracked as outcomes in our 
study; these events occur routinely in the hemodialysis population and thus these events would 
be expected without our study, thus making “relatedness” of these events to the study 
exceedingly difficult to determine. These outcomes will be collected between two months and 
two years from the occurrence based on the data source available. 
● The only expected risk for this study is of breach of confidentiality. The likelihood 
of this risk is very low and unexpected because of the confidentiality measures 
outlined in section 14.5 II. However, in the unlikely event that there were an 
adverse event related to breach of confidentiality, this would be reported to the 
IRB using the following generalized rating scale:0 - No adverse event 
● 1 - Mild AE – No treatment needed 
● 2 - Moderate AE – Resolved with treatment 
● 3 - Severe AE – Inability to carry on normal activities, required professional medical 
attention 
● 4 - Life-threatening or disabling AE 
● 5 - Fatal AE 
While breach of confidentiality is extremely unlikely and if it were occur it would be unlikely to be 
severe, if needed, we would nonetheless report any serious AEs according to the following 
typology: 
● Death 
● A life-threatening adverse drug experience 
● Inpatient hospitalization or prolongation of existing hospitalization 
● A persistent or significant disability/incapacity 
● A congenital anomaly/birth defect 
● Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered a serious adverse drug experience when, based upon 
appropriate medical judgment, they may jeopardize the patient or subject and may 
require medical or surgical intervention to prevent one of the outcomes listed in this 
definition. Examples of such medical events include allergic bronchospasm requiring 

 
 
58 |      Version Draft 7.0  December 2023 
 
intensive treatment in an emergency room or at home, blood dyscrasias or convulsions 
that do not result in inpatient hospitalization, or the development of drug dependency or 
drug abuse. 
Potential confidentiality breaches will be tracked as follows by UMSI and UM-KECC: 
● A log of data transfers, which will record the transfer’s date, time, sender, receiver, data 
contents, transmission vehicle, a yes/no checkbox identifying whether or not there was a 
potential confidentiality breach in that transfer, and a free-text box in which to describe 
the issue. Another free-text box will capture any remedies taken to address the issue 
(e.g., notifications, data deletion). 
● A log of security events, in which any attempted or successful security breaches, their 
dates/times, involved parties, data accesses, and remedies taken will be recorded. This 
will include any the details of any hacking attempts or inadvertent disclosures not 
involving data transfers, which would be captured as per above. 
Finally, the PI or a co-investigator will assess the relatedness of any breach of confidentiality to 
the study according to the following typology: 
● Definitely related 
● Probably related 
● Possibly related 
● Unlikely to be related 
● Definitely not related. 
We will also assess the expectedness of the event, although any breach of confidentiality would 
be inherently unexpected. 
9.3.1 
Serious Adverse Events 
 
N/A 
9.3.2 
Regulatory Reporting for Studies Conducted Under IND 
 
N/A 
9.3.3 
Regulatory Reporting for Studies Not Conducted Under IND 
 
N/A 
9.3.4 
Other Adverse Events (if applicable) 
 

 
 
59 |      Version Draft 7.0  December 2023 
 
N/A 
9.3.5 
Other Unanticipated Problems 
 
N/A 
9.3.6 
Reporting of Pregnancy 
 
N/A 
9.4 
TYPE AND DURATION OF FOLLOW-UP OF SUBJECTS AFTER ADVERSE EVENTS 
N/A 
9.5 
HALTING RULES 
N/A 
9.6 
SAFETY OVERSIGHT 
An external data safety monitoring board (DSMB) consisting of 5 members (outside of the 
University of Michigan) has been identified. The DSMB  includes a biostatistician unrelated to 
the trial, a patient, a nephrologist, and a layperson unrelated to the field (e.g., bioethicist). 
The DSMB met in 2021 for orientation to the protocol, and to advise on desired data for 
reporting. The DSMB will then meet annually during the trial implementation  and analysis 
periods, or more frequently as requested by DSMB members.  
The study team will produce interim analyses every year of the trial implementation period, or as 
requested by the DSMB. We currently anticipate reporting annually to the DSMB blinded data 
on IDH and mortality rates in each treatment arm. The study has no stopping rules. 
10 
CLINICAL MONITORING 
10.1 
SITE MONITORING PLAN 
 
I. Study Governance 
 
FMCNA and NKF will participate in the study in accordance with executed subcontracts. Prior to 
participation in the study, each facility’s Governing Body will review study materials and approve 
participation.  
 
II. Study Champion 
 

 
 
60 |      Version Draft 7.0  December 2023 
 
The Medical Director and Clinical Manager at each site with an intervention (n=15; the 5 clinics 
doing data collection only will not have a Study Champion) will then identify a “Study 
Champion,” who will ideally be a Clinic Manager or Staff Nurse. Each Study Champion will 
attend a train-the-trainer session with other Study Champions prior to intervention start at their 
sites. The Study Champion will speak with a University of Michigan Project Manager at least 
monthly during the trial in study facilities. The Study Champion’s role will involve: 
 
● Participating in quarterly Operations Committee meetings (to take place during the 
baseline and intervention periods) 
● Serving as a liaison to provide staff feedback to the University of Michigan Project 
Coordinator(s).  
o Examples: Post a study comments notebook in the break room, accept verbal 
comments from staff, and convey comments during Operations Committee calls. 
● Co-leading with Clinical Manager, discussion about checklist implementation at two staff 
meetings 
● Updating the Research Binder with current patient lists and any other updated 
documents throughout the study 
● Conveying positive messaging about the study 
III. Operations Committee 
 
An Operations Committees will be formed in each study facility with an intervention (no 
Operations Committee will be formed for clinics randomized to data collection only); this 
Committee will include staff members in authority positions such as the local Clinical Manager 
and Directors of Operations. The Clinical Manager is accountable for the operation of the 
facility, has authority over the staff in his or her assigned clinic, and has physical presence in the 
clinic on a regular basis. The Director of Operations is accountable for a group of clinics in the 
geographic area, and has authority over the Clinical Manager. The Operations Committee will 
meet three times over the course of the study, and include the Study Champion as per above, 
and others selected to represent different organizational levels and perspectives. Patient 
representatives (n=1-2) will also participate in the Operations Committee and will be selected 
based on the following criteria:  
 
1) Not excluded from the study on the basis of vulnerable status or opting out 
2) Access to email for receipt of meeting materials 
3) Sufficient English ability to participate in meetings (English as primary language) 
4) Sufficient hearing ability to participate in meetings by phone (per patient’s judgement) 
5) Nomination by Clinic Manager, or self-nomination.  
 
The Operations Committee will oversee intervention implementation in each of the study 
facilities. At the meetings, the UM Study Coordinator will provide feedback to the facility 
regarding intervention fidelity (e.g., checklist completion rates, staff training completion rates, 
patient retention rates across all five peer mentoring sessions). Feedback will be sought from 
facility staff regarding the intervention, and its impact upon facility operations. The Committee 
will also engage in collective problem-solving as needed as led by the UM study coordinator, 
who will schedule, plan, organize and lead Operations Committee meetings. 
 
IV. Role of Medical Director at Study Facilities 
 

 
 
61 |      Version Draft 7.0  December 2023 
 
In addition, the Medical Director at each site will communicate initial study information to 
medical colleagues (attending nephrologists and other providers) in the facility, and then 
communicate as needed to these colleagues throughout the study. In order to increase the 
appeal of participation, UM has also incorporated a total of $500 divided into two payments 
($250 each payment) for each of the Medical Directors of study facilities in the project budget for 
carrying out their responsibilities related to the study as described below. UM will be responsible 
for managing the payment process. Each payment will be triggered by completion of the 
Practice Patterns Survey associated with that payment (see attached Practice Patterns Survey - 
Medical Directors and Practice Patterns Survey - Nurse Managers). 
 
Payment #1 of $250 shall be compensation for the following activities: 
● Participate in the process of Governing Body approval for the study. 
● Communication of initial study information to medical colleagues (attending 
nephrologists and other providers) in the clinic. 
● Work with Clinical Manager to identify a Study Champion, if applicable. 
● Work with Clinical Manager to identify patients deemed vulnerable that should be 
excluded from the study, per the study’s exclusion criteria. 
● Complete the pre-intervention phase Practice Patterns Survey, to be completed during 
the 12- week baseline data collection period before the intervention phases begins. 
 
Payment #2 of $250 shall be compensation for the following activities: 
 
● General support of the study and communication as needed to medical colleagues 
(attending nephrologists and other providers) in the clinic. 
● Completion of the post-intervention phase Practice Patterns Survey, to be completed 
during the 12-week follow-up period following the intervention phase. 
 
V. UM staff monitoring of opt out process 
 
The University of Michigan is responsible for the opt out processes for patients. Under the 
direction of a UM study coordinator available online via initial enrollment, each patient will be 
given an information sheet by FMCNA staff. FMCNA staff will distribute the information sheet to 
patients, and record the date that a patient received the information sheet and the date of any 
opt outs (as applicable) on an Opt Out Worksheet, adding any new patients missing on the 
worksheet as needed. The UM study coordinator will be granted an FMCNA secure email 
address for communications concerning the opt out process and other study matters. 
 
VI. Assessment of Intervention Implementation (Aim 3) 
 
Feasibility Evaluation. The study will involve an initial pilot feasibility assessment for current 
study procedures. This will involve assessment of metrics concerning:  
(1) availability of a sufficient amount patient dialysis session data to measure the impact of the 
interventions on the primary outcome (data for 3,600 dialysis sessions for each of the 8 pilot 
clinics during the pilot intervention period);  
(2) sufficient patient participation in the peer mentoring program (up to 30 patients start peer 
mentoring in each of the trial period clinics with peer mentoring, and up to 22 patients finish peer 
mentoring in each of the pilot clinics with peer mentoring); and  

 
 
62 |      Version Draft 7.0  December 2023 
 
(3) sufficient staff participation in the online training sessions (at least 75% of the staff complete 
at least 90 minutes of training during the first 14-16 weeks of the intervention period in the pilot 
clinics with the provider intervention). 
 
To assess intervention implementation (Aim 3), monitoring activities will also seek to identify 
variation in implementation approaches adopted within different study facilities, and to 
characterize differences in intervention acceptance and workflow integration. These analyses 
will help with understanding any potential differences in intervention effects between sites, and 
with identifying and responding to any emergent implementation challenges throughout the trial. 
 
Meeting-based data collection will support study monitoring, and related Aim 3 analyses. 
Meeting data will be unobtrusively collected in all facilities in which there is an intervention. 
Specifically, these data collection activities will leverage already-planned project activities; no 
additional meetings will be planned specifically for this form of data collection.  UM researchers 
will attend the following events which are already planned as part of the trial; no audio or video-
recordings will be made of any meetings or sessions: 
  
● Online Staff Training Sessions 
o Staff Training regarding IDH prevention Parts 2 and 3 (14 facilities) 
o Staff Training regarding peer mentoring intervention and tablet management (14 
facilities) 
● Operations Committee (OC) meetings (15 facilities; the 5 clinics doing data collection 
only, will not have an Operations Committee) 
 
Online Training Sessions. At the Online Training Sessions, UM researchers will take 
descriptive field notes.161 Attendees will be informed that notes will be taken, the purpose of the 
notes, and that comments made during meetings may be tied to a staff member’s role but staff 
names will not be recorded. The attendees will be informed that they can decline to have their 
comments recorded. The field notes will document: 
● staff questions during the sessions;  
● staff members’ stated reactions to the interventions; and  
● discussions in which the staff talk about their plans for, and experience with, 
integrating the provider intervention into their workflows.  
 
OC meetings. At the OC meetings for each site, the meeting agendas will include a small 
number of questions directly related to study intervention implementation as provided in this 
document which UM investigators and/or staff will pose, then recording the answers in 
descriptive field notes. These questions are directed to FMCNA staff and will be asked after any 
patient representatives have left the meeting. The questions are as follows: 
 
● At Pre-intervention OC meeting: 
o Staff Intervention Facilities 
▪ 
We are planning to train you to use a checklist to identify patients at risk 
of intradialytic hypotension. The checklist will rely on information from the 
fluid management tab. Is there anything that we should consider about 
how you use the fluid management tab now that we should take into 
account in planning your training?  
● At the two OC meetings during intervention period: 
o Staff Intervention Facilities: 
▪ 
Your facility has been given a checklist to use to identify patients at 

 
 
63 |      Version Draft 7.0  December 2023 
 
increased risk of IDH. Please tell us about how you are using the 
checklist. 
● Follow-up questions as needed: 
o Who is completing the checklist? 
o When are they completing the checklist? 
o What do they do before completing the checklist? 
o What do they do after completing the checklist? 
▪ 
What is working well about using the checklist? 
▪ 
Are there things that are not working well with using the checklist? If so, 
what are they? 
o Patient Intervention Facilities: 
▪ 
Some patients at your facility have been given tablet computers for 
patients to use at home to obtain peer mentoring and education about 
IDH prevention. 
● Follow-up questions as needed: 
o Have patients brought their tablet computers into the 
clinic? If so, please tell us what happened. 
o Have patients talked to any of you about 
anything regarding tablet use? 
o Have you noticed any changes in topics that 
patients are bringing up in their appointments with 
you? 
o Has anyone started to record things at home and 
bring in data and do you have reason to believe 
it's because of the intervention? 
o Have you noticed patients talking to each other about the 
intervention? 
 
  
VII. Surveys 
 
A Practice Patterns survey will be completed by the Medical Director and Clinical Manager prior 
to, and after the intervention period. The survey will document fluid management practices used 
in each facility, including the no-intervention (usual care) sites. 
 
A patient satisfaction survey will be given by the NKF to patients after they complete the patient 
activation intervention. Results will be monitored in order to identify patient experiences with the 
multimedia educational modules and peer mentoring intervention. Aggregate results will be 
shared with NKF so that any necessary program adjustments can be made. 
 
A peer mentor satisfaction survey will be given by the NKF to peer mentors to assess their 
experiences with the study’s digital tools, training, and support. Aggregate results will be shared 
with NKF so that any necessary program adjustments can be made. 
 
VIII. Monitoring by Study Team 
 
The study team will conduct scheduled assessments of study recruitment, data integrity and 
quality, withdrawals, and compliance with protocol plan on a monthly basis. This information will 
be reported at the monthly project Steering Committee meetings.  

 
 
64 |      Version Draft 7.0  December 2023 
 
11 
STATISTICAL CONSIDERATIONS 
11.1 
STUDY HYPOTHESES 
We will compare two interventions to improve the cardiovascular/hemodynamic stability of 
hemodialysis care by pursuing the following specific aims: 
 
● Aim 1 Conduct a cluster-randomized controlled trial (CRCT) to test and compare the 
effects of the above HD facility-level interventions on the primary outcome of dialysis 
session stability over an intervention period of 24 weeks and a post-intervention follow-
up period of 12 weeks. 
● Aim 2 Test and compare the effects of the two HD facility-level interventions on 
secondary patient-centered clinical outcomes, including: patient symptoms, fluid 
adherence, dialysis adherence, quality of life, hospitalizations and mortality over the 
same timeframe. 
● Aim 3 Identify factors associated with successful implementation of the interventions, 
and ways in which implementation may influence intervention effectiveness. 
 
Our main study hypothesis is that hemodialysis session stability will significantly improve with 
either multimodal provider education or patient activation interventions, and that multimodal 
provider education will show a larger improvement. This hypothesis is based on our expectation 
that some hemodialysis patients might refuse or be unable to participate in peer mentoring, 
potentially leading to greater penetration of the provider intervention. We will test this main 
hypothesis and explore this potential explanation of any differential improvement as part of our 
planned sensitivity, mediation and moderation analyses. 
11.2 
SAMPLE SIZE CONSIDERATIONS 
I. 
Primary Outcome 
For Aim 1, the outcome is a dichotomous measure of HD stability, where an unstable session is 
defined as the dialysis session stability, where an unstable session is defined as SBP falling 
below 100 when the starting SBP was >=100.  This outcome will be collected through digital 
records for all HD sessions of all patients at each facility during the study period. The analysis 
will be done in two ways. First, as a continuous variable, as described in the power analysis. 
Using individuals with a minimum of 60 dialysis sessions, the proportion of unstable sessions 
will be computed. Linear mixed models will be employed to compare individuals in facilities in 
the two treatment arms to individuals in the non-intervention facilities. Random effects for facility 
clustering will be accounted for using the MIXED procedure in SAS. As a sensitivity analysis, 
dialysis session stability will also be examined as a yes/no variable and analysis will be carried 
out on the longitudinal dataset using logistic regression with a random effect for both patients 
and facilities, using the GLIMMIX procedure in SAS.  The random effects will model the 
correlations among the measurements at each level.  This analysis will use data from all 
patients, not just those with at least 60 dialysis sessions.  
 
Dialysis facilities will be randomized in a 2x2 factorial design to two study intervention or control 
groups.  Sample size is based on separate tests for each of the two treatment comparisons, and 
assumes no interaction between treatment types.  The primary outcome measure is session 
instability, particularly IDH, which occurs in approximately 20% of hemodialysis sessions in the 
usual practice setting in the US. The study is powered to detect a decrease from 20% to 15-

 
 
65 |      Version Draft 7.0  December 2023 
 
16% in the intervention group.  It is assumed that a minimum of 60 hemodialysis patients will be 
observed for at least 60 dialysis sessions and the outcome will be the proportion of unstable 
sessions, which we treat as a continuous variable.  These proportions among patients in a 
facility are assumed to be normally distributed with mean 0.20 in the control group and mean 
between 0.16 and 0.17 in the intervention group (a difference, d, of 0.034 to 0.043), with 
standard deviation (SD, or ‘sigma’) assumed to be in the range 0.08 to 0.10.  We conservatively 
assume n=60 patients per facility, i.e., a total of 60x20=1,200 patients. The power calculation is 
robust to changes in number of patients (m), as the calculation of K (number of clusters) only 
increases by ~1 if m is increased to 90.  The intraclass correlation coefficient for hemodialysis 
facilities is assumed to be 0.10. A significance level of 0.05 was assumed in all calculations.  
Table 5 gives the statistical power to detect a given difference (D, 0.034-0.043), with sigma 
values of 0.08 and 0.10, and number of clusters (dialysis units, k) per treatment group of 10 (20 
facilities total).   
 
Table 5 shows that detecting a difference of ~0.03 (i.e., 20% versus 17% of sessions unstable) 
with 80% power is only feasible with a SD (sigma) of 0.08 or less. If the standard deviation is as 
large as 0.10, we can detect a difference of 0.043 (i.e., 20% vs. 16%) with 81% power.  Put 
another way, if the smallest variance estimate is correct (sigma=0.08), we have 91% power to 
detect a 4% difference, and 80% power to detect a 3% difference. 
 
Table 5 - The power is shown to detect a difference in IDH rates (D) between groups 
assuming 3 possible standard deviations (sigma).  The minimum number of facilities 
(k) is also shown, illustrating some flexibility to accommodate drop-out.   Bolded cells 
show power >=80%. 
D 
0.034 
0.034 
 
0.040 
0.043 
 
Sigma 
0.08 
0.10 
 
0.08 
0.10 
 
K 
10 
10 
 
10 
10 
 
Power 
80% 
61% 
 
91% 
81% 
 
 
 
II. 
Secondary Outcomes 
Aim 2 incorporates six outcome measures: (1) patient symptoms (including a patient burden 
measure, dialysis recovery time, and proportion of sessions with each symptom), (2), fluid 
adherence (inter-dialytic weight gain), (3) dialysis adherence, (4) quality of life, (5) 
hospitalization (all-cause and by specific cause), and (6) mortality (all-cause and by specific 
cause), with will be analyzed at the individual level and summarized at the facility level.  Each 
will use a model format appropriate to the outcome type, but will otherwise follow the model 
strategy, including the secondary analyses, described for Aim 2 above.  The fluid adherence 
(Interdialytic weight gain), symptom and quality of life analyses, based on continuous outcome 
measures, will be carried out using mixed models (the MIXED procedure of SAS).  Note that the 
quality of life analyses will be based on data from two time points, one before intervention (the 
latest KDQOL survey that is within 12 months prior to the start of the intervention) and one 
during or after intervention (the earliest KDQOL survey that is within 12 months after the start of 
the intervention), rather than session-specific data as analyzed for the other outcomes. 
Analyses of missed or shortened HD sessions will employ logistic regression for longitudinal 
data, as in Aim 1. Analyses of hospitalization and mortality will use logistic regression for 
individual level data. As part of these models, we will test IDH-related variables (e.g., recent 

 
 
66 |      Version Draft 7.0  December 2023 
 
IDH, frequency of IDH in the past month) as potential predictors. In each case, the appropriate 
regression diagnostics will be used to assess model fit. 
 
Although the study was not powered specifically for these outcomes, many of the secondary 
outcomes are continuous variables for which power can be calculated based on effect sizes 
(multiples of the standard deviation) for any specific outcome, given the sample size of 20 
facilities required for Aim 1 analyses.  In the power analyses below, we present calculations 
based on four outcomes, percentage point change in facility proportion of individuals within 
optimum weight gain ranges between dialysis sessions (interdialytic weight gain between 2-5% 
of body weight, a measure of fluid adherence), patient recovery time, patient symptoms, and 
health-related quality of life scores.  
 
(a) Interdialytic Weight Gain (IDWG) 
 
The IDWG outcome for each patient will be the percentage of sessions in the optimum weight 
gain range between dialysis sessions (IDWG between 2-5% of body weight, a measure of fluid 
adherence).   We consider this patient-specific percentage over the 24-week intervention period 
as a continuous variable for the comparison of intervention versus control groups.  As above, 
we assume 20 facilities, and anticipate an average of 60 study patients per facility.  The patient-
specific percentages will then be used in the analysis testing intervention effects.  We will 
consider the average of the patient-level percentages to test intervention vs control groups. 
 
We assess the power to detect various differences between the intervention and control groups 
in percentage of IDWG values in the optimum weight gain range.  For example, a mean of 27% 
in the control group and 32% in the intervention group would be a difference of 5% more 
patients in the optimum range.  We assume an intra-class correlation coefficient (ICC, which 
measures how strongly patients are similar within center and differ between facilities) of either 
0.1 or 0.2 (lower ICC results in higher power).   We assume a standard deviation (SD) among 
patients of between 0.08 and 0.16 (expressed as a proportion rather than a percent to avoid 
confusion with other percentages), and a 2-sided significance level of 0.05. 
 
Table 6 - Entries are the statistical power for the given standard deviation (SD), 
intra-class correlation coefficient (ICC), and control vs. intervention difference.  
Power values ≥ 0.80 are boldface. 
Control vs. Intervention 
Difference in % IDWG 
within optimum range 
SD=0.10 
SD=0.15 
ICC=0.1 
ICC=0.2 
ICC=0.1 
ICC=0.2 
 
 
 
 
 
5% (e.g., 25% vs 30%) 
0.91 
0.68 
0.59 
0.36 
6% 
0.98 
0.83 
0.75 
0.49 
7% 
0.99 
0.92 
0.87 
0.62 
8% 
0.99 
0.97 
0.94 
0.73 
 
Table 6 above shows the statistical power for a range of SD, ICC, and Control vs. Intervention 
differences (D).   Power is around 90% or higher to detect differences of 7% or higher for all 
cases except SD=0.10, ICC=0.1 or 0.2.  In this worst case, we still have 73% power to detect a 
difference of 8% between intervention and control groups.  A difference of 6% to 8% would be 
clinically meaningful, as any difference in this range would likely be associated with less risk of 

 
 
67 |      Version Draft 7.0  December 2023 
 
IDH.  Effect sizes calculated from Table 5 values range from 0.04 to 0.12, reflecting a range 
from low/moderate to high/moderate effects.  In summary, the IDWG outcome measure is 
adequately powered to detect clinically meaningful effects, and is well powered for many of the 
scenarios in Table 5. 
 
(b) Patient Symptoms – Recovery Time 
 
At one dialysis session per week for the duration of the 24-week intervention, each study patient 
will report their recovery time from the previous dialysis session.  We conservatively assume 
that measures are recorded for 20 sessions per person.  We assume 20 facilities, and anticipate 
an average of 60 study patients per facility, including all shifts.  The recovery-time question 
shown on page four has eight ordinal answer choices plus "unable/declined" (which will be 
excluded from analyses). 
 
For the data analysis, we will consider the ordinal scale (1-8) as a continuous variable.  We will 
separately test recovery time for each intervention (provider education or patient activation) 
versus the control group.  Each patient's data over the 24-week intervention period will be 
averaged and used as their individual Mean Recovery Time (MRT).  The patient-specific MRTs 
will then be used in the analyses of intervention effects. We will then consider the group-level 
MRTs (the average of the patient-level MRTs) for comparing the intervention and control 
groups. 
 
In Table 7, we assess the power to detect various differences between the intervention mean 
and the control mean.  For example, an MRT of 4 (“after a long nap”) in the control group and 3 
(“after a short nap”) in the intervention group would be a difference of 1.  We assume an intra-
class correlation coefficient (ICC, which measures how strongly patients are similar within 
center and differ between facilities) of either 0.1 or 0.2 (lower ICC results in higher power).  We 
assume a MRT standard deviation (SD) among patients of between 1.5 (if the full range is not 
expressed) and 2.0 (estimated by full range/4), and a 2-sided significance level of 0.05. 
 
Table 7 -   Entries are the statistical power for the given standard deviation (SD), 
intraclass correlation coefficient (ICC), and control vs. intervention difference.  
Power values ≥ 0.80 are boldface. 
Control vs. Intervention 
Difference 
SD=1.5 
SD=2 
ICC=0.1 
ICC=0.2 
ICC=0.1 
ICC=0.2 
0.7 
0.87 
0.62 
0.64 
0.40 
0.8 
0.94 
0.73 
0.75 
0.49 
0.9 
0.98 
0.83 
0.84 
0.59 
1.0 
0.99 
0.90 
0.91 
0.68 
 
Table 7 above shows the statistical power for a range of SD, ICC, and Control vs. Intervention 
differences (D).   Power is around 80% or higher to detect differences of 0.9 or higher for all 
cases except SD=2, ICC=0.2.  In this worst case, we still have 68% power to detect a difference 
of 1.0 between intervention and control groups.  A difference of 0.8 to 1.0 would be clinically 
meaningful, and is much smaller than a SD by either assumption (effect size range from 0.40 to 
0.67, all considered a moderate effect size).  In summary, the recovery time outcome measure 
is well powered to detect meaningful effects. 
 

 
 
68 |      Version Draft 7.0  December 2023 
 
(c) Patient Symptoms – Symptom Burden Measure 
 
The Patient Symptom Burden measure will combine symptom frequency and severity for each 
of the following symptoms that are often indicative of IDH, if they occur during or after the 
dialysis session (not pre-dialysis): nausea, vomiting, abdominal pain, dizziness, muscle cramps, 
headache, chest pain, shortness of breath, palpitations, diaphoresis, and blurred vision (as 
listed in the Chair-side symptom module).  Although not yet fully developed, we assume that the 
range of the scale will be 0-100.  As above, we assume 20 facilities, and anticipate an average 
of 60 study patients per facility.   
 
Each patient's data over the 24-week intervention period will be averaged and used as their 
individual Symptom Burden (SB) mean.  We will use the group-level means (the average of the 
patient-level means) for comparing the intervention and control groups. 
 
In Table 7, we assess the power to detect various differences between the intervention mean 
and the control mean.  For example, a SB of 15 in the control group and 10 in the intervention 
group would be a difference of 5.  We assume an intra-class correlation coefficient (ICC, which 
measures how strongly patients are similar within center and differ between facilities) of either 
0.1 or 0.2 (lower ICC results in higher power).   We assume a SB standard deviation (SD) 
among patients of 10, and a 2-sided significance level of 0.05. 
 
Table 8 - Entries are the statistical power for a standard deviation (SD) 
of 10, intraclass correlation coefficient (ICC) of 0.1 and 0.2, and control 
vs. intervention difference of 4, 5, and 6 (on a 0-100 scale).  Power 
values ≥ 0.80 are in boldface. 
Control vs. Intervention Difference 
ICC=0.1 
ICC=0.2 
4 
0.75 
0.49 
5 (Effect Size=0.5) 
0.91 
0.68 
6 
0.98 
0.83 
 
Table 8 above shows the statistical power for a range of ICC, and Control vs. Intervention 
differences.   Power is around 90% or higher to detect differences of 5 or higher for ICC=0.1, 
and over 80% to detect differences of 6 or higher for ICC=0.2.  A difference of 5 would be an 
effect size of 0.5 (half of the SD), which is considered moderate, and clinically meaningful.  In 
summary, while we do not have data to provide more precise power estimates, the patient 
symptom burden outcome measure appears to be well powered to detect meaningful effects. 
 

69 |      Version Draft 7.0  December 2023
(d) Health-Related Quality of Life (HRQoL). The Kidney Disease Quality of Life instrument 
(KDQOL) is defined to have a mean of 50 and a standard deviation of 10. A 5-unit change is 
considered to be clinically meaningful.162 Based on data to which our team has access from the 
Dialysis Outcomes and Practice Patterns Study (DOPPS), we determined appropriate facility-
level intra-class correlation coefficient (ICC) for HRQoL scores to be 0.07. As shown in Figure 1, 
we explored power for detectable differences between 1-5 points and a range of sigma between 
10 and 12. We determined that with our planned 20 facilities containing 60 patients each, that 
we are adequately powered (>0.80) to detect differences as small as 4.5 points for all three 
assumed sigma values. This 
provides excellent power for 
detecting a difference between 
study arms in HRQoL.
11.3
PLANNED INTERIM 
ANALYSES (IF APPLICABLE)
The study team will produce 
interim analyses of selected 
study outcomes (IDH, mortality) 
every year of the trial 
implementation period, or as 
requested by the DSMB. We 
currently anticipate reporting 
annually to the DSMB blinded 
data on IDH and mortality rates 
in each treatment arm. The 
study has no stopping rules.
11.3.1
Safety Review 
The DSMB will meet early in the trial to advise on desired data for reporting. We will then meet 
annually in the trial implementation and analysis periods of the study, or more frequently as 
requested by DSMB members. We currently anticipate reporting annually to the DSMB blinded 
data on mortality rates in each treatment arm. The study has no stopping rules.
11.3.2 Efficacy Review
The DSMB will meet early in the trial to advise on desired data for reporting. We will then meet 
annually in the trial implementation and analysis periods of the study, or more frequently as 
requested by DSMB members. We currently anticipate reporting annually to the DSMB blinded 
data on IDH rates in each treatment arm. The study has no stopping rules.
11.4
FINAL ANALYSIS PLAN
Aim 1. Test and conduct a cluster-randomized controlled trial (CRCT) to compare the 
effects of the above HD facility-level interventions on the primary outcome of dialysis 
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session stability over an intervention period of 24 weeks and a post-intervention follow-
up period of 12 weeks.  
 
Preliminary data analysis. We will compare the four randomized groups to assess covariate 
balance on participant characteristics, such as demographics. This analysis will test for potential 
selection bias that might lead to confounding of study results. If study arms are found to be 
imbalanced on baseline characteristics, in addition to those specified in the analyses below, 
these characteristics will be included in the regression models as a sensitivity analysis. 
 
Analysis of Primary Outcome. For Aim 1, the outcome is a dichotomous measure of HD stability, 
where an unstable session is defined as the dialysis session stability, where an unstable 
session is defined as SBP falling below 100 when the starting SBP was >=100.  This outcome 
will be collected through digital records for all HD sessions of all patients at each facility during 
the study period. The analysis will be done in two ways. First, as a continuous variable, as 
described in the power analysis. Using individuals with a minimum of 60 dialysis sessions, the 
proportion of unstable sessions will be computed. Linear mixed models will be employed to 
compare individuals in facilities in the two treatment arms to individuals in the non-intervention 
facilities. Random effects for facility clustering will be accounted for using the MIXED procedure 
in SAS. As a sensitivity analysis, dialysis session stability will also be examined as a yes/no 
variable and analysis will be carried out on the longitudinal dataset using logistic regression with 
a random effect for both patients and facilities, using the GLIMMIX procedure in SAS.  The 
random effects will model the correlations among the measurements at each level.  This 
analysis will use data from all patients, not just those with at least 60 dialysis sessions. 
 
For the above analyses, the variables of primary interest are the main effects of the 
interventions. Session-level covariate adjustment will include: (1) weekday of session, (2) 
dialysis session shift, (3) average session blood flow rate; (4) average session dialysate flow 
rate, and (5) dialysate composition (sodium, potassium, magnesium). Patient-level covariate 
adjustment will comprise: (1) patient demographics (age, race, ethnicity, sex, employment, 
literacy, education level, language spoken); (2) time since first dialysis; (3) cause of ESRD, (4) 
treatment history; (5) total transplants; (6) vascular access type; (7) patient laboratory data 
(serum phosphorous, dialysis adequacy, anemia management (hemoglobin), iron indices 
(serum ferritin, serum iron), mineral metabolism indices (calcium, phosphate, PTH)); (8) 
comorbidity index; (9) individual comorbidities and comorbidities in combination, including 
COVID-19; (10) patient’s heart rate variability (based on variability in heart rate (HR) during 
dialysis session (difference between the highest and lowest heart rates, standard deviation of 
the heart rate measures, the square root of the mean squared differences of successive heart 
rate measures); (11) patient medications (prescriptions medications administered outside of 
center or in-center (including ESA prescription, iron, antibiotics and vitamin D analog), and non-
in-center prescriptions). Patient data will be censored while they are at COVID-19 isolation 
facilities. Regression diagnostics will be used to assess model fit. Checks for functional form of 
continuous adjustment covariates will be carried out and any transformations will be 
implemented prior to adding the intervention variables to the model. 
 
Three secondary analyses are planned for this Aim. The first will test the treatment effects in a 
similar model but adding adjustment for any covariates found to be unbalanced between 
treatment groups in preliminary analyses.  This has the ability to further adjust for important 
confounders of treatment effects, but because it will use data-driven covariate decisions that are 
subject to analysis bias, it will be interpreted with caution. The next secondary analysis will test 
the interaction between the two interventions to detect a possible synergistic or antagonistic 

 
 
71 |      Version Draft 7.0  December 2023 
 
effect. (Further discussed in the heterogeneity of effects section). Although the study is not 
powered to detect even moderate interaction effects, it is possible that a strong interaction could 
be detected, and such an effect would be of interest.   
 
The primary results will be based on the treatment effects tested in the initial models described 
for cluster-randomized trials with pre-planned covariates.  Intent-to-treat analyses will be carried 
out, so that any deviations from the randomized interventions will not be taken into account in 
the primary test of treatment effects. Additionally, we will conduct as-treated analyses for the 
peer mentoring intervention whereby only patients who received peer mentoring are compared 
to patients in the other treatment arms, with adjustment for the same factors as in the intent-to-
treat analyses. The small number of facilities (20) will preclude post-hoc adjustment for facility 
non-compliance with the interventions. 
 
The third will be a secondary analysis of patient proportion with IDH before versus after the 
intervention phase to test whether the intervention effects are maintained.  The basic analysis is 
a paired comparison of % IDH pre- versus post-intervention, with a few necessary adjustments. 
First, because the intervention phase will span 24 weeks and the maintenance phase will span 
only 12 weeks, the variance of the percent IDH will differ between periods. We will address that 
by using a mixed model with heterogeneous variance. This strategy will work for the situation of 
full duration of each patient's participation (24 weeks plus 12 weeks).  If there are enough 
patients who enter or exit during either period, we will do a similar analysis, but use patient-and 
phase-specific weights to adjust for differing variances. Second, there may be carry-over effects 
after the intervention phase that only last for a few weeks. We will test that possibility by 
classifying the 12 weeks of the post-intervention phase as separate one-month periods, and 
testing whether the monthly post-intervention IDH percentages are individually different from the 
intervention phase IDH percentages. Testing for a decreasing trend during the maintenance 
period will also be performed. Third, these analyses will be carried out separately among the 
four groups (provider training/checklist alone; peer mentoring alone; both interventions together, 
and neither intervention).  A joint analysis may also be performed to test for additive or 
interactive effects. 
 
Missing Data Issues (MD-1). Because ours is an educational intervention with support from the 
dialysis facility’s parent organization, we expect facility attrition to be very low. Nevertheless, if 
facilities do drop out during the intervention phase, they will be replaced and the intervention will 
take place at a new facility. A facility would need to be replaced if: 1) they request to leave the 
study; or 2) 75% of the staff do not complete the training within the first 14-16 weeks of the 
intervention period. 
 
As for missing outcome data for facilities in the study, data for our primary outcome as well as 
two secondary outcomes (fluid adherence/Interdialytic weight gain and dialysis session 
adherence) are gathered at the dialysis session level, using data that are automatically gathered 
when treatment is delivered.   
 
With IRB waiver of consent and waiver HIPAA authorization with an opt out process, we expect 
that we will not have significant attrition due to patient withdrawal since interventions will be 
provided at the facility-wide level.  Attrition may be seen in the patient activation (peer 
mentoring) intervention if patients choose not to participate in the peer mentoring program or if 
patients drop-out after starting the program. It is important to note that patients who drop out of 
the patient activation intervention will not be dropped from the overall study unless requested, 
and collection of outcome measures will continue.  Any attrition (lack of participation in the 

 
 
72 |      Version Draft 7.0  December 2023 
 
patient activation intervention) could contribute to a reduced estimate of treatment effect in 
analyses using the intent-to-treat principle; this reduction in estimated treatment effect would 
appropriately reflect the expected effect of this intervention in the general dialysis population.  
 
A final type of attrition may be the possibility of missing data due to patients not completing the 
self-reported quality of life (KDQOL) survey or the patient symptom question regarding recovery 
time. For example, some participants may refuse to answer certain questions or may miss 
follow-up surveys. Where possible, we will note reasons for missing data by triangulating data 
sources to determine whether a patient has moved to another facility, or in accordance with two 
of our outcomes, been hospitalized or died (MD-4).Although every effort will be made to collect 
these data, some missing surveys are still likely, particularly among those in ill health. We do 
not expect missing surveys to be associated with study arm, but missingness itself can be 
analyzed for treatment differences as a tertiary outcome measure.  The sample in each cross-
section will include living patients only, so death will not be a problem as it would be in a 
longitudinal QOL study.  We believe that this approach, along with our conservative 
assumptions regarding sessions needed as described previously, will largely prevent missing 
data for our primary outcome, as well as two secondary ones. Death will be tracked as an 
outcome, although the trial is not powered to assess this as a primary outcome. Data on 
subjects who leave the study site, will be used until their time departure from the study. 
 
We will compare the characteristics of those with missing data to those without missing data, to 
test whether characteristics are similar between the groups (see Preliminary Data Analysis) 
(MD-2). In addition to complete case analyses, we will use state-of-the-art statistical methods 
such as likelihood approaches and multiple imputation to deal with missing data (MD-3).160 
These sensitivity analyses will assess the robustness of the results to missing data (MD-5).  
 
Heterogeneity of Treatment Effect Analyses (HT-2; Moderation). The primary analysis will 
examine average treatment effects (ATE), but we will also examine heterogeneity of treatment 
effects (HTE) on HD session instability (IDH) rate for a variety of covariates, particularly those 
that are characterized by differential outcomes among HD patients (HT-1). Covariates of interest 
for HTE analyses include: age, race,163, ethnicity, level of education164, literacy,  presence of 
comorbidities, and heart rate variability (HT-4). Supporting these HTE analyses, greater benefits 
from peer mentoring for African Americans were found in a trial conducted by our advisory 
partner, NKFM.18 Depending on sample sizes obtained for each of the covariates of interest, 
either a subgroup analysis or an analysis including interaction terms will be employed to 
examine HTE (HT-3). Only two-way interactions between the treatment indicator and each of 
the covariates will be analyzed. There may be different moderators for the two interventions. 
 
Mediation Analyses. The second part of these analyses aim to identify mechanisms of action for 
the interventions, such as changes in patient or practitioner behavior and session 
characteristics; these changes in behavior will identify important pathways for improvement in 
reducing IDH. However, these analyses are not intended to be used for causal inferences. The 
basic mediation analysis involves 3 steps: (1) confirm that the intervention predicts the outcome 
(and if not, then mediation analysis is not relevant), (2) confirm that the intervention predicts the 
mediator (i.e., that the intervention has resulted in specific changes in patient or practitioner 
behavior; if not, then the potential mediator cannot mediate an intervention effect), and (3) in a 
model predicting the outcome with covariates including both the intervention and the mediator, 
confirm that the intervention effect has been reduced after adding the mediator to the model, 
and confirm that the mediator is a statistically significant  predictor of the outcome.  The role of 
moderation in a mediation analysis can also be tested.  Each potential mediator is tested 

 
 
73 |      Version Draft 7.0  December 2023 
 
separately, without adjusting for other mediators, although associations between mediators can 
separately be assessed for improved interpretation.   
 
Mediators of the Primary Outcome: The following variables will be examined as potential 
mediators of the treatment effect on the primary outcome of dialysis session stability: 
 
Patient-level variables: (1) patient session instability prevention behavior;(2) fluid management 
practice patterns; (3) number and categories of BP medications patient is taking; (4) fluid 
adherence (inter-dialytic weight gain); (5) dialysis adherence; (6) patient symptoms (symptom 
burden measure and recovery time); (7) hospitalizations for cardiovascular or fluid-related 
causes; and (8) quality of life. 
 
Session-level variables to be assessed for potential mediation effects include: (1) treatment time 
delivered; (2) average session UFR; (3) cooled dialysate used; (4) sodium modeling used; (5) 
ultrafiltration modeling used; (6) ultrafiltration variability for whole session, or up until incident of 
IDH (if IDH occurs) (difference between the highest and lowest UFR, standard deviation of the 
UFR measures, the square root of the mean squared differences of successive UFR measures); 
(7) sitting-to-standing difference in SBP (orthostasis at beginning of session); (8) starting SBP; 
(9) slope of changes in SBP over 30 minute intervals for whole session, or up until incident of 
IDH (if IDH occurs); (10) values and times of lowest and highest SBP readings as a measure of 
range of SBP during the dialysis session; (11) patient request re: fluid removal at this session; 
(12) fluid adherence (inter-dialytic weight gain) at this session; (13) previous achievement of 
post-dialysis target weight; and (14) previous session instability. 
 
Sensitivity Analyses. In addition to the sensitivity analyses described above, we will examine the 
effect that patient compliance/non-compliance rates, i.e., percent of patients who accept peer 
mentoring and checklist adherence for provider intervention, have on the results. The sensitivity 
analyses aim to assess the robustness of the conclusions based on the analyses of the primary 
outcome – specifically to determine whether the findings hold under different methods of 
defining the primary outcome. Thus we will conduct sensitivity analyses for the secondary 
measures of session instability described above. As part of this, because we will know the dates 
and causes of hospitalization and death by cardiovascular- or fluid-related causes, we will 
identify those events that took place on days in which dialysis was administered. Accordingly, 
we will conduct a sensitivity analysis of the primary outcome of dialysis session stability both 
with, and without, those events on dialysis days included. For the primary outcome analyses, we 
will also conduct a sensitivity analysis without the sessions of patients who begin that session 
with a sitting pre-dialysis SBP of 100-110 MmHg and whether the sitting SBP falls below 90 
mmHg (using lowest SBP during session) if starting SBP ≥100. 
 
Aim 2. Test and compare the effects of the two HD facility-level interventions on 
secondary patient-centered clinical outcomes, including: patient symptoms, fluid 
adherence, dialysis adherence, quality of life, hospitalizations and mortality over the 
same timeframe. 
 
Aim 2 incorporates six outcome measures: (1) patient symptoms (including a patient burden 
measure, dialysis recovery time, and proportion of sessions with each symptom), (2), fluid 
adherence (inter-dialytic weight gain), (3) dialysis adherence, (4) quality of life, (5) 
hospitalization (all-cause and by specific cause), and (6) mortality (all-cause and by specific 
cause) , with will be analyzed at the individual level and summarized at the facility level.  Each 

 
 
74 |      Version Draft 7.0  December 2023 
 
will use a model format appropriate to the outcome type, but will otherwise follow the model 
strategy, including the secondary analyses, described for Aim 2 above. This includes censoring 
of patient data while they are at another facility. The fluid adherence (Interdialytic weight gain), 
symptom and quality of life analyses, based on continuous outcome measures, will be carried 
out using mixed models (the MIXED procedure of SAS).  Note that the quality of life analyses 
will be based on data from two time points, one before intervention and one during intervention, 
rather than session-specific data as analyzed for the other outcomes. Analyses of missed or 
shortened HD sessions will employ logistic regression for longitudinal data, as in Aim 2. 
Analyses of hospitalization and mortality will use logistic regression for individual level data. As 
part of these models, we will test IDH-related variables (e.g., recent IDH, frequency of IDH in the 
past month) as potential predictors. In each case, the appropriate regression diagnostics will be 
used to assess model fit.  
 
 
In both Aims 1 and 2, the primary results will be based on the treatment effects tested in the 
initial models described for CRCTs with pre-planned covariates.  Depending on the specific 
outcome, covariate adjustment for these analyses will include: (1) patient demographics (age, 
race, ethnicity, sex, employment, literacy, education level, language spoken), (2) time since first 
dialysis, (3) cause of ESRD, (4) treatment history, (5) total transplants, (6) vascular access type, 
(7) patient  laboratory data (serum phosphorous, dialysis adequacy, anemia management 
(hemoglobin), iron indices (ferritin, serum Iron), mineral metabolism indices (calcium, 
phosphate, PTH)); (8) comorbidity index; (9) individual comorbidities and comorbidities in 
combination, including COVID-19; (10) patient’s heart rate variability for the whole session or up 
until IDH occurs (if IDH occurs) (based on variability in heart rate (HR) during dialysis session 
(Difference between the highest and lowest heart rates,  standard deviation of the heart rate 
measures, the square root of the mean squared differences of successive heart rate 
measures)); and (11) patient medications (prescriptions medications administered outside of 
center or in-center (including ESA prescription, iron, antibiotics and vitamin D analog)). Intent-to-
treat analyses will be carried out, which means that any deviations from the randomized 
interventions will not be taken into account in the primary test of treatment effects.  Additionally, 
we will conduct as-treated analyses for the peer mentoring intervention whereby only patients 
who received peer mentoring are compared to patients in the other treatment arms, with 
adjustment for the same factors as in the intent-to-treat analyses. The small number of facilities 
(20) will preclude post-hoc adjustment for facility non-compliance with the interventions. 
Heterogeneity of Treatment Effect Analyses (Moderation). As with the primary outcome 
analyses, the following potential moderators will be assessed: 1) patient demographics, 
including age, race, ethnicity, literacy, and education level; (2) comorbidities; and (3) heart rate 
variability. 
Mediation Analyses. Mediation analyses will be conducted for each of the six patient-level 
secondary outcomes: (1) patient symptoms; (2) fluid adherence (inter-dialytic weight gain); (3) 
dialysis adherence; (4) quality of life; (5) hospitalization; and (6) mortality. Depending on the 
secondary outcome in question, the following variables will be examined as potential mediators. 
Mediators of the Secondary Outcomes: Patient-level variables to be examined include: (1) 
patient session instability prevention behavior; (2) fluid management practice patterns; (3) 
number and categories of blood pressure medications patient is taking; (4) fluid adherence 
(inter-dialytic weight gain); (5) dialysis adherence; (6) patient symptoms (symptom burden and 
recovery time); (7) hospitalizations for cardiovascular or fluid-related causes in the past 4 
weeks; and (8) quality of life. 

 
 
75 |      Version Draft 7.0  December 2023 
 
The following session-level variables will be variables will be transformed into patient-level 
variables for the appropriate time period depending on the secondary outcome under 
examination, and assessed for mediation effects: (1) treatment time delivered; (2) average 
session UFR; (3) cooled dialysate used; (4) sodium modeling used; (5) ultrafiltration modeling 
used; (6) ultrafiltration variability for whole session, or up until incident of IDH (if IDH occurs) (ex: 
difference between the highest and lowest UFR, standard deviation of the UFR measures, the 
square root of the mean squared differences of successive UFR measures); (7) sitting-to-
standing difference in SBP (Orthostasis at beginning of session); (8) starting SBP; (9) slope of 
changes in SBP over 30 minute intervals for whole session, or up until incident of IDH (if IDH 
occurs); (10) values of lowest and highest SBP readings as a measure of range of SBP during 
the dialysis session; (11) patient requests regarding fluid removal; (12) fluid adherence (inter-
dialytic weight gain) prior to this session; (13) achievement of post-dialysis target weight; and 
(14) session instability (IDH). 
 
Aim 3. Identify factors associated with successful implementation of the Dialysafe 
interventions, and ways in which implementation may influence intervention 
effectiveness. 
 
Analysis of meeting data. Field notes compiled through training session and Operations 
Committee participation will serve as the basis for a rapid assessment process; information 
collected will be used to identify and understand barriers and facilitators and make any 
necessary modifications while the trial is ongoing.  
 
Using NVivo qualitative data analysis software, we will also analyze data thematically (Saldana, 
2016) to identify and explain types of implementation barriers and facilitators, and use 
qualitative analyses as supplementary explanations as we seek to explain the results of the 
trials, especially if there are differences in effectiveness between facilities implementing the 
same interventions.  
 
Usability data analysis. To assess usability of the checklist and patient intervention 
technologies, we will analyze usage data, with attention to compiling the following metrics: (1) 
time spent on each page; (2) number of abandoned checklist sessions, videoconferencing or 
patient education module sessions; (3) pages and click-through patterns preceding 
abandonment. Patient Intervention technology data may be included in publications and/or form 
the basis of future research. 
 
Implementation fidelity analyses. As mentioned above, we will use the captured fidelity data to 
create and track the following metrics: 
 
● Staff Checklist 
o Checklist completion rate by facility over specific time points (number of 
completed checklists / number of patient sessions (for patients included in the 
study) calculated over a given time period (e.g., a month) 
o Proportion of checklist sessions in which patients are identified as being at risk of 
IDH 
o Prevalence of  reasons why patients were identified as being at risk of IDH 
● Staff Training 
o Proportion of staff by role who completed each training session, tracked by 
facility 

 
 
76 |      Version Draft 7.0  December 2023 
 
o Average proportion of training elements completed 
o Proportion of training sessions in which all training elements completed 
● Patient Intervention 
o Average number of mentoring sessions completed per patient 
o Patient retention rates across all five peer mentoring sessions 
o Average peer mentoring session length 
o Education module completion rates by topic and section  
o Quiz completion rates 
o Average time spent on each educational module section 
o Average proportion of peer mentoring session components completed by session 
o Proportion of peer mentoring sessions in which all session components 
completed 
o Mentor-specific peer mentoring completion rates – for use by NKF in training and 
supporting mentors 
o Number of mentees who continue as mentees or mentors in the existing NKF 
peer mentoring program after intervention  
o Number of patients who accept the optional “tablet training call,” the length of the 
call, and the topics covered during the session (see section 44, “dialysafe pt 
tablet training plan”) 
o Whether patients have prior experience in using Apple or Android products 
● Technology Training Fidelity 
o Training completion rates 
o Average length of call 
o Percentage of calls completed as-scheduled vs. after rescheduling 
o Compilation of frequently asked questions 
o Compilation of common reasons for refusal to schedule call 
● Technology Support Calls 
o Number of tech support calls 
o Number of calls from each category of caller (mentee, mentor, clinic 
staff) 
o Average length of calls 
o Compilation of frequently asked questions 
o Compilation of common solutions to questions 
o Number of caller questions resolved after one call vs. after additional 
followup 
● Patient Activation Intervention Uptake 
o Stated interest in intervention, but lost to follow up by intervention 
stage (e.g. tablet received, tech training, starting peer mentoring, 
completion of peer mentoring, tablet returned) 
o Tech training completion  
o No shows for tech training 
o Number of peer mentoring sessions completed 
o No shows for peer mentoring sessions 
o List of educational sessions completed 
o List of quizzes completed 
o Frequency of fluid management goal setting module responses by 
patient in educational sessions, by session 
o Frequencies of values endorsed in values module in educational 
sessions  
o  
 

 
 
77 |      Version Draft 7.0  December 2023 
 
12 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
 
Table 9 – Sources of Materials and Access to Materials 
Patient activation intervention using peer mentoring  
 
Source 
Data Collection Mode 
Variables (examples) 
Who will have access 
FMCNA 
Electronic health record 
(EHR) and session data for 
each dialysis session 
Personal health information 
(PHI) (includes 
demographic information, 
comorbidities, medications, 
lab tests, dialysis session 
data, Quality of life survey) 
FMCNA will transfer a 
limited data set using 
unique FKC identifier for 
each patient 
 
 
UM-KECC 
Programmer/Analysts 
 
Co-PI Rajiv Saran, 
Biostatisticians 
National 
Kidney 
Foundation 
Peer Mentoring 
Management System 
(PMMS) stored on secure, 
HIPAA-compliant server at 
the University of Michigan 
Medical School 
Peer Mentor demographics 
(age, gender, race 
ethnicity, education) 
 
Mentor-mentee matches 
 
Scheduled peer mentoring 
sessions 
 
Average number of 
mentoring sessions 
completed per patient 
 
Patient retention rates 
across all five peer 
mentoring sessions 
National Kidney 
Foundation 
 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 
Michigan School of 
Information 
 
University of California 
at Irvine staff (system 
developers) 
National 
Kidney 
Foundation 
Patient Intervention 
Completion Data – Peer 
Mentoring live sessions 
 
Peer mentoring 
videoconference completion 
data via VSee stored in Peer 
Mentoring Management 
System (PMMS) with non-
identifying patient login 
Whether session was 
completed 
 
Number of people in 
session 
 
Session length 
 
Average peer mentoring 
session length 
National Kidney 
Foundation 
 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 
Michigan School of 
Information 
 
University of California 
at Irvine staff (system 
developers) 
Study team 
Patient Intervention 
Completion Data – Tablet-
based Educational Modules  
- each patient will be given a 
Education module 
completion rates by topic 
and section  
 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 

 
 
78 |      Version Draft 7.0  December 2023 
 
unique login ID at the 
beginning of the study, and 
this will be used to track 
usage of the educational 
modules; this log in ID will 
be identifiable only to study 
coordinators through the 
Peer Mentoring 
Management System 
(PMMS) 
No PHI will  be stored on the 
tablets at any time 
 
 
 
Quiz completion rates 
 
Average time spent on 
each educational module 
section 
 
Usability: (1) time spent on 
each page; (2) number of 
abandoned checklist 
sessions, 
videoconferencing or 
patient education module 
sessions; (3) pages and 
click-through patterns 
preceding abandonment. 
Michigan School of 
Information 
 
 
University of California 
at Irvine staff (system 
developers) 
National 
Kidney 
Foundation 
Checklist of peer mentoring 
training topic coverage 
 
Data transferred to Excel or 
Word format 
Fidelity of the peer 
mentoring training 
 
Proportion of training 
session in which all 
elements completed 
National Kidney 
Foundation 
 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 
Michigan School of 
Information 
National 
Kidney 
Foundation 
Checklists of topic coverage 
and behavior change 
technique implementation 
 
Data transferred to Excel or 
Word format 
Fidelity of the peer 
mentoring intervention  
 
Proportion of peer 
mentoring sessions in 
which all session 
components completed 
 
Mentor-specific peer 
mentoring completion rates  
National Kidney 
Foundation 
 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 
Michigan School of 
Information 
National 
Kidney 
Foundation 
Survey on Qualtrics Platform 
Peer Mentor satisfaction 
with peer mentoring 
National Kidney 
Foundation 
 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 
Michigan School of 
Information 
National 
Kidney 
Foundation 
Survey on Qualtrics Platform 
Patient mentee satisfaction 
with peer mentoring (see 
attached documents: Peer 
Mentee Satisfaction Survey 
and Peer Mentor 
Satisfaction Survey) 
National Kidney 
Foundation 
 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 

 
 
79 |      Version Draft 7.0  December 2023 
 
Michigan School of 
Information 
FMCNA 
Report on patient peer 
mentoring program 
completion, transferred from 
Peer Mentoring 
Management System by 
UMSI Principal Investigator 
and/or Study Coordinators 
with FKC ID2, which FMCNA 
will match to FKC ID1 
 
Report on patient peer 
mentoring completion send 
to UM-KECC using FKC ID1 
Number of Peer Mentoring 
Sessions Completed 
 
Peer Mentoring Start Date 
 
Peer Mentoring Stop Date 
FMCNA Data Analysts 
 
UM-KECC 
Programmer/Analysts 
 
Co-PI Rajiv Saran, 
Biostatisticians 
 
 
Study team 
Patient Training Fidelity 
Checklist 
 
Completed by UMSI study 
staff following technology 
training calls to patients who 
have joined peer mentoring 
 
Data transferred from paper 
form to Excel or Word format 
Items discussed during 
tech training call 
 
Major questions or issues 
outside of fidelity checklist 
 
“25.1_PM_Recruitment_an
d_Retention_Procedure” 
Tiffany Veinot 
 
UMSI Project 
Coordinators 
Study team 
Patient Technology Training 
Records 
 
Completed by UMSI study 
staff to track number of 
technology training calls 
without identifying patient 
names 
 
Stored on UMSI secure 
server and PMMS 
 
Whether patients in the 
peer mentoring program 
accept or decline a tech 
training call  
 
“Training Records” tab of 
“Tech Calls” document 
Tiffany Veinot  
 
UMSI Project 
Coordinators 
 
National Kidney 
Foundation Project 
Coordinators 
 
Kai Zheng, University of 
California at Irvine (Co- 
Investigator) 
 
Paid Developer at 
University of California 
at Irvine, supervised by 
Kai Zheng 
Study team 
Technology Support 
Records 
 
Completed by UMSI study 
coordinators to track the 
technical support provided to 
clinics and members of the 
Major questions or items 
discussed from calls to the 
study helpline 
 
Who contacted UMSI 
(mentee, mentor, clinic 
staff) 
Tiffany Veinot  
 
UMSI Project 
Coordinators 
 

 
 
80 |      Version Draft 7.0  December 2023 
 
peer mentoring program, 
without identifying patient or 
provider names 
 
Stored on UMSI secure 
server and PMMS 
 
 
Date and time of call 
 
“Tech support log” tab of 
“Tech Calls” document 
National Kidney 
Foundation Project 
Coordinators 
 
Kai Zheng, University of 
California at Irvine (Co- 
Investigator) 
 
Paid Developer at 
University of California 
at Irvine, supervised by 
Kai Zheng 
 
 
Provider education intervention 
 
FMCNA 
Electronic health record 
(EHR) and session data for 
each dialysis session 
Personal health information 
(PHI) (includes 
demographic information, 
comorbidities, medications, 
lab tests, dialysis session 
data, Quality of life survey) 
FMCNA will transfer a 
limited data set using 
unique FKC identifier for 
each patient 
 
 
UM-KECC 
Programmer/Analysts 
 
Co-PI Rajiv Saran, 
Biostatisticians 
Study team 
Practice Patterns Survey for 
(1) Medical Directors and (2) 
Nurse Managers delivered 
before and after intervention 
via Qualtrics Platform 
Practices for assessing 
patient estimated dry 
weight at facility  
 
Practices for managing 
intradialytic weight gain at 
facility 
 
Facility policies regarding 
fluid removal and 
ultrafiltration rates 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 
Michigan School of 
Information 
 
UM-KECC 
Programmer/Analysts 
 
Co-PI Rajiv Saran, 
Biostatisticians 
Study team 
Provider team training 
fidelity checklists – 
completed on paper and 
transferred to Excel 
Average proportion of 
training elements 
completed 
 
Proportion of training 
sessions in which all 
training elements 
completed 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 
Michigan School of 
Information 
 
Co-Investigator Sarah 
Krein 
Dialysis 
facilities 
Checklist Completion Data 
from Checklist application on 
tablet computer used at 
facility with facility-level login 
Checklist completion rate 
by facility over specific time 
points 
 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 

 
 
81 |      Version Draft 7.0  December 2023 
 
only; no tracking of individual 
staff 
 
 
Checklist completion data 
stored in database on 
secure, HIPAA-compliant 
server at the University of 
Michigan Medical School 
Proportion of checklist 
sessions in which patients 
are identified as being at 
risk of IDH 
 
Prevalence of  reasons 
why patients were 
identified as being at risk of 
IDH 
Michigan School of 
Information 
 
University of California 
at Irvine staff (system 
developers) 
Study team 
 
 
Online training attendance 
records - Paper form lists 
number in attendance by 
role only 
 
FMCNA clinics to share 
attendance by role in digital 
form via secure FMCNA 
email 
 
Data from paper form 
transferred to Excel or Word 
format and stored on secure 
research server at the 
University of Michigan 
School of Information 
(UMSI) 
Proportion of staff by role 
who completed each 
training session, tracked by 
facility 
 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 
Michigan School of 
Information 
 
Co-Investigator Sarah 
Krein 
 
FMCNA 
Completion of training in 
learning management 
system 
 
FMCNA shares training 
completion reports via 
SharePoint 
 
Data transferred to Excel or 
Word format and stored on 
secure research server at 
the University of Michigan 
School of Information 
(UMSI) 
Proportion of staff by role 
who completed each 
training session, tracked by 
facility 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 
Michigan School of 
Information 
 
Co-Investigator Sarah 
Krein 
 
Study team 
Field Notes from Meetings 
tracked by facility ID; will 
include participant IDs which 
refer to facility and 
professional role (e.g., 
dietitian, NP) 
 
Data will be stored in a Word 
Processing Program – Word 
and a Qualitative Data 
Identify and explain types 
of implementation barriers 
and facilitators 
 
Use qualitative analyses as 
supplementary 
explanations as we seek to 
explain the results of the 
trials, especially if there are 
differences in effectiveness 
Principal Investigator, 
Study Coordinators and 
Postdoctoral Research 
Fellow at University of 
Michigan School of 
Information 
 
Co-Investigator Sarah 
Krein 

 
 
82 |      Version Draft 7.0  December 2023 
 
Analysis Software package 
(e.g., NVivo) 
 
Files will be stored on a 
secure research server at 
the University of Michigan 
School of Information 
(UMSI) 
between facilities 
implementing the same 
interventions 
 
 
 
 
 
Note: data in the above table have been compiled based on the attached data flow diagram and 
the following attached documents: (1) implementation assessment plan; (2) peer mentor data 
relinking plan, (3) provider training fidelity checklists; (4) peer mentoring fidelity checklists; (5) 
peer mentee satisfaction survey; (6) peer mentor satisfaction survey; (7) practice patterns 
survey for Medical Directors; (8) practice patterns survey for Nurse Managers; and (8) HIPAA 
compliance of Dialysafe Tools; and (9) Data elements list. 
 
See attached data use agreement for use of data from FMCNA and Study Facilities. 
13 
QUALITY CONTROL AND QUALITY ASSURANCE 
All UM study personnel who have access to patient data will be educated regarding the need to 
protect confidentiality and the procedures to be followed to ensure such protection; all relevant 
staff will be required to sign a confidentiality agreement. All study personnel are required to 
complete and be certified by the Program for Education and Evaluation in Responsible 
Research and Scholarship (PEERRS) at the University of Michigan every 3 years. External key 
personnel will also be required to have human subjects certification via the UM PEERRS 
modules or equivalent training as approved by UM. NKF’s peer mentoring program coordinator 
and program assistant will have access to patient names, gender, clinic, treatment schedule, 
and telephone number, after patients have agreed to the peer mentoring program and have 
given permission for a UM Study Coordinator to share this information with NKF. While NKF is 
not a HIPAA-covered entity, it has offered a patient peer mentoring program for over seven 
years, and has handled this type of patient information on an ongoing basis in order to deliver 
this program. Study personnel will also be required to complete annual HIPAA training. 
14 
ETHICS/PROTECTION OF HUMAN SUBJECTS 
This section should include a description of the ethical considerations and context for the 
conduct of the trial. 
14.1 
ETHICAL STANDARD 
The investigator will ensure that this study is conducted in full conformity with the principles set 
forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human 
Subjects of Research, as drafted by the US National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 
46; 62 Federal Regulations 25691 (1997) and the Declaration of Helsinki and Good Clinical 
Practice (GCP).  
 

 
 
83 |      Version Draft 7.0  December 2023 
 
14.2 
INSTITUTIONAL REVIEW BOARD 
We are applying to have the University of Michigan IRB-MED serve as the central IRB for all 
study sites. FMCNA will have completed an Agreement to cede IRB review to the University of 
Michigan IRBMED. All 20 hemodialysis facilities are operated by FMCNA, and FMCNA will 
provide all data centrally through its corporate data warehouse to University of Michigan. 
 
14.3 
INFORMED CONSENT PROCESS 
I. Requested alterations to the informed consent process 
 
PATIENTS 
 
The patient information sheet contains content on the key elements of informed consent, but 
they will not be accompanied by a verbal dialogue to ensure informed consent nor records of 
having obtained consent. Staff at hemodialysis facilities will not obtain informed consent from 
patients. 
 
For the overall study, at each participating facility, the following actions will take place: 
 
1) A staff member (likely a patient care technician or nurse) will give each patient in the facility 
the patient information sheet, using the enclosed script. 
2) On a list, the facility staff member or UM Study Coordinator will record the fact that each 
individual patient received the information sheet, and record any opt-outs from patients. 
3) Patients may also call the UM School of Information research team via a 1-800 number (1-
844-864-3228) to ask questions and/or opt out of the study and/or discontinue peer mentoring. 
4) The list of informed patients, including opt-outs, will be shared with an FMCNA nurse, who 
will create an "ancillary order" in the electronic health record for each patient who does not opt 
out of the study.  
5) A list of patients participating in the study will be produced (and regularly updated); this will 
be kept in a research binder at each study facility. 
 
To offer patients peer mentoring: 
 
1) The patient information sheet indicates that patients may be contacted to offer them peer 
mentoring. 
2) Using SharePoint, a secure computing environment hosted by FMCNA, the list of patients in 
the study, their sex, clinic, phone number and treatment schedule (to find the best time to call 
the patient) will be shared with the UM School of Information Study Coordinator. 
3) The UM Study Coordinator will call the patient to offer them peer mentoring, using the script 
provided. 
Patients without regular access to a personal phone will be sent a pre-paid cell phone if 
they indicate interest in the peer mentoring program to their clinic manager. 
4) A volunteer Patient Advocate, as described in Section 5.3, may discuss the peer mentoring 
program with other patients or hand out a flyer (“Peer Mentor Program Flyer”). Discussion will 
be limited to that which is described in the “Patient Discussions” document; namely, the Patient 
Advocate’s experience as part of the peer mentor program and the contact information for the 
UMSI study staff. 
 

 
 
84 |      Version Draft 7.0  December 2023 
 
Again, this will not be a formal informed consent process, as we are concerned about creating 
bias since informed consent will introduce preferential uptake of peer mentoring. Additionally, 
obtaining consent may create an imbalance in study arms (i.e., consent of patients in only one 
arm of the study). 
 
FACILITY STAFF 
In addition to approval by the Regional Vice President and Medical Director, each facility will 
approve their participation in the trial through their governing body. Facility staff do not 
constitute human subjects in the research as we will not gather private identifiable information 
directly about any individual, and the educational intervention will take place at the facility as a 
whole; it would be impossible to offer the intervention to some staff but not others. Furthermore, 
with regard to fidelity measurement, only aggregate reports concerning completion of training 
and the use of the checklist will be produced. Field notes will also not contain any individual 
identifiers for staff. 
 
II. Rationale for waiver of informed consent requirement  
 
We are seeking to obtain IRB agreement to waive the usual requirement for individual patient 
consent for this pragmatic cluster randomized trial of educational interventions at the dialysis 
facility level; this request applied to the complete study. The following points are to serve as 
underlying rationale for requesting a waiver of informed consent in this context:  
 
1) The research involves no more than minimal risk to the subjects 
 
The project uses a facility-level educational intervention that utilizes proven educational/quality 
improvement approaches, with a goal of improving the cardiovascular/hemodynamic stability of 
hemodialysis care. There will be 20 hemodialysis facilities in the study, of which 10 will receive a 
healthcare provider-focused intervention (training and a checklist) and 10 will receive a patient 
activation intervention (peer mentoring and multimedia education materials). There will be no 
interruption in usual care, and care will be provided to the usual standard at minimum — and 
perhaps improved. Patients who participate in peer mentoring may benefit by learning new and 
better ways to care for themselves so as to prevent hypotensive episodes during hemodialysis. 
 
2) The research could not practicably (i.e., feasibly) be carried out without the waiver or 
alteration. 
 
This is a pragmatic cluster-randomized trial of educational interventions at the dialysis facility 
level. When an educational effort is initiated at any facility, all patients, without bias, should be 
afforded the opportunity to experience its potential benefits. Additionally, it would be impossible 
to make provider education apply to some patients but not others. The study could not 
practicably be carried out without the waiver of consent for the following reasons that relate to 
the validity of study findings: 
 
(a) 
The primary outcome is measured at the facility level, and missing data will undermine 
internal validity. The study’s primary outcome, intradialytic hypotension rate, is a facility-level 
outcome determined at the level of the entire facility. There is a need for as close to 100% 
participation as possible in order to accurately determine rates of intradialytic hypotension. 
Administration of informed consent would lead to a loss of subjects, leading to an inaccurate 
estimation of a facility’s intradialytic hypotension rate.  
 

 
 
85 |      Version Draft 7.0  December 2023 
 
(b) 
Potential introduction of bias will threaten internal validity.  Those who consent to 
participate in the study are more likely to be people who have a better outcome – that is, they 
may be less likely to have intradialytic hypotension, or to have it regularly. This is because 
intradialytic hypotension is intimately linked to patient behaviors, including adherence to fluid 
and dietary restrictions, as well as adhering to regular dialysis sessions. People who do not 
follow these guidelines, and are not motivated to change this, are less likely to choose to be 
involved in a study in which these behaviors will be scrutinized. This would lead to systematic 
exclusion of patients who experience intradialytic hypotension most frequently, and undermine 
the generalizability of the findings to the full patient population, particularly those most in need of 
the intervention. 
 
(c) 
Interference with the pragmatic nature of the trial will affect external validity. The 
interventions are meant to be delivered in the context of routine care, so that hemodialysis care 
providers can estimate the likely effect of intervention implementation on everyday practice. 
Seeking informed consent from all patients will alter usual care, and potentially undermine the 
pragmatic nature of the trial, and the related conclusions that can be drawn from study findings. 
 
In addition, the following pragmatic reasons makes individual-level consent impracticable: 
 
(d) 
This is designed as a large, population-based, pragmatic, facility-level study of 
previously validated educational interventions. There are approximately 1,400 prevalent patients 
at the 20 facilities to be included in the study (of whom we estimate 1,200 will not be excluded 
due to vulnerable status or opting out). It is not possible to obtain informed consent from this 
many patients within available funding levels. 
 
(e) 
This is a multi-state study that will take place in hemodialysis facilities in Michigan, Ohio, 
Massachusetts, Connecticut, California, Alabama, and other states to be determined.  
 
d)        We remain committed to providing detailed feedback about the results of the trial to the 
participating facilities, so that any potential benefits can continue to be experienced.  
 
There is precedence for the above approach in the context of pragmatic clinical trials86, the most 
recent examples in hemodialysis care being the time trial 
(https://clinicaltrials.gov/ct2/show/nct02019225), and the national opportunity to improve 
infection control in ESRD (NOTICE) project,81, 82 in which Co-PI Saran participated. 
 
3) The waiver or alteration will not adversely affect the rights and welfare of the subjects 
 
Intradialytic hypotension is an important concern among patients, and the research has received 
significant support from patients consulted via three focus groups in two parts of the country, a 
Steering Committee with two patient advocates, and a national Advisory Committee that 
involves seven patient advocates. This research will exclude vulnerable patients. Although a 
consent process is not practicable (see below), all patients in the study facilities will be given an 
information sheet about the study, and will be given an opportunity to opt-out of the research. All 
clinical data regarding patients will be received from FMCNA as a limited data set with a unique 
random FKC identifier. All data shall be destroyed seven years after completion of study. 
 
4) Whenever appropriate, the subjects or their Legally Authorized Representative will be 
provided with additional pertinent information after participation. 
 

 
 
86 |      Version Draft 7.0  December 2023 
 
At the end of the intervention in their facility, patient participants will be given access to a study 
Web site that will provide updates about the trial’s progress. Through this Web site and other 
communication vehicles, the study team will be available to answer questions from patients or 
staff at study facilities. We will work with the National Kidney Foundation (NKF) to present study 
results to peer mentors as part of a teleconference at the end of the study. We will also work 
with NKF to create user-friendly, written results summaries to be shared with focus group 
participants and mentors. Furthermore, upon completion of data analyses, a results “fact sheet” 
– an abridged final report detailing the study’s findings – will be made available at all study 
facilities (e.g., in the waiting room or on bulletin boards). These documents will be developed by 
the Steering Committee in consultation with the National Kidney Foundation and the Advisory 
Committee. 
14.4 
EXCLUSION OF WOMEN, MINORITIES, AND CHILDREN (SPECIAL POPULATIONS) 
We aim to include all non-vulnerable in-center patients at participating dialysis facilities. The trial 
is designed so as not to exclude anyone, including women and minorities to the extent they are 
represented at the dialysis facilities from the ages of 21 and older. We will only exclude 
vulnerable patients: those under 21 years of age, prisoners, those with a cognitive barrier, and 
those deemed vulnerable based on a cognitive barrier by the Clinical Manager, Medical 
Director, and/or Social Worker, and those with a lack of facility in English or Spanish (patients 
whose primary language is not English or Spanish). 
14.5 
SUBJECT CONFIDENTIALITY 
Subject confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents.  The study documentation, data, and all other information 
generated will be held in strict confidence.  
We understand the sensitive nature of patients’ medical records and of patient and provider 
input, and we have utmost concern for the human subjects who will be part of this study. We will 
seek a waiver of authorization from the Privacy Board and will take steps to ensure protection of 
confidentiality. Data obtained will be held strictly confidential in locked facilities and password-
protected computers. All information will be kept in password-protected databases, with secure 
servers. Computers will be locked or kept with only key study personnel at all times. Key study 
personnel will be restricted to only data they need to access. Electronic patient data described 
above will be transmitted to UM-KECC for archiving on their password-protected secure 
servers. Only FMCNA personnel, Co-PIs, study statisticians, and the programmer analysts at 
UM-KECC will have access to PHI for the purposes of Aim 1 and Aim 2 analyses, and Study 
Coordinators and the PI will have access to PHI for the purposes of managing the opt out 
process and offering patients peer mentoring. The National Kidney Foundation will have patient 
contact information and records of peer mentoring, but NKF is not a HIPAA-covered entity. Data 
sets created for analysis will not have personal identifiers. See the attached data flow diagram 
for further information. These safeguards have proven effective in securely keeping existing 
national data on all ESRD patients in the United States. Additional special provisions are 
outlined below. 
 
I. 
Limited Data Set 
 

 
 
87 |      Version Draft 7.0  December 2023 
 
All data held by the University of Michigan Kidney Epidemiology and Cost Center (UM-KECC) 
will be in the form of a limited data set, with patient data linked across sources using random 
identifiers created by FMCNA for each individual. For the session-level outcomes of intradialytic 
hypotension, adherence and symptoms, it will be important to conduct analyses that cluster 
according to the patient, and adjust for patient-level factors such as medications and 
comorbidities. As-treated analyses for peer mentoring also require identification of patients who 
received peer mentoring, the amount of peer mentoring received, and when it was received. 
Such analyses cannot be completed without patient-level identifiers.  
 
II. 
Handling of Protected Health Information (PHI) 
 
We are applying for a HIPAA Authorization Waiver Request as part of this study. The study 
involves examination of the impact of two educational interventions on clinical outcomes 
including intradialytic hypotension rates (primary outcome), dialysis adherence, fluid adherence 
(interdialytic weight gain), patient symptoms, quality of life, mortality and hospitalization. For 
these analyses, it is necessary to be able to link clinical information to a specific patient, and to 
be able to identify their facility and the amount of peer mentoring they have received (if 
applicable). It is also necessary to use medical records to identify whether a patient is 
vulnerable and should be included from the study (e.g., under age 21, prisoner). Thus, without 
the PHI to be used in the study, it will be impossible to assess who received the intervention, in 
what amount (e.g., peer mentoring receipt), and the effects of the interventions on the outcomes 
of intradialytic hypotension, dialysis adherence, interdialytic weight gain, patient symptoms, 
quality of life, hospitalizations, and mortality. Our plan to protect patient-subject identifiers from 
improper use or disclosure is as follows: 
1)  Each patient already will be given a unique ID (FKC ID1) that will be linked to patient data 
and stored at UM-KECC. UM-KECC is compliant with the Federal Information Security 
Management Act (FISMA). Furthermore, the organization undergoes an annual, comprehensive 
IT Risk Assessment, and monthly vulnerability scans to test the system. UM-KECC staff 
undergo background checks and training specifically for handling PHI.  
2) Patient Study data from FMCNA to UM-KECC will be transferred using a secure file transfer 
service, as a limited data set using the FKC random patient identifier (FKC ID1). 
3) Patients who are to be offered peer mentoring will be identified by FMCNA, and their names, 
clinics, genders, treatment schedules, telephone numbers and a random FKC ID2 given to the 
UM Study Coordinator (Note: this ID is different from that identified in 1) and 2) above). 
Participants will also be given a non-identifying ID automatically generated by PMMS based on 
the order they are added to the secure PMMS site. This will be used for for communication 
between UMSI study staff and NKF, as well as record keeping for technology training fidelity, 
technology training recruitment, and tech support calls. To obtain this information, the Study 
Coordinators will log into SharePoint, hosted on FMCNA’s secure servers, from which no 
information can be printed, transferred, or removed. The Study Coordinators will phone the 
patient, explain peer mentoring, and offer it to them. If the person agrees to receive peer 
mentoring, their contact information will be entered into the secure Peer Mentoring Management 
System (PMMS), which will be posted on a HIPAA-compliant server at the University of 
Michigan Medical School. The PMMS will then be accessed by the National Kidney Foundation 
(NKF) staff member, who will then conduct intake with that person. The patient will agree to UM 
sharing their information with NKF prior to doing so, and their date of birth (to facilitate matching 

 
 
88 |      Version Draft 7.0  December 2023 
 
to the FKC ID1 identifier) will be obtained from the patient, either by a University of Michigan 
School of Information Study Coordinator or the National Kidney Foundation. 
4) The NKF is not a HIPAA-covered entity. It will maintain records of peer mentoring provision, 
and schedules of peer mentoring sessions. For data analysis, peer mentoring records linked to 
a FKC ID2 identifier will permit linkage to clinical data that will be stored and analyzed by UM-
KECC for the study. 
5) Patients will use a study-provided tablet computer to be shipped to each patient. Using the 
tablet, they will connect with their peer mentor and to review multimedia educational modules 
(with quizzes). Each patient will be given a unique login ID at the beginning of the study, and 
this will be used to track usage of the educational modules (e.g., page views, modules 
completed, quiz completion). This log in ID will be identifiable only to study coordinators through 
the PMMS. An easily-remembered but non-identifying password will be supplied upon setting up 
each patients’ ID. Patients will be prompted to change the password to something private to 
them when signing into a tablet for the first time.  
When setting up this ID, a study coordinator will help each patient set up a series of easily 
remembered security questions. In the case that a patient forgets their password, they may 
answer these questions to gain access to their account and reset their password. If a patient 
needs additional assistance in accessing their account or resetting their password, they may 
contact the Dialysafe helpline, where a study coordinator may manually reset a patient’s 
password after confirming security questions. 
After completion of the patient activation intervention, UM Study Coordinators will mail return 
shipping materials to each patient. The patient will then be asked to use these materials to ship 
the tablets back to UM for cleaning and re-use with other patients. Prior to shipping, UM Study 
Coordinators will wipe all data off of the patient’s tablet using the remote tablet management 
program recommended by HITS (Health Information Technology & Services at Michigan 
Medicine). 
6) Patient peer mentoring sessions will be conducted through VSee videoconferencing software, 
a HIPAA-compliant tool (see Section 15 for details). 
7) FMCNA will share information with UM using its secure SharePoint computing environment 
(see Section 15 for details). 
8) Surveys will be administered using the HIPAA-compliant Qualtrics.com survey tool (see 
Section 15 for details). 
9) FMCNA will share the name of patient advocates as described in Section 5.3 with patients 
and visitors and other individuals associated with the Study such as UM Study Coordinators. 
UM Study Coordinators will call the patient advocates using the contact information they already 
have as part of the peer mentoring program to provide patient advocate training. 
UM-KECC and UMSI will never possess a crosswalk file with which to re-identify patients. Peer 
mentoring data (which includes patient name and date of birth) held in the peer mentoring 
management system will be retained according to terms of PCORI contract: for a period of three 
(3) years from the a) Contract Term Date, b) date of the final payment under the UM-PCORI 
Contract, or c) conclusion of any audit or litigation related to the UM-PCORI Contract, whichever 

 
 
89 |      Version Draft 7.0  December 2023 
 
is later. The crosswalk file with the FKC Random ID1 and FKC Random ID2 will be destroyed by 
FMCNA upon completion of data analyses. 
Information will not be reused or disclosed to anyone outside of the research team, unless 
required by law or oversight of the research study. 
 
 
III. 
Facilitating Patient Activation Intervention by National Kidney Foundation, and 
relinking of data for analyses by UM-KECC 
 
The University of Michigan School of Information (UMSI) will also have access to the patient's 
name, sex, dialysis shift, telephone number and FKC ID1 so that they can be offered peer 
mentoring. If the patient agrees to receive peer mentoring, their name, gender, facility, treatment 
schedule, phone number and date of birth (obtained by a UMSI Study Coordinator, Postdoctoral 
Research Fellow or PI) will be entered into the Peer Mentoring Management System for use by 
the National Kidney Foundation. It will be impossible to provide them with peer mentoring if we 
do not know who they are; this information will be retained by the National Kidney Foundation 
as they provide the peer mentoring service.  This information will be kept separate from the data 
held by UM-KECC. FMCNA will re-link peer mentoring data to patient data held by UM-KECC 
through the  use of FKC ID1 and FKC ID2; which FMCNA will use to link data prior to sending 
the peer mentoring data to UM-KECC using FKC ID1 as a unique identifier. UMSI and UM-
KECC will not have a crosswalk file to permit re-identification of any patients in peer mentoring 
(identified by FKC ID2) with the FKC ID1 identifier. Neither FMC nor UM-KECC will have access 
to the PMMS containing the automatically generated patient DS ID alongside other patient 
information contained in the system. 
 
At the conclusion of the peer mentoring intervention, using the Peer Mentoring Management 
System (PMMS), UMSI will generate a report of peer mentoring records with the data elements 
shown in the column headers of Table 10. This report will then be sent to FMCNA for linking of 
the FKC ID2 to the FKC ID1.   
 
 
Table 10 - Peer Mentoring Management System Sample Report 
FKC 
ID2 
Number of 
Peer 
Mentoring 
Sessions 
Complete
d 
Peer 
Mentori
ng Start 
Date 
Peer 
Mentoring 
Stop Date 
Number of 
Missed 
Peer 
Mentoring 
Sessions 
Complete
d Tech 
Training 
(Yes/No/
Not 
needed) 
Number 
of Missed 
Tech 
Training 
Sessions 
List of 
Educational 
Sessions 
Completed 
List of 
Educational 
Session 
Quizzes 
Completed 
Tablet 
Returned 
(Y/N) 
1489 
5 
6/1/2021 
8/24/2021 
2 
Yes 
1 
1, 3, 5 
1, 3, 5 
Y 
4572 
4 
6/5/2021 
8/15/2021 
1 
Not 
needed 
0 
1, 2, 3, 4 
1, 2, 3, 4 
N 
 
FMCNA will link the data in Table 10 with the FKC ID1 previously generated for purposes of the 
study, replacing FKC ID2 with FKC ID1. The FKC ID1 will be used to identify study participants 
and will be included in the data transferred from FMCNA to UM-KECC. FMCNA will generate a 
Peer Mentoring Report for UM-KECC that includes the FKC ID1 and it will contain the peer 
mentoring data required for data analysis (see Table 11). FMCNA will then provide this report to 
UM-KECC using the same procedure established for sharing other study data from FMCNA. 

 
 
90 |      Version Draft 7.0  December 2023 
 
 
This “Plan for Linking Peer Mentoring Records to UM-KECC Patient Data” (see attached 
document) preserves UM-KECC’s receipt of a limited data set by ensuring that identifiable 
patient data used by UMSI and NKF for the purposes of peer mentoring is kept separate from 
the limited data set used for analyses at UM-KECC. In this plan, FMCNA acts as an 
intermediary between UMSI and UM-KECC by linking patient peer mentoring data to the FKC 
ID1, which UM-KECC will then use to link peer mentoring records to other patient data. 
Therefore, UM-KECC will only receive the information outlined in Table 11 below. At the same 
time, project staff at UMSI will not have access to the limited data set which UM-KECC will use 
to analyze the data. 
 
Table 11 - Sample Peer Mentoring Report for UM-KECC 
FKC 
ID1 
Number of 
Peer 
Mentoring 
Sessions 
Completed 
Peer 
Mentori
ng Start 
Date 
Peer 
Mentoring 
Stop Date 
Number of 
Missed 
Peer 
Mentoring 
Sessions 
Completed 
Tech 
Training 
(Yes/No/No
t needed) 
Number 
of 
Missed 
Tech 
Training 
Sessions 
List of 
Education
al 
Sessions 
Complete
d 
List of 
Educationa
l Session 
Quizzes 
Completed 
Tablet 
Returned 
(Y/N) 
90000 
5 
6/1/2023 
8/24/2023 
2 
Yes 
1 
1, 3, 5 
1, 3, 5 
Y 
90001 
4 
6/5/2023 
8/15/2023 
1 
Not needed 
0 
1, 2, 3, 4 
1, 2, 3, 4 
N 
 
14.6 
STUDY DISCONTINUATION 
If the study were discontinued, all patients would continue to receive routine hemodialysis care. 
14.7 
FUTURE USE OF STORED SPECIMENS 
N/A 
15 
DATA HANDLING AND RECORD KEEPING 
The Principal Investigators are responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported.  Security measures to protect the privacy of research 
subjects are secure servers and file transfers, as well as password access will be used to 
protect the privacy of the research subjects. Qualtrics, a videoconferencing platform, checklist 
application and the peer mentoring management system are all HIPAA-compliant tools. 
 
UM-KECC. UM-KECC is the Data Coordinating Center for the Dialysafe study. 
Established in 1993, UM-KECC is an interdisciplinary research group primarily drawing from the 
SPH Departments of Biostatistics, Epidemiology and Health Management and Policy, and the 
UM Medical School Departments of Internal Medicine (Nephrology, Transplantation, and 
Cardiology), Surgery, and Pediatrics, as well as other UM departments. With 50 staff and 40 
associated faculty members, it conducts major projects in end-stage renal disease, chronic 
kidney disease, and organ transplantation. UM-KECC has substantial experience working with 

 
 
91 |      Version Draft 7.0  December 2023 
 
large databases in ESRD, CKD and transplantation. Its mission is to promote health, improve 
clinical practice and patient outcomes, optimize resource utilization, and inform public policy. 
UM-KECC facilities will serve as the home location for the work outlined in this proposal. 
 
The offices of the UM-KECC are located in a suite at the University of Michigan School of Public 
Health (SPH) on the central campus in Ann Arbor, Michigan. Exterior building doors are locked 
outside of usual business hours. UM-KECC and suite doors are locked at all times. Only 
authorized personnel have access via an electronic access system. Intra-building wiring 
connections between floors are made through locked basement phone closet. 
 
The UM-KECC system is connected to the Internet through the University of Michigan network. 
This connection is routed through a dedicated single-purpose firewall. Authentication of users 
and control of access to files is through Windows Server 2008 R2 security. 
 
UM-KECC is compliant with the Federal Information Security Management Act (FISMA), and 
has in place an Authority to Operate (ATO) from the Department of Health and Human Services 
(DHHS).  Furthermore, the organization undergoes an annual, comprehensive IT Risk 
Assessment, and monthly vulnerability scans to test the system.  
 
Fresenius Medical Care North America. FMCNA’s SharePoint is hosted on a secure 
shared drive on a windows file server and a secure Citrix server which contains computer 
applications needed for the research studies. Only approved research personnel will be granted 
access. The University of Michigan will log in remotely to access the secure environment. 
 
 
Virtual Environment for Peer Mentoring Management System (PMMS) and 
Checklist Usage tracking at University of Michigan Medical School.  The storage of 
Information relating to Dialysafe interventions, such as that which is needed to facilitate peer 
mentoring and collect checklist completion data, is imperative for study progress and 
completion. Data to be tracked on the PMMS includes basic patient demographics needed for 
peer mentor matching, patient dialysis schedules, and goals that the patient has selected as 
part of the program’s educational sessions. This information will be stored on a custom-
configured Michigan Medicine virtual environment, which is also the system utilized by the 
University of Michigan hospital system. The checklist tracking system will record the date, time, 
and IP address of each checklist usage session on the tablet computer to be provided to each 
facility, as well as all clicks on the system and time spent on each screen. 
 
The Michigan Medicine virtual environment is aligned with HIPAA requirement by adapting the 
process of Risk Assessment. Michigan Medicine conducts Risk Assessment and Risk 
Management on the virtual environment and they follow the Risk Analysis and Risk 
Management documented as stated below. The last risk assessment was completed in 
2018 and Michigan Medicine worked with IA on another risk assessment that was completed in 
2022. 
  
● 
164.308(a)(1)(ii)(A) – Risk Analysis – “Conduct an accurate and thorough 
assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and 
availability of electronic protected health information held by the covered entity.” 
● 
164.308(a)(1)(ii)(B)  - Risk Management - “Implement security measures sufficient to 
reduce risks and vulnerabilities to a reasonable and appropriate level to comply with 
the above” 
  

 
 
92 |      Version Draft 7.0  December 2023 
 
Michigan Medicine virtual machines (VMs) are routed through a Distributed Switch through the 
CISCO Fiber Interconnect on a CISCO switch that is managed by the Michigan Medicine Health 
Information Technology & Services network team. VMs are connected to the Internet through 
the University of Michigan network. 
  
Only privileged account access is allowed with required two factor authentication and the 
passwords are recycled every 12 hours.  All VMs are on private VLAN subnets that use Network 
address translation (NAT) behind our Information Assurance Firewall router.  All Public network 
IP addresses ports are blocked by default and opened as needed by the applications. 
Authentication of users and control of access to files is through Active Directory. 
  
In addition, Michigan Medicine adheres to the following safeguards for 
all Michigan Medicine systems: 
● 
Administrative Safeguards. These focus on policies, procedures, and 
documentation to train workforce members and appropriately permit or restrict their 
access to protected health information regulated by HIPAA. 
Examples include: 
o 
Security awareness training program for all staff 
● 
Physical Safeguards. These focus on limiting access to facilities and information 
systems in which electronic information systems are housed, as well as any physical 
media that contains or is used to access PHI. 
Examples include: 
o 
Applying Security updates regularly to Operating Systems 
o 
Annual audit of administrative access on servers 
● 
Technical Safeguards. These focus on limiting access to PHI to specific persons. 
Examples include: 
o 
Automatic password lockout 
o 
Assigning unique name or number to track user identity 
 
Sources: Correspondence with John Herlocher with technical writing from Emily Fuentes, 
Michigan Medicine Health Information Technology Services. (Note: this information can also be 
found in the attached document, HIPAA compliance of Dialysafe Tools.)  
 
VSee for Peer Mentoring Sessions.  VSee is a cloud-based audio/video/content sharing 
conferencing service approved for use at Michigan Medicine. As part of the Dialysafe project, 
we will use VSee to conduct peer mentoring sessions in which a patient dialyzing at an FMC 
facility will communicate with a peer mentor for five discussion sessions over 
approximately a 12 week period. The patient will connect to VSee using a study-provided tablet 
computer. Using the VSee Application Program Interface (API), the VSee-based peer mentoring 
sessions will be launched directly from the secure peer mentoring website for the educational 
modules. Any utilization of VSee by any Dialysafe team member, including associates at 
National Kidney Foundation, will occur through UM-hosted and protected accounts. Using a 
secure account provided to the NKF peer mentoring coordinator, the encrypted sessions will be 
scheduled in advance, and emails sent to the peer mentor and mentee will serve as 
confirmations and reminders. Additionally, for those patients who consent to receiving text 
messages, an automated SMS reminder will be sent prior to their session (See “Peer Mentor 
SMS Scripts”). VSee will store a record of all completed sessions and the 
number of attendees. This data will be collected to enable both verification that the session took 
place and the production of program statistics. VSee has a Business Associate Agreement 
with the University of Michigan, making it acceptable for use with PHI.  

 
 
93 |      Version Draft 7.0  December 2023 
 
Educational Modules and Staff Checklist on Tablet Computers. In addition to using the 
tablet computer to connect with their peer mentor, patients will also be asked to review 
multimedia educational modules (with quizzes) to be located on the study-provided tablet 
computer. In addition to using the tablet computer to connect with their peer mentor, patients will 
also be asked to review multimedia educational modules (with quizzes) to be located on the 
study-provided tablet computer. 
Tablet computers also will be supplied to clinics randomized to the provider training intervention. 
Staff who fill out the checklist will do so using a tablet computer, using a single secure login that 
the clinic will share. A shared facility password will be used for simplicity. The data entry into this 
tablet by clinic staff will be to place check marks on a checklist that is used for each patient 
treatment; there will be no patient identifiers associated with the data. Usage data, such as 
number and composition of completed checklists, will be collected at the clinic level and stored 
in the virtual environment described below.  
No PHI will be stored on tablets at any time. Tablets will solely be used to access applications, 
which will store only the aforementioned usage data on the device. (Note: this information can 
also be found in the attached document, HIPAA compliance of Dialysafe Tools.)  
As part of the patient activation intervention, email and text messages will be used to 
communicate with patients as follows: 
 
1) Reminders of upcoming peer mentoring sessions: with first name and last initial (not last 
name) - will include date and time of session 
2) Action plans:  with first name and last initial (not last name), selected goal, and plan for 
addressing barriers (see the patient intervention materials for the action plan format) (optional if 
patient wants to receive this after their session) 
3) Patients can choose to email pdf resources to themselves (optional; triggered by the patient) 
4) If the patient decides to do change their login ID, email addresses may be used as a login ID 
for the patient tablets 
5) Administration of intervention, including scheduling and rescheduling peer mentoring 
sessions and technology training sessions, and follow up regarding missed peer mentoring 
sessions or technology training sessions 
 
Emails and texts may be sent through: Michigan Medicine (level 2) email, the Peer Mentoring 
Management System, VSee, and/or a project phone. The project phone will be kept in a locked 
drawer when not in use. Email and text message scripts may be found in the following 
documents: 21. Peer Mentor Email Scripts; 26. Peer Mentor SMS Scripts.   
 
 
 
UM School of Information (UMSI) Servers. Data for Aim 3 will be stored and analyzed 
on a secure S-core Linux server at UMSI. These data do not include any PHI. These servers 
have regular automated backups scheduled by the UM School of Information computing 
support.  The storage media will conform to industry-standards for stability and accessibility. 
The investigators will ensure that the research data is migrated to new formats, platforms, and 
storage media as required by good practice in a secure environment (e.g., lockable computer 
systems with passwords, firewall system in place, power surge protection, virus/malicious 
intruder protection). 
 
 
Qualtrics.com survey platform. The Provider Practice Patterns Survey and the Peer 
Mentor and Mentee satisfaction surveys will be delivered via the secure Qualtrics.com software 

 
 
94 |      Version Draft 7.0  December 2023 
 
platform. Qualtrics, the web-based software to be used for surveys and referral of patients to 
peer mentoring is HIPAA-compliant, and UM has a contract with the company. These data will 
be downloaded onto UMSI servers for statistical analyses. 
15.1 
DATA MANAGEMENT RESPONSIBILITIES 
The limited patient data set will be transferred centrally from FMCNA to the Data Coordinating 
Center, UM-KECC. At UM-KECC, study data will be cleaned and transformed as needed. 
Codebooks will be created for study variables. Data cleaning and analysis will be performed by 
Data Analysts at UM-KECC under the supervision of the senior and junior biostatisticians for the 
study (Gillespie and Bragg-Gresham, respectively). 
 
The opt out process, as outlined in the attached document, will involve remote, virtual support 
by a UM staff member (see attached opt out process document for more detail). A scanned 
version of the Opt Out Worksheet document will be uploaded into FMCNA’s SharePoint 
environment; it is not possible to download or print from this environment.  
 
As shown in the attached data flow diagram, the patient data to be used to contact patients who 
have not opted out of the study will be shared with the team at the UM School of Information via 
FMCNA’s SharePoint environment. It will not be possible to print or download from this system. 
If a patient agrees to participate in peer mentoring, their name, date of birth, email address, 
clinic name, clinic ID and treatment shift will be entered into the peer mentoring management 
system (PMMS). The National Kidney Foundation will then use these data, and the PMMS 
scheduling and matching functions, to administer the peer mentoring component of the patient 
activation intervention. UM School of Information staff will generate reports of peer mentoring 
participation and share these with FMCNA for linking to the FKC ID1. The FKC ID1 and patient 
records will then be sent to UM-KECC (see attached data relinking process document). 
 
For Aim 3 analyses, checklist completion data will be located on a HIPAA compliant server at 
the University of Michigan School of Medicine (see attached document entitled, HIPAA 
compliance of Dialysafe tools). These data will be tracked by facility, but not by individual staff 
member. The PI, co-Investigator Zheng at the University of California at Irvine, a paid developer 
at University of California at Irvine (supervised by Dr. Zheng), a Postdoctoral Research Fellow, 
and UMSI Study Coordinators will have access to these data. Implementation data from the 
patient activation intervention for Aim 3 will be stored on the University of Michigan School of 
Information’s Peer Mentoring Management System, which will be stored on a HIPAA compliant 
server at the University of Michigan School of Medicine (see attached document entitled, HIPAA 
compliance of Dialysafe tools). The PI, co-Investigator Zheng at the University of California at 
Irvine, a paid developer at University of California at Irvine (supervised by Dr. Zheng), a 
Postdoctoral Research Fellow, UMSI Study Coordinators and staff at the National Kidney 
Foundation will have access to these data. 
 
Also for Aim 3 analyses, as shown in the attached Implementation Assessment document, a 
secure research server at the University of Michigan School of Information (UMSI) will be used 
to store: Field Notes from Meetings, training attendance records, LMS Training Completion 
Records, Online Training Fidelity Checklist (see attached). Only the Principal Investigator, co-
Investigator Krein, a Postdoctoral Research Fellow and UMSI Study Coordinators will have 
access to these data. This information will be linked to a Study Facility ID, but there will be no 
identifying information about individuals on this server.  

 
 
95 |      Version Draft 7.0  December 2023 
 
15.2 
DATA CAPTURE METHODS 
Data are collected routinely by FMCNA study. Data will be securely transferred for all study sites 
by FMCNA as part of limited data set transfers during the course of the study.  
15.3 
TYPES OF DATA 
Data for this study will include outcome measures, covariates, and potential mediators obtained 
from the electronic health record system at FMCNA. Additionally, intervention fidelity data will be 
gathered using digital platforms (e.g., checklist application, peer mentoring management 
system, learning management system), attendance sheets and checklists. A provider survey for 
medical directors and nurse managers at each facility will document fluid management practice 
patterns before and after the study. Satisfaction surveys will be completed by peer mentors and 
mentees. Field notes will be completed by Study Investigators at meetings associated with the 
interventions at study facilities: online staff training sessions and Operations Committee (OC) 
meetings. 
15.4 
TIMING/REPORTS 
An external data safety monitoring board (DSMB) consisting of 5 members (outside of the 
University of Michigan) has been identified after IRB review of the project. The DSMB includes a 
biostatistician unrelated to the trial, a patient, a nephrologist, and a layperson unrelated to the 
field (e.g., bioethicist). 
The DSMB has met for an orientation to the protocol, and to advise on desired data for 
reporting. The DSMC will then meet annually in the trial implementation and data analysis 
periods of the study, or more frequently as requested by DSMB members.  
 
The study team will produce interim analyses every year of the trial implementation period, or as 
requested by the DSMB. We currently anticipate reporting annually to the DSMB blinded data 
on IDH and mortality rates in each treatment arm. The study has no stopping rules. 
15.5 
STUDY RECORDS RETENTION 
Data contained in the peer mentoring management system will be retained according to terms 
of PCORI contract: for a period of three (3) years from the a) Contract Term Date, b) date of the 
final payment under the UM-PCORI Contract, or c) conclusion of any audit or litigation related to 
the UM-PCORI Contract, whichever is later. All other data will be retained for seven years from 
the end of the study. 
15.6 
PROTOCOL DEVIATIONS 
Because this is a pragmatic trial, interventions will be delivered as part of routine care, and the 
majority of data are collected routinely by hemodialysis facilities. Any deviations from or 
modifications to the protocol will be reported to the project manager who will then in return 
report it to IRB. Study coordinators will meet with the Operations Committee and Study 
Champion at each trial facility at regular intervals, and assess (as applicable, depending on site 
randomization) checklist completion rates, training implementation, and implementation of the 
patient activation intervention via tablet computer as patients dialyze (see Protocol). The Study 

 
 
96 |      Version Draft 7.0  December 2023 
 
Coordinator at the National Kidney Foundation will communicate at regular intervals with peer 
mentors and participants as specified in the study protocol. During this time, they will discuss 
the progress of the study, and questions related to peer mentor training and support, and study 
reporting, frequency, duration and quality of peer mentor–mentee interaction using the peer 
mentoring management system where applicable will be discussed and assessed. The Study 
Coordinators, in each meeting with facility staff and peer mentors, will recapitulate and reinforce 
study procedures.  
 
Protocol deviations that could occur would be the data of a patient who had opted out of the 
study mistakenly being sent to UM-KECC. This will be identified through spot audits conducted 
by the FMCNA Corporate Study Manager using the following process: 
 
● A UM research study coordinator will develop a schedule to audit a random selection of 
25% of clinics once during their 11-month study period. This is a total of 5 audits over 
the prospective study period. 
● For each audit, a UMSI research study coordinator will select 25% of patient names and 
compare the records of patient opt outs contained on a worksheet in FMCNA’s 
SharePoint computing environment. The Study Coordinator will compare the opt out 
Worksheet data with that clinic’s Ancillary Order Report in the Electronic Health Record 
System from which study data transfers are generated. If discrepancies are found, the 
Corporate Study Manager will inform a UM Study Coordinator. If any patient who opted 
out is found to have an order, a 100% audit is triggered and the FMCNA Custom 
Reporting and Data Analytics group will be contacted to see if any data was sent to UM. 
If data were sent, the FMCNA Custom Reporting and Data Analytics group will notify 
UM-KECC to delete the data as of the date of opt out, using the FKC ID1 to identify the 
patient. If other errors are identified, further audits depending on type and frequency of 
errors will be done. Possible discrepancies:  
a) Patient who opted out has an Order,  
b) Patient who did not opt out does not have an Order,  
c) Order has a start date, stop date, or Patient Information Sheet date different from the 
Opt Out Worksheet 
 
Note: this information is also found in the attached document entitled Opt Out Process. 
16 
PUBLICATION POLICY 
Following completion of the study, the investigator is expected to publish the results of this 
research in a scientific journal. The International Committee of Medical Journal Editors (ICMJE) 
member journals have adopted a trials-registration policy as a condition for publication.  This 
policy requires that all clinical trials be registered in a public trials registry such as 
ClinicalTrials.gov*, which is sponsored by the National Library of Medicine. Other biomedical 
journals are considering adopting similar policies. The study’s sponsor, the Patient-Centered 
Outcomes Research Institute (PCORI) requires that the Dialysafe be registered with 
ClinicalTrials.gov, and its results released on this site. The UM Principal Investigator is 
responsible for ensuring registration with ClinicalTrials.gov. 
 
The ICMJE defines a clinical trial as any research project that prospectively assigns human 
subjects to intervention or comparison groups to study the cause-and-effect relationship 
between a medical intervention and a health outcome.   

 
 
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17 
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SUPPLEMENTS/APPENDICES 
Supplements and Protocol Appendices 
● Data Assessment and Flow (section 44 of IRB application) 
● Implementation Assessment Plan 
● Patient Data Flow: Plan for Linking Peer Mentoring Records to UM-KECC Patient Data 
● Data Flow Diagram 
● Consent Process 

 
 
106 |      Version Draft 7.0  December 2023 
 
● Opt out process 
● Informed Consent Document 
● Patient Information Sheet distribution script 
● Script for UM Study Coordinator to use when calling patients to offer them Peer 
Mentoring 
● Help Line Scripts  
● Staff Incentive Plan for Checklist completion 
● Data elements list 
● Executed Data Use agreement/Business Associate Agreement 
● Surveys 
● Peer Mentee Satisfaction Survey   
● Peer Mentor Satisfaction Survey  
● Practice Patterns Survey - Medical Directors 
● Practice Patterns Survey - Nurse Managers 
 
Related Documents 
● HIPAA Compliance of Dialysafe Tools 
● Study Intervention Materials 
● Patient activation intervention materials 
● Patient Story Videos (by peer mentoring session; uploaded separately in IRB 
application per instructions) 
● Patient Education Sessions 1-5 (section 44 of IRB application) 
● Peer Mentor Training (section 44 of IRB application) 
● Dialysafe Peer Mentor Emergency Procedures 
● Peer Mentor Training Fidelity Checklist 
● Peer mentoring fidelity checklists 
● Provider intervention materials (section 44 of IRB application) 
● Staff training modules, parts 1-4  
● Provider Educational Intervention Advanced Practitioners (Physician, NP and PA 
training modules) 
● Provider training fidelity checklists 
● Checklist Application Overview
● Schedule of Events 
 
 
 

 
 
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