Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis
Phase: NA
Conditions: Dialysis
Sponsor: Albert Einstein College of Medicine

Peer mentorship to improve outcomes in patients 
on maintenance hemodialysis
PEER-HD
Protocol Number: 2018-01
National Clinical Trial (NCT) Identified Number:  NCT03595748
Principal Investigators: 
Ladan Golestaneh MD, MS 
Michal Melamed MD, MHS
Kerri Cavanaugh MD, MHS
Sponsors: 
 
Albert Einstein College of Medicine 
Vanderbilt University Medical Center
Grant Title: Peer Mentorship to Improved Outcomes in Patients on Maintenance Hemodialysis
Grant Number: R18DK118471
Funded by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Version Number:  v.3.0*
2021-04-30
*Acknowledgment that an earlier version (v1.0) employing different formatting was submitted 
and approved by the primary sponsor (Albert Einstein College of Medicine). This version reflects 
current activities as IRB approved at primary site and will serve as the protocol document for 
VUMC and any additional future AECOM updates.
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

CONFIDENTIALITY STATEMENT
This document is confidential communication. Acceptance of this document constitutes agreement by 
the recipient that no unpublished information contained herein will be published or disclosed without 
prior approval of the Principal Investigator or other participating study leadership and as consistent with 
the NIH terms of award. 
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

Summary of Changes from Previous Version:
See section 10.4 for detailed description
Affected 
Section(s)
Summary of Revisions Made
Rationale
Date of 
Revision
Throughout 
Protocol 
Remote consent procedure (telephone, 
email, or mail)
Re-opening of study after COVID 
crisis to accommodate social 
distancing
6/9/20
5.1
Inclusion Criteria (10) to include “or Spanish 
– Bronx, NY site)
Grammatical error
6/10/20
9.4.2
Analysis of the Primary Endpoints – ED Visit 
and Hospitalization Count language revision
Biostats review deemed 
revisions
6/10/20
9.4.3
Analysis of Secondary Endpoints & 
Feasibility Outcomes language revisions 
Biostats review deemed 
revisions 
6/10/20
9.4.5
Baseline Descriptive Statistics language 
revision
Biostats review deemed 
revisions
6/10/20
Throughout 
Protocol
Primary endpoint follow-up period from 18 
months to 9 months (12 months 
observational)
Timeline revision due to COVID 
pandemic 
4/30/21
6.1
Assignment of 3 mentees per mentor 
revised to 4 mentees 
Mentee assignment revisions to 
meet timeline goals 
4/30/21
7.2
T2 surveys administered at time of 
discontinuation 
Established assigned 
discontinuation surveys 
4/30/21
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

Peer mentorship to improve outcomes in patients on maintenance hemodialysis (PEER-HD)Version 3.0 
Protocol 2018-01
30 April 2021
Table of Contents
STATEMENT OF COMPLIANCE.......................................................................................................................................1
INVESTIGATOR’S SIGNATURE ........................................................................................................................................2
1
PROTOCOL SUMMARY......................................................................................................................................3
1.1
Synopsis..................................................................................................................................................3
1.2
Schema...................................................................................................................................................5
1.3
Schedule of Activities .............................................................................................................................5
2
INTRODUCTION.................................................................................................................................................6
2.1
Study Rationale ......................................................................................................................................6
2.2
Background ............................................................................................................................................7
2.3
Risk/Benefit Assessment......................................................................................................................10
2.3.1
Known Potential Risks ......................................................................................................10
2.3.2
Known Potential Benefits .................................................................................................11
2.3.3
Assessment of Potential Risks and Benefits .....................................................................12
3
OBJECTIVES AND ENDPOINTS .........................................................................................................................13
4
STUDY DESIGN ................................................................................................................................................14
4.1
Overall Design ......................................................................................................................................14
4.2
Scientific Rationale for Study Design....................................................................................................15
4.3
Justification for Intervention................................................................................................................15
4.4
End-of-Study Definition........................................................................................................................15
5
STUDY POPULATION .......................................................................................................................................15
5.1
Inclusion Criteria ..................................................................................................................................16
5.2
Exclusion Criteria..................................................................................................................................17
5.3
Lifestyle Considerations .......................................................................................................................17
5.4
Screen Failures .....................................................................................................................................17
5.5
Strategies for Recruitment and Retention ...........................................................................................17
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)..................................................................19
6.1
Study Intervention(s) or Experimental Manipulation(s) Administration..............................................19
6.1.1
Study Intervention or Experimental Manipulation Description .......................................19
6.1.2
Administration and/or Dosing ..........................................................................................22
6.2
Fidelity..................................................................................................................................................22
6.2.1
Interventionist Training and Tracking...............................................................................22
6.3
Measures to Minimize Bias: Randomization and Blinding ...................................................................22
6.4
Study Intervention/Experimental Manipulation Adherence................................................................23
6.5
Concomitant Therapy...........................................................................................................................23
6.5.1
Rescue Therapy ................................................................................................................23
7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL.............................................................................................................................23
7.1
Discontinuation of Study Intervention/Experimental Manipulation....................................................23
7.2
Participant Discontinuation/Withdrawal from the Study ....................................................................24
7.3
Lost to Follow-Up .................................................................................................................................24
8
STUDY ASSESSMENTS AND PROCEDURES.......................................................................................................25
8.1
Endpoint and Other Non-Safety Assessments .....................................................................................25
8.2
Safety Assessments..............................................................................................................................26
8.3
Adverse Events and Serious Adverse Events........................................................................................26
8.3.1
Definition of Adverse Events ............................................................................................26
8.3.2
Definition of Serious Adverse Events................................................................................27
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

Peer mentorship to improve outcomes in patients on maintenance hemodialysis (PEER-HD)Version 3.0 
Protocol 2018-01
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8.3.3
Classification of an Adverse Event....................................................................................27
8.3.4
Time Period and Frequency for Event Assessment and Follow-Up..................................29
8.3.5
Adverse Event Reporting ..................................................................................................29
8.3.6
Serious Adverse Event Reporting .....................................................................................29
8.3.7
Reporting Events to Participants ......................................................................................30
8.3.8
Events of Special Interest .................................................................................................30
8.3.9
Reporting of Pregnancy ....................................................................................................30
8.4
Unanticipated Problems.......................................................................................................................30
8.4.1
Definition of Unanticipated Problems..............................................................................30
8.4.2
Unanticipated Problems Reporting ..................................................................................30
8.4.3
Reporting Unanticipated Problems to Participants..........................................................31
9
STATISTICAL CONSIDERATIONS.......................................................................................................................31
9.1
Statistical Hypotheses ..........................................................................................................................31
9.2
Sample Size Determination..................................................................................................................32
9.3
Populations for Analyses......................................................................................................................32
9.4
Statistical Analyses...............................................................................................................................32
9.4.1
General Approach.............................................................................................................32
9.4.2
Analysis of the Primary Endpoint(s)..................................................................................33
9.4.3
Analysis of the Secondary Endpoint(s) .............................................................................33
9.4.4
Safety Analyses.................................................................................................................35
9.4.5
Baseline Descriptive Statistics ..........................................................................................35
9.4.6
Planned Interim Analyses .................................................................................................35
9.4.7
Sub-Group Analyses..........................................................................................................35
9.4.8
Tabulation of Individual Participant Data.........................................................................35
9.4.9
Exploratory Analyses ........................................................................................................36
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ......................................................36
10.1
Regulatory, Ethical, and Study Oversight Considerations ....................................................................36
10.1.1
Informed Consent Process................................................................................................36
10.1.2
Study Discontinuation and Closure...................................................................................37
10.1.3
Confidentiality and Privacy...............................................................................................37
10.1.4
Future Use of Stored Specimens and Data.......................................................................38
10.1.5
Key Roles and Study Governance .....................................................................................38
10.1.6
Safety Oversight................................................................................................................39
10.1.7
Clinical Monitoring ...........................................................................................................39
10.1.8
Quality Assurance and Quality Control.............................................................................39
10.1.9
Data Handling and Record Keeping ..................................................................................40
10.1.10
Protocol Deviations ..........................................................................................................41
10.1.11
Publication and Data Sharing Policy .................................................................................41
10.1.12
Conflict of Interest Policy..................................................................................................42
10.2
Additional Considerations....................................................................................................................42
10.3
Abbreviations and Special Terms .........................................................................................................42
10.4
Protocol Amendment History ..............................................................................................................43
11
REFERENCES....................................................................................................................................................43
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

Peer mentorship to improve outcomes in patients on maintenance hemodialysis (PEER-HD)Version 3.0 
Protocol 2018-01
30 April 2021
1                                                                                                   CONFIDENTIAL
STATEMENT OF COMPLIANCE
The trial will be conducted in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and the NIDDK 
Terms and Conditions of Award. The Principal Investigator will assure that no deviation from, or changes 
to the protocol will take place without prior agreement from the funding agency and documented 
approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate 
hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed 
Human Subjects Protection and ICH GCP Training.
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) 
must be obtained before any participant is consented. Any amendment to the protocol will require 
review and approval by the IRB before the changes are implemented to the study. All changes to the 
consent form(s) will be IRB approved; a determination will be made regarding whether a new consent 
needs to be obtained from participants who provided consent, using a previously approved consent 
form.
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

Peer mentorship to improve outcomes in patients on maintenance hemodialysis (PEER-HD)Version 3.0 
Protocol 2018-01
30 April 2021
2                                                                                                   CONFIDENTIAL
INVESTIGATOR’S SIGNATURE
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study 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 and ICH guidelines, as described in the Statement of Compliance above.
Co-Principal Investigators:
Signed:
Date:
4/30/21
Name: Ladan Golestaneh, MD MS (contact PI)
Title: Professor of Medicine
Signed:
Date:
4/30/21
Name: Michal Melamed, MD MHS
Title: Associate Professor of Medicine
Investigators Contact Information
Affiliation: Albert Einstein College of Medicine
Address: 3411 Wayne Ave, Suite 5H, Bronx, NY 10467
Telephone: 718-920-5442
Email: lgolesta@montefiore.org
Co-Principal Investigator, Clinical Site PI:
Signed:
           
Date:
4/30/21
Name: Kerri Cavanaugh, MD MHS
Title:
Associate Professor of Medicine
Investigator Contact Information
Affiliation: 
Vanderbilt University Medical Center
Address: 
2525 West End Avenue, Suite 400, Office 419, Nashville, TN, 37203
Telephone: 
615-936-7306
Email: 
kerri.cavanaugh@vumc.org
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

Peer mentorship to improve outcomes in patients on maintenance hemodialysis (PEER-HD)Version 3.0 
Protocol 2018-01
30 April 2021
3                                                                                                   CONFIDENTIAL
1
PROTOCOL SUMMARY
1.1
SYNOPSIS 
Title:
Peer Mentorship to improve outcomes in patients on maintenance 
hemodialysis
Short Title:
PEER-HD
Grant Number:
R18DK118471
Study Description:
Pragmatic trial to test the effects and implementation of a low cost, 
educational, telephone-based, peer-mentor intervention on ED visits 
and hospitalizations among high-risk patients receiving hemodialysis.
Objectives:
Primary Objectives:
1) To perform a randomized controlled trial to evaluate the effects of a 
3-month peer mentor intervention on a composite of ED visits and 
hospitalizations in patients on hemodialysis compared to usual care.
2) To test the feasibility of a dialysis peer training program.
Secondary Objective:
To evaluate the effect of peer mentoring intervention on dialysis 
adherence behaviors, dialysis knowledge, self-efficacy and perception 
of social support in intervention compared to control participants.
Endpoints:
Primary Endpoint: Composite count of ED visits and hospitalizations 
during 3 months of intervention and 15 months of follow up (18 
months observation).
Due to the covid pandemic and recommendations from the DSMB, 
after 4/30 all participants’ post-activity period follow up will be limited 
to 9 months (12 months of observation), or truncated to the current 
observation period total of between 12 and 18 months.
Secondary Endpoints: 
1) Dialysis treatment adherence – mean missed minutes per month
2) Mean monthly inter-dialytic weight gain (%), serum albumin (g/dL); 
3) Perceived self-efficacy, knowledge, perception of social support and 
quality of life.
Feasibility Endpoints (intervention only): 
1) number of telephone contacts per week; 
2) content of telephone conversations;
Feasibility of Peer Mentor Training:
1) attendance records for all sessions
2) change in pre-/post-knowledge assessments after training
3) content & descriptive evaluation of course evaluations
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

Peer mentorship to improve outcomes in patients on maintenance hemodialysis (PEER-HD)Version 3.0 
Protocol 2018-01
30 April 2021
4                                                                                                   CONFIDENTIAL
Study Population:
20 Mentor adult in-center hemodialysis patient participants 
200 Adult in-center hemodialysis patient participants
Enrolled from dialysis units in or near the Bronx, NY and Nashville, TN
Trial Type:
Pragmatic Randomized Trial 
Description of 
Sites/Facilities Enrolling 
Participants:
Participants are enrolled from multiple dialysis units affiliated with 
Albert Einstein (AECOM) College of Medicine and Vanderbilt University 
Medical Center (VUMC). AECOM will serve as the coordinating center.
Description of Study 
Intervention:
Intervention will have 2 phases:
1)
Mentor training 

4 Training sessions, 2 hours each covering topics in dialysis 
care, coaching and motivational interviewing techniques.

Refresher 2-hour session at 3-months and 10-months

Financial compensation by hour for training

Assessments of skills, role modeling & simulations, exit 
interviews
2)
Telephone based 3-month intervention by mentors for mentees 

Weekly phone contact with mentee (1-3 mentees per mentor) 

Social mixers at the dialysis facility, or other group activities
Usual care control group patient participants

Usual care as per facility procedures and protocols
All participants:
Provision of written educational material 
Study Duration:
48 months
Participant Duration:
Mentors: up to 30 months
Intervention or Control group participants: 12 to 18 months
Study Oversight:
National Institute of Diabetes and Digestive and Kidney Diseases / 
National Institutes of Health
Project Scientist: Kevin Chan, MD
Address:    2 Democracy Plaza
                   6707 Democracy Boulevard 
                   Bethesda, MD  20892-5458
Phone: 301-827-5251
Email: kevin.chan2@nih.gov
Data Safety & Monitoring 
Board:
Members: Dr. Rick Kaskel, MD PhD; Dr. William Southern MD MS; Dr. 
Irena Blanco MD MS
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

Peer mentorship to improve outcomes in patients on maintenance hemodialysis (PEER-HD)Version 3.0 
Protocol 2018-01
30 April 2021
5                                                                                                   CONFIDENTIAL
Governing IRBs
Local IRBs for each clinical enrollment site: 

Albert Einstein College of Medicine

Vanderbilt University Medical Center
1.2
SCHEMA 
Figure 1. Mentors  N~20
Figure 2. Patient Participants N=200 [All sites; Estimated enrollment AECOM=140; VUMC=60]
At the final study visit, all mentors and those randomized to the peer mentoring intervention will 
complete program evaluation interviews and surveys to gain feedback on the intervention. 
Due to impact of the covid pandemic, the study DSMB recommended prioritizing enrollment and 
reduction of follow-up observational time. The recommendation is to limit total observation time to 12-
months for intervention and control participants. Participants currently enrolled and who have passed 
the 12-month point will execute their T2 visit as soon as possible and truncate observation (13-18 
months). For those whose observation time is less than 12-months, or any new enrolled participants, 
the T2 assessment will be moved to the 12-month time point. Mentors, may complete T2 at 18-months 
(Einstein site), or may complete T2 visit at 12-months if all other mentor activities have been completed 
at the site. Medical record monthly review will only occur for the observation period and will also be 
truncated at the time of the T2 visit. This alteration of the study design was approved by the DSMB and 
also the NIH program officer.
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

Peer mentorship to improve outcomes in patients on maintenance hemodialysis (PEER-HD)Version 3.0 
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30 April 2021
6                                                                                                   CONFIDENTIAL
1.3
SCHEDULE OF ACTIVITIES 
Table 1.  Mentor and Patient participant study activities
Time of the start of the intervention activity with the first mentee will determine the start of when 
subsequent study visits (9-month; 18-month, or between 12-18-months) will occur for mentors.
Mentors
Pre-screening
(Pre-consent)
 
Visit 1 – Day 1
Training 1-4;   Within 6-8 
Weeks after V#1
Each Month
~Month 3, Month 10,        
as needed
Visit 2-Month 9 ± 30d
Visit 3-Mon 18 ± 30d; 
between 12-18M or at 
12M depending on date
Final visit Month 18 ± 30d 
between 12-18M or at 
12M depending on date
Review Eligibility 
x
Informed Consent
x
Demographics
x
Clinical history
x
Baseline assessments
x
Mentors (continued)
Pre-screening
    (Pre-consent)
Visit 1 – Day 1
  
Training 1-4;   Within 6-8   
 Weeks after V#1
   Each Month; Quarterly
  ~Month 3, Month 10,            
as needed
   Visit 2-Month 9 ± 30d
   Visit 3-Mon 18 ± 30d 
between 12-18M or at 12M 
depending on date
   Final visit Month 18 ± 30d 
between 12-18M or at 12M 
depending on date
Post training assessments 
(knowledge/formative/summative)
x
Coordinator survey/check-in
x
EMR Data Abstraction & Review
x
Peer Mentor Refresher course (as needed)
x
Optional social mixer or other group activity
x
9-month follow-up assessments
x
18-months follow up assessments
x
Program evaluation interviews & field notes
x
Intervention or 
Control Participants
Pre-screening
Visit 1 
Each Month
Every 3-4 Months, 
as needed
Visit 2 Month 3 ± 30d
Visit 3 Month 18 ± 30d 
between 12-18M or at 12M 
depending on date
Final visit Month 18 ± 30d 
between 12-18M or at 12M 
depending on date
Review Eligibility 
x
Informed Consent
x
Demographics
x
Clinical history
x
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

Peer mentorship to improve outcomes in patients on maintenance hemodialysis (PEER-HD)Version 3.0 
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Usual care group start time will begin at the time they receive the study kidney disease educational 
materials. Mentee group start time will begin at the time they receive their study phone and they are 
activated with their mentor. 
2
INTRODUCTION
2.1
STUDY RATIONALE 
The overarching goal of this research is to improve End Stage Kidney Disease (ESKD) related morbidity 
and mortality. The medical care of patients with ESKD is highly complex and expensive.1,2 
Hospitalizations drive up to 40% of the cost for ESKD care.2-9 Cardiovascular disease and infections 
account for over 50% of ESKD-related hospitalizations and contribute to disproportionate mortality in 
this patient population.10, 6, 11-22 We propose a pragmatic trial to test the implementation and impact on 
ED visit and hospitalization outcomes of a peer mentor led intervention designed to increase effective 
self-management in patients receiving hemodialysis, in a real-world setting with high potential for 
widespread dissemination.  
Patients receiving hemodialysis who can self-manage their fluid status effectively, are adherent to their 
dialysis schedule and to their dietary plan are hospitalized less frequently and have lower morbidity and 
mortality than patients who are less adherent.11, 14, 22-30 However, numerous impediments to dialysis self-
management exist including facility, physician and patient-level barriers. The following are patient-level 
barriers to optimal self-management: 1) poor knowledge about the rationale and metrics of estimated 
dry weight (EDW), 2) poor knowledge about the metrics of urea clearance and nutritional parameters, 3) 
under-utilization of available hours for unscheduled dialysis, and 4) low self-efficacy leading to non-
adherent schedule and dietary behaviors.31-43 Dialysis self-management education is often not successful 
in improving patients’ skills.44 Educational tools from dialysis facilities and providers are didactic, have 
medical jargon and lack concrete steps to mitigate patient visits to emergency departments (ED) and 
subsequent hospitalizations.4,4 45, 46 A culturally sensitive, easy to understand educational program that 
can increase hemodialysis self-management is critically needed.
Peer mentorship has been used effectively to enhance self-efficacy and self-management behaviors in 
patients with chronic disease.47-60 A single study of peer mentorship for ESKD patients found that peer 
mentors improved adherence and satisfaction with care among mentees.61 This strategy has high 
potential to improve the factors that drive hospitalizations among this high-risk patient group. The goal 
of this research is to implement a peer mentor training program to increase patients’ knowledge about 
the metrics of hemodialysis, enhance self-management to meet EDW, nutritional and adherence goals, 
and to enhance self-efficacy in mentees.38 The peer-mentor intervention is based on the information, 
motivation, behavior (IMB) model of health behavior and the Chronic Disease Self-Management 
Program.22, 44, 62-68 We will test the feasibility of implementation of this program and the efficacy of it to 
reduce hospitalizations in a pragmatic trial comparing the peer mentor intervention on mentees to a 
control group assigned to usual care. We hypothesize that a structured peer mentor telephone 
Baseline assessment surveys
x
Kidney Disease Educational Materials
x
Coordinator survey/check-in
x
EMR Data Abstraction & Review
x
3-month follow-up assessments 
x
18-month follow-up assessments, or between 12-18-
months as noted depending upon enrollment date
x
Optional social mixer or group activity (intervention)
x
Program evaluation interviews & field notes
x
IRB NUMBER: 2017-8531
IRB APPROVAL DATE: 05/04/2021

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intervention will be more effective than usual care in increasing hemodialysis related knowledge, self-
management adherent behaviors and in decreasing ED visits and hospitalizations in ESKD.
2.2
BACKGROUND 
2.2.1. Excessive hospitalization rates in patients treated with hemodialysis
There are over 400,000 ESKD patients in the United States and they constitute one of the most clinically 
complex and expensive patient groups.1 Patients treated with hemodialysis comprise 1% of the 
Medicare population but account for close to 9% of the total expenditures.2 Hospitalizations drive up to 
40% of the cost for ESKD care.1-3, 69 Patients receiving hemodialysis are hospitalized, on average, 2 times 
per year and over 35% of these patients are re-hospitalized within 30 days of discharge.3, 6, 8, 9, 70 During 
hospitalizations, patients’ nutritional status and mobility deteriorate, and the risk for infectious 
complications increases, all of which add to short-term morbidity and mortality.6, 14, 71, 72 
2.2.2. Hospitalizations are avoidable in patients treated with hemodialysis
Cardiovascular disease is the most common cause of hospitalizations in patients on hemodialysis, 
followed by infections and vascular access complications.2, 3, 10, 12, 17, 75 In the U.S., the rate of 
hospitalization for fluid overload is 40 per 100 person year with a risk of 30-day re-hospitalization of 
38%.10, 16 Fluid overload presenting as heart failure is the most common reason for ED visits in the U.S. 
and Canada.22, 76 Chronic fluid overload is common in patients treated with hemodialysis, is related to 
EDW achievement for each treatment, dialysis adherence and IDWG, and contributes to excessive and 
avoidable hospital resource utilization.  In a study examining the types of US claims used for fluid related 
ESKD hospitalizations, heart failure was the primary diagnosis in 83% of episodes, average cost was 
$6,372 per episode, and importantly total costs were more than $266 million per year.17 Patients on 
hemodialysis rarely demonstrate understanding of the metrics of EDW and IDWG that are important for 
patients’ ability to set goals, problem solve and understand their symptoms.44, 77 Complications related 
to low dialysis adherence contribute to avoidable hospitalizations in other ways and include infection 
risk, uremia related malnutrition and cognitive decline.36, 37, 78-81 Dialysis adherence and recognition of 
vascular access malfunction are important to prevent low dialysis clearance and malnutrition.33, 39, 82 
Patients are given monthly reports of dialysis parameters but they infrequently recognize its relation to 
uremia, access dysfunction, associated symptoms, and to outcomes.83-85 Poor patient self-management 
is associated with: 1) low dialysis adherence, 2) lack of self-examination of access and 3) dietary non-
adherence to IDWG limits leading to fluid overload, and malnutrition.86-89 These behaviors, in turn, lead 
to chronic and maladaptive clinical changes such as ventricular dysfunction and vascular calcification 
which increase the risk of hospitalizations in part attributed to self-referral to the ED because of poor 
understanding of and communication about fluid related symptoms by the patient to their clinician.
2.2.3 Avoidable hospitalizations: opportunities for intervention
Most cardiovascular hospitalizations in patients on hemodialysis are secondary to either cardiac or 
pulmonary disease related to chronic volume overload or to episodes of pulmonary edema manifesting 
as shortness of breath.4, 11, 17, 75 Patients who are adherent and can regularly achieve accurately 
prescribed EDWs do not develop complications of acute or chronic volume overload.22, 27, 29, 90-92  Up to 
50% of patients on hemodialysis are chronically fluid overloaded.12, 13, 75  Patients receiving dialysis skip 
8% and shorten 20% of their treatments on a regular basis which increases the risk of not meeting EDW 
goals.32, 33 Patient with high IDWG have a 35% higher risk for death, and those with chronic fluid 
overload have a greater than 2 times greater hazard ratio for mortality.13, 22 Relative IDWG greater than 
4% of body weight is associated with hospitalizations and IDWG >5.7% of body weight is associated with 
mortality.16 In a national database study, 34% of patients skipped treatments.33 Those patients who 
skipped at least one or more sessions per month or shorten at least one treatment per month had a 
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significantly higher HR for increased short-term, fluid related, hospitalizations (HR 1.13) and a 25% 
higher risk for mortality.33, 39, 93 
Uremia and non-adherence to dialysis are associated with malnutrition and inflammation, both of which 
are strongly associated with hospitalizations in patients with ESKD.3, 36-39, 94 Dialysis facility education 
focuses on isolated patient behaviors such as IDWG and dietary phosphorus intake. Education about the 
contribution of vascular access type and function, dietary and dialysis non-adherence to uremia, 
malnutrition and infection risk is not systematically undertaken by facility staff. Patients do not 
universally recognize or attribute the symptoms of uremia or IDWG to poor self-management 
behaviors.31, 34, 45, 77, 84, 89, 95-100 Uremia is not routinely diagnosed by staff because the urea reduction ratio 
(URR) metrics do not consider mean monthly urea and dialysis access recirculation is not factored into 
the majority of monthly reports.101 With regards to infection and sepsis related hospitalizations: 80% of 
patients start dialysis with a dialysis catheter and up to 20% of prevalent patients use catheters as their 
permanent vascular access.102-104 Patients with catheters have up to a 7 fold increase in infectious 
complications requiring hospitalizations as compared to patients who start dialysis with a fistula.102-104 
Fluid mismanagement, dialysis and dietary non-adherence, and catheter use are associated with 
cardiovascular and infectious morbidity, and resultant hospitalizations and mortality. These conditions 
are opportunities for a preventive intervention that can mitigate poor outcomes. With education, 
patients on hemodialysis are in a unique position to self-diagnose fluid overload, uremia and access 
dysfunction based on their symptoms, where dialysis facility and nephrologist metrics may fall short.
2.2.4 Patient level barriers to prevent avoidable hospitalizations
The barriers to hemodialysis self-management to prevent hospitalizations are multifactorial and related 
to 1) facility level barriers, 2) physician level barriers and 3) patient level barriers. Patient level barriers 
to self-management include 1) lack of knowledge, 2) negative attitudes about self-management and 3) 
low self-efficacy. Dialysis facility staff offer patients educational material on diet and fluid self-
management but the uptake of this material by patients is limited. Lack of knowledge among patients 
about the relationship between behaviors and outcomes limits adoption of concrete skills to improve 
outcomes. Forty three percent of patients on dialysis have limited health literacy and most patients have 
limited understanding of EDW and dietary principles pertaining to IDWG, urea clearance and nutrition.84, 
105-109  More than 25% of patients are unsure of their EDW and most patients do not attribute cramping 
or dyspnea to fluid management or realize that EDW varies with time and is adjustable.77, 109 Most 
patients are unaware of the option to use extra dialysis to achieve EDW.  
Attitudes about self-management including fear of failure and anxiety about obtaining necessary skills 
are common in ESKD. Self-management describes the process by which the patient becomes an active 
participant in his/her treatment.108, 110-111 Self-management by select patients on hemodialysis is 
successful as demonstrated by self-cannulation, home hemodialysis programs and newer programs 
wherein patients monitor and control their own in-center dialysis treatments using a computer 
interface.25 These patients had high self-care agency (self-efficacy) scores and quality of life.30 Most 
patients on hemodialysis have poor self-management skills and depend on dialysis facility staff.34, 35, 111-
113 A poor sense of the chronicity of ESKD,  the adverse effects of non-adherence and mistrust of dialysis 
facility staff, are common negative attitudes in those with poor self-management skills.43, 114-116
Low self-efficacy (the ability of an individual to set goals and the belief that s/he can achieve those goals) 
is common in dialysis patients and is directly related to suboptimal self-management behaviors.43, 66, 67, 
117-120 Self-efficacy is a mediator of self-management behaviors.66, 67, 111, 112 Patients with low self-efficacy 
comprise up to 1/3 of the dialysis population, are more likely to shorten or skip dialysis treatments, have 
high IDWG, and experience frequent hospitalizations.13, 33, 39, 82, 84 Low self-efficacy in dialysis patients is 
related to psychological, social and educational background.121-124 Lack of social support is a mediator of 
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low self-efficacy and non-adherence behaviors.40-42 One third of patients on hemodialysis have poor 
social support.125 Low perception of social support is associated with morbidity, hospitalizations and 
mortality in patients on hemodialysis independent of clinical variables.42 Some patients treated with 
hemodialysis have low social support, have low self-efficacy and poor self-management behaviors.
2.2.5 Improving self-efficacy can improve self-management skills
Self-management skills in chronic disease include goal setting, problem solving, communicating, 
resource utilization and self-tailoring.126-129  Self-efficacy is an important mechanism by which self-
management improves outcomes.66, 67, 111, 114, 127 Relevant self-management skills in patients on 
hemodialysis are setting dietary, treatment adherence and IDWG goals, communicating symptoms of 
fluid overload, cramping, uremia, and vascular access dysfunction to caregivers, and using available 
resources in dialysis facilities and vascular access centers to problem-solve. Patients’ reported self-
efficacy is more consistently associated with self-management behavior than demographic or clinical 
characteristics.46 Most patients treated with dialysis desire to understand numbers pertaining to their 
care and when furnished with knowledge and motivation, many patients are willing to extend 
treatments or to add extra sessions per week to attain optimal EDW.77, 109 The use of contextually 
sensitive interventions that improve social support and self-efficacy improve IDWG and dialysis 
treatment adherence.61, 121 
2.2.6 Peer mentorship to enhance self-management in patients treated with hemodialysis 
Peer mentorship has been effective in chronic diseases such as diabetes mellitus, depression, AIDS, and 
ESKD.52, 56, 57, 60, 130-137 Peer mentors are recruited members of a community that share similar health 
circumstances and thus have concrete and pragmatic knowledge derived from personal experience.133, 
138 In this way mentors act as knowledgeable equals by their target population and are not part of the 
healthcare system.44, 138 In fact, attainment of too much formal knowledge is detrimental to this status 
and runs the risk of transformation from a peer to a para-professional.48 Peer based interventions 
improve health related behaviors and self-management.55, 134 Self-efficacy can be increased by mastering 
performance, social modeling, interpretation of symptoms and social persuasion, all of which are 
supported by peer mentors. Peer mentors provide the following types of support to mentees: 1) 
emotional (increasing perception of social support/motivation), 2) affirmation and encouragement to 
persist in problem solving (increase self-efficacy/motivation) and 3) knowledge acquisition relevant to 
the practical aspects of self-management.134, 138 By providing emotional and affirmation support, peers 
encourage performance mastery, as role models, peers provide social persuasion and model effective 
behaviors, and by providing practical knowledge peers improve interpretation of symptoms and 
communication of those symptoms to caregivers. Peer mentor interventions in patients on hemodialysis 
have shown success in improved goals of care discussions, treatment adherence and quality of life 
parameters.61, 139, 127, 140, 141 Peer mentors in dialysis facilities are in a unique position to facilitate 
perceived social support.61, 129, 139 The Michigan state ESKD program and the National Kidney Foundation 
both have peer mentorship programs.60, 140 In other chronic disease states, a variety of peer mentorship 
models have shown variable success in the attainment of certain concrete outcomes.  Targeted, specific 
and contextually appropriate peer-mentor models are the most effective.60, 131, 139, 142 Peer interventions 
for patients on dialysis, however, have not defined a consistent and structured program to increase 
performance mastery, nor have they examined outcomes such as hospitalizations.
2.3
RISK/BENEFIT ASSESSMENT 
2.3.1
KNOWN POTENTIAL RISKS 
For mentors, the risks of the study include: 1) inconvenience of attending training sessions, 2) 
discomfort with assessments during training, 3) discomfort with ongoing weekly telephone based 
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interventions with mentees throughout the study, 4) confidentiality issues associated with research and 
health data, 5) conflicts or emotional distress with intervention with some of the mentees.  These risks 
will be discussed with the potential participants during the informed consent process.  
Inconvenience of attending training session. This study requires training sessions of peer mentors 
conducted at dialysis facilities for 2 hours weekly over 4 weeks.  This requires that the mentors come to 
the facility, or participate in a web-based version, outside of their regularly scheduled dialysis times and 
participate in training.  
Discomfort with assessments during training. We will use validated and novel tools to measure 
knowledge at baseline and after training about dialysis and kidney disease.  We will keep scores on 
these evaluations confidential and will not discuss them with other mentors.
Discomfort with weekly telephone-based intervention with mentees. During the informed consent 
process the expectations for each mentor will be discussed.  Mentors will be compensated for carrying 
out the expected mentor activities. There will be frequent opportunities for mentors to discuss with the 
research team any concerns. There will be explicit criteria for potential withdrawal as a mentor if they 
do not fulfil their expectations. If mentors drop out because of clinical illness or inability to continue we 
will substitute their position from the pool of trained mentors.
Confidentiality issues associated with research and health data. Because of the collection of personal 
health information and formative assessments, we will enter personal information in a de-identified 
manner according to a study ID.  All paper documents linking study ID and personal identifiers will be 
recorded in one location (electronic or hard copy) under the supervision of the site-PI.  Participants will 
sign an agreement to not disclose personal or health information about other participants.  
Conflicts or emotional distress arising between mentor/mentee pairs, or from one member dying during 
the intervention. If conflicts arise between mentor/mentee pairs, or if one of the parties decide to drop 
out of the study, the remaining member of the pair will be given the choice to continue in the study with 
a different mentor/mentee.  Reasons for conflict will be recorded as process outcomes. If one member 
of a pair dies during the intervention grief counseling will be provided by the dialysis facility social 
worker and study staff will offer connections with additional counseling services as requested.
For patient participants, the risks of the study include: 1) discomfort with being identified as a high-risk 
patient during screening, 2) discomfort with receiving telephone calls by mentors, 3) discomfort with 
getting assessments at study visits, 4) confidentiality issues associated with research and health data, 
and 5) conflicts or emotional distress with intervention mentors (if applicable).  These risks will be 
discussed with the potential participants during the informed consent process.  
Discomfort with being identified as a high-risk patient during screening. Because identifying patients as 
high risk to qualify as a mentee recruit may be associated with stigma in the dialysis facility, we will 
ensure all study staff are aware and receive communication training regarding this concern.  This will 
include discretion as part of the training.  
Discomfort with receiving telephone calls by mentors. While responding to telephone calls is optional 
and while patients can ignore telephone calls made to them by mentors, the design of the intervention 
depends on successful telephone contact between pairs.  This will be reviewed with all mentees during 
the informed consent process.  All subjects will be given the choice to opt out or to drop out of the study 
at any point.  The enrolled participants will have frequent opportunity to discuss concerns with the 
research coordinator and provide feedback on the intervention/mentor.
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Discomfort with study visits. Mentees will undergo assessments using validated instruments to 
determine self-efficacy, perception of social support, health literacy and quality of life.  These 
assessments will be scheduled at a time that is convenient for the subjects.  
Confidentiality issues associated with research and health data. We will collect demographic, clinical, 
behavioral and outcome data on all mentees and controls.  We will explain this during the informed 
consent process.  All data will be collected from institutional electronic health records and will be 
recorded in REDCap as de-identified.  All paper documents linking study ID and personal identifiers will 
be recorded in one location (electronic or hard copy) under the supervision of the site-PI.  
Conflicts or emotional distress arising between mentor/mentee pairs, or from one member dying during 
the intervention. If conflicts arise between mentor/mentee pairs, or if one of the parties decide to drop 
out of the study, the remaining member of the pair will be given the choice to continue in the study with 
a different mentor/mentee.  Reasons for conflict will be recorded as process outcomes. If one member 
of pair dies during the intervention grief counseling will be provided by the dialysis facility social worker 
and study staff will offer connections with additional counseling services as requested.
2.3.2
KNOWN POTENTIAL BENEFITS 
A peer mentorship intervention that can reduce ED visits and hospitalizations, may be a novel low-cost 
program that has major implications not just in the ESKD population, but also in other complex chronic 
diseases. The model shifts the focus of healthcare interventions towards patients’ education and self-
management.  Process measures that define easily reproducible implementation outcomes will have a 
major impact on the structure of accountable care. 
The following is a list of potential benefits gained from this study:
1) Paradigm Shift: The proposed research study will use peer mentorship to increase dialysis self-
management as an efficient intervention to reduce morbidity, mortality and cost.  This proposal has 
implications for major provider stakeholders including dialysis facilities, dialysis physicians, Accountable 
Care Organizations including ESKD seamless care organizations (ESCOs) and payers. The intervention will 
integrate a curriculum focused on self-management into ESKD education and serve as a model for future 
educational programs. This will shift the paradigm of care to supporting patient self-management 
directly through explicit partnerships with peer leaders derived from the local community. 
2) Educational Program: We will implement a structured, reproducible training program with 
participation by a multi-disciplinary team, including patients, and a curriculum that includes concrete 
self-management skills. For training peer mentors, we will develop a resource guide based on the 
chronic disease self-management program (CDSMP) framework that will be available for use by dialysis 
facilities.131 143 The CDSMP is a program developed at Stanford University to help patients better manage 
chronic conditions and their quality of life. The study design allows measurement of intensity, frequency 
and duration of effect of the peer-mentor intervention, to inform future scalability.48 55 131 134 144
3) Cost savings: Peer mentorship can translate into savings that exceed program costs by a ratio of 
5:1.145 146 The Institute of Medicine and the World Health Organization state that enhancing support for 
patient self-management is a top priority for improving healthcare in the U.S.131 Peer support as a tool 
to increase mentee self-efficacy and self-management, is less expensive than traditional case 
management models and is promising for providers and health systems with budgetary constraints. 
4) Addressing health disparities: Peer mentorship includes a culturally sensitive approach to increase 
self-management behaviors by minority groups who are at risk because of health care disparities. 
Health disparities affect minority patients undergoing hemodialysis in lower socio-economic 
neighborhoods.147 148 We will test peer mentorship process measures in our facilities across the Bronx, 
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where most of our patients are black and Hispanic, and in Nashville, with a black majority ESKD 
population, to understand the differential effects of peer mentorship across population groups.
5) Improving dialysis facility outcomes: Improving patients’ dialysis self-management may reduce 
hospitalizations which is a measure used to determine reimbursement rates. Reducing hospitalizations 
and improving adherence to dialysis may improve reimbursement for facility fees. Increased 
communication by patients through a cooperative/participatory framework may improve job 
satisfaction of dialysis staff. 
2.3.3
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
Overall, the risks to both mentor and mentee participants are no more than minimal above usual clinical 
practice and there are substantial potential benefits to intervention participants’ clinical outcomes, as 
well as improvements in the efficiencies of delivery of dialysis care. 
Protection of confidentiality.  Participant confidentiality will be carefully protected.  Facility staff will not 
be allowed access to trial data (single-blinded design).  All research staff will complete the Collaborative 
Institutional Training Initiative computer-based training program which includes a module on privacy 
and confidentiality. All study documents will include participants’ ID rather than personal names and 
these include survey documents and assessments. Only one form will link participants’ names and study 
IDs and this will be stored in a password protected and encrypted file overseen by the site PI.  
Publication of study results will not reveal any identifiable information.
3
OBJECTIVES AND ENDPOINTS 
Table 3.
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS
PUTATIVE 
MECHANISMS OF 
ACTION
Primary
To test the effects of a 
telephone-based peer 
mentor intervention on 
hospital resource utilizations
Composite count 
of ED visit and 
hospitalizations at 
the conclusion of 
the 12 to 18-
month (T2) 
observation period 
comparing mentee 
group to usual care 
group.
Some visits made by patients 
on hemodialysis to the ED and 
subsequent hospitalizations 
may be avoidable with better 
outpatient care coordination 
and patient engagement.  
Peers may be best suited to 
provide support for patient 
activation.
Improvements in 
patient 
knowledge, self-
efficacy, and skills 
related to self-
care and 
connecting with 
their dialysis care 
team.
Secondary
1) To test the effects of a 
mentor peer training 
program on the uptake of:
a) dialysis knowledge and 
b) mentorship skills.
a) Change in scores 
on knowledge 
assessments 
after training (BL, 
9M, 12-18M)
b) Uptake of skills 
involving 
a) Knowledge in mentors is 
important to then 
disseminate to mentees 
through the peer 
intervention. These skills are 
in the causal pathway related 
to adherence behaviors.
Coaching skills by 
mentors to 
improve mentee 
knowledge, self-
efficacy, 
communication 
skills and 
perceived social 
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OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS
PUTATIVE 
MECHANISMS OF 
ACTION
motivational 
interviewing, 
emotional support, 
non-judgmental 
listening and self-
efficacy promotion 
in role playing 
exercises
b) An established method of 
training program evaluation 
includes assessments by the 
trainer during role playing of 
mastery of skills by the 
trainee.
support are 
hypothesized to 
increase 
activation to 
success in dialysis 
self-care.
2) To test the effects of a 
telephone-based peer 
mentor intervention on 
adherence behaviors, 
perception of self-efficacy, 
perception of social support 
and overall nutrition as 
possible mediators in the 
association of this 
intervention with primary 
outcomes
Month 3 & M-12 
to 18 (T2)
Intervention 
compared to UC
a) Mean weekly 
missed minutes of 
dialysis;
b) Mean monthly 
IDWG;
c) Serum Alb; 
d) Self-efficacy;
e) Social support;
f) Knowledge 
The effects of the peer 
intervention on adherence 
behaviors and perception of 
social support may alter the 
causal pathway(s) of high 
hospitalization rates in 
hemodialysis.  Studies have 
shown an association 
between lack of patients’ 
engagement and social 
support and adherence 
behaviors in patients on 
hemodialysis.  Further studies 
have established the strong 
association between 
adherence behaviors and 
incidence of hospitalizations 
in this population.  
Low perception 
of social support 
and low self-
efficacy are 
associated with 
adherence 
behaviors and 
hospitalization 
outcomes.  
Tertiary/Exploratory 
To test the feasibility and 
fidelity of a peer training 
program on mentor uptake
a. Attendance 
records of training 
sessions; 
b. Formative 
assessments of 
each training 
session
To inform future 
dissemination by 
characterizing the structural 
elements of the training 
program methods
n/a
To test the feasibility of the 
telephone-based 
intervention on mentees 
assigned to the intervention 
group
a) number and 
duration of 
telephone contact 
made by 
mentor/mentee;
b) self-recorded 
content of 
mentor/mentee 
conversations;
Telephone records serve as 
the primary data to 
determine total dosing of 
intervention (minutes), as 
well as pattern of contact 
over the 3-month period
n/a
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4
STUDY DESIGN
4.1
OVERALL DESIGN
The goal of this study is to test the effects of a peer mentorship program on hospital utilization among 
high risk patients on hemodialysis as compared to a usual care control group. This is a two-arm 
pragmatic, randomized at the patient-level controlled trial. Exploratory analyses within the intervention 
arm will also be performed. Patients will be randomized in a 1:1 allocation and blinded to the research 
team until the disclosure of the randomization assignment. There will be enrollments in groups until 
each mentor has been randomly allocated their maximal number of mentees. Randomization will be 
computer generated and assigned by the coordinating center research team.
This is a multi-site trial, including dialysis units in Bronx, NY and Nashville, TN areas. The collaborating 
organizations include Albert Einstein College of Medicine (Coordinating Center) and Vanderbilt 
University Medical Center. 
Intervention: Hemodialysis peer mentoring training and telephone coaching program.
The control group will receive kidney disease education about dialysis treatment adherence and access 
care in alignment with standard of care. Usual care will be at the discretion of the participant’s clinical 
care team.  
No interim analyses are planned.
4.2
RATIONALE FOR STUDY DESIGN
Patient-level randomization. We decided against cluster randomization because the threat of 
contamination of the intervention in this study with usual care is low. Additionally, dialysis facility 
location and culture is a potential confounding variable since the receptivity of the staff to patient 
requests and provision of care in response to patient self-management enhancement may be different 
between units.154 We also decided against this method because of feasibility and power considerations. 
Single blinded randomization. Limitations to single blinding include patients speaking to staff and among 
themselves about their involvement with the study will be accounted for in the final analysis by tracking 
and adjusting for this variable through patient report.  Using sequential multiple assignment 
randomization would enable better understanding of the different elements of the treatment on 
outcomes as this design assigns one element of an intervention only to those patients that have not 
responded to first in a series of interventions. We decided against using this method of randomization 
because of feasibility and the lack of rigorous evidence available to inform sequential program delivery.
4.3
JUSTIFICATION FOR INTERVENTION
Why peer mentor design? Peer mentoring increased the completion of advanced directives among 
African Americans on hemodialysis highlighting demographic differences in its impact. 139 Peer 
mentorship also improved patient dialysis adherence and quality of life scores.61 Peer mentorship is 
effective in reducing anxiety, increasing perception of social support and self-efficacy through modeling 
and empathic listening, and is well suited to a dialysis population with a fixed schedule.52, 150 
Why telephone intervention? The use of a telephone had the advantage of being less expensive, easy to 
use and available to most patients on dialysis unlike interventions that require the use of the internet.60, 
138 Furthermore there are advantages such as confidentiality and immediacy of response as compared to 
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the use of email or internet which may make telephone interventions palatable to patients.133  We also 
felt that some maintenance of privacy through the use of telephone was important for the development 
of trust between the mentor/mentee pairs.52 Potential downfalls to use of telephone include no 
guarantee that a connection will be made, and the risk of losing contact because of frequent telephone 
number changes. Study telephones will be provided. 
A participant is considered to have completed the study if he or she has completed the baseline 
assessment, and the assessments at 3 months of intervention and 12-18 months of follow-up. An 
intention-to-treat approach will be considered in the analyses; however, an as-treated analysis will 
require a minimum of 60 minutes of telephone time during the 3-month intervention period between 
mentor/mentee pair. 
4.4
END-OF-STUDY DEFINITION
The end of the study for participants is defined as completion of the 12 to 18-month follow-up assessment 
shown in the Schedule of Activities (SoA), Section 1.3. The study will monitor participants’ EHR for 30 days 
after completion of the 12 to 18-month (T2) visit to assess for serious adverse events (SAEs).
5
STUDY POPULATION
Subjects for this study will be selected from a population of patients with ESKD on maintenance 
hemodialysis who receive treatment in one of affiliated dialysis facilities in the Bronx and Nashville.  The 
study population is comprised of dialysis patient Mentors and Mentees or Usual Care.
The study population will consist of approximately 17 mentors (7 in Nashville and 10 in the Bronx) who 
will be trained by the study team using the developed mentor training modules (Figure 3).  We will make 
it clear during the consent process that not all mentors may participate in the intervention phase. After 
mentor training, each mentor will be assigned to 1-4 intervention mentees for 3-month periods.  Patient 
participants will be recruited to try to achieve balance in the 1:1 allocation to intervention or usual care 
groups during study periods. There may remain differences in the counts in each group during each 
period depending upon randomization allocation.
Figure 3. Schema summary of mentor and patient group participants.
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At some dialysis facilities a HIPAA waiver form may be required to be signed by a potential participant 
prior to screening. This will depend upon individual facility requirements. A verbal consent may also be 
required by site-specific IRB processes or local regulations to proceed with screening.
5.1
INCLUSION CRITERIA
Mentors
Mentor participants must meet all of the following inclusion criteria:
1.
Provision of signed and dated informed consent form
2.
Stated willingness to comply with all study procedures and availability for the duration of the study 
3.
Males and females; Age > 21 years
4.
Diagnosis of ESKD and treatment with in-center hemodialysis for at least 1 year at the time of 
recruitment
5.
Dialysis treatment at one of the participating dialysis units
6.
No hospitalizations in the prior 6 months
7.
No unexcused absence or shortening (2 or more x 10 minutes per treatment) of dialysis treatments 
in the past 6 months
8.
Use of an AV fistula or graft as dialysis access
9.
Serum albumin 3.5 g/dL or greater in the month prior to enrollment
10. Fluent in English (or Spanish – Bronx, NY site)
Patient Participants [Intervention or Usual Care]
Patient participants must meet all of the following inclusion criteria:
1.
Provision of signed and dated informed consent form
2.
Stated willingness to comply with all study procedures, including randomization, and availability for 
the duration of the study 
3.
Males and females; Age > 21 years
4.
Dialysis treatment at one of the participating dialysis units
5.
One of the following criteria:
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a.
Diagnosis of ESKD and treatment with in-center hemodialysis for less than 90 days 
b.
One or more hospitalizations in the prior month
c.
One or more ED visits in the prior month
d.
More than 1 unexcused missed dialysis treatments in the prior month
e.
2 or more shortened (more than 10 minutes) dialysis treatments in the prior month
f.
Use of a catheter for dialysis access
g.
An average of more than 4% IDWG in any week during the prior month 
h.
Serum albumin less than 3.5 mg/dL in the prior month
6.
Fluent in English (or Spanish – Bronx, NY site)
5.2
EXCLUSION CRITERIA
Patients without ability to give informed consent, who opt out of being approached by staff after initial 
screening and who are actively recruited to another research study will not be approached for 
recruitment. All patients meeting eligibility criteria will be considered for inclusion.
Mentors
Any individual who meets any of the following criteria will be excluded from participation as a mentor:
1.
Severe cognitive impairment or psychiatric illness as determined by clinical provider
2.
Less than 6-month life expectancy as determined by clinical provider
3.
Active substance use, excluding cannabinoids
4.
Enrolled in another peer support or educational dialysis research study (discretion of study team)
Patient Participants
Any individual who meets any of the following criteria will be excluded from participation as a patient 
participant (intervention or usual care):
1.
Severe cognitive impairment or psychiatric illness as determined by clinical provider
2.
Less than 6-month life expectancy as determined by clinical provider
3.
Active substance use, excluding cannabinoids
4.
Enrolled in another peer support or educational dialysis research study (discretion of study team)
5.3
LIFESTYLE CONSIDERATIONS
N/A
5.4
SCREEN FAILURES
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Mentor screen failures will be 
kept on a reserve list from which to consider if one of the study mentors drops out.  Patient participant 
screen failures due to participation in another study, may be considered in the future.  Rescreened 
participants will be assigned the same participant number as for the initial screening.
5.5
STRATEGIES FOR RECRUITMENT AND RETENTION
Additional details are provided in the study manual of procedures. This protocol section includes an 
overview of the approaches to recruitment and retention of all study participants including mentors and 
patient participants. Mentors and patient participants will be recruited separately. While mentors will 
aim to be recruited at the start of the study, it is possible that new mentors during the study period will 
be needed if there is a loss of mentors due to illness, relocation, or withdrawal. Special populations will 
not be included in this research, including children. The affiliated dialysis units do not care for children, 
and children have different support needs warranting separate dedicated scientific investigation.
Mentors
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Screening will include all adult patients on hemodialysis at study affiliated dialysis units. The study team 
will inform dialysis unit staff (administrators, physicians, physician-extenders, nurses and technicians) 
about the study objectives and criteria during a group meeting, by flyers, by email or during individual 
conversations. The dialysis staff will be asked to refer patients who they think may be good mentors to 
the study team. The study team will then assess the patient for eligibility, after any required HIPAA 
waiver or other verbal consent by the patient is obtained including for evaluation of medical records if 
required. If this initial screening meets eligibility criteria the patient will be approached to inform them 
about the study, inform them about the mentor role, further assess eligibility and offer participation if 
eligible.  Potential participants may be approached in the dialysis facility or other mutually agreed 
location, by phone, by video research visit depending upon patient preference.
As this will predominantly be a referred participant role, we anticipate screening approximately 2-3 
times our enrollment target at each site for mentors. There are no exclusions based on sex, race or age. 
The study will aim to include diverse representation across the enrolled group of mentors. 
Retention
Mentors will be in close contact with the study coordinator to promote continual feedback and support 
for the duration of the study. This will include at a minimum monthly check-ins. There will also be 
opportunities to connect with other mentors during refresher training sessions. All efforts will be made 
by the study team to ensure the mentors understand the activities and time commitments for 
participating in this important role at the beginning of their involvement and throughout the study. The 
study will also disseminate to the mentors various brief thank you notes or cards spontaneously to show 
them appreciation for their efforts in addition to the study compensation plan.
Patient participants: Mentees and Usual Care
A target of 200 eligible patients will be enrolled in the study and randomized in a 1:1 allocation to either 
the mentee peer support intervention group or the usual care group. We anticipate screening 3-4 times 
the target enrollment number to (up to 600-800 patients) from across affiliated dialysis units to identify 
those who are eligible and invite them to participate. There are no criteria based on sex, race or age. We 
anticipate that the enrollment will reflect the overall demographic characteristics of each region with 
both approximately equal in sex distribution, New York with almost 40% Latino/Hispanic, 45% Black and 
Tennessee 50% Black and 50% non-Hispanic White. 
Several strategies will be employed to recruit patient participants from affiliated dialysis units. All 
strategies will be IRB approved. This will include referrals from usual clinical care providers to the study, 
informational flyer/handouts for patients, as well as screening of patient clinic rosters for potential 
eligibility. The study team will assess the patient for eligibility, after any required HIPAA waiver or other 
verbal consent by the patient is obtained including for evaluation of medical records if required.  If initial 
review of medical record confirms potential eligibility, the patient will be approached in person at the 
dialysis unit or other mutually agreed location, by phone or by video research visit.  If eligibility is 
confirmed, the patient will be informed about the study activities and expectation, invited to participate 
and if they agree proceed with informed consent. The informed consent process may be executed in-
person, by telephone or video procedures, or by electronic eConsent (RedCap). The dialysis facility staff 
will not be explicitly informed about the randomization assignment of patient participants.
Retention
Retention will be enhanced by 1) conducting research assessments by the mode preferred by the 
participants and this may include on-site in dialysis facilities or another agreed location in-person, by 
phone, video research visit or electronic survey, 2) close tracking of participant contact information 3) 
monitoring of telephone contact between mentor/mentee pairs, and 4) reimbursement for study 
activities (see next section). This level of reimbursement is standard for clinical research conducted at 
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our sites and is not considered undue inducement for participation.  There will be opportunities for 
participants to provide feedback to the research team and participate in group activities. The study team 
will send thank you notes throughout the study to show appreciation for participation.   
There will be a procedure in place for both mentors and mentees to report to the study team concerns 
about the matching or fit of the pair. If these concerns are not amenable to resolution, then a new 
matching will be performed for the mentee to complete the remaining activities of the planned 
intervention period. This will be recorded in the study record. 
Incentives for mentors: Peer mentors will be compensated $10 for each hour of attended training 
session (2 hours each), for travel back and forth and $15/hour for time spent on the telephone while 
mentoring. Partial time for calls will be offered at the following rate: 3-30 minutes $7.50 and >30 min 
$15. Similar compensation for any 2-hour refresher courses after the initial training with the same 
incentives will be offered.  Attempts to contact mentees at least four times during a week at different 
days and times will be compensated $12/week, unless a successful call is performed. While mentor 
participants will each get a phone they will be given instructions on their use for study purposes only. 
The telephone will be returned at the end of the study.  For the assessments completed at baseline, 9 
months and at 12 to 18 months, mentors will receive $50 for each visit. Sites may also provide 
compensation for travel costs if customary, included in the consent and IRB approved.
Incentives for patient participants: For the assessments completed at baseline, 3 months and at 12 to 18 
months, patient participants will receive $50 for each visit and may be offered transportation costs if 
customary, included in the consent and IRB approved. Participants assigned to the intervention will 
receive a study telephone for the duration of 3 months with specific instructions to use the telephone 
only for study purposes. The phone will be returned at the conclusion of the intervention period. 
Intervention participants will also be offered compensation for time spent successfully on the phone 
with their mentor. This will be compensated at $15/hour. Partial time for calls will be offered at the 
following rate: 3-30 minutes $7.50 and >30 min $15. The study will support a maximum of 2 hours per 
week per mentee for mentor calls.
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)
6.1
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION
6.1.1
STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION
Mentor Training
All enrolled mentors will participate in mentor training. Details of this training are described in the 
‘Mentor Training Manual’ and also the ‘PEER Mentor Training Manual’ (for the Trainer). A brief summary 
and overview is provided here. 
We will train enrolled mentors over 4 weekly sessions, 2 hours each at preferentially in person group 
format at dialysis facility conference rooms, or other research location. An alternative for group training 
will be by webinar format. The training program is informed by the chronic disease self-management 
program (CDSMP), developed by Dr. Katie Lorig at Stanford University, to a dialysis population. 
Additionally, the Information Motivation Behavior (IMB) health behavior framework serves at the basis 
to inform the key topics focused on during the mentor training and deployed during the telephone peer 
support intervention.68 (Figure 1)   
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We will use motivational interviewing, non-judgmental listening and boundary setting curricula adapted 
from programming provided by the Albert Einstein School of Medicine Division of General Internal 
Medicine for peer 
mentorship studies 
of opioid use, and 
programming in 
peer support of 
diabetes from the 
University of 
Michigan (Dr. 
Michele Heisler). 
The training focuses 
on maintaining and 
attaining a healthy 
EDW, understanding 
uremia, clearance, 
dialysis access and 
their relation to 
infection, and effectively self-advocating with a dialysis care team. The following skills will be included: 
a) confidentiality and setting boundaries with mentees, b) motivational interviewing, c) non-judgmental 
listening, d) emotional support, e) assistance with tailored goal setting and problem solving, f) increasing 
perception of self-efficacy and g) modeling self-management behaviors. The format of the training will 
include didactic teaching sessions from a clinician instructor with content expertise, role playing 
exercises, group discussion of cases, and independent study. Although group training is preferred, if this 
is not possible for an enrolled mentor then individual training by the instructor may also be provided to 
complete the four core sessions either in-person or using webinar/zoom format. 
Refresher courses will be offered periodically, at approximately 3 months and 10 months after initial 
training or as needed for individual mentor’s re-training. This will be at the discretion of the study team 
depending upon the information gathered during monthly and quarterly coordinator assessments of 
mentors (or mentee feedback).  These refresher sessions will be approximately 2 hours, and be 
delivered in person, individually or in a group, or by video/webinar. 
Trained mentors will receive a manual with all of the materials provided during training and this will 
serve as a reference for them throughout the study. There will be explicit support from the research 
team. It is possible that not all trained mentors will serve as intervention mentors and some may be 
assigned as ‘back-up’ mentors in the event an intervention mentor is not able to fulfil their role. Mentor 
selection will be discussed during training. The priority is optimizing the matching criteria between 
mentor/mentee pairs (sex, race (Hispanic, Black, White), age group (+ 15 years), and language). 
Selection criteria is not based on mentor performance during training. If matching criteria are not 
applied, then random selection of mentor assignments will be employed.
Assessments during the training will provide information both about feasibility and efficacy of the 
training on the desired knowledge, attitude and skill outcomes among mentors (See Section 8). 
Mentee Telephone PEER Support Program group
The mentor telephone PEER support intervention includes a trained mentor, who is assigned 1-4 
mentees. The mentees each will participate in telephone support for a 3-month period. Study 
telephones will be assigned to mentors and required to be used for all study activities and offered to 
mentees for use during the program. Intervention mentees will be offered a study supplied phone, or 
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permitted to use their own device with the understanding they will be responsible for any incurred costs 
on their own device.
Pairing mentors and mentees 
As noted above, the priority criteria for matching pairs includes and prioritized as: language, sex, age 
group, and race. Additionally, schedule availability and preferences by mentees will be considered.  
Mentor telephone support
Mentors are expected to call each mentee once a week, with a goal of talking for an average of 20 
minutes. Call durations of at least 3 minutes will be considered complete. Mentors are asked to make a 
minimum of four attempts to reach mentees by phone on different days and times throughout the 
week. Both mentors and mentees are offered compensation based on the time executed for study calls. 
Mentors and mentees are asked to record in a log a record of their calls including notes on discussions. 
Mentors will also be given a study digital recorder. They are expected to randomly record calls with 
mentees for fidelity and content review, approximate 3-4 over the intervention period for each mentee. 
Mentor and mentees are informed that telephone billing records will be reviewed for characterization of 
attempts and contacts between mentors and mentees. Communication between mentors and mentees 
after conclusion of the 3-month period is not expected but will be permitted. Mentors will continue to 
use their assigned study phone for all calls.
Optional social mixers, or other similar group gathering (in-person or virtual) will be offered for all 
mentor and mentee participants. This will provide an opportunity for mentors and mentees to provide 
informal feedback to each other, as well as an opportunity for informal interactions with the study team. 
A study newsletter for mentors to share knowledge and encourage retention may be used.
The frequency and the mean duration will be measured, the content of the call recorded in a notebook 
by each member of the team after contact. During mentor training, a schedule of suggested themes and 
discussion content for calls will be provided. In general, the focus of the first 4 weekly calls will be to 
increase knowledge of the mentee, and the last 8 weekly calls will focus on motivational interviewing, 
emotional and affirmation support. The structure will be flexible to the needs of individual mentees. 
If one member of the pair dies, then the study team will meet with the other member, provide 
counseling, engage the clinical provider, and offer being paired with another mentor/mentee.
All intervention mentees will also be provided kidney disease educational materials: 1. Kidney School: 
Follow Your Treatment Plan; and 2. National Kidney Foundation: Hemodialysis Access. They will also 
receive study-specific educational materials that are also provided to mentors. This includes: Mentor 
Training Manual Appendix documents 1 (EDW information), 2 (Skills checklist for fluid), 4 (Uremia 
information), 5 (What to do for uremia), 6 (Information card), and 18 (Action Planning).
Usual Care control group 
The usual care control group will be under the clinical care of the usual providers. The study will provide 
two kidney educational documents to the patient: 1. Kidney School: Follow Your Treatment Plan; and 2. 
National Kidney Foundation: Hemodialysis Access. They will also receive study-specific educational 
materials that are also provided to mentors. This includes: Mentor Training Manual Appendix 
documents 1 (EDW information), 2 (Skills checklist for fluid), 4 (Uremia information), 5 (What to do for 
uremia), and 6 (Information card).
6.1.2
ADMINISTRATION AND/OR DOSING
Mentor Training
As above, full details in training manual documents. The training will be delivered by clinician experts in 
dialysis care and patient-centered communication. Trainings include 4 core sessions, and refresher 
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modules. Additional individual re-training of mentors by study clinicians may also be provided. 
Attendance records will determine completion or dosing of mentor training.
Mentor PEER Phone Support
Mentors will contact their mentees at least once a week for a total of 12 weeks.  The mentees will also 
be given the option to contact their mentees should the need arise at any point during the 3-month 
intervention.  Phone billing records will be reviewed to determine the total dose of intervention (call 
minutes with mentor) total for the period, monthly average, and weekly average. The distribution of the 
range of call duration for each mentee will also be described. A minimum of 3 minutes completed is 
required to count as a completed call.
Additional in-person, or video interactions between mentors and mentees will be self-reported by 
mentors in their contact logs, or as observed by study team during social mixers. These interactions will 
be included in the dose calculation of the intervention.
The quality of the mentor/mentee interactions will be evaluated using content analysis of recordings and 
the contact logs of mentors and mentees. Additional information of the quality will be evaluated by the 
study coordinator in the monthly or quarterly surveys of mentors and mentees. 
6.2
FIDELITY
6.2.1
INTERVENTIONIST TRAINING AND TRACKING
The mentors are the interventionists in this study. Initial training will be evaluated and confirmed using 
knowledge surveys, and evaluations by the trainer of skills during training. During the intervention 
program monthly and quarterly surveys by the study team will be used to identify problems with 
delivering the intervention as planned. As described above, phone records will also be used to evaluate 
frequency and dosing of attempts and successful calls. These records will be reviewed as frequently as 
monthly, but not less than every four months. Less than 10 minutes total of contact time between 
mentor and mentee in one month will prompt addressing barriers to executing the intervention for both 
mentor and mentee by the study team. 
6.3
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING
We will randomize enrolled patient participants after completion of informed consent and the baseline 
visit utilizing a random number generator. As each subject is enrolled we will select envelopes with the 
random assignment to either the intervention or the usual care control group (1:1).  The randomization 
will occur in blocks of between 28 to 42 depending upon the number of mentor and planned assigned 
mentees at the site. The goal is to have approximately equal total number of enrolled participants within 
each ~3-month intervention period. There may be staggering of the window and timeline depending 
upon enrollment pacing. 
The mentee assignments will be blinded to usual care nephrologist and dialysis staff, but not to study 
subjects and mentors, because of the nature of intervention. The research team additionally will not be 
blinded to group assignment. While this may be preferred, it is not feasible in this pragmatic trial. 
Enrolled participants will be encouraged to complete visit surveys on their own, to limit interactions 
with study staff in the process of data collection.
Trial randomization codes will be stored in a single file maintained by the data coordinating center. They 
will be shared with the research team as described above for patient participant assignment. Should 
accidental unblinding occur prior to completion of a baseline visit for a participant, the PI will be notified 
and this will be documented as a protocol deviation.  
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No change in study activities will occur in the event that it is identified that a usual care provider is 
unblinded to study assignment of their patient.
6.4
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE
Adherence of mentees to the peer support intervention will be monitored by the research team 
including monthly surveys with the mentee asking about the calls with their mentors, as well as review 
of phone records (See Section 6.2.1). For mentees not participating in calls with mentor the study team 
will attempt to identify and address the barriers to participation.  If pairs want to disengage, we will give 
the option of pairing with another mentor/mentee from the pool. 
Attendance records and notes for participation in any social mixers (in-person or video) will also be 
maintained and reviewed for assessment of mentee participation in the intervention, including 
engagement with mentors. 
Although all activities are intended and preferred, mentees will not be withdrawn for not participating in 
the intervention. They will be included in the primary study analysis as intention-to-treat. Secondary 
analyses may include an adjustment variable considering the dose delivered of the intervention. 
6.5
CONCOMITANT THERAPY
 N/A
6.5.1
RESCUE THERAPY
 N/A
7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL
7.1
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
Conflicts or emotional distress may rise between mentors and paired mentees. The study team will get 
information from both mentor and mentee and determine the nature and severity of the conflict. If 
there are any concerns regarding emotional or physical safety of participants this will be recorded as an 
adverse event, reported to the DSMB and the participant(s) withdrawn from the intervention. The 
participant(s) may also be considered for withdrawal from the study overall depending upon the nature 
and severity of the event(s). 
A mentor may decide to discontinue the study in case of clinical illness, inability to commit to the 
intervention schedule, or for any other personal reason. Participants may withdraw from the 
intervention at any time by notifying the study personnel. Mentors may be withdrawn from the 
intervention due to acute or temporary illness, but may be reconsidered for reactivation if agreed upon 
by the mentor and the study investigator. Mentors may be discontinued from the intervention if the 
study team is unable to reach them or they do not fulfil their mentor responsibilities. Mentors who 
receive a kidney transplant may continue as mentors, but EMR data specific to dialysis will not be 
collected by the study. Other study visit activities including surveys will be collected.
A mentee may decide to discontinue the study in case of severe illness, conflict, or inability to 
participate. The PIs at each site will maintain a record of these events and drop-outs and report them to 
the DSMB or IRB as required. 
The PIs at each site will maintain a record of all adverse events, unanticipated problems, protocol 
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deviations or error.  A summary of these will be reported to the IRB.  These events will all be reviewed as 
potential reasons for discontinuation of the intervention (mentor or mentee), or withdrawal from the 
study overall. The PIs will be primarily responsible for this decision, however this will be reviewed by the 
DSMB, and if recommended an experienced clinician external to the study team.
If a clinically significant finding is identified (including, but not limited to changes from baseline) after 
enrollment, the investigator or qualified designee will determine if any change in participant 
management is needed. Any new clinically relevant finding will be reported as an adverse event (AE).
The data to be collected at the time of study intervention discontinuation will include the following:

The reason(s) for discontinuing the participant from the intervention and the date the 
intervention ceased will be recorded in the subject’s research file

Study assessments including visits for survey completion and EMR review will continue as per the 
usual assigned scheduled throughout the duration of the overall study period
7.2
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY
Participants are free to withdraw from participation in the study at any time upon request.
An investigator may discontinue a participant from the study for the following reasons:

Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up)

Any event or medical condition or situation occurs such that continued collection of follow-up 
study data would not be in the best interest of the participant or might require an additional 
treatment that would confound the interpretation of the study
o
Death 
o
illness requiring institutionalization or a change in their dialysis unit
o
illness of a mentor that leaves them unable to fulfil their mentor role in any way

The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation such as:
o
Receipt of a kidney transplant (patient participant mentee or usual care)
o
Change in mentation or cognition rendering the participant unable to participate, 
including suicidality
o
A change in the willingness of the participant to continue
o
A safety altercation between the paired participants
o
Verbal abuse or threats of physical abuse of any kind

If the participant is to be discontinued but is medically able and willing, the T2 surveys will be 
administered at the time of discontinuation. Monthly EMR review will also end at the time of 
the T2 survey completion or date of discontinuation as determined by the PI.
The reason for discontinuation or withdrawal will be recorded on the withdrawal study form. Subjects 
who sign the informed consent form and are randomized, but do not receive the study intervention may 
be replaced.  Subjects who sign the informed consent form, and are randomized and receive the study 
intervention, and subsequently withdraw, or are discontinued from the study, will not be replaced.
7.3
LOST TO FOLLOW-UP
A participant (either mentor or mentee) will be considered lost to follow-up if he or she fails to return 
for 2 or more scheduled study visits and study staff are unable to contact the participant after at least 6 
attempts.  We will minimize loss to follow up by inquiring with the dialysis facility about the participant’s 
whereabouts if mentors miss 2 or more training sessions, 2 or more scheduled weekly calls to mentees 
and/or 2 or more telephone calls from study staff; or as mentees or usual care group if they miss 1 or 
more study visits, and do not return calls from study staff.
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The following actions must be taken if a participant fails to return to the clinic for a required study visit:

The site will attempt to contact the participant, reschedule the missed visit within 14 days of 
scheduled visit, counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain if the participant wishes to and/or should continue in the study

Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 6 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address). These contact attempts will be 
documented in the participant’s study file. 

Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up
8
STUDY ASSESSMENTS AND PROCEDURES
8.1
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS
Refer to Section 5 for details regarding recruitment for mentors and patient participants for screening 
procedures to evaluate for eligibility, including execution of a HIPAA waiver prior to screening if required 
by local site regulations. Scoring for surveys is detailed in the PEER HD Survey Scoring guide.
Screening & Enrollment
Mentors. Potential participants will first undergo a screening of their EMR and the information will also 
be confirmed by interview with the patient prior to enrollment (RedCap: ‘Mentor Eligibility 
Questionnaire From EMR’). This includes questions about the inclusion/exclusion criteria.   
Patient Participants. Potential participants will first undergo a screening of their EMR and the 
information will also be confirmed by interview with the patient prior to enrollment (RedCap: ‘Mentee 
Eligibility Questionnaire From EMR’). This includes questions about the inclusion/exclusion criteria.   
Mentor Training Assessments
Mentors will be evaluated by post-training assessments. This will include the following:

Fluid Training Survey (Module 1; 6 items)

Uremia & Infection Training Survey (Module 2; 6 items)

Mentor Role Training Survey (Module 3; 5 items)
Each of these survey items has one correct answer. Score will be reported as % correct overall.

Mentor Role Play Self-Assessment (Modules 3 & 4; ‘Confident’ Likert-type responses; 11 items)

Formative Assessment after each module (Strongly agree to Strongly disagree; 11 items)

Summative Assessment at the conclusion of core training (open ended questions; 5 items)
Refresher training events will only include formative and/or summative post-training assessments.
Baseline Visit, 3-Month (Patient participants), 9-Month (Mentor), 12 to 18-Month (T2; All)
Surveys will be completed for all visits by both mentors and patient participants, unless otherwise 
specified. Mentors will complete baseline surveys prior to participating in training activities.
Baseline visit. Include the following assessments:

Demographics, health literacy, behaviors, and ED/Hospitalization self-reported use

Self-report of medical history and access to care 
All visits. Include the following assessments:

Quality of Life (RAND SF-36)

Depressive symptoms (CESD-10)

Dialysis Self-management Self-efficacy (PDialSMS)
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
Kidney Disease Self-Management Behaviors Index (KDBI)

Multidimensional Scale of Perceived Social Support (MSPSS)

Dialysis-specific Social Support Survey

Brief Kidney-COPE Survey

Chronic Hemodialysis Knowledge Survey (CHeKs)

CHeKs PLUS Survey

Communication Assessment Tool (CAT)
Mentee group only – 3-Month Visit. Include the following assessments:

Health Care Climate Questionnaire (HCCQ) Long Form

Checklist for Mentee Assessment of Mentors
Monthly all participants. Include the following assessment:

Self-report of ED visits and/or hospitalizations
Monthly & Quarterly Intervention Survey (Mentor)
Study personnel will contact all mentors to monthly and perform the ‘Study Staff Monthly Mentor 
Check-in Survey’. Additionally, mentors will perform a quarterly self-assessment.
Intervention recordings & logs & phone billing record review
Phone billing records for all mentor and mentee phones will be reviewed. All calls will be abstracted 
including: phone number called, date, time, and duration. A summary of weekly minutes between 
mentor and mentee pairs will be generated for characterization of intervention dosing as well as 
evaluation of execution of mentor and mentee responsibilities. If the mentor uses his/her own personal 
telephone to contact the mentees, the study staff may ask to review the pertinent personal telephone 
records with that mentor to ascertain the time spent mentoring.
Random recordings of calls will be submitted to the study team for qualitative review of content. Call 
logs by mentors and mentees will also be reviewed, coded and characterized for content notes.
Medical Record Review
All records reviewed will be from clinical care. All participants will provide HIPAA authorization as part of 
informed consent to request this information and permit its inclusion in the study. Additional permission 
for records requests from external health systems may be provided by the participant to the study. 
A review of medical records will be performed at baseline for all participants during their active study 
period. This will include insurance type, comorbidity evaluation, date of first dialysis ever, information 
from Form 2728 about pre-dialysis care, medications, dialysis schedule. ED visits and hospitalizations.
Monthly medical record review will include dialysis treatment duration prescribed and delivered, 
interdialytic weight gain mean (%) for the month, serum albumin, ED visits and unplanned 
hospitalizations.
8.2
SAFETY ASSESSMENTS
There are no dedicated safety assessments in this study given no more than minimal risk related to the 
intervention. However, all participants have a serious chronic medical condition (ESKD requiring 
dialysis). Coordinators will be trained to report any unexpected events to study PIs. Planned evaluations 
include feedback about the intervention to report concerns, or suggestions for improvements. 
8.3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS
8.3.1
DEFINITION OF ADVERSE EVENTS
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Due to the nature of the intervention this study is considered no more than minimal risk to participants. 
However, monitoring for adverse events will be included as described below given the study population 
is medically complex and at high risk for health events independent of the study.
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward occurrence 
associated with the use of an intervention in humans, whether or not considered intervention-related. 
Examples may include emotional distress, or study related anxiety.

The adverse events for mentors associated with this study include: 
o
Distress related to curriculum training duration and skills assessments
o
Distress related to telephone conversations with assigned mentees

The adverse events for patient participants, including intervention mentees, include:
o
The embarrassment and/or stigma of being identified as a high-risk patient
o
Distress related to concern for loss of privacy of health information by mentor disclosure
o
Distress related to telephone conversations with mentors
8.3.2
DEFINITION OF SERIOUS ADVERSE EVENTS
A serious adverse event (SAE) is any AE that is: 
fatal or results in death
life-threatening
requires or prolongs hospital stay
results in persistent or significant disability or incapacity
an important medical event*
*Important medical events are those that may not be immediately life threatening but are clearly 
of major clinical significance.
8.3.3
CLASSIFICATION OF AN ADVERSE EVENT
8.3.3.1
SEVERITY OF EVENT
All adverse events (AE), including serious adverse events (SAEs) will be assessed by the principal 
investigator, using the following defined grading system.  For any events deemed to be severe, and 
related to the intervention, a report will be written and submitted to the IRB as well as to the DSMB for 
further evaluation.
•
Not serious – Events require minimal or no treatment and do not interfere with the participant’s 
daily activities. 
•
Serious – Events that result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning.
•
Life-threatening – Events interrupt a participant’s usual daily activity and may require 
treatment. Severe events are usually potentially life-threatening or incapacitating.  Of note, the 
term “severe” does not necessarily equate to “serious”.  
•
Fatal
8.3.3.2
RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
The study site PI, an expert nephrology clinician, will review the events and determine relatedness with 
the study intervention. If the determination is not clear, the site PI will engage the DSMB to additionally 
review a de-identified version of the case and determine related-ness to the study intervention. 
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The PI and/or DSMB will grade the causality of the adverse event to any element of the study using the 
following categories. 
•
Definitely Related – The AE is known to occur with the study procedures, there is a reasonable 
possibility that the study procedures caused the AE, or there is a temporal relationship between 
the study procedures and the event. Reasonable possibility means that there is evidence to 
suggest a causal relationship between the study procedures and the AE.
•
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, occurs within a reasonable time after administration of the 
study procedures, is unlikely to be attributed to concurrent disease or other drugs. 
•
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate.
•
Unlikely to be Related – There is not a reasonable possibility that the study procedures caused 
the event, there is no temporal relationship between the study procedures and event onset, or 
an alternate etiology has been established.
8.3.3.3
EXPECTEDNESS 
A clinician with appropriate expertise in nephrology/dialysis will be responsible for determining whether 
an adverse event (AE) is expected or unexpected. An AE will be considered unexpected if the nature, 
severity, or frequency of the event is not consistent with the risk information previously described for 
the study procedures. As described previously some discomfort to mentors during training and their 
mentoring activities is expected.  Some conflicts may also arise between the mentor/mentee pairs which 
are to be expected as well.  These occurrences will be considered “expected”.
The following serious adverse events are anticipated in the hemodialysis population and are not 
considered “unexpected” or Unanticipated Problems. Note that the designation as “Anticipated” does 
not imply that the event is not an SAE but relates to the regulatory definition of Unanticipated Problems 
as provided in Section 8.4.

Death

Coronary Ischemia including:

Unstable angina

Acute MI

Coronary revascularization

Heart failure hospitalization or exacerbation

Cardiac arrest

Cardiac arrhythmia (ventricular or atrial)

Peripheral vascular revascularization

Amputation

Hypotension

Hypertension

Nausea or vomiting

Vascular Access Events including:

Catheter exchange, removal or thrombolysis

Arteriovenous graft or fistula complications
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
Thrombosis

Stenosis

Revascularization

Infection

Infections including:

Pneumonia

Bacteremia

Hemodialysis vascular access infection 
8.3.4
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP
The occurrence of an adverse event (AE) may come to the attention of study personnel during study 
visits and interviews of a study participant presenting for medical care, or review by a study monitor. All 
AEs, not otherwise precluded per the protocol, will be captured on the Adverse Event Log Form. 
Information collected includes event description, time of onset, clinician’s assessment of severity, 
relationship to study procedures (assessed only by those with the training and authority to make a 
diagnosis), assessment of expectedness, and time of resolution/stabilization of the event. All AEs will be 
followed to adequate resolution.
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. Changes in the severity of an AE will be documented 
to allow an assessment of the duration of the event at each level of severity to be performed. 
Documentation of onset and duration of each episode will be maintained for intermittent AEs.
In this study, ED visits and hospitalizations, including reasons for these encounters, are collected as 
solicited events as they serve as the primary outcome. Vascular access use are solicited, and satisfaction 
with the intervention will be solicited monthly. 
The study PIs, with the help of the research assistants, will record adverse events with start dates 
occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) 
after the last day of study participation.  At each study visit, the investigator will inquire about the 
occurrence of AE/SAEs since the last visit.  Events will be followed for outcome information until 
resolution or stabilization.
8.3.5
ADVERSE EVENT REPORTING 
All AEs will be assessed by a principal investigator, using the above protocol defined grading system.  
Disease-related events common in the study population are described in 8.3.3.3. All AEs will be 
documented on the AE Study Log Form and also in the individual participant research record. If the AE 
meets the criteria for an SAE it will be documented accordingly and reported to the PIs, DSMB and IRB if 
indicated (Unexpected and Probably or Definitely related to the Intervention). Events that meet criteria 
for reporting to the IRB, this will occur within 10 business days and also summarized in the continuing 
review. If the event is unexpected probably or related to the intervention and results in death, the event 
will be reported to the IRB within 3 days and also summarized at the continuing review, or as required 
by the local IRB. 
8.3.6
SERIOUS ADVERSE EVENT REPORTING 
SAEs will be evaluated as described previously and recorded on the Adverse Event Study Log Form. This 
include information about if the study intervention was discontinued, the reason why the event is 
classified as serious, and the assessment of relatedness to the intervention. Any additional records for 
evaluation will be requested as needed and continue until the event is resolved. AE forms may be 
completed by research coordinators, but must be reviewed and signed by a site investigator. SAEs that 
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are ongoing at the end of the trial will be followed to determine the final outcome. SAEs will be reported 
as per the timeline and requirements for AEs (Section 8.3.5). 
8.3.7
REPORTING EVENTS TO PARTICIPANTS 
Study findings, including an aggregated report about AEs and SAEs will be available to study participants 
in publicly available online sources (clinicaltrials.gov), scientific literature and any associated reports, 
and potentially websites of the investigators, or their organizations.
8.3.8
EVENTS OF SPECIAL INTEREST 
N/A
8.3.9
REPORTING OF PREGNANCY 
N/A
8.4
UNANTICIPATED PROBLEMS
8.4.1
DEFINITION OF UNANTICIPATED PROBLEMS
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human 
Research Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or 
others to include, in general, any incident, experience, or outcome that meets all of the following 
criteria:
•
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied;
•
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and
•
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized.
Examples may include events such as loss of study equipment with private information, or complaints by 
participants, family or staff members.
8.4.2
 UNANTICIPATED PROBLEMS REPORTING 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the DSMB and lead PI. The UP report will include the following information:
•
Protocol identifying information: protocol title and number, PI’s name, and the IRB project number
•
A detailed description of the event, incident, experience, or outcome 
•
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP
•
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:  
•
UPs that are serious adverse events (SAEs) will be reported to the IRB and to the DCC/study 
sponsor/funding agency within 10 days of the investigator becoming aware of the event. However, 
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if the UP is classified as probably or related to the intervention and results in death the IRB will be 
notified within 3 calendar days, or as required by the local IRB.  
•
If the unanticipated problem is unrelated to the intervention it will be documented on the Adverse 
Event Study Log Form and summarized and reported to the DSMB as part of continuing review.
8.4.3
REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
Reporting of UPs to participants will depend on the nature of the UP. This may include:  
•
Modification of informed consent documents to include a description of newly recognized risks
•
Provision of additional information about newly recognized risks to previously 
consented/enrolled participants.
9
STATISTICAL CONSIDERATIONS 
9.1
STATISTICAL HYPOTHESES

Primary Endpoint: 
The primary objective is to determine the effectiveness of a peer support telephone intervention 
compared with usual care to reduce a composite of ED visits and hospitalizations among patients 
receiving in-center hemodialysis for ESKD. The null hypothesis is that the count of composite events 
at the end of the study period between intervention and usual care are the same. The alternative 
hypothesis is that the count of composite events at the end of the study period are different. 

Secondary Endpoint(s):
o
To determine the effectiveness of a peer support phone intervention compared to usual care to 
improve: 

dialysis self-management including:

Dialysis treatment schedule adherence (mean minutes missed per month)

Inter-dialytic weight gain (IDWG) (mean monthly %)

nutritional status (serum albumin)

dialysis knowledge

dialysis self-management self-efficacy

social support (general and dialysis-specific)

coping skills

quality of life

communication with providers
The null hypothesis is that the secondary endpoint values at the end of the study period between 
intervention and usual care are the same. The alternative hypothesis is that the secondary endpoint 
values at the end of the study period are different.

Feasibility endpoint(s):
o
To determine the feasibility of a structured, multicomponent, multiple session peer mentor 
training program at two sites. There is no specified hypothesis. 
o
To determine the acceptance of peer mentor phone intervention by patients. There is no 
specified hypothesis.
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Table 4. Scientific Questions to be Addressed with the Trial 
Scientific question
Outcome(s)
Analysis
1. Does phone peer support improve 
outcomes at 18-months (*12 to 18-
months)?
Primary: composite endpoint 
count of ED visit and 
hospitalization events
Secondary:  Various as listed 
above
Poisson regression with two 
random intercepts. Random 
intercepts account for clusters by 
(1) mentor; (2) dialysis unit
See Section 9.4.2 (Primary); 9.4.3 
(Secondary)
2. Is a peer mentor training program 
feasible?
Attendance records
Pre- and Post-knowledge test 
scores
Satisfaction with training
Summative assessment  
Paired t-tests
Descriptive summaries and 
content analysis of qualitative data
3. Is a peer mentor training program 
accepted by patient receiving 
hemodialysis
Satisfaction with 
intervention
Communication rating of 
mentors
Descriptive
Content analysis of qualitative 
data
9.2
SAMPLE SIZE DETERMINATION
For evaluation of the primary endpoint, estimates are based on local dialysis unit hospitalization events 
in the past 12 months. For the control group, we expect 0.27 events per month (100 prevalent patients 
and 27 composite events per month). With 73 patients per group (after 25% drop-out), our study has 
>80% power to detect 20% reduction (i.e. a reduction of 0.054 visits per person-month) at type 1 error 
level 0.05.155 We will recruit at least 100 patients per group over the course of the study.
9.3
POPULATIONS FOR ANALYSES
For the primary endpoint comparison, an intention-to-treat analysis will be used, including all available 
data on randomized participants. It is expected that up to 20% of randomized participants may 
discontinue from the study prior to the end point. These participants will be included in the primary 
analysis and data from the monthly outcome ascertainment up until the last available time point will be 
used. As preparation for the follow-up period modification, events to date were evaluated at one site 
(Einstein) and were found to be more frequent than initial estimates. This informed the request for 
reduction in the follow-up period.
The characteristics of those who do not complete all study activities will be compared to those with 
complete follow-up to examine for potential biases introduced by differential follow-up among the two 
groups. These will be considered ancillary analyses. 
Secondary analyses will examine additionally an as-treated population. This will group any intervention 
patient who did not participate in more than 20 minutes total of the intervention during the three-
month period to be classified as the usual care group. 
9.4
STATISTICAL ANALYSES
9.4.1
GENERAL APPROACH
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Descriptive statistics will be used to provide for each variable: number of observations, mean, standard 
deviation, median, minimum and maximum for continuous variables; frequencies and proportions for 
categorical variables. Results will be reported in accordance with the extended CONSORT guidelines for 
pragmatic clinical trials using two-sided statistical tests and confidences intervals. For all analyses, the 
overall level of significance will be set at 0.05. All analyses will be adjusted for site. Adjustment variables 
will be pre-specified in the following sections.  All analyses will be performed using SAS v9.4 (SAS 
Institute, Cary, NC), STATA (College Station, Tx), or R (currently 3.6.1; https://cran.r-project.org/). 
Analyses of qualitative data will include content analysis, novel code generations as applicable, 
interpretation and descriptive reporting. 
9.4.2
ANALYSIS OF THE PRIMARY ENDPOINT(S)
ED Visit and Hospitalization Count
Each month all enrolled patients will be evaluated for ED visit or hospitalization encounters by both self-
report and medical record review. The events will be tabulated each month up to an 18-month period of 
follow-up. The rates of the composite event will be determined as event per patient-month and 
compared between the intervention and usual care group using Poisson regression with two random 
intercepts. In the regression model, the composite counts of ED visits and hospitalization during up to 
18-months follow-up is the outcome variable and the intervention assignment of the mentees is the 
primary binary predictor. The log of follow-up time will be included as offset. The random intercepts will 
account for the correlation between mentees who share a common mentor as well as the correlation 
between mentees who are from a common dialysis facility (out of seven facilities).  As a randomized 
controlled trial, we do not anticipate the need for covariate adjustment. However, if evaluation of 
patient characteristics by group identifies a failure of randomization and imbalance in key characteristics 
as an example including age, gender, comorbidity, race, or dialysis vintage they will be considered as 
adjustment variables in the analysis. We will control for type 1 error at 0.05. An exploratory analysis will 
consider the comparison between the groups but at 3-months of observation after the conclusion of the 
intervention delivery. 
We will perform residual analysis for the mixed effects models. For mixed effects models, we will 
examine marginal residuals to check linearity and within-subjects covariance matrix and conditional 
residuals to check outliers as well as normality and homoscedasticity of the residual errors. In case 
Pearson residual analyses indicate overdispersion in the Poisson mixed effects model, we will perform 
quasi-Poisson model. We will use robust sandwich estimator in the presence of misspecification of the 
covariance matrix (i.e. random effects structure).
All data analyses will be preceded by extensive data checking and verification to identify and resolve the 
reasons for missing values, inconsistencies, and out-of-range values. Although, we anticipate less than 
15% missing data, we will carefully examine whether missingness is completely at random (MCAR), at 
random (MAR) or informative (MNAR). Models proposed for analysis can handle incomplete data (i.e. 
entire subject is not deleted if missing data at one time point), but do require at least that missingness 
be at random. Modelling will consider using multiple imputation techniques of covariates to reduce 
potential biases.
9.4.3
ANALYSIS OF THE SECONDARY ENDPOINT(S)
The primary evaluation will be at the end of the study period (12 to 18-months) using all available data 
regardless of the period end for participants, and comparisons at 3M will be secondary. For the primary 
evaluation, we will test the longitudinal effect of a peer mentor led telephone intervention on mentee 
self-management skills including 1) dialysis adherence (mean number of outpatient dialysis hours per 
month), 2) mean monthly inter-dialytic weight gain (IDWG), and 3) mean monthly albumin levels. We 
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will compare the rate of change over time of the monthly secondary endpoints between two 
intervention groups using linear mixed effects regression model. In the regression model, the secondary 
endpoint (e.g. monthly mean dialysis hours) is the outcome variable with two main effects (the 
intervention assignment and months from baseline) and the interaction term between the main effects. 
The interaction term (i.e. the difference in slopes between two groups) is the primary predictor of 
interest. There will be three random intercepts to account for mentor effect, facility effect (out of seven 
facilities) and subject effect (to account for within correlation from repeated measurements). We will 
evaluate differences in baseline variables identified in Table 6 and if they are different between the 
groups, we will adjust for them as confounders. 
For the secondary evaluation at 3M, we will perform Wilcoxon rank-sum test to compare the 3-months 
change of secondary endpoints between the intervention mentee and control mentees. To account for 
confounders, we will also fit linear regression model with two random intercepts. In the regression 
model, the 3 months-change of secondary endpoint is the outcome variable and the intervention 
assignment of the mentees is the primary binary predictor. The random intercepts will account for the 
correlation between mentees who share a common mentor as well as the correlation between mentees 
who are from a common dialysis facility.  
Below, each endpoint is described including its source, scoring and planned analysis approach. 
Additional details for scoring of surveys is provided in the PEER HD Survey Scoring guide document.  
Within group (mentors) for change in outcomes over time will also be evaluated.
Outcomes derived from clinical EHR records
Dialysis treatment schedule adherence (mean minutes missed per month)
This outcome will be summarized as total minutes prescribed per month, minutes delivered per month 
and the missed minutes is the prescribed minus the delivered minutes. There will be no value less than 
zero (eg. no accounting for additional minutes). 
This is a repeated end-point with values for each month of the observation period (Months 1 through up 
to 18). The value itself is interval (0 – 240, or higher). 
Inter-dialytic weight gain (IDWG) (mean monthly, %)
This outcome will be summarized each month as the mean IDWG for the month prior in kilograms. The 
value will include all intervals regardless of time between treatments (2-days, 3-days or other), and will 
be calculated as the pre-weight minus the prior treatment post-weight. Prescribed dry weight will also 
be collected monthly to permit an average calculation of % of dry weight. This value is interval. 
Nutritional status (serum albumin g/dL)
The serum albumin collected for monthly labs will be collected. If there are multiple values in one 
calendar month, then the last value of the month will be collected. This is an interval variable.
Outcomes derived from patient-reported measures
Dialysis knowledge {CHeKS; CHeKS PLUS]
See scoring guide for full detail. These are multiple choice knowledge questionnaires where there is only 
one correct answer. The score will be % correctly answered of the total. Missing responses are scored as 
incorrect. At least 75% of the items must have answer to be scored. 
Dialysis self-management self-efficacy
The PDialSMS is collected at three times during the study. It is an interval value ranging from 8 to 40. 
Social support
This is measured with the 12 item Multidimentional Scale of Perceived Social Support (MSPSS). The total 
score is the sum across the 12 items (each 1-7) divided by 12. There are also 3 subscales (significant 
other, family, and friends) each composed of 4 items. This value is interval. 
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A dialysis-specific social support survey is also collected to characterize the frequency of interactions 
between the participant and other dialysis patients. There are six items (range 1-5) and the total score is 
the mean of the six items. 
Quality of life
This is measured with the RAND SF-36. Responses are standardized to a 0 to 100 scale and then 
averaged together to derived 8 subscale scores. Four of these then contribute to the physical 
component score (PCS), and four contribute to the mental component score (MCS). All values are 
interval. 
For the perception of social support and self-efficacy we will use linear regression with two random 
intercepts to compare the scores on the PKDSMS, social support survey and quality of life surveys 
between the intervention mentee and control mentees at the various time points. The outcome variable 
for the regression is the assessment scores and the predictor of interest is the binary indicator of 
intervention groups.
Coping skills
This is measured with the Brief K-COPE a kidney-oriented adaptation of the Brief COPE survey. It has 28 
items score 1 to 4. There are 14 subscales composed of 2 items each. The score for each subscale is the 
sum of the two individual items that compose that scale (2-8).  
Communication with providers
This is measured with the Communication Assessment Tool (CAT). There are 14 items with a response 
ranging from 1 to 5. The total score is the average of the 14 items. Question 15 is descriptive and not 
included in the overall score of the CAT. 
Feasibility Outcomes: We will perform Wilcoxon rank sum test to test the difference in pre-and post-
training knowledge assessments in the mentors (Baseline CHeKS; PLUS vs. 9M and 12 to 18M). The 
outcome variable for the regression is the difference between pre-and post-training scores and the 
parameter of interest is the intercept.  We will test if the intercept is zero.
For qualitative data, we will review the content of the individual surveys and develop a novel coding 
scheme to characterize the content including common themes identified. We will also provide 
descriptive results of the HCCQ survey characterizing mentees’ ratings of mentor communication.
9.4.4
SAFETY ANALYSES
Adverse events will be descriptively tabulated and included in the analysis report of the study.
9.4.5
BASELINE DESCRIPTIVE STATISTICS
All baseline variables will be summarized by treatment group using descriptive statistics (sample size, 
mean, standard deviation, median, minimum, and maximum) for continuous variables and by the 
number and percentage of patients for categorical variables. We will test the success of randomization  
by examining differences in the two treatment groups by performing two-sample Mann-Whitney non-
parametric test for continuous variables, and chi-square test for the categorical variables.
This will also include an evaluation of the degree of concordance between mentors and mentees for 
variables considered for pairing. This includes: sex, race/ethnicity, language, age category and schedule 
preferences.
9.4.6
PLANNED INTERIM ANALYSES 
No planned interim analyses.
9.4.7
SUB-GROUP ANALYSES
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Potential effect modification will be examined by including interaction terms between the intervention 
and patient characteristics such as sex, race/ethnicity, age, health literacy, numeracy, and depressive 
symptoms. For baseline factors with statistically significant interactions, intervention effects will be 
reported by subgroups. This will be applied to all endpoints (primary and secondary). 
9.4.8
TABULATION OF INDIVIDUAL PARTICIPANT DATA
Data will be tabulated as de-identified, without site or patient identifiers.
9.4.9
EXPLORATORY ANALYSES
In exploratory analyses, we will examine the dose of intervention (total minutes; average minutes per 
week), and the degree of concordance between mentor and mentee characteristics as a mediator or 
moderator of the impact of the intervention. 
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS
10.1.1 INFORMED CONSENT PROCESS
We will obtain informed consent from mentors and mentees separately. Recruitment procedures 
include screening for eligibility. Verbal consent will be provided by the participant for proceeding with 
screening. In some sites, a HIPAA consent form may be required prior to initiating any recruitment 
procedures, including screening for eligibility. We will comply with NIH Human Research Protections 
Program policies and procedures. The investigator will also comply with applicable regulatory 
requirements (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56) and will adhere to the ICH-GCP.  All of the 
informed documents are approved by the institutional review boards of each participating site.
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS
All documents, including recruitment scripts (in-person, virtual, phone or email/letter), will be IRB 
approved prior to use in this study. They will be available in English, and may be available in Spanish (site 
specific). Consent forms describing in detail the study intervention, study procedures, and risks will be 
given to the participant and written documentation of informed consent, or alterations in the procedure 
if IRB approved and described in the following section, will be completed prior to starting the study. 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION
Participants identified by the study recruitment strategies and who are deemed to be eligible for 
participation will provide informed consent. This may be performed according to local IRB approvals 
including the provision of written consent after an in-person discussion about the study with the 
research team. A copy of this written consent will be provided to the participant, stored in their research 
record, and many also be stored in their medical record, if required. Alterations of the consent process 
may also be performed if approved by local IRB. This may include a virtual research consent visit where 
the participant and study team have a video visit to discuss the study. The consent form will be provided 
ahead of time to the participant by mail, email (if provided by the participant and requested) or picked 
up at a clinic location if permitted. The patient may then return a signed copy of the consent to the 
research team. It will be stored as above. A phone consent process may also be performed similar to a 
virtual consent visit. A final option may be the execution of an electronic version of the consent form 
through RedCap. In this case, the participant will still have either a phone or virtual visit with the 
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coordinator to discuss the study. In place of a paper copy of the consent form, an electronic exact 
content copy will be sent to the patient by email link for their review and electronic signature. This will 
be stored in RedCap. A copy will be printed, if possible, and stored in the participant’s research file 
and/or medical record if required. Study materials may provide a web address or QR code to the study’s 
econsent if permitted by local IRB. Consent forms will be available in English, and may be available 
additionally in Spanish (site specific). 
All participants currently active in the study after 4/30 amendment approval, and any new enrollments, 
will execute the revised version of the informed consent document describing the revised study 
timeline.
10.1.2 STUDY DISCONTINUATION AND CLOSURE
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to study participants, investigator, funding agency, and 
regulatory authorities. If the study is prematurely terminated or suspended, the Principal Investigator 
(PI) will promptly inform study participants, the Institutional Review Board (IRB), and sponsor/funding 
agency and will provide the reason(s) for the termination or suspension. Study participants will be 
contacted, as applicable, and be informed of changes to study visit schedule.
Circumstances that may warrant termination or suspension include, but are not limited to:

Determination of unexpected, significant, or unacceptable risk to participants

Insufficient compliance to protocol requirements

Data that are not sufficiently complete and/or evaluable

Unforeseen circumstances, including natural disasters, that preclude safe execution of study 
activities
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, or other relevant regulatory or oversight bodies (DSMB).
10.1.3 CONFIDENTIALITY AND PRIVACY 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 
information from the study will be released to any unauthorized third party without prior written 
approval of the sponsor/funding agency. 
All research activities will be conducted in as private a setting as possible. The study monitor, other 
authorized representatives of the sponsor or funding agency, representatives of the Institutional Review 
Board (IRB), or regulatory agencies, may inspect all documents and records required to be maintained by 
the investigator, including but not limited to, medical records for the participants in this study. The clinical 
study site will permit access to such records.
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency 
requirements.  
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Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored at the study data coordinating center. This will not include the participant’s 
contact or identifying information. Rather, individual participants and their research data will be 
identified by a unique study identification number. The study data entry and study management 
systems used by study sites will be secured and password protected. At the end of the study, all study 
databases will be de-identified and archived at the data coordinating center, and shared with data 
repositories or other investigators as may be required or agreed upon for additional research.
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies 
It is NIH policy that the results and accomplishments of the activities that it funds should be made 
available to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms 
used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, 
and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not 
be traceable to a specific study participant). Plans for archiving and long-term preservation of the data 
will be implemented, as appropriate. 
Certificate of Confidentiality 
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), 
has issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, 
clinical or other human subjects research funded wholly or in part by the federal 
government.  Recipients of NIH funding for human subjects research are required to protect identifiable 
research information from forced disclosure per the terms of the NIH Policy (see 
https://humansubjects.nih.gov/coc/index). As set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 
8.3, recipients conducting NIH-supported research covered by this Policy are required to establish and 
maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance 
that the award is managed in compliance with Federal statutes, regulations, and the terms and 
conditions of award. It is the NIH policy that investigators and others who have access to research 
records will not disclose identifying information except when the participant consents or in certain 
instances when federal, state, or local law or regulation requires disclosure. NIH expects investigators to 
inform research participants of the protections and the limits to protections provided by a Certificate 
issued by this Policy.
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
Data collected for this study will be analyzed and stored at the Albert Einstein College of Medicine. A de-
identified dataset may also be shared with study investigators at Vanderbilt University Medical Center.  
After the study is completed including completion of analyses and publication of study results, the de-
identified, archived data may be transmitted to and stored at the NIH/NIDDK repository, for approved 
use by other researchers including those outside of the study. Permission to share data will be included 
in the informed consent. Additional requests by investigators may be made to the coordinating center 
for consideration of sharing of the de-identified dataset for IRB approved research. 
There will be no storing of biosamples for this study. 
10.1.5 KEY ROLES AND STUDY GOVERNANCE
This is a multi-site with shared responsibilities in a Multi-PI governance. There is no pre-identified 
medical monitor or independent study monitor given the no more than minimal risk of the intervention 
of this study. The safety of participants and execution of the study is overseen by a DSMB (See Section 
10.1.6)
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Principal Investigator
(Contact)
Co-PI
Co-PI
Ladan Golestaneh, MD MS
Professor of Medicine
Michal Melamed, MD MHS
Associate Professor of Medicine
Kerri Cavanaugh, MD MHS
Associate Professor of Medicine
Albert Einstein College of 
Medicine; Montefiore Medical 
Center
Albert Einstein College of Medicine
Vanderbilt University Medical 
Center
3411 Wayne Ave, Suite 5H, 
Bronx, NY 10804
1300 Morris Park Avenue, Ullmann 
615
Bronx, NY 10461
2525 West End Ave, Suite 450
Nashville, TN 37203
718-920-5442
718-430-2304
615-936-7306
lgolesta@montefiore.org
michal.melamed@einsteinmed.org
kerri.cavanaugh@vumc.org
10.1.6 SAFETY OVERSIGHT
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB) composed of 
individuals with the appropriate expertise, including care of patients on hemodialysis and behavioral 
clinical research. Members of the DSMB will be independent from the study conduct and free of conflict 
of interest. The DSMB will meet at least semiannually to assess safety and efficacy data from each arm 
of the study. The responsibilities of the DSMB include: 1) to review the feasibility and safety of the study 
protocols; 2) to review feasibility and safety of training materials for mentors; 3) to approve any 
adaptation of the protocols or training material; and 4) to review enrollment, study procedures and any 
events during the course of the study. A template of the DSMB report is available and includes 
descriptions of study activities by site, including enrollment, data collection and any AEs. The DSMB will 
provide its input to the study team, the site IRBs, and the National Institutes of Diabetes and Digestive 
and Kidney Diseases/National Institutes of Health.
The DSMB will be comprised of 3 individuals from Albert Einstein College of Medicine who are 
unaffiliated with the study and who have appropriate expertise. They will meet and vote on the 
approval of the protocol prior to initiation and the minutes of the meeting will be submitted to the IRB.  
The DSMB will review trial progress and will offer advice with respect to study continuation, 
modification and/or termination.  Case reports about any adverse events or protocol violations will be 
sent to the group, in addition to the IRB, at least every six months.  The DSMB will meet every 6 months 
and as needed via conference call/video meeting.
10.1.7 CLINICAL MONITORING
Each site Principal Investigator will be responsible for overseeing the safety of the study at his/her site. 
This safety monitoring will include careful assessment and appropriate reporting of adverse events as 
described in Section 8. Medical monitoring will include a regular assessment of the number and type of 
serious adverse events. Additionally, the study will be overseen by an Independent Data and Safety 
Monitoring Board (DSMB) (Section 10.1.6). 
Clinical site monitoring on-going by the site PIs and by the DSMB (2-3 meetings annually) will be 
conducted to ensure that the rights and well-being of trial participants are protected, that the 
reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in 
compliance with the currently approved protocol/amendment(s), with International Council on 
Harmonisation Good Clinical Practice (ICH GCP), and with applicable regulatory requirement(s). 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL
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Quality control and assurance measures will be implemented throughout the study starting with the 
development of this detailed study protocol and manual of operations.  The availability of these 
documents will standardize screening, recruitment, physical and laboratory measurement and data 
entry.  All study staff will be trained in the protocols for this study and will be observed for fidelity to 
protocol and retrained as needed while working on the study.  Peer mentors will be trained on 
proficiency with phones and intervention schedule and retrained as needed.  To assure data integrity, a 
REDCap database will be developed for the study that will include limits for inputs and pull-down menus 
for quality control during data entry.  In addition, 20% sample of questionnaires will be double entered 
to check for errors.  If a significant number of errors are found, all data will be double entered by two 
different personnel.
Each clinical site will perform internal quality management of study conduct, data collection, 
documentation and completion. All sites will follow a common quality management plan.
Quality control (QC) procedures will be implemented as follows:
Informed consent --- Study staff will review both the documentation of the consenting process as well 
as a percentage of the completed consent documents.  This review will evaluate compliance with GCP, 
accuracy, and completeness.  Feedback will be provided to the study team to ensure proper consenting 
procedures are followed. 
Source documents and the electronic data --- Data will be initially captured on source documents (see 
Section 10.1.9) and will ultimately be entered into the study database.  To ensure accuracy site staff will 
compare a sample of source data against the database, targeting key data points for review.
Intervention Fidelity — Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study. Procedures for ensuring fidelity of intervention delivery are described in 
Section 6.2.1. 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. This will be reported to the DSMB and IRB as required.
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities.
10.1.9 DATA HANDLING AND RECORD KEEPING 
Only approved trained study personnel will have access to data collection and management. Data will be 
maintained locally at each site secured in study research folders, or electronically secured. The data 
collected from enrolled participants will be entered into a secure RedCap database overseen by the data 
coordinating center (Albert Einstein). Only approved study personnel will be granted access to the study 
RedCap database. Authorized representatives of the NIH, sponsor, and regulatory agencies will be 
approved to examine (and when permitted by applicable law, to copy) clinical records for the purposes 
of quality assurance reviews, audits, and evaluation of the study safety, progress, and data validity. 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
All data collected will be as described in earlier sections of this protocol. This will include data derived 
from patient report, observations by the research team, medical records from varying sources, and 
phone billing records. Recordings of calls between mentor/mentee participants will be digital files, 
stored on a secure server at the site accessible to only study personnel. Any transcriptions or recordings 
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will be de-identified and stored electronically. Logs and diaries submitted by participants will be scanned 
as electronic files and any hard copies maintained in the research record.
Preferentially all data will be entered into the secure online database RedCap at the data coordinating 
center. When required, paper versions of the data collected or de-identified source documentation 
(medical records) will be stored in the participant’s research record. Participants may respond to surveys 
electronically, when they will directly enter the data and there will be no paper copy in the research file. 
This will be noted by the study coordinator. Similarly, if a phone interview is performed by a study 
coordinator, data may be directly entered into the RedCap database.
Instructions for completing forms will be additionally detailed in the MOP. A scoring guide for surveys 
will be included as part of the study data dictionary. 
The data coordinating center will perform a review of data every 4 months including evaluating the 
degree of missingness of forms or data points. This will be described by site and included for review by 
the DSMB. 
Data collection will be the responsibility of the clinical trial staff at the site under the supervision of the 
site investigator. The investigator will be responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. All source documents, when applicable, will be completed in a neat, 
legible manner to ensure accurate interpretation of data.  
Clinical data (including adverse events (AEs), and clinical laboratory data will be entered into RedCap, a 
21 CFR Part 11-compliant data capture system provided by the Data Coordinating Center. The data 
system includes password protection and internal quality checks, such as automatic range checks, to 
identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will be entered directly 
from the source documents.
10.1.9.2 STUDY RECORDS RETENTION 
Clinical Center investigators will retain study documents, including participant files and regulatory forms 
for at least 5 years after the close of the study, or longer depending on site institutional requirements. 
No records will be destroyed without the written consent of the sponsor/funding agency, if within 3 
years of the submission of the Federal Financial Report to the NIH by the coordinating center. It is the 
responsibility of the sponsor/funding agency to inform the investigator when these documents no 
longer need to be retained.
10.1.10
PROTOCOL DEVIATIONS  
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures 
(MOP) requirements. A protocol deviation is considered to be any change or alteration of the IRB-
approved study protocol without advanced IRB approval. A protocol exception is a one time, intentional 
change or alteration to the IRB-approved protocol that is approved by the IRB prior to execution.
Major deviations will be consider as any change that has the potential to adversely affect the rights, 
welfare or safety of participants, or adversely affect the integrity of the research data.
This may include: failure to obtain informed consent prior to research activities, use of an invalid 
consent form, enrollment of a participant who is ineligible, performing research not included in the 
protocol, failure to report AEs to the DSMB and/or IRB, use of recruitment procedures that are not IRB 
approved, or enrolling more participants than IRB approved. 
Minor deviations may be those that do not have the potential to affect the rights, welfare or safety of 
participants, or the integrity of the research data. This may include execution of a study visit beyond the 
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protocol define window. These deviations will be recorded and reported to the DSMB and IRB as a part 
of continuing review.
As a result of deviations, corrective actions will be developed by the site and implemented promptly. 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
major deviations within 7 working days of identification of the protocol deviation. All deviations will be 
addressed in study source documents, reported to NIDDK Program Official, DSMB and IRB. Protocol 
deviations will be sent to the reviewing Institutional Review Board (IRB) per their policies. The site 
investigator will be responsible for knowing and adhering to the reviewing IRB requirements. 
10.1.11
PUBLICATION AND DATA SHARING POLICY 
The PIs of the study will be responsible for developing publication procedures and resolving authorship 
issues. The study must comply with:

The NIH Public Access Policy, the NIH Policy on the Dissemination of NIH-Funded Clinical Trial 
Information, Clinical Trials Registration and Results Information Submission,

The NIH Data Sharing Policy (if applicable),

The NIH Data Sharing Policy and Implementation Guidance,

Any other relevant policies (e.g., NIH IC-specific data sharing or publication policy)
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication.
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals.  Data from this study may be requested from other researchers after publication of 
the primary study results by contacting the data coordinating center. Additionally, a de-identified 
dataset may be placed in the NIDDK data repository.  
10.1.12
CONFLICT OF INTEREST POLICY
All investigators are required to report all financial conflicts of interest on an annual basis as per site 
institutional and NIH policies. All conflicts of interest will be reported in manuscripts. If conflicts of 
interest arise during the conduct of the study, the sponsor organizations will review and make 
determinations regarding any necessary management.
10.2 ADDITIONAL CONSIDERATIONS
10.3 ABBREVIATIONS AND SPECIAL TERMS
AE
Adverse Event
AECOM
Albert Einstein College of Medicine
CFR
Code of Federal Regulations
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COC
Certificate of Confidentiality
CONSORT
Consolidated Standards of Reporting Trials
DCC
Data Coordinating Center
DSMB
Data Safety Monitoring Board
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act 
ICH
International Council on Harmonisation 
IRB
Institutional Review Board
ISM
Independent Safety Monitor
MOP
Manual of Procedures
NCT
National Clinical Trial
NIH 
National Institutes of Health
NIH IC
NIH Institute or Center
OHRP
Office for Human Research Protections
PI
Principal Investigator
QC
Quality Control
SAE
Serious Adverse Event
SOA
Schedule of Activities
SOC
System Organ Class
UP
Unanticipated Problem
US
United States
VUMC
Vanderbilt University Medical Center
10.4 PROTOCOL AMENDMENT HISTORY
Version
Date
Description of Change 
Brief Rationale
2.2
6/17/20
Grammatical revisions, formatting 
revisions, language updates to 
Biostats section 
Protocol Amendment from v2.1
3.0
4/30/21
Revisions include grammatical, 
formatting, timeline endpoints, 
mentee assignment, and 
discontinuation surveys
Protocol Amendment from v2.2
11
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