Pilot Testing of a Communication Intervention to Promote Shared Dialysis Decision Making in Older Patients With Chronic Kidney Disease (DIAL-SDM Trial)
Phase: NA
Conditions: End Stage Renal Disease, Chronic Kidney Diseases
Sponsor: University of Rochester

Date: 8/28/2025 
Pilot Testing of a Communication Intervention to Promote 
Shared Dialysis Decision-Making in Older Patients with Chronic 
Kidney Disease (DIAL-SDM Trial) 
 
 
Study Protocol and Statistical Analysis 
 
NCT04392440 
 
Date: 8/28/2025 
 

Pilot Testing of a Communication Intervention to Promote Shared Dialysis 
Decision-Making in Older Patients with Chronic Kidney Disease (DIAL-SDM Trial)
Principal Investigator (PI): Fahad Saeed, MD 
Co-investigators: Ronald Epstein, MD
Kevin Fiscella, MD
RGH Site PI: Pulkit Gandhi, MD
Research Coordinator: Brooke Daigneault
1.
PURPOSE OF THE STUDY AND BACKGROUND
1.1.
Objective:
The objectives of this study proposal are:
Aim 1 (primary): Assess the feasibility, acceptability, and fidelity of the DIAL-SDM intervention, as 
measured in both nephrologist and patient coaching sessions by the Feasibility of the Intervention 
Measure,1 Acceptability of the Intervention Measures,1 and fidelity checklists for both nephrologist 
and patients’ coaching sessions. We will also gather qualitative data from nephrologists, patient coaches, 
research coordinators, patients, and caregivers to guide the modification of the study protocol.
Aim 2: Generate preliminary effect sizes and examine the effect of the intervention on the following 
patient outcomes:
(a)
Active patient participation in dialysis decision-making, as measured by the Active Patient 
Participation Coding (APPC) scores from audio recordings of office visits.2,3
(b)
Shared dialysis decision-making, as measured by the modified OPTION scale scores,4 from 
audio recordings of office visits, and the patient-reported Shared Decision-Making 
Questionnaire and the Decisional Engagement Scale.5
(c)
Patients’ initial choice of ESRD treatment options (home vs. in-center dialysis vs. CM) at study 
entry and completion.
(d)
Patient report of prognostic discussions, as measured by the prognosis questionnaire.6
(e)
Decisional conflict, as measured by the decisional conflict scale.7
(f)
Patient report of goal concordant care, as measured by the goal concordant questionnaire.8
Aim 3: Aim 2: Generate preliminary effect sizes and examine the effect of the intervention on the 
following caregiver outcomes:
(a)
Decisional conflict, as measured by the decisional conflict scale. 6
(b)
Shared dialysis decision-making as measured by the Shared Decision-Making Questionnaire 
and the Decisional Engagement Scale.4,5

1.2.
Background:
National guidelines recommend that nephrologists engage patients with chronic kidney 
disease (CKD) in shared decision-making (SDM) before initiating dialysis.9,10 More than 200,000 
older adults receive dialysis for end-stage renal disease (ESRD),3 despite the high burden of 
treatment,11-14 and guidelines encourage physicians to consider conservative management 
(CM), rather than dialysis, for older patients with poor prognosis.9 In older adults with multiple 
co-morbidities, dialysis may have minimal impact on survival but worsens quality of life (QoL) 
and entails frequent hospitalizations.17,18 They often prefer maintaining QoL over prolonging 
life.17,18 They wish to know prognostic information but nephrologists infrequently engage these 
patients in meaningful discussions about their preferences and prognosis, including CM. 17,18 
As a result, patients often overestimate prognosis and have unrealistic expectations for a 
cure.18-23 Honest yet sensitive discussions about prognosis and treatment choices are 
associated with more realistic prognostic estimates and decisions better aligned with patients’ 
preferences.24,25 However, changing decision-making conversations is not straightforward.26,27 
There are currently no scientifically proven interventions to improve communication between 
nephrologists and older patients with CKD around shared decision-making (SDM) for dialysis 
initiation. Prior interventions with limited effectiveness that studied non-CKD patients 
generally addressed either clinicians’ or patients’ communication behaviors28-33or used a third 
party to facilitate communication.34,35 Yet the ecological framework and prior studies of SDM 
suggest that attention to both clinician and patient communication behaviors is essential to 
facilitate difficult conversations in the emotionally-sensitive, value-driven, and highly personal 
context of serious illness such as CKD.36-42 Therefore, we need to improve the process of 
decision-making 
about 
the 
initiation 
of 
dialysis, 
enhancing 
patient-physician 
communications so that they can meaningfully share treatment decisions. Patients’ voices 
need to be heard when they are facing difficult choices that will determine the course and 
quality of their lives.
2.
STUDY DESIGN
2.1.
Overview
We propose a prospective, cluster-randomized clinical trial of DIAL-SDM vs Usual Care (UC) 
with nephrologists from the renal group at Strong Memorial Hospital, Highland Hospital, FF 
Thompson, and Rochester General Hospital as the unit of randomization and patients as the 
unit of analyses. Routine nephrology follow-up of patients in both arms will be at the discretion 
of nephrologists.
2.2.
Rationale for Study Design
To examine the outcomes of the DIAL-SDM intervention for CKD patients ≥ 65 years (and their 
caregivers), a prospective, cluster-randomized design is preferred over a nonrandomized 
prospective design or retrospective design. If the results of this pilot study show feasibility and 
acceptability of the DIAL-SDM intervention (as hypothesized), we plan to design a larger-scale 
cluster randomized control trial.
3.
CHARACTERISTICS OF THE RESEARCH POPULATION
3.1.
Subject Characteristics

(a)
Number of Subjects: The study subjects include nephrologists, research coordinators, patient 
coaches, patients, and caregivers from Strong, Highland, FF Thompson, and Rochester General 
Hospital. The study will be performed between August 2021 and September 2025. 
Nephrologists (n= up to 16), in the Strong, Highland, FF Thompson, and Rochester General 
Renal Group will be eligible to participate and will provide informed consent. For physicians 
who withdraw from the study prior to the enrollment of their own participating patients, they 
will be replaced with additional physicians, therefore keeping the number of participating 
physicians up to 16. Research Coordinators (n=up to 3) who have assisted in the study will be eligible to 
participate in a qualitative interview and will provide informed consent. Patient Coaches (n=up to 3) who 
have assisted in the study will be eligible to participate in a qualitative interview and will provide informed 
consent. With a total sample size of 60 patients (approximately 5 patients per nephrologist 
depending on the total number of enrolled nephrologists), we would have 80% power at an 
alpha of 0.05, assuming a coefficient of variation of cluster sizes as high as 0.5 and an 
intracluster correlation coefficient of 0.1 to detect mean differences of at least 15 points 
(standard deviation 11) on the OPTION scale scores reflecting shared decision making between 
two groups. The data generated in this pilot study will be useful to generate effect size 
estimates for a future trial. We expect to enroll 36 caregivers assuming a 60% participation 
rate of caregivers. The proposed recruitment plan aligns with the goals of the K-23 which is a 
small pilot.
(b)
Gender and Age of Subjects: For patients, we will include men and women who are ≥65 years 
old. We expect the same distribution of men (48%) and women (52%) as of the general 
population. All adult caregivers (21-years or older) will be eligible to participate in the study. 
Based on prior research, we expect the following age distribution for caregivers: age 21-44 yrs.
= 15%; 45-54 yrs. = 25%; age 55-64 yrs. = 30%; 65-74 yrs. = 20%; age 75 yrs. or older = 10%. For 
caregivers, we expect that we‘ll enroll 38% male caregivers and 62% female caregivers. 41 In the 
Strong, Highland, FF Thompson, and Rochester General Hospital Renal Group, we have 9 female 
nephrologists, 19 male nephrologists, and 1-3 fellows/yr. Faculty age ranges from 34-65 plus.
(c)
Racial and Ethnic Origin: We do not restrict enrollment based on race or ethnic origin. The 
demographics of the population in the Greater Rochester area in 2010 was 77% White, 16.2% 
Black or African American, 8.5% Hispanic or Latino (either Black or White). We expect the racial 
and ethnic distribution of the enrolled subjects to be the following (Tables 1, 2 & 3): However, 
to encourage recruitment of minority participants, we will seek input on the study protocol from 
minority patients. Additionally, a coach will have the option to do home visits in order to prevent 
financial burden on the participants.
Table 1. Racial and Ethnic Category of Physicians
(Expected number of participants = 10)
Racial/Ethnic Category
White (including Latinos or Hispanics)
8 (80%)
Asians
2 (20%)
Table 2. Racial and Ethnic Category of Patients
(Total participants = 60)
Racial/Ethnic Category
White (including Latinos or Hispanics)
46 (77%)
Black or African American (including Latinos or Hispanics) 16%)
10 (16%)
Other
4 (7%)
Table 3. Racial and Ethnic Category of Caregivers
(Expected number of participants = 36)

Racial/Ethnic Category
White (including Latinos or Hispanics)
27 (77%)
Black or African American (including Latinos or Hispanics) 16%)
7 (16%)
Other
2 (7%)
(d)
Vulnerable Subjects: We do not plan to include vulnerable subjects such as children, pregnant 
women, fetuses, or prisoners. Employees (physicians/fellows) will be assured that taking part in 
research is not a part of their duties, and refusing to participate in the study will not affect their 
job. To ensure their autonomy, the research coordinator (rather than the PI) will consent them. 
We realize that some patients in the study may have a cognitive or decisional impairment. To 
protect the rights of these patients, we have specified all the details in section 4.2 (Process of 
Consent). Caregivers lacking capacity will be excluded from the study.
3.2. Inclusion and Exclusion Criteria
Participant inclusion and exclusion criteria are listed in Table 4.
Table 4. Inclusion and Exclusion Criteria
Physicians
Patients
Caregivers
Research Coordinator
Patient Coach
Physician 
Coach
Inclusion 
Criteria
1. Member of 
Strong 
nephrology 
group working 
at Strong 
Memorial 
Hospital, 
Highland 
Hospital, FF 
Thompson or 
Rochester 
General 
Hospital
2. Treat patients 
with CKD
1. Age ≥65 years old
2. Presence of 
advanced CKD stage 4 
or 5 (i.e. GFR, eGFR, 
or GFR by Cystatin ≤ 
25 ml/min)
3. Patient’s 
nephrologist is 
enrolled in the study 
and has seen that 
nephrologist at least 
once
4. Speaks English
5. Have not attended a 
dialysis education class 
or met with the dialysis 
education coordinator 
within 2 years prior to 
the study start date.
6. Have not made 
a dialysis decision
Consenting patients 
will be asked for 
permission to contact 
up to three caregivers, 
defined as a “family 
member, partner, 
friend or someone else 
who is involved with 
their health care issues, 
for example, someone 
whom they talk to 
about personal issues 
including medical 
decisions or who comes 
to doctor appointments 
with them. This person 
may also help with 
routine day-to-day 
activities, like 
transportation or 
paperwork.” The term 
“caregiver” is used here 
for scientific purposes 
only; it is not essential 
that this individual self-
identify as a caregiver.
1. Self-identified 
caregiver (per the 
definition above)
2. 21 years of age or 
older.
1. Assisted in the 
study by recruiting, 
consenting, and 
interviewing at least 
one subject.
1. Assisted in 
the study by 
completing at 
least one 
coaching 
session with a 
subject. 
1. Assisted in 
the study by 
completing at 
least one 
coaching 
session with a 
nephrologist

Exclusion 
Criteria
1. Expecting 
to leave in 
six months.
1. Patient has 
already been seen 
by a palliative care 
clinician or is 
enrolled in hospice
2. Is already on dialysis
3. Hospitalized at 
the time of 
recruitment
4. Cognitive 
impairment and no 
legally authorized 
representative is 
available
4. Support is offered 
primarily in a 
professional role 
(e.g., clergy).
5. Cognitive impairment
6. Did not recruit, 
consent, or 
interview any 
patients. 
7. Did not 
complete 
any 
coaching 
sessions 
with 
patients. 
8. Did not 
complete 
any 
coaching 
sessions 
with 
nephrologi
sts. 

5. Anyone needing a language 
interpreter (including sign 
language)
4.
SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT
4.1.
Method of Subject Identification and Recruitment
A Study personnel (PI or the RA) will provide an overview of the study to the nephrologists as a 
group, or meet with nephrologists in person or via Zoom to brief them on study procedures 
including physician measures (Table 5).
The PI will provide an overview of the study to the Research Coordinators as a group, or 
individually via Zoom or in person. 
A study personnel (PI or the RA) will provide an overview of the study to the patient coaches and 
physician coaches as a group, or individually via Zoom or in person. 
Based on the inclusion and exclusion criteria, the PI or RA will screen nephrology clinic patients at 
Strong, Highland, and FF Thompson for study eligibility using e-record and at Rochester General 
Hospital through RGH’s PI screening. The study team will communicate with the participating 
nephrologist’s in-person, via telephone, or by email if they have questions about the eligibility of 
a patient or need more information. This process is implemented to eliminate patients with 
favorable renal prognosis who are less likely to need dialysis in the future. The assumption is that 
participating nephrologists will permit all their patients to be approached, and this will be stated 
in the nephrologist consent form. However, nephrologists’ can decline patient participation in the 
study if a patient is unlikely to progress to needing dialysis. Data on nephrologists’ reasons for 
refusal and referral will be captured on a separate sheet.
After acquiring consent from the nephrologists, The RA will approach eligible patients (and 
caregivers, if present) either in person in the clinic, by calling them on the phone, emailing them, 
or sending them a message via MyChart. If through MyChart, eligible subjects will receive an email 
or text notifying them that they have a new research opportunity available in MyChart. It can only 
be viewed after they log in to MyChart and visit the Research Studies page. Subjects will see a 
description of the study, which is included on the attached MyChart for Recruitment Request form 
(uploaded as part of recruitment materials). Underneath the study description on the Research 
Studies page, subjects will indicate whether or not they are interested in participating by clicking 
on the corresponding button. This will trigger a notification that is sent to the study coordinator’s 
Inbasket in eRecord.
Interested subjects will then be contacted for screening as described in this protocol. Subjects 
who are not interested will not be contacted and will be removed from the pool of eligible 
subjects. If subjects do not indicate whether or not they are interested in participating, they may 
be re-sent the email notification one additional time, no sooner than one week after the first 
email was sent. When study accrual has been completed, outstanding research opportunities in 
MyChart will be rescinded.
Also, patients from Rochester General will only be approached if their participating nephrologist 
has discussed the study with them first, they are aware of what the study is about and they are 
agreeable to speaking with the RA. This will be done either in person or by telephone depending 
on the patient’s preference.

4.2.
Process of Consent
Nephrologists from Strong, Highland, FF Thompson, and Rochester General Hospital will 
provide written informed consent, after receiving details of the study. They should be able to 
understand the study objectives, procedures, risks, and potential benefits. For mailed consents, 
the date of the physician’s signature and the date of the research coordinator’s signature may 
be different. 
Informed consent will be obtained using the IRB-approved information sheet for Research 
Coordinators and Patient Coaches. This process will be completed by a member of the study 
team for patient coaches. For research coordinators this process will be completed by the 
principal investigator. 
Similarly, study patients from all sites will provide informed consent after receiving a detailed 
description of the study's aims, procedures, and the risks and benefits of participation. Initial 
discussion for patients at RGH will take place with the patient’s nephrologist or the RGH study- 
appointed PI. The scope of work conducted by the RGH study PI will consist of an initial 
discussion of the study with RGH nephrologists and RGH patients for recruitment and study 
participation purposes only. After initial discussion of the study with a member of the study 
team, either by telephone in person, or via Zoom, if the patient has expressed interest in 
participating, the consent form will either be handed to patients in person at either location and 
reviewed orally or mailed/emailed to the patient for review prior to the consent process. 
Patients will sign the consent document and enrolled into the study only if they have 
demonstrated an understanding of the study’s aims, procedures and risks/benefits. This 
understanding will be determined by their answers to questions that were designed to assess 
the patient’s understanding of the study. These questions can be found in their consent form. 
During and after the COVID-19 pandemic, patients will be consented in-person or via eConsent.
The consent document will be created using a REDCap-based electronic consent form. The IRB- 
approved consent form will be developed in REDCap, a secure, web-based, HIPAAcompliant, 
data collection platform with a user management system allowing project owners to grant and 
control varying levels of access to data collection instruments and data (e.g. read-only, de- 
identified-only data views) for other users. Potential subjects will participate in the consent 
process by:
eConsent Obtained in Person or Remotely with Required Remote Consent Process - 
Subject/Subject’s legally authorized representative is approached in person at the study site, 
either Strong, Highland or Rochester General Hospital, when both the research coordinator and 
subject are at the same location, or it may take place remotely (e.g. at the subject’s home or 
another convenient venue) and accesses the REDCap eConsent via a portable electronic device 
such as iPad, etc. If consent is being obtained at the subject’s home, a room that ensures privacy 
and confidentiality will be requested for the process. All subjects will have the option to use 
paper-based or electronic informed consent methods completely or partially throughout the 
informed consent process and will be consented remotely or in-person following institutional 
safety protocols. When consent is being obtained remotely, not in person, the study team will 
request verbal permission to send the eConsent via email or text. The request will state:
“Because URMC can’t control the security of email or text messages once we send them, we 
need your permission to text or email you. Do you want to receive the link to the eConsent 
via text or email?”
This permission will be documented and the email/text will not include PHI. Subject will be 
identified by the use of the “Survey Login” feature, the subject will be prompted to reply with 
the appropriate answers to two pre-designed questions. Correct responses to questions will 

grant entry and non-matching responses will block the individual based on specified settings. 
This verification, known as the Passcode Based on Known Information is a method where the 
research coordinator will simply inform the subject/subject’s legally authorized representative

that a combination of their demographic data will be used as their passcode. The study 
coordinator will use the combination of the subject’s date of birth, and street name as variables 
to represent the verification passcode which the subject/subject’s legally authorized 
representative will be prompted to answer when accessing the eConsent link. Subjects will have 
the capability to sign electronically with a stylus, mouse or finger. Once the consent form is 
signed and submitted, subjects will be able to receive a print out of the paper copy, download 
a PDF, and/or receive an email with a PDF attachment of the signed consent form. If a signed 
copy of the consent will be emailed to the subject using REDCap, the subjects will provide their 
email address on the completion page, the following statement will be included in the field 
where the email address will be provided:
Enter your email to receive confirmation message? A confirmation email will be sent to all 
respondents that have completed the survey, but because your email address is not on file, 
the confirmation email cannot be sent automatically. If you wish to receive it, please enter 
your email address below.
Documentation of how consent was obtained will be kept in the subject files to ensure an 
accurate representation of the consent process used to obtain consent with each subject. 
Patients in both Intervention and Usual Care arm will receive nephrology visit documentation 
as per clinical standards. Visits with coach will not be documented in the patient’s electronic 
medical record but on separate forms. Also, dialysis education for Usual Care arm is routinely 
not documented in patient’s electronic medical record.
Once a caregiver is identified, a member of the study team will independently approach the 
caregiver in person at the study site location or by telephone and ask if they would be willing to 
participate and provide written or eConsent. A caregiver can be consented right after a patient 
has consented to participate in the study if both are present together in the room. If the 
caregiver has expressed interest in participating the consent form will either be handed to them 
in person (or via Zoom) and reviewed orally or mailed/emailed to the caregiver for review prior 
to the consent process. Caregivers will sign the consent document and enrolled into the study 
only if the agree to participate in the study and they have demonstrated an understanding of 
the study’s aims, procedures and risks/benefits. The eConsent process for caregivers will be the 
same as the process as stated above for patients. During the COVID-19 pandemic, caregivers 
will be consented in-person following institutional safety protocols or via eConsent. Patients are 
eligible to participate in the study with or without a caregiver, but a caregiver will not be eligible 
to participate in the study without a patient. All participants should understand why this 
research is being done, what will happen during the study as well as possible risks and benefits. 
All consent documents will be stored in a locked drawer of the locked research coordinator's 
office located at Strong Memorial Hospital.
We will screen patients for cognitive impairment from their medical records. When obtaining 
informed consent for those with suspected cognitive impairment, we will formally assess 
capacity to consent using the University of California Brief Assessment of Capacity to Consent 
(UBACC) modified for our specific study design where needed. (Jeste DV, Palmer BW, 
Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief 
instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug; 
64(8):966-74 doi: 10.1001/archpsyc.64.8.966. PMID: 17679641.)

For patients who fail this screen or if the RA has additional concerns, we will require that their 
guardian participate in the consenting process and sign an informed consent. We will also 
require that patients still give consent, or at minimum assent if fully informed consent is not 
possible. For such patients, a legally authorized representative (LAR) will fill out the assessments 
and participate in coaching sessions, if assigned to the intervention group. In this study, the LAR 
will typically be, in order of priority: someone who is a healthcare agent by advance directive, 
or a healthcare surrogate decision maker by local law such as a spouse, adult child, or sibling. 
We are choosing to keep patients with limited capacity in our pilot as these patients may still 
be able to provide appropriate responses about their wishes etc. We will exclude the caregivers 
lacking capacity to consent for the study.
We will keep a record of the number of eligible physicians, patients and caregivers approached 
for potential enrollment as well as the number enrolled and declined. Reasons for refusal will 
be documented on a separate sheet. Patients deemed not to be eligible after approaching them 
will be informed about the lack of eligibility and their screening data will be maintained.
5.
METHODS AND STUDY PROCEDURES
5.1.
Overview of the Procedures
After a nephrologist has consented for the study, he/she will be asked to complete a study entry 
questionnaire. It should require no more than 15 minutes to complete the questionnaire (Table 
5).
Randomization: After enrollment and baseline data are obtained, nephrologists will be 
randomized to either the intervention or control group of the study by study personnel who will 
be blinded to their identities. This is a cluster RCT. Thus, patients of nephrologists in the 
intervention group will be assigned to the intervention group; patients of nephrologists in the 
control group will be assigned to the control group.
After a patient coach has completed all coaching sessions and follow up calls with their assigned 
subjects they will be asked to participate in a qualitative interview. 
After a physician coach has completed all coaching sessions and follow up correspondence with 
nephrologists enrolled in the intervention arm they will be asked to participate in a qualitative 
interview.
At study completion all assisting research coordinators will be asked to participate in a 
qualitative interview. 
Intervention:
Nephrologist component: We will conduct a pre-research focus group or individual sessions for 
nephrologists to learn about the skills and barriers that will help them become better 
communicators for shared dialysis decision-making. Nephrologists in the intervention group 
may be provided with supplies such as a notebook, pen and highlighter. They will then 
participate in a brief value affirmation exercise and goals of communication training at the time 
of enrollment and completion of their baseline assessments. Nephrologists will receive links to 
watch 5 communication training videos and then partake in up to three Zoom educational 
sessions, each approximately 45-60 minutes in duration, approximately 1-3 weeks apart, with 
standardized patient instructors (SPI) who will be enacting roles of patients with advanced 
kidney disease. The SPI will provide immediate oral feedback to the nephrologist. The specific 
communication behaviors that will be targeted include: (1) engagement, by acknowledging and 
prioritizing patient concerns (2) empathy (3) ASK-TELL-ASK approach (4) decision-making skills:

(a) value/preference clarification (b) compare options including conservative management (c) 
choose an option that seems to best fit with patient preferences. An effort will be made to tailor 
these sessions to the individual needs of a nephrologist by reviewing the identified needs and 
discussion with the coach. The communication coaching session will be audio-recorded, and 
nephrologists will receive written feedback via email following the sessions to reinforce their

learning. A manual and fidelity checklist will be developed to deliver this component of the 
intervention.
Patient recruitment at Strong, Highland and Rochester General Hospital will start once a 
nephrologist in the intervention group has completed at least two communication coaching 
sessions. At the end of each patient visit, nephrologists will be asked if (a) a preliminary RRT 
decision has been made? If not, is there a plan to discuss it in the next visit? Once a patient has 
made an RRT decision or has seen the nephrologist twice, either in-person or via Zoom, a final 
set of assessments will be completed. At the end of the study, to check for contamination, 
nephrologists in the intervention group will be asked if they were able to share newly learned 
communication skills with the nephrologists in the control group.
Upon completion of the decision-making process with the nephrologist, depending on patient’s 
choice, patients will be given a summary of the ‘next steps,’ prepared in conjunction with the 
treating nephrologist. A copy will be given to the patient by the research coordinator in-person 
or via mail: (1) When does the patient need to finalize the decision (only if the decision has not 
been made after two visits)? (2) At what GFR level, access will be placed? (3) Symptoms 
suggestive of need for dialysis (4) when will dialysis need to be initiated?
Patient component (and caregivers, if available):
Approximately, 2-4 weeks prior to the visit with a coach, patients will receive an educational 
booklet about renal replacement therapy options and conservative management and another 
booklet containing a list of most commonly asked questions. Educational booklet will also be 
sent in a video format. Participants in the intervention group will then meet with a coach for 
approximately 60-90 minutes within two weeks prior to an office visit with their nephrologist. 
This intervention can take place at the Strong Hospital site or an alternate location of the 
patient’s choice. If intervention takes place at the subject’s home, a room that ensures privacy 
and confidentiality will be requested for the process to take place. Also, if at subject’s home, 
study activities that are being conducted will use the same methods as if on site at URMC. During 
the first half of the coaching session, the coach will administer the value affirmation exercise, 
identify goals/preferences of kidney disease treatment so that they can articulate to the 
nephrologist and review renal replacement therapy options including conservative 
management with the patient. The coach will not answer any questions regarding RRT options 
but would rather help patients formulate questions about different RRT options including 
conservative management. Subsequently, the coach will give each patient (and caregiver) a list 
of commonly asked questions (“question prompt list” or QPL), and use brief role-plays to 
identify and help prepare patients to ask personally relevant questions during their upcoming 
nephrologist visit, so they can participate more actively and assertively in discussions with their 
nephrologist. If a patient has not read the education material or QPL, they will be given an 
opportunity to read the material or watch the video. Patient’s questions along with renal and 
overall prognosis, using standardized tools (Schmidt RJ, Landry DL, Cohen L, et al. Derivation 
and validation of a prognostic model to predict mortality in patients with advanced chronic 
kidney 
disease. 
Nephrology 
Dialysis 
Transplantation. 
2019;34(9):1517-1525. 
doi:10.1093/ndt/gfy305) (Tangri N, Stevens LA, Griffith J, et al. A predictive model for 
progression of chronic kidney disease to kidney failure. JAMA - Journal of the American Medical 
Association. 2011;305(15):1553-1559. doi:10.1001/jama.2011.451) will be forwarded to the 
nephrologist a day before the visit, either in-person or via e-mail. Patients (as well as the 
research coordinator) will also bring a list of their questions and visit checklist to the 
nephrologist. The nephrology visit will be audio recorded and the recordings will be destroyed 
after transcription and analyzation is complete. The coach will make a follow-up telephone call

(after the nephrology office visit) to address patients’ concerns. Patients (and caregivers) will 
be eligible to attend an additional coaching session if unable to make a decision about dialysis 
with their nephrologist in one session. A manual and fidelity checklist will be developed to 
deliver this component of the intervention. Patients will be able to participate in these sessions 
via zoom or in-person at Strong Hospital or an alternate location chosen by the patient (ex. 
patient’s home).
*If the research coordinator or coach will be traveling to a subject’s home, in order to ensure 
their safety, travel to homes will only take place during daylight hours. They will also ensure 
that there is another team member who knows where and when they are traveling. The 
research coordinator or coach will also know to cut the study visit short if or when necessary 
and that they will have means of communication with the PI by cell phone or 911 in the case of 
an emergency.
In addition, no mandated reporters will be entering the subjects home at any time but if there 
are any problematic behaviors observed in the home, the study team member witnessing the 
incident will report/discuss with the PI and, if necessary, the IRB.
Control Group patients (and caregivers, if available): will meet with the dialysis educator and 
their nephrologist, as per the standard clinic protocol, and complete three sets of assessments. 
Their first set of assessments will be done at study entry, the second set will be completed 
within 0-3 months of seeing their nephrologist and a decision has been finalized (spanning up 
to two visits), and their third set will be completed at study completion which will take place 
within 3-6 months after their nephrology visit.
Control Group Nephrologists: will receive no educational intervention and will deliver care to 
control patients using routine communication processes during the study period. After 
appointments with patients enrolled in the study, physicians in the control group will also be 
asked if (a) a preliminary RRT decision has been made? Once a patient has made an RRT decision 
or has seen the nephrologist twice, either in-person or via Zoom, a final set of assessments will 
be completed. Upon completion of their final qualitative interview, they will have access to 
communication videos and an opportunity to participate in a workshop to improve 
communication skills where nephrologists may be provided with supplies such as a notebook, 
pen and highlighter. However, up to two visits with their patients will be audio-recorded. Audio 
recordings will be destroyed after transcription and analyzation is complete. At the end of the 
study, to check for contamination, nephrologists in the control group, will be asked if they were 
able to learn new communication skills from the nephrologists in the intervention group.
Patients (and caregivers, if available): During recruitment periods, a research assistant will 
identify eligible patients by reviewing the clinic schedule at Strong, Highland Hospital, and FF 
Thompson (patients who meet the eligibility requirements at RGH will be identified by the RGH 
PI) to include all current patients who meet eligibility criteria. Patients will be introduced to the 
study in-person at the study site location or over the phone and asked by the research assistant 
if they are willing to speak in a private setting to learn more about the study. All patients will be 
told that the purpose of the study is to improve communication and decision-making between 
patients and nephrologists. Patients will be given time to think about participation, and if 
desired will be told how to contact the research assistant at a later time. The screening and 
consent process will continue as long as needed until the person obtaining consent is

comfortable that the prospective participant fully understands all aspects of study involvement. 
The research assistant will obtain written consent or eConsent from those who voluntarily 
choose to enroll, using approved consent forms. All patients (and caregivers, if available) will be 
asked to allow audio-recording of 1-2 future visits with their nephrologist depending on the 
status of dialysis decision-making, and for permission to participate in three sets of surveys, 
collection of demographic data, and the end-of-study interview, and exit interview for those 
who withdraw early from the study. We expect that most of the patients will need one in- 
person visit with a coach and one in-person visit with the nephrologist. We will keep a record 
of this data. For patients not able to make a decision after one visit (as assessed during the 
coach’s phone call after the nephrologist’s visit), an additional in-person coaching visit will be 
offered. For such patients, the follow-up nephrology visits will also be audio-recorded. Patients 
will be able to participate in these sessions via zoom or in-person.
Patients will be informed that this is a randomized study, and their own study assignment will 
depend on which assignment their nephrologist has received. They will be informed about the 
multiple phases of the study and that their total involvement will take about 60-90 minutes for 
each coaching session, approximately 30 minutes to complete each survey set, approximately 
15 minutes for each phone call from a coach, and approximately 30 minutes for an interview 
about the feasibility/acceptability of the study, approximately 5 minutes for an exit interview 
for those who withdraw early, till the end of the study. Patients will be asked for written 
permission to (a) Audio-record visits with their nephrologist and coaches (b) Complete surveys 
at study entry, within 0-3 months after visit(s) with their nephrologist, and within 3-6 months 
at study completion (c) Allow research staff to access their medical records (d) Participate in the 
end-of-study interview(d) participate in an exit interview upon study withdraw.
5.2.
Assessments and Measurements
The Tables show the assessment batteries that will be administered to nephrologists (Table 5), 
patients (Table 6), and caregivers (Table 7). With the exception of questions administered in 
the qualitative interview, all of the proposed items have been used extensively in prior research. 
The questionnaire batteries are attached in the Appendix. Assessments will occur at the 
following time points for all the participants.
Physicians: (1) Study entry of physician (2) study entry of the patient (3) qualitative assessment 
of the physicians in the intervention and control groups (4) communication workshop offered 
to control group.
Patient and caregiver assessments will occur at three time points: (1) at Study entry, (2) 0-3 
months from the nephrology visit once a decision has been finalized, spanning up to two visits, 
(3) within 3-6 months at study completion. 
Additionally, with the patient’s verbal permission, caregivers who are not interested in 
participating in this study are still welcome to be present to listen to the assessments and 
intervention via phone/any electronic media such as Skype, Zoom, etc. or in-person.
Patient Coaches: After all Intervention subjects have completed the coaching session the PI will 
conduct a Qualitative Interview to obtain perceptions of the coaching process, challenges faced, 
and successful strategies. 
Physician Coaches: After all intervention nephrologists have completed their coaching session 
the PI will conduct a Qualitative Interview to obtain perceptions of the coaching process, 
challenges faced, and successful strategies. 

Research Coordinators: At study completion the PI will conduct a Qualitative Interview to 
obtain perspectives on program implementation, logistical challenges, and suggestions for 
improvement.
1.
Audio-Recorded Data, Intervention and Control Arm: Patient’s visit with their nephrologists 
will be audio-recorded and recordings will be destroyed after transcription and analyzation have 
been completed. Providers that are precepting a Fellow who is enrolled in the study will be 
asked to give verbal consent to be audio recorded. If a preceptor does not consent the audio 
recorder will be paused during the preceptor’s time with the enrolled patient. Intervention arm

patients, caregivers and nephrologists will be interviewed by the RA after the last meeting with 
the nephrologist to assess the feasibility and acceptability of the DIAL-SDM intervention. For 
patients in the intervention arm, the interviewer will ask open-ended questions on (1) benefits 
of the intervention (2) barriers to accessing DIAL-SDM (3) usefulness of the dialysis options 
knowledge materials (4) dialysis decision making. Interviews will be audio recorded. Similarly, 
patients in the control group will be asked about (1) the process of dialysis decision-making (2) 
experience of communicating goals and preferences with their nephrologist and if their goals 
were discussed during the visits with their nephrologist. Patients who decide to withdraw from 
the study will be interviewed when the individual confirms their withdrawal and will be asked
(1) main reason for withdraw (2) suggestions for improving the study. These interviews will 
either take place at Strong Hospital or a location of patient’s choice (ex: patient’s home).
Medical Records Abstraction: We plan to record patients’ labs, co-morbid conditions, advanced 
care planning, hospitalizations and ER visits for a total of 6 months before and 6 months after 
study entry on an abstraction form. This retrospective abstraction will be performed only for 
participants who have already enrolled and completed the study; no new patients will be 
recruited or consented for this purpose. 
Because this is a retrospective study that involves retrospective chart review, we will also look 
at patient mortality, place of death, receipt of hospice services, receipt of aggressive procedures 
such as CPR, dialysis etc. and long-term healthcare utilization for both the control and 
intervention groups within 3 years of the subjects study completion date without patient 
consent.
Because this study involves only participants who are already enrolled and poses minimal risk, 
we are requesting approval to obtain HIPAA authorization verbally using a short script. This 
approach reduces burden for participants who have already completed study activities, while 
ensuring they are informed about the additional retrospective chart review. 
5.3.
Data Banking for Future Research Use
Data will be stored in a password protected file on a password protected computer in the 
research coordinator’s office. They may be used in future studies. Data will be de-identified to 
protect participants' privacy and then coded accordingly. Only the research investigators in this 
protocol will have access to the data. Each file will also be saved with password protection. The 
data will be stored for 7 years. Participants will not be re-contacted regarding the stored data.
5.4.
Genetic/Genomic Research Activities
There will not be any genetic and genomic research activities either as the primary objective of 
the study or as an ancillary activity.
5.5.
Costs to the Subject
There will be no cost to the subjects for the DIAL-SDM visits.
5.6.
Payment for Participation
Each patient will be paid up to a total of $100. This amount will defray participant travel costs 
while providing a small incentive without coercion. To protect the participant’s right to 
withdraw without penalty, payment will be prorated as the following: completion of first set of 
data collection, $50; Final set, $50. Participants who withdraw from the study and voluntarily 
complete an exit interview will receive payment of $10.
Each caregivers will receive $50 for each set of surveys, for a maximum of up to $100.

All payment to subjects and caregivers will be made with a gift card that for each visit will be 
uploaded with their $50 payment. These gift cards have no value until the department has been

made aware by the researcher that the gift cards have been given to the subjects and not lost 
or stolen. This process will be through the Embark system which will ensure the safety of the 
researcher who is distributing payment.
Each physician will receive a $100 gift card upon the completion of the study.
Each patient coach will receive a $50 gift card upon completion of the qualitative interview. 
Each physician coach will receive a $50 gift card upon completion of the qualitative interview. 
Each research coordinator will receive a $50 gift card upon completion of the qualitative 
interview. 
6.
CONCOMITANT AND DISALLOWED MEDICATION
There is no concomitant or disallowed medications in this study.
7.
SUBJECT WITHDRAWALS
Participants will be advised that they have the right to withdraw from the study at any time 
without prejudice. Participants may also be withdrawn from the research without their consent 
in the event of acute worsening of their kidney disease needing initiation of hemodialysis before 
completion of the study. If a caregiver withdraws from the study, another caregiver identified 
by the patient will be approached. All participants who withdraw from the study will be offered 
an exit interview.
8.
SAFETY AND REPORTABLE EVENTS
8.1.
Adverse Event Definition
An adverse event is any symptom, sign, illness, or experience which develops or worsens during 
the study, whether or not the event is considered related to study.
8.2.
Serious Adverse Event
A serious adverse event is defined as any adverse medical experience that results in any of the 
following outcomes:
•
Death
•
is life-threatening
•
requires inpatient hospitalization or prolongation of existing hospitalization
•
Results in persistent or significant disability/incapacity, or
•
requires medical or surgical intervention to prevent permanent impairment or damage.
8.3.
Recording Adverse Events
At each visit, patients will have the opportunity to report any adverse events by reporting all 
voluntary complaints of the participant.
All adverse events will be documented. Each adverse event will include a brief description of 
the experience, the date of onset, the date of resolution, the duration and type of experience, 
the severity, the relationship to study and contributing factors.
The recording of adverse events will occur once the participant signs consent until subject 
completes the study or withdraws from participation. The adverse experience will be followed 
until the adverse event is resolved or stabilized.

8.4.
Responsibilities for Reporting Serious Adverse Events
The investigator will record all serious adverse experiences that occur during the study period 
in an Adverse Event log. The study period for reporting serious adverse events starts from the

time of signing consent to the final study visit. The PI will be notified of all adverse events. The 
Investigator will comply with regulations and RSRB policy regarding the reporting of adverse 
events.
9.
RISK/BENEFIT ASSESSMENT
Human Subjects Involvement: This study involves human subjects; potential risks to patients, 
families and clinicians require careful consideration.
9.1.
Risks to Human Subjects
(a)
Human subject’s involvement and characteristics
Study subjects are nephrologists (n=12 or more/less), CKD patients (n=60) and their caregivers 
(n=36 or more/less). All subjects will provide informed consent. Subjects under age 21 are 
excluded from the study.
(b)
Potential risks
Privacy and confidentiality. There is a small potential for risk to patients and caregivers of 
disclosure of private material. Research staff will need to have patient and caregiver contact 
information including telephone number and address available for follow-up. Alternative 
procedures are not available.
Psychological or physical risk. There is potential risk for minor psychological discomfort among 
patients and caregivers while completing questionnaires or talking about symptoms of CKD, 
prognosis, and their other experiences during treatment for the illness. Patients and caregivers 
will be instructed to inform their physician as well as the research staff if they wish to refrain 
from discussing aspects of their illness or refuse to answer a particular question. Physical risks 
in this study – that is, risks associated with voluntarily responding to oral surveys and questions 
asked by a research assistant are low.
9.2. Adequacy of protection against risks
Privacy and confidentiality. Staff are trained regarding HIPAA and human subjects’ protections 
regulations and procedures. Any data collected will be stripped of any identifiers; a unique ID 
number will be generated for each subject and all data files. The linking file containing identifiers 
will not be stored in the central database repository. Data will be encrypted by applying a special 
scrambling code that makes the data unreadable to anyone who does not have a decryption 
key. Authorized personnel with access to this key can unscramble it. This file will be stored on a 
separate server and made accessible only to database administrators with the appropriate 
permissions. URMC-managed networks where data will be stored and maintained are protected 
by perimeter firewalls, supplemented by additional interior firewalls to protect particularly 
critical or vulnerable resources. During the period in which it will be necessary to keep personal 
identifying information for follow-up purposes, all personal electronic data will be kept in a 
password-protected file on a secure mainframe computer with firewall protection located 
behind locked doors. Paper data will be securely kept in a locked file cabinet. Subjects will be 
assigned identification numbers which will be used on all data; the link between name and ID 
number will also be kept in a separate password protected file. Participants will be advised as 
to the risks to confidentiality in the informed consent. No identifying information that associates 
names with voices will appear on transcripts of the recorded visits or on any portable electronic

equipment. All audio-recordings will be destroyed once all analyses have been completed. No 
identifying data will be used in any publications.
Psychological or physical risk. Staff will receive training in techniques for communicating 
effectively and sensitively with patients diagnosed with advanced CKD and their caregivers. 
Patients and caregivers will be informed that they have the right to terminate participation at 
any time and to refuse surveys or leave survey questions blank if they are uncomfortable for 
any reason. In the unlikely event of extreme psychological discomfort in a patient or caregiver, 
staff will be trained in procedures for ensuring necessary medical or professional intervention. 
The research assistants will be trained to identify and respond to emotional distress expressed 
during the interview. Research assistants will monitor for signs of distress (e.g., tearfulness, 
expression of discomfort, agitation). If a participant should become distressed, the research 
assistant will respond empathically and temporarily pause or stop the interview depending on 
the preference of the participant and the assessment of the researcher. If a participant becomes 
extremely distressed, the research assistant will contact Dr. Saeed. If the participant is under 
care with a psychotherapist or psychiatrist, they will be encouraged to contact the appropriate 
care provider; otherwise, referrals will be provided.
9.3. Potential benefits of the proposed research to the subjects and others
Some patients benefit from knowing that their participation in studies like this can help other 
patients and families in the future. Adequate safeguards to minimize inherent risks are in place. 
We believe the potential risks to subjects are reasonable in relation to the importance of the 
knowledge to be gained.
9.4. Importance of the knowledge to be gained
Communication skills is a growing area of healthcare with relatively little empirical data to 
identify “best practices” on dialysis-related decision making. This study will help to address 
important gaps in the science of communication with patients with CKD.
10.
CONFIDENTIALITY OF DATA AND INFORMATION STORAGE
To protect the confidentiality of participants, each participant will be de-identified and coded. 
These codes will not be derived from or related to the information about the individual, and 
cannot be translated to identify the individual. The identifying information will be kept separate 
from the research database. Only the PI will have the key to the codes. The codes will only be 
broken if there is a life-threatening result that calls for an intervention.
The research data will be stored in the locked office of the RA. Electronic version will be stored 
in a REDCap or a shared drive (password protected). All the files will be password protected, 
especially the file containing the key to the codes linking patients to their data. Paper 
documents will be locked in a drawer in the office of the RA. Excess copies of paper documents 
will be shredded. The PI and co-investigators will have access to de-identified data. Only the PI 
and RA will have the data with participant identifiers.
All data shared for the purpose of analysis will be de-identified and securely stored on the 
HIPAA-compliant UR Box.com. The storage and maintenance of data will occur within the 
URMC-managed networks, which are safeguarded by perimeter firewalls. Additionally, extra 
interior firewalls are in place to safeguard especially critical or vulnerable resources.
11.
DATA ANALYSIS AND MONITORING
11.1. Planned Statistical Analysis

This is a pilot cluster-randomized trial, where our communication outcomes (APPC scores) 32

and shared decision-making outcomes (OPTION scores)40 are measured at the level of the 
physician-patient dyad, while other outcomes (e.g., SDM questionnaire) 41 are measured at the 
level of the patient for descriptive analyses but adjusted for the clustering effect in final 
analyses. All analyses will be performed using SAS (version 9.4, Cary, NC). Patient and physician 
characteristics will be described using proportions for categorical variables and means (± 
standard deviations) or medians (interquartile range) for continuous variables. Quantitative 
analyses (Aims 1-2): Analyses of the Feasibility and Acceptability of the Intervention Measures 
(Aim 1) will be mainly descriptive. To compare group differences for the study outcomes (Aim 
2), we will use Wald-type tests from pre-specified mixed-effects linear regression models for 
continuous outcomes and generalized linear models with logit link function for binary 
outcomes. Analyses will be specified to account for the nesting of patients (the units of analysis) 
within physicians (the units of randomization). For all regression analyses, physician-level 
covariates for gender, years of experience, practice style, prior communication skills training, 
and the renal fellow status will be included, as well as patient-level covariates to adjust for 
demographic characteristics. All reported p values will be two sided, with p< 0.05 considered 
statistically significant. Qualitative analyses (Aim 1): Using Atlas.ti software, interviews of 
patients (30 minutes) and nephrologists (15 minutes) will be transcribed, de-identified, and 
verified for accuracy by a third party. Based on a modified phenomenological approach,152 I will 
work with Ladwig, MPH (data manager), under Dr. Epstein’s supervision, will create a coding 
scheme to characterize barriers, strengths, and areas of improvement for the proposed 
intervention and study design. Ten initial transcripts will be read and reread to reach an 
agreement. Disagreements will be resolved by discussion with the mentoring team. Remaining 
transcripts will be coded according to the coding scheme. Handling of missing data: The 
regression approach requires the “missing completely at random” (MCAR) assumption for valid 
inference, which may not be met for some outcomes in this study. Therefore, we will apply the 
response-dependent missingness—or the missing at random (MAR)—assumption when 
outcomes and missing data are less likely to be independent. We will examine the nature of the 
missing data and use the inverse probability weighting (IPW) approach, or multiple imputation, 
and sensitivity analyses, if necessary.
11.2. Data and Safety Monitoring
Despite the low risk associated with the proposed behavioral intervention, we have organized 
a data safety and monitoring (DSM) plan and will report directly to the University of Rochester 
Medical Center (URMC) and the Unity Hospital IRB
Daniel Croft, MD, MPH and Scott Liebman, MD, MPH will comprise the DSM board. Daniel Croft, 
MD, MPH is not involved in the study and has no relevant conflict of interests. Scott Liebman, 
MD, MPH has been randomly assigned to the Control arm and will continue to serve on the DSM 
board. The function of the DSM board will be to:
(a)
Systematically review screening materials to ensure that screening is conducted 
appropriately.
(b)
Systematically ensure that how many participants experiencing distress received a 
referral for psychiatric referrals to Dr. Adam Simning, and monitor their outcomes.
(c)
Monitor staff performance concerning the protection of privacy, confidentiality, 
maintenance of secure databases, and study procedures designed to reduce the risk of 
distress. Such concerns will be reported to both PI and the Univ. of Rochester IRB

(d)
Provide input to both the PI and the IRB on possible early termination of the study due to 
the safety or other relevant concerns.
The review board will meet by conference call or in-person every six months and confer on an 
as needed basis when adverse or difficult events occur. The URMC IRB will provide additional 
oversight.
11.3 Sharing of Information
De-Identified information may be shared to:
1.
The Department of Health and Human Services
2.
The University of Rochester
3.
American Society of Nephrology
4.
National Institute of Health (NIH)
5.
The University of Illinois Urbana-Champagne – Sadia Ashrafi and Dr. Andiara Schwingel (DUA)
6.
Mount St Joseph University- Rebecca Allen (DUA)
7.
University of Michigan- Areeba Jawed (DUA)
8.
Texas A&M University – Dr. Richard Street (DUA)
All de-identified qualitative data will be shared with Mount St Joseph University and University of 
Michigan. Only de-identified nephrologist communication training transcripts will be shared with The 
University of Illinois Urbana-Champagne. Only de-identified transcripts of patient nephrology visits will 
be shared with Texas A&M University. This information will be shared for data analysis purposes via the 
HIPAA compliant UR Box.com.
Only the study team will have access to the stored audio files and data.
All study data will be stored on password-protected shared drives, stored and maintained through the 
Information Services Division of the University of Rochester Medical Center, and adhering to all standard 
University IT policies and procedures.

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Table 5. Timing of administration of assessments for physicians
Measurement
References 
(if applicable)
# of items
Time of completion
Feasibility, 
acceptability and 
appropriateness of 
the intervention 
measures
Weiner et al, 
Implement 
Science, 2017
12
Study completion
Fidelity of the DIAL- 
SDM intervention
NA
30
After the completion 
of each coaching
session.
Aim-1
Qualitative 
Interviews
7
Study completion
Physician-patient 
communication: 
Active Patient 
Participation 
Coding (APPC)
scores
Street et al, Soc Sci 
Med. 2007
NA
Study completion 
(audio scripts)
Shared decision- 
making: OPTION 
scale
Elwyn G, Qual Saf 
Health Care. 2003
12
Study completion 
(audio scripts)
Comfort with 
shared decision
making
Degner et al, J of 
Clin
Epidemiology,1992
5
Study entry 
Study completion
Aim-2
Comfort with 
medical 
paternalism
Duberstein et al , 
JOSM 2019
1
Study entry
Physician 
demographics and
training experience
NA
7
Study entry
Other 
potential co- 
variates
Value Affirmation 
Exercise
9
Study entry 
(Intervention group)

Table 6. Timing of administration of assessments for patients
Assessment
References if 
applicable
# items
Time of completion
Feasibility of the
intervention 
measure
Feasibility of the
Question 
Prompt List
Feasibility of the 
Education
Booklet
Feasibility (patients 
approached vs 
enrolled)
Weiner et al, 
Implement 
Science, 2017
Feasibility of 
Education video
0-3 months (after 
last coaching 
session)
NA
Qualitative
interviews
0-3 months (after last
coaching session)
Acceptability of 
the Intervention 
measure
Acceptability of
the Question 
Prompt List
Acceptability of 
the Education
Booklet
Acceptability
Weiner et al, 
Implement 
Science, 2017
Acceptability of 
Education video
0-3 months (after 
last coaching 
session)
Aim-1
NA
Fidelity
After the coaching 
session (audio
recordings)
Physician-patient 
communication: 
Active Patient 
Participation Coding 
(APPC) scores
Street et al, Soc 
Sci Med. 2007
NA
3-6 months at 
Study completion 
(audio scripts)
Shared decision- 
making: OPTION 
scale
Elwyn G, Qual Saf 
Health Care. 2003
12
3-6 months at 
Study completion 
(audio scripts)
Shared decision- 
making 
questionnaire
Kristen L et al. 
Patient Educ 
Couns. 2010
9
0-3 months
3-6 months at Study 
completion
Aim-2
Decisional 
engagement scale
Hoerger et al, 
Psychol Assess.
2016
10
0-3 months
3-6 months at Study 
completion

Choice of renal 
replacement 
therapy modality
NA
1
Study entry 
0-3 months
3-6 months at Study 
completion
Prognostic 
discussion
Weeks et al, JAMA 
1998
10
Study entry 
0-3 months
3-6 months at Study 
completion
Decisional Conflict 
scale
Med Decis 
Making. 1995
10
Study entry 
0-3 months
3-6 months at Study 
completion
Goal Concordant 
Care Questionnaire
Curtis et al
2
Study entry 
0-3 months
3-6 months at Study 
completion
Demographics
NA
17
Study entry
Cavanaugh dialysis 
knowledge scale – 
Rochester version
Cavanaugh et al, 
CJASN 2009
14
Study entry 
0-3 months
3-6 months at Study 
completion
Human connection
scale
Mack et al Cancer
2009
16
Study entry
0-3 months
Healthcare climate 
questionnaire
XX
5
Study entry 
0-3 months
Quality of life 
(KDQOL)
32
Study entry 
0-3 months
3-6 months at Study 
completion
Control preference 
scale- Rochester 
version
Degner et al, Can J 
Nurs Res. 1990
1
Study entry
Health literacy
Davis et al, family 
medicine, 1991
6
Study entry
Trust - Primary Care 
Assessment Survey 
(PCAS) trust 
subscale
Safran DG, 
Kosinski M, Tarlov 
AR, Med Care.
1998;
8
Study entry 
0-3 months
3-6 months at Study 
completion
KARNOFSKY SELF-
REPORTED 
PERFORMANCE
Crooks at al. J 
Gerontol. 1991;
1
Study entry 
3-6 months at 
Study completion
OARS Comorbidity
Fillenbaum et al. J 
Gerontol. 1981;
15
Study entry
Press Ganey 
Patient Satisfaction 
Questionnaire
NA
16
Study entry 
0-3 months
Other 
potential 
co-variates
Perceived Efficacy in
Patient-Physician 
Interactions
JAGS, April 2015
5
Study entry 
0-3 months
3-6 months at Study 
completion

Advanced care 
planning
NA
4
Study entry
3-6 months at 
Study completion
Hospitalizations
NA
2
Study entry 
0-3 months
3-6 months at Study 
completion
Exit interview
NA
3
Upon withdrawal

Table 7. Assessments and timing of administration of assessments for caregivers
Assessment
References if 
applicable
# of items
Time of completion
Feasibility (patients 
approached vs 
enrolled)
Weiner et al, 
Implement 
Science, 2017
Feasibility of the 
intervention 
measure
Feasibility of the 
Question
Prompt List
Feasibility of the 
Education 
Booklet
Feasibility of
Education video
0-3 months (after 
last coaching 
session)
NA
Qualitative 
interviews
0-3 months (after 
last coaching 
session)
Acceptability of 
the Intervention
measure
Acceptability of 
the Question 
Prompt List
Acceptability of 
the Education
Booklet
Aim-1
Acceptability
Weiner et al, 
Implement 
Science, 2017
Acceptability of 
Education video
0-3 months (after 
last coaching 
session)
Aim-2
NA
Fidelity
After the coaching 
session (audio
recordings)
Zarit caregiver 
burden scale
Zarit et al, New 
York University 
Press,1985
22
Study entry 
0-3 months
3-6 months at Study 
completion
Shared decision- 
making 
questionnaire
Kristen L et al. 
Patient Educ 
Couns. 2010
9
0-3 months
3-6 months at Study 
completion
Decisional 
engagement scale
Hoerger et al, 
Psychol Assess. 
2016
10
0-3 months
3-6 months at Study 
completion
Aim-3
Choice of renal 
replacement 
therapy modality
NA
1
Study entry 3-6 
months at Study 
completion
Other 
potential
Demographics
NA
15
Study entry

Prognostic 
discussion
Weeks et al, JAMA 
1998
7
Study entry 
0-3 months
3-6 months at Study 
completion
Decisional Conflict 
scale
Med Decis 
Making. 1995
10
Study entry 
0-3 months
3-6 months at Study 
completion
Goal Concordant 
Care Questionnaire
Curtis et al
2
Study entry 
0-3 months
3-6 months at Study 
completion
Trust - Primary Care 
Assessment Survey 
(PCAS) trust 
subscale
Safran DG, 
Kosinski M, Tarlov 
AR, Med Care.
1998;
8
Study entry 
0-3 months
3-6 months at Study 
completion
co-variates
Human connection 
scale
16
Study entry 
0-3 months
Healthcare climate 
questionnaire
5
Study entry 
0-3 months
Perceived efficacy in 
patient-physician 
interactions
5
Study entry 
0-3 months
3-6 months at Study 
completion
Exit interview
NA
3
Upon withdrawal