Decision-Aid for Renal Therapy Pilot Trial (DART Pilot Trial)
Phase: NA
Conditions: Renal Insufficiency, Chronic, Kidney Failure, Chronic
Sponsor: Tufts University

 
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TUFTS MEDICAL CENTER/TUFTS UNIVERSITY RESEARCH PROTOCOL  
 
Version date: 10/05/17 
Principal Investigator: Ladin, Keren 
Study Title: Decision-Aid for Renal Therapy Pilot Trial (DART Pilot Trial) 
 
I. 
Aim and Hypotheses 
 
AIM 1. Examine the feasibility of recruitment and randomization of eligible advanced CKD patients into a RCT of 
DART versus UC; and the feasibility of maintaining participant engagement throughout the trial. 
 
Aim 1A. Assess the number of participants screened for participation per month. 
Aim 1B. Assess the percentage of screened eligible participants that are randomized.  
Aim 1C. Assess intervention adherence, defined as percentage of DART completed 
Aim 1D. Assess participant retention, defined as percentage of study assessments completed. 
 
AIM 2: Compare the effectiveness of DART to standard care on completion of advance care plans (primary), shared 
decision-making, and decisional conflict (secondary) in a diverse sample of older patients with kidney failure and 
their caregivers. Using an existing decision-aid not yet studied in the elderly, we will randomize patients at 2 centers 
to receive either DART or usual care. The Decision-Aid for Renal Therapy (DART) is an interactive web-based 
decision-aid that can empower patients and caregivers to select the modality that best suits them. 
 
H2a: Patients engaging with DART will be more likely to complete advance care plans than those who do not. 
H2b: Patients who engage with DART will experience higher rates of shared decision-making. 
H2c: Patients who engage with DART will experience significantly higher decisional concordance. 
 
 
II. 
Background and Rationale 
 
A. Background: In January, Medicare is likely to begin reimbursing end-of-life discussions. Aligning patient 
preferences (goals of care and values) with treatment is arguably the gold standard for quality health care. 
Treatment of life-limiting illness is especially preference-sensitive, where high-intensity care often offers 
marginal survival benefit but can worsen quality of life and increase costs. Elderly persons with end-stage renal 
disease (ESRD) face a choice between high-intensity dialysis and low-intensity medical management. In adults 
over 70 who are non-transplant eligible, dialysis confers only marginally better survival than medical 
management, while reducing independence, mobility, and increasing surgical interventions. During their last 
month of life, approximately 50% of elderly dialysis patients are admitted to an ICU compared with 24% of 
cancer patients, and only 20% of dialysis patients compared with 55% of cancer patients receive hospice 
services. This pattern of care is likely partly attributable to suboptimal shared and informed decision-making. 
 
Our recent studies of older dialysis patients find that many (1) do not recognize dialysis initiation as a choice, (2) 
rarely engage in end-of-life planning including conversations with physicians, (3) do not participate actively in 
treatment decision-making, and (4) experience regret. Our study and others found that only 10% of patients had 
discussed end-of-life care with physicians.  Many older ESRD patients experience significant cognitive decline 
while on dialysis requiring significant caregiver involvement in treatment and decision-making. 
 
 
B. Rationale: Successful end-of-life communication between patients, caregivers, and physicians is associated 
with superior psychosocial outcomes, less intensive treatment, greater satisfaction, and higher likelihood of 
death at home. The Decision-Aid for Renal Therapy (DART) is an interactive web-based decision-aid that can 
empower patients and caregivers to select the modality that best suits them. DART was developed using a 

 
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rigorous, validated, patient-engaged process and helps clarify decision-points and tradeoffs by providing 
individualized information about outcomes that matter most to patients. DART is designed to promote shared 
decision-making between patients, caregivers, and physicians and align preferences with treatment received. 
As a result, caregivers suffer high rates of depression, anxiety, and posttraumatic stress during and following 
bereavement. Our studies and others find that fewer than 10% of patients discussed EOL care with physicians, 
family, or friends. This pattern of care is partly attributable to lack of shared and informed decision-making. 
 
Although proven effective and in current use in the general population, DART’s effectiveness in an older population is 
unclear. The purpose of this project is to tailor and conduct a pilot study of DART’s feasibility and effectiveness to 
improve end-of-life planning and shared decision-making among older ESRD patients.  
 
 
 
III. 
Research Plan  (NOTE: Tufts Clinical and Translational Science Institute, 
www.tuftsctsi.org, can assist you with study design, sample size calculation, 
statistical analysis, clinical trials and database management, regulatory support, and 
expert consultation on topics including research processes and Data and Safety 
Monitoring Boards (DSMBs). Fill out the form located at 
http://informatics.tuftsctsi.org/pims/request.htm and Tufts CTSI will respond within 
two business days.) 
 
A. 
Experimental design: Participants (patient-caregiver dyads) will be randomized to receive 
either usual care or usual care plus DART. Randomization will ensure that the two study 
groups are comparable and will eliminate bias in intervention assignments. 
Randomization will be blocked by study site using blocks of randomly varying size.  
B. Sample size and statistical analysis(es): We will enroll 31 dyads (31 patients and 31 
accompanying caregivers), a sample size is sufficient to detect a difference between study groups 
of 30% vs. 65% completion of the advance directive, assuming a 2-sided test of proportions with 
alpha=0.05 and power=80%. This difference is significant and clinically meaningful. It is based on a 
conservative estimate of 30% completion of advance directives in the usual care (UC) group, which 
is likely to be an overestimate. 
 
 
C. Subject Characteristics 
1. Subject criteria:  
a) Inclusion criteria: CKD stages 4 or 5 (non-dialysis); 2) Age >=70; 3) English speaking; 4) willingness to 
be randomized to DART, and (5) able to sign informed consent, (6) Kidney Failure Risk Equation 
greater than 15% risk using [www.kidneyfailurerisk.com], (7) GFR<30 
b) Exclusion criteria: Non-English speaking patients will be excluded from this study because DART is an 
online educational program that is only available in English at this time.  
c) Withdrawal/Termination criteria: Death, withdrawal of consent, censoring for study end 
D. Risk/benefit assessment: This study does not pose more than minimal risk. 
 
1. Physical risk: None 
 
2. Psychological risk: Participants could experience mild discomfort with the survey 
questions or with the DART educational intervention. This risk is no greater than minimal 
risk, and participants can withdraw at any time.  
 
3. Social risk: Risk of loss of confidentiality. 
 
4. Economic risk: None 
 
5. Benefit of participating in the study: There is no direct benefit to participants. 
However, there is a potential for improving communication between clinicians, patients, 
and family members. An additional benefit is the potential for greater concordance 

 
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between patient values and treatment selection.  
 
Specific methods and techniques used throughout the study: The control group will receive usual care from their 
health care team for their chronic kidney disease. Following consent, participants (patient-
caregiver dyads) randomized to usual care will participate in three visits to the clinic: 
 
Visit 1 (60 minutes) 
 Participants will be given an education pamphlet, “Choosing a Treatment for Kidney Failure,” 
published by the National Kidney Foundation. A research team member will ask questions about 
the participant’s experiences making decisions about kidney disease and treatment, or helping a 
loved one make decisions about kidney disease and treatment.  
 
Visit 2 (30 minutes). This visit will take place 3 months after visit 1.  
Participants will be asked questions about their experiences making decisions regarding kidney 
disease treatment, their goals of medical care, and views about their health.  
 
Visit 3 (30 minutes). This visit will take place 6 months after visit 1.  
Participants will be asked questions about their experiences making decisions regarding kidney 
disease treatment, their goals of medical care, and views about their health. 
 
The survey instruments will not be audio or video recorded. 
 
 
We will attempt to align these three visits with the participants’ usual care visits.  
 
Intervention: Decision-Aid for Renal Therapy (DART) is an interactive, web-based decision-aid intended to 
facilitateshared decision-making among patients, caregivers, and clinicians. DART was designed using a rigorous 
scientific process with input from patients, clinicians, researchers, and health communication experts and has 
received the highest scores of any Chronic Kidney Disease (CKD) decision aid by International Patient Decision Aid 
Standards ( IPDAS). DART is accessible on devices (smart phones, tablets, computers) that many patients and 
caregivers already own or that will be made available to patients in a private setting in clinics. DART is designed to be 
accessible to diverse populations, including older adults with chronic conditions, persons residing in rural areas, and 
persons of varying socioeconomic backgrounds A significant advantage of decision-aids is their ability to be 
disseminated and implemented rapidly, potentially improving clinical practice and patient and caregiver outcomes. 
Participants who engage with DART watch an approximately 30-minute interactive video that explains treatment 
options for kidney failure and the benefits and risks of different treatment options. Participants have the opportunity 
to make notes while using the program and to print out questions and information from the program. DART 
administration is not part of usual care for chronic kidney disease patients at Tufts Medical Center.  
 
Administering DART and training. Participants randomized to DART will access DART during their first visit, 
which will take approximately 90 minutes (60 minutes for an interview and 30 minutes to interact with DART).  
Participants will interact with DART (use the program to learn about kidney disease treatments and understand 
the benefits and risks of different treatment options) in the clinic. A research assistant will help participants 
access and navigate DART on a tablet or desktop computer in the clinic. Patients and caregivers can complete 
DART together or separately. Participants will also receive an email link to DART if they wish to access it from 
their own tablet or computer at home.  
Participants randomized to DART can continue to access DART from home throughout the duration of the trial. 
Participants randomized to DART will also receive Usual Care.  
 

 
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Usual Care Comparator: Comparative effectiveness trials seek to compare two alternate therapeutic 
approaches. In this case, usual care (UC) is the most appropriate comparator because it represents the clinically 
relevant alternative treatment that patients and their caregivers are most likely to experience in current practice. = 
 
There is no current standard for pre-dialysis education, although the Centers for Medicare and Medicaid Services 
(CMS) reimburse chronic kidney disease education. All participants receive both printed and e-mailed electronic 
versions of ‘Choosing a Treatment For Kidney Failure’ https://www.kidney.org/sites/default/files/11-10-
0352_choosing_treat.pdf , written and published by the National Kidney Foundation, and commonly provided in 
current practice. By providing identical written materials describing treatment options in a balanced and fair way to 
all patients at the first study visit following randomization, we minimize content heterogeneity and bias associated 
with timing and setting. As part of assessments, we will query participants in both study arms regarding participation 
in dialysis education sessions. 
DART will not be administered to participants in the usual care group. 
 
Laboratory tests:. We will not conduct laboratory tests for this study. We will assess medical records for the following laboratory tests 
conducted as part of usual care for chronic kidney disease: serum creatinine (which is used to calculate glomerular filtration rate, or 
GFR), calcium, phosphate, bicarbonate, albumin, hemoglobin, urine albumin, urine protein and urine creatinine.   
1. Study Procedures: Eligible participants will be approached and, if interested, the study  
coordinator or trained research staff will obtain informed consent at Tufts Medical Center. Dr 
Vaidyanathapuram Balakrishnan, the St. Elizabeth’s Medical Center Principal Investigator, 
will screen eligible patients and oversee consent of interested patients at St. Elizabeth’s 
Medical Center. Eligible patients from St. Elizabeth’s Medical Center will first give Dr. 
Balakrishnan permission to be contacted about the study, including being approached for 
consent, by Tufts research staff. 
After providing consent, participants (patient-caregiver dyads) will be randomized to one of two 
study groups using REDCap. One group will receive usual care, and the second group will receive 
usual care plus DART. Participants in both study groups will complete three visits to the clinic: 
 
Visit 1 (60 minutes for participants in the usual care group; 90 minutes for participants in the DART 
study group) 
A research team member will ask questions about the participant’s experiences making decisions 
about kidney disease and treatment, or helping a loved one make decisions about kidney disease 
and treatment. Participants who are assigned to receive regular care will receive a printed 
educational pamphlet, “Choosing a Treatment for Kidney Failure,” published by the National 
Kidney Foundation. Participants who are assigned to DART will receive the educational 
pamphlet and will also have the opportunity to complete DART in the clinic setting. A research 
assistant will help participants access and navigate DART on a tablet or desktop computer in the 
clinic. Patients and caregivers can complete DART together or separately. Participants will also 
receive an email link to DART if they wish to access it from home.  
 
Visit 2 (30 minutes). This visit will take place three months after Visit 1. 
Participants in both study groups will be asked questions about their experiences making decisions 
regarding kidney disease treatment, their goals of medical care, and views about their health. 
 
Visit 3 (30 minutes). This visit will take place six months after Visit 1. 
Both sets of participants will be asked questions about their experiences making decisions regarding 
kidney disease treatment, their goals of medical care, and views about their health. 
 
We will attempt to align these three visits with the participants’ usual care visits. 
 

 
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Caregiver interviews will be conducted in-person at the clinic if they are accompanying the patient, or 
will be done by mail or phone. The caregiver will be given an addressed, stamped envelope in 
which to mail the survey back.  
 
 
 
 
 
 
2. Subject Timeline:       
Participants will be recruited over  10 months in 2 centers in Greater Boston (TMC and St Elizabeth’s 
Medical Center, a Tufts teaching affiliate in Brighton). This will allow a sufficient population to meet 
recruitment targets while ensuring a diverse sample, including understudied populations known to 
experience a greater burden of symptoms and greater difficulty in decision-making. Specific factors of 
interest include: race, ethnicity, and socioeconomic status. Patients and caregivers from these sites have 
expressed interest in participating in this study. St. Elizabeth’s is a Tufts University School of Medicine 
(TUSM) teaching hospital and a partner in the Tufts Clinical and Translational Science Institute (CTSI); 
multiple clinical and research collaborations are ongoing between TMC and SEMC. 
 
 
Follow-up time will be  6 months, with follow-up interviews conducted at 3 months and 6 months after 
the baseline visit. 
 
 
F. Assessment of Subject Safety and Development of a Data and Safety Monitoring Plan 
 
1. Definition of Serious Adverse Event (SAE) and Adverse Event (AE) for this study: 
Although none are anticipated, during the course of a research study, unanticipated 
problems involving risk to subjects or others, non-compliances, and other events may 
occur that need to be reported to the IRB in accordance with 45 CFR.46.103(b)(5) and 
21 CFR 56.108(b). We will follow the Tufts IRB Reportable New Information Policy. For 
this study, the intervention consists of patients and care partners receiving access to 
and viewing a decision-aid program that contains educational material about chronic 
kidney disease and treatment options. Receipt of access to this program and use of the 
program is intended to better inform patient of their options and prompt patients to 
raise questions with physicians about their future treatment options. The decision-aid 
should not interfere in any way with the patient-provider relationship. The decision-aid is 
not intended to influence the treatment options that patients select. Whether the patient 
has a medical event (e.g. dialysis initiation) is not an adverse event related to the study. 
Therefore, although we will collect data related to treatment choices, the intervention 
does not directly impact these choices, and therefore this study does not require a data 
safety plan. 
 
2. Reporting timeframe for SAEs and AEs: n/a 
3. Accountability procedures as they relate to drugs, devices, and data: n/a 
 
 
G. Subject Participation 
 
1. Recruitment: The study coordinator or Co-Investigator Dr. Dan Weiner will use medical records 
to identify potentially eligible participants from Tufts Medical Center based on the clinical and 
demographic data described above. The Co-Investigator at St. Elizabeth’s Medical Center, Dr. 
Vaidyanathapuram Balakrishnan, will use medical records and the clinic list to identify 
eligible participants from St. Elizabeth’s Medical Center.  The coordinator and/or PI/Co-I (Dr. 
Keren Ladin or Dr. Dan Weiner) will reach out to the clinician to inform them that their patient 
may be eligible for Tufts Medical Center participants. At St. Elizabeth’s Medical Center, eligible 

 
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subjects will first be contacted by Dr. Balakrishnan to assess interest in study participation and obtain 
their permission to be contacted further about the study by Tufts research staff.  He will oversee the 
consent process at SEMC. the clinician will approach the patient in the clinic, or the study 
coordinator/trained research staff, will approach the patient in the waiting room, at either Tufts Medical 
Center or St. Elizabeth’s Medical Center,to assess their interest in learning more about the study 
and give them a flyer advertising the study. The study coordinator or trained study staff from 
Tufts University will consent interested participants a quiet, private space at the clinic at either 
Tufts Medical Center or St. Elizabeth’s Medical Center (with the SEMC PI in the latter case)  In 
addition, the study coordinator or trained study staff from Tufts University will send a 
recruitment/opt-out letter to potentially eligible patients identified as described above, 
followed by a phone call 1 week later. The SEMC PI will send a recruitment/opt-out letter to 
eligible SEMC patients and follow-up with a phone call 1 week later. A flyer advertising the 
study will also be posted in the clinic at Tufts Medical Center and St. Elizabeth’s Medical Center 
to allow interested patients to contact the PI or study coordinator to learn more about the 
study. If interested, the coordinator or trained study staff from Tufts University will initiate the 
consent process, either in person or by phone followed by in-person.  
 
Please note that additional trained research staff that will have a study role at both Tufts 
Medical Center and St. Elizabeth’s Medical Center have not yet been identified. They will be 
added to the study protocol once identified through an amendment. 
 
Alternative strategies will include the Tufts CTSI to query the Tufts MC EHR for individuals age 70+, eGFR 
between 10 and 30, and a relationship with an outpatient provider affiliated with Tufts Medical 
Center. Using this list, coordinators will further screen for eligibility, including use of the kidney risk failure 
equation and evaluate notes for patient awareness of their chronic kidney disease.  If aware of kidney 
disease and eligible, opt-out letters (Appendix 2) will be sent to participants followed by a phone call 1 
weeks later. 
 
Patients will be asked to identify a primary caregiver/care partner with whom they discuss important 
matters and who would be most likely to make a decision for them in the case that they could not decide or 
communicate their wishes. The term caregiver does not imply that the patient requires immediate for 
fulltime care, but rather refers to the individual most likely to participate in decision-making and assistance 
with daily living. If the primary caregiver is accompanying the patient, the caregiver will also be approached 
after the patient has consented. The study will be explained to the caregiver, and the caregiver will be given 
the opportunity to consent to the study. If a caregiver is not accompanying the patient, we will ask the 
patient to identify a primary caregiver and for the caregiver’s contact information. A recruitment/opt-out 
letter will be sent to the caregiver, followed by a phone call 1 week later, to ask if s/he is interested in 
enrolling and to schedule a time for him/her to come into the clinic to consent for the study if interested. 
 
 A patient does not need a caregiver to participate in the study. 
The recruitment/opt-out letter (patient and caregiver), scripts for phone calls, and flyer are attached to 
this application. 
 
 
 
2. Registration: Patient and caregiver participant who have consented will be given unique 
identifiers after randomization. Patient-caregiver pairs (dyads) will receive either DART or usual care, 

 
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with randomization blocked by study site using blocks of randomly varying size using RedCap. 
Nephrologists will become aware of the randomization outcomes immediately prior to the clinic visit, as 
patients will bring with them a printed copy of their preferences and questions about treatment (an 
outcome of the DART). The unique participant identifiers will be used on all materials and survey forms 
following randomization. 
 
At the baseline visit, following consent and randomization, patients randomized to DART will receive usual care plus 
an email with a unique link to DART. During the baseline visit after completion of baseline surveys, a research team 
member will guide patients and caregivers randomized to DART on how to access and navigate DART on a tablet or 
desktop and how to print question prompts to facilitate discussions with their clinical team. This training will take 
approximately 15 minutes. To increase generalizability, we accommodate participants who do not currently have 
internet access by using web-enabled tablet set-up in a quiet, private room at the clinic to access DART.  Participants 
will receive a phone number to reach research team members for questions. 
 
 
3. Screening Interview/questionnaire:A screening script will not be used. The scales and 
questionnaires are provided as Appendix 1. 
 
We will not be audio or video recording the survey instruments.  
 
 
Construct 
Measure 
Month 
0 
3 
6 
Patient Assessments 
Decisional Capacity 
Decisional Conflict Scale 
x 
x* 
x 
Advanced Care Planning 
Completion of Advanced Directive 
x 
x* 
x 
Health related quality of life 
KDQOL-36 
x 
x 
Cognitive Function 
Montreal Cognitive Assessment 
x 
Patient and Caregiver Assessments 
Concordance 
Goals of Care Document 
x* 
Satisfaction with Care 
CANHELP Lite Questionnaire 
x 
x* 
Satisfaction with Life 
Satisfaction with Life Scale 
x 
x 
x 
Depression 
CESD-R 
x 
x 
Anxiety 
Hospital Anxiety and Depression Scale † 
x 
x 
Caregiver Assessments 
Caregiver Burden 
Caregiver Burden Scale 
x 
x* 
x 
 
 
4. Transportation: Interviews and surveys will be administered during regular clinical visits. 
In the case that a patient or caregiver prefer to complete the survey outside the clinic at our 
research lab at 574 Boston Avenue in Medford, we will provide a $5 transportation stipend 
and free parking. 
 
5. Informed consent process and timing of obtaining of consent: All eligible patients 
from Tufts Medical Center  identified as described above will be approached by the study 
coordinator and/or trained research staff from Tufts University and will be asked if they 
would like to learn more about the study. The SEMC PI, Dr. Balakrishnan, will make first 
contact with eligible patients from SEMC. The study coordinator and/or trained research 
staff from Tufts University will then describe the study, and walk through the informed 
consent form with the patient and caregiver. The SEMC PI and Tufts research staff will 
approach eligible, interested patients for consent at St. Elizabeth’s Medical Center. If 
interested, patients and caregivers will sign the informed consent and will be able to 
participate in the trial. Informed consent will take place in a quiet, private area in the clinic. 
We are currently submitting Agency/Contract Staff Action Forms for the PI (Dr. Keren Ladin) 
and study coordinator (Dr. Renuka Pandya) to Stacia Russell at St. Elizabeth Center’s Human 

 
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Resources department to obtain permission to enter St. Elizabeth’s Medical Center. 
Additional Agency/Contract Staff Action Forms will be submitted for each Tufts University 
study staff once they are identified. 
 
If a caregiver is not accompanying the patient, we will ask the patient to identify a primary 
caregiver and for the caregiver’s contact information. A recruitment/opt-out letter will be sent 
to the caregiver, followed by a phone call 1 week later, to ask if s/he is interested in enrolling 
and to schedule a time for him/her to come into the clinic to consent for the study if interested. 
 
 A patient does not need a caregiver to participate in the study. 
 
 
a. If non-English speaking persons will be enrolled, state the informed consent 
process for enrolling the subjects, including who will conduct the consent 
interview, use of interpreters, translated documents, etc.: n/a 
 
(NOTE: Exclusion of non-English speaking subjects from research requires ethical 
and scientific justification. This justification must be stated elsewhere in the 
protocol.) 
 
6. Location where study will be performed: The study will be performed at Tufts Medical 
Center, Nephrology Department and at St. Elizabeth’s Medical Center Nephrology 
Department.  
 
7. Personnel who will conduct the study, including: 
a. Present during study procedure(s) and their proximity during the study:  
Keren Ladin, PhD, PI 
Daniel Weiner, MD, MS, Co-I at Tufts Medical Center 
Renuka Pandya, PhD, Coordinator 
Vaidyanathapuram Balakrishnan, Co-I at St. Elizabeth’s Medical Center 
 
b. Primary responsibility for the following activities:  
 
i. Obtaining informed consent: Renuka Pandya, Keren Ladin, Vaidyanathapuram 
Balakrishnan (at St. Elizabeth’s Medical Center)  
 
ii. Providing on-going information to the study sponsor and the IRB: Keren 
Ladin, Renuka Pandya 
 
iii. Maintaining participant's research records: Keren Ladin; Renuka Pandya; Daniel 
Weiner (at Tufts Medical Center); Vaidyanathapuram Balakrishnan (at St. Elizabeth’s 
Medical Center) 
 
8. Subject fees: Keren Ladin 
 
9. Study results: Keren Ladin. Study results will not be given to subjects unless necessary. 
 
10. Procedures to protect subject confidentiality: Keren Ladin 
 
11. Confidentiality: Keren Ladin, Renuka Pandya, Daniel Weiner, Vaidyanathapuram 
Balakrishnan  
 
a. Certificate of Confidentiality: n/a 

 
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b. How data will be coded, recorded, and stored to protect confidentiality: All 
patient information will be de-identified using generated patient ID numbers. A file 
linking IDs and patient names will be password protected, and stored on an 
encrypted drive at the REACH Lab in Medford. This file will not contain any other data 
about patients. 
 
Paper surveys will be administered by trained research assistants. These will be 
stored securely in the REACH Lab in a locked file cabinet. The REACH Lab is keycard 
protected and is in a building with security personnel at the front desk. Surveys will 
coded into a de-identified database using REDCap. The file will be saved on the 
Research Drive at Tufts University, which is maintained by TSS. It is a secure and 
encrypted drive that is backed up daily.  
 
Medical record data drawn from medical charts will be gathered using the patient 
name, however when recorded, it will use only the patient’s unique ID. This data will 
be input into the REDCap database and stored securely on the encrypted Research 
drive maintained by TTS. The SEMC PI, Dr. Balakrishnan, will gather medical record 
data on SEMC participants and enter this information directly into the REDCap 
database. 
 
c. Parties who will have access to the date, including the key to the identity 
code: Keren Ladin, Daniel Weiner, Renuka Pandya, Vaidyanathapuram Balakrishnan 
 
d. Parties who will have access to research records: Keren Ladin, Daniel Weiner, 
Renuka Pandya, Vaidyanathapuram Balakrishnan 
 
 
12. Collaboration:  We will not share data from Tufts Medical Center to St. Elizabeth’s Medical 
Center.  
 
Overview of research team roles at St. Elizabeth’s Medical Center: 
 
Name 
Institutional Affiliation 
Role 
Keren Ladin 
Tufts University 
Recruitment of participants, 
obtaining informed consent, 
enrolling subjects, analysis 
of de-identified or 
identifiable data, interaction 
with participants, present 
during study procedures, 
preparation of study results, 
maintaining participant’s 
research records 
Renuka Pandya 
Tufts University 
Recruitment of participants, 
obtaining informed consent, 
enrolling subjects, analysis 
of de-identified or 
identifiable data, interaction 
with participants, present 
during study procedures, 
preparation of study results, 
maintaining participant’s 
research records 
Vaidyanathapuram 
St. Elizabeth’s Medical 
Recruitment of participants, 

 
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Balakrishnan 
Center 
obtaining informed consent, 
enrolling subjects, analysis 
of de-identified or 
identifiable data, interaction 
with participants, present 
during study procedures, 
preparation of study results, 
maintaining participant’s 
research records 
 
 
 
 
Please note that additional trained research staff that will have a study role at both Tufts 
Medical Center and St. Elizabeth’s Medical Center have not yet been identified. They will be 
added to the study protocol once identified through an amendment. 
 
13. Alternatives:      Patients who choose not to participate in this study will receive usual 
care for chronic kidney disease from their nephrologist.  
 
 
Successful recruitment is the major challenge of all clinical trials, although the sample in this 
pilot does not pose a significant challenge based on current population estimates of potentially eligible 
participants using local electronic health records. Recruitment barriers will be overcome by several 
approaches including: 1) personal outreach from treating physicians; 2) information sessions and 
individual meetings with clinic staff at participating clinics; and 3) written communication and follow-up 
telephone calls. Recruitment strategies are designed to minimize respondent burden. Should 
recruitment be below target, alternative strategies described below will be implemented within 3 
months of starting recruitment.  
 
14. How new information will be conveyed to the study subject and how it will be 
documented: New information will not be conveyed to study subjects. 
 
15. Payment, including a prorated plan for payment: Participants (each patient and 
caregiver in both study groups) will be offered a $25 gift card after completing the first visit, and 
an additional $15 gift card for each of the subsequent two follow-up visits, for a total of $55 for 
completing the entire study. In the case that a patient or caregiver prefers to complete the 
survey outside the clinic at our research lab at 574 Boston Avenue in Medford, we will 
provide a $5 gift card as a transportation stipend. We will use a participant payment log 
(attached in this amendment) to keep track of gift card disbursement. Participants will fill in the 
top half of the form (name, social security number, and address) after providing informed 
consent. The remainder of the form (gift card amount, date gift card distributed, and participant 
signature) will be completed after the participant receives the gift card.   
 
 
16. Payment for a research-related injury: none 
 
I. Outcome: This is a pilot study, and as such, our main outcomes are feasibility of the study 
design and recruitment, and usability of the intervention. Nonetheless, we estimate that 
patients who will be exposed to DART will be more likely to complete advance care plans, they 
will be more satisfied with their decisions and better informed of their treatment options. We 
also hypothesize that their caregivers will be more likely to know patients’ preferences for care. 
  
J. Tissue banking considerations: none 
 

 
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VULNERABLE POPULATIONS: Not recruiting children, prisoners, pregnant women, or persons with 
dementia, all of whom would be ineligible to participate.