A Pilot Study of The CKM JumpStart Tool
Phase: NA
Conditions: Chronic Kidney Diseases
Sponsor: University of Washington

 
 
 
 
 
 
 
 
 
A Pilot Study of The CKM JumpStart Tool 
Funding Agency: Doris Duke Charitable Foundation 
Award: Clinical Scientist Development Award 
Principal Investigator: Susan P.Y. Wong, MD 
Protocol 
2/15/2023 
 
 

 
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Abstract 
Objective(s) and Hypotheses: 
Conservative kidney management (CKM) is an important therapeutic alternative for patients 
who do not wish to pursue dialysis for their advanced chronic kidney disease (CKD). 
Conservatively managed patients can survive several years after their decision to pursue 
CKM and experience sustained quality of life until late in the course of illness.1 
Conservatively managed patients also spend less time in the hospital,2-5 less often 
experience burdensome procedures,2,5 and less often die in the hospital setting than patients 
treated with dialysis.5-9 Despite a growing body of evidence and clinical services to support 
patients who do not wish to pursue dialysis,10,11 patients rarely recall discussing more 
conservative options with their providers and are typically presented dialysis as the default 
treatment option for their advanced CKD.12,13 This study aims to test the acceptability and 
feasibility of a novel communical tool, The CKM JumpStart Tool. We hypothesize that the 
CKM JumpStart Tool will be feasible and acceptable to patients with advanced CKD and their 
providers and will help to support informed and shared decision-making for treatment of 
advanced CKD.  
 
Research Design: 
This is a randomized pilot study of patients with advanced CKD and their close persons who 
are receiving care at University of Washington (UW) Medicine and VA Puget Sound Health 
Care System (VAPSHCS). The study utilizes medical record review, qualitative interviews, 
and standardized questionnaires to assess the feasibility and acceptability of the CKM 
JumpStart Tool and to explore differences in decisional conflict and goal concordant care 
between patients and who receive the decision aid and those who do not.  
 
Methodology 
We will recruit 76 patients aged 18 years and older with advanced CKD as defined as an 
estimated glomerular filtration rate (eGFR <25 ml/min/1.73m2 from UW Medicine and 
VAPSHCS. We will randomize patients in a 1:1 fashion to either usual care or receipt of the 
CKM JumpStart Tool. Patients will complete study procedures by phone or in-person, over a 
total of 3 study visits. We will also recruit providers of patients who received the CKM 
JumpStart Tool about their experiences using the the CKM JumpStart Tool.  
 
Relevance 
 
 
 
 
 
 
 
 
           
An important step to towards helping patients choose the right treatment for them and their 
advanced CKD is to promote discussion of the different treatment options with their 
providers. The proposed study has the potential to lead to the creation of a cost-effective, 
time-saving and scalable intervention to improve the care of patients with advanced CKD.  
 

 
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List of Abbreviations 
 
CKD: chronic kidney disease 
Conservative Kidney Management: CKM 
eGFR: estimated glomerular filtration rate 
UW: University of Washington, Seattle WA 
VAPSHCS: VA Puget Sound Health Care System, Seattle WA 
KRI: Kidney Research Institute, University of Washington, Seattle WA 
VACOIN: VA Center of Innovation, Seattle WA.  

 
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Contents 
Protocol Title:  A Pilot Study of A Guide to Conservative Care .... Error! Bookmark not defined. 
1.0 
Study Personnel ................................................................................................................. 5 
2.0 
Introduction ........................................................................................................................ 5 
3.0 
Objectives .......................................................................................................................... 6 
4.0 
Resources and Personnel .................................................................................................. 6 
5.0 
Study Procedures .............................................................. Error! Bookmark not defined. 
5.1 Study Design ......................................................................................................................... 7 
5.2 Recruitment Methods ............................................................................................................ 9 
5.3 Informed Consent Procedures .............................................................................................. 9 
5.4 Inclusion/Exclusion Criteria ................................................................................................. 10 
5.5 Study Evaluations ............................................................................................................... 11 
5.6 Data Analysis ...................................................................................................................... 13 
5.7 Withdrawal of Subjects ........................................................................................................ 13 
6.0 
Reporting ......................................................................................................................... 13 
7.0 
Privacy and Confidentiality ............................................................................................... 13 
8.0 
Communication Plan ........................................................................................................ 14 
10.0 
References ....................................................................................................................... 15 
 

 
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1.0 
Study Personnel 
Principal Investigator:  
Susan P. Y. Wong, M.D.  
Associate Professor, Division of Nephrology, University of Washington (UW) 
Staff physician, VA Puget Sound Health Care System (VAPSHCS)  
Investigator, Kidney Research Institute (KRI) 
Core Investigator, VA Center of Innovation (VACOIN) 
1660 S. Columbian Way, Renal Dialysis Unit 5B-113, Seattle WA 98108 
Email: Susan.Wong2@va.gov; spywong@uw.edu 
Phone: 206-277-4376 
Fax: 206-764-2022 
Effort: 25% (8/8ths) 
 
Research Personnel 
 
Olivia Gaurghran, M.A. 
Research Coordinator, KRI 
Email: ollyg@uw.edu 
Phone:  
Effort: 80% 
 
Taryn Oestreich, M.P.H. 
Research Coordinator, KRI and VA Office of Geriatrics and Extended Care  
Phone: 425-286-4948 
Effort: 10% (4/8ths) 
 
Rachel Smith, B.A. 
Study Coordinator, KRI and VACOIN  
Email: Rachel.Smith2@va.gov 
Phone: 206-554-9461 
Effort: 10% (8/8ths) 
 
David Prince, Ph.D. 
Biostatistician, KRI  
Email: dprine3@uw.edu 
Phone: 206-685-3547 
Effort: 10% (WOC) 
2.0 
Introduction 
 
Chronic kidney disease (CKD) afflicts 1 in 7 Americans. Although dialysis is commonly regarded 
as a life-prolonging therapy for advanced CKD, there is growing recognition that dialysis is not 
always beneficial. Decisions about dialysis often involve difficult trade-offs between the potential 
gains in longevity and symptom management and the burdens of treatment including the 

 
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substantial time spent on dialysis, complications related to treatment, frequent interaction with 
healthcare system and loss of independence.  
 
Conservative kidney management (CKM) is an important option for patients who choose not to 
pursue dialysis that focuses on slowing the decline in renal function, active symptom 
management, advance care planning and the provision of appropriate palliative care. 
Conservatively managed patients can survive several years after their decision to pursue CKM 
and experience sustained quality of life until late in the course of illness.1 For adults aged ≥75 
years with significant comorbidity and functional impairment, dialysis might not improve 
survival2,9,14-17 and quality of life18-20 beyond what can be achieved with a more conservative 
approach for advanced CKD. Conservatively managed patients also spend less time in the 
hospital,2-5 less often experience burdensome procedures,2,5 and less often die in the hospital 
setting than patients treated with dialysis.5-9 
 
Despite a growing body of evidence and clinical services to support patients who do not wish to 
pursue dialysis,10,11 patients rarely recall discussing more conservative options with their 
providers.12,13 Although it is a professional obligation that all available treatment options are 
discussed with patients,21 many providers find it difficult or are reluctant to discuss conservative 
options for advanced CKD.22,23 Qualitative interviews with providers suggest that many feel ill- 
equipped to have a conversation about CKM or worry that if they do not offer dialysis, it would be 
perceived as “no care” or “giving up.”10,22  
 
The current application is to support a pilot study to test the acceptability and feasibility of a novel 
communication tool to help providers “jumpstart” a conversation about CKM with their patients 
that was created by the principal investigator (PI, Wong). The CKM JumpStart Tool has the 
potential to be a cost-effective, time-saving and scalable intervention to improve the care of 
patients with advanced CKD.  
3.0 
Objectives 
We aim to conduct a randomized pilot study to test the feasibility and acceptability of a novel 
communication tool, called The CKM JumpStart Tool, and explore preliminary outcomes, 
including decisional uncertainty and goal concordant care to inform a future clinical trial. We 
hypothesize that the decision aid will be feasible and acceptable to patients and their providers.   
4.0 
Resources and Personnel 
 
Study Sites:  
This study will involve VAPSHCS and the UW. Study subjects will be recruited from UW 
Medicine and VAPSHCS in Seattle. UW will be used only as a recruitment site for non-Veteran 
patients, and this protocol covers VA research activity only. Original study data collected with 
UW Medicine will be stored and at the KRI. Original study data collected at VAPSHCS will be 
stored at the VACOIN. Deidentified UW patient data will be moved to VA Puget Sound to 
facilitate pooled analysis. All data analyses will occur at VACOIN. No VA data will be shared with 
the UW.  
 
Study Team Personnel 
Susan Wong, MD, Principal Investigator: She will provide overall project leadership and 
supervision of study performance and progress. She will oversee all aspects of the study subject 

 
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recruitment and follow-up, data collection and management, analyzing and interpreting data, and 
preparing study findings for publication and presentation. She will have access to protected 
health information.   
 
Taryn Oestreich, MPH, Research Coordinator: She will assist with contacting and recruiting 
subjects, obtaining subject informed consent, administering the intervention and surveys, 
interviewing subjects, and collecting and analyzing study data. She will have access to protected 
health information.  
 
Rachel Smith, BA, Research Coordinator: She will assist with all aspects of study coordination. 
She will also assist with recruitment and data collection and analysis. She will transcribe audio-
recorded interviews collected for this study. She not have access to protected health information.  
 
David Prince, PhD, Biostatistician: He will perform the data analysis. He will have access to 
protected health information. 
5.0 Study Design 
 
We will conduct a randomized pilot study to test the feasibility and acceptability of the CKM 
JumpStart Tool among patients with advanced kidney disease and their providers using interview 
methodology and questionnaires. We will also explore preliminary outcomes including decisional 
uncertainty and goal concordant care to inform a future clinical trial. 
5.1 Study arms 
 
Patients will be randomized in a 1:1 fashion using a random number generator 
(www.randomizer.org) to either 1 of 2 groups, CKM Jumpstart Tool or Usual Care. All enrolled 
patients will complete surveys within 2 weeks of their following clinic visit with their provider (T2), 
and about 3 months after this clinic visit (T3). All study procedures will be conducted either by 
phone or in-person, at the patient’s convenience. Each visit will take about 20 minutes.  
 
 
The CKM JumpStart Tool 
The CKM JumpStart Tool is a 1-page handout that describes the values of a patient and words 
that a provider can try with the patient to explore the patient’ values more and to provide a 
values-based introduction to CKM. The values describes in the CKM JumpStart Tool is based on 
a patient’s response to a single validated question that asks the patient, if they had to choose, do 
they value care directed at longevity or comfort. A patient may also indicate whether they are 
unsure what kind of care they value more. Because there are 3 potential responses to the values 
question (longevity, comfort, unsure), there are 3 different versions of the CKM JumpStart Tool. 
(Appendix A.1 Intervention Materials: CKM JumpStart Tool Versions). The CKM JumpStart Tool 
does not contain any identifying information about the patient. 
 
Patients who are randomized to receive the CKM Jumpstart Tool will be surveyed at T1. Using 
the patient's answer to the values question, study staff will generate a CKM JumpStart Tool prior 
to their upcoming clinic visit with their provider. Study staff will inform the patient that their 
response to the values question will be shared with their provider prior to their next clinic visit and 
that their providers might bring up their values and treatment options for kidney disease, if the 

 
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situation permits. We will share the CKM Jumpstool with their provider by encrypted email 
(Appendix A.2. Intervention Materials: Provider Email Notification) prior to the visit. The email will 
contain a link to a brief video demonstrating the use the CKM JumpStart Tool 
(bit.ly/CKMJumpstart) and an attachment which describes the study in more detail (Appendix 
B.8: Provider Study Information Document). We will also provide the providers with a paper copy 
of the CKM JumpStart Tool on the day of their visit with the patient and remind them how to use 
the CKM JumpStart Tool using a standard script (Appendix A.3. Intervention Materials: Provider 
Script Notification). In both in email and in-person, we will assure the provider that they are not 
obligated to use CKM JumpStart Tool or discuss their patient’s values and CKM and that they 
are free to do so if they choose. We will also assure the provider that the patient consented to a 
potential discussion of their values and CKM if it should arise during their clinic visit.  
 
Usual care 
Patients randomized to usual care will also will be surveyed at T1 but will not have a CKM 
JumpStart Tool generated describing their values and their response to the values question will 
not be shared with their providers. They will receive care as they usually do from their provider. 
5.2 Potential Risks and Benefits 
 
Anticipated risks:  
The principal risk posed to patients is the potential loss of confidentiality. The proposed work 
requires the collection of protected health information to identify and recruit eligible patients and 
contact and maintain follow up with participating patients. We will also audio-record interviews 
with subjects during which personal information might be spoken. To minimize this risk, we have 
outlined steps below to safeguard patient confidentiality. These include restricting data analyses 
to only de-identified data files, keeping separate a crosswalk file linking study ID with personal 
identifiers and data analysis files, storage of data on password-protected secure servers and 
key-locked filing cabinets accessible to only study team members who have completed training 
in the protection of human subjects, and the aggregation of study data for presentations and 
publications in order to conceal the subjects’ identities. 
 
It is possible that patients might feel unease with discussing their illness experience. To minimize 
discomfort, patients will be assured that they can decline to answer any question they wish and 
will be free to discontinue the interview at any time. All patients will be reminded that they have 
the right to refuse to withdraw from the study at any time. 
 
It is possible that providers might worry that participation, not participating, and/or being candid in 
interviews might affect their standing at work. We will assure providers that their participation is 
entirely voluntary and that they are under no obligation to use the Tool or answer any question 
during the study. Their participation or lack thereof will not be reported to their supervisor, and 
we will keep all data collected on providers confidential. Any personal identifiers will be kept 
separate from the data collected and that analyses will only be conducted with de-identifed data. 
Results will be reported in aggregate and therefore be anonymous. 
 
Potential Benefits:  
Patients and providers may benefit from this research directly and indirectly. This study will 
explicitly allow participants the opportunity to describe their experiences, which may give 
participants an important outlet for describing both their concerns and successes. Participants 
may also gain satisfaction from participating in a research project designed to improve the quality 

 
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of care for patients with advanced CKD, which gives a sense that they are active contributors to 
important quality improvement processes. For patients who know little or nothing about CKM, 
discussion about CKM can be an educational experience for them. For clinicians who find it 
difficult to engage in goals-of-care conversations and discuss CKM, they might also learn new 
communication skills modelled by the CKM JumpStart Tool. 
 
With the measures outlined, we believe that the potential risks associated with the proposed 
work will be mitigated and will not outweigh the potential benefit to study subjects and the greater 
CKD population. The findings of this study will inform ongoing development of a novel 
communication tool to support shared decision-making for patients with advanced CKD and their 
providers.  
5.3 Recruitment Methods 
 
We aim to enroll up to 76 patients with advanced CKD and up to 30 of their providers in this 
study.  
 
Patients 
We are requesting a waiver of consent and HIPAA authorization to access the electronic medical 
records of patients to identify eligible patients for this study and to obtain their name and contact 
information for recruitment purposes only.  
 
We will mail an Introductory Letter (see Appendix B.1: Recruitment Materials: Patient 
Introductory Letter) introducing the study. We will then follow up with a phone call about 1 week 
later to confirm that patients receive the letter, introduce the study, and determine if they are 
interested in participating in the study using a standard script (see Appendix B.2. Recruitment 
Materials: Patient Introductory Script).  
 
We will not make more than 3 attempts to reach each patient by phone after mailing the 
introductory letter. 
 
Providers 
For enrolled patients who are randomized to the intervention, we will approach their providers in-
person after their visit with their enrolled patients to inquire whether they had used the CKM 
Jumpstart Tool during their visit with the patient, and if so, invite them to participate in a brief 
phone or in-person interview about their experience using the CKM JumpStart Tool. We will use 
a standard script to recruit providers (Appendix B.3 Recruitment Materials: Provider Recruitment 
Script). If providers are unavailable to speak after the clinic visit, we will approach providers 
using encrypted email within 1 week after the clinic visit (Appendix B.4. Recruitment Materials: 
Provider Recruitment Email) and invite them complete an interview. We are requesting a waiver 
of informed consent to inquire providers if they had used the CKM Jumpstart Tool during their 
visit and the primary reason for not using the Tool to determine providers’ eligibility to participate 
in the study.  
 
5.3 Informed Consent Procedures 
 
Patients  
 

 
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We will provide potential patients a Patient Study Information Document (Appendix B.5 
Recruitment Materials: Patient Study Information Document) either by mail or a link to an online 
version of the Patient Study Information Document for them to review and download 
(https://redcap.link/CKMjumpstart). The Patient Study Information Document describes the study 
procedures, risks, and benefits, and information on what to do and expect if they decide not to 
participate. We will provide this link verbally over the phone and read aloud the study information 
document. A copy of the Patient Study Information Document can also be downloaded from the 
webpage. For those who prefer to first review a mailed a paper copy of the Patient Study 
Information Document before deciding whether to participate, we will follow-up by phone in about 
1 week after the mailing. 
 
The Patient Study Information Document will be hosted on UW REDCap, however UW REDCap 
will not be used for the storage or analysis of any VA data, and no VA data will be shared with 
UW REDCap. The only use of UW REDCap in this study is to use the provided link to 
disseminate an information sheet that does not require patients to enter any information or to 
provide their electronic consent. 
 
Because the study procedures and intervention poses minimal risk to patients, and many 
patients prefer to complete study procedures remotely, we are requesting a waiver of written 
informed consent from patients to participate in the study. To ensure informed consent, we will 
use a “Teach-back Method” (see Appendix B.6. Recruitment Materials: Patient Teach-back 
Exercises) in which, after reviewing the study, we will ask patients a series of true/false questions 
about key aspects of the study aims, procedures and potential risks and benefits. Any responses 
that are incorrect or incomplete will be reviewed with patients, and they will be asked for 
responses to missed statements for a second time. We will repeat this teach-back approach a 
second time if there are aspects of the study that are still not understood by patients. Patients 
whose responses to statements are still incorrect after three responses would be considered to 
have inadequate understanding of the study and to be ineligible to participate. 
 
Patients will be informed that participation is fully voluntary and that their decision regarding 
participation will in no way affect their access to services or the quality of care they receive at the 
VA, and that their identifiable information will not, at any time, be linked to the digitally recorded 
interview or the subsequent transcript.  
 
Providers  
 
Because the study procedures and intervention pose minimal risk to providers and that 
intervention is intended to promote standard of care (i.e. discussion of available treatment 
options for advanced CKD with patients), we are requesting a waiver of written informed consent 
from providers to participate in study interviews. We will review the study with providers using a 
standard script (Appendix B.7. Recruitment Materials: Provider Consent Script), which will cover 
the aims of the study, study procedures, and potential risks and benefits. They will also receive a 
study information document (Appendix B.8: Provider Study Information Document) when they 
are provided the CKM JumpStart tool in an encrypted email. 
 
5.4 Inclusion/Exclusion Criteria 
 
Patients  

 
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Inclusion: 
• 
Adults aged ≥75 years 
• 
Advanced CKD as defined as having at least 2 outpatient measures of eGFR <25 
ml/min/1.73m2 separated by >90 days in the prior year and with at least 1 eGFR measure 
<20. 
• 
English-speaking 
• 
Receive care from a provider at UW Medicine or VAPSHCS 
• 
Open to discussing their values and treatment options for kidney disease with their 
provider. 
 
Exclusion: 
• 
Unable to complete the informed consent process 
• 
Currently receiving maintenance dialysis 
 
Providers  
Inclusion  
• 
Their patient is a participant in the study. 
• 
Are a UW Medicine or VAPSHCS provider or trainee. 
 
Exclusion 
• 
None 
 
5.5 Study Evaluations 
 
Patients 
The date of study enrollment will be the date that a patient’s consent is obtained. Patients will be 
followed through patient’s death, date of study withdrawal, or study completion, whichever is 
earliest. 
 
Patients will complete the following surveys and interviews at enrollment (T1), within 2 weeks of 
their following clinic visit with their provider (T2), and about 3 months after this clinic visit (T3). All 
study procedures will be conducted by phone. Each phone call will take a total of 15 to 30 
minutes. We will give participants a $20 gift card for each study visit that they complete. Gift 
cards will be mailed within five business days of a completed call.  
 
Demographic survey (Appendix C.1): At T1, patients will be asked their gender, age, race, prior 
education, total annual household income, current employment status, and self-rated overall 
health. 
 
EuroQol 5D (Appendix C.2): At T1, patients will be asked to complete a 5-item survey inquiring 
different domains of quality of life, including mobility, self-care, usual activities, pain/discomfort, 
and anxiety/depression, on a 5-point scale.24  
 
Control Preferences Scale (Appendix C.3): At T1, using a single question, patients will be asked 
to rate on a 5-point scale their preference in taking lead in medical decision-making.  
 

 
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Healthcare values (Appendix C.4): At T1, using a single validated question, we will ask patients 
about their preference for either extending life or preserving comfort. Patients will also have the 
option of indicating that they are uncertain about which they prefer. We will also ask whether they 
perceive that their provider provides care that is mostly directed at extending life or preserving 
comfort or are unsure. Patients will be considered as receiving goal concordant care if they 
perceive the care that they receive matches the care that they value.  
 
Quality of communication (Appendix C.5): At T1, T2 and T3, patients will be asked to rate the 
quality of serious illness communication with their providers using the 13-item subscale of the 
Quality of Communication Questionnaire.25-27  
 
Discussion of treatment options (Appendix C.6): At T1, patients will be asked if they had ever 
discussed CKM and dialysis with their provider. At T2 and T3, patients will again be asked if they 
had discussed these topics since the last study visit.  
 
Decisional conflict (Appendix C.7): At T1, T2 and T3, patients will be asked to complete the 4-
item SURE Test to assess their preference for dialysis vs. CKM and the decisional conflict they 
have about their options.28,29  
 
Post-clinic patient interview (Appendix C.8): At T2, patients assigned to the intervention will be 
invited to answer 4 open-ended questions about their clinical encounter with their provider. 
Questions will pertain to topics discussed during the encounter with their clinician, whether their 
provider asked them about their values, whether CKM was discussed, and their perception of 
CKM based on the conversation. Interviews will be audio-recorded then transcribed. We estimate 
that an interview will take 10-15 minutes to complete. 
 
Documentation of discussion of CKM with patients: At T2 and T3, we will review each patient’s 
recent nephrology clinic notes to determine whether providers documented a discussion with 
patients about CKM. Documentation will be transcribed into a Word document without personal 
identifiers. 
 
Providers 
 
Demographic information: From publicly available directories, we will ascertain providers’ gender, 
race, and years since completing their medical degree.  
 
Use of the CKM Jumpstart Tool (part of Appendix B.3): For providers whose patients were 
assigned to the intervention, we will ask them after their visit with their enrolled patient (T2) 
whether they had used the CKM Jumpstart Tool during their visit, and if not their reasons for not 
using the Tool. 
 
Post-clinic provider interview (Appendix C.9): For providers who used the CKM Jumpstart Tool, 
we will ask 4 open-ended questions about their clinical encounter with the patient and their 
experience using the CKM JumpStart Tool. Clinician responses will be recorded in writing, then 
transcribed into a Word document. We estimate that an interview will take 5 minutes to complete. 
Interviews will be conducted by phone or in-person in a private clinic room or office of the 
provider, per the provider’s preference. Providers will be offered a $10 gift card for their 
participation. 
 

 
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5.6 Data Analysis 
Feasibility and acceptability: As our primary outcome, and measure of feasibility, we will compare 
the proportion of patients in each study arm who reported having discussed CKM with their 
provider at T2 and T3. Based on prior work, the rate of patient-reported discussion of CKM with 
their health care providers in usual care settings is approximately 3%. The target sample size 
(n=76) is estimated to provide 80% power (two tailed, a=0.05) to detect an absolute difference of 
25% or more in rates of patient-provider discussion of CKM between the intervention and control 
groups assuming a 30% attrition rate. We will also evaluate the proportion of patients in each 
arm who has documentation in their nephrology clinic notes that CKM was discussed with the 
patient at T2 and T3.  
As a measure of acceptability, we collect attrition rates at T2 and T3. We will further 
assess user experience of the CKM JumpStart by performing a qualitative analysis of post-
intervention interviews with patients and providers, coding for themes elucidating pros, cons and 
other considerations with using the CKM JumpStart Tool and discussion about CKM.  
 
Exploratory outcomes: We will assess change (i.e., T3-T1 and T2-T1) in decision conflict about 
treatment decisions for advanced CKD and quality of communication scores. We will also assess 
change in the proportion of patients who reported receiving goal concordant care at each study 
time point based on patients. 
5.7 Withdrawal of Subjects 
Subjects will be informed during the consent process and at each study visit that they can 
choose to withdraw from the study at any point in time.  
 
There are no anticipated circumstances under which subjects will be withdrawn from the 
research without their consent. There are no anticipated consequences of a subject's decision to 
withdraw from the research. During data collection, study interviewers will assure participants 
that they can, at any time during the interview, refuse to answer any questions asked of them 
and may at any time elect to withdraw from the study. If a participant elects to withdraw during 
the phone call, the interviewer will immediately end the interview or questionnaires. 
5.0 
Reporting 
We do not anticipate any adverse events that might occur. However, any and all unanticipated 
problems, serious adverse events and protocol deviations will be recorded and reported 
immediately to the study Principal Investigator. Any serious adverse events and/or serious 
problems will be reported to the IRB within 5 business days. Additionally, the ISO and Privacy 
Officer will be notified within one hour of any improper use or disclosure of study data. The 
Principal Investigator will be the monitoring entity responsible for ensuring that all measures 
related to data security and protection of subject privacy and confidentiality are being followed. 
 
Subjects will be informed to contact the PI for all urgent and non-urgent questions and concerns 
at the following: Susan Wong, Phone: 206-277-4376. 
6.0 
Privacy and Confidentiality 
The proposed work will use protected health information. All study personnel who will have 
access to protected health information and/or will be involved in obtaining subject consent will be 
required to complete all necessary training in the protection of human subjects and privacy 

 
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through the Department of Veterans Affairs (VA) Learning University Talent Management 
System (TMS). All study personnel who have access to study and patient data have been 
approved by both the UW and VAPS. 
 
All subjects will be given a unique study ID, and data collected for this study will be associated 
with study IDs only. A separate crosswalk file linking study IDs with personal identifiers will be 
kept separate from data analysis files. Data analysis files will not contain personal identifiers. 
Chart passages containing information about discussion of CKM will be transcribed without 
personal identifiers. All interviews will be transcribed and purged of any personal identifiers by 
the transcriptionist. Data analysis will be conducted using only the de-identified transcripts. 
Patient responses during interviews will also be kept confidential from their providers and close 
persons. Likewise, information shared by close persons will not be shared with patients.  
 
Study data will be aggregated for presentations or publications related to the study in order to 
conceal the identities of subjects. 
7.0 
Communication Plan 
The Head of the Division of Nephrology at each medical center will be notified of any adverse 
events or changes to the study protocol.  
 
9.0      Information Security and Data Storage/Movement 
UW patient data, including recruitment information, audio-recordings of interviews, interview 
transcripts, patient tracking information, and survey responses will be stored at the KRI in secure 
study folders. After recruitment and data collection, deidentified UW patient data will be moved to 
VAPS for final pooled analysis. All analysis will take place at VAPS.  
 
The data flow for UW data is:  
UW patient > VA and UW approved staff > UW servers > deidentified data into VA servers.  
 
VA patient data, including recruitment information, audio-recordings of interviews, interview 
transcripts, patient tracking information, and survey responses, will be stored at VAPS in a 
secure J-drive study folder. No VA patient data will be shared with the UW, and all analysis will 
take place at VAPS.  
 
The data flow for VA data is: 
VA patient > VA and UW approved staff > VA servers 
 
For both UW and VA data, interviews will be digitally audio-recorded and downloaded from 
recording devices to secure study folders using a USB fire cable. After audio-recordings have 
been saved, audio files will be erased from audio-recorders. Audio files of interviews will be 
labeled with study IDs and date of the interview only and will be accessible to the transcriptionist 
through the secure study folder. Transcripts of audio files will be saved as Microsoft Word format 
directly to secure study folders. The transcriptionist will not be permitted to save copies of audio 
files or transcripts onto personal computers or devices.  
 
Survey study data will be assembled using structured forms designed in Microsoft Excel and 
saved in secure study folders. Data will be associated with study IDs only.  

 
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After deidentified UW data is moved to VAPS, all data collected at UW Medicine and VAPS will 
be stored on VACOIN access-protected servers on the J: drive. No VA data will be shared with 
the UW. Please note that although UW protocol is referenced here for informational purposes, 
this protocol only covers VA research activities. UW research activities are covered by UW IRB.  
 
Only VA and UW approved study team members will be authorized to access the study folders 
on the VACOIN secure server. The server is located at:   
 
VA Puget Sound Health Care System 
Office of Information and Technology 
1660 S. Columbian Way 
Building 1, Rm B70 
Seattle, WA  98108 
 
All research records, including the investigator’s research records, must be retained until 
disposition instructions are approved by the National Archives and Records Administration 
(NARA) and are published in VHA's Records Control Schedule (RCS 10-1). (VHA Handbook 
1200.05).  
 
After all data are analyzed and manuscripts summarizing study findings are published (estimated 
2029), all identifiable and crosswalk files will be destroyed. 
 
Data Sharing Plan: 
 
Partial restrictions to the data and/or materials apply: anonymized data for the study will be made 
available to interested parties upon written request and submission of a formal written research 
proposal that has undergone human subjects review. 
10.0 References 
1. USRDS. Annual Data Report, Atlas of Chronic Kidney Disease in the United States. Bethesda, 
Md.: National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney 
Diseases; 2017. 
2. Montez-Rath ME, Zheng Y, Tamura MK, Grubbs V, Winkelmayer WC, Chang TI. 
Hospitalizations and Nursing Facility Stays During the Transition from CKD to ESRD on Dialysis: 
An Observational Study. J Gen Intern Med 2017;32:1220-7. 
3. Wong SP, Kreuter W, O'Hare AM. Healthcare intensity at initiation of chronic dialysis among 
older adults. J Am Soc Nephrol 2014;25:143-9. 
4. Purnell TS, Auguste P, Crews DC, et al. Comparison of life participation activities among 
adults treated by hemodialysis, peritoneal dialysis, and kidney transplantation: a systematic 
review. Am J Kidney Dis 2013;62:953-73. 
5. Jassal SV, Chiu E, Hladunewich M. Loss of independence in patients starting dialysis at 80 
years of age or older. New England Journal of Medicine 2009;361:1612-3. 

 
Page 16 of 19 
A Pilot Study of The CKM JumpStart Tool 
Protocol 
2.15.2023 
6. Kurella Tamura M, Covinsky KE, Chertow GM, Yaffe K, Landefeld CS, McCulloch CE. 
Functional status of elderly adults before and after initiation of dialysis. N Engl J Med 
2009;361:1539-47. 
7. Kidney Disease: Improving Global O. KDIGO 2012 Clinical Practice Guidelines for the 
Evaluation and Management of Chronic Kidney Disease. Kidney Int 2012;3. 
8. Murtagh FE, Marsh JE, Donohoe P, Ekbal NJ, Sheerin NS, Harris FE. Dialysis or not? A 
comparative survival study of patients over 75 years with chronic kidney disease stage 5. 
Nephrol Dial Transplant 2007;22:1955-62. 
9. Smith C, Da Silva-Gane M, Chandna S, Warwicker P, Greenwood R, Farrington K. Choosing 
not to dialyse: evaluation of planned non-dialytic management in a cohort of patients with end-
stage renal failure. Nephron Clin Pract 2003;95:c40-6. 
10. Chandna SM, Da Silva-Gane M, Marshall C, Warwicker P, Greenwood RN, Farrington K. 
Survival of elderly patients with stage 5 CKD: comparison of conservative management and 
renal replacement therapy. Nephrol Dial Transplant 2011;26:1608-14. 
11. Verberne WR, Geers AB, Jellema WT, Vincent HH, van Delden JJ, Bos WJ. Comparative 
Survival among Older Adults with Advanced Kidney Disease Managed Conservatively Versus 
with Dialysis. Clin J Am Soc Nephrol 2016;11:633-40. 
12. Shum CK, Tam KF, Chak WL, Chan TC, Mak YF, Chau KF. Outcomes in older adults with 
stage 5 chronic kidney disease: comparison of peritoneal dialysis and conservative 
management. J Gerontol A Biol Sci Med Sci 2014;69:308-14. 
13. Rouveure AC, Bonnefoy M, Laville M. [Conservative treatment, hemodialysis or peritoneal 
dialysis for elderly patients: The choice of treatment does not influence the survival]. Nephrol 
Ther 2016;12:32-7. 
14. Da Silva-Gane M, Wellsted D, Greenshields H, Norton S, Chandna SM, Farrington K. Quality 
of life and survival in patients with advanced kidney failure managed conservatively or by 
dialysis. Clin J Am Soc Nephrol 2012;7:2002-9. 
15. Yong DS, Kwok AO, Wong DM, Suen MH, Chen WT, Tse DM. Symptom burden and quality 
of life in end-stage renal disease: a study of 179 patients on dialysis and palliative care. Palliat 
Med 2009;23:111-9. 
16. Seow YY, Cheung YB, Qu LM, Yee AC. Trajectory of quality of life for poor prognosis stage 
5D chronic kidney disease with and without dialysis. Am J Nephrol 2013;37:231-8. 
17. Davis JL, Davison SN. Hard choices, better outcomes: a review of shared decision-making 
and patient decision aids around dialysis initiation and conservative kidney management. Curr 
Opin Nephrol Hypertens 2017;26:205-13. 
18. Hussain JA, Flemming K, Murtagh FE, Johnson MJ. Patient and health care professional 
decision-making to commence and withdraw from renal dialysis: a systematic review of 
qualitative research. Clin J Am Soc Nephrol 2015;10:1201-15. 

 
Page 17 of 19 
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Protocol 
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19. Song MK, Lin FC, Gilet CA, Arnold RM, Bridgman JC, Ward SE. Patient perspectives on 
informed decision-making surrounding dialysis initiation. Nephrol Dial Transplant 2013;28:2815-
23. 
 
 
1. 
Wong SPY, Rubenzik T, Zelnick L, et al. Long-term Outcomes Among Patients With 
Advanced Kidney Disease Who Forgo Maintenance Dialysis: A Systematic Review. JAMA Netw 
Open. Mar 1 2022;5(3):e222255. doi:10.1001/jamanetworkopen.2022.2255 
2. 
Shum CK, Tam KF, Chak WL, Chan TC, Mak YF, Chau KF. Outcomes in older adults 
with stage 5 chronic kidney disease: comparison of peritoneal dialysis and conservative 
management. J Gerontol A Biol Sci Med Sci. Mar 2014;69(3):308-14. doi:10.1093/gerona/glt098 
3. 
van Loon IN, Goto NA, Boereboom FTJ, Verhaar MC, Bots ML, Hamaker ME. Quality of 
life after the initiation of dialysis or maximal conservative management in elderly patients: a 
longitudinal analysis of the Geriatric assessment in OLder patients starting Dialysis (GOLD) 
study. BMC Nephrol. Mar 29 2019;20(1):108. doi:10.1186/s12882-019-1268-3 
4. 
Verberne WR, Dijkers J, Kelder JC, et al. Value-based evaluation of dialysis versus 
conservative care in older patients with advanced chronic kidney disease: a cohort study. BMC 
Nephrol. Aug 16 2018;19(1):205. doi:10.1186/s12882-018-1004-4 
5. 
Wong SP, Yu MK, Green PK, Liu CF, Hebert PL, O’Hare AM. End-of-life care for patients 
with advanced kidney disease in the US Veterans Affairs Health Care System, 2000-2011. 
American Journal of Kidney Diseases. 2018:(in press). doi:10.1053/j.ajkd.2017.11.007 
6. 
Carson RC, Juszczak M, Davenport A, Burns A. Is maximum conservative management 
an equivalent treatment option to dialysis for elderly patients with significant comorbid disease? 
Clin J Am Soc Nephrol. Oct 2009;4(10):1611-9. doi:10.2215/CJN.00510109 
7. 
Kwok AO, Yuen SK, Yong DS, Tse DM. The Symptoms Prevalence, Medical 
Interventions, and Health Care Service Needs for Patients With End-Stage Renal Disease in a 
Renal Palliative Care Program. Am J Hosp Palliat Care. Dec 2016;33(10):952-958. 
doi:10.1177/1049909115598930 
8. 
Verberne WR, Ocak G, van Gils-Verrij LA, van Delden JJM, Bos WJW. Hospital 
Utilization and Costs in Older Patients with Advanced Chronic Kidney Disease Choosing 
Conservative Care or Dialysis: A Retrospective Cohort Study. Blood Purif. 2020;49(4):479-489. 
doi:10.1159/000505569 
9. 
Smith C, Da Silva-Gane M, Chandna S, Warwicker P, Greenwood R, Farrington K. 
Choosing not to dialyse: evaluation of planned non-dialytic management in a cohort of patients 
with end-stage renal failure. Nephron Clin Pract. 2003;95(2):c40-6. doi:10.1159/000073708 
10. 
Wong SPY, Boyapati S, Engelberg RA, Thorsteinsdottir B, Taylor JS, O'Hare AM. 
Experiences of US Providers in the Delivery of Conservative Care to Patients With Advanced 
Kidney Disease: A National Qualitative Study. Am J Kidney Dis. Sep 27 
2019;doi:10.1053/j.ajkd.2019.07.006 
11. 
Neumann ME. Medical management without dialysis offers alternative therapy. 
Nephrology News & Issues. 2021;35(January 2020):18-21.  
12. 
Song MK, Lin FC, Gilet CA, Arnold RM, Bridgman JC, Ward SE. Patient perspectives on 
informed decision-making surrounding dialysis initiation. Nephrol Dial Transplant. Nov 
2013;28(11):2815-23. doi:10.1093/ndt/gft238 
13. 
House TR, Wightman A, Rosenberg AR, Sayre G, Abdel-Kader K, Wong SPY. 
Challenges to Shared Decision Making About Treatment of Advanced CKD: A Qualitative Study 

 
Page 18 of 19 
A Pilot Study of The CKM JumpStart Tool 
Protocol 
2.15.2023 
of Patients and Clinicians. American Journal of Kidney Diseases. 2022;79(5):657-666.e1. 
doi:10.1053/j.ajkd.2021.08.021 
14. 
Murtagh FE, Marsh JE, Donohoe P, Ekbal NJ, Sheerin NS, Harris FE. Dialysis or not? A 
comparative survival study of patients over 75 years with chronic kidney disease stage 5. 
Nephrol Dial Transplant. Jul 2007;22(7):1955-62. doi:10.1093/ndt/gfm153 
15. 
Chandna SM, Da Silva-Gane M, Marshall C, Warwicker P, Greenwood RN, Farrington K. 
Survival of elderly patients with stage 5 CKD: comparison of conservative management and 
renal replacement therapy. Nephrol Dial Transplant. May 2011;26(5):1608-14. 
doi:10.1093/ndt/gfq630 
16. 
Verberne WR, Geers AB, Jellema WT, Vincent HH, van Delden JJ, Bos WJ. Comparative 
Survival among Older Adults with Advanced Kidney Disease Managed Conservatively Versus 
with Dialysis. Clin J Am Soc Nephrol. Apr 7 2016;11(4):633-40. doi:10.2215/CJN.07510715 
17. 
Rouveure AC, Bonnefoy M, Laville M. [Conservative treatment, hemodialysis or 
peritoneal dialysis for elderly patients: The choice of treatment does not influence the survival]. 
Nephrol Ther. Feb 2016;12(1):32-7. Traitement conservateur, hemodialyse ou dialyse 
peritoneale chez le sujet age : le choix du traitement ne modifie pas la survie. 
doi:10.1016/j.nephro.2015.07.473 
18. 
Da Silva-Gane M, Wellsted D, Greenshields H, Norton S, Chandna SM, Farrington K. 
Quality of life and survival in patients with advanced kidney failure managed conservatively or by 
dialysis. Clin J Am Soc Nephrol. Dec 2012;7(12):2002-9. doi:10.2215/CJN.01130112 
19. 
Yong DS, Kwok AO, Wong DM, Suen MH, Chen WT, Tse DM. Symptom burden and 
quality of life in end-stage renal disease: a study of 179 patients on dialysis and palliative care. 
Palliat Med. Mar 2009;23(2):111-9. doi:10.1177/0269216308101099 
20. 
Seow YY, Cheung YB, Qu LM, Yee AC. Trajectory of quality of life for poor prognosis 
stage 5D chronic kidney disease with and without dialysis. Am J Nephrol. 2013;37(3):231-8. 
doi:10.1159/000347220 
21. 
AMA Code of Medical Ethics. American Medical Association; 2001:chap Chapter One: 
Opinions on Patient-Physician Relationships. 
22. 
Ladin K, Pandya R, Kannam A, et al. Discussing Conservative Management With Older 
Patients With CKD: An Interview Study of Providers. Am J Kidney Dis. Jan 31 2018;71(5):627-
635. doi:10.1053/j.ajkd.2017.11.011 
23. 
Wong SPY, McFarland LV, Liu CF, Laundry RJ, Hebert PL, O’Hare AM. Care practices 
for patients with advanced kidney disease who forgo maintenance dialysis. JAMA Intern Med. 
2019;179(3):305-313. doi:10.1001/jamainternmed.2018.6197 
24. 
Breckenridge K, Bekker HL, Gibbons E, et al. How to routinely collect data on patient-
reported outcome and experience measures in renal registries in Europe: an expert consensus 
meeting. Nephrol Dial Transplant. Oct 2015;30(10):1605-14. doi:10.1093/ndt/gfv209 
25. 
Curtis JR, Wenrich MD, Carline JD, Shannon SE, Ambrozy DM, Ramsey PG. 
Understanding physicians’ skills at providing end-of-life care: perspectives of patients, families, 
and healthcare workers. J Gen Intern Med. 2001;16(41-49) 
26. 
Wenrich MD, Curtis JR, Shannon SE, Carline JD, Ambrozy DM, Ramsey PG. 
Communicating with dying patietns within the spectrum of medical care from terminal diagnosis 
to death. Arch Intern Med. 2001;161:868-874.  
27. 
Engelberg R, Downey L, Curtis JR. Psychometric characteristics of a quality of 
communication questionnaire assessing communication about end-of-life care. J Palliat Med. 
2006;9(1086-98)(5) 
28. 
Legere F, Kearing S, Clay K, et al. Are you SURE? Assessing patient decisional conflict 
with a 4-item screening test. Cam Fam Physician. 2010;56:e308-14.  

 
Page 19 of 19 
A Pilot Study of The CKM JumpStart Tool 
Protocol 
2.15.2023 
29. 
Ferron Parayre A, Labrecque M, Rousseau M, Turcotte S, Legare F. Validation of SURE, 
a four-item clinical checklist for detecting decisional conflict in patients. Med Decis Making. Jan 
2014;34(1):54-62. doi:10.1177/0272989X13491463 
30. 
Denger LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 
1997;29(3):21-43.