Home-based Conservative Care Model for Advanced Kidney Disease
Phase: NA
Conditions: Chronic Kidney Diseases
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
Home-based Conservative Care Model for Advanced Kidney Disease 
 
MIRB # 1710063 
Funding Agency: VA Health Services Research & Development  
(IIR 21-061; 01HX003446-01A2) 
 
Principal Investigator: Susan P.Y. Wong, MD 
4/1/2024 
 
 
 
 

 
Page 2 of 18 
 
Abstract 
Objective(s) and Hypotheses: 
Conservative care (CC) is an important therapeutic option for Veterans who do not wish to 
pursue maintenance dialysis for their advanced chronic kidney disease (CKD) and offers a 
whole-person, multidisciplinary approach to care that is focused on slowing disease progression, 
active symptom management, advance care planning, and provision of appropriate palliative 
care. Recent evidence from observational studies of CC programs in other developed countries 
indicate that for older patients (aged ≥75 years) with significant comorbidity and functional 
limitation, dialysis may not meaningfully lengthen survival or improve quality of life beyond what 
can be achieved with CC. Although 1 in 7 Veterans with advanced CKD do not pursue dialysis, 
there are no formal CC programs within the VA and few, if any, concerted efforts to establish 
these programs in non-VA settings. While formal CC programs do not currently exist in the VA, 
many of the elements of CC programs found in other developed countries and that are desirable 
to Veterans, families, and healthcare providers can be found in the VA’s Home-Based Primary 
Care (HBPC) program. HBPC provides home-based multidisciplinary primary care to Veterans 
with multimorbidity and functional limitation with the goal of supporting Veterans’ quality of life 
and mitigating the complications of illness through to the end of life. The investigators 
hypothesize that HBPC serves as the ideal starting ground to build the VA’s first CC program for 
Veterans with advanced CKD. 
 
Research Design: 
The investigators will conduct a randomized pilot trial of 30 Veterans with advanced CKD, their 
caregivers, and clinicians to assess the feasibility and acceptability of a novel CC Program, 
called “Kidney Care at Home Program” for advanced CKD delivered through the existing 
infrastructure of the HBPC program at VA Puget Sound Health Care System (VAPS). 
 
Methodology: 
The investigators will use implementation science and ethnographic research methods, including 
field observations, interviews, medical record review, and serial surveys to assess the feasibility 
and acceptability of the Kidney Care at Home Program vs. usual care among Veterans, 
caregivers, and clinicians. 
 
 
 

 
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List of Abbreviations 
 
BEDSCN: bed section 
CC: conservative care 
CKD: chronic kidney disease 
HBPC: Home-based Primary Care 
MDC: Multi-disciplinary care 
UW: University of Washington 
VAPS: VA Puget Sound Health Care System, Seattle WA 
VACOIN: VA Center of Innovation for Veteran-centered and Value-driven Care, Seattle WA.  
 
 
 
 

 
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Contents 
Protocol Title: Home-based conservative care model for advanced kidney disease .................... 5 
1.0 
Study Personnel ................................................................................................................. 5 
2.0 
Introduction ........................................................................................................................ 5 
3.0 
Objectives .......................................................................................................................... 6 
4.0 
Resources and Personnel .................................................. Error! Bookmark not defined. 
5.0 
Study Procedures .............................................................................................................. 6 
5.1 Study Design ..................................................................................................................... 6 
5.2 Recruitment Methods ........................................................................................................ 7 
5.3 Informed Consent .............................................................................................................. 8 
5.4 Inclusion/Exclusion Criteria ............................................................................................... 9 
5.5 Interventions .................................................................................................................... 10 
5.6 Study Evaluations ............................................................................................................ 11 
5.7 Data Analysis ................................................................................................................... 13 
5.8 Withdrawal of Subjects .................................................................................................... 14 
5.9 Potential Risks and Benefits ............................................................................................ 14 
6.0 
Reporting ......................................................................................................................... 15 
7.0 
Privacy and Confidentiality ............................................................................................... 15 
8.0  
Information Security and Data Storage/Movement .......................................................... 15 
9.0 
References ....................................................................................................................... 16 
 
 
 

 
Page 5 of 18 
 
 
 
Protocol Title: Home-based conservative care model for advanced kidney 
disease  
 
 
 
 
 
1.0 
Study Personnel 
 
Principal Investigator:  
Susan P. Y. Wong, M.D.  
Core Investigator, VA Center of Innovation for Veteran-centered and Value-driven Care 
(VACOIN) 
Staff Nephrologist, VA Puget Sound Health Care System (VAPS)  
Associate Professor of Medicine, University of Washington (UW) 
 
Co-Investigators:  
Stephanie Wheeler, MD MPH 
Medical Director for the Home-based Primary Care Program at VAPS  
 
Daniel Lam, MD 
Associate Professor of Medicine, UW 
 
Research Personnel 
Rachel Smith, BA 
Research Coordinator, VACOIN 
 
Olivia Gaughran, MA 
Research Coordinator, VACOIN 
 
Marieke van Eijk, PhD 
Senior Ethnographer, VACOIN/UW 
 
Taryn Oestreich, MPH 
Program Manager, VACOIN 
 
David Prince, PhD 
Biostatistician, UW 
 
2.0 
Introduction 
 
Chronic kidney disease (CKD) is a progressive life-limiting illness that afflicts 1 in 3 older 
Veterans aged ≥65 years.1 The care needs of patients with advanced CKD exceed those of most 
other patients with chronic illness2 and are attributable to their high burden of comorbidity3 and 
symptoms,4 frequent hospitalization5 and progressive loss of physical and cognitive function.6,7 
Although maintenance dialysis can extend survival in many patients with advanced CKD, dialysis 
also often demands significant lifestyle changes and frequent interaction with the healthcare 
system to manage the complications of illness and the treatment itself.5  

 
Page 6 of 18 
 
 
Conservative care (CC) is a multidisciplinary approach to caring for patients with advanced CKD 
who do not wish 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.8 
Recent evidence from observational studies of formal CC programs in other developed countries 
indicate that for older patients (aged ≥75 years) with significant comorbidity and functional 
limitation, dialysis may not meaningfully lengthen survival9 or improve quality of life10  beyond 
what can be achieved with CC. 
 
There are no formal CC programs within the VA and few, if any, concerted efforts to establish 
such programs in non-VA settings.11 In this context, it is not surprising that, regardless of age or 
comorbid burden, the vast majority (85.5%) of Veterans with advanced CKD are preparing for or 
are treated with dialysis.12 When decisions to forgo dialysis do occur, they tend to unfold in a 
chaotic manner, late in the illness trajectory, and with only a minority (38.7%) of Veterans 
enrolling in hospice.13,14 
 
Many of the elements of CC programs found in other developed countries8 and considered 
desirable by Veterans, their families and nephrologists11,15 can be found in the VA’s Home-Based 
Primary Care (HBPC) program. HBPC provides Veterans with multidisciplinary (MDC) primary 
care in their home through to the end of life.16 HBPC enrollees are not necessarily home-bound, 
but do have the kind of complex multimorbidity and functional limitations that are common among 
Veterans with advanced CKD.16 HPBC may reduce Veterans’ hospital, nursing home and 
emergency room use and increase their satisfaction with VA care.17 Missing from available data  
is guidance on how HBPC can improve CKD-specific outcomes.  
 
The investigators hypothesize that the MDC framework of HBPC serves as the ideal starting 
ground to build our nation’s first CC program for Veterans with advanced CKD.  
3.0 
Objectives 
The investigators aim to assess the feasibility and acceptability of a novel CC program, called 
the Kidney Care at Home Program, delivered through the HBPC infrastructure at VAPS among 
Veterans with advanced CKD, their caregivers and clinicians and explore preliminary outcomes 
of this CC Program. The investigators hypothesize that our HBPC-based CC model will be 
feasible and acceptable to Veterans, their caregivers, and clinicians. 
4.0 
Research Sites 
 
This study will involve VAPS. Study subjects will be recruited from VAPS. Original study data will 
be stored at the VACOIN. All data analyses will occur at VACOIN.  
5.0 
Study Procedures 
5.1 Study Design 
The investigators will conduct a randomized pilot study of Veterans with advanced CKD receiving 
care at the VAPS, their caregivers and VA clinicians to assess the feasibility and acceptability of 
usual care versus the Kidney Care at Home Program in caring for patients who do not wish to 
pursue maintenance dialysis. The investigators will use the RE-AIM implementation science 

 
Page 7 of 18 
 
framework and ethnographic research methods, including field observations of clinical 
encounters related to their kidney disease, qualitative interviews, serial surveys, and document 
review. Implementation science frameworks facilitate identification and understanding of the 
factors that promote uptake, practice, and effectiveness of an innovation (i.e. CC). RE-AIM 
categorizes factors into 5 domains: 1) Reach; 2) Effectiveness; 3) Adoption; 4) Implementation, 
and; 5) Maintenance.18 Ethnography is an immersive form of qualitative inquiry that supports a 
comprehensive “insider’s” understanding of a phenomenon as it is experienced and the 
“ecosystem” in which care is delivered through multiple data sources and perspectives.19 It also 
supports elucidation of processes, such as Veteran-caregiver-clinician dynamics, clinical 
workflow, and workgroup cultures, that are difficult to capture using objective measures but that 
are crucial to understanding the pros and cons of different care approaches and environments 
that might lead to observed health outcomes. 
5.2 Recruitment Methods 
Veterans: The investigators will access the electronic medical records of patients to identify 
eligible Veterans for this study and to obtain their name and contact information to contact 
eligible patients for recruitment purposes. A study team member will pre-screen medical records 
to identify those for documentation in clinical progress notes indicate that the Veteran does not 
wish to pursue dialysis. The investigators will contact patients’ VA primary care +/- nephrology to 
inform them that their patient has been identified as eligible for the study and to arrange a time to 
discuss the study, confirm whether the Veteran does not wish to pursue dialysis, and to inquire 
whether they agree to the Veterans’ participation in the study. If the provider judges that the 
Veteran is not suitable for the study, the investigators will not approach the patient. Patients will 
not otherwise be informed about the study, and would not be able to indicate their wish to join the 
study. Using flyers and faculty meetings, the investigators will also notify VA primary care 
providers and nephrologists about the study and invite them to refer any eligible Veterans not 
identified through chart review. The investigators will mail all potential Veterans a letter that 
introduces the study followed by a phone call to schedule a phone or in-person appointment at 
VAPS or Veteran’s home, per their preference, to discuss the study. During this initial call, the 
investigators will confirm with Veterans their desire not to pursue maintenance dialysis or kidney 
transplant. The investigators anticipate recruiting up to 30 Veterans 
 
Caregivers: The investigators will obtain the name and contact information of up to 1 caregiver 
from each enrolled Veteran to participate in the study. Similar to Veterans, the investigators will 
mail all potential caregivers a letter introducing the study followed by a phone call to discuss the 
study and to schedule a phone or in-person appointment at VAPS or Veteran’s home per their 
preference, to discuss the study. The investigators anticipate recruiting up to 30 caregivers. 
 
Interviewed Clinicians: From each enrolled Veteran, the investigators will obtain the names of VA 
clinicians whom the Veteran has identified as important to their CKD care throughout the 
duration in the study. The investigators will initially approach clinicians by encrypted email 
informing them of their Veterans’ participation in the study and to arrange a time to discuss the 
study and invite them to be interview about their perception of the enrolled Veterans’ kidney care 
experience. Based on our prior similar research, Veterans name 1-3 clinicians who are important 
in their kidney care,20 therefore the investigators anticipate recruiting up to 90 clinicians for 
interviews. The investigators also anticipate that interviewed clinicians might include those in the 
Kidney Care at Home Program if Veterans assigned to the intervention arm desire this. 
Investigators will not be involved in any recruitment or intervention activities. Only study team 
members unassociated in a supervisory relationship with HBPC clinicians will be involved in 
recruitment or study interventions such as interviews or encounter observations. 
 

 
Page 8 of 18 
 
Observed Clinicians: For enrolled Veterans, the investigators will perform field observations of 
their clinical encounters related to care for advanced CKD. Patients will choose which 
encounters they wish observed by a study team member. The investigators will review upcoming 
scheduled clinical encounters with each Veteran and inquire whether they pertain to care of their 
advanced CKD and if a member of the study team can observe the encounter. The investigators 
will also ask Veterans to inform us at their earliest convenience of any ad hoc clinical encounters 
scheduled that they wish to be observed. Whenever possible, the investigators will contact 
clinicians at least 2 days in advance of the encounter to inform them of their patients’ 
participation in the study and of the Veteran’s decision to have study staff accompany him/her to 
observe the encounter. The investigators will also add a read receipt notification to emails and 
secure messages to help ensure that clinicians received our notification about clinical 
observation. Researchers will speak with clinicians just before the encounter to let them know 
about the clinical observation and to confirm that they agree with the observation. Given our prior 
experience with similar research, we anticipate that Veterans will identify encounters from a 
range of 1-5 different medical specialties that are relevant to their kidney care.20 The 
investigators also anticipate that observed clinicians might include those in the Kidney Care at 
Home Program if Veterans assigned to the intervention arm desire that the investigators observe 
these encounters. Investigators will not be involved in any recruitment or intervention activities. 
Only study team members unassociated in a supervisory relationship with HBPC clinicians will 
be involved in recruitment or study interventions such as interviews or encounter observations. 
 
5.3 Informed Consent  
Veterans and Caregivers: During recruitment, the investigators will provide Veterans and 
caregivers the option of reviewing the study in greater depth in-person at VAPS of subject’s 
home. The investigators will use the consent form as a guide to explain the goals of the study, 
the study procedures, and potential risks and benefits. 
To ensure informed consent, the investigators will use a “teach-back” method in which, 
after reviewing the study, The investigators will ask Veterans and caregivers 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 Veterans and caregivers, and 
they will be asked for responses to missed statements for a second time. The investigators will 
repeat this teach-back approach a second time if there are aspects of the study that are still not 
understood by patients and close person. For a Veteran who is unable to provide correct 
answers after teach-back, the investigators will contact their legal surrogate to seek informed 
consent to participate in the study on behalf of the Veteran. Caregivers whose responses to 
statements are still incorrect after 3 rounds would be considered to have inadequate 
understanding of the study and to be ineligible to participate. Patients whose caregivers fail the 
informed consent process can still participate in the study, as Veterans can have multiple 
caregivers and the caregiver whom the Veteran nominates for the study is not necessarily the 
Veteran’s primary caregiver or legal surrogate. If study staff identify any concerns about a 
Veteran’s safety at home, they will be advised to raise this with the PI, who will then inform the 
patient’s primary care provider. Veterans and caregivers who demonstrate understanding of the 
study through teach-back will be asked to provide their written informed consent.  
Veterans and caregivers will be informed that participation is fully voluntary. Throughout 
the study, the investigators will verbally confirm Veterans’ and caregivers’ informed consent to 
participate before engaging in each study procedure. Prior to starting field observations, the 
investigators will also ask Veterans and caregivers if they agree to either audio-recording and/or 
note-taking during the encounter or if they agree to only observation with note-taking after the 
encounter has finished.  
 

 
Page 9 of 18 
 
Interviewed Clinicians: For clinicians identified by Veterans who are involved in their CKD care, 
the investigators will conduct in-depth interviews with them about their perception of the care that 
enrolled Veterans receive for their advanced CKD. The investigators will ask for their verbal 
consent to participate in up to 2 interviews during the duration that Veterans are participating in 
the study. Verbal consent will be captured at the start of the interview audio-recording. 
 
Observed Clinicians: For enrolled Veterans, the investigators will perform field observations of 
their clinical encounters related to care for advanced CKD. At the start of the clinical encounter, 
the investigators will remind clinicians about the Veteran’s decision to have study staff 
accompany him/her to observe the encounter and inform clinicians of what form of observation 
that the Veteran prefers (i.e. audio-recording and/or note-taking during the encounter or only 
observation with note-taking after the encounter has finished). The investigators will ask for 
clinicians’ verbal consent to observe the encounter. After the encounter and as needed, the 
investigators will request clinicians’ permission to ask clarifying questions regarding 
conversations or interactions during the encounter.  
If Veterans prefer audio-recording and/or note-taking during the encounter but clinicians 
are not agreeable to this, then the investigators will only observe the encounter and record notes 
after the encounter has finished. If clinicians do not agree to being observed, the investigators 
will inform the Veteran of this preference and will not observe the encounter.  
 
Other Persons: It is possible that during field observations of clinical encounters, persons other 
than enrolled participants, such as medical staff and Veterans’ acquaintances, may unexpectedly 
join the encounter and be present during conversations or interactions. If this should occur and if 
it does not disrupt the encounter, the investigators will notify the other person during the 
encounter that it is being observed by a study team member and what kind of observation is 
being performed (i.e. audio-recording and/or note-taking during the encounter or only 
observation with note-taking after the encounter). If introducing the study and study team 
member to the other person would disrupt the encounter, the investigators will notify the other 
person immediately after the encounter has been finished that it was observed by a study team 
member and what kind of observation was performed. The investigators will ask for other 
persons’ verbal consent to retain any de-identified data collected during the encounter.  
5.4 Inclusion/Exclusion Criteria 
Patients: 
Inclusion Criteria 
• 
Receives primary +/- nephrology care from VAPS as defined as having at least 1 
outpatient primary or nephrology visit in the prior year 
• 
Adults aged ≥18 years 
• 
Advanced CKD as defined as defined as having ³2 outpatient measures of an eGFR ≤20 
ml/min/1.73m2 separated ³90 days 
• 
Unsure or do not wish to undergo maintenance dialysis 
• 
Agreement by their VA primary +/- nephrology care provider that patients can participate 
in the study 
Exclusion Criteria 
• 
Unable to complete “teach-back” method of informed consent 
• 
Currently receiving maintenance dialysis 
• 
Currently enrolled in HBPC Program 
 
Caregivers: 
Inclusion Criteria 

 
Page 10 of 18 
 
• 
Adults aged ≥18 years 
• 
Nominated by enrolled patient as a caregiver whom patient agrees to participate in the 
study 
Exclusion Criteria 
• 
Unable to complete “teach-back” method of informed consent 
 
A Veteran who does not identify a caregiver or whose nominated caregiver does not wish to 
participate in the study, the Veteran is still eligible to participate in the study. If a Veteran 
withdraws from the study, their caregivers’ participation in the study is also terminated at that 
time. 
 
Clinicians: 
Inclusion Criteria 
• 
Employed at VAPS 
• 
Identified by enrolled Veterans as important to their CKD and nominated by the Veteran 
to be interviewed for the study 
Exclusion Criteria 
• 
None 
 
For a Veteran who does not identify a clinician or whose nominated clinician does not wish to 
participate in an interview, the Veteran will still be eligible to participate in the study. If a Veteran 
withdraws from the study, their clinicians will no longer be eligible to participate in interviews.  
5.5 Interventions 
For each consecutively enrolled Veteran, the investigators will randomly assign the Veteran and 
their caregiver to either usual care (i.e., control arm) or to the Kidney Care at Home Program 
(i.e., intervention arm). Randomization to each study arm will be computer generated with a 1:1 
allocation. 
 
Usual Care: Veterans with advanced CKD are typically cared for by a VAPS primary care 
provider. Additionally, they might receive specialty nephrology care at the VA. Enrolled Veterans 
who are assigned to usual care will continue to receive the care they had been receiving for their 
CKD by their primary care +/- nephrology provider. 
 
Intervention: Enrolled Veterans and their caregivers who are assigned to the intervention will be 
enrolled in the Kidney Care at Home Program. The Program will be delivered through the 
existing HBPC infrastructure at VAPS. The HBPC Program at VAPS is comprised of 8 HBPC 
teams, and each team is comprised on a lead physician or nurse practitioner, nurse, pharmacist, 
nutritionist, social worker, psychologist, therapist, and chaplain. Veterans will be assigned to the 
HBPC team serving their residential area. As is the standard of care for HBPC services, each 
member of their HBPC team that will perform an initial assessment of each Veteran within 3-
months of randomization. This includes review of each Veteran’s medical history and 
assessment of unmet medical and psychosocial needs. Additionally, the HBPC team will perform 
a focused CKD symptom assessment. On a monthly basis, the entire HBPC team will conduct 
MDC meetings to review each Veteran’s active medical issues, recent hospitalizations, and 
emergency room visits, psychosocial needs, and medical plan.  
At a minimum, subsequent clinical encounters and assessments for each Veteran will be 
scheduled no less than on a quarterly basis and more often as needed based on the HBPC 
team’s clinical judgment. The HBPC team will also treat identified problems and make 
appropriate referrals according to their discretion and clinical judgment. The HBPC Team will 

 
Page 11 of 18 
 
also have the freedom to change the frequency of their visits and the different team members 
involved in a patient’s care according to their clinical judgement. 
All clinical encounters, phone contact, and correspondence between a Veteran and any 
HBPC team member as part of the Program will be documented in the VA electronic medical 
record. Notes from monthly MDC meetings will also be documented in the medical record. The 
investigators will also be available between MDC meetings for urgent patient care-related 
questions. 
Because the Program will provide both primary and nephrology care, enrolled Veterans 
will transfer their primary +/- nephrology care to the CC Program. The CC Program will also 
continue to follow Veterans through hospital and nursing home admissions and to care for 
Veterans if they should change their minds and start dialysis and/or return to CC after a trial of 
dialysis so as to support care flexibility and continuity. Should Veterans withdraw from the study, 
the Program will assist the Veteran with returning to their original primary care +/- nephrologist. 
After Veterans complete the study, they will be given the option to continue with the Program for 
ongoing primary and CC until they no longer desire it or to return to their original primary care +/- 
nephrologist.  
The investigators will oversee implementation of the Program. In addition to the usual 
primary care provided by HBPC services, the Program will provide CC to enrolled subjects. The 
Program will incorporate the following CC care: patient-centered, whole-person and team-based 
care, shared decision-making, active symptom management, advance care planning and end-of-
life care.15 Specific care items reflecting these CC elements will draw from the clinical expertise 
of the investigative team, CC educational materials prepared by the investigative team, 
international consensus statements on CC best practices,21 publicly available provider and 
patient resources on CC, and existing patient resources on related topics of kidney disease, self-
care, and home and community-based resources that support Veterans’ independence at home 
from the VA Kidney, Whole Health, and GEC Programs. 
5.6 Study Evaluations 
The investigators will use a combination of surveys, interviews, field observations, and medical 
record review to compare usual care and the Kidney Care at Home Program. Subjects will be 
followed through death, study withdrawal, or 1-year follow-up, whichever comes first. Subjects 
will be asked to complete the following procedures at enrollment and every 3 months (+/- 1 
month) following randomization. Veterans and caregivers will receive a $40 incentive for each 
study visit that they complete (total of $200). Clinicians will not be provided compensation for 
their participation. 
 
Surveys:  
Demographic survey: At enrollment, Veterans and caregivers will be asked to complete a brief 
survey to collect information about their age, race, ethnicity gender, educational background, 
marital status, employment status, and annual household income. Each caregiver will also be 
asked their relationship to the Veteran, hours spent caregiving for the Veteran per week, and 
types of caregiving provided to the Veteran. For clinicians who participate in interviews, The 
investigators will ask their age, race, gender, professional role, year in clinical practice, and 
medical specialty.  
 
Health Outcomes Prioritization Scale: At each study visit, The investigators will ask Veterans 
about their preference for care to be directed at maintaining independence, maximizing longevity, 
reducing or eliminating pain, and reducing or eliminating dizziness, fatigue, and shortness of 
breath using the Health Outcomes Prioritization Scale.22 Veterans will also be asked whether 
they view the care they receive for their kidney disease as focused more on independence, 
longevity, pain relief, or relief of other symptoms. The language using in the Scale will be slightly 

 
Page 12 of 18 
 
adapted to support a 7th grade literacy level. The investigators will slightly adapt the Scale for 
caregivers to inquire their perception of patients’ healthcare priorities and the kind of care that 
patients receive.  
 
Zarit Burden Interview: With caregivers at each study visit, the investigators will administer a 12-
item survey that asks caregivers to rate the frequency with which they experience different forms 
of caregiver strain (nearly always).23   
 
Consultation Satisfaction Questionnaire: With Veterans and caregivers at each study visit, The 
investigators will administer a 17-item survey that asks raters about their level of agreement with 
statements about overall care, professionalism, communication, time spent and depth of the 
relationship with the clinicians involved in their kidney care, based on the last clinical visit.24 For 
Veterans and caregivers randomized to usual care, participants will be asked about care 
provided by their primary care provider and/or nephrologist. For Veterans and caregivers 
randomized to the intervention, participants will be asked about care provided by their Kidney 
Care at Home Program clinician. 
 
Edmonton Symptom Assessment Scale: At each study visit, Veterans will be asked about 10 
common physical and emotional symptoms of advanced CKD.25 
 
EuroQol 5D: At each study visit, Veterans will be asked to complete a 5-item survey inquiring 
difficulty with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on 5-
point scale. A 6th item asks patients to rate their overall health along a 0-100 visual analogue 
scale (higher scores indicating greater perceived health).26  
 
Clinicians important to kidney care: At each study visit, the investigators will ask each Veteran 
the names of VA clinicians whom they perceive as important to their kidney care and whom they 
would allow us to interview to learn more about their experiences caring for the Veteran. The 
investigators will use the local VAPS address book to obtain their contact email and phone 
number. 
 
Enrollment and attrition: The investigators will record reasons why eligible Veterans’ primary care 
+/- nephrology provider did not agree to recruitment of Veterans to participate in the study. The 
investigators will also record reasons for refusal to participate in the study by eligible Veterans. 
The investigators will ask enrolled subjects who withdraw from the study their reasons for 
withdrawal. 
 
Interviews: 
Veteran and caregiver interviews: At each study visit, Veterans and caregivers in each study arm 
will be invited to complete a 45- to 60-minute interview to ascertain their experiences with and 
perspectives on their kidney care. Approach to inquiry will be informed by the RE-AIM 
Framework and will follow a structured guide intended to elicit participants’ perspectives on: 1) 
reach; 2) effectiveness; and 3) implementation of respective approaches to care. Distinct 
interview guides will be used for participants initial interview, subsequent interviews, and final 
interviews during the study period. Non-specific probes will be used to prompt subjects to 
elaborate on their responses for greater depth and detail. Veterans and caregivers will be 
interviewed separately, in private, and in-person or by phone according to each person’s 
preference. All interviews will be audio-recorded then transcribed without personal identifiers. 
 
Clinician interviews: For clinicians who were nominated by enrolled Veterans to participate in 
interviews, the investigators will ask clinicians to complete a 30-minute interview by phone or 

 
Page 13 of 18 
 
securing messaging to ascertain their experiences with and perspectives on the Veterans’ kidney 
care using an interview guide similar to that for Veterans and caregivers. All interviews will be 
audio-recorded then transcribed without personal identifiers.  
 
Field Observations: At each study visit, the investigators will review with Veterans their upcoming 
VA clinical appointments and ask if they are related to their kidney disease and if the 
investigators can observe the clinical encounter. These clinical encounters can include face-to-
face, telephone, and video encounters. The investigators will also remind Veterans that they may 
contact us between study visits about any ad hoc clinical appointments related to their kidney 
disease that were scheduled and that they wish to be observed.  
For each observed encounter, the investigators will record the date of the encounter, 
encounter setting (e.g. home, clinic), and duration of the encounter. The investigators will also 
record persons present during the encounter based on their professional (e.g. nephrologist) or 
personal (e.g. caregiver) relationship to the Veteran. During the encounter, study staff will either 
digitally audio-record and/or note-take conversations and interactions or only observe and note-
take after the encounter per each subject’s preference. After the encounter is complete, the 
investigators will debrief with subjects about the encounter and ask subjects clarifying questions 
about the encounter as needed using a semi-structured guide. Notes will be transcribed into a 
Word document without any personal identifiers. Audio files will also be transcribed verbatim 
onto a Word document without personal identifiers. 
 
Medical Record Review:  
Progress Notes: The investigators will review all the clinical progress notes entered into each 
Veteran’s electronic medical record during follow-up and abstract passages documenting care 
considerations regarding CKD. Any abstracted text will be purged of personal identifiers and 
recorded into a Word document. The investigators will record the date, note title, clinical setting 
(e.g. emergency room), and provider type (e.g. nephrologist) from which passages were 
abstracted. The investigators will also review scanned healthcare documents, including advance 
directives, portable medical orders (e.g. POLST forms), and outside medical records, available in 
Veterans’ medical record that were completed during the study period and transcribe any 
relevant text without personal identifiers into a Word document. The investigators will record the 
date, note title, clinical setting (e.g. emergency room), and provider type (e.g. nephrologist) from 
which passages were abstracted. 
 
Clinical characteristics: The investigators will abstract relevant diagnoses in the year prior to 
enrollment to calculate a Charlson comorbidity index score.27 During follow-up, the investigators 
will record all measures of Veteran’s eGFR, hemoglobin, serum albumin, weight, blood pressure, 
and electrolytes and the dates during which they were measured. 
 
Healthcare utilization: The investigators will record all hospital, nursing facility, emergency room 
use, and palliative care consultations documented in the medical record during follow-up. The 
investigators will also record any hospice, social work, nutrition, pharmacy, therapist, mental 
health, and chaplaincy referrals and visits during follow-up. 
 
Dialysis status for advanced CKD: The investigators will record whether Veterans changed their 
mind about CC and received dialysis during follow-up. 
 
5.7 Data Analysis 
Feasibility and acceptability: As the primary aim, the investigators will perform an inductive 
thematic analysis28 of all qualitative data collected through interview transcripts, observational 
field notes, and passages from reviewed documents to ascertain the feasibility and acceptability 

 
Page 14 of 18 
 
of approaches to caring for Veterans who are do not wish to forgo dialysis with usual care vs. the 
Kidney Care at Home Program. The investigators will triangulate the qualitative research findings 
with quantitative measures collected that also reflect feasibility and acceptability of care 
approaches. The investigators will describe enrollment and attrition rates, the reasons for refusal 
and withdrawal of study, and care satisfaction scores using proportions and means where 
appropriate. HBPC providers will not actively be sought as the primary target for interviews or 
observed encounters. However, if they are identified as being important to a Veteran’s CKD care, 
acceptability and feasibility from the perspective of HBPC clinicians may be ascertained. 
Participation of HBPC clinicians would be based upon identification by Veterans, rather than their 
role within HPBC.  
 
Exploratory analyses: The investigators will describe healthcare utilization, caregiver burden, 
healthcare goals, perceived care, quality of life, and treatment with dialysis during follow-up using 
proportions and means where appropriate. Level of agreement in perception of healthcare goals 
and goal concordant care between Veterans and caregivers will be reported using the kappa 
statistic.  
5.8 Withdrawal of Subjects 
Subjects may withdraw from the study at any time. The investigators will inform subjects that any 
de-identified data collected prior to their withdrawal will be included in analyses. For Veterans 
who withdraw from the study, The investigators will facilitate their transfer back to the VA primary 
care +/- nephrology provider caring for the Veteran prior to the study. The lead physician or 
nurse practitioner of the HBPC team will contact the Veteran’s prior primary care +/- nephrology 
provider to review the Veteran’s clinical course during their participation in the study, and discuss 
any active clinical issues that requires close follow-up. 
5.9 Potential Risks and Benefits 
Anticipated Risk:  
Discontinuity in care: Veterans randomized to the Kidney Care at Home Program will transfer 
their primary +/- nephrology care from their existing primary care +/- nephrology provider to the 
Program. It can take time for Veterans to become comfortable interacting with a new clinical 
team and for the clinical team to get to know Veterans and familiarize themselves with Veterans’ 
clinical history. This can lead to delays in addressing health problems. To minimize this risk, the 
investigators will arrange that each patient have their first visit with the Program clinicians within 
3-months of enrollment in the Program. The lead physician or nurse practitioner of each 
Veteran’s HBPC team will also contact each Veterans’ primary care +/- nephrology provider to 
inform them of the date of their first visit with the Program clinicians and to obtain any pertinent 
history or active medical issues that require close monitoring at the outset of patients’ 
participation in the Program. These measures will help to ensure continuity in care for patients.  
 
Emotional or psychological unease: Subjects might feel uncomfortable during interviews 
discussing their care experience or when observed during encounters. To minimize this risk, 
throughout the course of the study and with each study visit, The investigators will verbally 
confirm their consent before undertaking each interview and survey and being observed. The 
investigators will assure subjects that they can choose not to answer any questions or complete 
any study procedure that they are not comfortable with. The investigators will also assure 
subjects that they can choose not to be observed.  
 
Potential Benefits: The Kidney Care at Home Program will be the first evidence-based CC 
program for Veterans with advanced CKD in the VA, if not the nation. Veterans and caregivers 
randomized to receive care through the Program may derive benefit from receipt of CC. 

 
Page 15 of 18 
 
Clinicians involved will receive formal training in CC, which may enhance clinical services for 
Veterans beyond those who participate in this study. The findings of this study will also inform 
how usual care services could also be improved for Veterans who do not wish to undergo 
dialysis and the caregivers and clinicians who support them. Completion of surveys and 
participation in interviews may encourage Veterans, caregivers, and clinicians to reflect on the 
meaning of their own care experiences which may be beneficial to them in and of itself. 
6.0 
Reporting 
The investigators 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 
. 
7.0 
Privacy and Confidentiality 
The proposed work requires the collection of 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 through the Department of Veterans Affairs (VA) Learning 
University Talent Management System (TMS) and Collaborative Institutional Training Initiative 
(CITI) Program. 
 
To safeguard against potential loss of confidentiality, 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 in separate from data analysis files. Data 
analysis files will not contain personal identifiers. Data analysis will be conducted using only the 
de-identified data files. 
 
Veteran, caregiver, and clinician interview and survey responses will also be kept confidential 
and not shared with each other or anyone outside the study team. Study data will be aggregated 
for presentations or publications related to the study in order to conceal the identities of subjects. 
 
The Head of the Division of Nephrology will be notified of any adverse events or changes to the 
study protocol.  
8.0  Information Security and Data Storage/Movement 
All analysis will take place at VAPS. All study data will be stored on local secure servers at VAPS 
in a secure J-drive study folder.  
 
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 
 

 
Page 16 of 18 
 
Digitally audio-recorded interviews and clinical encounters will be downloaded from recorders 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. Study staff responsible for transcription of audio files will not be permitted to save copies 
of audio files or transcripts onto personal computers or devices.  
 
Structured study data will be assembled using Microsoft Excel forms and saved in secure study 
folders. Medical record abstraction and field observation notes will be assembled using Microsoft 
Word documents and saved in secure study folders.  
 
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. 
9.0 
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