The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis.

The HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis (HOPE Trial) is a multicenter randomized trial addressing chronic pain among patients receiving maintenance hemodialysis for end-stage kidney disease. The trial uses a sequential, multiple assignment design with a randomized component for all participants (Phase 1) and a non-randomized component for a subset of participants (Phase 2). During Phase 1, participants are randomized to Pain Coping Skills Training (PCST), an intervention designed to increase self-efficacy for managing pain, or Usual Care. PCST consists of weekly, live, coach-led cognitive behavioral therapy sessions delivered by video- or tele-conferencing for 12 weeks followed by daily interactive voice response sessions delivered by telephone for an additional 12 weeks. At 24 weeks (Phase 2), participants in both the PCST and Usual Care groups taking prescription opioid medications at an average dose of ≥20 morphine milligram equivalents per day are offered buprenorphine, a partial opioid agonist with a more favorable safety profile than full-agonist opioids. All participants are followed for 36 weeks. The primary outcome is pain interference ascertained, for the primary analysis, at 12 weeks. Secondary outcomes include additional patient-reported measures and clinical outcomes including falls, hospitalizations, and death. Exploratory outcomes include acceptability, tolerability, and efficacy of buprenorphine. The enrollment target of 640 participants was met 27 months after trial initiation. The findings of the trial will inform the management of chronic pain, a common and challenging issue for patients treated with maintenance hemodialysis. NCT04571619.

Needs and Considerations for Standardization of Kidney Disease Education in Patients with Advanced CKD.

Kidney health advocacy organizations and leaders in the nephrology community have repeatedly emphasized the need to increase home dialysis utilization in the United States. Limited awareness and understanding of options for the management of kidney failure among patients living with advanced CKD is a significant barrier to increasing the selection and use of home dialysis. Studies have shown that providing targeted comprehensive patient education before the onset of kidney failure can improve patients' awareness of kidney disease and substantially increase the informed utilization of home dialysis. Unfortunately, in the absence of validated evidence-based education protocols, outcomes associated with home dialysis use vary widely among published studies, potentially affecting the routine implementation and reporting of these services among patients with advanced CKD. This review provides pragmatic guidance on establishing effective patient-centered education programs to empower patients to make informed decisions about their KRT and, in turn, increase home dialysis use.

VA-Based Peritoneal Dialysis Program Feasibility Considerations and Process Outline.

Background: Home dialysis utilization is lower among veterans than in the general US population. Several sociodemographic factors and comorbidities contribute to peritoneal dialysis (PD) underutilization. In 2019, the Veterans Health Administration (VHA) Kidney Disease Program Office convened a PD workgroup to address this concern. Observations: The PD workgroup was explicitly concerned by the limited availability of PD within the VHA, which frequently requires veterans to transition kidney disease care from US Department of Veterans Affairs medical centers (VAMCs) to non-VHA facilities when they progress from chronic kidney disease to end-stage kidney disease, causing fragmentation of care. Since the administrative requirements and infrastructure of VAMCs vary, the workgroup focused its deliberations on synthesizing a standard process for evaluating the feasibility and establishing a new PD program within any individual VAMC. A 3-phased approach was envisioned, beginning with ascertainment of prerequisites, leading to an examination of the clinical and financial feasibility through the process of data gathering and synthesis, culminating in a business plan that translates the previous 2 steps into an administrative document necessary for obtaining VHA approvals. Conclusions: VAMCs can use the guide presented here to improve therapeutic options for veterans with kidney failure by establishing a new or restructured PD program.

Serum Creatinine-to-Cystatin-C Ratio as a Potential Muscle Mass Surrogate and Racial Differences in Mortality.

OBJECTIVES: Serum creatinine-based estimated glomerular filtration rate equations and muscle mass are powerful markers of health and mortality risk. However, the serum creatinine-to-cystatin-C ratio may be a better indicator of health status. The objective of this study was to describe the relationship between creatinine-to-cystatin-C ratio and all-cause mortality when stratifying patients as per race and as per chronic kidney disease status. METHODS: This was a retrospective cohort study examining black and nonblack US veterans between October 2004 and September 2019, with baseline cystatin C and creatinine data from those not on dialysis during the study period. Veterans were divided into four creatinine-to-cystatin-C ratio groups: <0.75, 0.75-<1.00, 1.0-<1.25, and ≥1.25. The primary outcome of interest was all-cause mortality subsequent to the cystatin C laboratory measure. RESULTS: Among 22,316 US veterans, the mean (± standard deviation) age of the cohort was 67 ± 14 years, 5% were female, 82% were nonblack, and 18% were black. The proportion of black veterans increased across creatinine-to-cystatin-C ratio groups. In the fully adjusted model, compared with the reference (creatinine-to-cystatin-C ratio: 1.00-<1.25), a creatinine-to-cystatin-C ratio <0.75 had the highest mortality risk among both black and nonblack veterans (nonblack: hazard ratio [HR] [95% confidence interval {CI}]: 3.01 [2.78-3.26] and black: 4.17 [3.31-5.24]). A creatinine-to-cystatin-ratio ≥1.25 was associated with lower death risk than the referent in both groups (nonblack: HR [95% CI]: 0.89 [0.80-0.99] and black: HR [95% CI]: 0.55 [0.45-0.69]). However, there was a significant difference in the effect by race (Wald's P-value: <0.01). CONCLUSIONS: Higher creatinine-to-cystatin-C ratios indicate better health status and are strongly associated with lower mortality risk regardless of the kidney function level, and the relation was similar for both black and nonblack veterans, but with different strengths of effect across racial groups. Thereby, use of a fixed race coefficient in estimating kidney function may be biased.

Usability Testing of the Kidney Score Platform to Enhance Communication About Kidney Disease in Primary Care Settings: Qualitative Think-Aloud Study.

BACKGROUND: Patient awareness of chronic kidney disease (CKD) is low in part due to suboptimal testing for CKD among those at risk and lack of discussions about kidney disease between patients and clinicians. To bridge these gaps, the National Kidney Foundation developed the Kidney Score Platform, which is a web-based series of tools that includes resources for health care professionals as well as an interactive, dynamic patient-facing component that includes a brief questionnaire about risk factors for kidney disease, individualized assessment of risk for developing CKD, and self-management tools to manage one's kidney disease. OBJECTIVE: The aim of this study is to perform usability testing of the patient component of the Kidney Score platform among veterans with and at risk for kidney disease and among clinicians working as primary care providers in Veterans Affairs administration. METHODS: Think-aloud exercises were conducted, during which participants (veterans and clinicians) engaged with the platform while verbalizing their thoughts and making their perceptions, reasonings, and decision points explicit. A usability facilitator observed participants' behaviors and probed selectively to clarify their comprehension of the tool's instructions, content, and overall functionality. Thematic analysis on the audio-recording transcripts was performed, focusing on positive attributes, negative comments, and areas that required facilitator involvement. RESULTS: Veterans (N=18) were 78% (14/18) male with a mean age of 58.1 years. Two-thirds (12/18) were of non-White race/ethnicity, 28% (5/18) had laboratory evidence of CKD without a formal diagnosis, and 50% (9/18) carried a diagnosis of hypertension or diabetes. Clinicians (N=19) were 29% (5/17) male, 30% (5/17) of non-White race/ethnicity, and had a mean of 17 (range 4-32) years of experience. Veterans and clinicians easily navigated the online tool and appreciated the personalized results page as well as the inclusion of infographics to deliver key educational messages. Three major themes related to content and communication about risk for CKD emerged from the think-aloud exercises: (1) tension between lay and medical terminology when discussing kidney disease and diagnostic tests, (2) importance of linking general information to concrete self-management actions, and (3) usefulness of the tool as an adjunct to the office visit to prepare for patient-clinician communication. Importantly, these themes were consistent among interviews involving both veterans and clinicians. CONCLUSIONS: Veterans and clinicians both thought that the Kidney Score Platform would successfully promote communication and discussion about kidney disease in primary care settings. Tension between using medical terminology that is used regularly by clinicians versus lay terminology to promote CKD awareness was a key challenge, and knowledge of this can inform the development of future CKD educational materials.

Implications of Cross-System Use Among US Veterans With Advanced Kidney Disease in the Era of the MISSION Act: A Qualitative Study of Health Care Records.

Importance: Since 2014, when Congress passed the Veterans Access Choice and Accountability (Choice) Act (replaced in 2018 with the more comprehensive Maintaining Internal Systems and Strengthening Integrated Outside Networks [MISSION] Act), the Department of Veterans Affairs (VA) has been paying for US veterans to receive increasing amounts of care in the private sector (non-VA care or VA community care). However, little is known about the implications of these legislative changes for the VA system. Objective: To describe the implications for the VA system of recent increases in VA-financed non-VA care. Design, Setting, and Participants: This qualitative study was a thematic analysis of documentation in the electronic health records (EHRs) of a random sample of US veterans with advanced kidney disease between June 6, 2019, and February 5, 2021. Exposures: Mentions of community care in participant EHRs. Main Outcomes and Measures: Dominant themes pertaining to VA-financed non-VA care. Results: Among 1000 study participants, the mean (SD) age was 73.8 (11.4) years, and 957 participants (95.7%) were male. Three interrelated themes pertaining to VA-financed non-VA care emerged from qualitative analysis of documentation in cohort member EHRs: (1) VA as mothership, which describes extensive care coordination by VA staff members and clinicians to facilitate care outside the VA and the tendency of veterans and their non-VA clinicians to rely on the VA to fill gaps in this care; (2) hidden work of veterans, which describes the efforts of veterans and their family members to navigate the referral process, and to serve as intermediaries between VA and non-VA clinicians; and (3) strain on the VA system, which describes a challenging referral process and the ways in which cross-system care has stretched the traditional roles of VA staff and clinicians and interfered with VA care processes. Conclusions and Relevance: The findings of this qualitative study describing VA-financed non-VA care for veterans with advanced kidney disease spotlight the substantial challenges of cross-system use and the strain placed on the VA system, VA staff and clinicians, and veterans and their families in recent years. These difficult-to-measure consequences of cross-system care should be considered when budgeting, evaluating, and planning the provision of VA-financed non-VA care in the private sector.

Depression screening and clinical outcomes among adults initiating maintenance hemodialysis.

BACKGROUND: Transitioning to maintenance hemodialysis (HD) is a vulnerable period for persons with end-stage renal disease (ESRD), punctuated by high rates of depression, hospitalizations and death. Screening for depression during this time may help to improve patient outcomes but formal inquiry has yet to be conducted. Among a national Veteran cohort, we examined whether depression screening in the year prior to HD initiation led to improved outcomes in the year thereafter. METHODS: Associations between pre-ESRD depression screening and post-ESRD outcomes were examined with Cox proportional hazards models (mortality) and Poisson regression models (hospitalization). Hierarchal adjustment models accounted for sociodemographic, clinical, pre-ESRD care and dialysis characteristics. RESULTS: The final analytic cohort of the study was 30 013 Veterans of whom 64% underwent pre-ESRD depression screening. During the 12 months post-transition, the crude all-cause mortality rate was 0.32 person-year for those screened and 0.35 person-year for those not screened, while the median (interquartile range) hospitalizations were 2 (2, 2) per year for both groups. In fully adjusted models, pre-ESRD depression screening was associated with a lower risk of mortality [hazard ratio (95% confidence interval): 0.94 (0.90-0.99)] and hospitalization [incidence rate ratio (95% confidence interval): 0.97 (0.9-0.99)]. CONCLUSION: Depression screening among adults prior to maintenance HD transition may be associated with better outcomes during the following year.

The Kidney Score Platform for Patient and Clinician Awareness, Communication, and Management of Kidney Disease: Protocol for a Mixed Methods Study.

BACKGROUND: Patient awareness, clinician detection, and management of chronic kidney disease remain suboptimal, despite clinical practice guidelines and diverse education programs. OBJECTIVE: This protocol describes a study to develop and investigate the impact of the National Kidney Foundation Kidney Score Platform on chronic kidney disease awareness, communication, and management, by leveraging the Behavior Change Wheel, an implementation science framework that helps identify behavioral intervention targets and functions that address barriers to behavior change. METHODS: We interviewed 20 patients with chronic kidney disease and 11 clinicians to identify patient and clinician behaviors suitable for intervention and barriers to behavior change (eg, limited awareness of chronic kidney disease clinical practice guidelines within primary care settings, limited data analytics to highlight chronic kidney disease care gaps, asymptomatic nature of chronic kidney disease in conjunction with patient reliance on primary care clinicians to determine risk and order kidney testing). Leveraging the Behavior Change Wheel, the Kidney Score Platform was developed with a patient-facing online Risk Calculator and a clinician-facing Clinical Practice Toolkit. The Risk Calculator utilizes risk predictive analytics to provide interactive health information tailored to an individual's chronic kidney disease risk and health status. The Clinical Practice Toolkit assists clinicians in discussing chronic kidney disease with individuals at risk for and with kidney disease and in managing their patient population with chronic kidney disease. The Kidney Score Platform will be tested in 2 Veterans Affairs primary health care settings using a pre-post study design. Outcomes will include changes in patient self-efficacy for chronic kidney disease management (primary outcome), quality of communication with clinicians about chronic kidney disease, and practitioners' knowledge of chronic kidney disease guidelines. Process outcomes will identify usability and adoption of different elements of the Kidney Score Platform using qualitative and quantitative methods. RESULTS: As of September 2020, usability studies are underway with veterans and clinicians to refine the patient-facing components of the Kidney Score Platform before study initiation. Results and subsequent changes to the Kidney Score Platform will be published at a later date. The study is expected to be completed by December 2021. CONCLUSIONS: Results of this study will be used to inform integration of the Kidney Score Platform within primary care settings so that it can serve as a central component of the National Kidney Foundation public awareness campaign to educate, engage, and empower individuals at risk for and living with chronic kidney disease. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/22024.

Plant-Dominant Low-Protein Diet for Conservative Management of Chronic Kidney Disease.

Chronic kidney disease (CKD) affects >10% of the adult population. Each year, approximately 120,000 Americans develop end-stage kidney disease and initiate dialysis, which is costly and associated with functional impairments, worse health-related quality of life, and high early-mortality rates, exceeding 20% in the first year. Recent declarations by the World Kidney Day and the U.S. Government Executive Order seek to implement strategies that reduce the burden of kidney failure by slowing CKD progression and controlling uremia without dialysis. Pragmatic dietary interventions may have a role in improving CKD outcomes and preventing or delaying dialysis initiation. Evidence suggests that a patient-centered plant-dominant low-protein diet (PLADO) of 0.6­0.8 g/kg/day composed of >50% plant-based sources, administered by dietitians trained in non-dialysis CKD care, is promising and consistent with the precision nutrition. The scientific premise of the PLADO stems from the observations that high protein diets with high meat intake not only result in higher cardiovascular disease risk but also higher CKD incidence and faster CKD progression due to increased intraglomerular pressure and glomerular hyperfiltration. Meat intake increases production of nitrogenous end-products, worsens uremia, and may increase the risk of constipation with resulting hyperkalemia from the typical low fiber intake. A plant-dominant, fiber-rich, low-protein diet may lead to favorable alterations in the gut microbiome, which can modulate uremic toxin generation and slow CKD progression, along with reducing cardiovascular risk. PLADO is a heart-healthy, safe, flexible, and feasible diet that could be the centerpiece of a conservative and preservative CKD-management strategy that challenges the prevailing dialysis-centered paradigm.

Development, implementation and user experience of the Veterans Health Administration (VHA) dialysis dashboard.

BACKGROUND: Adults with end-stage renal disease (ESRD) requiring chronic dialysis continue to suffer from poor health outcomes and represent a population rightfully targeted for quality improvement. Electronic dashboards are increasingly used in healthcare to facilitate quality measurement and improvement. However, detailed descriptions of the creation of healthcare dashboards are uncommonly available and formal inquiry into perceptions, satisfaction, and utility by clinical users has been rarely conducted, particularly in the context of dialysis care. Therefore, we characterized the development, implementation and user experience with Veterans Health Administration (VHA) dialysis dashboard. METHODS: A clinical-quality dialysis dashboard was implemented, which displays clinical performance measures (CPMs) for Veterans with ESRD receiving chronic hemodialysis at all VHA facilities. Data on user experience and perceptions were collected via an e-mail questionnaire to dialysis medical directors and nurse managers at these facilities. RESULTS: Since 2016 the dialysis dashboard reports monthly on CPMs for approximately 3000 Veterans receiving chronic hemodialysis across 70 VHA dialysis facilities. Of 141 dialysis medical directors and nurse managers, 61 completed the questionnaire. Sixty-six percent of respondents did not find the dashboard difficult to access, 64% agreed that it is easy to use, 59% agreed that its layout is good, and the majority agreed that presentation of data is clear (54%), accurate (56%), and up-to-date (54%). Forty-eight percent of respondents indicated that it helped them improve patient care while 12% did not. Respondents indicated that they used the dialysis dashboard for clinical reporting (71%), quality assessment/performance improvement (QAPI) (62%), and decision-making (23%). CONCLUSIONS: Most users of the VHA dialysis dashboard found it accurate, up-to-date, easy to use, and helpful in improving patient care. It meets diverse user needs, including administrative reporting, clinical benchmarking and decision-making, and quality assurance and performance improvement (QAPI) activities. Moreover, the VHA dialysis dashboard affords national-, regional- and facility-level assessments of quality of care, guides and motivates best clinical practices, targets QAPI efforts, and informs and promotes population health management improvement efforts for Veterans receiving chronic hemodialysis.

Survival among Veterans Obtaining Dialysis in VA and Non-VA Settings.

BACKGROUND: Outcomes of veterans with ESRD may differ depending on where they receive dialysis and who finances this care, but little is known about variation in outcomes across different dialysis settings and financial arrangements. METHODS: We examined survival among 27,241 Veterans Affairs (VA)-enrolled veterans who initiated chronic dialysis in 2008-2011 at (1) VA-based units, (2) community-based clinics through the Veterans Affairs Purchased Care program (VA-PC), (3) community-based clinics under Medicare, or (4) more than one of these settings ("dual" care). Using a Cox proportional hazards model, we compared all-cause mortality across dialysis settings during the 2-year period after dialysis initiation, adjusting for demographic and clinical characteristics. RESULTS: Overall, 4% of patients received dialysis in VA, 11% under VA-PC, 67% under Medicare, and 18% in dual settings (nearly half receiving dual VA and VA-PC dialysis). Crude 2-year mortality was 25% for veterans receiving dialysis in the VA, 30% under VA-PC, 42% under Medicare, and 23% in dual settings. After adjustment, dialysis patients in VA or in dual settings had significantly lower 2-year mortality than those under Medicare; mortality did not differ in VA-PC and Medicare dialysis settings. CONCLUSIONS: Mortality rates were highest for veterans receiving dialysis in Medicare or VA-PC settings and lowest for veterans receiving dialysis in the VA or dual settings. These findings inform institutional decisions about provision of dialysis for veterans. Further research identifying processes associated with improved survival for patients receiving VA-based dialysis may be useful in establishing best practices for outsourced veteran care.

Emotional Impact of Illness and Care on Patients with Advanced Kidney Disease.

BACKGROUND AND OBJECTIVES: The highly specialized and technologically focused approach to care inherent to many health systems can adversely affect patients' emotional experiences of illness, while also obscuring these effects from the clinician's view. We describe what we learned from patients with advanced kidney disease about the emotional impact of illness and care. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: As part of an ongoing study on advance care planning, we conducted semistructured interviews at the VA Puget Sound Healthcare System in Seattle, Washington, with 27 patients with advanced kidney disease between April of 2014 and May of 2016. Of these, ten (37%) were receiving center hemodialysis, five (19%) were receiving peritoneal dialysis, and 12 (44%) had an eGFR≤20 ml/min per 1.73 m2 and had not started dialysis. Interviews were audiotaped, transcribed, and analyzed inductively using grounded theory methods. RESULTS: We here describe three emergent themes related to patients' emotional experiences of care and illness: (1) emotional impact of interactions with individual providers: when providers seemed to lack insight into the patient's experience of illness and treatment, this could engender a sense of mistrust, abandonment, isolation, and/or alienation; (2) emotional impact of encounters with the health care system: just as they could be affected emotionally by interactions with individual providers, patients could also be affected by how care was organized, which could similarly lead to feelings of mistrust, abandonment, isolation, and/or alienation; and (3) emotional impact of meaning-making: patients struggled to make sense of their illness experience, worked to apportion blame, and were often quick to blame themselves and to assume that their illness could have been prevented. CONCLUSIONS: Interactions with individual providers and with the wider health system coupled with patients' own struggles to make meaning of their illness can take a large emotional toll. A deeper appreciation of patients' emotional experiences may offer important opportunities to improve care.

Delivering a "New Deal" of Kidney Health Opportunities to Improve Outcomes Within the Veterans Health Administration.

Just as the "New Deal" aimed to elevate the "forgotten man" of the Great Depression through governmental relief and reform, so does the Department of Veterans Affairs (VA) health care system aim to improve the health of veterans with the invisible illness of chronic kidney disease through a concerted series of health care delivery reforms. Augmenting its primary care platform with advances in informatics and health service delivery initiatives targeting kidney disease, the VA is changing how nephrology care is provided to veterans with the goal of optimized population kidney health. As the largest provider of kidney health services in the country, the VA offers an instructive case study of the value of comprehensive health care coverage for people with chronic kidney disease. Recent reports of kidney health outcomes among veterans support the benefit of the VA's integrated health care delivery system. Suggestions to optimize veterans' kidney health further may be equally applicable to other health systems caring for people afflicted with kidney disease.

Plasma Biomarkers and Kidney Function Decline in Early and Established Diabetic Kidney Disease.

Biomarkers of diverse pathophysiologic mechanisms may improve risk stratification for incident or progressive diabetic kidney disease (DKD) in persons with type 2 diabetes. To evaluate such biomarkers, we performed a nested case-control study (n=190 cases of incident DKD and 190 matched controls) and a prospective cohort study (n=1156) using banked baseline plasma samples from participants of randomized, controlled trials of early (ACCORD) and advanced (VA NEPHRON-D) DKD. We assessed the association and discrimination obtained with baseline levels of plasma TNF receptor-1 (TNFR-1), TNFR-2, and kidney injury molecule-1 (KIM-1) for the outcomes of incident DKD (ACCORD) and progressive DKD (VA-NEPHRON-D). At baseline, median concentrations of TNFR-1, TNFR-2, and KIM-1 were roughly two-fold higher in the advanced DKD population (NEPHRON-D) than in the early DKD population (ACCORD). In both cohorts, patients who reached the renal outcome had higher baseline levels than those who did not reach the outcome. Associations between doubling in TNFR-1, TNFR-2, and KIM-1 levels and risk of the renal outcomes were significant for both cohorts. Inclusion of these biomarkers in clinical models increased the area under the curve (SEM) for predicting the renal outcome from 0.68 (0.02) to 0.75 (0.02) in NEPHRON-D. Systematic review of the literature illustrated high consistency in the association between these biomarkers of inflammation and renal outcomes in DKD. In conclusion, TNFR-1, TNFR-2, and KIM-1 independently associated with higher risk of eGFR decline in persons with early or advanced DKD. Moreover, addition of these biomarkers to clinical prognostic models significantly improved discrimination for the renal outcome.