The Complex Patchwork of Transportation for In-Center Hemodialysis.

Reliable transportation is an important determinant of access to health care and health outcomes that carries particular significance for people with ESKD. In the United States, there are almost half a million patients receiving treatment with in-center dialysis, translating into more than 70 million roundtrips to dialysis centers annually. Difficulty with transportation can interfere with patients' quality of life and contribute to missed or shortened dialysis treatments, increasing their risk for hospitalization. Medicare, the principal payer for dialysis in this country, has not traditionally provided coverage for nonemergency medical transportation, placing the burden of traveling to and from the dialysis center on patients and families and a range of other private and public entities that were not designed and are poorly equipped for this purpose. Here, we review the relationship between access to reliable transportation and health outcomes such as missed and shortened dialysis treatments, hospitalizations, and quality of life. We also describe current approaches to the delivery of transportation for patients receiving in-center hemodialysis, highlighting potential opportunities for improvement.

Dialysis for Chronic Kidney Failure: A Review.

Importance: More than 3.5 million people worldwide and 540 000 individuals in the US receive maintenance hemodialysis or peritoneal dialysis for the treatment of chronic kidney failure. The 5-year survival rate is approximately 40% after initiation of maintenance dialysis. Observations: Hemodialysis and peritoneal dialysis remove metabolic waste and excess body water and rebalance electrolytes to sustain life. There is no recommended estimated glomerular filtration rate (eGFR) threshold for initiating dialysis, and patient-clinician shared decision-making should help determine when to initiate dialysis. Persistent signs and symptoms of uremia (eg, nausea, fatigue) and volume overload (eg, dyspnea, peripheral edema), worsening eGFR, metabolic acidosis, and hyperkalemia inform the timing of therapy initiation. A randomized clinical trial reported no mortality benefit to starting dialysis at higher eGFR (10-14 mL/min/1.73 m2) vs lower eGFR (5-7 mL/min/1.73 m2) levels. Observational data suggested no differences in 5-year mortality with use of hemodialysis vs peritoneal dialysis. Cardiovascular (eg, arrhythmias, cardiac arrest) and infection-related complications of maintenance dialysis are common. In the US, hemodialysis catheter-related bloodstream infections occur at a rate of 1.1 to 5.5 episodes per 1000 catheter-days and affect approximately 50% of patients within 6 months of catheter placement. Peritonitis occurs at a rate of 0.26 episodes per patient-year and affects about 30% of individuals in the first year of peritoneal dialysis therapy. Chronic kidney failure-related systemic complications, such as anemia, hyperphosphatemia, hypocalcemia, and hypertension, often require pharmacologic treatment. Hypotension during dialysis, refractory symptoms (eg, muscle cramps, itching), and malfunction of dialysis access can interfere with delivery of dialysis. Conclusions and Relevance: In 2021, more than 540 000 patients in the US received maintenance hemodialysis or peritoneal dialysis for treatment of chronic kidney failure. Five-year survival rate after initiation of maintenance dialysis is approximately 40%, and the mortality rate is similar with hemodialysis and peritoneal dialysis. Decisions about dialysis initiation timing and modality are influenced by patient symptoms, laboratory trajectories, patient preferences, and therapy cost and availability and should include shared decision-making.

Patient-Centered Quality Measures for Dialysis Care: A Report of a Kidney Disease Outcomes Quality Initiative (KDOQI) Scientific Workshop Sponsored by the National Kidney Foundation.

Providing high-quality patient-centered care is the central mission of dialysis facilities. Assessing quality and patient-centeredness of dialysis care is necessary for continuous dialysis facility improvement. Based predominantly on readily measured items, current quality measures in dialysis care emphasize biochemical and utilization outcomes, with very few patient-reported items. Additionally, current metrics often do not account for patient preferences and may compromise patient-centered care by limiting the ability of providers to individualize care targets, such as dialysis adequacy, based on patient priorities rather than a fixed numerical target. Developing, implementing, and maintaining a quality program using readily quantifiable data while also allowing for individualization of care targets that emphasize the goals of patients and their care partners provided the motivation for a September 2022 Kidney Disease Outcomes Quality Initiative (KDOQI) Workshop on Patient-Centered Quality Measures for Dialysis Care. Workshop participants focused on 4 questions: (1) What are the outcomes that are most important to patients and their care partners? (2) How can social determinants of health be accounted for in quality measures? (3) How can individualized care be effectively addressed in population-level quality programs? (4) What are the optimal means for collecting valid and robust patient-reported outcome data? Workshop participants identified numerous gaps within the current quality system and favored a conceptually broader, but not larger, quality system that stresses highly meaningful and adaptive measures that incorporate patient-centered principles, individual life goals, and social risk factors. Workshop participants also identified a need for new, low-burden tools to assess patient goals and priorities.

KDOQI US Commentary on the 2020 ISPD Practice Recommendations for Prescribing High-Quality Goal-Directed Peritoneal Dialysis.

The recently published 2020 International Society for Peritoneal Dialysis (ISPD) practice recommendations regarding prescription of high-quality goal-directed peritoneal dialysis differ fundamentally from previous guidelines that focused on "adequacy" of dialysis. The new ISPD publication emphasizes the need for a person-centered approach with shared decision making between the individual performing peritoneal dialysis and the clinical care team while taking a broader view of the various issues faced by that individual. Cognizant of the lack of strong evidence for the recommendations made, they are labeled as "practice points" rather than being graded numerically. This commentary presents the views of a work group convened by the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) to assess these recommendations and assist clinical providers in the United States in interpreting and implementing them. This will require changes to the current clinical paradigm, including greater resource allocation to allow for enhanced services that provide a more holistic and person-centered assessment of the quality of dialysis delivered.

Telehealth for Home Dialysis in COVID-19 and Beyond: A Perspective From the American Society of Nephrology COVID-19 Home Dialysis Subcommittee.

The coronavirus disease 2019 (COVID-19) pandemic, technological advancements, regulatory waivers, and user acceptance have converged to boost telehealth activities. Due to the state of emergency, regulatory waivers in the United States have made it possible for providers to deliver and bill for services across state lines for new and established patients through Health Insurance Portability and Accountability Act (HIPAA)- and non-HIPAA-compliant platforms with home as the originating site and without geographic restrictions. Platforms have been developed or purchased to perform videoconferencing, and interdisciplinary dialysis teams have adapted to perform virtual visits. Telehealth experiences and challenges encountered by dialysis providers, clinicians, nurses, and patients have exposed health care disparities in areas such as access to care, bandwidth connectivity, availability of devices to perform telehealth, and socioeconomic and language barriers. Future directions in telehealth use, quality measures, and research in telehealth use need to be explored. Telehealth during the public health emergency has changed the practice of health care, with the post-COVID-19 world unlikely to resemble the prior era. The future impact of telehealth in patient care in the United States remains to be seen, especially in the context of the Advancing American Kidney Health Initiative.

Caring for Nephrology Patients and Staff During the COVID-19 Pandemic: Experiences of the Northwest Kidney Centers.

The Northwest Kidney Center (NWC) in Seattle, Washington, has been a leader in nephrology care for almost 60 years, opening the first hemodialysis unit in the United States in 1962. In February 2020, one of their patients was the first reported death from COVID-19 in the United States. On April 6, 2020, as a part of NNJ Extra - the Nephrology Nursing Journal's podcast series, Beth Ulrich, EdD, RN, FACHE, FAONL, FAAN, Editor-in-Chief of the Nephrology Nursing Journal, talked with the leaders of the Northwest Kidney Centers - Suzanne Watnick, MD, the Chief Medical Officer, and Liz McNamara, MN, RN, Vice President of Patient Care Services and the Chief Nursing Officer, who discussed dealing with the onset of COVID-19 at NWC, how their team worked together to provide care for their patients and support for their staff members, and the lessons they learned that can benefit others.

Influence of Baseline Diastolic Blood Pressure on Effects of Intensive Compared With Standard Blood Pressure Control.

BACKGROUND: In individuals with a low diastolic blood pressure (DBP), the potential benefits or risks of intensive systolic blood pressure (SBP) lowering are unclear. METHODS: SPRINT (Systolic Blood Pressure Intervention Trial) was a randomized controlled trial that compared the effects of intensive (target <120 mm Hg) and standard (target <140 mm Hg) SBP control in 9361 older adults with high blood pressure at increased risk of cardiovascular disease. The primary outcome was a composite of cardiovascular disease events. All-cause death and incident chronic kidney disease were secondary outcomes. This post hoc analysis examined whether the effects of the SBP intervention differed by baseline DBP. RESULTS: Mean baseline SBP and DBP were 139.7±15.6 and 78.1±11.9 mm Hg, respectively. Regardless of the randomized treatment, baseline DBP had a U-shaped association with the hazard of the primary cardiovascular disease outcome. However, the effects of the intensive SBP intervention on the primary outcome were not influenced by baseline DBP level (P for interaction=0.83). The primary outcome hazard ratio for intensive versus standard treatment was 0.78 (95% confidence interval, 0.57-1.07) in the lowest DBP quintile (mean baseline DBP, 61±5 mm Hg) and 0.74 (95% confidence interval, 0.61-0.90) in the upper 4 DBP quintiles (mean baseline DBP, 82±9 mm Hg), with an interaction P value of 0.78. Results were similar for all-cause death and kidney events. CONCLUSIONS: Low baseline DBP was associated with increased risk of cardiovascular disease events, but there was no evidence that the benefit of the intensive SBP lowering differed by baseline DBP. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01206062.

Calcimimetics and Bundled Reimbursement.

Since 2011, the Centers for Medicare & Medicaid Services has provided reimbursement for renal dialysis services furnished to Medicare beneficiaries through a bundled payment system known as the Prospective Payment System. Medications that have no injectable equivalent, known as "oral-only medications," are currently excluded from the bundle and are paid separately through Medicare Part D. Thus, before the development of etelcalcetide, the first injectable calcimimetic, calcimimetics were reimbursed outside the bundle. Etelcalcetide's introduction and approval for use in Medicare triggered a transition payment for a minimum of 2 years that will eventually result in the incorporation of calcimimetics into the dialysis bundle. Consequently, providers may face incentives to reduce calcimimetic use when the transition period has expired. The complexity of bone-mineral management in conjunction with the paucity of evidence-based recommendations in this area makes it difficult to predict the impact of this transition. Because these medications are expensive, a poor transition could have financial ramifications for dialysis organizations and potentially patient health. To ensure that patients are not adversely affected, it is critical that Medicare incorporate these medications into the bundle carefully, with close monitoring of outcomes.

The ESRD Quality Incentive Program-Can We Bridge the Chasm?

The ESRD Quality Incentive Program (QIP) is the first mandatory federal pay for performance program launched on January 1, 2012. The QIP is tied to the ESRD prospective payment system and mandated by the Medicare Improvements for Patients and Providers Act of 2008, which directed the Centers for Medicare and Medicaid Services to expand the payment bundle for renal dialysis services and legislated that payment be tied to quality measures. The QIP links 2% of the payment that a dialysis facility receives for Medicare patients on dialysis to the facility's performance on quality of care measures. Quality measures are evaluated annually for inclusion on the basis of importance, validity, and performance gap. Other quality assessment programs overlap with the QIP; all have substantial effects on provision of care as clinicians, patients, regulators, and dialysis organizations scramble to keep up with the frequent release of wide-ranging regulations. In this review, we provide an overview of quality assessment and quality measures, focusing on the ESRD QIP, its effect on care, and its potential future directions. We conclude that a patient-centered, individualized, and parsimonious approach to quality assessment needs to be maintained to allow the nephrology community to further bridge the quality chasm in dialysis care.

Combined angiotensin inhibition for the treatment of diabetic nephropathy.

BACKGROUND: Combination therapy with angiotensin-converting-enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) decreases proteinuria; however, its safety and effect on the progression of kidney disease are uncertain. Methods We provided losartan (at a dose of 100 mg per day) to patients with type 2 diabetes, a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of at least 300, and an estimated glomerular filtration rate (GFR) of 30.0 to 89.9 ml per minute per 1.73 m(2) of body-surface area and then randomly assigned them to receive lisinopril (at a dose of 10 to 40 mg per day) or placebo. The primary end point was the first occurrence of a change in the estimated GFR (a decline of ≥ 30 ml per minute per 1.73 m(2) if the initial estimated GFR was ≥ 60 ml per minute per 1.73 m(2) or a decline of ≥ 50% if the initial estimated GFR was <60 ml per minute per 1.73 m(2)), end-stage renal disease (ESRD), or death. The secondary renal end point was the first occurrence of a decline in the estimated GFR or ESRD. Safety outcomes included mortality, hyperkalemia, and acute kidney injury. Results The study was stopped early owing to safety concerns. Among 1448 randomly assigned patients with a median follow-up of 2.2 years, there were 152 primary end-point events in the monotherapy group and 132 in the combination-therapy group (hazard ratio with combination therapy, 0.88; 95% confidence interval [CI], 0.70 to 1.12; P=0.30). A trend toward a benefit from combination therapy with respect to the secondary end point (hazard ratio, 0.78; 95% CI, 0.58 to 1.05; P=0.10) decreased with time (P=0.02 for nonproportionality). There was no benefit with respect to mortality (hazard ratio for death, 1.04; 95% CI, 0.73 to 1.49; P=0.75) or cardiovascular events. Combination therapy increased the risk of hyperkalemia (6.3 events per 100 person-years, vs. 2.6 events per 100 person-years with monotherapy; P<0.001) and acute kidney injury (12.2 vs. 6.7 events per 100 person-years, P<0.001). Conclusions Combination therapy with an ACE inhibitor and an ARB was associated with an increased risk of adverse events among patients with diabetic nephropathy. (Funded by the Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development; VA NEPHRON-D ClinicalTrials.gov number, NCT00555217.).

ESRD care within the US Department of Veterans Affairs: a forward-looking program with an illuminating past.

The first governmental agency to provide maintenance hemodialysis to patients with end-stage renal disease (ESRD) was the Veterans Administration (VA; now the US Department of Veterans Affairs). Many historical VA policies and programs set the stage for the later care of both veteran and civilian patients with ESRD. More recent VA initiatives that target restructuring of care models based on quality management, system-wide payment policies to promote cost-effective dialysis, and innovation grants aim to improve contemporary care. The VA currently supports an expanded and diversified nationwide treatment program for patients with ESRD using an integrated patient-centered care paradigm. This narrative review of ESRD care by the VA explores not only the medical advances, but also the historical, socioeconomic, ethical, and political forces related to the care of veterans with ESRD.

Financial and medico-legal implications of late-start dialysis: understanding the present policies through a window of past performance.

In the United States, multiple stakeholders have impacted the timing of dialysis initiation for patients with end-stage renal disease. The optimal policy to start dialysis for this vulnerable population remains unknown. Historically, patients initiated dialysis weeks after the appearance of uremic symptoms. This changed not only due to an evolution in medical providers' practice but also due to changes in the care delivery system, the political imperatives, and the economic driving forces surrounding the care of these patients. One large randomized control trial looked at patient outcomes with strategies of early versus late start. The trial included an economic analysis. Depending on the specific comparison, cost was either lower in the late-start group or was equivalent between groups. This result would tend to favor a late-start strategy, where patients had an additional 6 months of dialysis-free time. However, the generalizability of this analysis has been questioned. Future care models that would include patients before and after dialysis initiation would be ideal to study cost and quality at the time of this transition of care. The recently implemented CMS Quality Incentive Program is one mechanism that could use such findings to implement a high-value strategy for patients starting chronic dialysis therapies.

System-Level Strategies to Improve Home Dialysis: Policy Levers and Quality Initiatives.

Advocacy and policy change are powerful levers to improve quality of care and better support patients on home dialysis. While the kidney community increasingly recognizes the value of home dialysis as an option for patients who prioritize independence and flexibility, only a minority of patients dialyze at home in the United States. Complex system-level factors have restricted further growth in home dialysis modalities, including limited infrastructure, insufficient staff for patient education and training, patient-specific barriers, and suboptimal physician expertise. In this article, we outline trends in home dialysis use, review our evolving understanding of what constitutes high-quality care for the home dialysis population (as well as how this can be measured), and discuss policy and advocacy efforts that continue to shape the care of US patients and compare them with experiences in other countries. We conclude by discussing future directions for quality and advocacy efforts.

Variation in oral calcitriol response in patients with stages 3-4 CKD.

BACKGROUND: Oral calcitriol decreases parathyroid hormone (PTH) concentrations in patients who have chronic kidney disease (CKD); however, treatment response is highly variable. We evaluated whether patient characteristics affect the PTH response to oral calcitriol in nondialysis patients with CKD in a clinic-based setting. STUDY DESIGN: Cohort study. SETTING & PARTICIPANTS: This study included 379 new oral calcitriol users in the Veterans' Affairs Northwest Health Network. All had stages 3-4 CKD, hyperparathyroidism, and a serum PTH measurement before and 1-6 months after initiating oral calcitriol therapy. PREDICTORS: Patient-level characteristics hypothesized to affect calcitriol response: race, body size, concurrent medications, and kidney function. OUTCOMES: Relative decrease in serum PTH concentration after starting oral calcitriol therapy. MEASUREMENTS: Data were abstracted from the Veterans' Affairs Northwest Health Network (VISN 20) Data Warehouse, which includes electronic pharmacy and laboratory records. RESULTS: Mean estimated glomerular filtration rate was 30 mL/min/1.73 m(2) and mean initial PTH concentration was 199 pg/mL. Regular- (0.25 µg/d) and low-dose (<0.25 µg/d) oral calcitriol were associated with on average 23% and 13% relative decreases in serum PTH concentrations, respectively. After adjustment for calcitriol dosage, initial PTH concentration, and time to follow-up measurement, African American race was associated with a blunted calcitriol response (geometric mean final PTH value, 26% higher; 95% CI, 8%-47%). Serum albumin concentration <3.5 g/dL also was associated with a diminished calcitriol response (geometric mean final PTH, 19% higher; 95% CI, 6%-35%). Although numbers were small, concurrent use of benzodiazepines and nonactivated vitamin D supplements was associated with a significantly greater PTH response. LIMITATIONS: Clinic-based study is limited by the availability of PTH measurements after starting calcitriol therapy. Study of a predominantly older male population. CONCLUSIONS: In patients with stages 3-4 CKD, African American race and low serum albumin level are associated with a diminished PTH response to oral calcitriol.