Palliative dialysis: Addressing the need for alternative dialysis delivery modes.

For some patients with kidney failure, particularly those who have limited life expectancy or severe comorbidities, the "standard" dialysis treatment regimen may be perceived as excessively burdensome and may not align well with the patient's own priorities. For such patients, a palliative approach to the provision of dialysis-whereby treatment is tailored to the needs of the individual so as to optimize quality of life and minimize disease-related symptoms, but limit treatment burden-might offer a way to better align the delivery of care with the life goals of the patient. Here, we discuss the fundamental principles of palliative dialysis: the patients who might most benefit from this approach, treatment strategies and considerations for implementation, as well as potential barriers to its provision.

The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration.

BACKGROUND: Data from clinical trials to inform practice in maintenance hemodialysis are limited. Incorporating randomized trials into dialysis clinical care delivery should help generate practice-guiding evidence, but the feasibility of this approach has not been established. METHODS: To develop approaches for embedding trials into routine delivery of maintenance hemodialysis, we performed a cluster-randomized, pragmatic trial demonstration project, the Time to Reduce Mortality in ESRD (TiME) trial, evaluating effects of session duration on mortality (primary outcome) and hospitalization rate. Dialysis facilities randomized to the intervention adopted a default session duration ≥4.25 hours (255 minutes) for incident patients; those randomized to usual care had no trial-driven approach to session duration. Implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data. We used multiple strategies to engage facility personnel and participating patients. RESULTS: The trial enrolled 7035 incident patients from 266 dialysis units. We discontinued the trial at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. For the primary analysis population (participants with estimated body water ≤42.5 L), mean session duration was 216 minutes for the intervention group and 207 minutes for the usual care group. We found no reduction in mortality or hospitalization rate for the intervention versus usual care. CONCLUSIONS: Although a highly pragmatic design allowed efficient enrollment, data acquisition, and monitoring, intervention uptake was insufficient to determine whether longer hemodialysis sessions improve outcomes. More effective strategies for engaging clinical personnel and patients are likely required to evaluate clinical trial interventions that are fully embedded in care delivery.

Redefining Medication Management in Dialysis: A Kidney Pharmacy Quality Pyramid.

Patients with end-stage renal disease treated with dialysis are often prescribed complex medication regimens, placing them at risk for drug-drug interactions and other medication-related problems. Particularly in the context of a broader interest in more patient-centered value-based care, improving medication management is an increasingly important focus area. However, current medication management metrics, designed for the broader patient population, may not be well suited to the specific needs of patients with kidney disease, especially given the complexity of medication regimens used by dialysis patients. We propose a kidney pharmacy-focused quality pyramid that is intended to provide a framework to guide dialysis organizations, health care providers, and/or clinicians with respect to an optimal medication management approach for dialysis patients. Incorporation of core programs in medication management, including medication reconciliation, safety programs, and medication therapy management for patients at high risk for medication-related problems, may result in improved outcomes. Although a growing body of evidence supports the concept that active medication management can improve medication adherence and reduce medication-related problems, these strategies are viewed as costly and are not widely deployed. However, if done effectively, pharmacy-led medication management has the potential to be one of the more cost-effective disease management strategies and may greatly improve outcomes for these complex patients.

Greater access to transplantation should be a priority: A view of the Dialysis PATIENTS Demonstration Act.

Fragmentation of care has been cited as a rationale toward moving to new care models with care coordination and a focus on value-based care delivery. This trend is gathering momentum in end-stage renal disease (ESRD) care given evident care gaps and the variety of healthcare entities that touch patients with ESRD in the course of their treatment. Although care models supported by chronic condition special needs plans and ESRD seamless care organizations (ESCOs) have advanced care and cost-effectiveness, their shortcomings limit their ability to support larger patient populations. New care models and potential organizational structures, such as those proposed in the Dialysis Patient Access To Integrated-care, Empowerment, Nephrologists, Treatments, and Services (PATIENTS) Demonstration Act, provide another approach toward reducing fragmentation of care, increasing patient health, and helping define better approaches to care for patients with ESRD so that they have the opportunity to be better transplant candidates. We recognize that this type of innovation represents change without certainty. We also believe that multiple levels of accountability, ongoing support for transplantation, and continued freedom of access to transplant professionals who participate in Medicare would prioritize patient health, quality of life, and choice with regard to transplantation with this care model.

Hepatitis C virus infection in patients with end-stage renal disease.

Chronic hepatitis C virus (HCV) infection is a major global health problem affecting 3-5 million people in the United States and over 100 million worldwide. Chronic HCV infection, which can lead to cirrhosis and hepatocellular carcinoma, also results in numerous other complications, including impairment of renal function. Because HCV is most often transmitted via parenteral exposure to blood or blood products, patients with end-stage renal disease (ESRD) treated with hemodialysis are at particular risk for infection. Historically, the medications available to treat HCV infection in these patients had significant side effects and were not particularly effective in generating a sustained virologic response. Since 2011, a number of direct-acting antiviral therapies have emerged that can lead to virological cure in the vast majority of patients, with low pill burden and few side effects. Here, we describe the biology and pathophysiology of HCV infection, and summarize current information on new therapies, with a particular focus on their application in patients with chronic kidney disease including ESRD.

Effects of Oral Nutritional Supplements on Mortality, Missed Dialysis Treatments, and Nutritional Markers in Hemodialysis Patients.

OBJECTIVE: Protein-energy wasting is common in end-stage renal disease patients undergoing dialysis and is strongly associated with mortality and adverse outcomes. Intradialytic oral nutritional supplements (ONS) reduce risk of mortality in these patients. Large studies characterizing the impact of ONS on other outcomes are lacking. We assessed the associations between administration of ONS and clinical and nutritional outcomes. DESIGN: Retrospective evaluation of a pilot program providing ONS to patients at a large dialysis organization in the United States. The pilot program provided ONS to in-center hemodialysis patients with serum albumin ≤3.5 g/dL at 408 facilities. SUBJECTS: ONS patients were compared to matched controls with serum albumin ≤3.5 g/dL, identified from facilities not participating in the ONS program (n = 3,374 per group). INTERVENTION: Receipt of ONS. MAIN OUTCOME MEASURES: Death, missed dialysis treatments, hospitalizations, serum albumin, normalized protein catabolic rate, and postdialysis body weight were abstracted from large dialysis organization electronic medical records. RESULTS: There was a 69% reduction in deaths (hazard ratio = 0.31; 95% confidence interval = 0.25-0.39), and 33% fewer missed dialysis treatments (incidence rate ratio = 0.77; 95% confidence interval = 0.73-0.82) among ONS patients compared to controls (P < .001 for both). The effects of ONS on nutritional indices were mixed: serum albumin was lower, whereas normalized protein catabolic rate values, a surrogate for dietary protein intake, and postdialysis body weights were higher for ONS patients compared to controls during follow-up. CONCLUSIONS: Our evaluation confirmed the beneficial effects of ONS in reducing mortality and improving some indices of nutritional status for hypoalbuminemic hemodialysis patients. We also report the novel finding that ONS can reduce the number of missed dialysis treatments. These results support the use of intradialytic ONS as an effective intervention to improve the outcomes in hemodialysis patients with low serum albumin.

Nephrologists and Integrated Kidney Disease Care: Roles and Skills Essential for Nephrologists for Future Success.

As the costs of caring for patients with end-stage renal disease have grown, so has the pressure to provide high-quality care at a lower cost. Prompted in large part by regulatory and legislative changes, reimbursement is shifting from a fee-for-service environment to one of value-based payment models. Nephrologists in this new environment are increasingly responsible not only for direct patient care, but also for population management and the associated clinical outcomes for this vulnerable population. This Perspective article aims to recognize the key role and skills needed in order to successfully practice within these new value-based care models. The new paradigm of delivering and financing care also presents opportunities for nephrologists to shape how care is delivered, define meaningful quality metrics, and share in the financial outcomes of these approaches. Though it will take time, the training and mind-set of nephrologists must evolve to accommodate these expanded practice expectations required by a system that demands measurement, reporting, accountability, and improvement, not only for individuals but also for populations of patients.

Dialysate Potassium, Serum Potassium, Mortality, and Arrhythmia Events in Hemodialysis: Results From the Dialysis Outcomes and Practice Patterns Study (DOPPS).

BACKGROUND: Sudden death is a leading cause of death in patients on maintenance hemodialysis therapy. During hemodialysis sessions, the gradient between serum and dialysate levels results in rapid electrolyte shifts, which may contribute to arrhythmias and sudden death. Controversies exist about the optimal electrolyte concentration in the dialysate; specifically, it is unclear whether patient outcomes differ among those treated with a dialysate potassium concentration of 3 mEq/L compared to 2 mEq/L. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: 55,183 patients from 20 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS) phases 1 to 5 (1996-2015). PREDICTOR: Dialysate potassium concentration at study entry. OUTCOMES: Cox regression was used to estimate the association between dialysate potassium concentration and both all-cause mortality and an arrhythmia composite outcome (arrhythmia-related hospitalization or sudden death), adjusting for potential confounders. RESULTS: During a median follow-up of 16.5 months, 24% of patients died and 7% had an arrhythmia composite outcome. No meaningful difference in clinical outcomes was observed for patients treated with a dialysate potassium concentration of 3 versus 2 mEq/L (adjusted HRs were 0.96 [95% CI, 0.91-1.01] for mortality and 0.98 [95% CI, 0.88-1.08] for arrhythmia composite). Results were similar across predialysis serum potassium levels. As in prior studies, higher serum potassium level was associated with adverse outcomes. However, dialysate potassium concentration had only minimal impact on serum potassium level measured predialysis (+0.09 [95% CI, 0.05-0.14] mEq/L serum potassium per 1 mEq/L greater dialysate potassium concentration). LIMITATIONS: Data were not available for delivered (vs prescribed) dialysate potassium concentration and postdialysis serum potassium level; possible unmeasured confounding. CONCLUSIONS: In combination, these results suggest that approaches other than altering dialysate potassium concentration (eg, education on dietary potassium sources and prescription of potassium-binding medications) may merit further attention to reduce risks associated with high serum potassium levels.

Metabolic Profiling of Impaired Cognitive Function in Patients Receiving Dialysis.

Retention of uremic metabolites is a proposed cause of cognitive impairment in patients with ESRD. We used metabolic profiling to identify and validate uremic metabolites associated with impairment in executive function in two cohorts of patients receiving maintenance dialysis. We performed metabolic profiling using liquid chromatography/mass spectrometry applied to predialysis plasma samples from a discovery cohort of 141 patients and an independent replication cohort of 180 patients participating in a trial of frequent hemodialysis. We assessed executive function with the Trail Making Test Part B and the Digit Symbol Substitution test. Impaired executive function was defined as a score ≥2 SDs below normative values. Four metabolites-4-hydroxyphenylacetate, phenylacetylglutamine, hippurate, and prolyl-hydroxyproline-were associated with impaired executive function at the false-detection rate significance threshold. After adjustment for demographic and clinical characteristics, the associations remained statistically significant: relative risk 1.16 (95% confidence interval [95% CI], 1.03 to 1.32), 1.39 (95% CI, 1.13 to 1.71), 1.24 (95% CI, 1.03 to 1.50), and 1.20 (95% CI, 1.05 to 1.38) for each SD increase in 4-hydroxyphenylacetate, phenylacetylglutamine, hippurate, and prolyl-hydroxyproline, respectively. The association between 4-hydroxyphenylacetate and impaired executive function was replicated in the second cohort (relative risk 1.12; 95% CI, 1.02 to 1.23), whereas the associations for phenylacetylglutamine, hippurate, and prolyl-hydroxyproline did not reach statistical significance in this cohort. In summary, four metabolites related to phenylalanine, benzoate, and glutamate metabolism may be markers of cognitive impairment in patients receiving maintenance dialysis.

Association of Vascular Access Type with Mortality, Hospitalization, and Transfer to In-Center Hemodialysis in Patients Undergoing Home Hemodialysis.

BACKGROUND AND OBJECTIVES: In individuals undergoing in-center hemodialysis (HD), use of central venous catheters (CVCs) is associated with worse clinical outcomes compared with use of arteriovenous access. However, it is unclear whether a similar difference in risk by vascular access type is present in patients undergoing home HD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Our study examined the associations of vascular access type with all-cause mortality, hospitalization, and transfer to in-center HD in patients who initiated home HD from 2007 to 2011 in 464 facilities in 43 states in the United States. Patients were followed through December 31, 2011. Data were analyzed using competing risks hazards regression, with vascular access type at the start of home HD as the primary exposure in a propensity score-matched cohort (1052 patients; 526 with CVC and 526 with arteriovenous access). RESULTS: Over a median follow-up of 312 days, 110 patients died, 604 had at least one hospitalization, and 202 transferred to in-center hemodialysis. Compared with arteriovenous access use, CVC use was associated with higher risk for mortality (hazard ratio, 1.73; 95% confidence interval, 1.18 to 2.54) and hospitalization (hazard ratio, 1.19; 95% confidence interval, 1.02 to 1.39). CVC use was not associated with increased risk for transfer to in-center HD. The results of analyses in the entire unmatched cohort (2481 patients), with vascular access type modeled as a baseline exposure at start of home HD or a time-varying exposure, were similar. Analyses among a propensity score-matched cohort of patients undergoing in-center HD also showed similar risks for death and hospitalization with use of CVCs. CONCLUSIONS: In a large cohort of patients on home HD, CVC use was associated with higher risk for mortality and hospitalization. Additional studies are needed to identify interventions which may reduce risk associated with use of CVCs among patients undergoing home HD.

Delivering Better Quality of Care: Relentless Focus and Starting with the End in Mind at DaVita.

The care of patients with end-stage renal disease has been evolving since the implementation of the Medicare entitlement for ESRD in 1973. Over the past 43 years, patients with ESRD have become increasingly complex with multiple comorbid conditions and the average age of new ESRD patients has continued to climb. Despite these challenges, progress has been made in improving mortality and morbidity, but the pace has generally been slow. The consolidation of the US dialysis industry has afforded large providers to achieve economies of scale and efficiencies. By reinvesting resources in innovative programs, the improvements in outcomes have accelerated. At DaVita, we have reimagined care for our ESRD patients by creating a Patient-Focused Quality Pyramid, an approach to holistic, patient-centered care that builds on the foundation of well-known dialysis metrics like adequacy and anemia management to drive more complex programs like fluid, medication, diabetes, and infection management. The ultimate goal is to improve survival, keep patients healthy and out of the hospital, enhance the patient experience of care, and thereby achieve optimal health-related quality of life. For two consecutive years, DaVita facilities, using this approach, have achieved superior performance in the CMS 5-Star rating program, most recently with 46% of facilities achieving 4 or 5 stars compared with only 23% of facilities outside of DaVita receiving 4 or 5 stars. This rating system has components of fundamentals, and more complex outcomes and our results are an external validation of the success of our approach in improving the lives of patients.

Racial and Ethnic Disparities in Use of and Outcomes with Home Dialysis in the United States.

Home dialysis, which comprises peritoneal dialysis (PD) or home hemodialysis (home HD), offers patients with ESRD greater flexibility and independence. Although ESRD disproportionately affects racial/ethnic minorities, data on disparities in use and outcomes with home dialysis are sparse. We analyzed data of patients who initiated maintenance dialysis between 2007 and 2011 and were admitted to any of 2217 dialysis facilities in 43 states operated by a single large dialysis organization, with follow-up through December 31, 2011 (n =: 162,050, of which 17,791 underwent PD and 2536 underwent home HD for ≥91 days). Every racial/ethnic minority group was significantly less likely to be treated with home dialysis than whites. Among individuals treated with in-center HD or PD, racial/ethnic minorities had a lower risk for death than whites; among individuals undergoing home HD, only blacks had a significantly lower death risk than whites. Blacks undergoing PD or home HD had a higher risk for transfer to in-center HD than their white counterparts, whereas Asians or others undergoing PD had a lower risk than whites undergoing PD. Blacks irrespective of dialysis modality, Hispanics undergoing PD or in-center HD, and Asians and other racial groups undergoing in-center HD were significantly less likely than white counterparts to receive a kidney transplant. In conclusion, there are racial/ethnic disparities in use of and outcomes with home dialysis in the United States. Disparities in kidney transplantation evident for blacks and Hispanics undergoing home dialysis are similar to those with in-center HD. Future studies should identify modifiable causes for these disparities.