Dialysis Organizations Research Articles

Comparative effectiveness of an individualized model of hemodialysis vs conventional hemodialysis: a study protocol for a multicenter randomized controlled trial (the TwoPlus trial)

BackgroundMost patients starting chronic in-center hemodialysis (HD) receive conventional hemodialysis (CHD) with three sessions per week targeting specific biochemical clearance. Observational studies suggest that patients with residual kidney function can safely be treated with incremental prescriptions of HD, starting with less frequent sessions and later adjusting to thrice-weekly HD. This trial aims to show objectively that clinically matched incremental HD (CMIHD) is non-inferior to CHD in eligible patients.MethodsAn unblinded, parallel-group, randomized controlled trial will be conducted across diverse healthcare systems and dialysis organizations in the USA. Adult patients initiating chronic hemodialysis (HD) at participating centers will be screened. Eligibility criteria include receipt of fewer than 18 treatments of HD and residual kidney function defined as kidney urea clearance ≥3.5 mL/min/1.73 m2 and urine output ≥500 mL/24 h. The 1:1 randomization, stratified by site and dialysis vascular access type, assigns patients to either CMIHD (intervention group) or CHD (control group). The CMIHD group will be treated with twice-weekly HD and adjuvant pharmacologic therapy (i.e., oral loop diuretics, sodium bicarbonate, and potassium binders). The CHD group will receive thrice-weekly HD according to usual care. Throughout the study, patients undergo timed urine collection and fill out questionnaires. CMIHD will progress to thrice-weekly HD based on clinical manifestations or changes in residual kidney function. Caregivers of enrolled patients are invited to complete semi-annual questionnaires. The primary outcome is a composite of patients’ all-cause death, hospitalizations, or emergency department visits at 2 years. Secondary outcomes include patient- and caregiver-reported outcomes. We aim to enroll 350 patients, which provides ≥85% power to detect an incidence rate ratio (IRR) of 0.9 between CMIHD and CHD with an IRR non-inferiority of 1.20 (α = 0.025, one-tailed test, 20% dropout rate, average of 2.06 years of HD per patient participant), and 150 caregiver participants (of enrolled patients).DiscussionOur proposal challenges the status quo of HD care delivery. Our overarching hypothesis posits that CMIHD is non-inferior to CHD. If successful, the results will positively impact one of the highest-burdened patient populations and their caregivers.Trial registrationClinicaltrials.gov NCT05828823. Registered on 25 April 2023.

Successful Implementation of Advance Care Planning in National Dialysis Organizations: The HIGHWay Project (RP111)

Successful Implementation of Advance Care Planning in National Dialysis Organizations: The HIGHWay Project (RP111)

Medicare advantage and dialysis facility choice.

To compare the characteristics of dialysis facilities used by traditional Medicare (TM) and Medicare advantage (MA) enrollees with end-stage kidney disease (ESKD). We used 20% TM claims and 100% MA encounter data from 2018 and publicly available data from the Centers for Medicare and Medicaid Services. We compared the characteristics of the dialysis facilities treating TM and MA patients in the same ZIP code, adjusting for patient characteristics. The outcome variables were facility ownership, distance to the facility, and several measures of facility quality. We identified point prevalent dialysis patients as of July 15, 2018. Compared to TM patients in the same ZIP code, MA patients were 1.84 percentage points more likely to be treated at facilities owned by the largest two dialysis organizations and 1.85 percentage points less likely to be treated at an independently owned facility. MA patients went to further and lower quality facilities than TM patients in the same ZIP code. However, these differences in facility quality were modest. For example, while the mean dialysis facility mortality rate was 21.85, the difference in mortality rates at facilities treating MA and TM patients in the same ZIP code was 0.67 deaths per 100 patient-years. Similarly, MA patients went to facilities that were, on average, 0.15 miles further than TM patients in the same ZIP code. MA enrollees with ESKD were more likely than TM enrollees in the same ZIP code to use the dialysis facilities owned by the two largest chains, travel further for care, and receive care at lower quality facilities. While the magnitude of differences in facility distance and quality was modest, the direction of these results underscores the importance of monitoring dialysis network adequacy as ESKD MA enrollment continues to grow.

Artificial Intelligence and Machine Learning in Dialysis: Ready for Prime Time?

Artificial Intelligence and Machine Learning in Dialysis: Ready for Prime Time?

The US Supreme Court and Future of Financing Dialysis Care.

The US Supreme Court and Future of Financing Dialysis Care.

Change in Payment Method and the Use of Etelcalcetide and PTH Values Among Dialysis Patients in Two Dialysis Organizations

Change in Payment Method and the Use of Etelcalcetide and PTH Values Among Dialysis Patients in Two Dialysis Organizations

Policy and Kidney Community Engagement to Advance toward Greener Kidney Care.

Policy and Kidney Community Engagement to Advance toward Greener Kidney Care.

Housing: A Critical Contributor to Kidney Disease Disparities.

Housing: A Critical Contributor to Kidney Disease Disparities.

Keys to Driving Implementation of the New Kidney Care Models.

Contemporary nephrology practice is heavily weighted toward in-center hemodialysis, reflective of decisions on infrastructure and personnel in response to decades of policy. The Advancing American Kidney Health initiative seeks to transform care for patients and providers. Under the initiative's framework, the Center for Medicare and Medicaid Innovation has launched two new care models that align patient choice with provider incentives. The mandatory ESRD Treatment Choices model requires participation by all nephrology practices in designated Hospital Referral Regions, randomly selecting 30% of all Hospital Referral Regions across the United States for participation, with the remaining Hospital Referral Regions serving as controls. The voluntary Kidney Care Choices model offers alternative payment programs open to nephrology practices throughout the country. To help organize implementation of the models, we developed Driver Diagrams that serve as blueprints to identify structures, processes, and norms and generate intervention concepts. We focused on two goals that are directly applicable to nephrology practices and central to the incentive structure of the ESRD Treatment Choices and Kidney Care Choices: (1) increasing utilization of home dialysis, and (2) increasing the number of kidney transplants. Several recurring themes became apparent with implementation. Multiple stakeholders from assorted backgrounds are needed. Communication with primary care providers will facilitate timely referrals, education, and comanagement. Nephrology providers (nephrologists, nursing, dialysis organizations, others) must lead implementation. Patient engagement at nearly every step will help achieve the aims of the models. Advocacy with federal and state regulatory agencies will be crucial to expanding home dialysis and transplantation access. Although the models hold promise to improve choices and outcomes for many patients, we must be vigilant that they not do reinforce existing disparities in health care or widen known racial, socioeconomic, or geographic gaps. The Advancing American Kidney Health initiative has the potential to usher in a new era of value-based care for nephrology.

Etelcalcetide Versus Cinacalcet in Hemodialysis Patients in the United States: A Facility Calcimimetic Approach to Assess Real-World Effectiveness

Rationale & ObjectiveSome US hemodialysis (HD) facilities switched from oral cinacalcet to intravenous etelcalcetide as the primary calcimimetic therapy to control parathyroid hormone (PTH) levels after the introduction of etelcalcetide in 2017. Although clinical trials have demonstrated the superior efficacy of etelcalcetide versus cinacalcet, evidence comparing real-world effectiveness is lacking.Study DesignProspective cohort.Setting & ParticipantsPatients receiving HD enrolled in US Dialysis Outcomes and Practice Patterns Study facilities.ExposureWe classified HD facilities on the basis of whether >75% of calcimimetic users were prescribed etelcalcetide (“etelcalcetide-first”) or cinacalcet (“cinacalcet-first”) from March-August 2019.OutcomesPTH, calcium, and phosphorus levels among calcimimetic users, all averaged in the 6 months after the exposure assessment period.Analytical ApproachWe used adjusted linear regression to compare outcomes using 2 approaches: (1) cross-sectional comparison of etelcalcetide-first and cinacalcet-first HD facilities; (2) pre-post comparison of HD facilities that switched from cinacalcet-first to etelcalcetide-first using facilities that remained cinacalcet-first as a comparison group.ResultsWe identified 45 etelcalcetide-first and 67 cinacalcet-first HD facilities; etelcalcetide-first (vs cinacalcet-first) facilities were more likely to be from small or independent dialysis organizations (86% vs 22%) and had higher total calcimimetic use (43% vs 29%) and lower active vitamin D use (66% vs 82%). In the cross-sectional analysis comparing etelcalcetide-first and cinacalcet-first HD facilities, the adjusted mean difference in PTH levels was −115 pg/mL (95% CI, −196 to −34) and the prevalence of a PTH level of >600 pg/mL was lower (prevalence difference, −11.4%; 95% CI, −19.3% to −3.5%). Among facilities that switched to etelcalcetide-first, the mean PTH level decreased from 671 to 484 pg/mL and the prevalence of a PTH level of >600 pg/mL decreased from 39% to 21%. Among facilities that remained cinacalcet-first, the mean PTH level increased from 632 to 698 pg/mL and the prevalence of a PTH level of >600 pg/mL increased from 37% to 43%. The adjusted difference-in-difference between the switch to etelcalcetide-first and the continuation of cinacalcet-first was −169 pg/mL (−249 to −90 pg/mL) for the mean PTH and −14.4% (−22.0% to −6.8%) for a PTH level of >600 pg/mL. We also observed slightly lower serum calcium levels and minimal differences in serum phosphorus levels between the etelcalcetide-first and the cinacalcet-first facilities.LimitationsResidual confounding.ConclusionsWe observed better PTH control in HD facilities that switched from using cinacalcet to etelcalcetide as the primary calcimimetic therapy. Further research is needed to investigate how the greater real-world effectiveness of intravenous etelcalcetide (vs oral cinacalcet) may affect clinical outcomes.

Dialysis Organization Online Information on Kidney Failure Treatments: A Content Analysis Using Corpus Linguistics

Rationale & ObjectiveDialysis organizations’ websites may influence patient decision making, but the websites have received almost no consideration. We investigated how/whether these websites present all kidney replacement therapy options and how the quality of life of these options is portrayed.Study DesignContent analysis using corpus linguistics (computer-assisted language analysis).SettingWebsite content aimed at patients from the 2 major dialysis organizations’ websites, totaling 226,968 words. The analysis took place from November 12, 2020, to March 30, 2021.Analytical ApproachWe used linguistic software (AntConc) to document the frequencies of words needed to present treatment options and quality of life information.ResultsOver both sites, dialysis mentions outstripped transplantation mentions. Organization A did not appear to reference conservative kidney management. Organization B mentioned dialysis more often than conservative management, at a ratio of 34:1. Organization A did not attribute symptoms to dialysis, whereas organization B had 12 mentions of dialysis-induced symptoms out of 87 total symptom references. Both organizations framed life on dialysis optimistically, suggesting that patients can continue to engage in “work,” “sex,” or “travel”; organization A referenced sex, work, and/or travel 123 times and organization B referenced these 262 times.LimitationsWe used quantitative analysis and linked ideas with certain keywords. We did not conduct a detailed qualitative inquiry.ConclusionsThe websites emphasized dialysis as a treatment for kidney failure, and the quality of life on dialysis was framed very optimistically. Qualitative studies of treatment modalities and the quality of life on dialysis in the patient-targeted material of dialysis organizations are needed.

Breaking the Barriers to Innovation in Kidney Care: The Time is Now.

Breaking the Barriers to Innovation in Kidney Care: The Time is Now.

ETC Model: How One Small Dialysis Organization Is Navigating Uncharted Policy Waters.

The ETC model proposes to increase access to home dialysis and transplant for patients with ESRD. Implementation of this model is happening while many dialysis organizations are still suffering the far-reaching effects of the coronavirus disease 2019 (COVID-19) pandemic. In addition, the model has the potential to negatively affect small and independent dialysis organizations disproportionately. It incentivizes home dialysis over transplant and promotes development of new home dialysis programs, rewards achievement over improvement, and places an excessive burden on small and independent dialysis organizations. Advantages of the program include the focus on self-care as an acceptable alternative to home dialysis for some patients and the potential for some organizations to make improvements in care with increased reimbursements. The authors hope that the Centers for Medicare and Medicaid Services will address many of these concerns in updated rulemaking and guidance.

Calcimimetic use in US hemodialysis facilities in first 2 years after the launch of etelcalcetide: A descriptive analysis of real-world clinical practice and outcomes.

This study described control of parathyroid hormone (PTH), phosphorus, and corrected calcium in adults initiating calcimimetics in small dialysis organizations after the introduction of etelcalcetide. This retrospective study using Visonex Clarity electronic health records between October 1, 2017, and December 31, 2019, identified adults ≥ 18 years of age receiving in-center hemodialysis as either a cinacalcet or etelcalcetide initiator based on their first calcimimetic use in 2018 (index date) with no prior calcimimetic use in the 3months preindex date. Patients were stratified by PTH at index date and were followed for 15 months. Subcohorts of patients who were persistent on a single calcimimetic for 15 months and of patients who had their calcimimetic changed from cinacalcet to etelcalcetide were also analyzed. A total of 677 patients initiated cinacalcet and 711 initiated etelcalcetide. Mean PTH (pg/ml), phosphorus, and corrected calcium (mg/dl) at baseline were 864, 5.9, and 9.3 for cinacalcet and 804, 5.9, and 9.4 for etelcalcetide, respectively. During follow-up, the proportion of initiators considered in-target (monthly average PTH < 600) increased from 48% to 62% with cinacalcet and from 56% to 86% with etelcalcetide in the baseline PTH 600 to < 800 subgroup; increased from 30% to 64% with cinacalcet and 31% to 59% with etelcalcetide among those with baseline PTH 800 to < 1000; and increased from 14% to 41% with cinacalcet and 12% to 58% with etelcalcetide among those with baseline PTH ≥1000. A similar pattern was observed for persistent users (n=646). For patients changed from cinacalcet to etelcalcetide (n=183), the proportion of patients considered in-target increased from 22% in the month prior to the treatment change to 51% in Month 6 postchange. Patients initiating calcimimetics at lower baseline PTH had better biochemical control than patients starting at higher PTH. Patients changed from cinacalcet to etelcalcetide had improvements in PTH control postchange.

A randomized controlled trial of two dialysate sodium concentrations in hospitalized hemodialysis patients.

Several large dialysis organizations have lowered the dialysate sodium concentration (DNa) in an effort to ameliorate hypervolemia. The implications of lower DNa on intra-dialytic hypotension (IDH) during hospitalizations of hemodialysis (HD) patients is unclear. In this double-blind, single center, randomized controlled trial (RCT), hospitalized maintenance HD patients were randomized to receive higher (142 mmol/L) or lower (138 mmol/L) DNa for up to six sessions. Blood pressure (BP) was measured in a standardized fashion pre-HD, post-HD and every 15 min during HD. The endpoints were: (i) the average decline in systolic BP (pre-HD minus lowest intra-HD, primary endpoint) and (ii) the proportion of total sessions complicated by IDH (drop of ≥20 mmHg from the pre-HD systolic BP, secondary endpoint). A total of 139 patients completed the trial, contributing 311 study visits. There were no significant differences in the average systolic blood pressure (SBP) decline between the higher and lower DNa groups (23 ± 16 versus 26 ± 16 mmHg; P = 0.57). The proportion of total sessions complicated by IDH was similar in the higher DNa group, compared with the lower DNa group [54% versus 59%; odds ratio 0.72; 95% confidence interval (95% CI) 0.36-1.44; P = 0.35]. In post hoc analyses adjusting for imbalances in baseline characteristics, higher DNa was associated with 8 mmHg (95% CI 2-13 mmHg) less decline in SBP, compared with lower DNa. Patient symptoms and adverse events were similar between the groups. In this RCT for hospitalized maintenance of HD patients, we found no difference in the absolute SBP decline between those who received higher versus lower DNa in intention-to-treat analyses. Post hoc adjusted analyses suggested a lower risk of IDH with higher DNa; thus, larger, multi-center studies to confirm these findings are warranted.

Trends in Dialysis Industry Consolidation After Medicare Payment Reform, 2006-2016

The dialysis industry is highly concentrated, with large dialysis organizations now providing dialysis for more than 85% of patients with kidney failure in the United States. In 2011, Medicare introduced a new Prospective Payment System (PPS) for end-stage kidney disease, which bundled payment for dialysis care into 1 payment per patient. Trends in dialysis facility consolidation after the PPS went into effect are unknown. To determine whether the introduction of the PPS in 2011 was associated with an acceleration in acquisitions and closures of small dialysis chains (<20 facilities) and independently owned facilities. This retrospective cohort study included all Medicare-certified independent or small chain-affiliated dialysis facilities in the continental US between 2006 and 2016. Data were obtained from Medicare and the US Renal Data System and were analyzed in 2020. The PPS. Discrete time hazard models were used to estimate the odds of acquisition and closure before the PPS (2006-2010) vs after the PPS (2011-2016). Analyses controlled for facility, market, and regional demographic characteristics. The average predicted marginal probabilities of acquisition and closure over time were estimated. The proportion of small chain-affiliated and independently owned facilities declined from 29% (1383 of 4750 facilities) in 2006 to 15% (1038 of 6738) in 2016. Among 13 481 facility-years, 6352 (47%) were for profit, and mean (SD) census was 68 (59) patients. Overall, 3286 (24%) facilities opened during the observation period. The proportion of acquisitions that occurred each year varied from 1.1% (12 of 1065 facilities in 2015) to 7.2% (86 of 1192 facilities in 2012), while closures varied from 0.8% (9 of 1065 facilities in 2015) to 2.2% (28 of 1286 facilities in 2010), making both fairly rare. There was a 3.48 higher odds of acquisition in the post-PPS period compared with the pre-PPS period (95% CI, 1.62-7.47; P = .001). The odds of closure before and after the PPS were not statistically significantly different (odds ratio, 2.03; 95% CI, 0.61-6.73; P = .25). Facilities that opened during the observation period had a 7.2% higher predicted probability of acquisition compared with older facilities (95% CI, 5.4%-9.0%; P < .001). In this cohort study of continental US Medicare-certified dialysis facilities, small-chain and independently owned facilities retained a declining share of the dialysis market. Further research should evaluate the effect of continued dialysis market consolidation on patient access, health care utilization, and clinical outcomes.

PDB30 Calcimimetic Use in United States (US) Hemodialysis Facilities in First Two Years after Launch of Etelcalcetide

This study described control of parathyroid hormone (PTH), and corresponding corrected calcium (Ca) and phosphorous in adults initiating calcimimetics during 2018 in small dialysis organizations after the introduction of etelcalcetide. This retrospective study using Visonex® Clarity electronic health records between 10/1/2017 and 12/31/2019 identified adults ≥18 years of age receiving in-center hemodialysis as either a cinacalcet or etelcalcetide initiator based on their first calcimimetic use in 2018 (index date) with no prior calcimimetic use in the 3 months pre-index date. Patients were stratified by PTH at baseline and were followed for 15 months from index date. Sub-groups of patients who were persistent on a single calcimimetic for 15 months and of patients who switched from cinacalcet to etelcalcetide were also analyzed. 677 patients initiated cinacalcet and 711 initiated etelcalcetide. Mean PTH (pg/mL), phosphorus and Ca (mg/dL) at baseline were 864, 5.9 and 9.3 for cinacalcet and 804, 5.9 and 9.4 for etelcalcetide. Over 15 months of follow-up the proportion of initiators with baseline PTH 600-<800 considered “in-target” (monthly average PTH <600) increased from 48% to 62% with cinacalcet and from 56% to 86% with etelcalcetide; among those with baseline PTH 800-<1000, the proportion increased from 30% to 64% with cinacalcet and 31% to 59% with etelcalcetide; and among those with baseline PTH ≥1000 this proportion increased from 14% to 41% with cinacalcet and 12% to 58% with etelcalcetide. A similar pattern was observed for persistent users (n=646). For patients switching from cinacalcet to etelcalcetide (n=183), the proportion of patients considered “in-target” increased from 22% in the month prior to switch to 51% in month 6 post-switch. Patients initiating calcimimetics at higher baseline PTH had poorer biomarker control than patients starting at lower PTH. Patients switched from cinacalcet to etelcalcetide had improvements in PTH control post-switch.

Systematic Review of Safety and Efficacy of COVID-19 Vaccines in Patients With Kidney Disease

Systematic Review of Safety and Efficacy of COVID-19 Vaccines in Patients With Kidney Disease

Evaluating national trends in outcomes after implementation of a star rating system: Results from dialysis facility compare.

To examine which factors are driving improvement in the Dialysis Facility Compare (DFC) star ratings and to test whether nonclinical facility characteristics are associated with observed longitudinal changes in the star ratings. Data were collected from eligible patients in over 6,000 Medicare-certified dialysis facilities from three annual star rating and individual measure updates, publicly released on DFC in October 2015, October 2016, and April 2018. Changes in the star rating and individual quality measures were investigated across three public data releases. Year-to-year changes in the star ratings were linked to facility characteristics, adjusting for baseline differences in quality measure performance. Data from publicly reported quality measures, including standardized mortality, hospitalization, and transfusion ratios, dialysis adequacy, type of vascular access for dialysis, and management of mineral and bone disease, were extracted from annual DFC data releases. The proportion of four- and five-star facilities increased from 30.0% to 53.4% between October 2015 and April 2018. Quality improvement was driven by the domain of care containing the dialysis adequacy and hypercalcemia measures. Additionally, independently owned facilities and facilities belonging to smaller dialysis organizations had significantly lower odds of year-to-year improvement than facilities belonging to either of the two large dialysis organizations (Odds Ratio [OR]: 0.736, 95% Confidence Interval [CI]: 0.631-0.856 and OR: 0.797, 95% CI: 0.723-0.879, respectively). The percentage of four- and five-star facilities has increased markedly over a three-year time period. These changes were driven by improvement in the specific quality measures that may be most directly under the control of the dialysis facility.

Home Dialysis in the Coronavirus Disease 2019 Era.

The coronavirus disease 2019 pandemic has had a significant impact on patients with end-stage kidney disease and their care, especially given the potential for severe coronavirus disease 2019 in those with a depressed immune status. Patients receiving in-center hemodialysis have been particularly affected by this pandemic because of their need to travel multiple times a week to receive treatment. Although patients on home dialysis are able to avoid such exposure, they face their own unique challenges. In this review, we will discuss the challenges posed by the coronavirus disease 2019 pandemic for patients on home dialysis, the impact of coronavirus disease 2019 on various aspects of their care, and the resultant rapid adaptations in policy/health-care delivery mechanisms with implications for the future care of patients on home dialysis.