In-Center Hemodialysis: Time for a Paradigm Shift

In-Center Hemodialysis: Time for a Paradigm Shift

Chronic hemodialysis (HD) in the United States is almost universally conducted on a thrice-weekly schedule, which means sessions are spaced 2 or 3 days apart. Kjellstrand et al.¹ have described the “unphysiology” of dialysis, given that solutes and extracellular volume gradually increase between HD sessions and peak at the end of the 3-day interval. Not surprisingly, extracellular volume overload, right atrial and right ventricle dilation, cardiovascular hospitalizations, and mortality are highest on the day after the 3-day interval.² Accordingly, the first dialysis of the week is often characterized by high ultrafiltration rates and rapid shifts in electrolyte and acid-base balance, which provide a mechanistic explanation for why patients are at higher risk of mortality and hospitalization at that time.

Almost 20 years ago, to address this heightened risk, Scribner and Twardowski³ proposed every-other-day dialysis (EODD). These pioneers in dialysis recognized the obstacles to putting this approach into practice but argued that improved health-related quality of life (HRQoL) would lead to increasing acceptance by patients, medical staff, and dialysis organizations.

Implementing EODD poses challenges to patients, providers, and payers. However, the likelihood of improved clinical outcomes should motivate all stakeholders to develop innovative approaches. Optimal planning of an EODD pilot study would use a process similar to that advocated by the Patient-Centered Outcomes Research Institute, in which all stakeholders participate. If such a pilot study is successful, broader implementation would require regular follow-up stakeholder meetings.

Effects on Patients

The Frequent Hemodialysis Network trial (FHN) demonstrated beneficial effects of more frequent HD, including a significant decrease in left ventricular mass index⁴ in patients undergoing HD six times weekly compared with those receiving conventional thrice-weekly HD. We recognize that receiving more-frequent dialysis in the FHN trial was associated with adverse effects on residual renal function (RRF) and vascular access. However, EODD is less demanding than dialysis five or six times a week because it entails only two versus eight to 12 extra treatments every 4 weeks. Accordingly, we postulate that EODD will achieve many of the benefits of more frequent HD without producing adverse effects on RRF or vascular access.

The approach to incident patients requires special consideration, in light of the rapid decrease in RRF and high mortality in the first 12 months of HD. Given that incremental HD may be associated with better preservation of RRF, some investigators have argued that the use of this modality, rather than more frequent HD, may improve clinical outcomes in incident patients.⁵

We anticipate that patients may initially resist adopting a new dialysis schedule that changes weekly and includes two Sundays a month. Automated text messaging, which decreases the frequency of missed treatments, can be used to encourage adherence with dialysis schedules. If EODD results in a decrease in hospitalizations and an improvement in HRQoL, this may foster increasing acceptance of the approach.⁶

Transportation issues may pose a significant challenge to implementing EODD. Fortunately, the increasing availability of innovations such as Uber Health, which allows medical facilities to book transportation on their clients’ behalf, may facilitate adherence with a dialysis schedule that includes different treatment days from week to week.

Patients who undergo frequent home dialysis face many of their own challenges, including long-term patient and family stress, the need for a support person, dealing with equipment storage, and difficulty cannulating the vascular access. Therefore, it seems reasonable that the lack of these challenges with in-center EODD may make it substantially more acceptable to patients compared with frequent home HD.

Effects on Providers

Although EODD would incur additional labor, utility, and maintenance costs for providers, some of these additional costs may be mitigated. For example, providers who keep an outpatient HD facility open on Sundays to dialyze participants in the EODD pilot study could also treat patients on a conventional thrice-weekly schedule who missed a treatment during the week or who need an extra treatment because of volume overload, severe hypertension, or hyperkalemia. Having two extra scheduled treatments a month with EODD also may allow a provider to still bill for 13 treatments a month even if a patient has missed one or two scheduled treatments because of hospitalization. In addition, patients on HD who currently visit an emergency department on Sundays and require admission for emergent treatment could instead be treated at the open outpatient HD facility. Because EODD may reduce hospitalizations, facilities that are participating in an ESRD Seamless Care Organization (ESCO) might receive a significant benefit. Lastly, if EODD leads to improved survival, an increase in the prevalent HD population would help improve providers’ financial performance.

Ensuring adequate staffing for all shifts represents a major challenge to implementing EODD. We recognize that higher job satisfaction among HD nurses and technicians is associated with increased attention to patients’ psychosocial and educational needs.⁷ Therefore, both patient care employees and technical staff must have significant roles in the planning and implementation of EODD. Some current staff members may not be able to work Sundays, some may actually prefer working a Sunday daytime shift to a Friday or Saturday evening shift, and some may be initially resistant to the idea but will likely agree if the financial incentives are appropriate. Arrangements must be made to ensure adequate time for achieving optimal performance of the technical aspects of dialysis, including maintaining water quality and dialysis machines, as well as ongoing quality control and assurance.

Effects on Payers

Although the direct cost for EODD procedures will increase because of the two extra treatments every 4 weeks for EODD compared with conventional HD, the total cost per patient may decrease because of fewer days in the hospital and emergent dialysis sessions. However, if the anticipated improvement in patient survival gradually increases the number of patients on prevalent HD, the total cost of the ESRD program would increase accordingly.

Alternative payment models (APMs), including ESCOs, are increasing in popularity. However, because participation in APMs is voluntary, assessment of clinical outcomes is subject to possible selection bias. To address this, Levy et al.⁸ have advocated a trial of mandatory participation in an APM. If a pilot study demonstrates feasibility and safety, a series of planning meetings with representatives from the Center for Medicare and Medicaid Innovation and commercial payers should follow.

We recognize the formidable challenges in implementing EODD. Katopodis et al.⁹ conducted a small, 12-month, randomized clinical trial of EODD versus thrice-weekly HD. Patients in the EODD arm experienced significant reductions in body weight, BP, and left ventricular mass. Although observational studies^6,10 conducted outside the United States have shown that it is possible to overcome the challenges of conducting EODD, implementing it in the United States will require careful planning with input from all stakeholders.

We propose that it is time to consider conducting a multicenter pilot study of EODD. Specifically, we envision a study designed to address the following questions related to feasibility and safety: (1) Can facilities managed by for-profit and not-for-profit providers implement a program of EODD, given the challenges inherent in operating 7 days a week? (2) Can such facilities recruit adequate numbers of staff members and patient participants, and will they adhere to a schedule that changes weekly? (3) Will facilities with an EODD program detect a significant safety signal?

To address these questions, an EODD pilot study would monitor primary outcomes such as hospitalizations and mortality, vascular access outcomes, and changes in RRF, left ventricular mass index, and HRQoL; and financial performance. It would also monitor secondary outcomes, such as interdialytic weight gain and BP control. Given the rapid growth of alternate payment plans, the pilot study may include some facilities within an ESCO.⁸ Data from a pilot study would provide valuable guidance on the potential benefits of EODD and its possible implementation in the United States.

Disclosures

A.G. and P.Z. are employees of Dialysis Clinic, Inc.