Abstract

More frequent dialysis, typically performed five to six times per week at home, has been associated with a number of clinical, cardiovascular, and health-related quality of life (HRQOL) benefits. Daily therapy often results in a burden for patients and care partners. A continuous quality improvement (CQI) initiative was conducted to evaluate if an alternate day, longer duration therapy (3.5 treatments with six to 10 hour treatments per week) would provide a viable alternative for home hemodialysis (HHD). This initiative demonstrated that every other day (EOD) nocturnal HD is a feasible alternative option to daily HHD and should be considered to individualize home dialysis therapy.

Introduction

There is considerable evidence that more frequent dialysis is a superior treatment of end-stage renal disease compared to conventional thrice weekly hemodialysis (CHD). However, there is no consensus regarding the “optimal frequency” of dialysis.

CHD remains the most prevalent dialysis prescription worldwide for patients suffering from ESRD; however, mortality remains high despite recent improvements. Only 50% of dialysis patients are still alive after three years,1 with the long (two-day) interdialytic interval, in particular, presenting a heightened risk for patients.2

More frequent dialysis, typically performed five to six times per week in a home environment, has been associated with a number of improved clinical outcomes, including increased survival and cardiovascular function, lower incidence of dialysis-induced cardiac injury (myocardial stunning), and control of hypertension and hyperphosphatemia. Frequent dialysis has also been associated with a number of HRQOL benefits, including improved mental and physical health, less time to recover from dialysis, reduced depressive symptoms, restless legs, and sleep disorders.3,4,5,6,7,8,9,10,11

While it intuitively makes sense to replace 24/7 functioning kidneys with daily therapy, more frequent therapy presents a number of challenges to health professionals, patients and their families. Frequent HD typically involves higher dialysis treatment costs, the potential for increased vascular access interventions,3 and increased burden of therapy. Burden of therapy in particular can be a major challenge to HHD patients and their partners, often leading to “burn-out” and drop-out with return to in-center HD.

One alternative for patients and their care partners experiencing burn-out is to reduce the frequency of treatments from five to six treatments per week to an every other day schedule (EOD = 3.5 treatments per week), and at the same time increasing the duration of therapy from two to four hours to six to 10 hours. Typically, this regimen results in an increase in total weekly treatment time from 15-20 hours to 25-30 hours, but seven to 10 fewer treatments per month.

Schiller-figure1

This form of therapy is common in Australia and New Zealand where home dialysis accounts for 28% and 51% of the dialysis population, respectively.12 Alternate day/night therapy accounts for 32% of all HHD and 89% of all nocturnal hemodialysis (NHD) in Australia.13 The Australian experience reports positive clinical outcomes when utilizing this therapy regimen, including improved phosphate control, volume control, and patient wellbeing.13

Read also: Education key to increasing home dialysis 

Due to high drop-out rates in our HHD program, with burden of therapy being the major cause, we initiated a CQI program to examine if a less frequent (3.5 treatments per week) and extended hours (six to 10 hours per treatment) therapy regimen would allow for adequate dialysis delivery. We used the SystemOneTM (NxStage Medical, Lawrence Mass.), a portable, HHD machine approved for nocturnal hemodialysis by the U.S. Food and Drug Administration in December 2014. We hypothesized that this regimen may help reduce the burden of therapy and provide a viable alternative to allow individualized home hemodialysis for our patients.

Methods

Six Satellite Healthcare-WellBound dialysis centers participated in the CQI program. Prevalent stable HHD patients, prescribed HHD five to six days per week with the NxStage SystemOne, were invited to participate. All interested patients were evaluated by a multidisciplinary team, including nephrologists, nursing team, social workers, and other health workers as required. Only patients judged to be clinically stable per review of laboratory parameters and clinical assessment by their nephrologist and the CQI team were accepted into the program.

During Phase A, participants were asked to continue their routine frequent HHD prescription (five to six days per week) for four weeks. No changes or restrictions were made on treatment duration, blood flow rates, or volume of dialysate delivered. During Phase B, prescriptions were adjusted to 3.5 treatments per week, six to 10 hours per treatment, for a period of eight weeks. The target EOD therapy prescribed was varied according to each participant’s dry weight. As a guide, participants weighing ≤ 60 kg, 60 to ≤ 80 kg, 80 to ≤ 100 kg and > 100 kg were prescribed 30, 40, 50, and 60 liters of dialysate, respectively. Target treatment duration was six to 10 hours. Blood flow rate was maintained constant at 250 ml/min. Dialysate flow rate was set at 62.5–125 mL, resulting in flow fractions (ratio of dialysate flow rate to blood flow rate) of 0.25–0.5. Participants were trained on the use of an infusion pump for delivering anticoagulant and a leak detection device for dialyzing during the night.

Patients were meant to return to baseline prescription during Phase A+ for another four weeks. However, several patients decided to remain on the alternate day schedule.

Data collection

Data collected for this study included patient demographics, ESRD history, dialysis prescription, vascular access type, comorbidities, medication usage, employment, and social status per medical records. The Kidney Disease Quality of Life (KDQOL) and Beck Depression Inventory-Fast Scale (BDI-FS) surveys were administered prior to phase A, and at the end of each phase by a trained and qualified staff member. Standard laboratory data including pre and post electrolytes, Kt/V, and blood counts were collected monthly throughout the study. Systolic and diastolic blood pressure data were also collected during the monthly visit in each phase.

Table 1 Baseline Characteristics of patient population

Table 1
Baseline Characteristics of patient population

Results

Eighteen patients from six Satellite Healthcare-WellBound centers in California participated in this CQI initiative. Two patients discontinued during Phase B, one due to the inability to sleep while dialyzing, and the second patient due to ongoing access issues. Both patients remained on daily HHD at the end of the study.

Of the 16 participants who completed phases A and B, 7 elected to continue the alternate, nocturnal HHD schedule while 9 returned to their original daily prescription as intended for phase A+. Of these 9 participants, 8 later transitioned back to the alternate nocturnal schedule by the end of phase A+, resulting in 15 of the 16 patients choosing the EOD extended hour nocturnal HHD schedule post-study. The flow of patients in the CQI program is outlined in Figure 1.

In Table 1, we describe the baseline characteristics of the 18 participants. Mean age was 52 years, 78% were men, nine were white, 17 were dialyzed with an arteriovenous fistula and seven had diabetes. Their median duration of HHD prior to baseline was 12 months with a median ESRD vintage of 33 months. Thirteen patients were either married or had a significant other – relationship, five were actively full or part-time employed. All but one participant was living with a partner or family member. The one “solo dialysis patient” was approved for unassisted dialysis after consultation with the nephrologist, nursing team, social worker and family members at the initiation of HHD prior to the study.

A summary of the HHD therapies delivered during phase A and B is presented in Table 2.

Table2-Schiller

Laboratory values and clinical outcomes

Standard plasma laboratory data collected at the end of Phase A & B are presented in Table 3. In brief, there were no significant differences in any key laboratory parameter between the phases. Data for Phase A+ are not presented due to the mixed therapy schedules. However, when comparing lab results from patients who returned to their original prescription, no differences were noted when compared with either Phase A or Phase B.

Standardized Kt/V was calculated monthly. Mean Kt/V results at the end of Phase B, after completing 8 weeks of EOD-extended hour therapy, was slightly higher than at the end of phase A (2.56 ± 0.63 for Phase A vs. 2.69 ± 0.61 for Phase B).

There were also no significant differences in systolic or diastolic blood pressure between the phases during the monthly follow-up visits (data not shown).

Table3-Schiller

HRQOL outcomes

The Kidney Disease Quality of Life (KDQOL) and Beck Depression Inventory – Fast Scale (BDI-FS) surveys were collected at baseline and the end of each phase. No significant differences were observed in any of the KDQOL domains.

Discussion

ESRD is a challenging disease that affects over half a million Americans,1 the majority of whom are treated with conventional in-center, thrice weekly hemodialysis. Home alternative therapies continue to be underutilized in the US, despite survey results which suggest 93% of nephrologists and 89% of renal nurses would choose a home based therapy if they personally were initiating renal replacement.14 The gap between what is perceived to be the best form of therapy, versus what is actually prescribed, is a major concern.

Due to a concerted focus on home therapy education and training in our WellBound centers, penetration among patients who are cared for at Satellite Healthcare over the past 10 years ranged between 21-23%. Currently more than 1,400 patients are dialyzing at home with 12% of them being treated with HHD. The delivery of HHD therapy with the System One is based on volume delivered to achieve a desired single treatment Kt/V in order to achieve a standard weekly Kt/V > 2.0. Single treatment Kt/V is chosen dependent on the weekly frequency chosen per KDOQI recommendations.15

The benefits of short daily HHD include improvement in quality of life, sleep, depressive symptoms and improved survival when compared to matched patients undergoing conventional center HD. Time to recovery after HHD therapy has been found to be reduced to less than 60 minutes—considerably faster compared to thrice weekly HD. At the same time, it needs to be acknowledged that time to set up the machine and finish administrative tasks impacts patients’ lives in different ways than thrice weekly in-center HD.

The majority of HHD patients are prescribed five to six daily treatments per week lasting two to four hours each. However patient motivation, lifestyles, and thus, adherence, shift over time, requiring more attention by the care team to adapt to these changes. As the home dialysis program has developed, several frequency and duration patterns for HHD have emerged based on physician prescription. As there are no definite data to support one frequency over another, it is unclear what the optimal prescription for HHD is. And since most HHD programs have limited number of patients, it is challenging to optimize prescription patterns to guarantee individualized therapy tailored to patients’ needs.

Burden of therapy is a major issue for home dialysis patients and their care partners. A daily five to six days per week dialysis schedule is likely to put patients at risk of being overwhelmed. For some patients, this can lead to “burn-out,” often resulting in discontinuing home therapy and returning to in-center.

Our program has experienced drop rates similar to those published in the NxStage FREEDOM study data, which reported nearly half of the patients prescribed SDHD dropped prior to the 12 month mark. 8,10,11 The main cause for patients to return in-center was found to be indeed burden of therapy, suggesting some of these drops are potentially avoidable.16

We hypothesized that a less frequent schedule may alleviate some of the burden. Therefore, we designed this CQI project to explore if a longer duration nocturnal therapy schedule could provide a viable option for HHD with the potential to reduce patient burn-out. Every other day dialysis has the advantage of a less demanding treatment schedule while maintaining the clinical benefits of longer duration therapy and avoiding the long interdialytic interval. Depending on the prescription, it may also have economic advantages over more frequent therapy. It is these potential benefits that have led to its popularity in Australia and New Zealand. Kerr et al. reported clinical benefits approaching that seen with 5-6x per week NHD, yet more affordable for providers and acceptable for patients.13

Conclusion

The results of our CQI program suggest that EOD nocturnal HHD is a viable alternative providing adequate small solute clearance, as evidenced by standard Kt/V achieved in the 2.6 range. It is also evident that the less frequent schedule was a preferred choice for patients with seven of the 16 patients who had experienced eight weeks of EOD dialysis choosing to continue this regimen. Of the nine patients who went back to short daily HHD therapy, eight returned to the alternate day schedule one month later. Twelve months after the completion of the CQI project we investigated the frequency and modality status of the 15 patients who at the end of the project continued on EOD HHD, and found that seven remained on this schedule, four were transplanted, one patient died and two were lost to follow-up due to transfer to other centers. Only one patient had transferred to in-center HD.

Dialyzing at home every other night while sleeping gives patients a break from treatments on the alternate nights and brings value to ESRD care by improving patient experience and containing costs at the same time.

References

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