A Standardized Care Pathway Increases Optimal Dialysis Starts

ABSTRACT

Objective: To determine whether an intensive value-based care educational program that includes a standardized end-stage renal disease (ESRD) transition pathway would improve the number of optimal starts within Kidney Contracting Entities (KCEs).

Study Design: Retrospective cohort study.

Methods: We recorded optimal starts, defined as the initiation of dialysis without a central venous catheter, and the initial modality type (hemodialysis vs peritoneal dialysis [PD]) in adult Medicare patients in a Comprehensive Kidney Care Contracting program. The setting was 4 KCEs within a single physician-led nephrology organization. Data were recorded each quarter (Q) during 2022. During Q1-Q2, patients and clinicians received formal instruction on the benefits of optimal starts. Starting in Q3, we implemented a standardized care pathway for patients at high risk for transition to ESRD. The proportion of optimal starts and the proportion of initial PD from Q1-Q2 vs Q3-Q4 were compared using the χ2 test.

Results: A total of 328 study-eligible patients initiated dialysis in 2022, including 166 (50.6%) in Q1-Q2. The proportion of optimal starts increased from 42.8% (71/166) in Q1-Q2 to 58.0% (94/162) in Q3-Q4 (P = .006). The proportion of PD starts increased from 18.7% (31/166) in Q1-Q2 to 28.4% (46/162) in Q3-Q4 (P = .038).

Conclusions: Optimal starts are a key metric of success in value-based care models. We observed a significant increase in optimal starts and in the number of patients starting on PD after implementing a standardized ESRD transition pathway as part of an intensive value-based care educational program.

Am J Manag Care. 2024;30(12):In Press

Takeaway Points

We observed a significant increase in optimal starts for dialysis and in peritoneal dialysis rates after implementing a standardized end-stage renal disease transition pathway.

• Optimal starts (defined as dialysis without a central venous catheter) increased 36% from quarter (Q) 1-Q2 to Q3-Q4 of 2022: 42.8% to 58.0%.
• We observed a 52% increase in peritoneal dialysis starts from Q1-Q2 to Q3-Q4: 18.7% to 28.4%.
• Patients with congestive heart failure had a significant 47% increase in optimal starts from Q1-Q2 to Q3-Q4: 36% to 53%.

Chronic kidney disease (CKD) care is shifting from a fee-for-service model focusing on volume of care and profitability of services to a value-based care (VBC) model that rewards better outcomes.1,2 It is well established that starting end-stage renal disease (ESRD) care with peritoneal dialysis (PD) or hemodialysis (HD) with an arteriovenous (AV) fistula or AV graft rather than a central venous catheter (CVC) produces better mortality, morbidity, and cost outcomes.3-7 In fact, the initiation of dialysis without a CVC is considered an “optimal start” by CMS.1,2 The initiation of HD using a CVC is considered a nonoptimal start, which has also been termed a suboptimal, urgent, crash, or unplanned start.3,8-10 Because PD is almost always started without a CVC, it is a strategic way to increase optimal starts. Additionally, PD is associated with greater patient satisfaction, significantly lower costs, and better clinical outcomes (particularly in the near term) compared with HD.11-14 Unfortunately, the majority of patients in the US initiate ESRD care on HD with a CVC.11,15

To address this quality gap, various government agencies have encouraged “fistula first, catheter last”–type programs to increase the number of optimal dialysis starts. In 2003, CMS developed the Fistula First Breakthrough Initiative with the assistance of the Institute for Healthcare Improvement.16 In 2019, HHS launched the Advancing American Kidney Health initiative, and 1 of its 3 major goals is to increase (up to 80%) the number of new patients with ESRD treated with PD or receiving a transplant by 2025.1,17 In 2022, CMS launched the Kidney Care Choices model, which includes the Comprehensive Kidney Care Contracting (CKCC) payment options for nephrology professionals. The CKCC options are open to participation by Kidney Contracting Entities (KCEs). These organizations are required by CMS to include nephrologists or nephrology practices and transplant providers; dialysis facilities are optional.18

The CKCC options incentivize providers to achieve optimal starts by making them a major metric to earn back the quality withhold, a key determinant of the High-Performers Pool bonus.19 This bonus is in addition to optimal starts driving shared savings.1,2 Each KCE devises its own approach to achieve its optimal starts goal.

Our quality initiative designed and implemented a new standardized ESRD transition pathway. We then compared patients experiencing optimal and nonoptimal starts over the evolution of the pathway.

METHODS

This is a retrospective analysis of a quality initiative undertaken in 2022. The setting was 4 geographically diverse KCEs in the US within a single physician-led nephrology organization. All patients were adults (aged ≥ 18 years) with Medicare in a CKCC program. There was no minimum duration that patients were required to have Medicare. CKCC defines an optimal ESRD start as a new patient with ESRD who started renal replacement therapy by receiving a preemptive kidney transplant, by initiating PD, or by initiating HD via AV fistula or AV graft.18 For this analysis, the optimal start definition excludes patients who received a preemptive kidney transplant. We recorded the proportion of optimal starts, the initial modality type (HD vs PD), demographics, clinically relevant comorbidities, the Charlson Comorbidity Index (CCI) score, the CMS Hierarchical Condition Category (HCC) risk score, inpatient visits, and costs for the first 6 months of ESRD and 6-month mortality. Medicare determines an optimal start based on Form 2728 data, which were not accessible for most (~88%) patients. When Form 2728 data were unavailable, we reviewed the claims data to determine whether an optimal start occurred. Data were recorded each quarter (Q) for 2022.

We determined the optimal start rate for patients in the 4 KCEs who had started dialysis as a Medicare beneficiary during the 3 years prior to the start of the CKCC program to estimate our baseline optimal start rate. The access present at the start of dialysis was based on claims data showing placement of HD or PD access without a CVC before the first outpatient dialysis. All patients during this period to the end date of the analysis had their own care team, received home visits after any hospitalization, and were surveyed for depression (via the 9-Item Patient Health Questionnaire) and activity levels.

Table 1 outlines the steps taken to increase optimal starts. Specifically, during Q1-Q2, clinicians and patients were formally instructed on the clinical benefits of optimal starts. Clinicians but not patients also were told of the financial benefits associated with optimal starts. In-person and online teleconference meetings were conducted with KCE physicians and advanced practice providers to review best practices for patients approaching the transition to ESRD. A navigator program was provided to the patients due to the complexity of following all the steps to achieve an optimal start. Here, each patient was assigned a conciergelike staff member to help coordinate the logistics of making appointments to see other doctors (eg, for vessel mapping, surgeon visit, clearance consultations) to facilitate placing an AV fistula, AV graft, or a PD catheter.

Toward the end of Q2, the VBC medical director and clinical leaders from each KCE began meeting to develop an updated plan to improve the optimal start rate. This collaborative effort led to the development of the Optimal Start Journey (Figure 1), which details a standardized ESRD transition pathway for patients at high risk of transitioning to ESRD. The Optimal Start Journey outlines when each step should be completed based on the patient’s estimated glomerular filtration rate (eGFR). Starting in Q3, this standardized pathway was deployed across all 4 KCEs. During this time, all KCE physicians were given an Optimal Start Journey newsletter. Additionally, in-person visits and online meetings emphasizing adherence to the Optimal Start Journey were held first with practice leaders and then with all physicians. Treatment teams were given lists of patients with eGFR values less than 18 mL/min/1.73 m2 so they could concentrate their efforts on following the Optimal Start Journey for these individuals. Physicians were asked to document the patient’s AV access plan in the electronic health record (EHR) and explicitly record whether a fistula was mature. Moreover, physicians were aware that patient records would be subject to audit during this time and patients with stage 5 CKD were to be assessed as being “on track” or “off track” for optimal starts. The explicitly stated goal was to have 100% of patients with stage 5 CKD be on track.

Specifically, the designation of on track vs off track for patients with stage 5 CKD is dependent on their eGFR, the ESRD modality they have chosen, and their planned access. Determination was made by nurses and nephrologists on the central VBC team based on information in the EHR. For a future HD patient whose access type will be an AV fistula, they are only on track if the fistula is in place and the EHR note says that the fistula is mature and/or ready to use for dialysis. For a future HD patient whose access type will be an AV graft, they are on track as long as the eGFR is at least 11 mL/min/1.73 m2 but off track once the eGFR is below 11 mL/min/1.73 m2 if the AV graft is not yet placed. For a future PD patient, they are considered on track if the eGFR is at least 11 mL/min/1.73 m2 but off track if the eGFR is less than 11 mL/min/1.73 m2 and the PD catheter is not yet placed. Other ways to be considered on track would be if a donor was approved for a preemptive kidney transplant or if a patient planned to enter hospice care and forgo dialysis, provided the nephrologist agreed that this was a well-considered plan.

We summarized variables using medians and IQRs for continuous data and counts and percentages for categorical data. Six-month cost data were calculated as the total inpatient, outpatient, and dialysis costs from the first full month after the patient started dialysis through the end of month 6. Six-month mortality was defined as a death for any cause from the CMS transition date to 180 days post transition. We compared variables between patients by optimal start status using the Mann-Whitney U test for continuous data and the χ2 test (or the Fisher exact test when counts were < 5) for categorical data. Among optimal start patients, we repeated these analyses on Q1-Q2 vs Q3-Q4. We derived an adjusted relative risk of having an optimal start in Q3-Q4 vs Q1-Q2 using logistic regression with age, sex, and the CCI score as covariates. All inferences with a P value less than .05 were considered statistically significant. This educational program–based quality improvement project did not require review by an institutional review board. All analyses were done using Stata/MP 18.0 for Windows (StataCorp LLC).

RESULTS

The historic optimal start rate among patients in the 4 KCEs who had started dialysis as a Medicare beneficiary during the 3 years prior to the start of CKCC was 29%. A total of 328 adult Medicare patients initiated dialysis in 2022, including 166 (50.6%) in Q1-Q2. There were 165 patients with optimal starts (50.3%) in 2022. The proportion of optimal starts increased by 36%, going from 42.8% (71/166) in Q1-Q2 to 58.0% (94/162) in Q3-Q4 (P = .006). The adjusted relative risk ratio for Q3-Q4 vs Q1-Q2 in optimal starts was 1.40 (95% CI, 1.13-1.64; P = .004). The proportion of PD starts increased by 52%, going from 18.7% (31/166) in Q1-Q2 to 28.4% (46/162) in Q3-Q4 (P = .038) (Figure 2).

Optimal start status did not differ by age or sex (Table 2). However, patients with optimal starts were significantly less likely to have congestive heart failure (CHF) compared with non–optimal start patients (69.1% vs 87.7%; P < .001). Chronic obstructive pulmonary disease (COPD) prevalence was also lower in patients with optimal starts (20.0% vs 31.9%; P = .014), and the median (IQR) CCI score (which has CHF and COPD as components) and CMS HCC score were significantly lower as well, at 7 (5-8) vs 9 (7-11) (P < .001) and 8 (6-10) vs 9 (6-11) (P = .043), respectively. After starting dialysis, inpatient visits in the first full 6 months were significantly lower in the patients with optimal starts. For example, 33.9% of the optimal start patients had at least 1 inpatient visit vs 49.1% for the nonoptimal start patients (P = .005). Optimal start patients also had a lower rate of multiple (≥ 2) inpatient visits: 13.3% vs 23.3%, respectively (P = .019). Correspondingly, there were significantly higher median 6-month inpatient, outpatient, and dialysis costs for patients with nonoptimal starts vs optimal starts: $41,437 vs $30,463 (P < .001). Notably, even among patients with no inpatient admissions, median costs were still higher in the non–optimal start vs the optimal start patients: $30,637 vs $25,621 (P = .008). Finally, 6-month mortality was mathematically higher in the non–optimal start patients, but the difference was not statistically significant at 13.5% vs 9.7% (P = .282).

The patients in Q3-Q4 who attained an optimal start appeared similar to the optimal start patients in Q1-Q2 (Table 3), although the CMS HCC score was modestly higher in Q3-Q4, suggesting a higher comorbidity burden. Furthermore, in the 71 patients without CHF, their optimal start rate in Q1-Q2 was 67.6% (25/37) and was 76.5% (26/34) in Q3-Q4 (P = .405). In contrast to the stable optimal start rates over time in patients without CHF, among the 257 patients with CHF, their optimal start rate went from 35.7% (46/129) in Q1-Q2 to 53.1% (68/128) in Q3-Q4 (P = .005).

DISCUSSION

Ramer and Koncicki wrote, “The need to plan defines nephrology as a medical specialty,” which augments the maxim, “People do not plan to fail; they fail to plan.”20 Our results show that proper planning with a standardized ESRD transition pathway outlined in the Optimal Start Journey was associated with a 36% increase in optimal starts (relative risk, 1.40; 95% CI, 1.13-1.64) and a 52% increase in PD. We also observed that the patients with optimal starts tended to be healthier, as evidenced by significantly less CHF and COPD. These patients also fared better than the patients with nonoptimal starts, with significantly fewer inpatient visits within 6 months. The optimal start patients also had lower median costs within 6 months, even among patients with no inpatient admissions. We feel these associations are both statistically and clinically significant, although we cannot quantify with this study design how much of these improvements in outcomes are directly attributable to optimal starts.

In one of the few contemporary studies that examined transition to dialysis planning and its association with optimal starts, Poonawalla et al examined 7026 Medicare patients with ESRD in 2017. In a subset of 1963 patients with preindex CKD stage 5, 29.5% experienced a planned optimal start.9 Similarly, our Medicare patients in the 4 KCEs who had started dialysis during the 3 years prior to the start of the CKCC program had a 29% optimal start rate. The rates reported by Poonawalla et al and in our historic data are significantly lower than the optimal start rates of 42.8% in Q1-Q2 of 2022. This suggests these KCEs were providing better care, even before this specific quality initiative was implemented.However, there was no progressive improvement from Q1 to Q2. Consequently, we believe our standardized care pathway implemented at the start of Q3 played a substantial role in the increase of our optimal start rate to the 58.0% observed in our cohort in Q3-Q4.

Wong et al compared costs of optimal vs nonoptimal starts and differentiated between a crash start, defined as initiating HD with a CVC, and suboptimal starts, which were outpatient HD with a CVC or inpatient HD without a CVC. They found that the 12-month costs before and after the start of HD were greatest among the crash starts and lowest among the optimal starts, with costs among the suboptimal starts being between these 2 groups.10

The differences in optimal starts among patients with and without CHF are notable. We observed higher rates of CHF in the non–optimal start patients, and this finding is supported by several other studies.21-24 The presence of CHF tends to confound the prediction of when dialysis will be needed, with some patients with CHF requiring dialysis sooner than expected.21-25 A novel finding from our analysis is that the use of the Optimal Start Journey was associated with a significant increase in optimal starts among patients with CHF, which is a population shown to be at increased risk for HD with a CVC both in North America and in Europe.21-24 We did not see an increase in optimal start rates over time among patients without CHF, although the majority of these patients did have optimal starts.

There was no statistical difference in age or sex by optimal start status or among patients who had an optimal start in Q1-Q2 vs Q3-Q4, which we feel indicates proper treatment. Evidence is mixed on whether women are less likely to attain a mature AV fistula due to having smaller veins on average than men.26,27 There is also some evidence that older patients have slower AV fistula maturation.26,28,29 That said, it is not recommended to use sex or advanced age alone as contraindications for having AV fistulas in place in advanced CKD, and it appears that these factors did not affect whether a patient had an optimal start in this cohort.

Given the originality of the Optimal Start Journey program, it is challenging to find direct comparators in the literature. However, in 2020, the International Home Dialysis Roundtable did address the need for increased PD usage by having more intensive educational efforts on the benefits of PD to increase patient engagement and by involving key clinical stakeholders to better advocate for greater PD use.30 Similarly, both Flanagin et al and Himmelfarb et al listed a series of proposed solutions to increase PD use in the US that included better education on the benefits of PD for both patients and clinicians and more clinical resources to encourage PD, such as telehealth visits.31,32 Many of these recommendations were incorporated in the Optimal Start Journey, supporting that the program itself is well designed.

Although embedded PD catheters, AV fistula, and AV graft can be placed in advance and require little to no maintenance until use, externalized PD catheters are placed when dialysis is initiated. Our Optimal Start Pathway includes guidance to place an externalized PD catheter when the eGFR reaches 11 mL/min/1.73 m2 and to start dialysis soon afterward. In alignment with recent literature, we encouraged physicians to start dialysis using an incremental PD approach.33 Thus, our pathway represents the expert recommendations of the physician authors, given the absence of a clinical consensus on when to initiate dialysis. Nationally, the mean eGFR at the start of dialysis in 2022 was 9.9 mL/min/1.73 m2.34 Accordingly, our guideline does not encourage substantially earlier initiation of dialysis than current practice patterns.

Limitations

One limitation of this analysis is that it is unknown how the COVID-19 pandemic affected care. Next, we do not know how well the Optimal Start Journey would perform among KCEs treating patients with very different demographics and/or chronic comorbidity burdens from what we observed here. As with any analysis of claims data, it is possible that patients had certain comorbidities (eg, CHF) that were not coded for or were miscoded, although we believe this was uncommon. Also, this analysis can only show an association rather than a causal relationship between the Optimal Start Journey and the increase in optimal starts. Additionally, it is unknown how much improvement would have happened had we not undertaken this quality initiative. We encourage a future study to improve upon this quality initiative by having a control group and adjusting for trends over time to provide more consistent and less biased estimates of the association of a VBC program and optimal starts.

CONCLUSIONS

The KCEs in the CKCC program that used the standardized ESRD transition pathway outlined in the Optimal Start Journey significantly increased the number of optimal starts for their adult Medicare patients. This association was true even among high-risk patients with CHF. This quality initiative cannot determine how much improvement in optimal starts is due solely to the standardized pathway or show a causal relationship. However, we believe these promising associations merit further study in a large, case-control study design to definitively determine the impact of the pathway, given the importance of optimal HD starts to patients both in and outside VBC models.

Acknowledgments

The authors would like to thank Sima Aziz from Panoramic Health for her contributions to this project.

Author Affiliations: Panoramic Health (RGM, DMM, DE, SH, NV), Tempe, AZ; OptiStatim, LLC (BHN), Longmeadow, MA; Lake Michigan Nephrology (KK), St Joseph, MI; West Coast Kidney Institute (RS), Concord, CA.

Source of Funding: Panoramic Health.

Author Disclosures: Dr Marcus is an employee and board member of and owns stock in Panoramic Health. Mr Miller, Mr Eckhardt, Dr Henry, Dr Kwon, and Dr Vakharia are employees of and own equity/shares in Panoramic Health. Dr Nathanson’s company, OptiStatim, was paid a consulting fee for data analysis for this manuscript by Panoramic Health. Dr Sharma is a board member of and owns stock in Panoramic Health.

Authorship Information: Concept and design (RGM, DMM, BHN, RS, NV); acquisition of data (DMM, BHN, DE, SH); analysis and interpretation of data (RGM, DMM, BHN, DE, SH, KK, RS, NV); drafting of the manuscript (RGM, BHN, KK, RS); critical revision of the manuscript for important intellectual content (RGM, DMM, BHN, KK, RS); statistical analysis (BHN, SH); administrative, technical, or logistic support (DMM, DE); and supervision (RS, NV).

Address Correspondence to: Roy G. Marcus, MD, Panoramic Health, 850 W Rio Salado Pkwy, Ste 201, Tempe, AZ 85281. Email: rmarcus@panoramichealth.com.

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