Long-term Clinical Outcomes Among Responders and Nonresponders to the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey.

RATIONALE & OBJECTIVE: The In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey, introduced into the End-Stage Renal Disease Quality Incentive Program, is the only patient-reported outcome currently used for value-based reimbursement in dialysis. Current response rates are ∼30% and differences in long-term clinical outcomes between survey responders and nonresponders are unknown. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Patients from all Dialysis Clinic Incorporated facilities from across the United States who met survey eligibility (aged ≥18 years and had been treated at their facility for at least 3 months). EXPOSURES: Patient-level demographic, clinical, and treatment-related characteristics. OUTCOMES: Mortality, all-cause hospitalization, and kidney transplantation. ANALYTICAL APPROACH: Time-to-event analyses using competing-risks models. Sensitivity analyses performed after multiple imputation for missing covariate data. RESULTS: Among 10,395 eligible patients, 3,794 (36%) responded to the survey. During a median follow-up of 33 months, 4,588 patients died, 7,638 patients were hospitalized at least once, and 789 patients received a transplant. In multivariable models, survey response was associated with lower mortality (subdistribution hazard ratio [sHR], 0.80; 95% CI, 0.75-0.86) and hospitalization (sHR, 0.94; 95% CI, 0.89-0.99) and higher likelihood for a kidney transplant (sHR, 1.27; 95% CI, 1.10-1.46). Results were consistent across sensitivity analyses after multiple imputation for missing covariates. LIMITATIONS: Small amount of missing covariate data, baseline covariate data assigned at the first month of the 3-month survey administration period, reasons for nonresponse unknown. CONCLUSIONS: Response to the ICH CAHPS survey is associated with lower risk for mortality and hospitalization and higher likelihood for kidney transplantation. These findings suggest that survey responders are healthier than nonresponders, emphasizing the need for caution when interpreting facility-level survey results to inform quality improvement and public policy efforts and the critical need to better capture patient-reported outcomes from more vulnerable patients.

Multidisciplinary Medication Therapy Management and Hospital Readmission in Patients Undergoing Maintenance Dialysis: A Retrospective Cohort Study.

RATIONALE & OBJECTIVES: Dialysis patients frequently experience medication-related problems. We studied the association of a multidisciplinary medication therapy management (MTM) with 30-day readmission rates. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Maintenance dialysis patients discharged home from acute-care hospitals between May 2016 and April 2017 who returned to End-Stage Renal Disease Seamless Care Organization dialysis clinics after discharge were eligible. Patients who were readmitted within 3 days, died, or entered hospice within 30 days were excluded. EXPOSURE: MTM consisting of nurse medication reconciliation, pharmacist medication review, and nephrologist oversight was categorized into 3 levels of intensity: no MTM, partial MTM (defined as an incomplete MTM process), or full MTM (defined as a complete MTM process). OUTCOME: The primary outcome was 30-day readmission. ANALYTICAL APPROACH: Time-varying Prentice, Williams, and Peterson total time hazards models explored associations between MTM and time to readmission after adjusting for age, race, sex, diabetes comorbidity, albumin level, vascular access type, kidney failure cause, dialysis vintage and modality, marital status, home medications, frequent prior hospitalizations, length of stay, discharge diagnoses, hierarchical condition category, and facility standardized hospitalization rates. Propensity score matching was performed to examine the robustness of the associations in a comparison between the full- and no-MTM exposure groups on time to readmission. RESULTS: Among 1,452 discharges, 586 received no MTM, 704 received partial MTM, and 162 received full MTM; 30-day readmission rates were 29%, 19%, and 11%, respectively (P < 0.001). Compared with no MTM, discharges with full MTM had the lowest time-varying risk for readmission within 30 days (HR, 0.26; 95% CI, 0.15-0.45); discharges with partial MTM also had lower readmission risk (HR, 0.50; 95% CI, 0.37-0.68). In propensity score-matched sensitivity analysis, full MTM was associated with lower 30-day readmission risk (HR, 0.20; 95% CI, 0.06-0.69). LIMITATIONS: Reliance on observational data. Residual bias and confounding. CONCLUSIONS: MTM services following hospital discharge were associated with fewer 30-day readmissions in dialysis patients. Randomized controlled studies evaluating different MTM delivery models and cost-effectiveness in dialysis populations are warranted.

Hemodialysis patient characteristics associated with better experience as measured by the In-center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey.

BACKGROUND: Patient experience in hemodialysis (HD) is measured twice yearly in all in-center HD patients in the United States using the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey. Survey scores are publically available and incorporated into the dialysis payment system. Despite its importance, little is known about factors associated with better experience scores. We studied the association between patient-level characteristics and experience scores in a large real-world cohort of HD patients. METHODS: This is a cross-sectional analysis of ICH CAHPS administration in 2012. All in-center HD patients in Dialysis Clinic, Incorporated facilities nationally over 18 years old and receiving HD at their facility for at least 3 months were eligible. Predictors include patient demographic, clinical, and treatment-related characteristics. Outcomes include high global rating scores across three domains (Nephrologist, Dialysis Staff, Dialysis Center) and high composite scores across three domains (Nephrologists' Communication and Caring, Quality of Dialysis Center Care and Operations, and Providing Information to Patients). RESULTS: Among 3369 respondents, older age and telephone (vs. mail) administration of the survey were associated with higher global ratings, while shortened HD treatments were associated with lower global ratings. Lower education and telephone administration were associated with higher composite scores, while older age, and shortened HD treatments were associated with lower composite scores. CONCLUSIONS: Several patient characteristics and mode of survey administration are associated with higher experience scores. Future research should assess HD facility characteristics associated with higher scores and interventions that might improve experience accounting for these associations.

Evaluation of non-response to the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey.

BACKGROUND: The In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey is the first patient reported outcome measure included in the U.S. Medicare End Stage Renal Disease Quality Incentive Program. Administered twice yearly, it assesses in-center dialysis experience and survey responses are tied to dialysis facility payments. Low response rates, currently approximately 35%, raise concern for possible underrepresentation of patient groups. METHODS: Cross-sectional analysis of survey administration in 2012 to all in-center hemodialysis patients in Dialysis Clinic, Inc. (DCI) facilities nationally over 18 years old who received hemodialysis at their facility for at least 3 months. Patient-level covariates included demographic, clinical, laboratory, and functional characteristics. Random effects multivariable logistic regression was used to assess survey non-response. RESULTS: Among 11,055 eligible patients 6541 (59%) were non-responders. Of the remaining 4514 responders, 549 (14%) surveys were not usable due to presence of proxy help or incomplete responses. Non-responders were more likely to be men, non-white, younger, single, dual Medicare/Medicaid eligible, less educated, non-English speaking, and not active on the transplant list; non-responders had longer ESRD vintage, lower body mass index, lower serum albumin, worse functional status, and more hospitalizations, missed treatments, and shortened treatments. Similar associations were found using more parsimonious multivariable analyses and after imputing missing data. CONCLUSIONS: Non-responders to the ICH CAHPS significantly differed from responders, broadly spanning individuals with fewer socioeconomic advantages and greater illness burden, raising limitations in interpreting facility survey results. Future research should assess reasons for non-response to improve ICH CAHPS generalizability and utility.

Sex, race, and hemodialysis vascular access processes.

PURPOSE: Hemodialysis (HD) patients who are female or black receive fewer arteriovenous fistulas (AVF) and more grafts (AVG). We evaluated race- and sex-based differences for three process exposures: access surgery, peripherally-inserted central catheters (PICCs), and vascular imaging. METHODS: US Renal Data System with linked Medicare claims for patients initiating HD between April 2010 - December 2011 were used to identify PICC placement, imaging, AVF and AVG surgeries, and the vascular accesses in use at individual HD treatments. Poisson, logistic, and Cox regression models adjusted for clinical and demographic variables were used to evaluate relationships between process exposures, vascular access outcomes, and sex. RESULTS: Among 18,883 individuals initiating HD with catheters with at least one surgical claim for AVF or AVG, women had 16% more PICC and 5% more imaging (p = 0.002), were 43% less likely to have AVF surgery and 68% more likely to have AVG surgery (p<0.001). The odds of AVF surgery producing a working AVF were 18% lower and of AVG surgery producing a working AVG 38% higher (p<0.001). Black patients had 24% more PICCs and 12% more imaging, were 48% less likely to have AVF surgery and 84% more likely to have AVG surgery (p<0.001). The odds of achieving a working AVF were 8% lower and of a working AVG were 38% higher. The hazard of future catheter use after AVF creation was 25% higher for women (p<0.001), but did not differ by race. CONCLUSIONS: Divergences in vascular access by race and sex were partly related to differential process exposures. Black and female patients had more AVG and less AVF surgery, and more PICC and imaging. Success rates were lower for AVF surgery and higher for AVG surgery. Further work is needed to determine whether choices of process exposures arise from differential ability to detect veins on physical examination.

Comorbidity ascertainment from the ESRD Medical Evidence Report and Medicare claims around dialysis initiation: a comparison using US Renal Data System data.

BACKGROUND: The end-stage renal disease Medical Evidence Report serves as a source of comorbid condition data for risk adjustment of quality metrics. We sought to compare comorbid condition data in the Medical Evidence Report around dialysis therapy initiation with diagnosis codes in Medicare claims. STUDY DESIGN: Observational cohort study using US Renal Data System data. SETTING & PARTICIPANTS: Medicare-enrolled elderly (≥66 years) patients who initiated maintenance dialysis therapy July 1 to December 31, 2007, 2008, or 2009. INDEX TESTS: 12 comorbid conditions ascertained from claims during the 6 months before dialysis therapy initiation, the Medical Evidence Report, and claims during the 3 months after dialysis therapy initiation. REFERENCE TEST: None. RESULTS: Comorbid condition prevalence according to claims before dialysis therapy initiation generally exceeded prevalence according to the Medical Evidence Report. The κ statistics for comorbid condition designations other than diabetes ranged from 0.06 to 0.43. Discordance of designations was associated with age, race, sex, and end-stage renal disease Network. During 23,930 patient-years of follow-up from 4 to 12 months after dialysis therapy initiation (8,930 deaths), designations from claims during the 3 months after initiation better discriminated risk of death than designations from the Medical Evidence Report (C statistics of 0.674 vs 0.616). Between the Medical Evidence Report and claims, standardized mortality ratios changed by >10% for more than half the dialysis facilities. LIMITATIONS: Neither the Medical Evidence Report nor diagnosis codes in claims constitute a gold standard of comorbid condition data; results may not apply to nonelderly patients or patients without Medicare coverage. CONCLUSIONS: Discordance of comorbid condition designations from the Medical Evidence Report and claims around dialysis therapy initiation was substantial and significantly associated with patient characteristics, including location. These patterns may engender bias in risk-adjusted quality metrics. In lieu of the Medical Evidence Report, claims during the 3 months after dialysis therapy initiation may constitute a useful source of comorbid condition data.

Guiding principles and checklist for population-based quality metrics.

The Centers for Medicare and Medicaid Services oversees the ESRD Quality Incentive Program to ensure that the highest quality of health care is provided by outpatient dialysis facilities that treat patients with ESRD. To that end, Centers for Medicare and Medicaid Services uses clinical performance measures to evaluate quality of care under a pay-for-performance or value-based purchasing model. Now more than ever, the ESRD therapeutic area serves as the vanguard of health care delivery. By translating medical evidence into clinical performance measures, the ESRD Prospective Payment System became the first disease-specific sector using the pay-for-performance model. A major challenge for the creation and implementation of clinical performance measures is the adjustments that are necessary to transition from taking care of individual patients to managing the care of patient populations. The National Quality Forum and others have developed effective and appropriate population-based clinical performance measures quality metrics that can be aggregated at the physician, hospital, dialysis facility, nursing home, or surgery center level. Clinical performance measures considered for endorsement by the National Quality Forum are evaluated using five key criteria: evidence, performance gap, and priority (impact); reliability; validity; feasibility; and usability and use. We have developed a checklist of special considerations for clinical performance measure development according to these National Quality Forum criteria. Although the checklist is focused on ESRD, it could also have broad application to chronic disease states, where health care delivery organizations seek to enhance quality, safety, and efficiency of their services. Clinical performance measures are likely to become the norm for tracking performance for health care insurers. Thus, it is critical that the methodologies used to develop such metrics serve the payer and the provider and most importantly, reflect what represents the best care to improve patient outcomes.

The culture of education in a large dialysis organization: informing patient-centered decision making on treatment options for renal replacement therapy.

Challenged by the observation that newly admitted dialysis patients were often unaware of their treatment options, Fresenius Medical Care, North America developed a program to improve information delivered to chronic kidney disease (CKD) patients prior to their need for renal replacement therapy. Six years ago, the Treatment Options Program (TOPs) was established utilizing a standardized approach to educate individuals with CKD Stages 3 and 4. The program education focuses on modality and vascular access options. A key component includes follow-up at predetermined intervals, offering additional education and patient reminders to continue to work with their physician in selecting a preferred renal replacement modality. Since program inception, over 73,000 individuals have been educated through TOPs. Home therapy utilization as first treatment is higher in the patient population that received TOPs education. Similarly, participants had a higher rate of permanent vascular access with decreased use of hemodialysis catheters upon admission. Avoiding hemodialysis catheter use and expanding home therapy utilization both offer potential benefits to all stakeholders: patients, providers, and payors, particularly as we move toward accountable healthcare systems. The ability to expand the TOPs program relies on seeing patients early enough to allow each patient time to process the information and work with their physician to select the modality and access that best meets their healthcare and lifestyle needs. Educating our patients facilitates empowerment and active participation in their therapy, a much coveted component of patient-centered health care for the renal provider community as we look to the future.

Medicare reimbursement policies and hemodialysis vascular access outcomes: a need for change.

In March 2010, the Center for Medicare and Medicaid Services (CMS) convened several clinical technical expert panels (C-TEP) to provide recommendations for improving various aspects of hemodialysis management. One of the C-TEPs was tasked with recommending measures to decrease vascular access-related infections. The members of this C-TEP, who are the authors of this manuscript, concluded unanimously that the single most important measure would be to remove financial and regulatory barriers to timely placement and revision of hemodialysis fistulas and the concurrent avoidance of catheter use. The following position paper outlines the financial barriers to improved vascular access outcomes and our proposals for a future CMS demonstration project.

Choice of vascular access among incident hemodialysis patients: a decision and cost-utility analysis.

BACKGROUND AND OBJECTIVES: Arteriovenous fistulas (AVFs) are widely accepted as the preferred hemodialysis vascular access type. However, supporting data have failed to consider morbidity and mortality incurred during failed creation attempts and may therefore overstate potential advantages. This study compares survival, quality-adjusted survival, and costs among incident hemodialysis patients after attempted placement of AVFs or arteriovenous grafts (AVGs). DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Analogous Markov models were created, one each for AVF and AVG. Patients entered consideration at the time of first access creation, contemporaneous with dialysis initiation. Subsequent outcomes were determined probabilistically; transition probabilities, utilities, and costs were gathered from published sources. To ensure comparability between AVFs and AVGs, the timing and likelihood of access maturation were measured in a contemporary cohort of incident hemodialysis patients. RESULTS: Mean (SD) overall survival was 39.2 (0.8) and 36.7 (1.0) months for AVFs and AVGs, respectively: difference (95% confidence interval [CI]) 2.6 (1.8, 3.3) months. Quality-adjusted survival was 36.1 (0.8) and 32.5 (0.9) quality-adjusted life months (QALMs) for AVFs and AVGs, respectively: difference (95% CI) 3.6 (2.8, 4.3) QALMs. The incremental cost-effectiveness ratio (95% CI) for AVFs relative to AVGs was $446 (-6023, 6994) per quality-adjusted life year saved. CONCLUSIONS: AVFs are associated with greater overall and quality-adjusted survival than AVGs. Observed differences were much less pronounced than might be expected from existing literature, suggesting that prospective identification of patients at high risk for AVF maturational failure might enable improvements in health outcomes via individualization of access planning.

Association between achievement of hemodialysis quality-of-care indicators and quality-of-life scores.

BACKGROUND: Incremental achievement of quality indicator goals has been associated with progressive improvement in mortality and hospitalization risk in hemodialysis (HD) patients. STUDY DESIGN: Descriptive cross-sectional study. SETTING & PARTICIPANTS: All 33,879 HD patients treated at Fresenius Medical Care North America facilities for >90 days with scorable 36-Item Short Form Health Survey responses from January 1, 2006, to December 31, 2006. PREDICTOR: We hypothesized that achieving up to 5 HD goals before the survey (albumin >or= 4.0 g/dL, hemoglobin of 11-12 g/dL, equilibrated Kt/V >or= 1.2, phosphorus of 3.5-5.5 mg/L, and absence of HD catheter) results in better self-reported quality of life (QoL). OUTCOMES & MEASUREMENTS: Distributions of Physical and Mental Component Summary (PCS/MCS) scores within and across quality indicator categories determined during the prior 90 days from survey date (compared using analysis of covariance and linear regression models, with adjustment for case-mix and each of the quality indicators). RESULTS: Incremental achievement of up to 5 goals was associated with progressively higher PCS and MCS scores (both P for trend < 0.001). Compared with patients meeting all 5 goals (n = 4,208; reference group), case-mix-adjusted PCS score was lower by 1.8 point with only 4 goals met (n = 11,785), 3.4 points for 3 goals (n = 10,906), 4.9 points for 2 goals (n = 5,119), 5.9 points for 1 goal (n = 1,592), and 7.8 points in the 269 patients who failed to meet any goal (each P < 0.001 vs the reference group). The corresponding decreases in case-mix-adjusted MCS scores were 1.0 point for 4 goals met, 1.7 point for 3 goals, 2.3 points for 2 goals, 3.0 points for 1 goal, and 4.7 points with no goal met, with each P < 0.001 compared with the MCS score from patients who achieved all 5 goals. LIMITATIONS: Potential residual confounding from unmeasured covariates. CONCLUSION: Patients progressively meeting more quality goals report incrementally better QoL. Further studies are needed to determine whether prospective achievement of quality goals will result in improved QoL for HD patients.

Potential impact of nutritional intervention on end-stage renal disease hospitalization, death, and treatment costs.

OBJECTIVE: Our objective was to estimate the effect of an improvement in nutrition, represented by albumin concentrations, on hospitalization, mortality, and Medicare end-stage renal disease (ESRD) program cost. DESIGN: Based on published trials, the impact of an improvement in serum albumin of +0.2 g/dL from a hypothetical nutritional program for severely malnourished patients with albumin < or = 3.5 g/dL (base case) was estimated by reassigning patients to higher albumin categories, along with outcome risks associated with the new albumin category. SETTING: Data from Fresenius Medical Care North America (Waltham, MA) were utilized in regression models to determine the association between albumin and change in albumin concentration with outcomes. RESULTS: Albumin < or = 3.5 g/dL was associated with a > 2-fold increase in death and hospitalization risk, compared to > or = 4 g/dL (P < .001) in this population. An increase in albumin concentration was associated with a lower risk of death and hospitalization, whereas a declining albumin concentration led to worse outcomes. Projections for the United States dialysis population from the base case showed approximately 1400 lives saved, approximately 6000 hospitalizations averted, and approximately $36 million in Medicare cost savings resulting from a reduction of approximately 20,000 hospital days. A sensitivity analysis, varying the albumin response to +0.1 and +0.3 g/dL combined with varying albumin responder rates to 25% and 75% of patients, revealed robust results. CONCLUSION: Nutritional interventions that increase serum albumin by > or = 0.2 g/dL (e.g., via oral nutritional supplements) may lead to considerable improvements in mortality, hospitalization, and treatment costs.

Dialyzer best practice: single use or reuse?

Outcome studies have shown either no additional risk or a small additional risk for hospitalization and mortality associated with reprocessing dialyzers. Although the risks from reprocessing dialyzers have yet to be fully elucidated, reuse can be done safely if it is performed in full compliance with the standards of Association for the Advancement of Medical Instrumentation (AAMI). Like most industrial processes, however, complete control of the reuse process in a clinical environment and full compliance with regulations at all times is difficult. Potential errors and breakdowns in the reuse process are continuing concerns. The quality controls for reprocessing of dialyzers are not equal to the rigor of the manufacturing process under the purview of the U.S. Food and Drug Administration (FDA). Therefore, if one were to determine "best practice," single use is preferable to reuse of dialyzers based on medical criteria and risk assessment. The long-term and cumulative effects of exposure to reuse reagents are unknown and there is no compelling medical indication for reprocessing of dialyzers. The major impediment when deciding to convert from reuse to single use of dialyzers is economic. The experience in Fresenius Medical Care-North America (FMCNA) facilities demonstrates that converting from a practice of reuse to single use is achievable. However, the overall economic impact of conversion to single use is provider specific. The dominance of reuse has been negated of late by a major shift in practice toward single use. Physicians and patients should be well informed in making decisions regarding the practice of single use versus reuse of dialyzers.