COVID-19 and Hospitalization Among Maintenance Dialysis Patients: A Retrospective Cohort Study Using Time-Dependent Modeling.

Rationale & Objective: The coronavirus disease 2019 (COVID-19) pandemic has had a profound impact on hospitalizations in general and on dialysis patients in particular. This study modeled the impact of COVID-19 on hospitalizations of dialysis patients in 2020. Study Design: Retrospective cohort study. Setting & Participants: Medicare patients on dialysis in calendar year 2020. Predictors: COVID-19 status was divided into 4 stages: COVID1 (first 10 days after initial diagnosis), COVID2 (extends until the Post-COVID stage), Post-COVID (after 21 days with no COVID-19 diagnosis), and Late-COVID (begins after a hospitalization with a COVID-19 diagnosis); demographic and clinical characteristics; and dialysis facilities. Outcome: The sequence of hospitalization events. Analytical Approach: A proportional rate model with a nonparametric baseline rate function of calendar time on the study population. Results: A total of 509,609 patients were included in the study, 63,521 were observed to have a SARS-CoV-2 infection, 34,375 became Post-COVID, and 1,900 became Late-COVID. Compared with No-COVID, all 4 stages had significantly greater adjusted risks of hospitalizations with relative rates of 18.50 (95% CI, 18.19-18.81) for COVID1, 2.03 (95% CI, 1.99-2.08) for COVID2, 1.37 (95% CI, 1.35-1.40) for Post-COVID, and 2.00 (95% CI, 1.89-2.11) for Late-COVID. Limitations: For Medicare Advantage patients, we only had inpatient claim information. The analysis was based on data from the year 2020, and the effects may have changed due to vaccinations, new treatments, and new variants. The COVID-19 effects may be somewhat overestimated due to missing information on patients with few or no symptoms and possible delay in COVID-19 diagnosis. Conclusions: We discovered a marked time dependence in the effect of COVID-19 on hospitalization of dialysis patients, beginning with an extremely high risk for a relatively short period, with more moderate but continuing elevated risks later, and never returning to the No-COVID level.

The Impact of COVID-19 on Postdischarge Outcomes for Dialysis Patients in the United States: Evidence from Medicare Claims Data.

Background: Recent investigations have shown that, on average, patients hospitalized with coronavirus disease 2019 (COVID-19) have a poorer postdischarge prognosis than those hospitalized without COVID-19, but this effect remains unclear among patients with end-stage kidney disease (ESKD) who are on dialysis. Methods: Leveraging a national ESKD patient claims database administered by the US Centers for Medicare and Medicaid Services, we conducted a retrospective cohort study that characterized the effects of in-hospital COVID-19 on all-cause unplanned readmission and death within 30 days of discharge for patients on dialysis. Included in this study were 436,745 live acute-care hospital discharges of 222,154 Medicare beneficiaries on dialysis from 7871 Medicare-certified dialysis facilities between January 1 and October 31, 2020. Adjusting for patient demographics, clinical characteristics, and prevalent comorbidities, we fit facility-stratified Cox cause-specific hazard models with two interval-specific (1-7 and 8-30 days after hospital discharge) effects of in-hospital COVID-19 and effects of prehospitalization COVID-19. Results: The hazard ratios due to in-hospital COVID-19 over the first 7 days after discharge were 95% CI, 1.53 to 1.65 for readmission and 95% CI, 1.38 to 1.70 for death, both with P<0.001. For the remaining 23 days, the hazard ratios were 95% CI, 0.89 to 0.96 and 95% CI, 0.86 to 1.07, with P<0.001 and P=0.50, respectively. Effects of prehospitalization COVID-19 were mostly nonsignificant. Conclusions: In-hospital COVID-19 had an adverse effect on both postdischarge readmission and death over the first week. With the surviving patients having COVID-19 substantially selected from those hospitalized, in-hospital COVID-19 was associated with lower rates of readmission and death starting from the second week.

Association of the Comprehensive ESRD Care Model with Treatment Adherence.

Background: Poor adherence to scheduled dialysis treatments is common and can cause adverse clinical and economic outcomes. In 2015, the Centers for Medicare and Medicaid Innovation launched the Comprehensive ESRD Care (CEC) Model, a novel modification of the Accountable Care Organization framework. Many model participants reported efforts to increase dialysis adherence and promptly reschedule missed treatments. Methods: With Medicare databases covering 2014-2019, we used difference-in-differences models to compare treatment adherence among patients aligned to 1037 CEC facilities relative to those aligned to matched comparison facilities, while accounting for their differences at baseline. Using dates of service, we identified patients who typically received three weekly treatments and the days when treatments typically occurred. Skipped treatments were defined as days when the patient was not hospitalized but did not receive an expected treatment, and rescheduled treatments as days when a patient who had skipped their previous treatment received an additional treatment before their next expected treatment date. Results: Patients in the CEC Model had higher odds of attending as-scheduled sessions relative to the comparison group, although the effect was only marginally significant (OR, 1.02; 95% CI, 1.00 to 1.04, P=0.08). Effects were stronger among females (OR, 1.03; 95% CI, 1.00 to 1.06, P=0.06) than males (OR, 1.01; 95% CI, 0.98 to 1.04, P=0.49), and among those aged <70 years (OR, 1.02; 95% CI, 1.00 to 1.05, P=0.04) than those aged ≥70 years (OR, 1.00; 95% CI, 0.96 to 1.04, P=0.96). The CEC was associated with higher odds of rescheduled sessions (OR, 1.09; 95% CI, 1.05 to 1.14, P<0.001). Effects were significant for both sexes, but were larger among males (OR, 1.11; 95% CI, 1.05 to 1.18, P<0.001) than females (OR, 1.07; 95% CI, 1.02 to 1.13, P=0.01), and effects were significant among those <70 years (OR, 1.12; 95% CI, 1.07 to 1.17, P<0.001), but not those ≥70 years (OR, 0.99; 95% CI, 0.92 to 1.07, P=0.80). Conclusions: The CEC Model is intended to incentivize strategies to prevent costly interventions. Because poor dialysis adherence may precipitate hospitalizations or other adverse events, many CEC Model participants encouraged adherence and promptly rescheduled missed treatments as strategic priorities. This study suggests these efforts were a success, although the absolute magnitudes of the effects were modest.

Understanding the Tradeoffs Between Travel Burden and Quality of Care for In-center Hemodialysis Patients.

BACKGROUND: Renal dialysis is a lifesaving but demanding therapy, requiring 3 weekly treatments of multiple-hour durations. Though travel times and quality of care vary across facilities, the extent to which patients are willing and able to engage in weighing tradeoffs is not known. Since 2015, Medicare has summarized and reported quality data for dialysis facilities using a star rating system. We estimate choice models to assess the relative roles of travel distance and quality of care in explaining patient choice of facility. RESEARCH DESIGN: Using national data on 2 million patient-years from 7198 dialysis facilities and 4-star rating releases, we estimated travel distance to patients' closest facilities, incremental travel distance to the next closest facility with a higher star rating, and the difference in ratings between these 2 facilities. We fit mixed effects logistic regression models predicting whether patients dialyzed at their closest facilities. RESULTS: Median travel distance was 4 times that in rural (10.9 miles) versus urban areas (2.6 miles). Higher differences in rating [odds ratios (OR): 0.56; 95% confidence interval (CI): 0.50-0.62] and greater area deprivation (OR: 0.50; 95% CI: 0.48-0.53) were associated with lower odds of attending one's closest facility. Stratified models were also fit based on urbanicity. For rural patients, excess travel was associated with higher odds of attending the closer facility (per 10 miles; OR: 1.05; 95% CI: 1.04-1.06). Star rating differences were associated with lower odds of receiving care from the closest facility among urban (OR: 0.57; 95% CI: 0.51-0.63) and rural patients (OR: 0.18; 95% CI: 0.08-0.44). CONCLUSIONS: Most dialysis patients have higher rated facilities located not much further than their closest facility, suggesting many patients could evaluate tradeoffs between distance and quality of care in where they receive dialysis. Our results show that such tradeoffs likely occur. Therefore, quality ratings such as the Dialysis Facility Compare (DFC) Star Rating may provide actionable information to patients and caregivers. However, we were not able to assess whether these associations reflect a causal effect of the Star Ratings on patient choice, as the Star Ratings served only as a marker of quality of care.

COVID-19 Risk Factors and Mortality Outcomes Among Medicare Patients Receiving Long-term Dialysis.

Importance: There is a need for studies to evaluate the risk factors for COVID-19 and mortality among the entire Medicare long-term dialysis population using Medicare claims data. Objective: To identify risk factors associated with COVID-19 and mortality in Medicare patients undergoing long-term dialysis. Design, Setting, and Participants: This retrospective, claims-based cohort study compared mortality trends of patients receiving long-term dialysis in 2020 with previous years (2013-2019) and fit Cox regression models to identify risk factors for contracting COVID-19 and postdiagnosis mortality. The cohort included the national population of Medicare patients receiving long-term dialysis in 2020, derived from clinical and administrative databases. COVID-19 was identified through Medicare claims sources. Data were analyzed on May 17, 2021. Main Outcomes and Measures: The 2 main outcomes were COVID-19 and all-cause mortality. Associations of claims-based risk factors with COVID-19 and mortality were investigated prediagnosis and postdiagnosis. Results: Among a total of 498 169 Medicare patients undergoing dialysis (median [IQR] age, 66 [56-74] years; 215 935 [43.1%] women and 283 227 [56.9%] men), 60 090 (12.1%) had COVID-19, among whom 15 612 patients (26.0%) died. COVID-19 rates were significantly higher among Black (21 787 of 165 830 patients [13.1%]) and Hispanic (13 530 of 86 871 patients [15.6%]) patients compared with non-Black patients (38 303 of 332 339 [11.5%]), as well as patients with short (ie, 1-89 days; 7738 of 55 184 patients [14.0%]) and extended (ie, ≥90 days; 10 737 of 30 196 patients [35.6%]) nursing home stays in the prior year. Adjusting for all other risk factors, residing in a nursing home 1 to 89 days in the prior year was associated with a higher hazard for COVID-19 (hazard ratio [HR] vs 0 days, 1.60; 95% CI 1.56-1.65) and for postdiagnosis mortality (HR, 1.31; 95% CI, 1.25-1.37), as was residing in a nursing home for an extended stay (COVID-19: HR, 4.48; 95% CI, 4.37-4.59; mortality: HR, 1.12; 95% CI, 1.07-1.16). Black race (HR vs non-Black: HR, 1.25; 95% CI, 1.23-1.28) and Hispanic ethnicity (HR vs non-Hispanic: HR, 1.68; 95% CI, 1.64-1.72) were associated with significantly higher hazards of COVID-19. Although home dialysis was associated with lower COVID-19 rates (HR, 0.77; 95% CI, 0.75-0.80), it was associated with higher mortality (HR, 1.18; 95% CI, 1.11-1.25). Conclusions and Relevance: These results shed light on COVID-19 risk factors and outcomes among Medicare patients receiving long-term chronic dialysis and could inform policy decisions to mitigate the significant extra burden of COVID-19 and death in this population.

Acute Kidney Injury Requiring Dialysis and Incident Dialysis Patient Outcomes in US Outpatient Dialysis Facilities.

BACKGROUND AND OBJECTIVES: About 30% of patients with AKI may require ongoing dialysis in the outpatient setting after hospital discharge. A 2017 Centers for Medicare & Medicaid Services policy change allows Medicare beneficiaries with AKI requiring dialysis to receive outpatient treatment in dialysis facilities. Outcomes for these patients have not been reported. We compare patient characteristics and mortality among patients with AKI requiring dialysis and patients without AKI requiring incident dialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We used a retrospective cohort design with 2017 Medicare claims to follow outpatients with AKI requiring dialysis and patients without AKI requiring incident dialysis up to 365 days. Outcomes are unadjusted and adjusted mortality using Kaplan-Meier estimation for unadjusted survival probability, Poisson regression for monthly mortality, and Cox proportional hazards modeling for adjusted mortality. RESULTS: In total, 10,821 of 401,973 (3%) Medicare patients requiring dialysis had at least one AKI claim, and 52,626 patients were Medicare patients without AKI requiring incident dialysis. Patients with AKI requiring dialysis were more likely to be White (76% versus 70%), non-Hispanic (92% versus 87%), and age 60 or older (82% versus 72%) compared with patients without AKI requiring incident dialysis. Unadjusted mortality was markedly higher for patients with AKI requiring dialysis compared with patients without AKI requiring incident dialysis. Adjusted mortality differences between both cohorts persisted through month 4 of the follow-up period (all P=0.01), then, they declined and were no longer statistically significant. Adjusted monthly mortality stratified by Black and other race between patients with AKI requiring dialysis and patients without AKI requiring incident dialysis was lower throughout month 4 (1.5 versus 0.60, 1.20 versus 0.84, 1.00 versus 0.80, and 0.95 versus 0.74; all P<0.001), which persisted through month 7. Overall adjusted mortality risk was 22% higher for patients with AKI requiring dialysis (1.22; 95% confidence interval, 1.17 to 1.27). CONCLUSIONS: In fully adjusted analyses, patients with AKI requiring dialysis had higher early mortality compared with patients without AKI requiring incident dialysis, but these differences declined after several months. Differences were also observed by age, race, and ethnicity within both patient cohorts.

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

OBJECTIVE: 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 SOURCES: 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. STUDY DESIGN: 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 COLLECTION: 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. PRINCIPAL FINDINGS: 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). CONCLUSIONS: 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.

The profile inter-unit reliability.

To assess the quality of health care, patient outcomes associated with medical providers (eg, dialysis facilities) are routinely monitored in order to identify poor (or excellent) provider performance. Given the high stakes of such evaluations for payment as well as public reporting of quality, it is important to assess the reliability of quality measures. A commonly used metric is the inter-unit reliability (IUR), which is the proportion of variation in the measure that comes from inter-provider differences. Despite its wide use, however, the size of the IUR has little to do with the usefulness of the measure for profiling extreme outcomes. A large IUR can signal the need for further risk adjustment to account for differences between patients treated by different providers, while even measures with an IUR close to zero can be useful for identifying extreme providers. To address these limitations, we propose an alternative measure of reliability, which assesses more directly the value of a quality measure in identifying (or profiling) providers with extreme outcomes. The resulting metric reflects the extent to which the profiling status is consistent over repeated measurements. We use national dialysis data to examine this approach on various measures of dialysis facilities.

Arteriovenous Fistula Use in the United States and Dialysis Facility-Level Comorbidity Burden.

RATIONALE & OBJECTIVE: Patients with multiple comorbid conditions are less likely to use an arteriovenous fistula (AVF) for hemodialysis vascular access. Some dialysis facilities have high rates of AVF placement despite having patients with many comorbid conditions. This study describes variation in facility-level use of AVFs across the facility-level burden of patient comorbid conditions. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Medicare patients receiving hemodialysis for 1 year or more in US dialysis facilities. PREDICTORS: Facility-level burden of patient comorbid conditions; patient characteristics. OUTCOMES: Odds of AVFs versus other access types; facility-level use of AVFs. ANALYTICAL APPROACH: Facility-level comorbidity burden was calculated by summing individual comorbid conditions, determining the average per patient, then defining 11 groups based on facility percentile ranking. Generalized estimating equations with a logit link were used to estimate the odds of AVF placement at the patient level. For the facility-level analysis, a generalized estimating equation model with the identity link was fit to characterize the percentage of AVF use at each facility. RESULTS: Overall, AVF use was 65.8% in 315,919 prevalent hemodialysis patients among 5,813 facilities. After adjustment for patient characteristics, AVF use was 0.27, 0.30, 1.05, and 1.74 percentage points lower than the median among facilities in the 61st to 70th, 71st to 80th, 81st to 90th, and 91st to 99th percentiles of comorbidity, respectively, and 0.42, 0.63, 1.34, and 1.90 percentage points higher than the median among facilities in the 31st to 40th, 21st to 30th, 11th to 20th, and 1st to 10th percentiles of comorbidity, respectively. Facilities in the greater than 99th percentile of comorbidity burden had AVF use that was 3.47 percentage points lower than the median. Facilities in the less than 1st percentile of comorbidity burden had AVF use that was 2.64 percentage points greater than the median. LIMITATIONS: Limited to Medicare dialysis-dependent patients treated for 1 year or more. CONCLUSIONS: After adjustment for patient characteristics, we found small differences in facility rates of AVF use except in the extremes of high or low levels of comorbidity burden. Our study demonstrates that dialysis facilities with a relatively high patient comorbidity burden can achieve similar fistula rates as facilities with healthier patients. Although high comorbidity burden does not explain low facility AVF use, additional study is needed to understand differences in AVF use rates between facilities with similar comorbidity burdens.

Comparative effectiveness analysis of Medicare dialysis facility survey processes.

BACKGROUND: To assure and improve the quality and safety of care provided by dialysis facilities, federal oversight has been conducted through periodic survey assessment. However, with the growing number of individuals living with ESRD and dialysis facilities, state survey agencies have faced challenges in time and resources to complete survey activities. Therefore, the survey process ('Basic Survey' used prior to 2013) was redesigned in order to develop a more efficient process ('Core Survey' newly implemented since 2013). The purpose of this analysis was to evaluate and compare dialysis facility survey outcomes between the Core and Basic Survey processes, using a causal inference technique. The survey outcomes included condition-level citations, total citations (condition- and standard-level), and citation rate per survey-hour. METHODS: For comparisons of non-randomly assigned survey types, propensity score matching was used. Data were drawn from CMS' Quality Improvement Evaluation System (QIES) database from January 1, 2013 through July 31, 2014. Covariates available included survey type, facility characteristics (state, urban, practices catheter reuse, dialysis modalities offered, number of patients, mortality, hospitalization, infection) and survey-related characteristics (number of surveyors, time since last survey). RESULTS: Compared to the Basic Survey, the Core Survey identified 10% more total citations (P = 0.001) and identified condition-level citations more frequently, although the latter finding did not reach statistical significance. These findings suggest an increase of 10% in citation rate (i.e. ratio between citations and survey time) with the Core survey process (P = 0.002). CONCLUSIONS: Greater efficiency has implications for attenuating the time-intensive burden of the state survey process, and improving the safety and quality of care provided by dialysis facilities.

Patient Perspectives on the Choice of Dialysis Modality: Results From the Empowering Patients on Choices for Renal Replacement Therapy (EPOCH-RRT) Study.

BACKGROUND: Little is known about factors that are important to patients with advanced kidney disease and their perspectives at the time they choose a dialysis modality. EPOCH-RRT, a study supported in part by the Patient-Centered Outcomes Research Institute (PCORI), was designed to assist patients with this choice by identifying such factors and effectively provide relevant information. STUDY DESIGN: Cross-sectional study, designed and conducted in collaboration with a multistakeholder advisory panel that included patients, caregivers, and health care professionals. SETTING & PARTICIPANTS: 180 patients with advanced chronic kidney disease (CKD; estimated glomerular filtration rate < 25mL/min/1.73m2), either non-dialysis-dependent (NDD-CKD; n=65) or on dialysis therapy (hemodialysis [HD], n=77; or peritoneal dialysis, n=38), recruited across the United States through social media and in-person contacts. METHODOLOGY: Semistructured telephone interviews including open- and closed-ended questions. ANALYTICAL APPROACH: Mixed methods, integrating quantitative and qualitative approaches; themes identified through content analysis of interview transcripts by 2 independent coders. RESULTS: Themes most often reported as important were keeping as much independence as possible, quality and quantity of life, and flexibility in daily schedule. Other factors (eg, concern about the way they look) differed across patient subgroups based on age, sex, and NDD-CKD/dialysis modality. Among patients who had initiated dialysis therapy, almost half (47%) the HD patients believed that the decision to be treated by HD had largely not been their choice; this was only reported by 3% of peritoneal dialysis patients. LIMITATIONS: Recruitment through social media and willingness to participate in lengthy telephone interviews resulted in a select sample that may not be representative of the broader advanced CKD population; therefore, generalizability of findings cannot be determined. CONCLUSIONS: Incorporation of patient priorities in care improves health outcomes. Given the perceived limited role in the choice of dialysis treatment, our findings support the need for interventions to improve shared decision making on dialysis treatment options, targeting both patients and clinicians.

Risk Adjustment and the Assessment of Disparities in Dialysis Mortality Outcomes.

Standardized mortality ratios (SMRs) reported by Medicare compare mortality at individual dialysis facilities with the national average, and are currently adjusted for race. However, whether the adjustment for race obscures or clarifies disparities in quality of care for minority groups is unknown. Cox model-based SMRs were computed with and without adjustment for patient race for 5920 facilities in the United States during 2010. The study population included virtually all patients treated with dialysis during this period. Without race adjustment, facilities with higher proportions of black patients had better survival outcomes; facilities with the highest percentage of black patients (top 10%) had overall mortality rates approximately 7% lower than expected. After adjusting for within-facility racial differences, facilities with higher proportions of black patients had poorer survival outcomes among black and non-black patients; facilities with the highest percentage of black patients (top 10%) had mortality rates approximately 6% worse than expected. In conclusion, accounting for within-facility racial differences in the computation of SMR helps to clarify disparities in quality of health care among patients with ESRD. The adjustment that accommodates within-facility comparisons is key, because it could also clarify relationships between patient characteristics and health care provider outcomes in other settings.

Has dialysis payment reform led to initial racial disparities in anemia and mineral metabolism management?

Implementation of the Medicare ESRD prospective payment system (PPS) and changes to dosing guidelines for erythropoiesis-stimulating agents (ESAs) in 2011 appear to have influenced use of injectable medications among dialysis patients. Given historically higher ESA and vitamin D use among black patients, we assessed the effect of these policy changes on racial disparities in the management of anemia and mineral metabolism. Analyses used cross-sectional monthly cohorts for a period-prevalent sample of 7384 maintenance hemodialysis patients at 132 facilities from the Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor. Linear splines with knots at each policy change were used in survey-weighted regressions to estimate time trends in hemoglobin (Hgb), erythropoietin (EPO) dose, intravenous (IV) iron dose, ferritin, transferrin saturation (TSAT) concentration, parathyroid hormone (PTH), IV vitamin D dose, cinacalcet use, and phosphate binder use. From August 2010 to December 2011, mean Hgb declined from 11.5 to 11.0 g/dl (P<0.001), mean EPO dose declined from 20,506 to 14,777 U/wk (P<0.001), and mean serum PTH increased from 340 to 435 pg/ml (P<0.001). No meaningful differences by race were observed regarding the rates of change of management practices or laboratory measures (all P>0.21). Mean EPO and vitamin D dose and serum PTH levels remained higher in blacks. Despite evidence that anemia and mineral metabolism management practices have changed significantly over time, there was no immediate indication of racial disparities resulting from implementation of the PPS or ESA label change. Further studies are needed to examine effects among patient and facility subgroups.

Association between oral nutritional supplementation and clinical outcomes among patients with ESRD.

BACKGROUND AND OBJECTIVES: Oral nutritional supplementation (ONS) was provided to ESRD patients with hypoalbuminemia as part of Fresenius Medical Care Health Plan's (FMCHP) disease management. This study evaluated the association between FMCHP's ONS program and clinical outcomes. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Analyses included FMCHP patients with ONS indication (n=470) defined as 2-month mean albumin <3.8 g/dl until reaching a 3-month mean ≥3.8 g/dl from February 1, 2006 to December 31, 2008. Patients did not receive ONS if deemed inappropriate or refused. Patients on ONS were compared with patients who were not, despite meeting ONS indication. Patients with ONS indication regardless of use were compared with Medicare patients with similar serum albumin levels from the 2007 Centers for Medicare and Medicaid Services Clinical Performance Measures Project (CPM). Cox models calculated adjusted hospitalization and mortality risks at 1 year. RESULTS: Among patients with indication for ONS, 276 received supplements and 194 did not. ONS use was associated with 0.058 g/dl higher serum albumin overall (P=0.02); this difference decreased by 0.001 g/dl each month (P=0.05) such that the difference was 0.052 g/dl (P=0.04) in month 6 and the difference was no longer significant in month 12 . In analyses based on ONS use, ONS patients had lower hospitalization at 1 year (68.4%; P<0.01) versus patients without ONS (88.7%), but there was no significant reduction in mortality risk (P=0.29). In analyses based on ONS indication, patients with indication had lower mortality at 1 year (16.2%) compared with CPM patients (23.4%; P<0.01). CONCLUSIONS: These findings suggest that ONS use was associated with significantly lower hospitalization rates but had no significant effect on mortality in a disease management setting.