Identifying Major Barriers to Home Dialysis (The IM-HOME Study): Findings From a National Survey of Patients, Care Partners, and Providers.

RATIONALE & OBJECTIVE: Developing strategies to improve home dialysis use requires a comprehensive understanding of barriers. We sought to identify the most important barriers to home dialysis use from the perspective of patients, care partners, and providers. STUDY DESIGN: This is a convergent parallel mixed-methods study. SETTING & PARTICIPANTS: We convened a seven-member advisory board of patients, care partners, and providers who collectively developed lists of major patient/care partner-perceived barriers and provider-perceived barriers to home dialysis. We used these lists to develop a survey that was distributed to patients, care partners, and providers-through the American Association of Kidney Patients and the National Kidney Foundation. The surveys asked participants to: 1) rank their top three major barriers (quantitative); and 2) describe barriers to home dialysis (qualitative). ANALYTICAL APPROACH: We compiled a list of the top three patient/care partner-perceived and top three provider-perceived barriers (quantitative) and conducted a directed content analysis of open-ended survey responses (qualitative). RESULTS: There were 522 complete responses (233 providers; 289 patients/care partners). The top three patient/care partner-perceived barriers were: fear of performing home dialysis; lack of space; and the need for home-based support. The top three provider-perceived barriers were: poor patient education; limited mechanisms for home-based support staff, mental health, and education; and lack of experienced staff. We identified nine themes through qualitative analysis: limited education; financial disincentives; limited resources; high burden of care; built environment/structure of care delivery that favor in-center hemodialysis; fear and isolation; perceptions of inequities in access to home dialysis; provider perspectives about patients; and patient/provider resiliency. LIMITATIONS: This was an online survey that is subject to non-response bias. CONCLUSIONS: The top three barriers to home dialysis for patient/care partners and providers incompletely overlap, suggesting the need for diverse strategies that simultaneously address patient-perceived barriers at home and provider-perceived barriers in the clinic.

Impact of SARS-CoV-2 Infection on Long-Term Depression Symptoms among Veterans.

BACKGROUND: Prior research demonstrates that SARS-COV-2 infection can be associated with a broad range of mental health outcomes including depression symptoms. Veterans, in particular, may be at elevated risk of increased depression following SARS-COV-2 infection given their high rates of pre-existing mental and physical health comorbidities. However, few studies have tried to isolate SARS-COV-2 infection associations with long term, patient-reported depression symptoms from other factors (e.g., physical health comorbidities, pandemic-related stress). OBJECTIVE: To evaluate the association between SARS-COV-2 infection and subsequent depression symptoms among United States Military Veterans. DESIGN: Survey-based non-randomized cohort study with matched comparators. PARTICIPANTS: A matched-dyadic sample from a larger, stratified random sample of participants with and without known to SARS-COV-2 infection were invited to participate in a survey evaluating mental health and wellness 18-months after their index infection date. Sampled participants were stratified by infection severity of the participant infected with SARS-COV-2 (hospitalized or not) and by month of index date. A total of 186 participants in each group agreed to participate in the survey and had sufficient data for inclusion in analyses. Those in the uninfected group who were later infected were excluded from analyses. MAIN MEASURES: Participants were administered the Patient Health Questionnaire-9 as part of a phone interview survey. Demographics, physical and mental health comorbidities were extracted from VHA administrative data. KEY RESULTS: Veterans infected with SARS-COV-2 had significantly higher depression symptoms scores compared with those uninfected. In particular, psychological symptoms (e.g., low mood, suicidal ideation) scores were elevated relative to the comparator group (MInfected = 3.16, 95%CI: 2.5, 3.8; MUninfected = 1.96, 95%CI: 1.4, 2.5). Findings were similar regardless of history of depression. CONCLUSION: SARS-COV-2 infection was associated with more depression symptoms among Veterans at 18-months post-infection. Routine evaluation of depression symptoms over time following SARS-COV-2 infection is important to facilitate adequate assessment and treatment.

Risk of Suicide-Related Outcomes After SARS-COV-2 Infection: Results from a Nationwide Observational Matched Cohort of US Veterans.

BACKGROUND: Negative mental health-related effects of SARS-COV-2 infection are increasingly evident. However, the impact on suicide-related outcomes is poorly understood, especially among populations at elevated risk. OBJECTIVE: To determine risk of suicide attempts and other self-directed violence (SDV) after SARS-COV-2 infection in a high-risk population. DESIGN: We employed an observational design supported by comprehensive electronic health records from the Veterans Health Administration (VHA) to examine the association of SARS-COV-2 infection with suicide attempts and other SDV within one year of infection. Veterans with SARS-COV-2 infections were matched 1:5 with non-infected comparators each month. Three periods after index were evaluated: days 1-30, days 31-365, and days 1-365. PARTICIPANTS: VHA patients infected with SARS-COV-2 between March 1, 2020 and March 31, 2021 and matched non-infected Veteran comparators. MAIN MEASURES: Suicide attempt and other SDV events for the COVID-19 and non-infected comparator groups were analyzed using incidence rates per 100,000 person years and hazard ratios from Cox regressions modeling time from matched index date to first event. Subgroups were also examined. KEY RESULTS: 198,938 veterans with SARS-COV-2 (COVID-19 group) and 992,036 comparators were included. Unadjusted one-year incidence per 100,000 for suicide attempt and other SDV was higher among the COVID-19 group: 355 vs 250 and 327 vs 235, respectively. The COVID-19 group had higher risk than comparators for suicide attempts: days 1-30 hazard ratio (HR) = 2.54 (CI:2.05, 3.15), days 31-365 HR = 1.30 (CI:1.19, 1.43) and days 1-365 HR = 1.41 (CI:1.30, 1.54), and for other SDV: days 1-30 HR = 1.94 (CI:1.51, 2.49), days 31-365 HR = 1.32 (CI:1.20, 1.45) and days 1-365 HR = 1.38 (CI:1.26, 1.51). CONCLUSIONS: COVID-19 patients had higher risks of both suicide attempts and other forms of SDV compared to uninfected comparators, which persisted for at least one year after infection. Results support suicide risk screening of those infected with SARS-COV-2 to identify opportunities to prevent self-harm.

Perspectives on the optimal timing of advance care planning among Japanese patients undergoing dialysis and clinicians: a cross-sectional study.

KEY MESSAGES: The majority of dialysis patients and clinicians favor early advance care planning in our sample. Yet, there is a disconnect: only 11% of patients discussed future care with their clinicians. Our findings indicate Japanese dialysis patients and clinicians support proactive advance care planning at or before dialysis initiation. BACKGROUND: Little is known about the optimal timing of discussions about advance care planning among dialysis patients and clinicians engaged in dialysis care. We aimed to explore the preferred timing for advance care planning and assess actual participation in advance care planning among dialysis patients and their clinicians. METHODS: A scenario-based survey on Japanese patients aged ≥65 years on dialysis and clinicians involved in their dialysis care was performed. Participants were asked if they would feel prepared to engage in advance care planning with their clinicians, offering a choice among four hypothetical stages within the illness trajectory, extending from the initiation of dialysis to a later phase characterized by the patient's extreme frailty. RESULTS: Overall, 181 patients and 128 clinicians participated in the study. Among these, 131 (72%) patients, and 84 (66%) clinicians indicated that they would prefer to initiate advance care planning around the time of dialysis initiation. Only 20 patients (11%) indicated that they had participated in advance care planning with at least one clinician, including 11 (6%) who indicated that they had discussed their preferences around life-sustaining treatments and 8 (4%) who had discussed their preferences around dialysis continuation. CONCLUSIONS: While fewer than 11% of patients undergoing dialysis and their clinicians enrolled in our study had participated in advance care planning, most indicated that they would be comfortable initiating the discussion around the time of dialysis initiation. These findings suggest untapped opportunities to engage patients in advance care planning early in the course of their dialysis.

The Complex Patchwork of Transportation for In-Center Hemodialysis.

Reliable transportation is an important determinant of access to health care and health outcomes that carries particular significance for people with ESKD. In the United States, there are almost half a million patients receiving treatment with in-center dialysis, translating into more than 70 million roundtrips to dialysis centers annually. Difficulty with transportation can interfere with patients' quality of life and contribute to missed or shortened dialysis treatments, increasing their risk for hospitalization. Medicare, the principal payer for dialysis in this country, has not traditionally provided coverage for nonemergency medical transportation, placing the burden of traveling to and from the dialysis center on patients and families and a range of other private and public entities that were not designed and are poorly equipped for this purpose. Here, we review the relationship between access to reliable transportation and health outcomes such as missed and shortened dialysis treatments, hospitalizations, and quality of life. We also describe current approaches to the delivery of transportation for patients receiving in-center hemodialysis, highlighting potential opportunities for improvement.

Design and analysis of outcomes following SARS-CoV-2 infection in veterans.

BACKGROUND: Understanding how SARS-CoV-2 infection impacts long-term patient outcomes requires identification of comparable persons with and without infection. We report the design and implementation of a matching strategy employed by the Department of Veterans Affairs' (VA) COVID-19 Observational Research Collaboratory (CORC) to develop comparable cohorts of SARS-CoV-2 infected and uninfected persons for the purpose of inferring potential causative long-term adverse effects of SARS-CoV-2 infection in the Veteran population. METHODS: In a retrospective cohort study, we identified VA health care system patients who were and were not infected with SARS-CoV-2 on a rolling monthly basis. We generated matched cohorts within each month utilizing a combination of exact and time-varying propensity score matching based on electronic health record (EHR)-derived covariates that can be confounders or risk factors across a range of outcomes. RESULTS: From an initial pool of 126,689,864 person-months of observation, we generated final matched cohorts of 208,536 Veterans infected between March 2020-April 2021 and 3,014,091 uninfected Veterans. Matched cohorts were well-balanced on all 39 covariates used in matching after excluding patients for: no VA health care utilization; implausible age, weight, or height; living outside of the 50 states or Washington, D.C.; prior SARS-CoV-2 diagnosis per Medicare claims; or lack of a suitable match. Most Veterans in the matched cohort were male (88.3%), non-Hispanic (87.1%), white (67.2%), and living in urban areas (71.5%), with a mean age of 60.6, BMI of 31.3, Gagne comorbidity score of 1.4 and a mean of 2.3 CDC high-risk conditions. The most common diagnoses were hypertension (61.4%), diabetes (34.3%), major depression (32.2%), coronary heart disease (28.5%), PTSD (25.5%), anxiety (22.5%), and chronic kidney disease (22.5%). CONCLUSION: This successful creation of matched SARS-CoV-2 infected and uninfected patient cohorts from the largest integrated health system in the United States will support cohort studies of outcomes derived from EHRs and sample selection for qualitative interviews and patient surveys. These studies will increase our understanding of the long-term outcomes of Veterans who were infected with SARS-CoV-2.

COVID-19 Vaccination Effectiveness Against Infection or Death in a National U.S. Health Care System : A Target Trial Emulation Study.

BACKGROUND: Little is known about real-world COVID-19 vaccine effectiveness (VE) in racially and ethnically diverse, elderly populations with high comorbidity burden. OBJECTIVE: To determine the effectiveness of messenger RNA COVID-19 vaccines. DESIGN: Target trial emulation study comparing newly vaccinated persons with matched unvaccinated controls. SETTING: U.S. Department of Veterans Affairs health care system. PARTICIPANTS: Among persons receiving care in the Veterans Affairs health care system (n = 5 766 638), those who received at least 1 dose of the Moderna or Pfizer-BioNTech COVID-19 vaccine from 11 December 2020 to 25 March 2021 (n = 2 099 871) were matched to unvaccinated controls in a 1:1 ratio according to demographic, clinical, and geographic characteristics. INTERVENTION: Follow-up for SARS-CoV-2 infection or SARS-CoV-2-related death, defined as death within 30 days of infection, began after the vaccination date or an identical index date for the matched unvaccinated controls and continued until up to 30 June 2021. MEASUREMENTS: Vaccine effectiveness against SARS-CoV-2 infection or SARS-CoV-2-related death. RESULTS: Vaccinated and unvaccinated groups were well matched; both were predominantly male (92.9% vs. 93.4%), had advanced age (mean, 68.7 years in both groups), had diverse racial and ethnic distribution (for example, Black: 17.3% vs. 17.0%, Hispanic: 6.5% vs. 6.1%), and had substantial comorbidity burden. Vaccine effectiveness 7 or more days after the second vaccine dose was 69% (95% CI, 67% to 70%) against SARS-CoV-2 infection and 86% (CI, 82% to 89%) against SARS-CoV-2-related death and was similar when follow-up was extended to 31 March versus 30 June. Vaccine effectiveness against infection decreased with increasing age and comorbidity burden. LIMITATION: Predominantly male population and lack of data on SARS-CoV-2 variants. CONCLUSION: In an elderly, diverse, high-comorbidity population, COVID-19 VE against infection was substantially lower than previously reported, but VE against death was high. Complementary infection mitigation efforts remain important for pandemic control, even with vaccination. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.

Effectiveness of mRNA COVID-19 Vaccine Boosters Against Infection, Hospitalization, and Death: A Target Trial Emulation in the Omicron (B.1.1.529) Variant Era.

BACKGROUND: The effectiveness of a third mRNA COVID-19 vaccine dose (booster dose) against the Omicron (B.1.1.529) variant is uncertain, especially in older, high-risk populations. OBJECTIVE: To determine mRNA booster vaccine effectiveness (VE) against SARS-CoV-2 infection, hospitalization, and death in the Omicron era by booster type, primary vaccine type, time since primary vaccination, age, and comorbidity burden. DESIGN: Retrospective matched cohort study designed to emulate a target trial of booster vaccination versus no booster, conducted from 1 December 2021 to 31 March 2022. SETTING: U.S. Department of Veterans Affairs health care system. PARTICIPANTS: Persons who had received 2 mRNA COVID-19 vaccine doses at least 5 months earlier. INTERVENTION: Booster monovalent mRNA vaccination (Pfizer-BioNTech's BNT162b2 or Moderna's mRNA-1273) versus no booster. MEASUREMENTS: Booster VE. RESULTS: Each group included 490 838 well-matched persons, who were predominantly male (88%), had a mean age of 63.0 years (SD, 14.0), and were followed for up to 121 days (mean, 79.8 days). Booster VE more than 10 days after a booster dose was 42.3% (95% CI, 40.6% to 43.9%) against SARS-CoV-2 infection, 53.3% (CI, 48.1% to 58.0%) against SARS-CoV-2-related hospitalization, and 79.1% (CI, 71.2% to 84.9%) against SARS-CoV-2-related death. Booster VE was similar for different booster types (BNT162b2 or mRNA-1273), age groups, and primary vaccination regimens but was significantly higher with longer time since primary vaccination and higher comorbidity burden. LIMITATION: Predominantly male population. CONCLUSION: Booster mRNA vaccination was highly effective in preventing death and moderately effective in preventing infection and hospitalization for up to 4 months after administration in the Omicron era. Increased uptake of booster vaccination, which is currently suboptimal, should be pursued to limit the morbidity and mortality of SARS-CoV-2 infection, especially in persons with high comorbidity burden. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.

Trends Over Time in the Risk of Adverse Outcomes Among Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection.

BACKGROUND: We aimed to describe trends in adverse outcomes among patients who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) between February and September 2020 within a national healthcare system. METHODS: We identified enrollees in the national United States Veterans Affairs healthcare system who tested positive for SARS-CoV-2 between 28 February 2020 and 30 September 2020 (n = 55 952), with follow-up extending to 19 November 2020. We determined trends over time in incidence of the following outcomes that occurred within 30 days of testing positive: hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and death. RESULTS: Between February and July 2020, there were marked downward trends in the 30-day incidence of hospitalization (44.2% to 15.8%), ICU admission (20.3% to 5.3%), mechanical ventilation (12.7% to 2.2%), and death (12.5% to 4.4%), which subsequently plateaued between July and September 2020. These trends persisted after adjustment for sociodemographic characteristics, comorbid conditions, documented symptoms, and laboratory tests, including among subgroups of patients hospitalized, admitted to the ICU, or treated with mechanical ventilation. From February to September, there were decreases in the use of hydroxychloroquine (56.5% to 0%), azithromycin (48.3% to 16.6%), vasopressors (20.6% to 8.7%), and dialysis (11.6% to 3.8%) and increases in the use of dexamethasone (3.4% to 53.1%), other corticosteroids (4.9% to 29.0%), and remdesivir (1.7% to 45.4%) among hospitalized patients. CONCLUSIONS: The risk of adverse outcomes in SARS-CoV-2-positive patients decreased markedly between February and July, with subsequent stabilization from July to September. These trends were not explained by changes in measured baseline patient characteristics and may reflect changing treatment practices or viral pathogenicity.

Cirrhosis and Severe Acute Respiratory Syndrome Coronavirus 2 Infection in US Veterans: Risk of Infection, Hospitalization, Ventilation, and Mortality.

BACKGROUND AND AIMS: Whether patients with cirrhosis have increased risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the extent to which infection and cirrhosis increase the risk of adverse patient outcomes remain unclear. APPROACH AND RESULTS: We identified 88,747 patients tested for SARS-CoV-2 between March 1, 2020, and May 14, 2020, in the Veterans Affairs (VA) national health care system, including 75,315 with no cirrhosis-SARS-CoV-2-negative (C0-S0), 9,826 with no cirrhosis-SARS-CoV-2-positive (C0-S1), 3,301 with cirrhosis-SARS-CoV-2-negative (C1-S0), and 305 with cirrhosis-SARS-CoV-2-positive (C1-S1). Patients were followed through June 22, 2020. Hospitalization, mechanical ventilation, and death were modeled in time-to-event analyses using Cox proportional hazards regression. Patients with cirrhosis were less likely to test positive than patients without cirrhosis (8.5% vs. 11.5%; adjusted odds ratio, 0.83; 95% CI, 0.69-0.99). Thirty-day mortality and ventilation rates increased progressively from C0-S0 (2.3% and 1.6%) to C1-S0 (5.2% and 3.6%) to C0-S1 (10.6% and 6.5%) and to C1-S1 (17.1% and 13.0%). Among patients with cirrhosis, those who tested positive for SARS-CoV-2 were 4.1 times more likely to undergo mechanical ventilation (adjusted hazard ratio [aHR], 4.12; 95% CI, 2.79-6.10) and 3.5 times more likely to die (aHR, 3.54; 95% CI, 2.55-4.90) than those who tested negative. Among patients with SARS-CoV-2 infection, those with cirrhosis were more likely to be hospitalized (aHR, 1.37; 95% CI, 1.12-1.66), undergo ventilation (aHR, 1.61; 95% CI, 1.05-2.46) or die (aHR, 1.65; 95% CI, 1.18-2.30) than patients without cirrhosis. Among patients with cirrhosis and SARS-CoV-2 infection, the most important predictors of mortality were advanced age, cirrhosis decompensation, and high Model for End-Stage Liver Disease score. CONCLUSIONS: SARS-CoV-2 infection was associated with a 3.5-fold increase in mortality in patients with cirrhosis. Cirrhosis was associated with a 1.7-fold increase in mortality in patients with SARS-CoV-2 infection.

Risk Factors for Testing Positive for Severe Acute Respiratory Syndrome Coronavirus 2 in a National United States Healthcare System.

BACKGROUND: Identifying risk factors for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection could help health systems improve testing and screening strategies. The aim of this study was to identify demographic factors, comorbid conditions, and symptoms independently associated with testing positive for SARS-CoV-2. METHODS: This was an observational cross-sectional study at the Veterans Health Administration, including persons tested for SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR) between 28 February and 14 May 2020. Associations between demographic characteristics, diagnosed comorbid conditions, and documented symptoms with testing positive for SARS-CoV-2 were measured. RESULTS: Of 88 747 persons tested, 10 131 (11.4%) were SARS-CoV-2 PCR positive. Positivity was associated with older age (≥80 vs <50 years: adjusted odds ratio [aOR], 2.16 [95% confidence interval {CI}, 1.97-2.37]), male sex (aOR, 1.45 [95% CI, 1.34-1.57]), regional SARS-CoV-2 burden (≥2000 vs <400 cases/million: aOR, 5.43 [95% CI, 4.97-5.93]), urban residence (aOR, 1.78 [95% CI, 1.70-1.87]), black (aOR, 2.15 [95% CI, 2.05-2.26]) or American Indian/Alaska Native Hawaiian/Pacific Islander (aOR, 1.26 [95% CI, 1.05-1.52]) vs white race, and Hispanic ethnicity (aOR, 1.52 [95% CI, 1.40-1.65]). Obesity and diabetes were the only 2 medical conditions associated with testing positive. Documented fevers, chills, cough, and diarrhea were also associated with testing positive. The population attributable fraction of positive tests was highest for geographic location (35.3%), followed by demographic variables (27.1%), symptoms (12.0%), obesity (10.5%), and diabetes (0.4%). CONCLUSIONS: The majority of positive SARS-CoV-2 tests were attributed to geographic location, demographic characteristics, and obesity, with a minor contribution of chronic comorbid conditions.

Changes in the associations of race and rurality with SARS-CoV-2 infection, mortality, and case fatality in the United States from February 2020 to March 2021: A population-based cohort study.

BACKGROUND: We examined whether key sociodemographic and clinical risk factors for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and mortality changed over time in a population-based cohort study. METHODS AND FINDINGS: In a cohort of 9,127,673 persons enrolled in the United States Veterans Affairs (VA) healthcare system, we evaluated the independent associations of sociodemographic and clinical characteristics with SARS-CoV-2 infection (n = 216,046), SARS-CoV-2-related mortality (n = 10,230), and case fatality at monthly intervals between February 1, 2020 and March 31, 2021. VA enrollees had a mean age of 61 years (SD 17.7) and were predominantly male (90.9%) and White (64.5%), with 14.6% of Black race and 6.3% of Hispanic ethnicity. Black (versus White) race was strongly associated with SARS-CoV-2 infection (adjusted odds ratio [AOR] 5.10, [95% CI 4.65 to 5.59], p-value <0.001), mortality (AOR 3.85 [95% CI 3.30 to 4.50], p-value < 0.001), and case fatality (AOR 2.56, 95% CI 2.23 to 2.93, p-value < 0.001) in February to March 2020, but these associations were attenuated and not statistically significant by November 2020 for infection (AOR 1.03 [95% CI 1.00 to 1.07] p-value = 0.05) and mortality (AOR 1.08 [95% CI 0.96 to 1.20], p-value = 0.21) and were reversed for case fatality (AOR 0.86, 95% CI 0.78 to 0.95, p-value = 0.005). American Indian/Alaska Native (AI/AN versus White) race was associated with higher risk of SARS-CoV-2 infection in April and May 2020; this association declined over time and reversed by March 2021 (AOR 0.66 [95% CI 0.51 to 0.85] p-value = 0.004). Hispanic (versus non-Hispanic) ethnicity was associated with higher risk of SARS-CoV-2 infection and mortality during almost every time period, with no evidence of attenuation over time. Urban (versus rural) residence was associated with higher risk of infection (AOR 2.02, [95% CI 1.83 to 2.22], p-value < 0.001), mortality (AOR 2.48 [95% CI 2.08 to 2.96], p-value < 0.001), and case fatality (AOR 2.24, 95% CI 1.93 to 2.60, p-value < 0.001) in February to April 2020, but these associations attenuated over time and reversed by September 2020 (AOR 0.85, 95% CI 0.81 to 0.89, p-value < 0.001 for infection, AOR 0.72, 95% CI 0.62 to 0.83, p-value < 0.001 for mortality and AOR 0.81, 95% CI 0.71 to 0.93, p-value = 0.006 for case fatality). Throughout the observation period, high comorbidity burden, younger age, and obesity were consistently associated with infection, while high comorbidity burden, older age, and male sex were consistently associated with mortality. Limitations of the study include that changes over time in the associations of some risk factors may be affected by changes in the likelihood of testing for SARS-CoV-2 according to those risk factors; also, study results apply directly to VA enrollees who are predominantly male and have comprehensive healthcare and need to be confirmed in other populations. CONCLUSIONS: In this study, we found that strongly positive associations of Black and AI/AN (versus White) race and urban (versus rural) residence with SARS-CoV-2 infection, mortality, and case fatality observed early in the pandemic were ameliorated or reversed by March 2021.

Perspectives on Conservative Care in Advanced Kidney Disease: A Qualitative Study of US Patients and Family Members.

RATIONALE & OBJECTIVE: Little is known about perceptions of conservative care among patients with advanced kidney disease in the United States. STUDY DESIGN: Qualitative study using cognitive interviewing about attitudes regarding conservative care using decision aids on treatments for advanced kidney disease developed outside the United States. SETTING & PARTICIPANTS: 14 patients 75 years or older with advanced kidney disease, defined as estimated glomerular filtration rate≤20mL/min/1.73m2 and not receiving maintenance dialysis, and 6 of their family members. ANALYTICAL APPROACH: Thematic analysis of participants' reactions to descriptions of conservative care taken from various clinical care decision aids. RESULTS: Participants were mostly White (n=15) and had at least some college education (n=16). Four themes emerged from analysis of interviews: (1) core elements of conservative care: aspects of conservative care that were appealing to participants included a whole-person, team-based, and structured approach to care that focused on symptom management, maintaining current lifestyle, and managing health setbacks; (2) importance of how conservative care is framed: participants were more receptive to conservative care when this was framed as an active rather than passive treatment approach and were receptive to statements of uncertainty about future course of illness and prognosis; (3) an explicit approach to shared decision making: participants believed decisions about conservative care and dialysis should address considerations about risk and benefits of treatment options, family and clinician perspectives, and patients' goals, values, and preferences; and (4) relationship between conservative care and dialysis: although conservative care models outside the United States are generally intended to serve as an alternative to dialysis, participants' comments implied that they did not see conservative care and dialysis as mutually exclusive. LIMITATIONS: Themes identified may not generalize to the broader population of US patients with advanced kidney disease and their family members. CONCLUSIONS: Participants were favorably disposed to a whole-person multidisciplinary approach to conservative care, especially when framed as an active treatment approach. Models of conservative care excluding the possibility of dialysis were less embraced, suggesting that current models will require adaptation to meet the needs of US patients and their families.

Burden and Cost of Caring for US Veterans With CKD: Initial Findings From the VA Renal Information System (VA-REINS).

Kidney disease is a common, complex, costly, and life-limiting condition. Most kidney disease registries or information systems have been limited to single institutions or regions. A national US Department of Veterans Affairs (VA) Renal Information System (VA-REINS) was recently developed. We describe its creation and present key initial findings related to chronic kidney disease (CKD) without kidney replacement therapy (KRT). Data from the VA's Corporate Data Warehouse were processed and linked with national Medicare data for patients with CKD receiving KRT. Operational definitions for VA user, CKD, acute kidney injury, and kidney failure were developed. Among 7 million VA users in fiscal year 2014, CKD was identified using either a strict or liberal operational definition in 1.1 million (16.4%) and 2.5 million (36.3%) veterans, respectively. Most were identified using an estimated glomerular filtration rate laboratory phenotype, some through proteinuria assessment, and very few through International Classification of Diseases, Ninth Revision coding. The VA spent ∼$18 billion for the care of patients with CKD without KRT, most of which was for CKD stage 3, with higher per-patient costs by CKD stage. VA-REINS can be leveraged for disease surveillance, population health management, and improving the quality and value of care, thereby enhancing VA's capacity as a patient-centered learning health system for US veterans.

End-of-Life Care among US Adults with ESKD Who Were Waitlisted or Received a Kidney Transplant, 2005-2014.

BACKGROUND: The care of patients in the United States who have ESKD is often shaped by their hopes and prognostic expectations related to kidney transplant. Little is known about how patients' engagement in the transplant process might relate to patterns of end-of-life care. METHODS: We compared six measures of intensity of end-of-life care among adults in the United States with ESKD who died between 2005 and 2014 after experiencing differing exposure to the kidney transplant process. RESULTS: Of 567,832 decedents with ESKD, 27,633 (5%) had a functioning kidney transplant at the time of death, 14,653 (3%) had a failed transplant, 16,490 (3%) had been removed from the deceased donor waitlist, 17,010 (3%) were inactive on the waitlist, 11,529 (2%) were active on the waitlist, and 480,517 (85%) had never been waitlisted for or received a transplant (reference group). In adjusted analyses, compared with the reference group, patients exposed to the transplant process were significantly more likely to have been admitted to an intensive care unit and to have received an intensive procedure in the last 30 days of life; they were also significantly more likely to have died in the hospital. Those who died on the transplant waitlist were also less likely than those in the reference group to have been enrolled in hospice and to have discontinued dialysis before death. CONCLUSIONS: Patients who had engaged in the kidney transplant process received more intensive patterns of end-of-life care than other patients with ESKD. These findings support the relevance of advance care planning, even for this relatively healthy segment of the ESKD population.

Thematic Analysis of Hospice Mentions in the Health Records of Veterans with Advanced Kidney Disease.

BACKGROUND: Patients with advanced kidney disease are less likely than many patients with other types of serious illness to enroll in hospice. Little is known about real-world clinical decision-making related to hospice for members of this population. METHODS: We used a text search tool to conduct a thematic analysis of documentation pertaining to hospice in the electronic medical record system of the Department of Veterans Affairs, for a national sample of 1000 patients with advanced kidney disease between 2004 and 2014 who were followed until October 8, 2019. RESULTS: Three dominant themes emerged from our qualitative analysis of the electronic medical records of 340 cohort members with notes containing hospice mentions: (1) hospice and usual care as antithetical care models: clinicians appeared to perceive a sharp demarcation between services that could be provided under hospice versus usual care and were often uncertain about hospice eligibility criteria. This could shape decision-making about hospice and dialysis and made it hard to individualize care; (2) hospice as a last resort: patients often were referred to hospice late in the course of illness and did not so much choose hospice as accept these services after all treatment options had been exhausted; and (3) care complexity: patients' complex care needs at the time of hospice referral could complicate transitions to hospice, stretch the limits of home hospice, and promote continued reliance on the acute care system. CONCLUSIONS: Our findings underscore the need to improve transitions to hospice for patients with advanced kidney disease as they approach the end of life.

Experiences of US Nephrologists in the Delivery of Conservative Care to Patients With Advanced Kidney Disease: A National Qualitative Study.

RATIONALE & OBJECTIVE: It is relatively unusual for US patients with advanced chronic kidney disease (CKD) to forgo initiation of maintenance dialysis. Our objective was to describe practice approaches of US nephrologists who have provided conservative care for members of this population. STUDY DESIGN: Qualitative study using semi-structured interviews. SETTING & PARTICIPANTS: A national sample of 21 nephrologists experienced in caring for patients with advanced CKD who decided not to start dialysis. ANALYTICAL APPROACH: Grounded theory methods to identify dominant themes reflecting nephrologists' experiences with and approaches to conservative care for patients with advanced CKD. RESULTS: Nephrologists who participated in this study were primarily from academic practices (n=14) and urban areas (n=15). Two prominent themes emerged from qualitative analysis reflecting nephrologists' experiences with and approaches to conservative care: (1) person-centered practices, which described a holistic approach to care that included basing treatment decisions on what mattered most to individual patients, framing dialysis as an explicit choice, being mindful of sources of bias in medical decision making, and being flexible to the changing needs, values, and preferences of patients; and (2) improvising a care infrastructure, which described the challenges of managing patients conservatively within health systems that are not optimally configured to support their needs. Participating nephrologists described cobbling together resources, assuming a range of different health care roles, preparing patients to navigate health systems in which initiation of dialysis served as a powerful default, and championing the principles of conservative care among their colleagues. LIMITATIONS: The themes identified likely are not generalizable to most US nephrologists. CONCLUSIONS: Insights from a select group of US nephrologists who are early adopters of conservative care signal the need for a stronger cultural and health system commitment to building care models capable of supporting patients who choose to forgo dialysis.

Ethical Concerns in the Care of Patients with Advanced Kidney Disease: a National Retrospective Study, 2000-2011.

BACKGROUND: Understanding ethical concerns that arise in the care of patients with advanced kidney disease may help identify opportunities to support medical decision-making. OBJECTIVE: To describe the clinical contexts and types of ethical concerns that arise in the care of patients with advanced kidney disease. DESIGN: Retrospective cohort study. PARTICIPANTS: A total of 28,568 Veterans with advanced kidney disease between 2000 and 2009 followed through death or 2011. EXPOSURE: Clinical scenarios that prompted clinicians to consider an ethics consultation as documented in the medical record. MAIN MEASURES: Dialysis initiation, dialysis discontinuation, receipt of an intensive procedure during the final month of life, and hospice enrollment. KEY RESULTS: Patients had a mean age of 67.1 years, and the majority were male (98.5%) and white (59.0%). Clinicians considered an ethics consultation for 794 patients (2.5%) over a median follow-up period of 2.7 years. Ethical concerns involved code status (37.8%), dialysis (54.5%), other invasive treatments (40.6%), and noninvasive treatments (61.1%) and were related to conflicts between patients, their surrogates, and/or clinicians about treatment preferences (79.3%), who had authority to make healthcare decisions (65.9%), and meeting the care needs of patients versus obligations to others (10.6%). Among the 20,583 patients who died during follow-up, those for whom clinicians had considered an ethics consultation were less likely to have been treated with dialysis (47.6% versus 62.0%, adjusted odds ratio [aOR] 0.63, 95% CI 0.53-0.74), more likely to have discontinued dialysis (32.5% versus 20.9%, aOR 2.07, CI 1.61-2.66), and less likely to have received an intensive procedure in the last month of life (8.9% versus 18.9%, aOR 0.41, CI 0.32-0.54) compared with patients without documentation of clinicians having considered consultation. CONCLUSIONS: Clinicians considered an ethics consultation for patients with advanced kidney disease in situations of conflicting preferences regarding dialysis and other intensive treatments, especially when these treatments were not pursued.

International variation in dialysis discontinuation in patients with advanced kidney disease.

BACKGROUND: Decisions about dialysis for advanced kidney disease are often strongly shaped by sociocultural and system-level factors rather than the priorities and values of individual patients. We examined international variation in the uptake of conservative approaches to the care of patients with advanced kidney disease, in particular discontinuation of dialysis. METHODS: We employed an observational cohort study design using data collected from patients maintained on long-term hemodialysis between 1996 and 2015 in facilities across 12 developed countries participating in the Dialysis Outcomes and Practice Patterns Study (DOPPS). The main outcome was discontinuation of dialysis therapy. We analyzed the association between several patient characteristics and time to dialysis discontinuation by country and phase of study entry. RESULTS: A total of 259 343 DOPPS patients contributed data to the study, of whom 48 519 (18.7%) died during the study period. Of the decedents, 5808 (12.0%) discontinued dialysis before death. Rates of discontinuation were higher within the first few months after initiation of dialysis, among older adults, among those with a greater number of comorbidities and among those living in an institution. After adjustment for age, sex, dialysis duration, diabetes and dialysis era, rates of discontinuation were highest in Canada, the United States and Australia/New Zealand (33.8, 31.4 and 21.5 per 1000/yr, respectively) and lowest in Japan and Italy (< 0.1 per 1000/yr). Crude discontinuation rates were highest in dialysis facilities that were more likely to offer comprehensive conservative renal care to older adults. INTERPRETATION: We found persistent international variation in average rates of dialysis discontinuation not explained by differences in patient case-mix. These differences may reflect physician-, facility- and society-level differences in clinical practice. There may be opportunities for international cross-collaboration to improve support for patients with end-stage renal disease who prefer a more conservative approach.

Dialysis adequacy reconsidered: The person comes first.

Although many nephrologists see value in maximizing clearance and time on dialysis, clinical trials have failed to show a clear and consistent benefit of increasing clearance above the minimum threshold level recommended in clinical practice guidelines or of increasing dialysis session length or frequency. Available evidence suggests that patients and clinicians do not necessarily agree on what matters most when it comes to dialysis care, and that what patients consider to be an adequate dialysis session is highly individual and has little to do with solute clearance. Qualitative studies suggest that patients value spending less time on dialysis, having the dialysis procedure go smoothly, and being treated like an individual by staff members. Because many patients feel that they have little choice but to show up for their dialysis sessions, failing to involve them in decisions about time spent on the machine can contribute to feelings of powerlessness and loss of control, erode their sense of self, and diminish the quality of therapeutic relationships. On the other hand, a flexible and shared approach to decision-making about time spent on dialysis (and other aspects of care) can help to strengthen relationships, uphold personhood, and align care with what matters most.