Global Policy Barriers and Enablers to Exercise and Physical Activity in Kidney Care.

OBJECTIVE: Impairment in physical function and physical performance leads to decreased independence and health-related quality of life in people living with chronic kidney disease and end-stage kidney disease. Physical activity and exercise in kidney care are not priorities in policy development. We aimed to identify global policy-related enablers, barriers, and strategies to increase exercise participation and physical activity behavior for people living with kidney disease. DESIGN AND METHODS: Guided by the Behavior Change Wheel theoretical framework, 50 global renal exercise experts developed policy barriers and enablers to exercise program implementation and physical activity promotion in kidney care. The consensus process consisted of developing themes from renal experts from North America, South America, Continental Europe, United Kingdom, Asia, and Oceania. Strategies to address enablers and barriers were identified by the group, and consensus was achieved. RESULTS: We found that policies addressing funding, service provision, legislation, regulations, guidelines, the environment, communication, and marketing are required to support people with kidney disease to be physically active, participate in exercise, and improve health-related quality of life. We provide a global perspective and highlight Japanese, Canadian, and other regional examples where policies have been developed to increase renal physical activity and rehabilitation. We present recommendations targeting multiple stakeholders including nephrologists, nurses, allied health clinicians, organizations providing renal care and education, and renal program funders. CONCLUSIONS: We strongly recommend the nephrology community and people living with kidney disease take action to change policy now, rather than idly waiting for indisputable clinical trial evidence that increasing physical activity, strength, fitness, and function improves the lives of people living with kidney disease.

Intradialytic exercise improves left ventricular mass in hemodialysis patients.

Graham-Brown et al. report the results of a randomized controlled trial in patients on hemodialysis in which a 6-month intradialytic cycling program led to significant reduction in left ventricular mass as compared to the control group. However, there was no significant effect on physical function, physical activity or health-related quality of life.

Comparison of Dialysis Unit and Home Blood Pressures: An Observational Cohort Study.

RATIONALE & OBJECTIVE: Prior studies of patients receiving maintenance hemodialysis have shown that, on average, blood pressure (BP) measured predialysis is higher than BP measured at home. We hypothesized that a subset of hemodialysis patients has BP that is higher when measured at home than when measured predialysis and this subgroup of patients has a higher prevalence of left ventricular hypertrophy. STUDY DESIGN: Prospective cohort. SETTING & PARTICIPANTS: 97 hypertensive hemodialysis patients enrolled in the Blood Pressure in Dialysis Study (BID), a randomized trial of comparing target predialysis BP ≤140/90 to 155-165/90 mm Hg. EXPOSURE: Differences between predialysis and next-day home systolic BP measured ≥6 times over 1 year. OUTCOME: Left ventricular mass index (LVMI) by cardiac magnetic resonance imaging. ANALYTICAL APPROACH: A hierarchical clustering analysis divided patients into 3 clusters based on the average and variability of differences in systolic predialysis and home BP. Clusters were compared with respect to clinical factors and LVMI. RESULTS: Mean differences between predialysis and home systolic BP were 19.1 (95% CI, 17.0 to 21.1) mm Hg for cluster 1 ("home lower"), 3.7 (95% CI, 1.6 to 5.8) mm Hg for cluster 2 ("home and predialysis similar"), and -9.7 (95% CI, -12.0 to -7.4) mm Hg for cluster 3 ("home higher"). Systolic BP declined during dialysis in clusters 1 and 2 but increased in cluster 3. Interdialytic weight gains did not differ. After adjusting for sex and treatment arm, LVMI was higher in cluster 3 than in clusters 1 and 2: differences in means of 10.6 ± 4.96 (SE) g/m2 (P = 0.04) and 12.0 ± 5.08 g/m2 (P = 0.02), respectively. LIMITATIONS: Limited statistical power. CONCLUSIONS: Nearly one-third of participants had home BPs higher than predialysis BPs. These patients had LVMI higher than those with similar or lower BPs at home, indicating that their BP may have been undertreated.

Using Patient-Reported Measures to Improve Outcomes in Kidney Disease.

Patients with CKD and ESRD are vulnerable to increased mortality rates and other poor outcomes. Among those with ESRD, their health-related quality of life (HRQOL) is shown little to no improvement as they undergo treatments such as dialysis and providers concurrently manage other health issues that complicate their already vulnerable state. This review synthesizes evidence demonstrating that a focus on measuring and monitoring patient-reported outcomes (PRO) such as pain and depression can improve HRQOL. Patient-centered care has the potential to create an efficient way for clinicians to address specific challenges facing patients. While there is an emerging literature assessing the use of PROs in kidney research, by examining relevant research in other disciplines it is possible to generate better ways to use PROs in this high-risk population. Electronic health records as well as various other electronic methods of communication between the clinician and patient may serve to accelerate the trajectory toward patient-centered care using PROs.

Pain management in patients with chronic kidney disease and end-stage kidney disease.

PURPOSE OF REVIEW: This review evaluates current recommendations for pain management in chronic kidney disease (CKD) and end-stage kidney disease (ESKD) with a specific focus on evidence for opioid analgesia, including the partial agonist, buprenorphine. RECENT FINDINGS: Recent evidence supports the use of physical activity and other nonpharmacologic therapies, either alone or with pharmacological therapies, for pain management. Nonopioid analgesics, including acetaminophen, topical analgesics, gabapentinoids, serotonin-norepinephrine reuptake inhibitors, and TCA may be considered based on pain cause and type, with careful dose considerations in kidney disease. NSAIDs may be used in CKD and ESKD for short durations with careful monitoring. Opioid use should be minimized and reserved for patients who have failed other therapies. Opioids have been associated with increased adverse events in this population, and thus should be used cautiously after risk/benefit discussion with the patient. Opioids that are safer to use in kidney disease include oxycodone, hydromorphone, fentanyl, methadone, and buprenorphine. Buprenorphine appears to be a promising and safer option due to its partial agonism at the mu opioid receptor. SUMMARY: Pain is poorly managed in patients with kidney disease. Nonpharmacological and nonopioid analgesics should be first-line approaches for pain management. Opioid use should be minimized with careful monitoring and dose adjustment.

Nephrology Provider Surprise Question Response and Hospitalizations in Older Adults with Advanced CKD.

BACKGROUND: Older adults with advanced non-dialysis-dependent chronic kidney disease (NDD-CKD) face a high risk of hospitalization and related adverse events. METHODS: This prospective cohort study followed nephrology clinic patients ≥60 years old with NDD-CKD stages 4-5. After an eligible patient's office visit, study staff asked the patient's provider to rate the patient's risk of death within the next year using the surprise question ("Would you be surprised if this patient died in the next 12 months?") with a 5-point Likert scale response (1, "definitely not surprised" to 5, "very surprised"). We used a statewide database to ascertain hospitalization during follow-up. RESULTS: There were 488 patients (median age 72 years, 51% female, 17% black) with median estimated glomerular filtration rate 22 mL/min/1.73 m2. Over a median follow-up of 2.1 years, the rates of hospitalization per 100 person-years in the respective response groups were 41 (95% confidence interval [CI]: 34-50), "very surprised"; 65 (95% CI: 55-76), "surprised"; 98 (95% CI: 85-113), "neutral"; 125 (95% CI: 107-144), "not surprised"; and 120 (95% CI: 94-151), "definitely not surprised." In a fully adjusted cumulative probability ordinal regression model for proportion of follow-up time spent hospitalized, patients whose providers indicated that they would be "definitely not surprised" if they died spent a greater proportion of follow-up time hospitalized compared with those whose providers indicated that they would be "very surprised" (odds ratio 2.4, 95% CI: 1.0-5.7). There was a similar association for time to first hospitalization. CONCLUSION: Nephrology providers' responses to the surprise question for older patients with advanced NDD-CKD were independently associated with proportion of future time spent hospitalized and time to first hospitalization. Additional studies should examine how to use this information to provide patients with anticipatory guidance on their possible clinical trajectory and to target potentially preventable hospitalizations.

When ESKD complicates the management of pain.

Pain is one of the most common symptoms reported by patients with end-stage kidney disease (ESKD) and negatively impacts their health-related quality of life (HRQOL), dialysis adherence, healthcare utilization, and mortality. There are a number of patient-related and health system-related barriers that make it very challenging to treat pain in these patients. Moreover, the limited availability of efficacious and safe nonopiate analgesic options has led to over-use of opioids in this population. We propose a framework for pain assessment and tailored treatment using nonpharmacological and pharmacological approaches to optimize pain management and opioid use. Additionally, we recommend system-level changes to improve care coordination and pain management in ESKD patients.

Barriers and facilitators for engagement and implementation of exercise in end-stage kidney disease: Future theory-based interventions using the Behavior Change Wheel.

Theory-driven interventions are required to increase the adoption and implementation of physical activity and exercise programs among patients with ESKD. The Behavior Change Wheel (BCW) represents a synthesis of behavior change theories and can be used to aid the systematic development of theory-driven interventions designed to change exercise behavior. The goal of this review was to synthesize barriers and facilitators to engagement and implementation of exercise and develop theory-based recommendations for exercise behavior change interventions in patients with ESKD. We applied the BCW in the current context of exercise for ESKD patients and conducted an analysis of patients' and health care professionals' (HCPs) capabilities, opportunities, and motivations to engage or promote exercise, respectively. Our analysis identified a number of salient barriers that could be targeted via intervention to increase levels of physical activity and exercise. Intervention functions identified as most likely to change patient behavior included training, enablement, education, restructuring environment, persuasion, modeling, incentivizing, and coercion. Similarly, intervention functions most likely to change HCPs behavior for exercise promotion included training, modeling, education, environmental restructuring, persuasion, and incentivizing. We also considered potential over-arching policy changes required to support these interventions. Our findings provide theory-based recommendations that can help inform future clinical and research decision-making for implementing exercise interventions in these patients. However, high-quality research in this area is desperately needed to ensure that interventions not only be theory-driven, but evidence-based.

BP in Dialysis: Results of a Pilot Study.

The optimal BP target for patients receiving hemodialysis is unknown. We randomized 126 hypertensive patients on hemodialysis to a standardized predialysis systolic BP of 110-140 mmHg (intensive arm) or 155-165 mmHg (standard arm). The primary objectives were to assess feasibility and safety and inform the design of a full-scale trial. A secondary objective was to assess changes in left ventricular mass. Median follow-up was 365 days. In the standard arm, the 2-week moving average systolic BP did not change significantly during the intervention period, but in the intensive arm, systolic BP decreased from 160 mmHg at baseline to 143 mmHg at 4.5 months. From months 4-12, the mean separation in systolic BP between arms was 12.9 mmHg. Four deaths occurred in the intensive arm and one death occurred in the standard arm. The incidence rate ratios for the intensive compared with the standard arm (95% confidence intervals) were 1.18 (0.40 to 3.33), 1.61 (0.87 to 2.97), and 3.09 (0.96 to 8.78) for major adverse cardiovascular events, hospitalizations, and vascular access thrombosis, respectively. The intensive and standard arms had similar median changes (95% confidence intervals) in left ventricular mass of -0.84 (-17.1 to 10.0) g and 1.4 (-11.6 to 10.4) g, respectively. Although we identified a possible safety signal, the small size and short duration of the trial prevent definitive conclusions. Considering the high risk for major adverse cardiovascular events in patients receiving hemodialysis, a full-scale trial is needed to assess potential benefits of intensive hypertension control in this population.

The associations of hemodialysis access type and access satisfaction with health-related quality of life.

OBJECTIVE: In addition to age and comorbidities, health-related quality of life (HRQOL) is known to predict mortality in hemodialysis (HD) patients. Understanding the association of vascular access type with HRQOL can help surgeons to provide patient-centered dialysis access recommendations. We sought to understand the impact of HD access type on HRQOL. METHODS: We conducted a cross-sectional prospective study of community-dwelling prevalent HD patients in Pittsburgh, Pennsylvania. We assessed patient satisfaction with their access using the Vascular Access Questionnaire (VAQ) and HRQOL with the Short Form Health Survey. We compared access satisfaction and HRQOL across access types. We used logistic regression modeling to evaluate the association of access type with satisfaction and multivariate analysis of variance to evaluate the association of both of these variables on HRQOL. RESULTS: We surveyed 77 patients. The mean age was 61.8 ± 15.9 years. Arteriovenous fistula (AVF) was used by 62.3%, tunneled dialysis catheter (TDC) by 23.4%, and arteriovenous graft (AVG) by 14.3%. There was a significant difference in satisfaction by access type with lowest median VAQ score (indicating highest satisfaction) in patients with AVF followed by TDC and AVG (4.5 vs 6.5 vs 7.0; P = .013). Defining a VAQ score of <7 to denote satisfaction, AVF patients were more likely to be satisfied with their access, compared with TDC or AVG (77% vs 56% vs 55%; P = NS). Multivariate regression analysis yielded a model that predicted 46% of the variance of VAQ score; important predictors of dissatisfaction included <1 year on dialysis (ß = 3.36; P < .001), increasing number of access-related hospital admissions in the last year (ß = 1.69; P < .001), and AVG (ß = 1.72; P = .04) or TDC (ß = 1.67; P = .02) access. Mean physical and mental QOL scores (the composite scores of Short Form Health Survey) were not different by access type (P = .49; P = .41). In an additive multivariate analysis of variance with the two composite QOL scores as dependent variables, 25.8% of the generalized variance in HRQOL (effect size) was accounted for by access satisfaction with only an additional 3% accounted for by access type. CONCLUSIONS: HD patients experience greatest satisfaction with fistula, and access satisfaction is significantly associated with better HRQOL. Controlling for access satisfaction, there is no significant independent association of access type on HRQOL. Future research should investigate the relationship between access satisfaction, adherence to dialysis regimens, mortality, and the consequent implications for patient-centered care.

Association of Intradialytic Hypertension with Left Ventricular Mass in Hypertensive Hemodialysis Patients Enrolled in the Blood Pressure in Dialysis (BID) Study.

BACKGROUND/AIMS: Intradialytic hypertension (IDH), or paradoxical rise in blood pressure (BP) during hemodialysis (HD) is associated with increased morbidity and mortality. The association between IDH and increased left ventricular mass (LVM), a well-known risk factor for adverse cardiovascular outcomes in HD patients, has not been studied. The aim of our study is to evaluate the cross-sectional association of intradialytic change in BP with cardiac structure and function measured by cardiac MRI in hypertensive HD patients enrolled in the multi-center Blood Pressure in Dialysis (BID) clinical trial. METHODS: Participants in the BID study were categorized into 3 groups based on average change (Δ) in systolic blood pressure (SBP) (post-HD SBP minus pre-HD SBP) during HD over a 1 month period: group 1 - patients with an increase in SBP ≥ 10mm Hg during HD (IDH); group 2 -patients with SBP decrease of greater ≥10mm Hg during HD; group 3 - patients with SBP increase or decrease by < 10mm Hg during HD. LVM index (LVMI) was measured using cardiac MRI, which were centrally read. Baseline characteristics were compared in the 3 groups and multivariable regression models were fitted for the adjusted association of IDH with LVMI. RESULTS: Among the 80 participants, 7 (8.8%) had IDH and had average Δ SBP 17.0 ± 10.1 mmHg during HD. Patients with IDH were less likely to be diabetic, had lower pre-dialysis SBP and lower percent interdialytic weight gain as compared to the other 2 groups (p=0.02, p< 0.001 and p=0.02 respectively). In multivariable regression analyses, IDH was significantly associated with LVMI (adjusted mean difference relative to SBP decreased group [95% confidence interval (CI)] = 12.5 [3.6, 21.5], p=0.01) after adjusting for age, sex, diabetes, IDWG%, pre-HD SBP and beta blocker use. Every 1 mm rise in ΔSBP during HD was associated with 0.2 g/m2 increase in LVMI in adjusted models (p=0.04). CONCLUSION: IDH is independently associated with higher LVMI in hypertensive HD patients and may contribute to increased cardiovascular events.

Reliability and Utility of the Surprise Question in CKD Stages 4 to 5.

BACKGROUND: Prognostic uncertainty is one barrier to engaging in goals-of-care discussions in chronic kidney disease (CKD). The surprise question ("Would you be surprised if this patient died in the next 12 months?") is a tool to assist in prognostication. However, it has not been studied in non-dialysis-dependent CKD and its reliability is unknown. STUDY DESIGN: Observational study. SETTING & PARTICIPANTS: 388 patients at least 60 years of age with non-dialysis-dependent CKD stages 4 to 5 who were seen at an outpatient nephrology clinic. PREDICTOR: Trinary (ie, Yes, Neutral, or No) and binary (Yes or No) surprise question response. OUTCOMES: Mortality, test-retest reliability, and blinded inter-rater reliability. MEASUREMENTS: Baseline comorbid conditions, Charlson Comorbidity Index, cause of CKD, and baseline laboratory values (ie, serum creatinine/estimated glomerular filtration rate, serum albumin, and hemoglobin). RESULTS: Median patient age was 71 years with median follow-up of 1.4 years, during which time 52 (13%) patients died. Using the trinary surprise question, providers responded Yes, Neutral, and No for 202 (52%), 80 (21%), and 106 (27%) patients, respectively. About 5%, 15%, and 27% of Yes, Neutral, and No patients died, respectively (P<0.001). Trinary surprise question inter-rater reliability was 0.58 (95% CI, 0.42-0.72), and test-retest reliability was 0.63 (95% CI, 0.54-0.72). The trinary surprise question No response had sensitivity and specificity of 55% and 76%, respectively (95% CIs, 38%-71% and 71%-80%, respectively). The binary surprise question had sensitivity of 66% (95% CI, 49%-80%; P=0.3 vs trinary), but lower specificity of 68% (95% CI, 63%-73%; P=0.02 vs trinary). LIMITATIONS: Single center, small number of deaths. CONCLUSIONS: The surprise question associates with mortality in CKD stages 4 to 5 and demonstrates moderate to good reliability. Future studies should examine how best to deploy the surprise question to facilitate advance care planning in advanced non-dialysis-dependent CKD.

Impact of Cognitive Function Change on Mortality in Renal Transplant and End-Stage Renal Disease Patients.

BACKGROUND: Limited evidence from small-scale studies, mainly involving end-stage renal disease (ESRD) patients, suggests that kidney transplantation may improve cognitive function. We examined changes in cognitive function after a kidney transplant and its association with survival in advanced chronic kidney disease (CKD)/ESRD patients. METHODS: In a prospective study design, cognitive performance of 90 patients (50.6 ± 13.1 years, 66.7% men, 27.8% blacks, 76% CKD stages 4-5) was assessed at the respective patients' residences using established neurocognitive tests. RESULTS: Among the 90 patients, 44 received a kidney transplant (KTx group) while 46 did not (no-KTx group). After a mean follow-up of ∼19 months, there was no significant change in scores for majority of cognitive tests in either group. Older age, but not diabetes or renal function status (CKD vs. ESRD), was a determinant of poor follow-up cognitive performance. Additionally, poor attention/psychomotor speed and executive performance (as measured by Trails A and Stroop test, respectively) was associated with higher mortality over a mean follow-up of 4.7 years, even after adjustment for age, sex, diabetes, CKD or ESRD status and kidney transplant status. CONCLUSION: Overall, cognitive function does not significantly improve after kidney transplant or significantly decline in non-transplanted, advanced CKD/ESRD patients. Poor attention, psychomotor speed and executive performance independent of transplant status were associated with higher mortality over time.

Knowledge, barriers and facilitators of exercise in dialysis patients: a qualitative study of patients, staff and nephrologists.

BACKGROUND: Despite growing evidence on benefits of increased physical activity in hemodialysis (HD) patients and safety of intra-dialytic exercise, it is not part of standard clinical care, resulting in a missed opportunity to improve clinical outcomes in these patients. To develop a successful exercise program for HD patients, it is critical to understand patients', staff and nephrologists' knowledge, barriers, motivators and preferences for patient exercise. METHODS: In-depth interviews were conducted with a purposive sample of HD patients, staff and nephrologists from 4 dialysis units. The data collection, analysis and interpretation followed Criteria for Reporting Qualitative Research guidelines. Using grounded theory, emergent themes were identified, discussed and organized into major themes and subthemes. RESULTS: We interviewed 16 in-center HD patients (mean age 60 years, 50% females, 63% blacks), 14 dialysis staff members (6 nurses, 3 technicians, 2 dietitians, 1 social worker, 2 unit administrators) and 6 nephrologists (50% females, 50% in private practice). Although majority of the participants viewed exercise as beneficial for overall health, most patients failed to recognize potential mental health benefits. Most commonly reported barriers to exercise were dialysis-related fatigue, comorbid health conditions and lack of motivation. Specifically for intra-dialytic exercise, participants expressed concern over safety and type of exercise, impact on staff workload and resistance to changing dialysis routine. One of the most important motivators identified was support from friends, family and health care providers. Specific recommendations for an intra-dialytic exercise program included building a culture of exercise in the dialysis unit, and providing an individualized engaging program that incorporates education and incentives for exercising. CONCLUSION: Patients, staff and nephrologists perceive a number of barriers to exercise, some of which may be modifiable. Participants desired an individualized intra-dialytic exercise program which incorporates education and motivation, and they provided a number of recommendations that should be considered when implementing such a program.

Bidirectional relationship of hypertension with obstructive sleep apnea.

PURPOSE OF REVIEW: Hypertension (HTN) and obstructive sleep apnea (OSA) are coexistent in millions of people, and both have been associated with heart disease, stroke, and premature death. OSA is an important risk factor for HTN. However, the relationship between OSA and HTN may be bidirectional, with high blood pressure (BP) contributing to an increased risk and severity of OSA. The aim of this review is to summarize the current literature supporting a bidirectional relationship of sleep apnea and HTN. RECENT FINDINGS: The treatment of HTN to a lower BP target may improve sleep apnea by improving upper airway tone, by targeting hormone pathways (aldosterone, renin-angiotensin system) that may exacerbate OSA, and by reducing the nocturnal rostral fluid shifts through the use of a low-sodium diet, diuretics, and dialysis. SUMMARY: Intensive BP and volume overload control may be a promising approach to treat OSA. Future studies examining the hormonal mechanisms and comparing the effect of different antihypertensive medications on OSA are needed.

Ecological momentary assessment of fatigue, sleepiness, and exhaustion in ESKD.

BACKGROUND: Many patients on maintenance dialysis experience significant sleepiness and fatigue. However, the influence of the hemodialysis (HD) day and circadian rhythms on patients' symptoms have not been well characterized. We sought to use ecological momentary assessment to evaluate day-to-day and diurnal variability of fatigue, sleepiness, exhaustion and related symptoms in thrice-weekly maintenance HD patients. METHODS: Subjects used a modified cellular phone to access an interactive voice response system that administered the Daytime Insomnia Symptom Scale (DISS). The DISS assessed subjective vitality, mood, and alertness through 19 questions using 7- point Likert scales. Subjects completed the DISS 4 times daily for 7 consecutive days. Factor analysis was conducted and a mean composite score of fatigue-sleepiness-exhaustion was created. Linear mixed regression models (LMM) were used to examine the association of time of day, dialysis day and fatigue, sleepiness, and exhaustion composite scores. RESULTS: The 55 participants completed 1,252 of 1,540 (81%) possible assessments over the 7 day period. Multiple symptoms related to mood (e.g., feeling sad, feeling tense), cognition (e.g., difficulty concentrating), and fatigue (e.g., exhaustion, feeling sleepy) demonstrated significant daily and diurnal variation, with higher overall symptom scores noted on hemodialysis days and later in the day. In factor analysis, 4 factors explained the majority of the observed variance for DISS symptoms. Fatigue, sleepiness, and exhaustion loaded onto the same factor and were highly intercorrelated. In LMM, mean composite fatigue-sleepiness-exhaustion scores were associated with dialysis day (coefficient and 95% confidence interval [CI] 0.21 [0.02 - 0.39]) and time of day (coefficient and 95% CI 0.33 [0.25 - 0.41]. Observed associations were minimally affected by adjustment for demographics and common confounders. CONCLUSIONS: Maintenance HD patients experience fatigue-sleepiness-exhaustion symptoms that demonstrate significant daily and diurnal variation. The variability in symptoms may contribute to poor symptom awareness by providers and greater misclassification bias of fatigue related symptoms in clinical studies.

Optimizing Care Delivery in Patients with Chronic Kidney Disease in the United States: Proceedings of a Multidisciplinary Roundtable Discussion and Literature Review.

BACKGROUND: Approximately 37 million individuals in the United States (US) have chronic kidney disease (CKD). Patients with CKD have a substantial morbidity and mortality, which contributes to a huge economic burden to the healthcare system. A limited number of clinical pathways or defined workflows exist for CKD care delivery in the US, primarily due to a lower prioritization of CKD care within health systems compared with other areas (e.g., cardiovascular disease [CVD], cancer screening). CKD is a public health crisis and by the year 2040, CKD will become the fifth leading cause of years of life lost. It is therefore critical to address these challenges to improve outcomes in patients with CKD. METHODS: The CKD Leaders Network conducted a virtual, 3 h, multidisciplinary roundtable discussion with eight subject-matter experts to better understand key factors impacting CKD care delivery and barriers across the US. A premeeting survey identified topics for discussion covering the screening, diagnosis, risk stratification, and management of CKD across the care continuum. Findings from this roundtable are summarized and presented herein. RESULTS: Universal challenges exist across health systems, including a lack of awareness amongst providers and patients, constrained care team bandwidth, inadequate financial incentives for early CKD identification, non-standardized diagnostic classification and triage processes, and non-centralized patient information. Proposed solutions include highlighting immediate and long-term financial implications linked with failure to identify and address at-risk individuals, identifying and managing early-stage CKD, enhancing efforts to support guideline-based education for providers and patients, and capitalizing on next-generation solutions. CONCLUSIONS: Payers and other industry stakeholders have opportunities to contribute to optimal CKD care delivery. Beyond addressing the inadequacies that currently exist, actionable tactics can be implemented into clinical practice to improve clinical outcomes in patients at risk for or diagnosed with CKD in the US.

Effectiveness of an Advance Care Planning Intervention in Adults Receiving Dialysis and Their Families: A Cluster Randomized Clinical Trial.

Importance: Evidence of effectiveness of advance care planning (ACP) strategies for patients receiving dialysis and their families is needed. Objectives: To test the effectiveness of an ACP intervention to prepare patients and their surrogates for end-of-life (EOL) decision-making and to improve surrogate bereavement outcomes. Design, Setting, and Participants: This cluster randomized clinical trial, An Effectiveness-Implementation Trial of SPIRIT (Sharing Patients' Illness Representations to Increase Trust) in ESRD, was conducted from December 2017 to March 2023 and included 42 dialysis clinics in 5 US states (Georgia, New Mexico, North Carolina, Pennsylvania, and Virginia) randomized to provide intervention or usual care. Recruitment was from February 15, 2018, to January 31, 2022, and patient-surrogate dyads were followed up for 21 months (until January 17, 2023) or until patient death. Intervention: Each clinic selected 1 or 2 health care workers (eg, nurse practitioner, registered nurse, or social worker) to conduct 45- to 60-minute ACP discussions with dyads in the clinic or remotely. After March 13, 2020 (commencement of the COVID-19 emergency declaration), all discussions were conducted remotely. An ACP summary was placed in patients' medical records. Main Outcomes and Measures: The primary, 2-week preparedness outcomes were dyad congruence on EOL goals of care, patient decisional conflict, surrogate decision-making confidence, and a composite of dyad congruence and surrogate decision-making confidence. Secondary bereavement outcomes were anxiety, depression, and posttraumatic distress 3 months after patient death. To adjust for COVID-19 pandemic effects on bereavement outcomes, a variable to indicate the timing of baseline and 3-month assessment relative to the COVID-19 emergency declaration was created. Results: Of the 426 dyads enrolled, 231 were in the intervention clinics, and 195 were in the control clinics. Among all dyads, the mean (SD) patient age was 61.9 (12.7) years, and the mean (SD) surrogate age was 53.7 (15.4) years. At 2 weeks, after adjusting for baseline values, dyad congruence (odds ratio [OR], 1.61; 95% CI, 1.12-2.31; P = .001), decisional conflict scores (ß, -0.10; 95% CI, -0.13 to -0.07; P < .001), and the composite (OR, 1.57; 95% CI, 1.06-2.34; P = .03) were higher in the intervention group than in the control group. Surrogate decision-making confidence was similar between groups (ß, 0.06; 95% CI, -0.01 to 0.13; P = .12). Among 77 bereaved surrogates, after adjusting for baseline values and assessment timing, intervention group anxiety was lower than control group anxiety (ß, -1.55; 95% CI, -3.08 to -0.01; P = .05); however, depression (ß, -0.18; 95% CI, -2.09 to 1.73; P = .84) and posttraumatic distress (ß, -0.96; 95% CI, -7.39 to 5.46; P = .75) were similar. Conclusions and Relevance: In this randomized clinical trial, the ACP intervention implemented by health care workers at dialysis centers improved preparation for EOL decision-making but showed mixed effectiveness on bereavement outcomes. The ACP intervention implemented in dialysis centers may be an effective strategy to the dyad preparation for end-of-life care as opposed to the current focus on advance directives. Trial Registration: ClinicalTrials.gov Identifier: NCT03138564.

Electronic Health Record Population Health Management for Chronic Kidney Disease Care: A Cluster Randomized Clinical Trial.

Importance: Large gaps in clinical care in patients with chronic kidney disease (CKD) lead to poor outcomes. Objective: To compare the effectiveness of an electronic health record-based population health management intervention vs usual care for reducing CKD progression and improving evidence-based care in high-risk CKD. Design, Setting, and Participants: The Kidney Coordinated Health Management Partnership (Kidney CHAMP) was a pragmatic cluster randomized clinical trial conducted between May 2019 and July 2022 in 101 primary care practices in Western Pennsylvania. It included patients aged 18 to 85 years with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73m2 with high risk of CKD progression and no outpatient nephrology encounter within the previous 12 months. Interventions: Multifaceted intervention for CKD comanagement with primary care clinicians included a nephrology electronic consultation, pharmacist-led medication management, and CKD education for patients. The usual care group received CKD care from primary care clinicians as usual. Main Outcomes and Measures: The primary outcome was time to 40% or greater reduction in eGFR or end-stage kidney disease. Results: Among 1596 patients (754 intervention [47.2%]; 842 control [52.8%]) with a mean (SD) age of 74 (9) years, 928 (58%) were female, 127 (8%) were Black, 9 (0.6%) were Hispanic, and the mean (SD) estimated glomerular filtration rate was 36.8 (7.9) mL/min/1.73m2. Over a median follow-up of 17.0 months, there was no significant difference in rate of primary outcome between the 2 arms (adjusted hazard ratio, 0.96; 95% CI, 0.67-1.38; P = .82). Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker exposure was more frequent in intervention arm compared with the control group (rate ratio, 1.21; 95% CI, 1.02-1.43). There was no difference in the secondary outcomes of hypertension control and exposure to unsafe medications or adverse events between the arms. Several COVID-19-related issues contributed to null findings in the study. Conclusion and Relevance: In this study, among patients with moderate-risk to high-risk CKD, a multifaceted electronic health record-based population health management intervention resulted in more exposure days to angiotensin-converting enzyme inhibitors/angiotensin receptor blockers but did not reduce risk of CKD progression or hypertension control vs usual care. Trial Registration: ClinicalTrials.gov Identifier: NCT03832595.

The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis.

The HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis (HOPE Trial) is a multicenter randomized trial addressing chronic pain among patients receiving maintenance hemodialysis for end-stage kidney disease. The trial uses a sequential, multiple assignment design with a randomized component for all participants (Phase 1) and a non-randomized component for a subset of participants (Phase 2). During Phase 1, participants are randomized to Pain Coping Skills Training (PCST), an intervention designed to increase self-efficacy for managing pain, or Usual Care. PCST consists of weekly, live, coach-led cognitive behavioral therapy sessions delivered by video- or tele-conferencing for 12 weeks followed by daily interactive voice response sessions delivered by telephone for an additional 12 weeks. At 24 weeks (Phase 2), participants in both the PCST and Usual Care groups taking prescription opioid medications at an average dose of ≥20 morphine milligram equivalents per day are offered buprenorphine, a partial opioid agonist with a more favorable safety profile than full-agonist opioids. All participants are followed for 36 weeks. The primary outcome is pain interference ascertained, for the primary analysis, at 12 weeks. Secondary outcomes include additional patient-reported measures and clinical outcomes including falls, hospitalizations, and death. Exploratory outcomes include acceptability, tolerability, and efficacy of buprenorphine. The enrollment target of 640 participants was met 27 months after trial initiation. The findings of the trial will inform the management of chronic pain, a common and challenging issue for patients treated with maintenance hemodialysis. NCT04571619.