Faculty Bibliography

IMPORTANCE/UNASSIGNED:Hispanic and Latino individuals with hemodialysis-dependent kidney failure experience social barriers that may increase their risk for volume-related complications, including fluid accumulation between dialysis sessions or interdialytic weight gain (IDWG). Higher IDWG contributes to cardiovascular complications, hospitalizations, and poor quality of life. Minimizing IDWG is prioritized by patients, clinicians, and payers; yet, high IDWG remains common despite dietary education. OBJECTIVE/UNASSIGNED:To determine if community health worker (CHW) support reduces IDWG among Hispanic and Latino individuals receiving hemodialysis. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This parallel group, unblinded, multicenter, community-partnered, randomized clinical trial was conducted at 5 dialysis centers in Denver, Colorado, between November 2020 and August 2022. Self-identified Latino or Hispanic adults receiving in-center hemodialysis were eligible. Data were analyzed from August 2024 to July 2025. INTERVENTION/UNASSIGNED:Participants were randomized 1:1 to the Navigate-Kidney intervention or standard care. In Navigate-Kidney, CHWs followed a framework-driven, patient-centered protocol to support patient social needs and provide health navigation and culturally responsive kidney care education, including dietary modification and fluid restriction education. CHWs met participants biweekly for at least 6 visits. Standard care had no trial-driven culturally responsive components. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was change in IDWG from 90 days prior to intervention to 180 days postintervention, calculated as a percentage of estimated dry weight. Secondary outcomes included missed and shortened dialysis sessions, health care utilization, and patient activation. Between-group IDWG differences were estimated with piecewise linear mixed models. RESULTS/UNASSIGNED:Of 139 participants (mean [SD] age, 56.8 [12.9] years; 68 [49%] female), 68 were randomly assigned to Navigate-Kidney and 71 to standard care. Postintervention trends in percentage of estimated dry weight differed between Navigate-Kidney and standard care, which corresponded to a difference between groups of -0.46 percentage points (95% CI, -0.78 to -0.14 percentage points) in IDWG after 180 days of follow-up (P = .01). Mean IDWG was 3.26% (95% CI, 2.83%-3.68%) and 3.72% (95% CI, 3.30%-4.14%) in Navigate-Kidney and standard care, respectively. There were fewer shortened dialysis sessions with Navigate-Kidney vs SC (median [IQR], 0.1 [-1.2 to 1.1] vs 0.6 [-0.5 to 1.8]; P = .02), as well as greater improvement in the Patient Activation Measure (median [IQR], 1.8 [-2.2 to 5.2] points vs -2.2 [-7.4 to 2.5] points; P = .005). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this randomized clinical trial, a culturally tailored CHW intervention modestly lowered IDWG and improved dialysis adherence and patient activation among Hispanic and Latino patients with hemodialysis-dependent kidney failure. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03978806.

IMPORTANCE/UNASSIGNED:Latino individuals with dialysis-dependent kidney failure experience social challenges that render self-management of kidney disease difficult. In the Navigate-Kidney trial, a community health worker (CHW) intervention for Latinos receiving dialysis, intervention recipients experienced a decrease in interdialytic weight gain, a surrogate end point for patient self-management. Understanding how the Navigate-Kidney trial was experienced by participants is important when considering scalability and sustainment of the intervention. OBJECTIVE/UNASSIGNED:To examine participant perspectives on their experience in the Navigate-Kidney intervention. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This qualitative study used semistructured interviews with participants receiving the Navigate-Kidney intervention. Participants received care at dialysis centers in Denver, Colorado, between November 2020 and August 2022 and were randomized to receive the Navigate-Kidney intervention. Interview transcripts were deidentified and analyzed using deductive thematic analysis. Data were examined from September 2024 to July 2025. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The main outcomes were the themes and subthemes from the interviews. RESULTS/UNASSIGNED:Twenty-four Latino individuals (11 females [46%]; 13 males [54%]; mean [SD] age of 56 [11] years) participated. The identified themes and subthemes were (1) build trust through understanding health experience (cultivating a personalized connection, promoting optimism and resilience, demonstrating consistency and reliability); (2) address multilevel social and structural challenges to facilitate health system navigation (addressing health insurance barriers, improving food security, relieving the stress of administrative and financial tasks, bridging registered dietitian guidance, enabling attendance of and adherence to dialysis sessions and appointments, coordinating nonnephrology clinical care); (3) provide patient-centered education (improving language concordant communication, promoting health and numeracy literacy, providing culturally responsive dietary restriction); and (4) enhance self-management (exploring opportunities for transplant and peritoneal dialysis, facilitating quality of dialysis care and symptom management, encouraging medication adherence, increasing confidence in diet and fluid intake self-management, achieving clinical parameter targets, activating patients). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this qualitative study of participants in the Navigate-Kidney trial, participants' experience with CHWs built trusting relationships through empathy and consistent support, helped them navigate complex health and social systems, provided culturally and linguistically tailored education, and empowered them to manage their care. Understanding participant perspectives about those activities that promoted health and well-being is critical for future patient-centered adaptations of Navigate-Kidney and similar interventions.

INTRODUCTION/UNASSIGNED:Moderate-to-strenuous exercise reduces risk for disability and cardiovascular disease, yet many older adults with chronic kidney disease (CKD) remain sedentary. Most exercise interventions in patients with CKD are not grounded in models of behavior change and are thus limited by dropout. We aimed to test whether patient activation-the knowledge, confidence, and skill to engage in a behavior-associates with exercise frequency. We further aimed to explore characteristics of adults reporting high versus low activation. Our overarching goal was to provide initial evidence of whether activation could be a target for an exercise intervention for older adults with CKD. METHODS/UNASSIGNED:We conducted a convergent parallel mixed-methods study informed by the Capability, Opportunity, Motivation, and Behavior (COM-B) model. We collected psychological (including Patient Activation Measure-13 [PAM-13]) and physiological factors corresponding to each component of COM-B. We cross-sectionally tested whether patient activation was associated with exercise (via the Exercise Vital Sign). We interviewed participants and their caregivers. RESULTS/UNASSIGNED:< 0.05) increase in weekly exercise days, independent of demographics, comorbidities, cognition, and frailty. Activated participants reported more caregiver support, a sense of identity tied to vocation, and altruism. CONCLUSION/UNASSIGNED:Patient activation associates with exercise frequency in older adults with CKD. Based on qualitative findings, improving activation may involve caregiver support, volunteerism, and vocational rehabilitation.

INTRODUCTION/BACKGROUND:Nearly 40% of adults receiving life-saving dialysis for kidney failure report depressive symptoms. With more than 40 000 Canadians on dialysis, this is a significant health burden. Cognitive behavioural therapy (CBT) has been shown to be effective for treating depressive symptoms; however, it is rarely considered or used for people receiving dialysis. The aim of this realist study is to evaluate and explain how, why, for whom and in what circumstances therapist-guided and remotely delivered CBT works in order to provide equitable mental healthcare to individuals with depressive symptoms receiving dialysis. METHODS AND ANALYSIS/METHODS:The project will include a realist synthesis, a quantitative cohort study and a realist evaluation. Realist methodology is a theory-driven approach that seeks to explain how generative mechanisms are shaped by contextual features, giving rise to outcome patterns. We will begin by developing an initial programme theory (IPT) from the literature and interviews with CBT therapists to understand how CBT is intended to work and for whom. We will use data from the quantitative cohort study to identify contexts that may shape outcome patterns in CBT for people receiving dialysis. This includes previously collected survey data and data from a longitudinal cohort study, both sourced from people across Canada undergoing dialysis. We will test and refine the IPT using data from a realist evaluation and existing literature. The realist evaluation will involve participants from the quantitative cohort study who received therapist-guided, remotely delivered CBT. ETHICS AND DISSEMINATION/BACKGROUND:Ethical approvals have been granted. We have planned a wide range of dissemination strategies: journal manuscripts and conference presentations, executive memos for administrators of renal programmes in Canada, an online inventory of resources for depressive symptoms and presentations of findings together with patient partners at all participating sites. PROSPERO REGISTRATION NUMBER/UNASSIGNED:CRD42023476184.

Pain Coping Skills Training (PCST) is a first-line cognitive-behavioral, non-pharmacological treatment for chronic pain and comorbid symptoms. PCST has been shown to be effective in racially and ethnically diverse cohorts across several chronic medical conditions. However, PCST has not been evaluated in those with end stage kidney disease (ESKD) receiving in-center maintenance hemodialysis. Due to the high rates of morbidity associated with ESKD, and time-intensive treatment, an adaptation of PCST was warranted to address the unique challenges experienced by people living with ESKD. Using current guidelines developed by Card and colleagues for intervention adaptation, PCST was adapted so that it could be implemented among people living with ESKD in a national multisite trial. The objective of this paper was to describe the adaption process outlined by Card and colleagues including how the team selected an effective intervention to adapt, developed a program model, identified mismatches in the original intervention and study population, and then adapted the intervention for those with ESKD treated with in-center maintenance hemodialysis. Finally, we briefly describe future directions for clinical practice and research with the adapted PCST intervention for those with ESKD.Trial registration: ClinicalTrials.gov #NCT04571619.

IMPORTANCE/UNASSIGNED:Chronic pain is common among individuals with dialysis-dependent kidney failure. OBJECTIVE/UNASSIGNED:To evaluate the effectiveness of pain coping skills training (PCST), a cognitive behavioral intervention, on pain interference. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This multicenter randomized clinical trial of PCST vs usual care was conducted across 16 academic centers and 103 outpatient dialysis facilities in the US. Adults undergoing maintenance hemodialysis and experiencing chronic pain were randomly assigned to PCST or usual care in a 1:1 ratio. Participants were followed in the trial for 36 weeks. Enrollment began on January 4, 2021, and follow-up ended on December 21, 2023. INTERVENTIONS/UNASSIGNED:PCST consisting of 12 weekly coach-led sessions via video or telephone conferencing, followed by 12 weeks of daily interactive voice response sessions. Usual care had no trial-driven pain intervention. MAIN OUTCOMES/UNASSIGNED:The primary outcome was pain interference measured with the Brief Pain Inventory (BPI) Interference subscale (score range of 0-10, with higher scores indicating more pain interference). Secondary outcomes included pain intensity, pain catastrophizing, quality of life, depression, and anxiety. RESULTS/UNASSIGNED:A total of 643 participants (mean [SD] age, 60.3 [12.6] years; 288 [44.8%] female) were randomized, with 319 assigned to PCST and 324 assigned to usual care. At week 12 (primary end point), the PCST group had a larger reduction in the BPI Interference score than the usual care group (between-group difference, -0.49; 95% CI, -0.85 to -0.12; P = .009). The effect persisted at week 24 (between-group difference in BPI Interference score, -0.48; 95% CI, -0.86 to -0.11) but was diminished at week 36 (between-group difference in BPI Interference score, -0.34; 95% CI, -0.72 to 0.04). A decrease in BPI Interference score greater than 1 point (minimal clinically important difference) occurred in 143 of 281 participants (50.9%) in the PCST group vs 108 of 295 participants (36.6%) in the usual care group at 12 weeks (odds ratio, 1.79; 95% CI, 1.28-2.49) and 142 of 258 participants (55.0%) in the PCST group vs 113 of 264 participants (42.8%) in the usual care group at 24 weeks (odds ratio, 1.59; 95% CI, 1.13-2.24). Favorable changes with PCST were also apparent for secondary outcomes of pain intensity, quality of life, depression, and anxiety at weeks 12 and/or 24, as well as for pain catastrophizing at weeks 24 and 36. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this randomized clinical trial of patients undergoing maintenance hemodialysis, PCST had benefits on pain interference and other pain-associated outcomes. While the effect on the overall cohort was of modest magnitude, the intervention resulted in a clinically meaningful improvement in pain interference for a substantial proportion of participants. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04571619.

INTRODUCTION/UNASSIGNED:Multidisciplinary care (MDC) for late-stage chronic kidney disease (CKD) has been associated with improved patient outcomes compared with traditional nephrology care; however, the optimal MDC model is unknown. In 2015, we implemented a novel MDC model for patients with late-stage CKD informed by the Chronic Care Model conceptual framework, including an expanded MDC team, care plan meetings, clinical risk prediction, and a patient dashboard. METHODS/UNASSIGNED:) enrolled from May 2015 to February 2020 in the Program for Education in Advanced Kidney Disease (PEAK). Our primary composite outcome was an optimal transition to end-stage kidney disease (ESKD) defined as starting in-center hemodialysis (ICHD) as an outpatient with an arteriovenous fistula (AVF) or graft (AVG), or receiving home dialysis, or a preemptive kidney transplant. Secondary outcomes included home dialysis initiation, preemptive transplantation, vascular access at dialysis initiation, and location of ICHD initiation. We used logistic regression to examine trends in outcomes. Results were stratified by race, ethnicity, and insurance payor, and compared with national and regional averages from the United States Renal Data System (USRDS) averaged from 2015 to 2019. RESULTS/UNASSIGNED: = 0.018) in multivariable adjusted results. Optimal transitions to ESKD and home dialysis rates were higher than the national USRDS data (58% vs. 30%; 23% vs. 11%) across patient race, ethnicity, and payor. CONCLUSION/UNASSIGNED:Patients enrolled in a novel comprehensive MDC model coupled with risk prediction and health information technology were nearly twice as likely to achieve an optimal transition to ESKD and start dialysis at home, compared with national averages.

RATIONALE & OBJECTIVE/UNASSIGNED:The majority of patients with kidney failure receiving dialysis own mobile devices, but the use of mobile health (mHealth) technologies to conduct surveys in this population is limited. We assessed the reach and acceptability of a short message service (SMS) text message-based survey that assessed coronavirus disease 2019 (COVID-19) vaccine hesitancy among patients receiving dialysis. STUDY DESIGN & EXPOSURE/UNASSIGNED:A cross-sectional SMS-based survey conducted in January 2021. SETTING & PARTICIPANTS/UNASSIGNED:Patients receiving in-center hemodialysis, peritoneal dialysis, or home hemodialysis in a nonprofit dialysis organization in New York City. OUTCOMES/UNASSIGNED:(1) Reach of the SMS survey, (2) Acceptability using the 4-item Acceptability of Intervention Measure, and (3) Patient preferences for modes of survey administration. ANALYTICAL APPROACH/UNASSIGNED:We used Fisher exact tests and multivariable logistic regression to assess sociodemographic and clinical predictors of SMS survey response. Qualitative methods were used to analyze open-ended responses capturing patient preferences. RESULTS/UNASSIGNED:Among 1,008 patients, 310 responded to the SMS survey (response rate 31%). In multivariable adjusted analyses, participants who were age 80 years and above (aOR, 0.49; 95% CI, 0.25-0.96) were less likely to respond to the SMS survey compared with those aged 18 to 44 years. Non-Hispanic Black (aOR, 0.58; 95% CI, 0.39-0.86), Hispanic (aOR, 0.31; 95% CI, 0.19-0.51), and Asian or Pacific Islander (aOR, 0.46; 95% CI, 0.28-0.74) individuals were less likely to respond compared with non-Hispanic White participants. Participants residing in census tracts with higher Social Vulnerability Index, indicating greater neighborhood-level social vulnerability, were less likely to respond to the SMS survey (fifth vs first quintile aOR, 0.61; 95% CI, 0.37-0.99). Over 80% of a sample of survey respondents and nonrespondents completely agreed or agreed with the Acceptability of Intervention Measure. Qualitative analysis identified 4 drivers of patient preferences for survey administration: (1) convenience (subtopics: efficiency, multitasking, comfort, and synchronicity); (2) privacy; (3) interpersonal interaction; and (4) accessibility (subtopics: vision, language, and fatigue). LIMITATIONS/UNASSIGNED:Generalizability, length of survey. CONCLUSIONS/UNASSIGNED:An SMS text message-based survey had moderate reach among patients receiving dialysis and was highly acceptable, but response rates were lower in older (age ≥ 80), non-White individuals and those with greater neighborhood-level social vulnerability. Future research should examine barriers and facilitators to mHealth among patients receiving dialysis to ensure equitable implementation of mHealth-based technologies.

BACKGROUND:Chronic insomnia is common in patients undergoing in-center hemodialysis, yet there is limited evidence on effective treatments for this population. OBJECTIVE:To compare the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), trazodone, and placebo for insomnia in patients undergoing long-term hemodialysis. DESIGN:Randomized, multicenter, double-blinded, placebo-controlled trial. (ClinicalTrials.gov: NCT03534284). SETTING:26 dialysis units in Albuquerque, New Mexico, and Seattle, Washington. PARTICIPANTS:Patients with Insomnia Severity Index (ISI) score of 10 or greater, with sleep disturbances on 3 or more nights per week for 3 or more months. INTERVENTION:Participants were randomly assigned to 6 weeks of CBT-I, trazodone, or placebo. MEASUREMENTS:The primary outcome was the ISI score at 7 and 25 weeks from randomization. RESULTS: = 41). The change in ISI scores from baseline to 7 weeks with CBT-I or trazodone was no different from placebo: CBT-I, -3.7 (95% CI, -5.5 to -1.9); trazodone, -4.2 (CI, -5.9 to -2.4); and placebo, -3.1 (CI, -4.9 to -1.3). There was no meaningful change in ISI scores from baseline to 25 weeks: CBT-I, -4.8 (CI, -7.0 to -2.7); trazodone, -4.0 (CI, -6.0 to -1.9); and placebo, -4.3 (CI, -6.4 to -2.2). Serious adverse events (SAEs), particularly serious cardiovascular events, were more frequent with trazodone (annualized cardiovascular SAE incidence rates: CBT-I, 0.05 [CI, 0.00 to 0.29]; trazodone, 0.64 [CI, 0.34 to 1.10]; and placebo, 0.21 [CI, 0.06 to 0.53]). LIMITATION:Modest sample size and most participants had mild or moderate insomnia. CONCLUSION:In patients undergoing hemodialysis with mild or moderate chronic insomnia, there was no difference in the effectiveness of 6 weeks of CBT-I or trazodone compared with placebo. The incidence of SAEs was higher with trazodone. PRIMARY FUNDING SOURCE:National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases.

Individuals living with CKD are disproportionately burdened by a multitude of adverse clinical and person-centered outcomes. When patients transition from advanced kidney disease to kidney failure, the psychosocial effects as well as social determinants of health challenges are magnified, making this a particularly difficult time for patients beginning kidney replacement therapy. The key social determinants of health challenges often include food and housing insecurity, poverty, unreliable transportation, low level education and/or health literacy, lack of language interpreters and culturally concordant educational materials, lack of health care insurance coverage, and mistrust of the health care system. Psychosocial and physical stressors, such as depression, anxiety, sexual dysfunction, sleep difficulty, fatigue, and pain, are often part of the illness burden among individuals living with CKD and can interact synergistically with the social challenges making the transition to kidney replacement therapy particularly challenging. To better support patients during this time, it is critical that social and structural determinants of health as well as mental health be assessed and if needs are identified, that services be provided.