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Pain Coping Skills Training for Patients Receiving Hemodialysis: The HOPE Consortium Randomized Clinical Trial

Dember, Laura M; Hsu, Jesse Y; Mehrotra, Rajnish; Cavanaugh, Kerri L; Kalim, Sahir; Charytan, David M; Fischer, Michael J; Jhamb, Manisha; Johansen, Kirsten L; Becker, William C; Pellegrino, Bethany; Eneanya, Nwamaka D; Schrauben, Sarah J; Pun, Patrick H; Unruh, Mark L; Morasco, Benjamin J; Mehta, Mansi; Miyawaki, Nobuyuki; Penfield, Jeffrey; Bernardo, Leah; Brintz, Carrie E; Cheatle, Martin D; Doorenbos, Ardith Z; Heapy, Alicia A; Keefe, Francis J; Krebs, Erin E; Kuzla, Natalie; Nigwekar, Sagar U; Schmidt, Rebecca J; Steel, Jennifer L; Wetmore, James B; White, David M; Kimmel, Paul L; Cukor, Daniel
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.
PMID: 39786400
ISSN: 2168-6114
CID: 5781482

Clinical Outcomes of a Novel Multidisciplinary Care Program in Advanced Kidney Disease (PEAK)

Shimonov, Daniil; Tummalapalli, Sri Lekha; Donahue, Stephanie; Narayana, Vidya; Wu, Sylvia; Walters, Lisa S; Billman, Roberta; Desiderio, Barbara; Pressman, Sandra; Fielding, Oliver; Sweeney, Kariel; Cukor, Daniel; Levine, Daniel M; Parker, Thomas S; Srivatana, Vesh; Silberzweig, Jeffrey; Liu, Frank; Bohmart, Andrew
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.
PMCID:11489444
PMID: 39430180
ISSN: 2468-0249
CID: 5742192

Social and Behavioral Barriers to Effective Care During the Transition to End-Stage Kidney Care

Cervantes, Lilia; Sinclair, Matthew; Camacho, Claudia; Santana, Cecilia; Novick, Tessa; Cukor, Daniel
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.
PMID: 38403390
ISSN: 2949-8139
CID: 5707412

Reach, Acceptability, and Patient Preferences of a Mobile Health-Based Survey to Assess COVID-19 Vaccine Hesitancy Among Patients Receiving Dialysis

Tummalapalli, Sri Lekha; Benda, Natalie C; Cukor, Daniel; Levine, Daniel M; Silberzweig, Jeffrey; Reading Turchioe, Meghan
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.
PMCID:11261113
PMID: 39040544
ISSN: 2590-0595
CID: 5707432

Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial

Mehrotra, Rajnish; Cukor, Daniel; McCurry, Susan M; Rue, Tessa; Roumelioti, Maria-Eleni; Heagerty, Patrick J; Unruh, Mark
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.
PMID: 38224591
ISSN: 1539-3704
CID: 5707402

Response to COVID-19: The Outpatient Dialysis Setting

Silberzweig, Jeffrey; Wu, Sylvia; Sinclair, Matthew; Watson, Thomas; Welder, Nancy; Concepcion, Danilo; Yee, Jerry; Speed, Felicia; Cukor, Daniel; Schiller, Brigitte; Weiner, Daniel
PMCID:10356158
PMID: 36795086
ISSN: 1555-905x
CID: 5707562

Anxiety and Response to Treatment of Depression in People Undergoing Maintenance Hemodialysis [Letter]

Cukor, Daniel; Rue, Tessa; Heagerty, Patrick; Unruh, Mark; Hedayati, S Susan; Mehrotra, Rajnish
PMCID:10564366
PMID: 37094333
ISSN: 1555-905x
CID: 5707382

Comparison of the accuracy of the 7-item HADS Depression subscale and 14-item total HADS for screening for major depression: A systematic review and individual participant data meta-analysis

Wu, Yin; Levis, Brooke; Daray, Federico M; Ioannidis, John P A; Patten, Scott B; Cuijpers, Pim; Ziegelstein, Roy C; Gilbody, Simon; Fischer, Felix H; Fan, Suiqiong; Sun, Ying; He, Chen; Krishnan, Ankur; Neupane, Dipika; Bhandari, Parash Mani; Negeri, Zelalem; Riehm, Kira E; Rice, Danielle B; Azar, Marleine; Yan, Xin Wei; Imran, Mahrukh; Chiovitti, Matthew J; Boruff, Jill T; McMillan, Dean; Kloda, Lorie A; Markham, Sarah; Henry, Melissa; Ismail, Zahinoor; Loiselle, Carmen G; Mitchell, Nicholas D; Al-Adawi, Samir; Beck, Kevin R; Beraldi, Anna; Bernstein, Charles N; Boye, Birgitte; Büel-Drabe, Natalie; Bunevicius, Adomas; Can, Ceyhun; Carter, Gregory; Chen, Chih-Ken; Cheung, Gary; Clover, Kerrie; Conroy, Ronán M; Costa-Requena, Gema; Cukor, Daniel; Dabscheck, Eli; De Souza, Jennifer; Downing, Marina; Feinstein, Anthony; Ferentinos, Panagiotis P; Flint, Alastair J; Gallagher, Pamela; Gandy, Milena; Grassi, Luigi; Härter, Martin; Hernando, Asuncion; Jackson, Melinda L; Jenewein, Josef; Jetté, Nathalie; Julião, Miguel; Kjærgaard, Marie; Köhler, Sebastian; König, Hans-Helmut; Krishna, Lalit K R; Lee, Yu; Löbner, Margrit; Loosman, Wim L; Love, Anthony W; Löwe, Bernd; Malt, Ulrik F; Marrie, Ruth Ann; Massardo, Loreto; Matsuoka, Yutaka; Mehnert, Anja; Michopoulos, Ioannis; Misery, Laurent; Nelson, Christian J; Ng, Chong Guan; O'Donnell, Meaghan L; O'Rourke, Suzanne J; Öztürk, Ahmet; Pabst, Alexander; Pasco, Julie A; Peceliuniene, Jurate; Pintor, Luis; Ponsford, Jennie L; Pulido, Federico; Quinn, Terence J; Reme, Silje E; Reuter, Katrin; Riedel-Heller, Steffi G; Rooney, Alasdair G; Sánchez-González, Roberto; Saracino, Rebecca M; Schellekens, Melanie P J; Scherer, Martin; Benedetti, Andrea; Thombs, Brett D; Et Al,
The seven-item Hospital Anxiety and Depression Scale Depression subscale (HADS-D) and the total score of the 14-item HADS (HADS-T) are both used for major depression screening. Compared to the HADS-D, the HADS-T includes anxiety items and requires more time to complete. We compared the screening accuracy of the HADS-D and HADS-T for major depression detection. We conducted an individual participant data meta-analysis and fit bivariate random effects models to assess diagnostic accuracy among participants with both HADS-D and HADS-T scores. We identified optimal cutoffs, estimated sensitivity and specificity with 95% confidence intervals, and compared screening accuracy across paired cutoffs via two-stage and individual-level models. We used a 0.05 equivalence margin to assess equivalency in sensitivity and specificity. 20,700 participants (2,285 major depression cases) from 98 studies were included. Cutoffs of ≥7 for the HADS-D (sensitivity 0.79 [0.75, 0.83], specificity 0.78 [0.75, 0.80]) and ≥15 for the HADS-T (sensitivity 0.79 [0.76, 0.82], specificity 0.81 [0.78, 0.83]) minimized the distance to the top-left corner of the receiver operating characteristic curve. Across all sets of paired cutoffs evaluated, differences of sensitivity between HADS-T and HADS-D ranged from -0.05 to 0.01 (0.00 at paired optimal cutoffs), and differences of specificity were within 0.03 for all cutoffs (0.02-0.03). The pattern was similar among outpatients, although the HADS-T was slightly (not nonequivalently) more specific among inpatients. The accuracy of HADS-T was equivalent to the HADS-D for detecting major depression. In most settings, the shorter HADS-D would be preferred. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
PMID: 36689386
ISSN: 1939-134x
CID: 5707372

How Are Albertans "Adjusting to and Coping With" Dialysis? A Cross-Sectional Survey

Schick-Makaroff, Kara; Berendonk, Charlotte; Overwater, Jordan; Streith, Laura; Lee, Loretta; Escoto, Manuel; Cukor, Daniel; Klarenbach, Scott; Sawatzky, Richard
BACKGROUND/UNASSIGNED:Depression and anxiety are commonly reported (40% and 11%-52%) among adults receiving dialysis, compared with ~10% among all Canadians. Mental health in dialysis care is underrecognized and undertreated. OBJECTIVE/UNASSIGNED:(1) To describe preferences for mental health support reported by Albertans receiving dialysis; (2) to compare depression, anxiety, and quality-of-life (QOL) domains for people who would or would not engage in support for mental health; and (3) to explore sociodemographic, mental health, and QOL domains that explain whether people would or would not engage in support for mental health. DESIGN/UNASSIGNED:A cross-sectional survey. SETTING/UNASSIGNED:Alberta, Canada. PATIENTS/UNASSIGNED:Adults receiving all modalities of dialysis (N = 2972). MEASUREMENTS/UNASSIGNED:An online survey with questions about preferences for mental health support and patient-reported outcome measures (Patient Health Questionnaire-9 [PHQ-9], Generalized Anxiety Disorder-7 [GAD-7], and Kidney Disease QOL Instrument-36 [KDQOL-36]). METHODS/UNASSIGNED:tests (for continuous variables) to compare the distributions of the above measures for two groups: Albertans receiving dialysis who would engage or would not engage in support for mental health. We subsequently conducted a series of binary logistic regressions guided by the purposeful variable selection approach to identify a subset of the most relevant explanatory variables for determining whether or not people are more likely to engage in support for mental health (objective 3). To further explain differences between the two groups, we analyzed open-text comments following a summative content analysis approach. RESULTS/UNASSIGNED:) of the variance and with 66.6% correct classification. We analyzed 146 comments in response to the question, "Is there anything else you like to tell us." The top 2 categories for both groups were QOL and impact of dialysis environment. The third category differed: those who would engage wrote about support, whereas those who would not engage wrote about "dialysis is the least of my worries." LIMITATIONS/UNASSIGNED:A low response rate of 12.9% limits representativeness; people who chose not to participate may have different experiences of mental health. CONCLUSIONS/UNASSIGNED:Incorporating patients' preferences and willingness to engage in support for mental health will inform future visioning for person-centered mental health care in dialysis.
PMCID:9421011
PMID: 36046483
ISSN: 2054-3581
CID: 5707362

A Mobile Health-Based Survey to Assess COVID-19 Vaccine Intent and Uptake Among Patients on Dialysis

Tummalapalli, Sri Lekha; Cukor, Daniel; Bohmart, Andrew; Levine, Daniel M; Parker, Thomas S; Liu, Frank; Perlman, Alan; Srivatana, Vesh; Turchioe, Meghan Reading; Ibrahim, Said A; Silberzweig, Jeffrey
PMCID:8667463
PMID: 34926872
ISSN: 2468-0249
CID: 5707302