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Rationale and design of technology assisted stepped collaborative care intervention to improve patient-centered outcomes in hemodialysis patients (TACcare trial).

ABSTRACT: Most hemodialysis (HD) patients experience symptoms of depression, pain and fatigue that impair their health-related quality of life (HRQOL) significantly. These symptoms are associated with increased hospitalization and mortality, mediated by behavioral factors (e.g. non-adherence to medication and dialysis) and biological factors (e.g. inflammatory cytokines). Prior interventions to alleviate symptoms and improve HRQOL showed limited effectiveness in HD patients and their effect on bio-behavioral mediators is lacking evidence. It is imperative to improve patient-centered dialysis care and to address call from Kidney Disease Improving Global Outcomes (KDIGO) guidelines for integration of symptom assessment and management in routine HD-care. Technology-Assisted stepped Collaborative Care (T?Ccare) is a multi-center randomized controlled trial (RCT) of 150 diverse HD patients from Pennsylvania and New Mexico, designed to compare the effectiveness of a 12-week stepped collaborative care intervention (cognitive behavioral therapy, CBT) with an attention control arm of technology-delivered health education. Collaborative care provides an integrated multi-disciplinary structured management plan. Furthermore, a stepped approach to pharmacotherapy and/or CBT allows for individualization of treatment according to patients' clinical status, preferences and treatment response. To simplify the delivery of CBT and to minimize patient and provider burden, we will use live video-conferencing with patients in dialysis units. We will examine the effect of these interventions on patient symptoms, HRQOL, treatment adherence and inflammatory biomarkers. This RCT tests a readily implementable intervention that can be integrated in routine HD-care and will generate novel and meaningful insights on strategies to alleviate common symptoms and improve HRQOL in HD.

SUBMITTER: Roumelioti ME

PROVIDER: S-EPMC6168366 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Rationale and design of technology assisted stepped collaborative care intervention to improve patient-centered outcomes in hemodialysis patients (TĀCcare trial).

Roumelioti Maria-Eleni ME Steel Jennifer L JL Yabes Jonathan J Vowles Kevin E KE Vodovotz Yoram Y Beach Scott S Rollman Bruce B Weisbord Steven D SD Unruh Mark L ML Jhamb Manisha M

Contemporary clinical trials 20180909

Most hemodialysis (HD) patients experience symptoms of depression, pain and fatigue that impair their health-related quality of life (HRQOL) significantly. These symptoms are associated with increased hospitalization and mortality, mediated by behavioral factors (e.g. non-adherence to medication and dialysis) and biological factors (e.g. inflammatory cytokines). Prior interventions to alleviate symptoms and improve HRQOL showed limited effectiveness in HD patients and their effect on bio-behavio ...[more]

PMID: 30208343

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Project description:ImportancePatients with end-stage kidney disease (ESKD) undergoing long-term hemodialysis often experience a high burden of debilitating symptoms for which effective treatment options are limited.ObjectiveTo compare the effectiveness of a stepped collaborative care intervention vs attention control for reducing fatigue, pain, and depression among patients with ESKD undergoing long-term hemodialysis.Design, setting, and participantsTechnology Assisted Stepped Collaborative Care (TĀCcare) was a parallel-group, single-blinded, randomized clinical trial of adult (≥18 years) patients undergoing long-term hemodialysis and experiencing clinically significant levels of fatigue, pain, and/or depression for which they were considering treatment. The trial took place in 2 US states (New Mexico and Pennsylvania) from March 1, 2018, to June 31, 2022. Data analyses were performed from July 1, 2022, to April 10, 2023.InterventionsThe intervention group received 12 weekly sessions of cognitive behavioral therapy delivered via telehealth in the hemodialysis unit or patient home, and/or pharmacotherapy using a stepped approach in collaboration with dialysis and primary care teams. The attention control group received 6 telehealth sessions of health education.Main outcomes and measuresThe coprimary outcomes were changes in fatigue (measured using the Functional Assessment of Chronic Illness Therapy Fatigue), average pain severity (Brief Pain Inventory), and/or depression (Beck Depression Inventory-II) scores at 3 months. Patients were followed up for 12 months to assess maintenance of intervention effects.ResultsThere were 160 participants (mean [SD] age, 58 [14] years; 72 [45%] women and 88 [55%] men; 21 [13%] American Indian, 45 [28%] Black, 28 [18%] Hispanic, and 83 [52%] White individuals) randomized, 83 to the intervention and 77 to the control group. In the intention-to-treat analyses, when compared with controls, patients in the intervention group experienced statistically and clinically significant reductions in fatigue (mean difference [md], 2.81; 95% CI, 0.86 to 4.75; P = .01) and pain severity (md, -0.96; 95% CI, -1.70 to -0.23; P = .02) at 3 months. These effects were sustained at 6 months (md, 3.73; 95% CI, 0.87 to 6.60; P = .03; and BPI, -1.49; 95% CI, -2.58 to -0.40; P = .02). Improvement in depression at 3 months was statistically significant but small (md -1.73; 95% CI, -3.18 to -0.28; P = .02). Adverse events were similar in both groups.Conclusions and relevanceThis randomized clinical trial found that a technology assisted stepped collaborative care intervention delivered during hemodialysis led to modest but clinically meaningful improvements in fatigue and pain at 3 months vs the control group, with effects sustained until 6 months.Trial registrationClinicalTrials.gov Identifier: NCT03440853.

Project description:BACKGROUND:Cardiovascular disease (CVD) is the leading cause of death in the US and incurs high health care costs. While many initiatives promote the implementation of ABCS (aspirin therapy, blood pressure control, cholesterol management, and smoking cessation) measures, most primary care practices (PCPs) lack quality improvement (QI) support and resources to achieve meaningful targets. The Healthy Hearts for Oklahoma (H2O) Study proposes to build a QI infrastructure by (1) constructing a sustainable Oklahoma Primary Healthcare Improvement Collaborative (OPHIC) to support dissemination and implementation (D&I) of QI methods; (2) providing QI support in PCPs to better manage patients at risk for CVD events. Parallel to infrastructure building, H2O aims to conduct a comprehensive evaluation of the QI support D&I in primary care and assess the relationship between QI support uptake and changes in ABCS measures. METHODS:H2O has partnered with public health agencies and communities to build OPHIC and facilitate QI. H2O has 263 small primary care practices across Oklahoma that receive the bundled QI intervention to improve ABCS performance. A stepped-wedge designed is used to evaluate D&I of QI support. Changes in ABCS measures will be estimated as a function of various components of the QI support and capacity and readiness of PCPs to change. Notes from academic detailing and practice facilitation sessions will be analyzed to help interpret findings on ABCS performance. DISCUSSION:H2O program is designed to improve cardiovascular health and outcomes for more than 1.25 million Oklahomans. The infrastructure established as a result of this funding will help reach medically underserved Oklahomans, particularly among rural and tribal populations. Lessons learned from this project will guide future strategies for D&I of evidence-based practices in PCPs. Trained practice facilitators will continue to serve as critical resource to assists small, rural PCPs in adapting to the ever-changing health environment and continue to deliver quality care to their communities.

Project description:We describe the study design and methods used in a 9-month pedometer-based worksite intervention called "ASUKI Step" conducted at the Karolinska Institutet (KI) in Stockholm, Sweden and Arizona State University (ASU) in the greater Phoenix area, Arizona."ASUKI Step" was based on the theory of social support and a quasi-experimental design was used for evaluation. Participants included 2,118 faculty, staff, and graduate students from ASU (n = 712) and KI (n = 1,406) who participated in teams of 3-4 persons. The intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week. Study aims were: 1) to have a minimum of 400 employee participants from each university site reach a level of 10,000 steps per day on at least 100 days (3.5 months) during the trial period; 2) to have 70% of the employee participants from each university site maintain two or fewer inactive days per week, defined as a level of less than 3,000 steps per day; 3) to describe the socio-demographic, psychosocial, environmental and health-related determinants of success in the intervention; and 4) to evaluate the effects of a pedometer-based walking intervention in a university setting on changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness.Incentives were given for compliance to the study protocol that included weekly raffles for participation prizes and a grand finale trip to Arizona or Sweden for teams with most days over 10,000 steps."ASUKI Step" is designed to increase the number of days employees walk 10,000 steps and to reduce the number of days employees spend being inactive. The study also evaluates the intra- and interpersonal determinants for success in the intervention and in a sub-sample of the study, changes in physical fitness and body composition during the study.Current Controlled Trials NCT01537939.

Project description:BackgroundCompared to in-centre, home hemodialysis is associated with superior outcomes. The impact on patient experience and clinical outcomes of consistently providing the choice and training to undertake hemodialysis-related treatment tasks in the in-centre setting is unknown.MethodsA stepped-wedge cluster randomised trial in 12 UK renal centres recruited prevalent in-centre hemodialysis patients with sites randomised into early and late participation in a 12-month breakthrough series collaborative that included data collection, learning events, Plan-Study-Do-Act cycles, and teleconferences repeated every 6 weeks, underpinned by a faculty, co-production, materials and a nursing course. The primary outcome was the proportion of patients undertaking five or more hemodialysis-related tasks or home hemodialysis. Secondary outcomes included independent hemodialysis, quality of life, symptoms, patient activation and hospitalisation. ISRCTN Registration Number 93999549.Results586 hemodialysis patients were recruited. The proportion performing 5 or more tasks or home hemodialysis increased from 45.6% to 52.3% (205 to 244/449, difference 6.2%, 95% CI 1.4 to 11%), however after analysis by step the adjusted odds ratio for the intervention was 1.63 (95% CI 0.94 to 2.81, P = 0.08). 28.3% of patients doing less than 5 tasks at baseline performed 5 or more at the end of the study (69/244, 95% CI 22.2-34.3%, adjusted odds ratio 3.71, 95% CI 1.66-8.31). Independent or home hemodialysis increased from 7.5% to 11.6% (32 to 49/423, difference 4.0%, 95% CI 1.0-7.0), but the remaining secondary endpoints were unaffected.ConclusionsOur intervention did not increase dialysis related tasks being performed by a prevalent population of centre based patients, but there was an increase in home hemodialysis as well as an increase in tasks among patients who were doing fewer than 5 at baseline. Further studies are required that examine interventions to engage people who dialyse at centres in their own care.

Project description:BackgroundPolypharmacy is prevalent among hospitalized older adults, particularly those being discharged to a post-care care facility (PAC). The aim of this randomized controlled trial is to determine if a patient-centered deprescribing intervention initiated in the hospital and continued in the PAC setting reduces the total number of medications among older patients.MethodsThe Shed-MEDS study is a 5-year, randomized controlled clinical intervention trial comparing a patient-centered describing intervention with usual care among older (≥50 years) hospitalized patients discharged to PAC, either a skilled nursing facility (SNF) or an inpatient rehabilitation facility (IPR). Patient measurements occur at hospital enrollment, hospital discharge, within 7 days of PAC discharge, and at 60 and 90 days following PAC discharge. Patients are randomized in a permuted block fashion, with block sizes of two to four. The overall effectiveness of the intervention will be evaluated using total medication count as the primary outcome measure. We estimate that 576 patients will enroll in the study. Following attrition due to death or loss to follow-up, 420 patients will contribute measurements at 90 days, which provides 90% power to detect a 30% versus 25% reduction in total medications with an alpha error of 0.05. Secondary outcomes include the number of medications associated with geriatric syndromes, drug burden index, medication adherence, the prevalence and severity of geriatric syndromes and functional health status.DiscussionThe Shed-MEDS trial aims to test the hypothesis that a patient-centered deprescribing intervention initiated in the hospital and continuing through the PAC stay will reduce the total number of medications 90 days following PAC discharge and result in improvements in geriatric syndromes and functional health status. The results of this trial will quantify the health outcomes associated with reducing medications for hospitalized older adults with polypharmacy who are discharged to post-acute care facilities.Trial registrationThis trial was prospectively registered at clinicaltrials.gov ( NCT02979353 ). The trial was first registered on 12/1/2016, with an update on 09/28/17 and 10/12/2018.

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Rationale and design of technology assisted stepped collaborative care intervention to improve patient-centered outcomes in hemodialysis patients (TACcare trial).

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Rationale and design of technology assisted stepped collaborative care intervention to improve patient-centered outcomes in hemodialysis patients (TĀCcare trial).

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