Rationale and design of technology assisted stepped collaborative care intervention to improve patient-centered outcomes in hemodialysis patients (T(A)over-barCcare trial)

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 (A) over bar 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, CDT) 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.