Technology Assisted stepped Collaborative Care Intervention to Improve Patient-centered Outcomes in Hemodialysis

大多数接受血液透析(HD)的终末期肾病(ESRD)患者经历了大量的 症状负担，严重损害了他们与健康相关的生活质量(HRQOL)。此外，患者 抑郁、疼痛和疲劳的症状与住院和死亡率的增加有关， 可能受到行为因素的影响，如不坚持药物治疗和透析，以及 炎性细胞因子等生物因素。鉴于先前干预措施的有效性有限， 血液透析患者缓解症状和改善HRQOL，且缺乏证据表明其对生物行为的影响 介体，我们建议的研究满足了提供以患者为中心的透析护理的迫切需求，同时 推进对潜在炎症过程的机械性洞察。我们的团队已经成功地 演示了阶梯式协作护理干预(SCCI)在其他慢性病患者中的有效性 患者群体。协作式护理提供综合的多学科结构化管理计划； 药物治疗和/或行为治疗的分步方法允许个体化治疗 根据患者的临床状态、喜好和治疗反应。为了简化交付， SCCI的行为治疗组件，并减少相关患者和提供者的负担，我们的多 由肾病学、心理学和健康技术专家组成的学科团队开创并测试了 在透析单元中使用视频会议提供行为治疗。我们的初步研究表明， 该方法是可行的、可接受的，并且只需要最少的额外资源。建议的目标是 技术辅助阶段性协作护理干预(TASCCI)研究旨在测试 SCCI对缓解症状群和改善HRQOL的多中心随机对照试验 来自宾夕法尼亚州和新墨西哥州的160名不同的HD患者。我们将比较我们的 使用技术提供的健康教育的注意力控制部门进行干预，以改善关键患者- 以结果为中心。具体地说，我们将检查1)抑郁(主要结果)、疼痛、疲劳的变化 和干预12周后的HRQOL(目标1)，2)对药物和透析依从性的影响(目标2)； 炎性生物标志物水平的变化(目标3)。这项研究直接响应了肾脏疾病的号召 改善全球结果(KDIGO)，在常规中整合症状评估和管理 ESRD护理。TASCCI可能为缓解常见的患者症状提供一种可行和足智多谋的方法。 并改善HD患者的HRQOL，便于采用并整合到常规透析护理中 广泛传播。

Majority of the end-stage renal disease (ESRD) patients on hemodialysis (HD) experience a substantial symptom burden, which significantly impairs their health-related quality of life (HRQOL). Additionally, patient symptoms of depression, pain and fatigue are associated with increased hospitalization and mortality, potentially mediated by behavioral factors such as non-adherence to medication and dialysis, as well as biological factors such as inflammatory cytokines. Given the limited effectiveness of prior interventions to alleviate symptoms and improve HRQOL in HD patients, and lack of evidence on their effect on bio-behavioral mediators, our proposed study fulfills a critical need for providing patient-centered dialysis care, while advancing mechanistic insights into the underlying inflammatory process. Our team has successfully demonstrated the effectiveness of a stepped collaborative care intervention (SCCI) in other chronically ill patient populations. Collaborative care provides an integrated multi-disciplinary structured management plan; and a stepped approach for pharmaco- and/or behavioral-therapy allows for individualization of treatment according to patients' clinical status, preferences and treatment response. In order to simplify the delivery of the behavioral therapy component of SCCI and reduce the associated patient and provider burdens, our multi- disciplinary team of experts in nephrology, psychology, and health technology pioneered and tested the delivery of behavioral therapy using video-conferencing in dialysis units. Our pilot study showed that this approach is feasible, acceptable and requires minimal additional resources. The goal of the proposed Technology Assisted Stepped Collaborative Care Intervention (TASCCI) study is to test the effectiveness of SCCI for alleviating symptom clusters and improving HRQOL in a multi-center randomized controlled trial of 160 diverse HD patients from Pennsylvania and New Mexico. We will compare the effectiveness of our intervention with an attention control arm of technology-delivered health education to improve key patient- centered outcomes. Specifically, we will examine 1) changes in depression (primary outcome), pain, fatigue and HRQOL after 12 week intervention (Aim 1), 2) effect on medication and dialysis adherence (Aim 2); and 3) changes in levels of inflammatory biomarkers (Aim 3). This study directly responds to call from Kidney Disease Improving Global Outcomes (KDIGO) for integration of symptom assessment and management in routine ESRD care. TASCCI may provide a feasible and resourceful approach to alleviate common patient symptoms and improve HRQOL for HD patients that could be readily adopted and integrated in routine dialysis care for wide-scale dissemination.