Technology Assisted Stepped collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients

大多数接受血液透析（HD）的终末期肾病（ESRD）患者会出现以下情况： 严重的症状负担，严重损害其健康相关生活质量 （HRQOL）。此外，患者的抑郁、疼痛和疲劳症状与 住院和死亡率增加，可能由行为因素介导， 不坚持药物治疗和透析，以及生物因素，如炎症 细胞因子鉴于先前的干预措施对缓解症状和改善 HD患者的HRQOL，以及缺乏其对生物行为介质影响的证据，我们 拟议的研究满足了提供以患者为中心的透析护理的关键需求， 推进了对潜在炎症过程的机制性认识。我们的团队成功地 证明了阶梯式协作护理干预（SCCI）在其他 慢性病患者群体。协作护理提供了一个综合的多学科 结构化的管理计划;以及药物和/或行为治疗的阶梯式方法， 根据患者的临床状况、偏好和 治疗反应。为了简化SCCI的行为治疗部分的提供， 我们的多学科专家团队， 肾脏学，心理学和健康技术开创并测试了行为疗法的实施。 在透析单位使用视频会议进行治疗。我们的试点研究表明，这种方法是 可行、可接受，需要的额外资源极少。建议的目标 技术辅助分步协作护理干预（TASCCI）研究是为了测试 SCCI缓解症状群和改善HRQOL的多中心研究 来自宾夕法尼亚州和新墨西哥州的150例不同HD患者的随机对照试验。我们将 将我们干预的有效性与技术提供的注意力控制臂进行比较， 健康教育，以改善以病人为中心的结果。具体来说，我们将研究1） 12周干预后抑郁（主要结局）、疼痛、疲劳和HRQOL的变化（目的 1），2）对药物治疗和透析依从性的影响（目的2）;和3） 炎症生物标志物（目的3）。这项研究直接响应了肾脏疾病改善的号召 全球结局（KDIGO），用于在常规ESRD护理中整合症状评估和管理。 TASCCI可以提供一种可行的和足智多谋的方法来缓解常见的患者症状， 改善HD患者的HRQOL，易于采用并纳入常规透析护理 进行大规模传播。

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 150 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.