North Florida / South Georgia Veteran Healthcare System, Gainesville, FL, USA.
Division of Nephrology, Hypertension and Transplantation, University of Florida, 1600 Archer Road, Gainesville, FL, 32610, USA.
BMC Nephrol. 2022 Mar 30;23(1):121. doi: 10.1186/s12882-022-02740-8.
Informed dialysis selection and greater home dialysis use are the two long-desired, underachieved targets of advanced chronic kidney disease (CKD) care in the US healthcare system. Observational institutional studies have shown that comprehensive pre-kidney failure, conventionally referred to as end stage kidney disease education (CPE) can improve both these outcomes. However, lack of validated protocols, well-controlled studies, and systemic models have limited wide-spread adoption of CPE in the US. We hypothesized that a universal CPE and patient-centered initiation of kidney replacement therapy can improve multiple clinical, patient-centered and health service outcomes in advanced CKD and kidney failure requiring dialysis therapy.
Trial to Evaluate and Assess the effects of CPE on Home dialysis in Veterans (TEACH-VET) is a multi-method randomized controlled trial aimed to evaluate the effects of a system-based approach for providing CPE to all Veterans with advanced CKD across a regional healthcare System. The study will randomize 544 Veterans with non-dialysis stage 4 and 5 CKD in a 1:1 allocation stratified by their annual family income and the stage of CKD to an intervention (CPE) arm or control arm. Intervention arm will receive a two-phase CPE in an intent-to-teach manner. Control arm will receive usual clinical care supplemented by resources for the freely-available kidney disease information. Participants will be followed after intervention/control for the duration of the study or until 90-days post-kidney failure, whichever occurs earlier.
The primary outcome will assess the proportion of Veterans using home dialysis at 90-days post-kidney failure, and secondary outcomes will include post-intervention/control CKD knowledge, confidence in dialysis decision and home dialysis selection. Qualitative arm of the study will use semi-structured interviews to in-depth assess Veterans' satisfaction with the intervention, preference for delivery, and barriers and facilitators to home dialysis selection and use. Several post-kidney failure clinical, patient-centered and health services outcomes will be assessed 90-days post-kidney failure as additional secondary outcomes.
The results will provide evidence regarding the need and efficacy of a system-based, patient-centered approach towards universal CPE for all patients with advanced CKD. If successful, this may provide a blueprint for developing such programs across the similar healthcare infrastructures throughout the country.
NCT04064086 .
在美国医疗体系中，透析选择的知情化和提高家庭透析的使用比例是先进的慢性肾脏病（CKD）护理长期以来未能实现的两个目标。观察性机构研究表明，全面的肾衰竭前教育（CPE），通常被称为终末期肾病教育，可以改善这两个结果。然而，缺乏经过验证的方案、对照研究和系统模型限制了 CPE 在全美范围内的广泛应用。我们假设，普遍的 CPE 和以患者为中心的肾脏替代治疗的启动可以改善先进 CKD 和需要透析治疗的肾衰竭患者的多项临床、以患者为中心和卫生服务结果。
退伍军人中评估和评估 CPE 对家庭透析影响的试验（TEACH-VET）是一项多方法随机对照试验，旨在评估为整个区域医疗系统中患有先进 CKD 的所有退伍军人提供基于系统的 CPE 的效果。该研究将对 544 名非透析阶段 4 和 5 CKD 的退伍军人进行 1:1 随机分配，分配方式为他们的年度家庭收入和 CKD 分期分层，分为干预（CPE）组或对照组。干预组将以意向施教的方式接受两阶段的 CPE。对照组将接受常规临床护理，并补充可免费获得的肾脏疾病信息资源。在干预/对照后，参与者将在研究期间或直到肾衰竭后 90 天内（以先发生者为准）进行随访。
主要结果将评估 90 天内肾衰竭后使用家庭透析的退伍军人比例，次要结果将包括干预后/对照后的 CKD 知识、对透析决策和家庭透析选择的信心。研究的定性部分将使用半结构化访谈深入评估退伍军人对干预的满意度、对交付方式的偏好以及家庭透析选择和使用的障碍和促进因素。90 天内还将评估其他次要结果的几个肾衰竭后临床、以患者为中心和卫生服务结果。
研究结果将为基于系统、以患者为中心的方法为所有先进 CKD 患者提供普遍的 CPE 的必要性和疗效提供依据。如果成功，这可能为在全国类似医疗基础设施中开发此类项目提供蓝图。
NCT04064086。
