Older patients with advanced chronic kidney disease (CKD) often are inadequately prepared to make informed decisions about treatments including dialysis and cardiopulmonary resuscitation. Further, evidence shows that patients with advanced CKD do not commonly engage in advance care planning (ACP), may suffer from poor quality of life, and may be exposed to end-of-life care that is not concordant with their goals. We aim to study the effectiveness of a video intervention on ACP, treatment preferences and other patient-reported outcomes.
The Video Images about Decisions for Ethical Outcomes in Kidney Disease trial is a multi-centre randomised controlled trial that will test the effectiveness of an intervention that includes a CKD-related video decision aid followed by recording personal video declarations about goals of care and treatment preferences in older adults with advancing CKD. We aim to enrol 600 patients over 5 years at 10 sites.
Regulatory and ethical aspects of this trial include a single Institutional Review Board mechanism for approval, data use agreements among sites, and a Data Safety and Monitoring Board. We intend to disseminate findings at national meetings and publish our results.
NCT04347629.
患有晚期慢性肾脏病(CKD)的老年患者往往没有充分准备好就透析和心肺复苏等治疗做出明智的决策。此外,有证据表明,晚期CKD患者通常不参与预先护理计划(ACP),可能生活质量较差,并且可能接受与他们的目标不一致的临终关怀。我们旨在研究视频干预对ACP、治疗偏好和其他患者报告结果的有效性。
“肾脏病伦理结局决策相关视频图像”试验是一项多中心随机对照试验,将测试一种干预措施的有效性,该干预措施包括一个与CKD相关的视频决策辅助工具,然后记录患有进展性CKD的老年患者关于护理目标和治疗偏好的个人视频声明。我们的目标是在5年内从10个地点招募600名患者。
该试验的监管和伦理方面包括单一的机构审查委员会审批机制、各试验点之间的数据使用协议以及一个数据安全与监测委员会。我们打算在全国性会议上公布研究结果并发表我们的研究结论。
NCT04347629(这可能是一个临床试验注册号之类的标识)