Renal-Electrolyte and Hypertension Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, USA.
BMJ Open. 2022 Apr 8;12(4):e059313. doi: 10.1136/bmjopen-2021-059313.
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）的老年患者在做出有关透析和心肺复苏等治疗的知情决策方面往往准备不足。此外，有证据表明，晚期 CKD 患者通常不会参与预先护理计划（ACP），可能会遭受生活质量下降的困扰，并且可能会接受不符合其目标的临终关怀。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。
《关于肾脏疾病中伦理结果的决策的视频图像试验》是一项多中心随机对照试验，旨在测试一项干预措施的有效性，该干预措施包括 CKD 相关的视频决策辅助工具，然后记录有关目标护理和治疗偏好的个人视频声明，用于患有进展性 CKD 的老年患者。我们的目标是在 5 年内从 10 个地点招募 600 名患者。
本试验的监管和伦理方面包括单一的机构审查委员会批准机制、站点之间的数据使用协议和数据安全与监测委员会。我们打算在全国会议上传播研究结果并发表我们的研究结果。
NCT04347629。
