Chang Jae Hyun, Kim Yong Chul, Song Sang Heon, Kim Soojin, Jo Min-Woo, Kim Sejoong
Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.
Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Kidney Res Clin Pract. 2023 Nov;42(6):751-761. doi: 10.23876/j.krcp.22.019. Epub 2023 Apr 14.
Patients with chronic kidney disease (CKD) should be educated about their condition so that they can initiate dialysis at the optimal time and make an informed choice between dialysis modalities. Shared decision-making (SDM) empowers patients to select their own treatment and improves patient outcomes. This study aimed to evaluate whether SDM affects the choice of renal replacement therapy among CKD patients.
This is a multicenter, open-label, randomized, pragmatic clinical trial. A total of 1,194 participants with CKD who are considering renal replacement therapy were enrolled. The participants will be randomized into three groups in a 1:1:1 ratio: the conventional group, extensive informed decision-making group, and SDM group. Participants will be educated twice at months 0 and 2. Videos and leaflets will be provided to all patients. Patients in the conventional group will receive 5 minutes of education at each visit. The extensive informed decision-making group will receive more informed and detailed education using intensive learning materials for 10 minutes each visit. Patients in the SDM group will be educated for 10 minutes each visit according to illness perception and item-based analysis. The primary endpoint is the ratio of hemodialysis to peritoneal dialysis and kidney transplantation among the groups. Secondary outcomes include unplanned dialysis, economic efficiency, patient satisfaction, patient evaluation of the process, and patient adherence.
The SDM-ART is an ongoing clinical study to investigate the effect of SDM on the choice of renal replacement therapy in patients with CKD.
慢性肾脏病（CKD）患者应接受关于自身病情的教育，以便他们能在最佳时机开始透析，并在透析方式之间做出明智选择。共同决策（SDM）使患者能够选择自己的治疗方案并改善患者预后。本研究旨在评估共同决策是否会影响CKD患者肾脏替代治疗的选择。
这是一项多中心、开放标签、随机、实用性临床试验。共纳入1194名正在考虑肾脏替代治疗的CKD参与者。参与者将按1:1:1的比例随机分为三组：传统组、广泛知情决策组和共同决策组。参与者将在第0个月和第2个月接受两次教育。将向所有患者提供视频和宣传册。传统组患者每次就诊将接受5分钟的教育。广泛知情决策组将使用强化学习材料每次就诊接受更全面、详细的教育，时长为10分钟。共同决策组患者将根据疾病认知和基于项目的分析每次就诊接受10分钟的教育。主要终点是各组中血液透析与腹膜透析及肾移植的比例。次要结局包括非计划透析、经济效率、患者满意度、患者对治疗过程的评价以及患者依从性。
SDM-ART是一项正在进行的临床研究，旨在调查共同决策对CKD患者肾脏替代治疗选择的影响。
