Kidney Res Clin Pract.  2023 Nov;42(6):751-761. 10.23876/j.krcp.22.019.

Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients (SDM-ART trial): study protocol for randomized clinical trial

Affiliations
  • 1Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea
  • 2Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea
  • 3Department of Internal Medicine and BioMedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Republic of Korea
  • 4Division of Communication and Media, Ewha Womans University, Seoul, Republic of Korea
  • 5Department of Preventive Medicine, University of Ulsan College of Medicine, Seoul, Republic of Korea
  • 6Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea

Abstract

Background
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. Methods: 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. Discussion: 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.

Keyword

Chronic renal insufficiency; Peritoneal dialysis; Renal dialysis; Shared decision making
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