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

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.

Keywords: Chronic renal insufficiency; Peritoneal dialysis; Renal dialysis; Shared decision making.

Figure 1.. Overview flow chart of the SDM-ART (Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients) trial.

CKD, chronic kidney disease; RRT, renal replacement therapy; EIDM, extensive informed decision-making; SDM, shared decision-making.

Figure 2.. Education methods and materials provided to each group.

EIDM, extensive informed decision-making; SDM, shared decision-making. aPatients filled out illness perception and self-assessment items at month 0 and were educated according to illness perception and item-based analysis at month 2.

Figure 3.. Timeline of study procedures and outcome assessments.

ECG, electrocardiogram. ^aScreening visit: Complete blood count (hemoglobin, hematocrit, white blood cells, and platelets), sodium, potassium, chloride, total CO₂, protein, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, gamma-glutamyl transferase, blood urea nitrogen (BUN), creatinine, calcium, phosphorus, uric acid, glucose, total bilirubin, total cholesterol, low-density lipoprotein cholesterol, triglyceride, and estimated glomerular filtration rate (eGFR). Visit 1–7: Complete blood count, sodium, potassium, chloride, protein, albumin, AST, ALT, BUN, creatinine, calcium, phosphorous, and eGFR. ^bEQ-5D-5L (the 5-level EQ-5D version of the EuroQol group) and HINT-8 (the Korean Health-Related Quality of Life Instrument with 8 items). ^cOnly the shared decision-making group at visit 1 and all groups at visit 7.