NCT04976166

Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients

Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients (SDM-ART Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,194 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Shared decision making (SDM) is an approach where clinicians and patients make decisions together using the best available evidence. An understanding of the patient's treatment goals, the advantages and disadvantages of treatment options, and the likelihood of achieving the outcomes are important to patients. International guidelines recommend that all patients with chronic kidney disease (CKD) at pre-dialysis stage should be educated to improve their knowledge and understanding of their condition and to choose the options for renal replacement therapy (RRT). Despite these recommendations, pre-dialysis educations are often infrequent. Many patients feel unprepared. Wrong or insufficient understanding due to insufficient explanation of treatment can lead to negative emotions. This may lead to a situation in which the patient loses the opportunity to make patient's own choices, resulting in emergency dialysis or dialysis modality that is not suitable for patients. Therefore, this study aims to evaluate whether SDM has an effect on the choice of RRT among CKD patients.

Detailed description

This study will be conducted as a multicenter, open-label, randomized, pragmatic clinical trial. A total of 1,194 participants with CKD considering RRT will be randomized into 3 groups. Patients in the conventional group will have education using leaflets. Patients in the extensive informed decision making (EIDM) group will receive more detailed education using intensive learning materials than those in the conventional group. Shared decision making (SDM) group patients will have education according to questionnaires of self-assessment items using a self-developed counseling calendar.

Conditions

• Chronic Kidney Disease Stage 5

Interventions

Type	Name	Description
BEHAVIORAL	Education	More informed and detailed education
BEHAVIORAL	Education	Shared decision making
BEHAVIORAL	Education	education as usual

Timeline

• Start date: 2021-02-26
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-07-26
• Last updated: 2022-03-25

Locations

19 sites across 1 country: South Korea