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

Seoul National University

Status: Enrolling

Conditions: Chronic Kidney Disease Stage 5

Treatments: Behavioral: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04976166

SDMART

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,194 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic kidney disease whose nephrologist predicts initiation of renal replacement therapy within 12 months:

  1. Patients with grade 5 of chronic kidney disease [defined as a creatinine-based estimated glomerular filtration rate (eGFR) < 15 ml/dL/1.73m2 at least 2 times at intervals of 2 weeks or longer]
  2. Patients with the cystatin C-based eGFR < 15 ml/dL/1.73m2 at least once if the creatinine-based eGFR does not accurately evaluate the kidney function of patient due to patient characteristics
  3. Patients whose nephrologist require renal replacement therapy within 12 months due to the patient's comorbidities even when the eGFR is 15ml/dL/1.73m2 or higher

• Patients aged between 19 and 80 years

• Patients who understand the study

• Patients who have no permanent access device for long-term maintenance dialysis

Exclusion criteria

• Patients who have contraindication to perform peritoneal dialysis due to abdominal surgery
• Patients whose life expectancy is less than 6 months due to underlying diseases
• Patients who have enrolled in other clinical trials within 3 months or plan to participate in other clinical trials during this clinical trial period
• Patients judged by the investigator to be inappropriate for participation in this clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,194 participants in 3 patient groups

Conventional group

Active Comparator group

Description:

Videos and leaflets will be provided. Patients will have education using leaflets for 5 minutes in each hospital at months 0 and 2, respectively.

Treatment:

Behavioral: Education

Behavioral: Education

Behavioral: Education

Extensive Informed Decision Making group

Experimental group

Description:

Videos, leaflets, and intensive learning materials will be provided. Patients in the EIDM group will receive more informed and detailed education than those in the conventional group. Patients will have education for more than 10 minutes at months 0 and 2, respectively.

Treatment:

Behavioral: Education

Behavioral: Education

Behavioral: Education

Shared Decision Making group

Experimental group

Description:

Videos, leaflets, and intensive learning materials will be provided. Patients will check self-assessment items, and then have education according to the patients' preference using a self-developed counseling calendar. Patients will have education for more than 10 minutes at months 0 and 2, respectively.

Treatment:

Behavioral: Education

Behavioral: Education

Behavioral: Education