Clinical trial NCT04976166: Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients
Official title: Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients (SDM-ART Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease Stage 5
Keywords: chronic kidney disease
dialysis
shared decision making
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 1194
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The ratio of hemodialysis to non-hemodialysis
timeFrame: 12 months
Secondary outcomes:
measure: Economic efficiency using a cost-utility analysis
timeFrame: Month 2, and 12
measure: Patients' satisfaction assessed by Patient Satisfaction Questionnaire (ZUF-8)
timeFrame: Month 0, 2, and 12
measure: Patients' evaluation of the SDM process assessed by Shared Decision-Making Questionnaire (SDM-Q-9)
timeFrame: Month 0, 2, and 12
measure: Patients' adherence to medication assessed by Morisky 8-item Medication Adherence Scale (MMAS-8)
timeFrame: Month 0, 2, and 12
measure: unplanned dialysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang Seoul National University Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon Eulji Medical Center
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Woman's University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sejoong Sejoong, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: