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

Chronic Kidney Disease Stage 5 Clinical Trial

— SDM-ART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976166
• Other study ID #: SDMART
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2022
• Source: Seoul National University Hospital
• Contact: Sejoong Kim, MD,PhD
• Phone: +82-10-9496-4899
• Email: sejoong[@]snubh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1194
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Education
More informed and detailed education
• Education
Shared decision making
• Education
education as usual

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Daejeon Eulji Medical Center	Daejeon
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Bundang Seoul National University Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Ewha Woman's University Seoul Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Eunpyeong St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ratio of hemodialysis to non-hemodialysis	To compare the proportion of hemodialysis versus non-hemodialysis (peritoneal dialysis and kidney transplantation) treatments among the groups	12 months
Secondary	Economic efficiency using a cost-utility analysis	The incremental cost-utility ratio (ICUR) is calculated by the ratio of differences in costs and utilities.	Month 2, and 12
Secondary	Patients' satisfaction assessed by Patient Satisfaction Questionnaire (ZUF-8)	The ZUF-8 is an 8-items questionnaire to assess satisfaction in patients using a scale from 1,"poor" to 4,"excellent". Originally, ZUF-8 used a 4-point scale, but in this study, the investigators further extended the scoring system of this questionnaire from four to five incremental stages of perceived satisfaction, i.e. "poor (1)," rather good (2)," good (3)," very good (4)," extraordinary (5)". The minimum value is 8 and the maximum value is 40. Higher scores mean a better outcome.	Month 0, 2, and 12
Secondary	Patients' evaluation of the SDM process assessed by Shared Decision-Making Questionnaire (SDM-Q-9)	The SDM-Q-9 questionnaire is a nine item measure. Items are reported with six response options ranging from 0, "completely disagree", to 5, "completely agree". In this study, six response options were converted into five incremental stages, i.e. "strongly disagree (1)," somewhat disagree (2)," neither disagree nor agree (3)," somewhat agree (4)," strongly agree (5)". To calculate the total scale score, items are summed resulting in a range from 9-45. Higher scores reflect a participant's participation in shared decision making regarding their treatment.	Month 0, 2, and 12
Secondary	Patients' adherence to medication assessed by Morisky 8-item Medication Adherence Scale (MMAS-8)	The MMAS-8 is an 8-items questionnaire and the scale included 7 items with yes/no response options and 1 item with a 5-point Likert scale response option. Cumulative score based on 8 items are used to obtain final adherence score ranging from 0 to 8. Adherence is defined accordingly as low (score 0-5), medium (score 6-7) and high (score 8).	Month 0, 2, and 12
Secondary	unplanned dialysis	To compare the rate of unplanned dialysis among the groups	12 months