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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04976166
• Collaborator: (none)
• Enrollment: 1,194
• Locations: 19
• Arms: 3
• Anticipated Duration (Months): 45.1
• Patients Per Site: 62.8
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Stage 5	Behavioral: Education; Behavioral: Education; Behavioral: Education	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients (SDM-ART Trial)
• Actual Study Start Date: Feb 26, 2021
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional group Videos and leaflets will be provided. Patients will have education using leaflets for 5 minutes in each hospital at months 0 and 2, respectively.	Behavioral: Education; education as usual
Experimental: Extensive Informed Decision Making group 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.	Behavioral: Education; More informed and detailed education
Experimental: Shared Decision Making group 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.	Behavioral: Education; Shared decision making

Outcome Measures

Primary Outcome Measures

1. The ratio of hemodialysis to non-hemodialysis [12 months]

   To compare the proportion of hemodialysis versus non-hemodialysis (peritoneal dialysis and kidney transplantation) treatments among the groups

Secondary Outcome Measures

1. Economic efficiency using a cost-utility analysis [Month 2, and 12]

   The incremental cost-utility ratio (ICUR) is calculated by the ratio of differences in costs and utilities.

2. Patients' satisfaction assessed by Patient Satisfaction Questionnaire (ZUF-8) [Month 0, 2, and 12]

   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.

3. Patients' evaluation of the SDM process assessed by Shared Decision-Making Questionnaire (SDM-Q-9) [Month 0, 2, and 12]

   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.

4. Patients' adherence to medication assessed by Morisky 8-item Medication Adherence Scale (MMAS-8) [Month 0, 2, and 12]

   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).

5. unplanned dialysis [12 months]

   To compare the rate of unplanned dialysis among the groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bundang Seoul National University Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620
2	Kyungpook National University Chilgok Hospital	Daegu		Korea, Republic of
3	Kyungpook National University Hospital	Daegu		Korea, Republic of
4	Daejeon Eulji Medical Center	Daejeon		Korea, Republic of
5	Dongguk University Ilsan Hospital	Goyang		Korea, Republic of
6	Chonnam National University Hospital	Gwangju		Korea, Republic of
7	Gachon University Gil Medical Center	Incheon		Korea, Republic of
8	Pusan National University Hospital	Pusan		Korea, Republic of
9	Ewha Woman's University Seoul Hospital	Seoul		Korea, Republic of
10	Korea University Guro Hospital	Seoul		Korea, Republic of
11	Kyung Hee University Hospital at Gangdong	Seoul		Korea, Republic of
12	Samsung Medical Center	Seoul		Korea, Republic of
13	Seoul National University Boramae Medical Center	Seoul		Korea, Republic of
14	Seoul National University Hospital	Seoul		Korea, Republic of
15	Severance Hospital	Seoul		Korea, Republic of
16	The Catholic University of Korea Eunpyeong St. Mary's Hospital	Seoul		Korea, Republic of
17	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul		Korea, Republic of
18	Ulsan University Hospital	Ulsan		Korea, Republic of
19	Yonsei University Wonju Severance Christian Hospital	Wonju		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Sejoong Sejoong, MD,PhD, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sejoong Kim, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04976166
• Other Study ID Numbers: SDMART
• First Posted: Jul 26, 2021
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sejoong Kim, Professor, Seoul National University Hospital: chronic kidney disease; dialysis; shared decision making
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

No Results Posted as of Mar 25, 2022