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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease Stage 5
• Intervention / Treatment: Behavioral: Education; Behavioral: Education; Behavioral: Education

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 Type: Interventional
• Enrollment (Anticipated): 1194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sejoong Kim, MD,PhD; Phone Number: +82-10-9496-4899; Email: sejoong@snubh.org

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Recruiting
    • Kyungpook National University Chilgok Hospital
  • Daegu, Korea, Republic of
    • Recruiting
    • Kyungpook National University Hospital
  • Daejeon, Korea, Republic of
    • Recruiting
    • Daejeon Eulji Medical Center
  • Goyang, Korea, Republic of
    • Recruiting
    • Dongguk University Ilsan Hospital
  • Gwangju, Korea, Republic of
    • Recruiting
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of
    • Recruiting
    • Gachon University Gil Medical Center
  • Pusan, Korea, Republic of
    • Recruiting
    • Pusan National University Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Boramae Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • Kyung Hee University Hospital at Gangdong
  • Seoul, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Ewha Woman's University Seoul Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea Eunpyeong St. Mary's Hospital
  • Ulsan, Korea, Republic of
    • Recruiting
    • Ulsan University Hospital
  • Wonju, Korea, Republic of
    • Recruiting
    • Yonsei University Wonju Severance Christian Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Bundang Seoul National University Hospital
      • Contact: Sejoong Kim, MD,PhD; Phone Number: +82-10-94964899; Email: sejoong2@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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; More informed and detailed education; Behavioral: Education; Shared decision making; 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; Behavioral: Education; Shared decision making; Behavioral: Education; education as usual
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; More informed and detailed education; Behavioral: Education; Shared decision making; Behavioral: Education; education as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
unplanned dialysis	To compare the rate of unplanned dialysis among the groups	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: chronic kidney disease; dialysis; shared decision making
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: SDMART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No