Decision Support for the Renal Replacement Therapy With End-stage Renal Disease

NCT03921437 | Completed

• 1 other identifier: 1-1-7-05-114
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Patients often need more comprehensive information and clearer communication in order to to understand the complications, risks, cost and impacts on life quality associated with different treatment options. The purpose of this study is to investigate the efficacy of a decision support intervention on reducing conflict and improving satisfaction in making the renal replacement therapy decision among patients with end-stage renal disease. This study will be a randomized controlled trail. They will be randomly assigned to the experimental or the control group. Participants in the experimental group will receive the decision support intervention provided by the patient educators through using a decision support tool. The control participants will receive the routine care. Independent t-tests will be used to analyze between-group differences in autonomy preference index, renal replacement therapy knowledge, decision self-efficacy, decision conflict, decision regret, and decision satisfaction at different data collection points.Generalized Estimating Equations will be used to analyze between group differences in the changes of renal replacement therapy knowledge, decision self-efficacy, and decision conflict across time.

Conditions

Chronic Renal Disease

Keywords

Chronic Renal Diseases; Decision-making

Outcome Measures

Primary Outcomes (4)

• Control Preferences Scale

  The control preferences construct is defined as "the degree of control an individual wants to assume when decisions are being made about medical treatment." The CPS consists of five cards that each portrays a different role in treatment decision-making using a statement and a cartoon. A and B represent the individual making the treatment decisions, C represent the individual making the decisions jointly with the physician, and D and E represent the physician making the decisions.

  10 minutes

• Scale of knowledge

  To measure the patient's relevant disease knowledge, dialysis modalities and items that should be tracked over time. The scale mainly applied a dichotomy response (right/wrong), but to prevent patient guessing, add the choice of 'I don't know' as well. There are 20 questions in total with a total possible score ranging from 0-20. The higher the subject's score, the more knowledge he/she was presumed to possess.

  10 minutes

• Decision Self-Efficacy: Decision Self-Efficacy Scale

  Using the Decision Self-Efficacy Scale developed by O'Connor (1995) to measure self-confidence or belief in decision-making ability, including joint decision making, the scale has a total of 11 questions, 0-4 points. Scored by 5 points, 0 points means no confidence at all, and 4 points means very confident. In order to help explain the score more easily, the scale multiplies the score by 25, and the score ranges from 0 (nothing at all). Confidence) to 100 points (very confident). The 0 point is expressed as "very low self-efficacy" and the 100 points means "very high self-efficacy" (O'Connor, 1995). The internal consistency of the scale is 0.92 with a correlation with the knowledge (r = 0.47) and support (r = 0.45).

  10 minutes

• Decisional Conflict

  A total of 16 questions, 5 points method Sub-(0-4), which is used to measure the decision-making disturbances of patients involved in treatment decision-making, including uncertainty, feelings, lack of relevant information, unclear personal values, feelings of lack of support, and decision satisfaction. Table (O'Connor, 1995). The summary score is converted to 0-100 points. According to the manual, the higher the total score, the higher the decision-making trouble, and the score greater than 37.5 is the relevant decision delay. The scale was originally used in patients who received influenza vaccine or breast cancer screening. The decision was made on whether or not to treat 909 patients. The internal consistency coefficient of the scale ranged from 0.78 to 0.92 with good reliability and validity. O'Connor, 1995).

  10 minutes

Secondary Outcomes (2)

• Decisional Satisfaction: Satisfaction with Decision (SWD)

  10 minutes

• Decisional Regret

  10 minutes

Study Arms (2)

decision support intervention

EXPERIMENTAL

The intervention measures in this study were discussed with the nephrologist and CKD health teachers. Based on theoretical considerations, the experimental group provides decision support. Measures, including CKD Guardian as a decision-maker, and the use of e-book software to develop medical decision-assist tools, and the application and decision-making mode complemented by introduction and selection, including team discussions, option discussions, and decision-making conversations. The control group is introduced with traditional care instructions for routine care. The experimental group and the control group were referred to the CKD health teacher for the introduction of renal replacement therapy by the physician. The experimental group was guided by CKD Health Education to guide the patients to participate in the discussion, discuss the advantages and disadvantages of each treatment and guide patients to explore preferences. And value, supplemented by discussion and final decision.

Radiation: decision support intervention

routine care

NO INTERVENTION

According to the nursing routine provide paper education.

Interventions

decision support intervention RADIATION

CKD Guardian is the decision-maker and uses the e-book software to develop medical decision-assist tools, and applies this tool and decision-directed mode to introduce and select. The implementation steps include team discussion, option discussion and decision-making. The group is introduced with traditional care instructions for routine care.

Also known as: routine care

decision support intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Inclusion conditions: 1. The fifth stage of chronic renal failure diagnosed by a physician. 2. The physician advises and informs the patient who has to undergo renal replacement therapy but has not yet decided what treatment to take. 3. Being able to communicate in Mandarin and Taiwan. 4. Ages over 20 years old. Exclusion conditions: 1. Cognitive impairment: The MMSE of the above-mentioned educators was 26 points, and the national minimum was \< 21 points, those who are not educated are \<16 points, and the case is excluded. 2. Patients who have received non-emergency dialysis treatment. 3. Patients with severe cardiopulmonary dysfunction, severe shock, low blood pressure, and large bleeding are not controlled. 4. Patients with chronic active hepatitis, cirrhosis or liver failure. 5. A history of cancer that may be transferred. 6. Severe bleeding tendency. 7. Loss of peritoneal function or extensive peritoneal adhesion, unable to use peritoneal dialysis. 8. Unable to correct physiological defects, may interfere with peritoneal dialysis, or increase the chance of infection, such as umbilical hernia. 9. The patient is unable to operate the fluid change, hand shake, and no family members can assist. 10. Patients who are blind, have poor eyesight, and have difficulty operating.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Tri-Service General Hospital: collaborator

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, 886, Taiwan

Location

Related Publications (3)

• AHRQ. (2016). The Share Approach-Health Literacy and Shared Decision Making: A Reference Guide for Health Care Providers. Retrieved from http://www.ahrq.gov/professionals/ education/curriculum-tools/ Shared decision making/tools/tool-4/index.html

  BACKGROUND

• Chang YT, Hwang JS, Hung SY, Tsai MS, Wu JL, Sung JM, Wang JD. Cost-effectiveness of hemodialysis and peritoneal dialysis: A national cohort study with 14 years follow-up and matched for comorbidities and propensity score. Sci Rep. 2016 Jul 27;6:30266. doi: 10.1038/srep30266.

  PMID: 27461186 BACKGROUND

• Lin ML, Huang CT, Chen CH. Reasons for family involvement in elective surgical decision-making in Taiwan: a qualitative study. J Clin Nurs. 2017 Jul;26(13-14):1969-1977. doi: 10.1111/jocn.13600. Epub 2016 Dec 18.

  PMID: 27681338 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tasw Jyy Wang, PhD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Adopting the method of unnamed, the analysis uses de-named coding, who will not know who the respondent is.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN PhD Professor

Model Details: A random 1:1 assignment was made using a random number table to generate a sequence, and the participants were randomly divided into an experimental group and a control group.

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: April 18, 2019
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)