Clinical trial NCT03921437: Decision Support for the Renal Replacement Therapy With End-stage Renal Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Disease
Keywords: Chronic Renal Diseases
Decision-making
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Tri-Service General Hospital
First posted: 2019-04-19
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: I. Research object: In the outpatient department of a medical center in a medical center in the north, the case was collected, and the sample was selected conveniently. The patients who met the following sample selection conditions were selected, and 128 patients who agreed to participate in the study and filled out the consent form were studied by Random Allocation. The software software generates a random assignment list, which is then assigned to the experimental group and the control group.

2.The number of samples is calculated The number of samples required is calculated by G power (version 3.1.9.2) statistical software (Faul, Erdfelder, Buchner, \& Lang, 2009), and the repeated measures ANOVA of the F test is used to compare the difference between the two groups (between factors) due to lack of intervention. The reference data of the effect size of the measure, the estimated measure should be moderately beneficial for the degree of decision-making, so according to the cohen's rule (Cohen, 1988) f2 is 0.30, the significant level α is 0.05, and the statistical power value is 0.05. It is 0.80, repeated measurement 3 times, the correlation between repeated measurements is 0.5, the total number of samples is estimated to be 86, each group is 43, and in addition, in order to make the secondary effect variable, there are enough samples, and consider The exit and omission values were about 20%. Therefore, 128 end-stage renal patients were selected from the hospital outpatient nephrology case management database. About 64 people in the experimental group and the control group participated in the study.

3. Intervention measures The intervention measures in this study were discussed with the nephrologist and CKD health teachers. Based on theoretical considerations, both the experimental group and the control group can accept the introduction and selection of renal replacement therapy, but the decision support measures are different, and the experimental group provides decision support. Measures include the use of CKD Guardian as a decision-maker and the development of medical decision aids by e-book software, and the application and decision-directed model complemented by introduction and selection. The implementation steps include team discussion, option discussion and decision making. The conversation is conducted while the control group is introduced with traditional care care.

Eligibility criteria: 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.

Primary outcomes:
measure: Control Preferences Scale
timeFrame: 10 minutes
measure: Scale of knowledge
timeFrame: 10 minutes
measure: Decision Self-Efficacy: Decision Self-Efficacy Scale
timeFrame: 10 minutes
measure: Decisional Conflict
timeFrame: 10 minutes
Secondary outcomes:
measure: Decisional Satisfaction: Satisfaction with Decision (SWD)
timeFrame: 10 minutes
measure: Decisional Regret
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Tasw Jyy Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.