Clinical trial NCT05666544: Renal Replacement Therapies Decision Aids
Official title: Developing and Effectiveness Evaluation of Web-based Situation Renal Replacement Therapies Patient Decision Aids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End-stage Renal Disease
Renal Replacement Therapy
Decision Aid
Decision-making
Keywords: End-stage Renal Disease
Renal Replacement Therapy
Patient Decision Aid
Shared Decision-Making
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Different renal replacement therapy methods will cause significant impacts on the physical, mental, and social for patients with end-stage renal disease. Application shared decision-making should be able to effectively assist patients in choosing suitable renal replacement therapy. Currently, most of the patient decision aid of renal replacement therapy are written health education leaflets, which have problems such as too many words, more difficult content, and inconvenience. In shared decision-making, even though different treatment options are communicated to patients, there is still a gap between "understanding" and "real experience", it will be creating uncertainty of decision, and emphasizing true situational learning strategies should be a viable auxiliary method. Therefore, this study aims to develop a web-based patient decision aid of renal replacement therapy and integrates situational learning strategies into it. First, investigators have conducted a qualitative study to explore the related experience of patients with end-stage renal disease the decision-making needs in renal replacement therapy choice, and the experience and barrier of reading paper patient decision aid. Next, based on the results of the pilot study, the modified Delphi method will be used to collect the opinions of experts, and the situational learning theory will be integrated into the patient decision aid to develop the web-based situation renal replacement therapies patient decision aid. After completion, investigators will apply quasi-experimental, a repeated measurement that will be adopted to analyze the effectiveness of web-based patient decision aid of renal replacement therapy in shared decision-making in patients with end-stage renal disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosed by nephrologists as patients with chronic kidney disease, and GFR \<30 ml/min/1.73m2.
* As a patient admitted to the "Pre-ESRD care plan".
* Clear awareness, ability to communicate in Mandarin and Taiwanese, and agree to participate in the research.
* Those who are unable to answer the questions without other serious diseases or diseases affecting the mind.

Exclusion Criteria:

* Those who cannot freely choose hemodialysis or peritoneal dialysis due to absolute contraindications.

Primary outcomes:
measure: Changes to the Preparation for Decision Making Scale (PrepDMS)
timeFrame: Baseline and immediately post-intervention.
measure: Changes to the Decisional Conflict Scale (DCS)
timeFrame: Baseline, immediately post-intervention, and one-month post-intervention.
measure: Changes to the Decision Self Efficacy Scale (DSES)
timeFrame: Baseline, immediately post-intervention, and one-month post-intervention.
measure: Decision Regret Scale (DRS)
timeFrame: One-month post-intervention.
measure: Changes to the Renal Replacement Therapy Knowledge Scale (RRTKS)
timeFrame: Baseline and immediately post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
References:
citation: Davis JL, Davison SN. Hard choices, better outcomes: a review of shared decision-making and patient decision aids around dialysis initiation and conservative kidney management. Curr Opin Nephrol Hypertens. 2017 May;26(3):205-213. doi: 10.1097/MNH.0000000000000321.
citation: Gionfriddo MR, Leppin AL, Brito JP, Leblanc A, Boehmer KR, Morris MA, Erwin PJ, Prokop LJ, Zeballos-Palacios CL, Malaga G, Miranda JJ, McLeod HM, Rodriguez-Gutierrez R, Huang R, Morey-Vargas OL, Murad MH, Montori VM. A systematic review of shared decision making interventions in chronic conditions: a review protocol. Syst Rev. 2014 Apr 15;3:38. doi: 10.1186/2046-4053-3-38.
citation: Bailey RA, Pfeifer M, Shillington AC, Harshaw Q, Funnell MM, VanWingen J, Col N. Effect of a patient decision aid (PDA) for type 2 diabetes on knowledge, decisional self-efficacy, and decisional conflict. BMC Health Serv Res. 2016 Jan 14;16:10. doi: 10.1186/s12913-016-1262-4.
citation: Buhse S, Muhlhauser I, Heller T, Kuniss N, Muller UA, Kasper J, Lehmann T, Lenz M. Informed shared decision-making programme on the prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial. BMJ Open. 2015 Nov 13;5(11):e009116. doi: 10.1136/bmjopen-2015-009116.