Clinical trial NCT05407896: End-Stage Kidney Disease Interactive Decision Aid for the Elderly (myKIDNEY)
Official title: End-Stage Kidney Disease Interactive Decision Aid for the Elderly (myKIDNEY)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End-Stage Kidney Disease
Keywords: end-stage kidney disease
decision aid
shared decision making
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
name: National University Hospital, Singapore
First posted: 2022-06-07
Enrollment: 208
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pre-post study design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Decision aids are highly recommended for decisions when there is no "right" treatment choice. The goal is to help patients choose a treatment that is consistent with their preferences and to minimize decisional conflict and regret. A case where there is no "right" treatment concerns the decision to undergo dialysis or supportive care (i.e., conservative management) for elderly (aged ≥70) patients with end-stage kidney disease. The investigators propose to develop an interactive web-based decision aid and test its effectiveness via a pre-post study design. This research aims to reduce decisional conflict for elderly ESKD patients and caregivers.

Detailed description: For patients aged 75 and above with comorbidities, the benefits of dialysis over kidney supportive care, which focuses on maintaining quality of life as opposed to life extension, are not clear. As there is no clear or "right" treatment choice, treatment decisions should be informed by patient preferences. However, currently in Singapore most patients choose dialysis and express decisional conflict and regret. Decision aids (DAs) together with values clarification methods (VCMs) can help patients choose a treatment that is concordant with their preferences and treatment goals. To help minimize decisional conflict among elderly ESKD patients, the first aim of this proposal is to adapt the current materials the investigators have developed (booklet and video) for elderly ESKD patients in a prior effort (NMRC/HSRG/0080/2017) into an interactive web-based tool called myKIDNEY. It will provide patients with tailored and relevant information based on their age and medical history, and help them identify and express their preferences via an interactive VCM. The second aim of the proposal is to test the benefits of counselling with myKIDNEY to standard renal counselling via a pre-post study design. The primary hypothesis is that patients and caregivers who receive counselling with myKIDNEY will report less decisional conflict compared to those who receive standard counselling. The investigators also hypothesize that fewer patients in the intervention arm will opt for dialysis, which is the more costly and invasive treatment option. If the proposed study shows evidence that the interactive tool improves decision-making quality in the local setting, this will result in a better patient experience. If fewer patients choose dialysis as per our hypothesis, this will also generate cost savings for the health system while at the same time allowing patients to choose their preferred treatment with lower chances of decisional conflict.

Eligibility criteria: Inclusion Criteria (patients):

* Incident CKD Stage 5 patients with GFR\<15ml/min
* Aged 70 years or older-
* Have not undergone counselling with a renal counsellor
* Cognitively intact as determined by the Abbreviated Mental Test (AMT)
* Speak and read English or Mandarin

Inclusion Criteria (caregivers):

* Primary informal caregiver for an eligible patient (primarily involved in providing care, ensuring provision of care, and/or in making decisions regarding patient's care)
* Aged 21 years and older
* Direct relative of the patient

Exclusion Criteria:

- Patients deemed to be mentally incompetent, and those not aware of their diagnosis will be excluded.

Primary outcomes:
measure: Decisional conflict scale (0 to 100; higher scores indicate higher decisional conflict)
timeFrame: 1 hour
Secondary outcomes:
measure: Stated preferred treatment
timeFrame: Assessed after renal counselling (within 2 weeks after renal counselling)
measure: Actual treatment choice
timeFrame: 6 months after renal counselling
measure: Actual treatment choice
timeFrame: 12 months after renal counselling
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References: