iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

Study Overview
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Brief Summary
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The investigators developed iChoose Kidney -- a shared decision-making support tool accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers with a simple, standardized, easily accessible, statistically robust tool for use in the clinic to guide patient education and healthcare decision-making about treatment options of dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with estimates of their individualized 1 and 3-year risks of mortality on dialysis vs. transplantation, based on previous national data. The tool has the potential to improve communication and decision-making between patients and their healthcare providers and improve access to kidney transplantation among patients with ESRD. This will be a two-arm, randomized study, and will be conducted at 3 large transplant centers with diverse patient populations. One group of patients will receive standard education alone during their scheduled transplant evaluation. The second group will receive the standard education as well have the provider use the iChoose Kidney aid with them. The project timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and outcome evaluation. This study will assess how well the iChoose decision aid works in improving patient knowledge, preferences for treatment, and patient access to transplant. The study will also assess whether providers find the tool useful for providing ways to share information with patients about ways to treat their kidney disease.

Official Title
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iChoose Kidney Decision Aid for Treatment Options Among End-Stage Renal Disease (ESRD) Patients

Conditions
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End-Stage Kidney Disease, Kidney Failure, Chronic, Kidney Transplantation

Intervention / Treatment
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* Behavioral: iChoose Kidney Decision Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of end-stage renal disease (ESRD) and on dialysis for < 1 year English-speaking Subjects coming in for transplant medical evaluation Age > 18 years Exclusion Criteria: Severe cognitive or visual impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>These subjects are receiving standard patient education | |
| Experimental: iChoose Kidney Decision Aid<br>These subjects receive iChoose Kidney Decision Aid along with standard patient education | Behavioral: iChoose Kidney Decision Aid<br>* Providers will use a shared decision making tool with patients via iPhone, iPad, or web which explains predicted individualized risk of mortality on dialysis vs. transplant during the evaluation appointment for kidney transplant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options. | Patient knowledge of the survival benefit of transplant and the patient's individualized mortality risk | Up to 19 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient access to transplant | Evaluation completion, waitlisting, transplant | Up to 19 months |