iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic; End-Stage Kidney Disease; Kidney Transplantation
• Interventions: Behavioral: iChoose Kidney Decision Aid

• Registration Number: NCT02235571
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-06
• Study First Submitted QC: 2014-09-06
• Study First Posted: 2014-09-10
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 470

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

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Exclusion Criteria

• Severe cognitive or visual impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iChoose Kidney Decision Aid	iChoose Kidney Decision Aid	These subjects receive iChoose Kidney Decision Aid along with standard patient education

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient access to transplant	Up to 19 months	Evaluation completion, waitlisting, transplant

Trial Locations

Locations (3)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Northwestern University (Kovler Transplant Center); 🇺🇸 Chicago, Illinois, United States

Emory Transplant Center; 🇺🇸 Atlanta, Georgia, United States