Overview

This trial is active, not recruiting.

Conditions end-stage kidney disease, kidney failure, chronic, kidney transplantation
Treatment ichoose kidney decision aid
Sponsor Emory University
Collaborator Columbia University
Start date September 2014
End date November 2015
Trial size 450 participants
Trial identifier NCT02235571, IRB00076067

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
These subjects are receiving standard patient education
(Experimental)
These subjects receive iChoose Kidney Decision Aid along with standard patient education
ichoose kidney decision aid
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.

Primary Outcomes

Measure
Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options.
time frame: Up to 19 months

Secondary Outcomes

Measure
Patient access to transplant
time frame: Up to 19 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title iChoose Kidney Decision Aid for Treatment Options Among End-Stage Renal Disease (ESRD) Patients
Principal investigator Rachel Patzer, PhD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Emory University.