iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic; Kidney Transplantation; End-Stage Kidney Disease
• Intervention / Treatment: Behavioral: iChoose Kidney Decision Aid

• Study Type: Interventional
• Enrollment (Actual): 470
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Transplant Center
  • Illinois
    • Chicago, Illinois, United States
      • Northwestern University (Kovler Transplant Center)
  • New York
    • New York, New York, United States
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; These subjects are receiving standard patient education
Experimental: iChoose Kidney Decision Aid; These subjects receive iChoose Kidney Decision Aid along with standard patient education	Behavioral: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient treatment preferences	Patient preference for transplant vs. dialysis	Up to 19 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Northwestern University; Columbia University; Satellite Healthcare; Norman S. Coplon Extramural Grant Program
• Investigators: Principal Investigator: Rachel Patzer, PhD, MPH, Emory University

Publications and helpful links

General Publications

• Patzer RE, McPherson L, Basu M, Mohan S, Wolf M, Chiles M, Russell A, Gander JC, Friedewald JJ, Ladner D, Larsen CP, Pearson T, Pastan S. Effect of the iChoose Kidney decision aid in improving knowledge about treatment options among transplant candidates: A randomized controlled trial. Am J Transplant. 2018 Aug;18(8):1954-1965. doi: 10.1111/ajt.14693. Epub 2018 Mar 26.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 6, 2014
• First Submitted That Met QC Criteria: September 6, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: IRB00076067

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No