iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235571
• Other study ID #: IRB00076067
• Status: Completed
• Phase: N/A
• First received: September 6, 2014
• Last updated: October 5, 2017
• Start date: September 2014
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Kidney Transplantation
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Emory Transplant Center	Atlanta	Georgia
United States	Northwestern University (Kovler Transplant Center)	Chicago	Illinois
United States	Columbia University Medical Center	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Emory University	Columbia University, Norman S. Coplon Extramural Grant Program, Northwestern University, Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient treatment preferences	Patient preference for transplant vs. dialysis	Up to 19 months
Primary	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	Patient access to transplant	Evaluation completion, waitlisting, transplant	Up to 19 months