Clinical trial NCT02235571: iChoose Decision Kidney Aid for End-Stage Renal Disease Patients
Official title: iChoose Kidney Decision Aid for Treatment Options Among End-Stage Renal Disease (ESRD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Kidney Disease
Kidney Failure, Chronic
Kidney Transplantation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Northwestern University
name: Satellite Healthcare
name: Norman S. Coplon Extramural Grant Program
First posted: 2014-09-10
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options.
timeFrame: Up to 19 months
Secondary outcomes:
measure: Patient access to transplant
timeFrame: Up to 19 months
Other outcomes:
measure: Patient treatment preferences
timeFrame: Up to 19 months
Locations:
city: Atlanta
country: United States
facility: Emory Transplant Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University (Kovler Transplant Center)
state: Illinois
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Emory University
name: Rachel Patzer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.