iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

NCT02235571 | Completed DMC

• 1 other identifier: IRB00076067
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 3

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.

Conditions

End-Stage Kidney Disease; Kidney Failure, Chronic; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient access to transplant

  Up to 19 months

Other Outcomes (1)

• Patient treatment preferences

  Up to 19 months

Study Arms (2)

Control

NO INTERVENTION

These subjects are receiving standard patient education

iChoose Kidney Decision Aid

EXPERIMENTAL

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

Behavioral: iChoose Kidney Decision Aid

Interventions

iChoose Kidney Decision Aid BEHAVIORAL

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.

iChoose Kidney Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe cognitive or visual impairment

Sponsors & Collaborators

• Emory University: lead
• Columbia University: collaborator
• Northwestern University: collaborator
• Satellite Healthcare: collaborator
• Norman S. Coplon Extramural Grant Program: collaborator

Study Sites (3)

Emory Transplant Center

Atlanta, Georgia, 30322, United States

Location

Northwestern University (Kovler Transplant Center)

Chicago, Illinois, United States

Location

Columbia University Medical Center

New York, New York, United States

Location

Related Publications (1)

• 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.

  PMID: 29446209 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Patzer, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 6, 2014
• First Posted: September 10, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (3)