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iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iChoose Kidney Decision Aid
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory Transplant Center
  • Northwestern University (Kovler Transplant Center)
  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

iChoose Kidney Decision Aid

Arm Description

These subjects are receiving standard patient education

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient access to transplant
Evaluation completion, waitlisting, transplant

Full Information

First Posted
September 6, 2014
Last Updated
October 5, 2017
Sponsor
Emory University
Collaborators
Columbia University, Northwestern University, Satellite Healthcare, Norman S. Coplon Extramural Grant Program
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1. Study Identification

Unique Protocol Identification Number
NCT02235571
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Columbia University, Northwestern University, Satellite Healthcare, Norman S. Coplon Extramural Grant Program

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Kidney Disease, Kidney Failure, Chronic, Kidney Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
470 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
These subjects are receiving standard patient education
Arm Title
iChoose Kidney Decision Aid
Arm Type
Experimental
Arm Description
These subjects receive iChoose Kidney Decision Aid along with standard patient education
Intervention Type
Behavioral
Intervention Name(s)
iChoose Kidney Decision Aid
Intervention Description
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 Outcome Measure Information:
Title
Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options.
Description
Patient knowledge of the survival benefit of transplant and the patient's individualized mortality risk
Time Frame
Up to 19 months
Secondary Outcome Measure Information:
Title
Patient access to transplant
Description
Evaluation completion, waitlisting, transplant
Time Frame
Up to 19 months
Other Pre-specified Outcome Measures:
Title
Patient treatment preferences
Description
Patient preference for transplant vs. dialysis
Time Frame
Up to 19 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Patzer, PhD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Transplant Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University (Kovler Transplant Center)
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29446209
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.
Results Reference
derived

Learn more about this trial

iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

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