iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

NCT ID: NCT02235571

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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End-Stage Kidney Disease Kidney Failure, Chronic Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

These subjects are receiving standard patient education

Group Type NO_INTERVENTION

No interventions assigned to this group

iChoose Kidney Decision Aid

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

Group Type EXPERIMENTAL

iChoose Kidney Decision Aid

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

Satellite Healthcare

OTHER

Sponsor Role collaborator

Norman S. Coplon Extramural Grant Program

UNKNOWN

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Rachel Patzer, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Patzer, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory Transplant Center

Atlanta, Georgia, United States

Site Status

Northwestern University (Kovler Transplant Center)

Chicago, Illinois, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29446209 (View on PubMed)

Other Identifiers

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IRB00076067

Identifier Type: -

Identifier Source: org_study_id