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OpenTrials
Completed

NCT Number: NCT02235571

iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Transplant Center, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options.

    Time frame: Up to 19 months

    Patient knowledge of the survival benefit of transplant and the patient's individualized mortality risk

Secondary outcomes

  1. Patient access to transplant

    Time frame: Up to 19 months

    Evaluation completion, waitlisting, transplant

Other outcomes

  1. Patient treatment preferences

    Time frame: Up to 19 months

    Patient preference for transplant vs. dialysis

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Columbia University
  • Norman S. Coplon Extramural Grant Program
  • Northwestern University
  • Satellite Healthcare

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 10, 2014
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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