Using Shared Decision Making to Improve Kidney Transplantation Rates

NCT ID: NCT06141499

Last Updated: 2025-06-10

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-12

Study Completion Date

2025-02-21

Brief Summary

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The goal of this clinical trial is to increase shared decision-making between dialysis providers and patients in order to increase patients' probability of transplantation and to reduce socioeconomic/racial disparities in access to kidney transplantation.

Participants will receive educational material over the course of 4-6 months about different aspects of the kidney transplant and waitlisting process.

Detailed Description

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Kidney transplantation is the preferred treatment choice for patients with end stage kidney disease (ESKD), yet only a small proportion of patients with incident ESKD are counseled about their transplant options. Often, a smaller minority of patients reach the transplant waitlist in a timely manner. Increasing the likelihood of transplantation for patients with ESKD can lead to longer survival, better quality of life, and reduced costs of care.

The kidney transplant and waitlist process is a complex and multi-step process that occurs over an extended period of time. This process involves transitions of care between multiple providers and requires patients to be proactive in their medical evaluations.

This study will deliver educational materials to dialysis care teams and provide quarterly, personalized informational letters to patients, with the aim of increasing shared decision-making between patients and providers by giving them the information needed to initiate conversations about kidney transplantation.

Conditions

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End Stage Renal Disease Kidney Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Enrolled providers and enrolled patients will receive different interventions; outcomes assessed for these two groups will be different.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Providers

Dialysis providers will receive educational material about the kidney transplantation and waitlisting process.

Group Type EXPERIMENTAL

Provider educational materials

Intervention Type BEHAVIORAL

Dialysis providers will receive educational material about the kidney transplantation and waitlisting process.

Patients

Dialysis patients will receive letters with information about their status within the kidney transplantation and waitlisting process.

Group Type EXPERIMENTAL

Patient letters

Intervention Type BEHAVIORAL

Dialysis patients will receive letters with information about their status within the kidney transplantation and waitlisting process. Letters will describe kidney waitlist status, living donor transplantation, Hepatitis C positive kidney transplants, and high Kidney Donor Profile Index (KDPI) transplants.

Interventions

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Provider educational materials

Dialysis providers will receive educational material about the kidney transplantation and waitlisting process.

Intervention Type BEHAVIORAL

Patient letters

Dialysis patients will receive letters with information about their status within the kidney transplantation and waitlisting process. Letters will describe kidney waitlist status, living donor transplantation, Hepatitis C positive kidney transplants, and high Kidney Donor Profile Index (KDPI) transplants.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* On a waitlist or undergoing an evaluation at the Columbia University/New York Presbyterian Hospital (CU/NYPH) Transplant Center or at the Cleveland Clinic (CC)
* Receiving hemodialysis at one of the following dialysis clinics:

* Fresenius Kidney Care City Dialysis
* DaVita Kidney Care Haven Dialysis
* DaVita Melrose Dialysis
* DaVita Highbridge Dialysis
* Rogosin Institute East Side Dialysis Unit
* Rogosin Institute West Side Dialysis Unit

Exclusion Criteria

* Speaking a language other than English or Spanish
* Younger than 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kidney Transplant Collaborative

UNKNOWN

Sponsor Role collaborator

National Kidney Foundation, United States

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Sumit Mohan, MD

Professor of Medicine and Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sumit Mohan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University

New York, New York, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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AAAU1202

Identifier Type: -

Identifier Source: org_study_id

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