Using Shared Decision Making to Improve Kidney Transplantation Rates

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Kidney Failure
• Intervention / Treatment: Behavioral: Provider educational materials; Behavioral: Patient letters

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Providers; Dialysis providers will receive educational material about the kidney transplantation and waitlisting process.	Behavioral: Provider educational materials; Dialysis providers will receive educational material about the kidney transplantation and waitlisting process.
Experimental: Patients; Dialysis patients will receive letters with information about their status within the kidney transplantation and waitlisting process.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient knowledge of individual waitlist status	Patient knowledge of individual waitlist status will be measured by one Yes/No question on the patient survey using McNemar's test.	Baseline (day 1), post letter 1 (approx 1 month later), post letter 2 (approx 1 month later), post letter 3 (approx 1 month later), post intervention (approx 4-6 months total)
Change in frequency of shared decision-making conversations,	Frequency of shared decision-making conversations will be measured by two Yes/No questions on the patient survey using McNemar's test.	Baseline (day 1), post letter 1 (approx 1 month later), post letter 2 (approx 1 month later), post letter 3 ( approx 1 month later), post intervention (approx 4-6 mos total)
Change in donor kidney preferences	Patient preferences for kidneys from living donors, kidneys from Hepatitis C positive donors, and kidneys from high KDPI donors will be measured by six Yes/No questions on the patient survey using McNemar's test.	Baseline (day 1), post letter 1 (approx 1 month later), post letter 2 (approx 1 month later), post letter 3 (approx 1 month later), post intervention (approximately 4-6 mos total)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dialysis provider attitudes, as measured on provider survey	Dialysis providers' attitudes and comfort with discussing the kidney waitlist and transplantation process will be measured on the provider survey. Questions will be scored on a 1-5 Likert scale, with 1 indicating low comfort level and 5 indicating high comfort level. Total scores range from 5-25 with a higher score indicating a better outcome.	Post-educational session, Day 1
Provider assessment of patient letters, as measured on provider survey	Providers' assessment of the helpfulness of patient letters will be measured by five questions on the provider survey. Questions will be scored on a 1-5 Likert scale, with 1 indicating low helpfulness and 5 indicating high helpfulness. Total scores range from 5-25 with a higher score indicating a better outcome.	End of intervention/at completion of letter delivery (4-6 months)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Kidney Transplant Collaborative; National Kidney Foundation, United States
• Investigators: Principal Investigator: Sumit Mohan, MD, MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Actual): February 21, 2025
• Study Completion (Actual): February 21, 2025

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Transplantation; Shared Decision Making; Kidney Transplant
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic
• Other Study ID Numbers: AAAU1202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No