Using Shared Decision Making to Improve Kidney Transplantation Rates

Not Applicable

• Conditions: End Stage Renal Disease; Kidney Failure
• Interventions: Behavioral: Provider educational materials; Behavioral: Patient letters

• Registration Number: NCT06141499
• Lead Sponsor: Columbia University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-21
• Study Start: 2024-01-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Providers	Provider educational materials	Dialysis providers will receive educational material about the kidney transplantation and waitlisting process.
Patients	Patient letters	Dialysis patients will receive letters with information about their status within the kidney transplantation and waitlisting process.

Primary Outcome Measures

Name	Time	Method
Change in frequency of shared decision-making conversations,	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)	Frequency of shared decision-making conversations will be measured by two Yes/No questions on the patient survey using McNemar's test.
Change in donor kidney preferences	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)	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.
Change in patient knowledge of individual waitlist status	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)	Patient knowledge of individual waitlist status will be measured by one Yes/No question on the patient survey using McNemar's test.

Secondary Outcome Measures

Name	Time	Method
Provider assessment of patient letters, as measured on provider survey	End of intervention/at completion of letter delivery (4-6 months)	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.
Change in dialysis provider attitudes, as measured on provider survey	Post-educational session, Day 1	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.

Trial Locations

Locations (2)

Columbia University; 🇺🇸 New York, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States