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Completed

NCT Number: NCT06141499

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Provider educational materials

Behavioral

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

Patient letters

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.

Primary outcomes

  1. Change in patient knowledge of individual waitlist status

    Time frame: 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.

  2. Change in frequency of shared decision-making conversations,

    Time frame: 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.

  3. Change in donor kidney preferences

    Time frame: 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.

Secondary outcomes

  1. Change in dialysis provider attitudes, as measured on provider survey

    Time frame: 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.

  2. Provider assessment of patient letters, as measured on provider survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Kidney Transplant Collaborative
  • National Kidney Foundation, United States

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2023
Registry last updated
Jun 10, 2025

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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