Using Shared Decision Making to Improve Kidney Transplantation Rates

End Stage Renal Disease Clinical Trial

Official title:

Using Shared Decision Making to Improve Kidney Transplantation Rates

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06141499
• Other study ID #: AAAU1202
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 12, 2024
• Est. completion date: January 20, 2025

Study information

• Verified date: January 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 450
• Est. completion date: January 20, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Behavioral:
• Provider educational materials
Dialysis providers will receive educational material about the kidney transplantation and waitlisting process.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Columbia University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Kidney Transplant Collaborative, National Kidney Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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
Secondary	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)