Using Shared Decision Making to Improve Kidney Transplantation Rates

NCT06141499 | Completed

• 1 other identifier: AAAU1202
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease; Kidney Failure

Keywords

Kidney Transplant; Transplantation; Shared Decision Making

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in dialysis provider attitudes, as measured on provider survey

  Post-educational session, Day 1

• Provider assessment of patient letters, as measured on provider survey

  End of intervention/at completion of letter delivery (4-6 months)

Study Arms (2)

Providers

EXPERIMENTAL

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

Behavioral: Provider educational materials

Patients

EXPERIMENTAL

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

Behavioral: Patient letters

Interventions

Provider educational materials BEHAVIORAL

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

Providers

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Speaking a language other than English or Spanish
• Younger than 18 years of age

Sponsors & Collaborators

• Columbia University: lead
• Kidney Transplant Collaborative: collaborator
• National Kidney Foundation, United States: collaborator

Study Sites (2)

Columbia University

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Sumit Mohan, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology

Model Details: Enrolled providers and enrolled patients will receive different interventions; outcomes assessed for these two groups will be different.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: January 12, 2024
• Primary Completion: February 21, 2025
• Study Completion: February 21, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)