Clinical trial NCT06141499: Using Shared Decision Making to Improve Kidney Transplantation Rates
Official title: Using Shared Decision Making to Improve Kidney Transplantation Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Kidney Failure
Keywords: Kidney Transplant
Transplantation
Shared Decision Making
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Kidney Transplant Collaborative
name: National Kidney Foundation, United States
First posted: 2023-11-21
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Enrolled providers and enrolled patients will receive different interventions; outcomes assessed for these two groups will be different.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in patient knowledge of individual waitlist status
timeFrame: 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)
measure: Change in frequency of shared decision-making conversations,
timeFrame: 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)
measure: Change in donor kidney preferences
timeFrame: 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:
measure: Change in dialysis provider attitudes, as measured on provider survey
timeFrame: Post-educational session, Day 1
measure: Provider assessment of patient letters, as measured on provider survey
timeFrame: End of intervention/at completion of letter delivery (4-6 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Columbia University
name: Sumit Mohan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: