Shared Decision Making Tools for Kidney Transplantation

No longer recruiting at 1 trial location

Overseen By Miko Yu, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Non-English/Spanish, Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help dialysis patients better understand the kidney transplant process and increase their chances of receiving a transplant. It focuses on enhancing communication between patients and healthcare providers to address barriers such as socioeconomic and racial disparities. Participants will receive educational materials, including patient letters and provider resources, about their transplant status and the overall process. Ideal candidates are those on a waitlist or being evaluated for a kidney transplant at specific hospitals and currently undergoing dialysis at designated clinics. As an unphased trial, this study provides participants with valuable insights and support in navigating the kidney transplant process.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on education about kidney transplantation rather than changing your medication.

What prior data suggests that these educational materials are safe for use in this trial?

Research has shown that educational materials for kidney transplant patients and their healthcare providers are generally safe and well-received. Studies indicate that when patients learn more about their kidney transplant care, their quality of life and long-term health can improve. For instance, educational efforts can increase patients' understanding of potential transplant complications by about 10%.

For healthcare providers, educational materials enhance their understanding of kidney transplant options without causing harm. Research suggests these materials are effective and generally well-tolerated, with no reports of negative effects directly linked to receiving this information.

Overall, research supports the safety of educational programs related to kidney transplants. They help both patients and providers make informed decisions without introducing risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to empower both dialysis patients and their healthcare providers in the kidney transplantation process. Unlike traditional approaches that may leave patients and providers with limited information, this trial uses personalized patient letters and targeted educational materials for providers to enhance understanding and decision-making. This method aims to improve communication, ensure patients are better informed about their status and options, and help providers guide their patients more effectively through the transplant waitlisting process. By potentially streamlining and personalizing the decision-making process, these tools could pave the way for more efficient and patient-centered care in kidney transplantation.

What evidence suggests that this trial's educational materials could be effective for increasing shared decision-making in kidney transplantation?

This trial will evaluate the impact of shared decision-making tools for kidney transplantation. Research has shown that kidney transplant recipients often enjoy a better quality of life and live longer than those who remain on dialysis. In this trial, dialysis patients will receive letters with information about their status in the kidney transplantation and waitlisting process. Studies highlight that educating patients is key to improving these outcomes. For instance, when patients learn about their transplant options, they can better manage the process, potentially increasing their chances of receiving a transplant. Meanwhile, dialysis providers in this trial will receive educational material about the kidney transplantation and waitlisting process. Access to educational resources helps healthcare providers stay informed about the latest practices and provide culturally respectful care. Overall, these efforts aim to make the transplant process easier and fairer for everyone involved. ^{2 5 6 7 8}

Who Is on the Research Team?

Sumit Mohan, MD, MPH

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for adults on hemodialysis at select clinics in New York and Cleveland who are either on a kidney transplant waitlist or undergoing evaluation at CU/NYPH Transplant Center or the Cleveland Clinic. Participants must speak English or Spanish.

Inclusion Criteria

I am undergoing hemodialysis at a specified clinic.

You are currently on a waitlist or being evaluated for a transplant at Columbia University/New York Presbyterian Hospital (CU/NYPH) or at the Cleveland Clinic (CC).

Exclusion Criteria

I am under 18 years old.

I speak a language other than English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants receive educational materials and personalized informational letters about the kidney transplantation and waitlisting process

4-6 months

Quarterly letters

Follow-up

Participants are monitored for changes in knowledge and preferences regarding kidney transplantation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patient letters
• Provider educational materials

Trial Overview The study aims to improve kidney transplantation rates by using educational materials to enhance decision-making between patients and providers over a period of 6-12 months, focusing also on reducing disparities in access.

How Is the Trial Designed?

Group I: Providers Experimental Treatment 1 Intervention

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

Group II: Patients Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Kidney Foundation

Collaborator

Trials

33

Recruited

85,800+

Kidney Transplant Collaborative

Collaborator

Trials

1

Recruited

450+

National Kidney Foundation, United States

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10530762/

Enhancing Kidney Transplant Care through the Integration ... This article explores the potential integration of a sophisticated chatbot, an AI-powered conversational agent, to enhance kidney transplant practice.

2. kidneyregistry.com kidneyregistry.com/news/national-kidney-registrys-2025-outcomes-report-highlights-superior-kidney-transplant-success-rates/

National Kidney Registry Reports Superior Transplant ... Sensitized patients (> 80% cPRA) experienced a 38% lower 3-year death-censored graft failure rate compared to non-NKR transplant recipients.

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2841031

Patient Participation in Kidney Transplant Candidacy— ... Kidney transplant offers patients with chronic kidney disease improved quality of life and better long-term outcomes. For patients to ...

4. mdpi.com mdpi.com/2227-9032/10/8/1559

Effectiveness of Expressive Writing in Kidney Transplanted ... This study aimed to investigate the psychological and biological effects of expressive writing on renal transplant patients, in order to develop methods that ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425001053

System Interventions to Achieve Early and Equitable ... The primary outcome measures patients' completion of kidney transplant evaluation using health system medical and administrative records (i.e., documentation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9163311/

Patient-Reported Outcomes as Endpoints in Clinical Trials ... Patient-reported outcomes (PROs) that assess individuals' perceptions of life participation, medication adherence, disease symptoms, and therapy ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0966327423001387

Success rate and safety of living donor kidney ... Meta-analysis of outcomes from five studies showed a survival rate of 0.93 (95% confidence interval [CI]: 0.88 to 0.97, P < 0.001) after ≥3 years, while ...

8. journals.lww.com journals.lww.com/kidney360/fulltext/2024/01000/incidence_of_kidney_failure_after_primary_organ.11.aspx

Incidence of Kidney Failure after Primary Organ Transplant The objective of this study was to quantify the incidence of kidney failure after liver, heart, or lung transplantation and identify pretransplant predictors.