Shared Decision Making Tool for Kidney Transplant Candidates

Recruiting at 1 trial location

Overseen By Cory Schaffhausen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hennepin Healthcare Research Institute

Disqualifiers: Non-English, Under 18, opt out, others

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve decision-making for individuals on the kidney transplant waiting list. Participants will use an online tool, Donor Plan Donor Choice, to learn about and discuss various donor options with their healthcare provider. This tool is part of the Kidney Offer Shared Decision Making process. The trial will compare this new decision-making process to usual care to determine which method helps patients better understand their choices. Individuals who have been waiting for a kidney transplant for over three months and speak English are well-suited for this study. As an unphased trial, this study offers participants the chance to contribute to innovative approaches in kidney transplant decision-making.

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 decision-making tools rather than medication changes.

What prior data suggests that the Shared Decision Making tool is safe for kidney transplant candidates?

Research shows that the Shared Decision Making tool for kidney transplant candidates helps patients make informed choices about donor options. This tool is neither a medication nor a medical procedure, so it lacks typical safety concerns like side effects or adverse reactions. Instead, it aims to enhance communication and understanding between patients and healthcare providers.

Studies have found that patients appreciate tools like this, finding them helpful for understanding complex information and making decisions that best suit their needs. Since this trial involves an educational tool rather than a drug or surgery, the main focus is on its effectiveness in aiding patients, not on physical safety. Participants generally report feeling more informed and confident in their decisions when using such tools. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Shared Decision Making Tool for kidney transplant candidates because it empowers patients to actively participate in their treatment choices. Unlike the usual care, which typically involves standard education and counseling, this tool facilitates a more personalized and collaborative decision-making process between patients and healthcare providers. By enhancing communication and understanding, it aims to improve patient satisfaction and potentially lead to better outcomes for those considering a kidney transplant.

What evidence suggests that the Shared Decision Making tool is effective for kidney transplant candidates?

Research has shown that tools like the Donor Plan Donor Choice, part of the Shared Decision Making Intervention in this trial, assist kidney transplant candidates and their doctors in making better decisions. Studies have found that these tools can increase satisfaction and improve patients' understanding of treatment options. One study discovered that personalized support systems for kidney transplants could predict potential kidney offers, aiding candidates in making informed choices. Additionally, understanding differences in how kidney offers are accepted can enhance decision-making. These tools aim to improve communication between patients and doctors, potentially leading to more successful transplant outcomes. Participants in this trial will receive either the Shared Decision Making Intervention or usual care, which includes standard patient education and counseling. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who have been on the kidney transplant waiting list for more than three months. It's not suitable for those under 18, non-English speakers, patients who opt out of research, or anyone unable to give informed consent.

Inclusion Criteria

English-speaking

I have been on the transplant list for more than 3 months.

I am on the waiting list for a kidney transplant.

Exclusion Criteria

Non-English speaking

I am under 18 years old.

I choose not to participate in research studies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants review the Donor Plan Donor Choice tool and discuss a Kidney Offer Plan with a transplant provider

Up to 2 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for knowledge, decisional conflict, distress, and shared decision making outcomes

Up to 2 months

What Are the Treatments Tested in This Trial?

Interventions

• Kidney Offer Shared Decision Making

Trial Overview The study tests a tool called 'Donor Plan Donor Choice' designed to help kidney transplant candidates make decisions with their doctors about organ offers. Participants will use an online educational tool and discuss donor types with providers.

How Is the Trial Designed?

Group I: Shared Decision Making Intervention Experimental Treatment 1 Intervention

Receives the Shared Decision Making Intervention

Group II: Usual Care Active Control 1 Intervention

Receives Usual Care, eg. usual patient education and counseling for kidney transplant candidates.

Who Is Running the Clinical Trial?

Hennepin Healthcare Research Institute

Lead Sponsor

Trials

94

Recruited

77,100+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A new self-assessment tool was developed to help patients with chronic kidney disease (CKD) make informed decisions about their dialysis options, based on their personal values and preferences.

The tool was validated through a survey of 330 patients, revealing three key factors—health, lifestyle, and dialysis environment—that influence decision-making, highlighting differences in perceptions between hemodialysis and peritoneal dialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a shared decision-making intervention regarding dialysis modality: development and validation of self-assessment items for patients with chronic kidney disease. Kim, S., Park, JT., Shin, SJ., et al.[2022]

Living kidney donation poses risks to healthy individuals, making informed consent and education crucial for ensuring donor safety and equitable decision-making across transplant centers.

The proposed 3-Step (S) Model enhances the informed consent process by structuring discussions around living donation into three key phases, aiming to standardize communication while allowing for personalized donor experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 3-Step Model of informed consent for living kidney donation: a proposal on behalf of the DESCaRTES Working Group of the European Renal Association. Grossi, AA., Sever, MS., Hellemans, R., et al.[2023]

Patient education and shared decision-making significantly improve outcomes for patients with chronic kidney disease, particularly in choosing kidney replacement therapies.

The introduction of The Nephrologist's Shared Decision-Making Checklist provides a practical tool for healthcare providers to enhance patient involvement in treatment decisions, potentially increasing the use of home dialysis and improving overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting Shared Decision-Making and Home Dialysis in End-Stage Kidney Disease. Campbell-Montalvo, R., Jia, H., Shukla, AM.[2023]

Shared decision making (SDM) in kidney transplantation is important but faces unique challenges, such as fragmented patient-provider relationships and the unpredictable nature of organ offers, which can complicate patient engagement.

Despite these challenges, the paper argues that SDM is feasible in kidney transplantation and suggests strategies like improving communication and education to enhance patient and provider involvement in decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunities for shared decision making in kidney transplantation. Gordon, EJ., Butt, Z., Jensen, SE., et al.[2023]

A pilot study involving 81 renal transplant candidates showed that a mobile app significantly improved patients' knowledge about kidney transplantation, with test scores increasing from 9.1 to 13.8 out of 20 (P < .001).

The app was well-received, with 86% of patients feeling it enhanced their understanding and was culturally appropriate, indicating its potential as an effective educational tool for diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultural competency of a mobile, customized patient education tool for improving potential kidney transplant recipients' knowledge and decision-making. Axelrod, DA., Kynard-Amerson, CS., Wojciechowski, D., et al.[2022]

Implementing shared decision-making earlier in the treatment process for patients with chronic kidney disease can enhance patient understanding of their options, potentially leading to better outcomes such as improved survival and slower disease progression.

By discussing treatment options proactively, nephrologists can help preserve vital resources, including central veins for future dialysis access, and ensure patients are better prepared for the transition to dialysis when necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choosing wisely and beyond: shared decision making and chronic kidney disease. Tuso, P.[2022]

A comprehensive review identified 145 interventions aimed at supporting shared decision-making (SDM) for treatment decisions in advanced kidney disease, including prognostic tools, educational programs, patient decision aids, and multicomponent initiatives.

Despite the variety of interventions, there is no clear evidence on which is the most effective for SDM, and many studies are based on observational research with inconsistent outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared decision-making in advanced kidney disease: a scoping review. Engels, N., de Graav, GN., van der Nat, P., et al.[2022]

A scoping review of 24 studies on shared decision making (SDM) training for healthcare professionals caring for chronic kidney disease (CKD) patients revealed that while there is some evidence of effectiveness, the quality and design of these studies vary significantly, with only 5 being of high quality.

The review highlighted a lack of standardized curricula and public access to educational materials, indicating that while training exists, its impact on improving SDM processes from the patient's perspective remains largely untested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare professional education in shared decision making in the context of chronic kidney disease: a scoping review. Meijers, B., Wellekens, K., Montomoli, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05879302

Shared Decision Making for Kidney Transplant Candidates ... The goal of this pilot randomized trial is to learn about shared decision making in kidney transplant candidates. The aim of this proposal is to evaluate the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12064594/

A Kidney Transplant Support System for Patient-Clinician ... This decision support system called Kidney Transplant Support System has the capacity to forecast a sequence of potential kidneys offered to a candidate on the ...

3. clinicaltrial.be clinicaltrial.be/en/details/290106?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Shared Decision Making for Kidney Transplant Candidates ... The aim of this proposal is to evaluate the Donor Plan Donor Choice tool to promote high-quality Shared Decision Making for providers and kidney ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1600613525000462

The dynamics of deceased donor kidney transplant ... This study quantified the variability in kidney offer acceptance decisions attributable to clinicians vs centers and examined the role of donor quality in ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05879302/shared-decision-making-for-kidney-transplant-candidates-to-plan-for-an-organ-offer-decision

Shared Decision Making for Kidney Transplant Candidates ... The goal of this pilot randomized trial is to learn about shared decision making in kidney transplant candidates.

6. ebm.bmj.com ebm.bmj.com/content/29/Suppl_1/A10.2

022 Shared decision making for kidney organ offer ... We expanded an online decision support tool to include a printable Kidney Offer Plan (KOP) to guide patients and clinicians in shared decision making.

7. withpower.com withpower.com/trial/phase-kidney-diseases-7-2023-8d029

Shared Decision Making Tool for Kidney Transplant ... This trial aims to help kidney transplant candidates make better decisions by using an online tool that educates them about donor options, facilitates ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9494569/

Shared decision-making in advanced kidney disease Shared decision-making (SDM) has been recognised as the preferred model to help patients with AKD understand their treatment options, and make ...