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

Trial Summary

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 data supports the effectiveness of the treatment 'Shared Decision Making Tool for Kidney Transplant Candidates'?

Research shows that shared decision-making, where patients and doctors work together to make healthcare decisions, improves outcomes in chronic kidney disease and other conditions. This approach helps patients understand their treatment options better and can lead to improved survival and slower disease progression. ^{1 2 3 4 5}

Is shared decision making for kidney transplant candidates safe?

The research does not provide specific safety data for shared decision making in kidney transplant candidates, but it emphasizes the importance of informed consent and patient education to ensure safe and effective decision-making. ^{1 2 5 6 7}

How is the Shared Decision Making Tool for Kidney Transplant Candidates treatment different from other treatments?

This treatment is unique because it focuses on shared decision making, a collaborative process where patients and healthcare providers work together to make informed decisions about kidney transplants. Unlike traditional approaches, it emphasizes patient education and empowerment, helping patients understand their options and align treatment with their personal values and preferences. ^{1 2 3 5 8}

What is the purpose of this trial?

This trial aims to help kidney transplant candidates make better decisions by using an online tool that educates them about donor options, facilitates discussions with doctors, and gathers their preferences.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Opportunities for shared decision making in kidney transplantation. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Supporting Shared Decision-Making and Home Dialysis in End-Stage Kidney Disease. [2023]

3. Korea (South) 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Shared decision-making in advanced kidney disease: a scoping review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England 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. [2023]

7. Denmark pubmed.ncbi.nlm.nih.gov

Cultural competency of a mobile, customized patient education tool for improving potential kidney transplant recipients' knowledge and decision-making. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Healthcare professional education in shared decision making in the context of chronic kidney disease: a scoping review. [2023]