Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision

End Stage Renal Disease Clinical Trial

Official title:

Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05879302
• Other study ID #: Pro00067603
• Secondary ID: 1R01DK134482
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: January 2024
• Source: Hennepin Healthcare Research Institute
• Contact: Cory Schaffhausen
• Phone: (612) 873-5300
• Email: schaf390[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 Donor Plan Donor Choice tool to promote high-quality Shared Decision Making for providers and kidney transplant candidates at two transplant centers.

Participants will:

• Review an online education tool, Donor Plan Donor Choice.

• Discuss a Kidney Offer Plan with a transplant provider.

• Answer questions about willingness to consider different donor types.

Researchers will compare the Shared Decision Making group to usual care to generate pilot data and implementation outcomes for a larger trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidate on the kidney transplant waiting list

• Greater than 3 months since listing for transplant

• 18 Years of age or older

• English-speaking

Exclusion Criteria:

• Non-English speaking

• < 18 years of age

• Patients who choose to opt out of research.

• Unable to provide informed consent

Related Conditions & MeSH terms

• End Stage Renal Disease
• End-Stage Kidney Disease
• Esrd
• Kidney Diseases
• Kidney Failure, Chronic
• Kidney Transplantation

Intervention

Behavioral:
• Kidney Offer Shared Decision Making
The intervention consists of receiving the Donor Offer Plan (DOP), reviewing a web-based educational module about donor offers including practice offer videos, followed by a discussion about the DOP with a transplant nurse coordinator.

Locations

Country	Name	City	State
United States	Hennepin Healthcare	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Willingness to accept donor organs at risk of discard	Willingness to accept a donor kidney offer will be measured by three items on a 5-point Likert scale anchored by "strongly agree" and "strongly disagree." Willingness to accept will be defined by answers of "agree" or "strongly agree."	Up to 2 months
Secondary	Knowledge	10 Knowledge questions relating to organ offers and organ quality	Up to 2 months
Secondary	Decisional Conflict	16 Decisional Conflict questions (Ottawa scale)	Up to 2 months
Secondary	Distress	5 STOP-D (Screening Tool for Psychological Distress) questions	Up to 2 months
Secondary	Shared Decision Making	9 items of the SDMQ9 for Shared Decision Making	Up to 2 months