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

Not Applicable

Recruiting

• Conditions: End-Stage Kidney Disease; End Stage Renal Disease; Kidney Transplantation; Esrd
• Interventions: Behavioral: Kidney Offer Shared Decision Making

• Registration Number: NCT05879302
• Lead Sponsor: Hennepin Healthcare Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-05-30
• Study Start: 2024-04-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shared Decision Making Intervention	Kidney Offer Shared Decision Making	Receives the Shared Decision Making Intervention

Primary Outcome Measures

Name	Time	Method
Willingness to accept donor organs at risk of discard	Up to 2 months	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."

Secondary Outcome Measures

Name	Time	Method
Decisional Conflict	Up to 2 months	16 Decisional Conflict questions (Ottawa scale)
Shared Decision Making	Up to 2 months	9 items of the SDMQ9 for Shared Decision Making
Knowledge	Up to 2 months	10 Knowledge questions relating to organ offers and organ quality
Distress	Up to 2 months	5 STOP-D (Screening Tool for Psychological Distress) questions

Trial Locations

Locations (2)

Hennepin Healthcare; 🇺🇸 Minneapolis, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States