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

NCT05879302 | Completed DMC

• 2 other identifiers: Pro000676031R01DK134482
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Transplantation; Esrd; End Stage Renal Disease; End-Stage Kidney Disease

Keywords

Shared Decision Making; SDM; Transplantation; Organ offer; Kidney offer; KDPI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Knowledge

  Up to 2 months

• Decisional Conflict

  Up to 2 months

• Distress

  Up to 2 months

• Shared Decision Making

  Up to 2 months

Study Arms (2)

Shared Decision Making Intervention

EXPERIMENTAL

Receives the Shared Decision Making Intervention

Behavioral: Kidney Offer Shared Decision Making

Usual Care

NO INTERVENTION

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

Interventions

Kidney Offer Shared Decision Making BEHAVIORAL

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.

Shared Decision Making Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate on the kidney transplant waiting list
• Greater than 3 months since listing for transplant
• Years of age or older
• English-speaking

You may not qualify if:

• Non-English speaking
• \< 18 years of age
• Patients who choose to opt out of research.
• Unable to provide informed consent

Sponsors & Collaborators

• Mayo Clinic: collaborator
• Hennepin Healthcare Research Institute: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Hennepin Healthcare

Minneapolis, Minnesota, 55415, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All study personnel involved in screening and enrollment will be masked to upcoming randomization assignments
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 30, 2023
• Study Start: April 3, 2024
• Primary Completion: February 17, 2026
• Study Completion: February 17, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)