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

January 3, 2024 updated by: Cory Schaffhausen, Hennepin Healthcare Research Institute

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin Healthcare
        • Contact:
      • Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shared Decision Making Intervention
Receives the Shared Decision Making 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.
No Intervention: Usual Care
Receives Usual Care, eg. usual patient education and counseling for kidney transplant candidates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willingness to accept donor organs at risk of discard
Time Frame: 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."
Up to 2 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00067603
  • 1R01DK134482 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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