- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05879302
Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision
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
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cory Schaffhausen
- Phone Number: (612) 873-5300
- Email: schaf390@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55415
- Hennepin Healthcare
-
Contact:
- Cory Schaffhausen
- Phone Number: 612-873-5300
- Email: schaf390@umn.edu
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
Contact:
- Kasey Boehmer
- Phone Number: 507-422-5538
- Email: Boehmer.Kasey@mayo.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
|
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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