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

Study Overview
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Brief Summary
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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.

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

Conditions
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End Stage Renal Disease, End-Stage Kidney Disease, Kidney Transplantation, Esrd

Intervention / Treatment
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* Behavioral: Kidney Offer Shared Decision Making


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared Decision Making Intervention<br>Receives the Shared Decision Making Intervention | Behavioral: Kidney Offer Shared Decision Making<br>* 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.<br>|
| No Intervention: Usual Care<br>Receives Usual Care, eg. usual patient education and counseling for kidney transplant candidates. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shared Decision Making, SDM, Transplantation, Organ offer, Kidney offer, KDPI