Communicating About Choices in Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to test the impact of a newly developed educational program on kidney transplant candidates' communication about living and deceased donor kidney transplantation.

Detailed Description
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The Communicating about Choices (COACH) in Transplantation program educates patients with end stage renal disease, who are waitlisted for kidney transplantation, about kidney disease and the risks, benefits and processes for both living and deceased donor transplantation. The program also teaches key communication skills needed to effectively initiate and manage conversations about transplantation.

Official Title
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Communicating About Choices in Transplantation (COACH)

Conditions
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End Stage Renal Disease and Kidney Transplantation

Intervention / Treatment
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* Behavioral: COACH Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Wait listed for kidney transplantation in active status Adult (at least 18 years of age) English speaking Capable of making medical decisions (i.e., not cognitively impaired) Non-institutionalized Exclusion Criteria: Not listed for kidney transplantation

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Patients in this arm will receive only the education offered by the transplant center, as required by Medicaid. Upon completion of all data collection activities, patients in this arm will be offered the program. | |
| Experimental: COACH Program<br>Participants randomized to the intervention condition will attend a COACH session held in a small group format. The session provides information on living and deceased donor transplantation (i.e., the processes, risks and benefits) and on the key communication skills needed to effectively initiate and maintain conversations about transplantation. | Behavioral: COACH Program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in engagement in discussion of living and deceased donor transplantation | 2 self-report items: whether transplantation was discussed (yes/no) and the number of discussions held | Baseline (upon enrollment); 1 month post; 3 months post | 
| Change in knowledge of living and deceased donor transplant | 15 True/False Questions | Upon enrollment (baseline); 1 month post; 2 months post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intentions to discuss living and deceased donor transplantation | 3-item, 7-point Likert-type scale | Upon enrollment (baseline); 1 month post; 3 months post | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End stage renal disease, Kidney transplantation, Transplant options (living and deceased donor), Patient education, Communication skills training