Reducing Disparities in Living Donor Transplant Among African Americans

Not Applicable

Completed

• Conditions: Kidney Transplant
• Interventions: Behavioral: Living ACTS website; Behavioral: Standard transplant education procedures

• Registration Number: NCT03819686
• Lead Sponsor: Emory University

Brief Summary

For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment, and living donor kidney transplantation (LDKT) is preferable. Nevertheless, there are pervasive racial disparities in access to LDKT. The main outcome of this study is change in the proportion of study participants who have at least one living donor inquiry by friends/family over study period.The long-term objective is to understand the combined effect of a systems-level intervention (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.

Detailed Description

For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment. Moreover, living donor kidney transplantation (LDKT) offers numerous advantages such as better kidney quality, increased short- and long-term graft survival, lower rates of acute rejection, and reduced health care cost. Nevertheless, there are pervasive racial disparities in access to LDKT, with white ESRD patients four times more likely to receive a LDKT than African American ESRD patients. The main outcome of this study is change in the proportion of study participants who have at least one living donor inquiry by friends/family over 12 months from baseline.The long-term objective is to understand the combined effect of a systems-level intervention that enhances communication between dialysis facility and transplant center clinicians (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Study Start: 2019-02-04
• Primary Completion: 2024-01-26
• Study Completion: 2024-01-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

• All patients referred (from dialysis facility, chronic kidney disease clinic, or self) and scheduled for an evaluation at one of the four study sites within the study time period.
• African American or Black
• age 18 to 70 years
• BMI < 39
• English-speaking

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Living ACTS website	Standard transplant education procedures	In addition to the provision of standard transplant education procedures, a patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching the 20-minute video).
Living ACTS website	Living ACTS website	In addition to the provision of standard transplant education procedures, a patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching the 20-minute video).
Standard transplant education procedures	Standard transplant education procedures	Usual Care, which involves the provision of standard transplant education procedures at each transplant center, which entail reviewing a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two 10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.

Primary Outcome Measures

Name	Time	Method
Change in percent of patients with at least one inquiry from a potential living donor	Baseline, 12 months	Data collection form that captures potential recipient ID (i.e. study participant), date of living donor inquiry, and donor inquiry ID, will be securely obtained from each transplant center following a 12 month period from enrollment. Data will be collected electronically for all study participants through a secure, HIPAA-compliant data server (QualityNet). The percent of patients with at least one inquiry from a potential living donor among patients who receive Living ACTS will be compared to those who receive a control website with embedded educational video.

Secondary Outcome Measures

Name	Time	Method
Change in knowledge and understanding of donation/transplantation assessment score	Baseline, 12 months	Scale includes 13 true/False questions, score ranges from 0 to 13, 0 Min-12 Maximum
Change in motivation scale score to ask a family member to be a living donor	Baseline, 12 months	9-item scale assesses motivation to ask a family member to be a living donor. Potential responses range from 1 to 5 with higher values indicate stronger agreement with the statement.
Change in confidence in initiating a conversation about LDKT	Baseline, 12 months	10-item behavioral skills scale measures confidence in initiating a conversation about LDKT. Potential responses range from 1 to 5 with higher values indicate stronger confidence.

Trial Locations

Locations (1)

Emory Transplant Center; 🇺🇸 Atlanta, Georgia, United States