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临床试验/NCT03819686
NCT03819686已完成不适用

Reducing Disparities in Living Donor Transplant Among African Americans

Emory University1 个研究点 分布在 1 个国家目标入组 416 人开始时间: 2019年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
416
试验地点
1
主要终点
Percent of Patients With at Least One Inquiry From a Potential Living Donor

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

Living ACTS website

Experimental

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).

干预措施: Living ACTS website (Behavioral)

Living ACTS website

Experimental

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).

干预措施: Standard transplant education procedures (Behavioral)

Standard transplant education procedures

Other

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.

干预措施: Standard transplant education procedures (Behavioral)

结局指标

主要结局

Percent of Patients With at Least One Inquiry From a Potential Living Donor

时间窗: 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.

次要结局

  • Knowledge and Understanding of Donation/Transplantation Assessment Score(Baseline, Day 1 immediately post-intervention)
  • Motivation Scale Score to Ask a Family Member to be a Living Donor(Baseline, Day 1 immediately post-intervention)
  • Confidence in Initiating a Conversation About LDKT(Baseline, Day 1 immediately post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kimberly R Jacob Arriola

Professor

Emory University

研究点 (1)

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