Optimizing Kidney Transplant Patients' Informed Consent for Increased Risk Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 4
- 主要终点
- Knowledge of increased risk donor kidney transplants
研究概览
简要总结
The objective of this study is to evaluate kidney transplant candidates' comprehension about increased risk donor kidneys necessary for informed consent. We have developed a web-based tool that educates and assesses candidates' comprehension (Inform Me), as a supplement to current informed consent processes. We will then compare the effectiveness of the current informed consent processes supplemented by Inform Me, with the current consent processes alone for kidney transplant.
详细描述
The shortage of kidneys for kidney transplantation results in almost 10,000 deaths per year in the United States. One strategy to increase the number of available kidneys is to offer kidney transplant candidates kidneys that come from donors who have an increased risk of transmission of human immunodeficiency virus (HIV), Hepatitis B and Hepatitis C. Increased risk kidney donors are defined as those who have engaged in behaviors associated with an increased risk of HIV, Hepatitis B, and Hepatitis C, and comprise approximately 9% of all US deceased organ donors. The Organ Procurement and Transplantation Network policy mandated informed consent from recipients who accept increased risk kidneys. The objective of this study is to increase study participants' comprehension about increased risk donor kidneys necessary for informed consent. To accomplish this objective, we will develop a web-based tool that educates and assesses participants' comprehension (Inform Me), as a supplement to current informed consent processes. We will then compare the effectiveness of the current informed consent processes supplemented by Inform Me, with the current consent processes alone. The tool will utilize health information technology to deliver information about the definition of, risks, benefits, and alternatives to using increased risk donor kidneys via a web-based application. Computer adaptive learning will personalize information presented to each candidate according to his/her comprehension levels in interactive chapters to increase comprehension. Inform Me will facilitate nurses' primary role as patient educators.
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
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •21 years or older
- •Kidney Transplant candidates eligible: 1) completed the first phase of transplant evaluation education, and 2) wait-listed patients expected to receive a transplant within the next 6 months, returning for re-evaluation.
排除标准
- •No special classes of study participants, including fetuses, neonates, prisoners, institutionalized individuals, or other vulnerable populations will be included in the proposed study. Although pregnant women will be eligible for participation in the study, they are unlikely to be selected for kidney transplantation.
结局指标
主要结局
Knowledge of increased risk donor kidney transplants
时间窗: 1 week
Assess knowledge of increased risk donor kidneys
次要结局
- Willingness to accept an increased risk donor kidney transplant(1 week)
研究者
Elisa Gordon
Principal Investigator
Northwestern University
