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临床试验/NCT05879302
NCT05879302已完成不适用

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

Hennepin Healthcare Research Institute3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月3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
100
试验地点
3
主要终点
Willingness to accept donor organs at risk of discard

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

All study personnel involved in screening and enrollment will be masked to upcoming randomization assignments

入排标准

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

入选标准

  • Candidate on the kidney transplant waiting list
  • Greater than 3 months since listing for transplant
  • 18 Years of age or older
  • English-speaking

排除标准

  • Non-English speaking
  • < 18 years of age
  • Patients who choose to opt out of research.
  • Unable to provide informed consent

研究组 & 干预措施

Shared Decision Making Intervention

Experimental

Receives the Shared Decision Making Intervention

干预措施: Kidney Offer Shared Decision Making (Behavioral)

Usual Care

No Intervention

Receives Usual Care, eg. usual patient education and counseling for kidney transplant candidates.

结局指标

主要结局

Willingness to accept donor organs at risk of discard

时间窗: Up to 2 months

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."

次要结局

  • Decisional Conflict(Up to 2 months)
  • Shared Decision Making(Up to 2 months)
  • Knowledge(Up to 2 months)
  • Distress(Up to 2 months)

研究者

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

Cory Schaffhausen

Investigator

Hennepin Healthcare Research Institute

研究点 (3)

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