Shared decision making for kidney transplant candidates to plan for an organ offer decision

项目总结/摘要 目前将肾脏捐赠器官分配给等待移植的候选人的过程导致 大量的捐赠器官被丢弃，护理费用和负担增加，以及在治疗期间的高死亡率。 等候名单该系统的特点是，在移植时， 中心或患者。患者在移植评估期间接受有关捐赠者的教育， 众所周知，评价是一种压倒一切的经历。被接受进入等候名单的患者可以 等待几年才接到关于报价的电话，这可能是在深夜，而病人是 睡眠，并要求在30分钟内做出决定。多年前的教育保留率很低，患者 如果捐献者有潜在的危险因素，如接触传染病， 由于风险规避、焦虑和恐惧而提供。患者可以自由拒绝提供而不受惩罚;然而， 证据一致表明，接受一项提议几乎在所有情况下都能带来生存利益。之间 候选人谁收到了至少一个捐赠者提供，超过30%的病人死亡后，提供给他们的名单 都被拒绝了共享决策（SDM）是一种帮助患者思考、交谈和感受的方法， 来处理病人的特殊情况SDM是在患者、家属和 临床医生，目的是制定一个医学上，实际上，和情感上可取的计划。最佳SDM 应该帮助患者在实际器官提供之前制定计划，在患者接受器官移植的这段时间内， 久等了这项研究将使用一个在线工具，捐助者计划捐助者呼吁（DPDC），这是由患者完成后， 被列入候补名单，但在提供之前。该在线工具是为虚拟或在- 与他们的移植提供者进行个人SDM会话。DPDC工具受到行为改变理论的启发 并且是在具有用户反馈的多次迭代中遵循以人为中心的设计过程而开发的。 这种以患者为中心的工具是使用系统方法开发的，以补充其他干预措施， 支持临床医生做出的决定。拟议的研究将提供试点数据，使用随机 与使用DPDC工具对患者和提供者进行的SDM干预相比， 网站.试点随机试验将确定SDM对患者计划器官的影响和质量 目标1（Aim 1）主要的结果将是愿意接受捐赠器官，增加丢弃的风险。 次要分析将包括决策冲突、知识、患者希望和痛苦的变化， 做决定所花费的时间。本研究将评价SDM与DPDC、屏障的可接受性 干预措施的采用，以及患者实施成功的其他主要指标， 供应商（目标2）。这项研究将使我们能够完善干预和实施，以促进全面的 多中心随机试验。这一提议满足了改善捐助方提供捐助决定的迫切需要， 减少患者死亡率、透析时间对健康的负面影响以及活性供体肾脏的丢弃。

Project Summary/Abstract The current process to allocate kidney donor organs to candidates who are waiting for a transplant results in high numbers of discarded donor organs, an increased cost and burden of care, and high mortality while on the waiting list. This system is characterized by high rates of offers declined by either clinicians at transplant centers or patients. Patients receive education about donor offers during their transplant evaluation, and this evaluation is known to be an overwhelming experience. Patients who are accepted onto the waitlist may then wait several years before receiving a call about an offer, which may come late at night while patients are sleeping and requires a decision within 30 minutes. Retention of education from years ago is low, and patients who are offered a donor with potential risk factors, such as an exposure to infectious disease, may decline the offer due to risk aversion, anxiety, and fear. Patients are free to decline offers without penalty; however, evidence consistently shows that accepting an offer provides a survival benefit in nearly all cases. Among candidates who have received at least one donor offer, over 30% of patients die on the list after offers to them are declined. Shared decision making (SDM) is a method for helping patients think, talk, and feel through how to handle the patient’s unique situation. SDM is conducted in conversations between patients, family, and clinicians with the purpose of developing a medically, practically, and emotionally desirable plan. Optimal SDM should help patients develop a plan in advance of the actual organ offer, during the period of time patients are waiting. The study will use an online tool, Donor Plan Donor Call (DPDC), which is completed by patients after being placed on the waiting list but in advance of an offer. The online tool is preparation for a virtual or in- person SDM session with their transplant provider. The DPDC tool was informed by behavior change theory and was developed following a human-centered design process over multiple iterations with user feedback. This patient-centered tool was developed using a systems approach to complement other interventions to support offer decisions made by clinicians. The proposed research will provide pilot data using a randomized trial of usual care compared to the SDM intervention using the DPDC tool with patients and providers at 2 sites. The pilot randomized trial will determine the impact and quality of SDM for patients to plan for an organ offer (Aim 1). The primary outcome will be willingness to accept donor organs at increased risk of discard. Secondary analyses will include changes in decisional conflict, knowledge, patient hope and distress, and duration of time spent making a decision. The study will evaluate the acceptability of SDM with DPDC, barriers to adoption of the intervention, and other leading indications of implementation success with patients and providers (Aim 2). This research will allow us to refine the intervention and implementation to facilitate a fully powered multi-center randomized trial. This proposal fills a critical need to improve donor offer decisions to reduce patient mortality, the negative health effects from time on dialysis, and discards of viable donor kidneys.