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

肾移植候选者共同决策以规划器官提供决策

• 批准号: 10563760
• 负责人: Cory R Schaffhausen
• 金额: $ 27.03万
• 依托单位: HENNEPIN HEALTHCARE RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-15 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10563760
• 关键词: Address; Adoption; Anxiety; Behavior; Caring; Clinical Trials; Communicable Diseases; Complement; Conflict (Psychology); Data; Decision Making; Development; Dialysis patients; Dialysis procedure; Disease; Distress; Education; Educational Intervention; Emotional; End stage renal failure; Enrollment; Evaluation; Exposure to; Face; Family; Feedback; Fright; Future; Goals; Health; Intervention; Interview; Kidney; Kidney Transplantation; Knowledge; Medical; Methodology; Methods; Mission; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Organ; Organ Donor; Organ Transplantation; Outcome; Participant; Patient Education; Patients; Persons; Preparation; Process; Provider; Quality of life; Questionnaires; Randomized; Reporting; Research; Risk; Risk Factors; Sampling; Site; Sleep; Solid; Surgeon; System; Theory of Change; Time; Transplant Recipients; Transplantation; Waiting Lists; behavior change; care burden; cost; cost comparison; demographics; design; effective intervention; experience; future implementation; human centered design; implementation evaluation; improved; intervention refinement; mortality; novel; patient engagement; patient oriented; post intervention; preference; primary outcome; randomized trial; response; secondary analysis; shared decision making; success; theories; tool; transplant centers; treatment as usual; user centered design; virtual; willingness

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.

项目摘要/摘要 当前将肾脏捐献器官分配给等待移植的候选人的过程 大量废弃的捐赠者器官，成本增加和护理燃烧以及高死亡率 等待清单。该系统的特征是，任何一个临床医生在移植时都会下降的要约率很高 中心或患者。患者在移植评估期间接受了有关捐赠者的教育，这 评估是一种压倒性的经历。被接受到候补名单的患者可能会 等待几年，然后接到有关要约的电话，这可能会在晚上很晚才 睡觉，需要在30分钟内做出决定。几年前的教育保留很低，患者 为他们提供潜在危险因素的捐助者，例如暴露于传染病，可能会降低 由于厌恶风险，焦虑和恐惧而提出。患者可以自由降低报价而无需处罚；然而， 证据始终表明，在几乎所有情况下，接受要约都提供了生存收益。之中 至少收到一份捐助者的候选人，超过30％的患者在向他们提供的候选人死亡之后死亡 被拒绝。共享决策（SDM）是一种帮助患者思考，交谈和感觉的方法 处理患者的独特情况。 SDM在患者，家庭和 临床医生的目的是制定医学，实际和情感上的计划。最佳SDM 应该帮助患者在实际的器官报价之前制定计划，在患者的时间内 等待。该研究将使用在线工具，捐赠计划捐赠者电话（DPDC），该捐赠者呼叫（DPDC）由患者完成 被放在等待名单上，但在提议之前。在线工具是准备虚拟或in- 与移植提供商的人SDM会议。 DPDC工具通过行为改变理论告知 并在以用户反馈的多次迭代为中心的设计过程后开发。 这种以患者为中心的工具是使用系统方法来完成其他干预措施的 支持提供临床医生做出的决定。拟议的研究将使用随机的 与使用DPDC工具的患者和提供者相比，与SDM干预相比，常规护理的试验与患者和提供者为2 站点。试点随机试验将确定SDM的影响和质量对患者的计划 提供（目标1）。主要结果将愿意接受捐赠风险增加的捐赠者器官。 次要分析将包括决策冲突，知识，耐心和困扰的变化，以及 做出决定的时间。该研究将评估SDM使用DPDC的可接受性 采用干预措施，以及其他领先的指标，证明患者的实施成功和 提供者（AIM 2）。这项研究将使我们能够完善干预和实施，以促进一个充分的 动力多中心随机试验。该建议填补了改善捐助者提供决定的迫切需要 降低患者死亡率，时间对透析的负面影响以及可行的供体肾脏的丢弃。