Improving Dysvascular Amputee Outcomes by Enhancing Shared Decision Making Through the Development and Implementation of a Patient Decision Aid and a Decision Support Tool

截肢节段的选择对周围动脉疾病和糖尿病患者有深远的影响。 对许多功能结果的影响。没有临床指南或证据明确定义 在任何个体患者中推荐的截肢水平。人们越来越强调保护 足部的一部分（经跖骨[TM]截肢），以尽量减少解剖损失的 希望能保持灵活性。这一基本假设受到质疑，因为 延迟愈合或愈合失败率高，导致需要长期伤口护理，重复手术 最后，需要进行经胫骨（TT）水平截肢。经胫骨截肢术与 愈合失败的风险大大降低，活动性结果相似，但死亡率略高。然而，在这方面， 经胫骨截肢可能对其他结果产生不利影响，如身体形象，生活质量， 假肢装配需求和/或康复治疗强度。每个病人都可能会优先考虑这些 根据他们的价值观和偏好，以不同的方式产生结果。退伍军人健康管理局 (VHA)强调了以病人为中心的护理的重要性，其定义为"建立 医生、患者及其家属（适当时）之间的伙伴关系，以确保决策 尊重病人的需求、需要和喜好，并征求病人对教育和支持的意见， 需要自己做决定，参与自己的护理。"使用患者决策辅助工具（PtDA）， 医生决策支持工具（DST）已被提倡为关键组件，可用于 加强患者对重要决策的参与，并确保他们做出的选择符合 对他们来说最重要的结果。因此，本研究的目的是提高 需要血管障碍性下肢截肢的退伍军人的康复结果， 正在考虑血管障碍性TM或TT截肢。我们建议开发两种护理点"工具"， 加强截肢水平选择时的共同决策，并将其纳入网络， 一个名为AMPDECIDE的门户网站：1）DST将利用我们经过验证的AMPREDICT预测模型， 告知提供者患者的功能活动性、死亡率和愈合失败的特定风险/概率， 每个主要截肢水平，2）PtDA将教育患者截肢手术，假体使用， 告知他们结果的差异，并帮助他们确定和排列其结果的优先次序。我们将 然后使用AMPDECIDE门户中的工具在共享决策过程中进行试点试验， 告知未来的大规模临床试验，以确定它们的使用是否会导致再次截肢的数量减少， 保持功能寿命年数，并提高患者满意度。为了实现这些目标，我们将使用 混合方法。DST和PtDA的开发将根据定性需求进行 评估在两个拟定节段接受血管障碍性截肢的患者，以及， 参与截肢节段选择的医生。还将进行系统性综述， 提供与需求评估所界定的结果差异有关的必要证据。需求 评估和系统回顾将成为迭代式PtDA开发的基础。一个关键 PtDA的组成部分将是一个价值澄清练习，以确保患者能够定义他们的 结果优先级，因此在两个截肢水平之间进行选择。价值观澄清练习 我们建议使用多准则决策分析（MCDA）。DST将与医生一起制定 输入，以确保格式，结构和输出将满足他们的临床护理需要。试点研究将 在AMPDECIDE门户网站中与一组患者/医生配对使用这些工具， 截肢水平决定。成果评价将评估其对以下方面的近期成果的影响： 决策冲突、知识、与患者价值观的一致性以及患者实际截肢水平的选择。

The choice of amputation level in patients with peripheral arterial disease and diabetes can have profound effects on many functional outcomes. There are no clinical guidelines or evidence that clearly define a recommended amputation level in any individual patient. There has been an increased emphasis on preserving a portion of the foot (transmetatarsal [TM] amputation) in an effort to minimize the anatomic loss of the extremity with the hope of preserving mobility. This fundamental assumption has been questioned due to the high rate of delayed or failure of healing, which results in the need for prolonged wound care, repeated surgery and in the end, the need for a transtibial (TT) level amputation. The transtibial amputation is associated with a much-reduced risk of failure of healing, a similar mobility outcome, but somewhat higher mortality. However, transtibial amputation may have adverse effects on other outcomes, such as body image, quality of life, prosthetic fitting demands, and/or rehabilitation treatment intensity. Each patient will likely prioritize these outcomes in different ways based upon their values and preferences. The Veterans Health Administration (VHA) has emphasized the importance of patient-centric care, which is defined as “health care that establishes a partnership among practitioners, patients, and their families (when appropriate) to ensure that decisions respect patients' wants, needs and preferences and solicit patients' input on the education and support they need to make decisions and participate in their own care.” The use of Patient Decision Aids (PtDA) and physician decision support tools (DST) have been advocated as critical components that can be used to enhance patient participation in important decisions, and to ensure that the choice they make is aligned with the outcomes that are most important to them. The purpose of this research, therefore, is to improve the rehabilitation outcome of Veterans who require a dysvascular lower extremity amputation, where either a dysvascular TM or TT amputation is being considered. We propose to develop two point of care “tools” to enhance shared decision making at the time of amputation level selection that will be integrated into a web- based portal called AMPDECIDE: 1) the DST will utilize our validated AMPREDICT prediction models to inform providers of patient specific risks/probabilities for functional mobility, mortality, and failure of healing at each major amputation level, and 2) the PtDA will educate patients about amputation surgery, prosthetic use, inform them about the outcome differences, and help them determine and rank their outcome priorities. We will then perform a pilot trial using the tools in the AMPDECIDE portal in a shared decision making process that will inform a future large scale clinical trial to determine if their use results in reduced numbers of reamputations, preservation of functional life years, and enhanced patient satisfaction. To accomplish these aims we will use a mixed methods approach. The development of both the DST and PtDA will be informed by a qualitative needs assessment of patients who have undergone dysvascular amputation at the two proposed levels, as well as, physicians who are involved in amputation level selection. A systematic review will also be performed to provide the necessary evidence related to outcomes differences defined by the needs assessment. The needs assessment and systematic review will then form the underpinnings of the iterative PtDA development. A key component of the PtDA will be a values clarification exercise to ensure that patients are able to define their outcome priorities and, therefore, choose between the two amputation levels. The values clarification exercise we propose is the use of a MultiCriteria Decision Analysis (MCDA). The DST will be developed with physician input to ensure that the format, structure and output will meet their clinical care needs. The pilot study will utilize these tools in the AMPDECIDE portal with a group of patient/physician dyads who are facing the amputation level decision. The outcomes evaluation will assess its effect on the near-term outcomes of decisional conflict, knowledge, concordance with patient values, and patients' actual amputation level choice.