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

周围动脉疾病和糖尿病患者截肢水平的选择可能会有深远的影响 对许多功能结果的影响。没有临床指南或证据可以清楚地定义 任何个体患者的建议截肢水平。人们越来越重视保护 足部的一部分(经跖骨[TM]截肢)，以尽量减少足部的解剖学损失 四肢瘫痪，希望能保持机动性。这一基本假设受到了质疑，因为 愈合延迟或失败的比率很高，这导致需要长时间的伤口护理，需要重复手术 最后，需要进行经胫骨(TT)水平截肢。经胫骨截肢与一种 愈合失败的风险大大降低，行动能力相似，但死亡率略高。然而， 经胫骨截肢可能会对其他结果产生不利影响，如身体形象、生活质量、 假体装配要求和/或康复治疗强度。每个病人很可能会优先考虑这些 根据他们的价值观和偏好，他们会以不同的方式取得成果。退伍军人健康管理局 (VHA)强调了以患者为中心的护理的重要性，这被定义为“建立 医生、患者及其家人之间的伙伴关系(在适当的情况下)，以确保决策 尊重患者的意愿、需要和偏好，征求患者对他们的教育和支持意见 需要自己做决定，参与自己的照顾。患者决策辅助工具(PtDA)和 医生决策支持工具(DST)一直被认为是可用于 加强患者对重要决策的参与，并确保他们做出的选择与 对他们来说最重要的结果。因此，这项研究的目的是改善 需要进行血管功能障碍截肢的退伍军人的康复结局 血管功能障碍的TM或TT截肢正在考虑之中。我们建议开发两种护理“工具”，以 在选择截肢水平时增强共享决策，并将其整合到网络中- 基于名为AMPDECIDE的门户：1)DST将利用我们经过验证的AMPREDICT预测模型来 向提供者告知患者特定的功能活动、死亡率和愈合失败的风险/概率 每个主要截肢级别，以及2)PtDA将教育患者关于截肢手术，假肢使用， 告知他们结果的不同之处，并帮助他们确定和排列结果的优先顺序。我们会 然后在共享的决策制定流程中使用AMPDECIDE门户中的工具执行试点试验 通知未来的大规模临床试验，以确定使用它们是否会减少截肢次数， 延长了功能寿命，提高了患者满意度。为了实现这些目标，我们将使用 混合方法的方法。DST和PtDA的发展将受到质量需求的影响 在两个拟议水平对接受血管功能障碍截肢的患者进行评估，以及， 参与截肢节段选择的医生。还将进行系统审查，以 提供与需求评估定义的结果差异相关的必要证据。需求 然后，评估和系统审查将构成迭代PtDA开发的基础。一把钥匙 PtDA的组成部分将是一项价值澄清活动，以确保患者能够定义他们的 结果优先，因此，在两个截肢级别之间进行选择。价值澄清练习 我们建议使用多准则决策分析(MCDA)。DST将与医生一起开发 投入，以确保格式、结构和输出将满足他们的临床护理需求。这项初步研究将 将AMPDECIDE门户中的这些工具与一组面对 截肢级别决定。成果评价将评估其对#年近期成果的影响。 决策冲突、知识、与患者价值观的一致性、患者实际截肢节段的选择。

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.