A multi-site trial to test benefits of adding a personalized risk calculator to an online decision aid for left ventricular assist device

项目总结 连续流左心室辅助装置(LVADs)现已成为与心脏移植相媲美的黄金标准 晚期心力衰竭。然而，关于哪些患者最有可能受益的不确定性依然存在。 治疗。为风险预测和支持决策提供更个性化方法的新技术- 改进当前缺乏能力的临床风险计算器和决策辅助工具是至关重要的 (A)计算患者的个性化和高度可变的个性化风险，(B)将这些风险传达给 患者的价值观和目标，并与他们的医疗保健团队讨论这些因素，以及(C) 充分利用数字化医疗系统和平台，提供最快捷、最高效的更新 快速变化的风险。这意味着在知情和高质量的决策制定方面存在着重大差距，这也 潜在地对健康和临床结果产生负面影响。这项建议的目的是改善患者的 通过提供全面和个性化的临床决策，提供关于左冠状动脉前降支的知情和共享决策 为LVAD候选人提供的支持系统，以交互方式指导他们了解如何获得治疗 期权与其表示的值一致，给出了个性化的风险估计，并为他们提供了一种工具 将这些价值观传达给他们的临床团队。我们将通过更新和集成经过验证的 在线风险预测和沟通工具--心脏结局风险评估(CORA) 由康奈尔大学的同事开发，使用我们经过有效性测试的决策辅助工具(Decision 一起)为LVAD。为了实现这一目标，在目标1中，我们将进行深入的定性访谈，以确定 患者和医生在使用CORA时的实际、伦理和背景考虑，而我们的 康奈尔大学的同事们同时更新和(重新)验证更新后的模型，以应对现有的LVAD风险 预测模型，以及将CORA与我们的决策辅助工具的调整和数字化版本集成在一起。在AIM 然后，我们将把患者和医生的实际、伦理和背景考虑转化为 对CORA进行具体改进，并与患者和医生进行可接受性/可行性测试 使用更新后的经过验证的系统。这些步骤将在AIM 3中达到高潮，这是一项多地点随机对照试验 为了评估个性化临床决策方法对知情人士和价值观的影响- 和谐选择，共享决策结果。这一贡献将是重大的，因为它 将解决更好地识别和响应患者需求的具体和动态性质的迫切需要 在寻求高级心力衰竭治疗方面。我们的方法是创新的，因为它利用了最先进的技术 技术预测模型和LVAD决策支持，综合了来自 生物工程师、计算机科学家、领先的心力衰竭心脏病专家、决策科学家和医学伦理学家。 这个为期五年的项目是可行的，因为它建立在六年的开发、实施和 传播LVAD决策支持，并对LVAD准确的风险预测模型进行了十年的研究。

PROJECT SUMMARY Continuous flow left ventricular assist devices (LVADs) now rival heart transplant as the gold standard for advanced heart failure. However, uncertainty persists over which patients are most likely to benefit from treatment. New technologies for a more personalized approach to risk prediction and supported decision- making are crucially needed to improve current clinical risk calculators and decision aids which lack the ability to (a) calculate patients’ individualized and highly variable personalized risks, (b) communicate those risks to patients in the context of their values and goals and discuss these factors with their health care team, and (c) capitalize upon digitalized health systems and platforms to provide most expeditious and efficient updates to rapidly-changing risk. This represents a significant gap in informed and high-quality decision making that also potentially negatively affects health and clinical outcomes. The objective of this proposal is to improve patients’ informed and shared decision making about LVAD by providing a holistic and personalized clinical decision support system for LVAD candidates that interactively guides their understanding of how available treatment options align with their expressed values, given their personalized risk estimates, and provides them with a tool to communicate these values to their clinical team. We will do this by updating and integrating a validated online risk prediction and communication tool, the Cardiac Outcomes Risk Assessment (CORA) developed by our colleagues at Cornell University, with our efficacy-tested decision aid (Deciding Together) for LVAD. To accomplish this, in Aim 1 we will conduct in-depth qualitative interviews to identify patients’ and physicians’ practical, ethical, and contextual considerations while using CORA, while our colleagues at Cornell simultaneously update and (re-)validate the updated model against existing LVAD risk prediction models, as well as integrate CORA with an adapted and digitalized version of our decision aid. In Aim 2, we will then translate patients' and physicians’ practical, ethical and contextual considerations into concrete improvements to CORA and conduct acceptability/feasibility testing with patients and physicians using the updated, validated system. These steps will culminate in Aim 3, a multi-site randomized controlled trial to evaluate the impact of a personalized approach to clinical decision making on informed and values- concordant choice and shared decision-making outcomes. This contribution will be significant because it will address the urgent need to better identify and respond to the specific and dynamic nature of patient needs in seeking advanced heart failure treatment. Our approach is innovative in that it harnesses state of the art technology prediction models and LVAD decision support, synthesizing diverse expertise from a team of bioengineers, computer scientists, leading heart failure cardiologists, decision scientists, and medical ethicists. This five-year project is feasible in that it builds on 6 years of research on the development, implementation and dissemination of LVAD decision support and a decade of research into accurate risk prediction models for LVAD.