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

一项多站点试验，测试将个性化风险计算器添加到左心室辅助装置在线决策辅助中的好处

• 批准号: 10266106
• 负责人: Jennifer Blumenthal-Barby
• 金额: $ 39.65万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10266106
• 关键词: multi; site; trial; test; benefits

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.

项目摘要 连续流动左心室辅助装置（LVAD）现在可以与心脏移植竞争，成为心脏移植的黄金标准。 晚期心力衰竭然而，不确定性仍然存在，哪些患者最有可能受益于 治疗新技术为风险预测和辅助决策提供更加个性化的方法- 迫切需要改进目前临床风险计算器和决策辅助工具， （a）计算患者的个体化和高度可变的个性化风险，（B）将这些风险传达给 患者在他们的价值观和目标的背景下，并与他们的医疗保健团队讨论这些因素，以及（c） 利用数字化卫生系统和平台，提供最迅速、最有效的更新， 快速变化的风险这表明在知情和高质量决策方面存在重大差距， 可能对健康和临床结果产生负面影响。这项建议的目的，是改善病人的 通过提供全面和个性化的临床决策，对LVAD做出知情和共享的决策 LVAD候选人的支持系统，以交互方式指导他们了解可用的治疗 选项与他们表达的价值相一致，考虑到他们的个性化风险估计，并为他们提供了一个工具， 将这些价值观传达给临床团队。我们将通过更新和整合一个经过验证的 在线风险预测和沟通工具，心脏结局风险评估（CORA） 由我们康奈尔大学的同事开发，使用我们经过功效测试的决策辅助工具（决策 一起）用于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 康奈尔大学的同事同时更新和（重新）验证了更新后的模型对现有LVAD风险的影响 预测模型，以及将CORA与我们的决策辅助工具的适应性和数字化版本相集成。在Aim中 2，我们将把病人和医生的实际，道德和背景考虑转化为 对CORA进行具体改进，并对患者和医生进行可接受性/可行性测试 使用经过更新和验证的系统。这些步骤将最终在目标3，多地点随机对照试验 评估个性化的临床决策方法对知情和价值观的影响- 一致的选择和共同的决策结果。这一贡献将是巨大的，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 寻求更好的心力衰竭治疗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6年的开发，实施和 传播LVAD决策支持和对LVAD准确风险预测模型的十年研究。