Outpatient Worsening Heart Failure in an Integrated Health Care Delivery System: An Innovative Approach to Characterizing a Novel Clinical Entity

综合医疗服务系统中门诊患者心力衰竭恶化：表征新临床实体的创新方法

• 批准号: 10475613
• 负责人: Andrew Patrick Ambrosy
• 金额: $ 19.21万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10475613
• 关键词: Acute; Address; Affordable Care Act; Algorithms; Award; California; Cardiac; Caring; Characteristics; Clinical; Clinical Trials; Computer software; Data; Data Sources; Devices; Disease; Electronic Health Record; Environment; Epidemiology; Event; Funding; Future; Goals; Gold; Guidelines; Health Policy; Health Services; Health system; Heart failure; Hospitalization; Hospitals; Impairment; Incentives; Incidence; Integrated Delivery of Health Care; International; K-Series Research Career Programs; Knowledge; Learning; Location; Logistics; Machine Learning; Manuals; Medical; Mentors; Mentorship; Methodology; Morbidity - disease rate; Natural History; Natural Language Processing; Outcome; Outpatients; Patient Care; Patients; Pattern; Pharmaceutical Preparations; Physicians; Pragmatic clinical trial; Public Health; Recommendation; Recording of previous events; Reporting; Research; Research Methodology; Research Personnel; Research Project Grants; Research Proposals; Resources; Risk; Science; Scientist; Series; System; Training; United States National Institutes of Health; Work; adjudication; analytical method; base; clinical encounter; clinical risk; cohort; deep learning; design; evidence base; experience; health care delivery; health related quality of life; high risk; hospital readmission; implementation science; improved; innovation; interest; machine learning algorithm; mortality; novel; programs; prospective; readmission rates; skills; standard of care; success; trend; unstructured data

PROJECT SUMMARY/ABSTRACT Although the management of ambulatory heart failure (HF) has been revolutionized by evidence-based drug and device therapies, there has been no such parallel progress in the care of patients admitted for worsening HF (WHF). To incentivize health systems to reduce 30-day readmissions, the Affordable Care Act (ACA) launched the Hospital Readmission Reduction Program (HRRP) in 2012, which penalizes hospitals financially if they have higher than expected risk-adjusted 30-day readmission rates for conditions including HF. Although the HRRP has modestly reduced readmissions, this program has had the unintended consequence of shifting a significant fraction of HF-related care to the outpatient setting. Thus, there is a growing interest in the field to disentangle WHF from location of care and move away from using hospitalization as a surrogate for acute decompensated HF. However, little is known about the epidemiology, clinical profile, treatment patterns, and/or outcomes of outpatient WHF. In addition, while the overall survival of ambulatory HF patients has improved dramatically, guideline-directed medical therapy (GDMT) has had minimal impact on impairments in health- related quality of life (HRQOL). Despite this reality, there are few real-world data sources available to describe the trajectory of HRQOL in the ambulatory setting. To address these critical knowledge gaps, we propose (1) to systematically describe the contemporary epidemiology, clinical characteristics, treatment patterns, and outcomes associated with outpatient WHF and (2) to evaluate the impact of an episode of outpatient WHF on generic and disease-specific HRQOL in the context of a fully integrated health care delivery system. The first objective will leverage observational data from a large, state-of-the-art, and validated electronic health record (EHR) system and machine learning algorithms for natural language processing (NLP) to systematically ascertain and comprehensively characterize episodes of outpatient WHF. The second objective will prospectively apply this software-based solution to evaluate generic and disease-specific HRQOL among patients with a recent clinical encounter for outpatient WHF. The overarching goal of this career development award is to provide me with the requisite training in research methodology and project experience to build upon my past successes as a traditional clinical trialist in order to also becoming a leader in health services, implementation science, and pragmatic clinical trials within a learning health system. Strengths of my proposal include my prior relevant training and track record in research, the experience and commitment of my mentors, collaborators, and consultants, and the vast institutional resources and support. In summary, this research proposal will employ innovative analytic approaches to elucidate the epidemiology, clinical features, and outcomes of this previously underappreciated and novel clinical entity. Given the current trend towards managing acute cardiac conditions primarily in the ambulatory setting, these findings have immediate implications for formulating public health policy as well as the design and conduct of future clinical trials.

项目概要/摘要 尽管循证药物彻底改变了动态心力衰竭 (HF) 的治疗 和设备疗法，但在因病情恶化而入院的患者的护理方面还没有取得类似的进展 高频（WHF）。为了激励卫生系统减少 30 天再入院率，平价医疗法案 (ACA) 2012 年启动了医院再入院减少计划 (HRRP)，对医院进行经济处罚 如果他们的心力衰竭等疾病的风险调整后 30 天再入院率高于预期。虽然 HRRP 适度减少了再入院率，该计划产生了意想不到的后果： 心力衰竭相关护理的很大一部分是在门诊进行的。因此，人们对该领域越来越感兴趣 将 WHF 与护理地点分开，并不再使用住院作为急性发作的替代方法 失代偿性心力衰竭。然而，人们对流行病学、临床概况、治疗模式和/或 门诊 WHF 的结果。此外，虽然门诊心力衰竭患者的总体生存率有所改善 引人注目的是，指南指导的药物治疗（GDMT）对健康损害的影响微乎其微。 相关生活质量 (HRQOL)。尽管存在这种现实，但很少有现实世界的数据源可以用来描述 门诊环境中 HRQOL 的轨迹。为了解决这些关键的知识差距，我们建议（1） 系统地描述当代流行病学、临床特征、治疗模式和 与门诊 WHF 相关的结果；(2) 评估门诊 WHF 发作对患者的影响 在完全整合的医疗保健提供系统的背景下，通用和特定疾病的 HRQOL。第一个 Objective 将利用来自大型、最先进且经过验证的电子健康记录的观察数据 （EHR）系统和自然语言处理（NLP）的机器学习算法，以系统地 确定并全面描述门诊 WHF 发作的特征。第二个目标将 前瞻性地应用这种基于软件的解决方案来评估一般和特定疾病的 HRQOL 最近临床出现门诊 WHF 的患者。此职业发展的总体目标 该奖项旨在为我提供必要的研究方法和项目经验方面的培训，以供我借鉴 我过去作为传统临床试验师的成功，也是为了成为卫生服务领域的领导者， 在学习健康系统内实施科学和务实的临床试验。我的优点 提案包括我之前的相关培训和研究记录、我的经验和承诺 导师、合作者和顾问，以及大量的机构资源和支持。综上所述，这 研究计划将采用创新的分析方法来阐明流行病学、临床特征、 以及这个先前被低估的新颖临床实体的结果。鉴于目前的趋势 主要在门诊环境中管理急性心脏病，这些发现具有直接意义 对制定公共卫生政策以及未​​来临床试验的设计和进行的影响。