Symptom Care at Home-Heart Failure: Developing and piloting a symptom monitoring and self-management coaching system for patients with heart failure

这是一份K23奖项的申请表，给住院和家庭经验丰富的临床医生康有荣。 医疗保健环境，独立开发和测试心力衰竭(HF)的创新干预措施 有效和可扩展的管理，以及改善对心力衰竭患者的护理。K23将为她提供 在四个关键职业发展领域获得关键技能所需的支持：1)加强以下方面的专门知识 基于患者报告结果(PRO)数据的心力衰竭症状和自我管理；2)在 家庭症状管理干预测试的临床试验设计与实施；3) 获得进一步的专业发展和领导技能；以及4)获得发展和适应的技能 技术辅助干预(即基于应用程序的平台)。为了实现她的目标，康博士组建了一个 由Kathi Mooney博士(主要导师)组成的跨学科导师团队，国际 使用电话干预的肿瘤学症状管理方面的公认专家；Josef Stehlik (共同导师)，一位经验丰富的心脏病专家，有专注于心力衰竭治疗的独立研究生涯；以及 加里·唐纳森(顾问)，多变量纵向统计分析专家。 让出院后症状负担较低的心衰患者留在家中是具有挑战性的。证据 表明心力衰竭症状识别延迟和自我管理不善与计划外有关 急诊科就诊和再住院。旨在预防再次住院的临床试验 远程监测已经显示出有限的效用，这表明仅监测物理变化可能不是 足以在家中维持心力衰竭患者的稳定性。最近的一项癌症研究表明，患者 通过家庭症状护理(SCH)，接受癌症化疗的患者症状减少了40%。 一种计算机接口电话交互语音响应系统，将患者报告的症状与 自动化的实时、自我管理的辅导。虽然少数心衰研究使用了干预措施， 监测症状，还没有研究测试一种监测和提供实时自我管理的系统 为特定的职业教练量身定做的教练。Kang博士的目标是试验使SCH系统适应HF 从而产生支持全功率随机对照试验以测试适应的SCH-HF的初步数据 可以广泛传播的系统。她分两部分提出了以下具体目标：目标1] 定制实时自我管理教练系统，将心力衰竭症状监测和自我管理 对SCH-HF系统进行管理培训；和目标2]进行试点随机对照试验(RCT) 评估SCH-HF系统的可行性、可接受性和初步疗效。拟议的研究 具有重要意义，因为它扩展了我们对使用PRO进行心力衰竭症状监测和管理的理解 在家里的环境中。这项建议具有创新性，因为它整合了心衰临床医生和患者的观点，以 开发一个日常家庭监控和实时自我管理的辅导系统。

This is a K23 award application for Dr. Youjeong Kang, an experienced clinician in inpatient and home health care settings, to independently develop and test innovative interventions for heart failure (HF) management that are effective and scalable, as well as improve care for HF patients. The K23 will provide her the support necessary to acquire critical skills in four key career development areas: 1) enhance expertise in HF symptoms and self-management based on patient-reported outcomes (PRO) data; 2) develop expertise in clinical trial design and implementation for the home-based symptom management intervention testing; 3) acquire further professional development and leadership skills; and 4) obtain skills in developing and adapting technology-aided interventions (i.e., app-based platform). To achieve her goals, Dr. Kang has assembled an interdisciplinary mentoring team comprised of Drs. Kathi Mooney (Primary Mentor), an internationally recognized expert in oncology symptom management using telephone-enabled interventions; Josef Stehlik (Co-Mentor), an experienced cardiologist with an independent research career focused on HF treatments; and Gary Donaldson (Advisor), an expert in multivariate longitudinal statistical analyses. Keeping HF patients at home with a low symptom burden after hospital discharge is challenging. Evidence shows that delay in HF symptom recognition and poor self-management are associated with unplanned emergency department visits and rehospitalizations. Clinical trials aimed at preventing rehospitalization using telemonitoring have shown limited utility suggesting that monitoring physical changes alone may not be sufficient to maintain stability of HF patients at home. A recent cancer study has demonstrated that patients receiving cancer chemotherapy achieved a 40% reduction in symptoms using Symptom Care at Home (SCH), a computer-interface telephonic interactive voice response system pairing patient-reported symptoms with automated real-time, self-management coaching. While a few HF studies have used interventions that monitored symptoms, no studies have tested a system that monitors and provides real-time, self-management coaching tailored to specific PRO. Dr. Kang’s objective is to pilot an adaption of the SCH system to HF resulting in preliminary data to support a fully-powered randomized control trial to test an adapted SCH-HF system that could be widely disseminated. She proposes the following Specific Aims over two-parts: Aim 1] Tailor the real-time self-management coaching system to integrate HF symptom monitoring and self- management coaching into the SCH-HF system; and Aim 2] Conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and preliminary efficacy of the SCH-HF system. The proposed research is significant because it expands our understanding into HF symptom monitoring and management using PRO in the home setting. The proposal is innovative because it integrates HF clinician and patient perspectives to develop a daily home monitoring and real-time self-management coaching system.