Optimizing an Early Palliative Care Intervention for Advanced HF Patients

项目摘要/摘要 这份K99/R00申请书描述了申请者Rachel Wells，PhD，RN， 以及她计划获得成为领先的独立临床医生所需的知识和培训 研究人员开发和测试早期姑息护理干预措施，以优化患者的预后 服务不足的晚期心力衰竭(HF)患者。这项培训和拟议的研究是 重要性是因为：1)晚期心力衰竭患者的大量未得到满足的姑息治疗需求；2)很少 研究人员正在研究姑息治疗干预组件的潜在机制，以优化 干预效果；以及3)开发有效和可扩展的心力衰竭姑息治疗干预措施是一种 重点研究重点。K99的总体目标是在发展行为方面获得高级研究培训 干预，使用多阶段优化策略(MOST)进行随机对照试验，以及 先进的研究道德，以完善和试验非专业导航员主导的早期姑息治疗的组成部分 在美国南部对服务不足的晚期心衰患者进行干预 干预(使用Lay Navigator优化心力衰竭的姑息护理以减少痛苦)， 将通过受过训练的非专业导航员激活晚期心力衰竭患者来提高生活质量(QOL) 教练。K99阶段的具体培训目标是：(1)制定和定制干预措施， 是：1)使用严格的保真程序进行手动处理，以增强复制和可扩展性；1)量身定做 服务不足的人群；以及1)由业馀导航员领导；(2)发展设计和领导区域工作队的技能 MOST框架；(3)继续进行研究伦理培训。一项全面的培训计划已经完成 与资深研究专家指导团队共同开发，包括密集的面对面交流 指导、正式课程/研讨会、临床试验观察和出席会议。K99 将通过采访a)患有晚期心衰的未得到充分服务的人，b)非专业医疗保健来实现研究目标 导航员，以及c)姑息治疗和心力衰竭临床医生，以修改和完善心力衰竭的内容、格式和交付 姑息治疗干预组成部分。R00阶段的总体目标是进行优化 试点使用23因素级设计来评估新改进的 坚持干预。R00阶段研究的具体目标是：1)确定可行性 和可接受性使用高度创新的最阶乘设计方法来注册和保留40 对心力衰竭患者进行24周和2)探讨个体化干预成分和 在基线后12周和24周，成分交互作用对患者结果(生活质量，主要结果)的影响。这个 结果将直接支持R01应用程序进行全功率最大析因试验以测试效果 个体化姑息治疗干预成分对晚期心力衰竭患者预后的影响。

PROJECT SUMMARY/ABSTRACT This K99/R00 application describes the background and experience of the applicant, Rachel Wells, PhD, RN, and her plan to acquire the knowledge and training necessary to become a leading independent clinical investigator in developing and testing early palliative care interventions that optimize the outcomes of underserved individuals living with advanced heart failure (HF). This training and proposed research are of importance because: 1) substantial unmet palliative care needs of persons living with advanced HF; 2) few investigators are examining the mechanisms underlying palliative care intervention components to optimize intervention effect; and 3) the development of efficacious and scalable palliative care interventions in HF is a key research priority. The overall K99 goals are to gain advanced research training in developing behavioral interventions, conducting randomized controlled trials using the Multiphase Optimization Strategy (MOST), and advanced research ethics to refine and pilot test components of a lay navigator-led early palliative care intervention for underserved persons with advanced HF in the Southern U.S. The goal of the UPHOLDS intervention (Utilizing Palliative Care for Heart Failure Optimized using Lay Navigators to Decrease Suffering), will be to improve quality of life (QOL) by activating advanced HF patients through trained lay navigators coaching. The specific training objectives during the K99 phase are to: (1) develop and tailor interventions that are: 1a) manualized with rigorous fidelity procedures for enhanced replication and scalability; 1b) tailored to underserved populations; and 1c) led by lay navigators; (2) develop skills to design and lead RCTs using the MOST framework; and (3) continue training in research ethics. A comprehensive training plan has been developed in concert with mentorship team of senior research experts and includes intensive face-to-face mentorship, formal coursework/workshops, clinical trial observerships, and conference attendance. The K99 research aim will be met using interviews with a) underserved persons with advanced HF, b) lay healthcare navigators, and c) palliative care and HF clinicians, to modify and refine the content, format and delivery of HF palliative care intervention components. The overall goal during the R00 phase is to conduct an optimization pilot using a 23 factorial design to assess acceptability, feasibility, and potential efficacy of the newly refined UPHOLDS intervention. The research specific aims during the R00 phase are to: 1) determine the feasibility and acceptability of using a highly innovative MOST factorial design approach to enroll and retain 40 advanced HF patients for 24 weeks and 2) explore the preliminary efficacy of individual intervention components and component interactions on patient outcomes (QOL, primary outcome) at 12- and 24- weeks after baseline. The results will directly support an R01 application to conduct a fully powered MOST factorial trial to test the effects of individual palliative care intervention components on advanced HF patient outcomes.