Optimizing an Early Palliative Care Intervention for Advanced HF Patients

项目总结/摘要 本K99/R 00申请描述了申请人Rachel威尔斯博士，注册护士的背景和经验， 她计划获得必要的知识和培训，成为一个领先的独立的临床 研究人员在开发和测试早期姑息治疗干预措施，优化的结果， 患有晚期心力衰竭（HF）的未得到充分服务的个体。这项培训和拟议的研究是 重要性是因为：1）晚期HF患者的姑息治疗需求大量未得到满足; 2）很少 研究人员正在研究姑息治疗干预成分的机制， 干预效果;和3）在HF中开发有效和可扩展的姑息治疗干预措施是一个 重点研究。K99的总体目标是在发展行为方面获得高级研究培训。 干预措施，使用多阶段优化策略（MOST）进行随机对照试验，以及 先进的研究伦理，以完善和试点测试外行导航员领导的早期姑息治疗的组成部分 UPHOLDS的目标是为美国南部服务不足的晚期HF患者提供干预。 干预（使用非专业导航仪优化心力衰竭姑息治疗以减少痛苦）， 将通过经培训的非专业导航员激活晚期HF患者来改善生活质量（QOL） 教练K99阶段的具体培训目标是：（1）制定和调整干预措施， 是：1a）采用严格的保真度程序进行手动化，以增强复制和可扩展性; 1b）针对 服务不足的人群;和1c）由外行导航员领导;（2）开发使用 社会变革管理计划框架;（3）继续开展研究伦理培训。一个全面的培训计划已经 与高级研究专家的指导团队合作开发，包括密集的面对面交流 指导、正式课程/研讨会、临床试验观察员和会议出席。K99 通过对a）服务不足的晚期HF患者，B）非专业医疗保健人员进行访谈， 导航员，以及c）姑息治疗和HF临床医生，以修改和完善HF的内容、格式和交付 姑息治疗干预的组成部分。R 00阶段的总体目标是进行优化 试点使用23因子设计，以评估可接受性，可行性和潜在的有效性，新的完善 支持干预。R 00阶段的研究具体目标是：1）确定可行性 使用高度创新的MOST析因设计方法招募和保留40名高级研究员， HF患者24周，2）探索单个干预成分的初步疗效， 基线后12周和24周时组分相互作用对患者结局（QOL，主要结局）的影响。的 结果将直接支持R 01应用程序进行充分把握度的MOST析因试验，以测试影响 个体姑息治疗干预成分对晚期HF患者结局的影响。

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.