Optimizing an Early Palliative Care Intervention for Advanced HF Patients

优化晚期心力衰竭患者的早期姑息治疗干预

• 批准号: 10821109
• 负责人: Rachel D Wells
• 金额: $ 24.9万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-07 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10821109
• 关键词: Address; Adult; Advance Care Planning; Affect; African American population; Anxiety; Behavior Therapy; Cardiomyopathies; Care given by nurses; Caregivers; Cities; Clinical Investigator; Clinical Trials; Communication; Complex; Consultations; Data; Decision Making; Development; Disease; Doctor of Philosophy; Dose; Educational workshop; Effectiveness; Elderly; Enrollment; Family Caregiver; Feedback; Funding; Future; Goals; Guidelines; Health Care Costs; Health Services Accessibility; Healthcare; Healthcare Systems; Heart failure; Hospitalization; Hospitals; Individual; Intervention; Interview; Kansas; Knowledge; Knowledge acquisition; Lead; Learning Skill; Life; Maintenance; Manuals; Measures; Mediator; Mental Depression; Mentorship; Methods; Modeling; Moods; Morbidity - disease rate; Outcome; Outpatients; Pain intensity; Pain interference; Palliative Care; Participant; Patient-Focused Outcomes; Patients; Persons; Phase; Population Intervention; Postdoctoral Fellow; Prevalence; Problem Solving; Procedures; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Research; Research Ethics; Research Personnel; Research Priority; Research Training; Self Care; Self Efficacy; Strategic Planning; Structure; Symptoms; System; Telephone; Testing; Training; Translating; Underserved Population; Work; acceptability and feasibility; automated text message; design; emotional distress; experience; follow-up; formative assessment; health care service utilization; health related quality of life; improved; improved outcome; innovation; intervention effect; mortality; multiphase optimization strategy; pilot test; post intervention; primary outcome; rural dwellers; secondary outcome; skills; sociodemographics; symposium; symptom management; systematic review; telephone session

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.

项目摘要/摘要 此K99/R00应用程序描述了申请人Rachel Wells，PhD，RN， 她的计划是获得成为领先的独立临床所必需的知识和培训的计划 研究人员开发和测试早期姑息治疗干预措施，以优化 服务不足的人患有晚期心力衰竭（HF）。这项培训和拟议的研究是 重要的是：1）具有高级HF的人的大量未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基础机制以优化 干预效果； 3）在HF中开发有效且可扩展的姑息治疗干预措施是 关键的研究优先级。 K99的总体目标是获得发展行为的高级研究培训 干预措施，使用多相优化策略（大多数）进行随机对照试验，以及 高级研究伦理学，用于完善和试验的测试组件，由外行导航员领导的早期姑息治疗 干预服务不足的人在美国南部有高级HF的人 干预（利用姑息治疗使用外行导航器优化心力衰竭以减轻痛苦）， 通过训练有素的外行导航员激活高级HF患者，将改善生活质量（QOL） 教练。 K99阶段的特定培训目标是：（1）开发和量身定制干预措施 为：1A）用严格的忠诚度程序手动，以增强复制和可伸缩性； 1b）量身定制 服务不足的人口；和1C）由外行导航员领导； （2）使用该技能来设计和使用 大多数框架； （3）继续研究研究道德。全面的培训计划已经 与高级研究专家的指导团队共同开发，包括密集面对面 指导，正式课程/讲习班，临床试验观察工作和会议出勤。 K99 研究目标将通过与a）高级HF的服务不足的人进行实现，b）外行医疗保健 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 姑息治疗干预组件。 R00阶段的总体目标是进行优化 使用23个阶乘设计的飞行员来评估新精制的可接受性，可行性和潜在功效 维护干预。 R00阶段的研究特定目的是：1）确定可行性 以及使用高度创新的大多数阶乘设计方法的可接受性来注册和保留40个高级 HF患者24周和2）探讨个人干预组件和 基线后12和24-周，在患者结局（QOL，主要结果）上的成分相互作用。这 结果将直接支持R01应用程序，以进行完全动力的大多数阶乘试验以测试效果 高级HF患者结局的个别姑息治疗干预组件。