Rise-HP: Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis; A Stakeholder Engaged Intervention to Improve Health-Related Quality of Life

项目总结/摘要 过敏性肺炎（HP）是一种经常无法治愈的，潜在的进行性间质性肺纤维化 疾病（ILD），治疗选择有限，导致健康相关生活质量（HRQOL）较差。患者 患有HP的患者严重缺乏对疾病的了解，不确定性，高度警惕， 焦虑和抑郁的感觉，以及对他们的生活方式和家庭环境的明显破坏。HRQOL是 被美国胸科学会强调为ILD研究中以患者为中心的优先终点。尽管 因此，没有设计干预措施来改善HP患者的HRQOL，突出了 以病人为中心的护理的关键差距。本提案的目的是开发和试点测试一种行为和 教育干预（“惠普支持和教育干预的重新构想：“RISE-HP”）， HP-HRQOL和患者知识的关键领域，作为改善患者生活的创新策略， HP患者。我假设一个干预，提供同伴教练使用认知行为原则 结合理论导向的患者教育可提高HP患者的HRQOL。为了实现这一 目的，我提出以下研究目标：1。确定改进HP的障碍和促进因素- 具体的HRQOL、患者感知的知识差距和利益相关者偏好，以告知框架， RISE-HP干预2.）与利益相关者一起开发并迭代完善新的RISE-HP干预措施 输入. 3.）第三章进行一项初步随机对照试验，以确定RISE的可行性和可接受性- HP干预。我将与一个病人咨询委员会密切合作，以实现该提案的所有目标。结果 将为多中心随机对照试验奠定基础，以测试 RISE-HP干预。我将扩展我之前在观察性研究设计和分析方面的培训， 发展基本技能，成为一名独立的调查员，拥有专业知识， 干预发展，定性研究方法，行为和教育干预，以及 真实世界的临床试验与实施结果的评估。我将接受三位导师的指导 国际公认的临床科学家，莫妮卡萨福德博士，费尔南多马丁内斯博士和罗伯特Kaner博士。 我们一起为我设计了一个职业发展计划，通过携带体验学习来获得技能。 研究目标，辅之以教学工作和其他职业发展基准。通过 进行拟议的研究，我将朝着我的长期职业目标，成为一个 一名独立研究者专注于以患者为中心的ILD结局研究，特别是通过开发和 测试改善HRQOL的干预措施。该提案将通过开发一种新的 以患者为中心的干预，旨在改善HP患者的HRQOL，并允许我建立第一个HP- 具体的多站点基础设施，用于更大规模的国家混合I型有效性实施试验。

Project Summary/Abstract Hypersensitivity Pneumonitis (HP) is an often incurable and potentially progressive fibrotic interstitial lung disease (ILD) with limited treatment options that leads to poor health-related quality of life (HRQOL). Patients with HP experience a profound lack of knowledge about the disease, uncertainty, intense hypervigilance, feelings of anxiety and depression, and marked disruption to their lifestyle and home environment. HRQOL is highlighted by the American Thoracic Society as a priority patient-centered endpoint in ILD research. Despite this, no interventions have been designed to improve the HRQOL of patients living with HP, highlighting a crucial gap in patient centered care. The objective of this proposal is to develop and pilot test a behavioral and educational intervention (“Reimagining Interventions for Support and Education in HP: “RISE-HP”) that targets the key domains of HP-HRQOL and patient knowledge as an innovative strategy to improve the lives of patients with HP. I hypothesize an intervention that delivers peer coaching using cognitive behavioral principles combined with theory-driven patient education will improve HRQOL of patients with HP. To accomplish this objective, I propose the following research aims: 1.) Determine the barriers and facilitators of improving HP- specific HRQOL, patient perceived knowledge gaps, and stakeholder preferences to inform the framework for the RISE-HP intervention 2.) Develop and iteratively refine the novel RISE-HP intervention with stakeholder input. 3.) Conduct a pilot randomized controlled trial to determine the feasibility and acceptability of the RISE- HP intervention. I will work closely with a patient advisory committee through all Aims of the proposal. Findings from this study will lay the groundwork for a multi-center randomized controlled trial to test the effectiveness of the RISE-HP intervention. I will expand on my prior training in observational study design and analysis to develop foundational skills to become an independent investigator with expertise in stakeholder-engaged intervention development, qualitative research methods, behavioral and educational interventions, and conduct of real-world clinical trials with assessment of implementation outcomes. I will be mentored by three internationally recognized clinician scientists, Dr. Monika Safford, Dr. Fernando Martinez, and Dr Robert Kaner. Together we designed a career development plan for me to gain skills through experiential leaning by carrying out the research aims supplemented by didactic work and additional career development benchmarks. By conducting the proposed research, I will advance toward my long-term career goal of becoming an independent investigator focused on patient-centered outcomes research in ILD, specifically by developing and testing interventions that improve HRQOL. This proposal will advance the ILD field by developing a novel patient-centered intervention aimed at improving HRQOL of patients with HP and allow me to build the first HP- specific multisite infrastructure for a larger national hybrid type I effectiveness-implementation trial.