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

Rise-HP：重新构想对过敏性肺炎的支持和教育干预措施；

• 批准号: 10687074
• 负责人: Kerri Aronson
• 金额: $ 17.32万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10687074
• 关键词: Address; Advisory Committees; American; Antigens; Anxiety; Attitude; Behavior Therapy; Behavioral; Benchmarking; Chest; Chronic Disease; Clinical Trials; Clinical Trials Design; Cognitive; Cognitive Therapy; Collaborations; Development; Development Plans; Disease; Education; Educational Intervention; Educational Materials; Effectiveness; Effectiveness of Interventions; Exposure to; Extrinsic allergic alveolitis; Feeling; Focus Groups; Foundational Skills; Foundations; Fright; Frustration; Future; Goals; Health; Home environment; Hybrids; Infrastructure; International; Interstitial Lung Diseases; Intervention; Investigation; Knowledge; Knowledge acquisition; Learning; Life Style; Measures; Medicine; Mental Depression; Mentors; Observational Study; Outcome; Outcomes Research; Participant; Patient Education; Patient Outcomes Assessments; Patient-Centered Care; Patient-Focused Outcomes; Patients; Peer Group; Persons; Protocols documentation; Psychometrics; Qualitative Research; Randomized, Controlled Trials; Research; Research Design; Research Methodology; Research Personnel; Review Literature; Sampling; Scientist; Self Efficacy; Site; Social isolation; Societies; Source; Statistical Data Interpretation; Surveys; System; Testing; Thinness; Training; Uncertainty; Universities; Virginia; Visit; Work; acceptability and feasibility; attentional control; career; career development; coping; design; eHealth; effectiveness testing; effectiveness/implementation trial; evidence base; experience; fibrotic interstitial lung disease; health administration; health related quality of life; implementation evaluation; implementation outcomes; implementation science; improved; innovation; instrument; novel; patient oriented; peer; peer coaching; pilot test; preference; randomized trial; recruit; retention rate; skills; theories; therapy development; virtual; web site; Address; Advisory Committees; American; Antigens; Anxiety; Attitude; Behavior Therapy; Behavioral; Benchmarking; Chest; Chronic Disease; Clinical Trials; Clinical Trials Design; Cognitive; Cognitive Therapy; Collaborations; Development; Development Plans; Disease; Education; Educational Intervention; Educational Materials; Effectiveness; Effectiveness of Interventions; Exposure to; Extrinsic allergic alveolitis; Feeling; Focus Groups; Foundational Skills; Foundations; Fright; Frustration; Future; Goals; Health; Home environment; Hybrids; Infrastructure; International; Interstitial Lung Diseases; Intervention; Investigation; Knowledge; Knowledge acquisition; Learning; Life Style; Measures; Medicine; Mental Depression; Mentors; Observational Study; Outcome; Outcomes Research; Participant; Patient Education; Patient Outcomes Assessments; Patient-Centered Care; Patient-Focused Outcomes; Patients; Peer Group; Persons; Protocols documentation; Psychometrics; Qualitative Research; Randomized, Controlled Trials; Research; Research Design; Research Methodology; Research Personnel; Review Literature; Sampling; Scientist; Self Efficacy; Site; Social isolation; Societies; Source; Statistical Data Interpretation; Surveys; System; Testing; Thinness; Training; Uncertainty; Universities; Virginia; Visit; Work; acceptability and feasibility; attentional control; career; career development; coping; design; eHealth; effectiveness testing; effectiveness/implementation trial; evidence base; experience; fibrotic interstitial lung disease; health administration; health related quality of life; implementation evaluation; implementation outcomes; implementation science; improved; innovation; instrument; novel; patient oriented; peer; peer coaching; pilot test; preference; randomized trial; recruit; retention rate; skills; theories; therapy development; virtual; web site

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.

项目摘要/摘要 高敏性肺炎（HP）是一种常常无法治愈的肺部纤维化间质性肺 疾病（ILD）的治疗选择有限，导致与健康相关的生活质量（HRQOL）。患者 惠普经历了对疾病，不确定性，强烈的过度维护的深刻了解， 焦虑和沮丧的感觉，并明显破坏了他们的生活方式和家庭环境。 HRQOL是 由美国胸腔学会强调，是ILD研究中以患者为中心的优先端。尽管 这尚未设计干预措施来改善HP患者的HRQOL，突出显示 以患者为中心的护理中的关键差距。该建议的目的是开发和试点测试行为和 教育干预措施（“重新构想惠普的支持和教育干预措施：“ Rise-HP”） HP-HRQOL和患者知识的关键领域是改善生活的创新策略 HP患者。我假设一种干预措施，该干预措施使用认知行为原则提供同行指导 结合理论驱动的患者教育将改善HP患者的HRQOL。实现这一目标 目的，我提出以下研究目的：1。）确定改善HP-的障碍和促进因子 特定的HRQOL，患者感知的知识差距以及利益相关者的喜好，以告知框架 RISE-HP干预2.）与利益相关者一起发展并迭代地完善新型Rise-HP干预 输入。 3.）进行试验随机对照试验，以确定RISE的可行性和可接受性 - 惠普干预。我将通过该提案的所有目标与患者咨询委员会紧密合作。发现 从这项研究中将为多中心随机对照试验奠定基础，以测试 RISE-HP干预。我将在观察研究设计和分析方面的先前培训扩展到 发展基本技能，成为具有利益相关者参与的专业知识的独立研究者 干预开发，定性研究方法，行为和教育干预措施并进行 现实世界中的临床试验，并评估实施结果。我会被三个 国际公认的临床科学家Monika Safford博士，Fernando Martinez博士和Robert Kaner博士。 我们一起为我设计了一个职业发展计划，以通过携带经验丰富的倾向来获得技能 该研究的目的是补充教学工作和其他职业发展基准。经过 进行拟议的研究，我将朝着自己的长期职业目标迈进 独立研究者专注于ILD中以患者为中心的结果研究，特别是通过开发和 测试改善HRQOL的干预措施。该建议将通过发展小说来推动ILD领域 以患者为中心的干预措施，旨在改善HP患者的HRQOL，使我能够建立第一个HP- 针对大型国家混合型I型实施试验的特定多站点基础设施。