Phase III Trial of Pocket PATH: A Computerized Intervention to Promote Self-Care

说明(由申请人提供)：对当前赠款的竞争性修订(袖珍路径第三阶段试验：促进自我护理的计算机化干预(NR010711)是针对2009年美国复苏和再投资法案支持的NOT-OD-09-058通知提交的。与其他实体器官的受者相比，肺移植受者经历了更多与移植相关的并发症，更高的卫生资源利用率和死亡率。众所周知，预防和检测早期并发症可以减少未来肺功能受损的可能性，从而降低发病率和死亡率。尽管在整个肺移植过程中，用于支持个体的捐赠器官和财政资源稀缺，但很少有试验测试旨在促进自我护理行为和患者与临床医生合作的干预措施，目的是改善与移植相关的健康，减少肺移植后的资源利用。目前试验的目的是比较一种新型干预措施Pocket Path(个人健康跟踪助理)与标准护理相比在促进肺移植后自我护理和改善健康结果方面的效果。Pocket Path为肺移植患者提供了一个手持设备，带有定制的数据记录、趋势和决策支持程序，以促进他们的自我护理行为。这一竞争性修订的总体目的是将目前资助的PocketPATH项目的范围扩展到患者行为之外，以支持临床医生通过与患者的合作和伙伴关系促进更好的健康结果的已知行为(例如，支持患者激活、用于评估病情变化的及时数据审查和主动沟通)。我们现在建议设计和测试一个基于Web的临床医生界面(Pocket Path Link)，以支持使用Pocket Path设备的患者和他们的临床医生合作伙伴之间的远程数据共享和通信。然后，我们将把患者当前的Pocket Path功能与临床医生的新Pocket Path Link功能结合起来，创建一个称为Pocket Path Synergy的完全集成的应用程序，这样，患者和临床医生共同工作的组合将产生比各自单独工作的总和更好的健康结果。Pocket Path Synergy将最新的互动健康技术与患者积极参与其护理所带来的好处的证据相结合，并将患者与临床医生之间的协作与共享的临床决策之间的联系结合在一起，以获得更好的健康结果。该提案具有创新性，与NINR支持的竞争性修订的科学优先事项非常匹配，包括促进健康、疾病预防、自我管理和将技术整合到临床实践中。与家长赠款一样，虽然我们的工作是针对肺移植受者的需求，但它有可能为干预措施提供信息，以促进患有其他慢性病的个人共享临床医生管理。 这一竞争性修订将使我们能够通过以下方式为ARRA的目标作出贡献： 1.通过雇佣更多的人员(可用性专家/人机)来刺激经济 所需资源包括：采购更多的设备(手持设备、语音和数据服务计划、虚拟专用服务器、网络屏幕捕获软件)，以及增加订约承办服务(软件工程师/程序员)。 2.通过增加当前项目目标的价值，加快科研评价和转化的速度，加快科研节奏。由于修订期的完成恰逢R01的最后一年，我们将进行所有必要的前期工作，建议进行一项全面的翻译研究研究，以评估Pocket Path Synergy在促进移植后健康共享管理方面的成功，从而改善健康结果。 公共卫生相关性：此次修订的目的是将目前资助的Pocket Path项目的范围扩展到患者行为之外，以支持已知通过与患者的合作和伙伴关系促进更好的健康结果的临床医生行为(例如，支持患者激活、及时审查数据以评估病情变化和主动沟通)。尽管Pocket Path正在设计并在肺移植接受者中进行测试，但几乎没有任何修改，这种干预措施有可能通过促进自我护理行为产生更广泛的影响，从而改善其他固体器官接受者和患有其他慢性病的人的健康结果。拟议的修订非常符合ARRA(NOT-OD-09-058)的目标以及以下倡议和优先事项：1)国家护理研究所强调产生和测试新技术以改善自我管理，2)NIH路线图倡议，建立协作的跨学科团队以促进健康，3)最近的医学研究所报告，让患者参与健康技术的设计。

DESCRIPTION (provided by applicant): This Competitive Revision to the current grant (Phase III Trial of Pocket PATH: A Computerized Intervention to Promote Self-Care (NR010711) is being submitted in response to Notice NOT-OD-09-058 supported by the American Recovery and Reinvestment Act of 2009. Lung transplant recipients experience more transplant-related complications, higher health resource utilization and mortality than recipients of other solid organs. Prevention and detection of early complications is known to reduce the likelihood of future impairments in lung function and therefore morbidity and mortality. Despite the scarce donor organs and financial resources expended to support individuals throughout the lung transplant experience, few trials have tested interventions designed to promote self-care behaviors and patient-clinician collaboration with the aim of improving transplant-related health and reducing resource utilization after lung transplant. The purpose of the current trial is to compare the efficacy of a novel intervention, Pocket PATH (Personal Assistant for Tracking Health) for promoting self-care and improving health outcomes relative to standard care after lung transplantation. Pocket PATH provides lung transplant recipients a handheld device with customized data recording, trending and decision-support programs to promote their self-care behaviors. The overall purpose of this competitive revision is to extend the scope of the currently funded PocketPATH project beyond patient behaviors to also support the clinician behaviors known to promote better health outcomes through collaboration and partnership with patients (e.g., support of patient activation, timely data review for evaluation of condition changes and proactive communication). We now propose to design and test a web-based clinician interface (Pocket PATH Link) to support remote data sharing and communication between patients using the Pocket PATH device and their clinician partners. We will then combine the current Pocket PATH features for patients with the new Pocket PATH Link features for clinicians to create a fully integrated application called Pocket PATH Synergy, so that the combination of patients and clinicians working together will lead to health outcomes that are better than the sum of each working separately. Pocket PATH Synergy melds the latest interactive health technologies with the evidence regarding the benefits of patients' being active participants in their care, and the link between patient-clinician collaboration and shared clinical decision making on better health outcomes. The proposal is innovative and well matched to the scientific priorities of NINR-supported competitive revisions including health promotion, disease prevention, self-management and integrating technology into clinical practice. As in the parent grant, while our work is targeted to the needs of lung transplant recipients, it has the potential to inform interventions to promote shared clinician management for individuals living with other chronic illnesses. This competitive revision will allow us to contribute to the aims of the ARRA in the following ways: 1. Stimulate the economy by hiring additional personnel (a usability specialist/human computer interaction specialist and programmer/data base specialist, and trainer/data collector), procuring additional equipment (handheld devices, voice and data service plans, virtual private server, and web-screen capture software), and increasing contracted services (software engineer/programmer). 2. Accelerate the tempo of scientific research by increasing the value of the current project goals and accelerating the rate of evaluation and translation of scientific research. Since completion of the revision period coincides with the final year of the R01, we will have all requisite preliminary work to propose a full-scale translational research study to evaluate the success of Pocket PATH Synergy in promoting shared management of post-transplant health and hence better health outcomes. PUBLIC HEALTH RELEVANCE: The purpose of this revision is to extend the scope of the currently funded Pocket PATH project beyond patient behaviors to also support the clinician behaviors known to promote better health outcomes through collaboration and partnership with patients (e.g., support of patient activation, timely data review for evaluation of condition changes and proactive communication). Although Pocket PATH is being designed and tested with lung transplant recipients, with little modification this intervention has the potential to have a broader impact by promoting self-care behaviors, and thus improving health outcomes, in recipients of other solid organs and in persons with other chronic illnesses. The proposed revision fits well with the goals of the ARRA (NOT -OD-09-058) and the following initiatives and priorities: 1) National Institute of Nursing Research's emphasis on generating and testing new technologies to improve self-management, 2) the NIH Roadmap initiative to build collaborative, interdisciplinary teams to promote health, and 3) the recent Institute of Medicine report to involve patients in the design of health technologies.