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

描述（由申请人提供）：为响应2009年美国复苏和再投资法案支持的no - od -09-058号通知，现提交对当前资助（Pocket PATH III期试验：计算机干预促进自我护理（NR010711））的竞争性修订。肺移植受者比其他实体器官受者经历更多的移植相关并发症，更高的健康资源利用率和死亡率。预防和发现早期并发症可以降低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，用于支持个体的供体器官和财政资源稀缺，但很少有试验测试旨在促进自我保健行为和医患合作的干预措施，目的是改善肺移植后的移植相关健康和减少资源利用。当前试验的目的是比较一种新型干预措施——Pocket PATH（追踪健康的个人助理）在促进肺移植术后自我护理和改善健康结果方面的疗效。Pocket PATH为肺移植受者提供了一个手持设备，该设备具有定制的数据记录、趋势和决策支持程序，以促进他们的自我保健行为。这次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，同时支持临床医生的行为，通过与患者的协作和伙伴关系来促进更好的健康结果（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）。我们现在建议设计和测试一个基于网络的临床医生界面（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，我们将结合当前的患者Pocket PATH功能和新的临床医生Pocket PATH Link功能，创建一个完全集成的应用程序，称为Pocket PATH Synergy，这样患者和临床医生一起工作的组合将导致比各自单独工作的总和更好的健康结果。Pocket PATH Synergy将最新的交互式卫生技术与患者积极参与其护理的益处的证据融合在一起，并将患者-临床协作与共享临床决策之间的联系联系在一起，以获得更好的健康结果。该建议具有创新性，与国家自然资源研究所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、自我管理和将技术纳入临床实践。与父母资助一样，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疾病的个人的共享临床医生管理。

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.