Evaluating the implementation and impact of navigator-delivered ePRO home symptom monitoring and management

项目总结 Basch(合作者)和他的同事进行的随机对照试验表明，每周一次的电子 癌症患者的基于家庭的前期症状监测，并向临床医生发出自动警报(Home EPRO) 与降低医疗保健利用率、改善生活质量和提高总体存活率有关。 然而，这些试验是使用研究资金支持的基础设施进行的。知识鸿沟 仍然是关于家庭ePRO在现实世界中的最佳实施策略和有效性。 为了解决这一差距，来自两个机构的调查人员将进行大规模的、以人口为基础的 对所有接受治疗的成年癌症患者实施循证家庭ePRO干预 化疗，包括非洲裔美国人、农村居民和 在社会经济上处于不利地位的个人。这一实施将利用Medicare的基础设施 支付改革项目(肿瘤科护理模式、肿瘤科护理优先模式)，这些项目需要 支持患者导航员，这是实施家庭ePRO的天然劳动力。我们的假设是 部署的实施战略将导致导航员交付的Home ePRO取得成功，这将 改善患者和卫生系统的结果。使用综合框架进行实施 研究(CFIR)，这一假设将使用具有三个特定目标的混合类型2设计进行验证：1) 通过多个实践对所有癌症患者实施导航仪交付的家庭ePRO进行评估 站点；2)检查实施导航器时使用的障碍、促进者和实施策略- 提供家庭ePRO；以及3)评估家庭ePRO对临床和使用结果的影响。在目标1中， 家庭ePRO将使用实施结果(服务渗透率、提供商)进行评估 采用/渗透、干预保真度)。在目标2中，我们将评估患者和医疗团队对 导航员主导的家庭ePRO的障碍和促进者，用于解决这些问题的实施战略 障碍、实施战略忠诚度，以及对实施战略能力的看法 使用迭代定性分析。在目标3中，患者水平的结果(功能状态、痛苦、抑郁、 医疗保健利用率、成本、存活率)将使用真实数据源进行评估。该项目具有创新性。 因为这将是第一次评估导航员主导的全民家庭ePRO的真实实施情况的研究 接受化疗的癌症患者，这种方法既可立即扩展，又可在 基于价值的支付模式。这项拟议的研究意义重大，因为它有望证明 成功实施导航员交付的家庭ePRO和ePRO干预的有效性 不同的患者群体。此外，该项目将生成一个成功的实施蓝图 可以很容易地应用于其他患者报告的结果的实施战略，有可能 随着医疗保健向基于价值的系统过渡，积极影响患者护理。

PROJECT SUMMARY Randomized controlled trials by Basch (collaborator) and colleagues demonstrated that weekly electronic home-based PRO symptom monitoring with automated alerts to clinicians (Home ePRO) in cancer patients was associated with reduced healthcare utilization, improved quality of life, and increased overall survival. However, these trials were administered using infrastructure supported by research funding. A knowledge gap remains about optimal implementation strategies for and effectiveness of Home ePROs in real-world settings. To address this gap, investigators from two institutions will conduct a large-scale, population-based implementation of an evidence-based Home ePRO intervention for all adult cancer patients receiving chemotherapy, including vulnerable populations such as African Americans, rural residents, and socioeconomically disadvantaged individuals. This implementation will leverage infrastructure from Medicare's payment reform projects (Oncology Care Model, Oncology Care First Model), which require and financially support patient navigators, a natural workforce for Home ePRO implementation. Our hypothesis is that the deployed implementation strategies will result in successful navigator-delivered Home ePRO, which will improve both patient and health system outcomes. Using the Consolidated Framework for Implementation Research (CFIR), this hypothesis will be tested using a hybrid type 2 design with three specific aims: 1) evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites; 2) examine the barriers, facilitators, and implementation strategies used in implementing navigator- delivered Home ePRO; and 3) assess the impact of Home ePRO on clinical and utilization outcomes. In Aim 1, Home ePRO will be evaluated using implementation outcomes (service penetrance, provider adoption/penetration, intervention fidelity). In Aim 2, we will gauge patient and healthcare team perceptions of barriers and facilitators of navigator-led Home ePRO, implementation strategies used to address these barriers, implementation strategy fidelity, and perception of implementation strategy ability to address barriers using an iterative qualitative analysis. In Aim 3, patient-level outcomes (functional status, distress, depression, healthcare utilization, cost, survival) will be evaluated using real-world data sources. The project is innovative because it will be the first study to evaluate real-world implementation of navigator-led Home ePRO for all cancer patients receiving chemotherapy, an approach that is both immediately scalable and sustainable within value-based payment models. The proposed research is significant because it is expected to demonstrate successful implementation of navigator-delivered Home ePRO and effectiveness of the ePRO intervention on diverse patient populations. Furthermore, the project will generate an implementation blueprint of successful implementation strategies that can be easily applied to other patient-reported outcomes, with the potential to positively impact patient care as health care transitions to a value-based system.