ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients

ROAMM-EHR：出院后手术患者实时症状监测系统的试点试验

• 批准号: 10451981
• 负责人: Todd Manini
• 金额: $ 22.88万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-15 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10451981
• 关键词: Accelerometer; Behavioral; Caring; Clinical; Clinical Trials; Collaborations; Communities; Community Integration; Data; Data Analytics; Devices; Early Intervention; Ecological momentary assessment; Elderly; Electronic Health Record; Elements; Eligibility Determination; Evaluation; Evidence Based Medicine; Fatigue; Foundations; Future; Gait; Global Positioning System; Goals; Health; Health Care Costs; Health Personnel; Healthcare; Human; Human Resources; Intervention; Knowledge; Masks; Measures; Medical; Mission; Mobile Health Application; Modeling; Monitor; Moods; Nature; Operative Surgical Procedures; Orthopedic Surgery; Outcome; Outcome Measure; Outcome Study; Outcomes Research; Pain; Participant; Patient Care; Patient Monitoring; Patient Self-Report; Patient-Focused Outcomes; Patients; Pattern; Pharmaceutical Preparations; Physical Function; Physicians; Pilot Projects; Preparation; Private Sector; Process; Process Measure; Provider; Public Health; Public Sector; Qualitative Research; Quality of life; Randomized; Randomized Clinical Trials; Recovery; Rehabilitation therapy; Replacement Arthroplasty; Reporting; Research; Research Design; Research Personnel; Safety; Scheme; Social Functioning; Standardization; Symptoms; System; Technology; Testing; Time; TimeLine; Training; United States National Institutes of Health; Walking; advanced disease; age group; comparison group; data visualization; disease diagnosis; efficacy evaluation; evidence base; experience; healing; health data; high reward; high risk; high risk population; improved; indexing; innovation; mHealth; older patient; opioid use; patient portal; pilot trial; prescription opioid; prevent; quality assurance; recruit; retention rate; sensor; smart watch; standard of care; surgery outcome; symptom management; symptomatic improvement; tool; usability; wearable device; wound healing

Project Summary In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. While existing sensors and devices collect relevant information from patients, such information is rarely shared with healthcare providers, potentially preventing timely interventions. Existing patient portals are typically static in nature— they lack remote and real-time capabilities for monitoring symptoms, medication use, activity levels and community mobility. These is vital information for understanding how patients recover from surgical procedures— this is particularly true for older adults who are highly vulnerable to poor recovery. The objectives of this application are to: 1) implement our existing Real-Time and Online Assessment and Mobility Monitor (ROAMM) smartwatch app platform into the electronic health record (EHR) to form the ROAMM-EHR platform and 2) test its feasibility in a pilot randomized clinical trial (RCT) in older patients (n= 50, >60 yrs) discharged after orthopedic surgery in preparation for a definitive trial. The central hypothesis is that integrating patient generated health data with the EHR system will improve symptom management and carry over into better outcomes, e.g. mobility function, lower pain, and better quality of life indices compared to the standard of care. The rationale is that ecological momentary assessment of patient symptoms can promote earlier and more informed micro-interventions such as changing medications, enhancing rehabilitation or performing more check-ins, resulting in improved patient outcomes. The pilot RCT will accomplish operational aims to refine and establish several elements for the future trial, including: the onboarding and behavioral approaches for using ROAMM-EHR, randomization scheme, study outcomes, quality assurance and standardization, recruitment and retention rates, data analytic strategies, technical implementation, and patient and staff usability/acceptability. The approach is innovative, because study will represent the first effort to not only build and implement but also to formally test a real-time post-surgical symptom surveillance platform by integrating patient generated health data from wearable devices with the EHR system. The proposed research is significant since timely post-surgical recovery will prevent both long- and short-term poor outcomes in older adults. The expected outcomes are 1) a new smart watch enabled symptom surveillance platform that will facilitate post-surgical care management and 2) the necessary knowledge for planning a definitive trial to reduce the major gap of evidence-based medicine for mHealth interventions. At its completion, the implementation and rigorous evaluation of ROAMM-EHR will not only test a transformative clinical tool, it will serve as a foundation for others in both public and private sectors who strive to capitalize on the promise of mHealth apps in healthcare.

项目摘要 近年来，移动健康（MHealth）应用程序已承诺改善对健康状况的监测 改善临床结果。尽管现有的传感器和设备从患者那里收集相关信息，但 信息很少与医疗保健提供者共享，从而有可能阻止及时的干预措施。现存的 患者门户通常是静态的 - 它们缺乏监视的遥远和实时功能 症状，药物使用，活动水平和社区流动性。这些是理解的重要信息 患者如何从外科手术过程中恢复过来 - 对于高度高度的老年人来说尤其如此 容易恢复不良。本应用程序的目标是：1）实施我们现有的实时实时和 在线评估和移动监控器（ROAMM）智能手表应用程序平台进入电子健康记录 （EHR）形成ROAMM-EHR平台和2）在试验的随机临床试验（RCT）中测试其可行性 骨科手术后，老年患者（n = 50年，> 60年）出院，为确定试验做准备。这 中心假设是，将患者产生的健康数据与EHR系统整合在一起将改善症状 管理并结束更好的结果，例如流动性功能，较低的疼痛和更好的生活质量 指数与护理标准相比。理由是对患者的生态瞬时评估 症状可以促进较早，更明智的微型干扰，例如改变药物， 增强康复或进行更多检查，从而改善患者的结果。飞行员RCT 将实现运营目标，以完善和建立未来审判的几个要素，包括： 使用ROAMM-EHR，随机化方案，研究成果的入职和行为方法， 质量保证和标准化，招聘和保留率，数据分析策略，技术 实施以及患者和员工的可用性/可接受性。这种方法是创新的，因为研究将 代表不仅要建立和实施的第一个努力，还代表正式测试实时外科手术 症状监视平台通过将可穿戴设备的患者产生的健康数据与 EHR系统。拟议的研究很重要，因为及时的手术后恢复将防止长期 老年人的短期结局。预期的结果是1）启用了新的智能手表 症状监视平台将有助于手术后护理管理，2）必要 规划最终试验的知识，以减少MHealth的循证医学差距 干预措施。完成后，对Roamm-EHR的实施和严格评估不仅将测试 变革性的临床工具，它将为努力的公共部门和私营部门中的其他人提供基础 利用医疗保健中MHealth应用程序的承诺。