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: 10641873
• 负责人: Todd Manini
• 金额: $ 19.06万
• 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 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10641873
• 关键词: Accelerometer; Behavioral; 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; Managed Care; 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 Discharge; Patient Monitoring; Patient Self-Report; Patient-Focused Outcomes; Patients; Pattern; Pharmaceutical Preparations; Phonetics; Physical Function; Physicians; Pilot Projects; Preparation; Private Sector; Process; Process Measure; Provider; Public Health; Public Sector; Qualitative Research; Quality of life; Randomized; Recovery; Rehabilitation therapy; Replacement Arthroplasty; Reporting; Research; Research Design; Research Personnel; Safety; Scheme; Social Functioning; Standardization; Symptoms; System; Technology; Testing; Time; Training; United States National Institutes of Health; Walking; advanced disease; age group; comparison group; compliance behavior; data visualization; disease diagnosis; efficacy evaluation; electronic health record system; evidence base; experience; healing; health data; high reward; high risk; high risk population; improved; indexing; innovation; mHealth; older patient; opioid use; patient portal; patient retention; pilot trial; prescription opioid; prevent; quality assurance; randomized, clinical trials; recruit; retention rate; sensor; smart watch; standard of care; symptom management; symptomatic improvement; timeline; 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)应用程序承诺改善对健康状况的监控，以 改善临床结果。虽然现有的传感器和设备从患者那里收集相关信息，如 很少与医疗保健提供者共享信息，这可能会阻碍及时的干预。现有 患者门户通常是静态的-它们缺乏远程和实时监控功能 症状、用药情况、活动水平和社区流动性。这些信息对于理解 患者如何从手术中恢复-这对老年人来说尤其如此，他们高度 容易受到不良恢复的影响。此应用程序的目标是：1)实施我们现有的实时和 在线评估和移动监测(ROAMM)智能手表应用程序平台进入电子健康记录 (EHR)建立ROAMM-EHR平台；2)在#年的试点随机临床试验(RCT)中测试其可行性 年龄较大的患者(n=50，60岁)在骨科手术后出院，为最终的试验做准备。这个 中心假设是，将患者生成的健康数据与EHR系统相结合将改善症状 管理并带来更好的结果，例如活动功能、更低的痛苦和更好的生活质量 与护理标准相比较的指数。其基本原理是对患者的生态瞬时评估 症状可以促进更早和更知情的微观干预，如更换药物， 加强康复或进行更多的检查，从而改善患者的预后。试点RCT 将实现业务目标，为今后的审判完善和确立若干要素，包括： 使用ROAMM-EHR的入职和行为方法，随机方案，研究结果， 质量保证和标准化、招聘和保留率、数据分析战略、技术 实施，以及患者和工作人员的可用性/可接受性。这种方法是创新的，因为研究将 不仅是构建和实施，而且是正式测试手术后实时 症状监测平台，将患者从可穿戴设备生成的健康数据与 电子病历系统。这项拟议的研究具有重要意义，因为手术后及时恢复将防止长期的 以及老年人的短期不良结果。预期结果是1)启用新的智能手表 症状监测平台，将促进术后护理管理和2)必要的 规划最终试验以缩小循证医学在移动健康领域的主要差距的知识 干预措施。在其完成后，ROAMM-EHR的实施和严格评估不仅将考验 变革性的临床工具，它将为公共和私营部门的其他人提供基础，他们努力 为了利用mHealth应用程序在医疗保健领域的前景。