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.

项目概要 近年来，移动健康（mHealth）应用程序承诺改善对健康状况的监控 改善临床结果虽然现有的传感器和设备可以收集患者的相关信息，例如 信息很少与医疗保健提供者共享，这可能会妨碍现有的及时干预。 患者门户本质上通常是静态的——它们缺乏远程和实时监控功能 症状、药物使用、活动水平和社区流动性这些都是了解的重要信息。 患者如何从外科手术中恢复——对于高度依赖的老年人来说尤其如此 该应用程序的目标是：1）实现我们现有的实时和恢复能力。 在线评估和行动监测（ROAMM）智能手表应用程序平台纳入电子健康记录 (EHR) 形成 ROAMM-EHR 平台，2) 在试点随机临床试验 (RCT) 中测试其可行性 老年患者（n = 50，> 60 岁）在骨科手术后出院，为最终试验做准备。 中心假设是将患者生成的健康数据与 EHR 系统集成将改善症状 管理并带来更好的结果，例如活动功能、减轻疼痛和提高生活质量 与护理标准相比的基本原理是对患者进行生态瞬时评估。 症状可以促进更早、更明智的微观干预，例如改变药物、 加强康复或更有效的检查，从而改善患者的治疗结果。 将实现运营目标，为未来的试验完善和建立几个要素，包括： 使用 ROAMM-EHR 的入职和行为方法、随机化方案、研究结果、 质量保证和标准化、招聘和保留率、数据分析策略、技术 该方法是创新的，因为研究会。 首次努力不仅构建和实施，而且正式测试实时术后 症状监测平台，将患者从可穿戴设备生成的健康数据与 电子病历系统的研究意义重大，因为及时的术后恢复将防止长期的并发症。 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 规划最终试验的知识，以缩小移动医疗循证医学的主要差距 完成后，ROAMM-EHR 的实施和严格评估不仅会测试 变革性的临床工具，它将作为公共和私营部门其他努力奋斗的人的基础 充分利用移动医疗应用程序在医疗保健领域的前景。