Evaluation of a Mobile Application for Patients and Clinical Decision-making Support Tools for Prescribers to Decrease Opioid Misuse and Habit-forming Behaviors Following Post-operative Prescription

对患者移动应用程序和处方者临床决策支持工具的评估，以减少术后处方后阿片类药物滥用和习惯形成行为

• 批准号: 10390242
• 负责人: Steven Walther
• 金额: $ 76.2万
• 依托单位: CONTINUOUS PRECISION MEDICINE, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10390242
• 关键词: Absence of pain sensation; Adherence; Affect; Algorithms; Anti-Inflammatory Agents; Behavior; Client; Clinical; Communication; Communities; Computer software; Data; Data Analytics; Data Management Resources; Data Reporting; Databases; Devices; Distress; Dose; Drug Kinetics; Drug Modelings; Ecosystem; Ensure; Epidemic; Euphoria; Evaluation; Feedback; Funding; Habits; Health Insurance Portability and Accountability Act; Heroin; Heroin Users; Intervention; Lead; Logistics; Measures; Monitor; Morphine; Opioid; Organism; Outcome; Outcome Measure; Pain; Pain management; Patient Monitoring; Patient Self-Report; Patients; Pattern; Persons; Pharmaceutical Preparations; Pharmacodynamics; Phase; Physicians; Postoperative Pain; Postoperative Period; Provider; Public Health; Records; Regimen; Reporting; Schedule; Signal Transduction; Small Business Innovation Research Grant; Support System; Symptoms; System; Testing; Time; Withdrawal; clinical decision support; clinical decision-making; dashboard; data management; data portal; data visualization; digital; drug seeking behavior; experience; improved; innovation; medication compliance; milligram; misuse of prescription only drugs; mobile application; opioid epidemic; opioid misuse; opioid use; opioid use disorder; overdose death; pain relief; pain score; patient-clinician communication; pharmacodynamic model; pharmacokinetic model; precision medicine; prescription opioid; prevent; provider portal; real time monitoring; satisfaction; success; support tools; system architecture; treatment planning; usability

PROJECT SUMMARY/ABSTRACT Opioid misuse is an epidemic and a public health crisis. At least 2 million people have an opioid use disorder (OUD) involving prescription opioids, and 600,000 have heroin OUD6. Alarmingly, 80% of heroin users used prescription opioids before transitioning to heroin7. It is therefore critical to ensure that opioid pain therapies are administered safely, in a way that minimizes the potential for aberrant drug related behaviors. This necessitates individualized opioid regimens and strict adherence, enabling effective pain control without producing euphoria or withdrawals, both of which can lead to drug seeking behaviors. Continuous Precision Medicine (CPM) aims to develop a software ecosystem to reduce opioid misuse and over-prescription in postoperative patients. In a self-funded Phase I, we have developed clinical decision support software, which consists of a server for data management and analytics and a mobile client application for the patient. The digital platform delivers a personalized schedule, records dosing and pain levels, and motivates adherence to dosing by scoring compliance. In this project, we propose to evaluate and improve the CPM suite of clinical decision support tools and provide clinicians and patients with immediately actionable information to decrease over-prescription and misuse of opioids during the post-operative period. In the proposed Phase II SBIR project, CPM will refine and evaluate the mobile application, deploy and test a Prescriber Portal with dashboard functions to enable physicians to overlay pharmacokinetic and pharmacodynamic modeling to improve prescribing practices and deter drug-habit-forming behavior, and prepare materials for a 501(k) application submission. The CPM app, patient data, and provider portal, taken together and optimally employed to improve patient-provider communication and treatment planning, has the potential to prevent negative sequelae associated with over-prescription and misuse of opioids, including opioid use disorder, overdose, and death.

项目摘要/摘要 阿片类药物滥用是一种流行病，也是一种公共卫生危机。至少有200万人使用阿片类药物 涉及处方类阿片类药物的精神障碍，600,000人有海洛因OUD6。令人震惊的是，80%的海洛因吸毒者 在过渡到英雄7之前使用处方阿片类药物。因此，确保阿片类疼痛是至关重要的 治疗是安全的，以一种将异常药物相关行为的可能性降至最低的方式。 这需要个体化的阿片类药物方案和严格的坚持，从而实现有效的疼痛控制，而无需 产生欣快感或退缩，这两者都可能导致寻求毒品的行为。连续精度 医学(CPM)旨在开发一个软件生态系统，以减少阿片类药物的滥用和过度处方 在术后患者中。在自筹资金的第一阶段，我们开发了临床决策支持软件， 它由用于数据管理和分析的服务器和用于患者的移动客户端应用程序组成。 数字平台提供个性化的时间表，记录剂量和疼痛程度，并激励 通过对遵从性进行评分来坚持服药。在本项目中，我们建议对CPM套件进行评估和改进 临床决策支持工具，并为临床医生和患者提供即时可操作的信息 减少术后阿片类药物的过度处方和滥用。在拟议的第二阶段 SBIR项目，CPM将改进和评估移动应用程序，部署和测试Prescriber门户 仪表板功能使医生能够叠加药代动力学和药效学建模，以 改进处方做法，遏制吸毒成瘾行为，并为501(K)计划准备材料 提交申请。CPM应用程序、患者数据和提供商门户结合在一起，以最佳方式 用于改善患者与提供者的沟通和治疗计划，有可能预防 与过量处方和滥用阿片类药物有关的负面后遗症，包括阿片类药物的使用 紊乱、服药过量和死亡。