Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and Reduce Refill Rates after Cancer Surgery

药丸分配系统在增加未使用阿片类药物的处置并降低癌症手术后补充率方面的功效

• 批准号: 10665967
• 负责人: DAWN HERSHMAN
• 金额: $ 28.79万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10665967
• 关键词: Brief Pain Inventory; Cancer Research Network; Client satisfaction; Clinical; Computerized Medical Record; Consumption; Data; Devices; Enrollment; Feedback; Guidelines; Intervention; Interview; Malignant Neoplasms; Mastectomy; Measures; Medical Waste Disposal; Methods; NIH Program Announcements; Operating System; Operative Surgical Procedures; Opioid; Pain; Pain management; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pilot Projects; Population; Postoperative Care; Postoperative Pain; Postoperative Period; Procedures; Prospective, cohort study; Provider; Quality Control; Questionnaires; Random Allocation; Randomized; Reporting; Research; Risk; Running; Schedule; Secure; Source; Southwest Oncology Group; Structure; Surveys; System; Tablet Computer; Technology; Time; Woman; cancer surgery; clinical practice; cohort; cost; cost effective; design; experience; implementation science; improved; mechanical device; mobile computing; novel; opioid epidemic; opioid misuse; opioid tapering; opioid use; pill; prescription monitoring program; prescription opioid; preservation; prevent; public health emergency; randomized trial; reconstruction; response; smartphone application; standard of care; usability

ABSTRACT The opioid epidemic is a public health emergency, and 91% of misused opioids originate from provider prescriptions. Left-over post-operative opioids are a major source of misuse and diversion: 70% of pills prescribed go unused, but only 9% are disposed appropriately. Interventions to date have focused on limiting prescription duration, implementing prescription guidelines, and strategies to promote disposal of unused pills. These piecemeal approaches have shown mixed efficacy in studies and clinical practice and are insufficient in isolation. A more all-encompassing solution would ideally limit prescription size, securely store pills, provide guidance on safe opioid use and tapering, and offer an easy method for unused pill disposal to prevent diversion. In partnership with Addinex Tech, we have developed a novel pill-dispensing system (PDS) for post-operative opioid use, centered around an inexpensive, password-protected device. The mechanical device is associated with a smartphone application (app) that provides patients with one-time passwords to dispense opioid tablets from the device as needed, on a prescriber-defined schedule. The app also provides clinical guidance for pain management based on patient-reported pain levels and suggests opioid tapering strategies when indicated. When patients no longer require opioids for pain, the device can be mailed in a prepaid envelope for disposal. In a pilot study of 30 patients who underwent major cancer-related surgery, 24 (80%) returned the device. Out of 567 total opioid pills prescribed, 397 (70%) went unused, and 332 (84%) of those were disposed of by mail. Building off these encouraging results, and in response to Program Announcement (PA-21-110) we propose a prospective cohort study of this technology in 140 patients who undergo major cancer-related surgery. Since our pilot study, we have expanded the reach of our PDS: the app is now supported by multiple operating systems and is available in Spanish. These improvements will enable the enrollment of a more diverse patient cohort and will increase the generalizability of the findings. We will assess rates of device return and unused pill disposal, as well as the impact of the PDS on reducing opioid consumption and refills. We will concomitantly evaluate the PDS from the patient perspective, in terms of pain control quality, implementation science measures of acceptability, and qualitative measures of patient satisfaction. Our cost-effective PDS has the potential to meaningfully reduce post-operative opioid misuse and diversion while preserving pain control. The results of this study will inform a large, randomized trial of our system.

抽象的 阿片类药物流行病是突发公共卫生事件，91% 的滥用阿片类药物来自提供者 处方。术后残留的阿片类药物是滥用和转移的主要来源：70% 的药物 规定的未使用，但只有 9% 得到妥善处理。迄今为止的干预措施主要集中在限制 处方持续时间、实施处方指南以及促进未使用药物处置的策略。 这些零碎的方法在研究和临床实践中显示出不同的功效，并且在治疗方面还不够。 隔离。理想情况下，更全面的解决方案将限制处方大小、安全地存储药丸、提供 关于阿片类药物的安全使用和逐渐减少的指导，并提供一种简单的方法来处理未使用的药丸，以防止转移。 我们与 Addinex Tech 合作，开发了一种用于术后的新型药丸分配系统 (PDS) 阿片类药物的使用，以廉价、受密码保护的设备为中心。机械装置关联 通过智能手机应用程序 (app) 为患者提供一次性密码以分配阿片类药物片剂 根据需要，按照处方者定义的时间表从设备进行操作。该应用程序还提供疼痛的临床指导 根据患者报告的疼痛程度进行管理，并在有需要时建议阿片类药物逐渐减少的策略。 当患者不再需要阿片类药物来止痛时，可以将设备装在预付费信封中邮寄以供处置。 在一项对 30 名接受过重大癌症相关手术的患者进行的试点研究中，24 名患者 (80%) 归还了该设备。出去 在总共开具的 567 粒阿片类药物药丸中，有 397 粒（70%）未使用，其中 332 粒（84%）通过邮寄方式处理掉。 在这些令人鼓舞的成果的基础上，为了响应计划公告 (PA-21-110)，我们提出了 该技术对 140 名接受重大癌症相关手术的患者进行了前瞻性队列研究。自从我们的 试点研究中，我们扩大了 PDS 的覆盖范围：该应用程序现在支持多个操作系统 并且有西班牙语版本。这些改进将使更多样化的患者群体得以注册， 将增加研究结果的普遍性。我们将评估设备退货率和未使用的药丸处置率， 以及 PDS 对减少阿片类药物消费和补充的影响。我们将同时评估 PDS从患者角度出发，在疼痛控制质量方面，实施科学的措施 可接受性以及患者满意度的定性测量。我们具有成本效益的 PDS 有潜力 有意义地减少术后阿片类药物的滥用和转移，同时保持疼痛控制。这样做的结果 研究将为我们系统的大型随机试验提供信息。