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 阿片类药物流行是公共卫生的紧急情况，有91％的滥用阿片类药物来自提供者 处方。剩下的术后阿片类药物是滥用和转移的主要来源：70％的药丸 规定未使用，但只有9％的处置适当地处置。迄今为止的干预措施集中于限制 处方持续时间，实施处方指南以及促进处置未使用药丸的策略。 这些零碎的方法在研究和临床实践中表现出混合功效，并且不足 隔离。理想情况下，更无所不包的解决方案将限制处方尺寸，安全储存药，提供 关于安全阿片类药物使用和逐渐变细的指南，并为防止不使用的药丸处置提供了一种简单的方法来防止转移。 与Addinex Tech合作，我们开发了一种新颖的药丸分解系统（PDS） 阿片类药物的使用围绕廉价，密码保护的设备。机械设备相关 使用智能手机应用程序（APP）为患者提供一次性密码以分配阿片类药片 根据需要从设备上按照处方定义的时间表。该应用程序还提供疼痛的临床指导 基于患者报告的疼痛水平的管理，并在指示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疼痛时，可以将该设备邮寄到预付费的信封中以进行处置。 在一项针对30例接受主要癌症相关手术的患者的试点研究中，有24名（80％）返回了该设备。出去 在规定的567份阿片类药丸中，有397（70％）未使用，其中332（84％）是通过邮件处置的。 建立这些令人鼓舞的结果，并回应计划公告（PA-21-110），我们提出了一个 该技术的前瞻性队列研究对140例接受了与癌症相关的主要手术的患者进行了研究。自从我们 试点研究，我们扩大了PD的影响力：该应用程序现在得到了多个操作系统的支持 并提供西班牙语。这些改进将使更多样化的患者队列的招生和 将增加调查结果的普遍性。我们将评估设备回报率和未使用的药丸处置， 以及PDS对减少阿片类药物消耗和补充的影响。我们将同时评估 从患者的角度来看，PD在疼痛控制质量方面，实施科学措施 可接受性和患者满意度的定性措施。我们具有成本效益的PD有可能 有意义地减少术后阿片类药物滥用和转移，同时保留疼痛控制。结果的结果 研究将为我们系统的大型随机试验提供信息。