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.

摘要 阿片类药物流行是一种突发公共卫生事件，91%的滥用阿片类药物来自提供者 处方。手术后遗留的阿片类药物是滥用和转移注意力的主要来源：70%的药物 处方没有使用，但只有9%的人得到了适当的处理。到目前为止，干预措施的重点是限制 处方持续时间，执行处方指南，以及促进未用药处置的战略。 这些零碎的方法在研究和临床实践中显示出好坏参半的效果，在 与世隔绝。更全面的解决方案将理想地限制处方大小，安全地存储药片，提供 指导安全使用阿片类药物和逐渐减少，并为未使用的药片提供一种简便的方法，以防止转用。 我们与Addinex Tech合作，开发了一种用于术后的新型避孕药分配系统(PDS 阿片类药物的使用，以一种廉价的密码保护设备为中心。机械设备已关联 使用智能手机应用程序(APP)，为患者提供一次性密码来分发阿片类药物 根据需要，按照处方方定义的时间表从设备中取出。这款应用程序还为疼痛提供临床指导 根据患者报告的疼痛程度进行管理，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止痛时，该设备可以用预付信封邮寄处理。 在一项对30名接受了与癌症相关的大手术的患者进行的初步研究中，24人(80%)退回了该设备。输出 在总共开出的567片阿片类药物中，有397片(70%)没有使用，其中332片(84%)是通过邮寄处理的。 在这些令人鼓舞的结果的基础上，并响应计划宣布(PA-21-110)，我们建议 对140名接受癌症相关大手术的患者进行了这项技术的前瞻性队列研究。因为我们的 在试点研究中，我们已经扩大了我们的PDS的覆盖范围：该应用程序现在支持多种操作系统 并且有西班牙语版本。这些改进将使登记的患者队列更加多样化，并 将增加研究结果的概括性。我们将评估设备退货率和未使用的药片处理率， 以及PDS对减少阿片类药物消费和再灌装的影响。我们将同时评估 从患者的角度来看，在疼痛控制质量方面，实施科学的措施 可接受性和患者满意度的定性测量。我们经济实惠的PDS具有以下潜力 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 这项研究将为我们的系统进行一次大规模的随机试验。