Prevention of Opioid Use Disorder After Surgery: A Pilot and Feasibility Study

手术后预防阿片类药物使用障碍：试点和可行性研究

• 批准号: 10056744
• 负责人: Jeffrey Lawrence Schnipper
• 金额: $ 40.28万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10056744
• 关键词: Absence of pain sensation; Acute; Caregivers; Caring; Cellular Phone; Cessation of life; Chronic; Clinic; Communication; Counseling; Data; Day Surgery; Development; Dose; Emergency department visit; Family; Feasibility Studies; Future; Goals; Heroin; Hospitalization; Hospitals; Intervention; Interview; Learning; Measures; Methods; Monitor; Operative Surgical Procedures; Opioid; Opioid Analgesics; Orthopedic Surgery procedures; Orthopedics; Outpatients; Overdose; Pain; Pain management; Patient Self-Report; Patients; Pharmacists; Pilot Projects; Population; Postoperative Care; Postoperative Pain; Postoperative Period; Prescription opioid overdose; Prevention; Prevention program; Provider; Research; Risk Factors; Safety; Self Administration; Standardization; Suggestion; Surgeon; Surgical Management; Symptoms; Testing; Time; United States; Visit; base; community setting; design; follow-up; functional status; health care service utilization; health information technology; implementation research; implementation science; improved; innovation; intervention program; morphine equivalent; multi-component intervention; non-opioid analgesic; opioid epidemic; opioid misuse; opioid mortality; opioid overdose; opioid use; opioid use disorder; overdose death; patient engagement; patient population; prescription opioid; prevent; primary outcome; secondary outcome; stem; success; tool; treatment as usual; working group

The United States is in the midst of an opioid use crisis, including a disturbing rise in deaths from opioid overdoses and devastating personal and societal effects of opioid use disorder (OUD). OUD often starts with prescription opioid use, such as for the treatment of moderate to severe pain in post-operative patients. Previous studies have shown that a substantial number of patients who receive opioids for common surgical procedures develop persistent opioid use, a necessary first step towards OUD and its sequelae. A balanced approach to postoperative pain management for surgical patients is urgently needed to prevent persistent post- operative opioid use before it develops, thus helping to stem the tide of the opioid use crisis while still managing patients’ pain. The objective of this study is to design and pilot test the feasibility of a Multi-faceted persistent Opioid use Prevention Program (MOPP) to support safer opioid prescribing, self-administration and monitoring, and reduce persistent opioid use and opioid misuse for patients transitioning to the community setting after major orthopedic surgery. The multi-faceted intervention includes: 1) pharmacist-led discharge counseling of patients and caregivers and communication with post-discharge providers; 2) standardized opioid prescribing discharge order sets for each surgery type; 3) a post-discharge pain management follow-up visit (with additional contact as needed) embedded within routine post-operative care for managing pain and opioid use; and 4) a patient engagement pain management app for assessing pain, function, and possible development of OUD. These components have shown promise in prior studies of chronic opioid use but have not been previously implemented or evaluated in combination in this population with a goal of preventing persistent opioid use. The design of MOPP and its implementation will be continuously guided by a patient-family advisory council and diverse stakeholder steering committee and interdisciplinary working group. The primary outcome of the intervention will be persistent opioid use (in the 6 months after surgery) based on state-wide prescription data. Secondary outcomes will include long-term opioid episodes; morphine-equivalent dose of opioids prescribed at discharge; total post-operative opioids dispensed in the 6 months after surgery; self-reported pain, function, and signs or symptoms suggestive of opioid misuse 90 and 180 days after surgery; and post-operative healthcare utilization. We will measure intervention fidelity and use the Consolidated Framework for Implementation Research (CFIR) to guide qualitative interviews of patients, caregivers, and providers to identify barriers and facilitators of implementation. These approaches will help improve the implementation plan and provide lessons learned for future implementation efforts. The proposed study will provide valuable preliminary data to inform the development of a larger study to design, implement, and evaluate effective strategies to prevent persistent opioid use and subsequent opioid use disorder for post-surgical patients.

美国正处于阿片类药物使用危机之中，包括阿片类药物死亡人数令人不安的上升。 阿片类药物使用障碍(OUD)的过量和破坏性的个人和社会影响。OUD通常以 处方类阿片类药物的使用，如用于治疗术后患者的中度至重度疼痛。 先前的研究表明，相当数量的接受阿片类药物的患者用于普通外科手术 程序发展了持续的阿片类药物使用，这是走向OUD及其后遗症的必要的第一步。一个平衡的 迫切需要对手术患者进行术后疼痛管理，以防止持续的术后疼痛 在阿片类药物发展之前使用阿片类药物，从而有助于遏制阿片类药物使用危机的浪潮，同时仍 管理病人的痛苦。 这项研究的目的是设计和初步测试多方面持续使用阿片类药物的可行性 预防计划(MOPP)，以支持更安全的阿片类药物处方、自我给药和监测，以及 减少阿片类药物的持续使用和阿片类药物滥用 整形外科手术。多方面的干预措施包括：1)药师主导的出院咨询 和照顾者以及与出院后提供者的沟通；2)标准化的阿片类药物处方出院 每种手术类型的医嘱集；3)出院后疼痛管理随访(有额外联系 根据需要)嵌入常规术后护理以控制疼痛和阿片类药物的使用；以及4)患者 接洽疼痛管理应用程序，用于评估疼痛、功能和OUD的可能发展。这些 成分在先前的慢性阿片类药物使用研究中显示出了希望，但在此之前还没有 在这一人群中联合实施或评估，目的是防止持续使用阿片类药物。这个 MOPP的设计和实施将继续由患者-家庭咨询委员会和 不同利益攸关方指导委员会和跨学科工作组。改革的主要结果是 干预措施将是基于全州处方数据的持续阿片类药物使用(手术后6个月)。 次要结果将包括长期的阿片类药物发作；吗啡等量的阿片类药物处方在 出院；术后6个月内阿片类药物的使用总量；自我报告的疼痛、功能、 术后90天和180天出现阿片类药物滥用的体征或症状 医疗保健利用率。我们将衡量干预保真度，并使用综合框架 实施研究(CFIR)，指导对患者、护理人员和提供者的定性访谈，以 确定实施的障碍和促进者。这些方法将有助于改进执行情况。 为今后的执行工作规划和提供经验教训。拟议的研究将提供有价值的 初步数据为设计、实施和评估有效性的更大规模研究的开发提供信息 预防术后患者持续使用阿片类药物和随后的阿片类药物使用障碍的策略。