Consensus-based algorithms to address opioid misuse behaviors among individuals prescribed long-term opioid therapy: developing implementation strategies and pilot testing

基于共识的算法，用于解决接受长期阿片类药物治疗的个体中阿片类药物滥用行为：制定实施策略和试点测试

• 批准号: 10202542
• 负责人: Jessica S Merlin
• 金额: $ 23.48万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10202542
• 关键词: Address; Adopted; Aggressive behavior; Alcohols; Algorithms; Appointment; Behavior; Centers for Disease Control and Prevention (U.S.); Clinic; Clinical; Collaborations; Consensus; Consolidated Framework for Implementation Research; Delphi Study; Diagnosis; Diagnostic and Statistical Manual of Mental Disorders; Dose; Drug Prescriptions; Educational Materials; Effectiveness; Electronic Health Record; Goals; Group Interviews; Guidelines; Helping to End Addiction Long-term; Individual; Insurance; Insurance Carriers; Intervention; Investigation; Medical; Medical center; Methods; Monitor; Opioid; Pain; Pain management; Participant; Patient Monitoring; Patients; Pharmaceutical Preparations; Policies; Primary Health Care; Provider; Randomized; Recommendation; Research; Research Personnel; Risk; Risk Reduction; Site; Standardization; Surveys; Symptoms; Syndrome; System; Testing; Time; Training; United States National Institutes of Health; Universities; Visit; Waiting Lists; acceptability and feasibility; base; care providers; chronic pain; clinical decision support; effectiveness outcome; evidence base; experience; health care service organization; hybrid type 2 trial; implementation strategy; improved; innovation; novel; opioid epidemic; opioid misuse; opioid therapy; opioid use disorder; outreach; pilot trial; prescription opioid; pressure; programs; recruit; standard of care; substance use

Project Summary: Despite a growing understanding of the risks of long-term opioid therapy (LTOT), it contin- ues to be frequently prescribed and remains a mainstay of treatment for chronic pain. The CDC Guideline for Prescribing Opioids for Chronic Pain is geared toward primary care providers and has been adopted as the standard of care by many healthcare organizations and insurers. Importantly, it encourages monitoring of pa- tients on LTOT for opioid-related harms. By implementing monitoring, primary care providers may uncover var- ious concerning behaviors, sometimes called aberrant drug-related behaviors or opioid misuse behaviors, that arise among individuals prescribed LTOT for chronic pain. These behaviors (e.g., missed appointments, using more opioid medication than prescribed, asking for an increase in opioid dose, aggressive behavior, and alco- hol and other substance use) are common, concerning, and may represent unsafe use of LTOT or a develop- ing opioid use disorder (OUD). However, the CDC Guideline and other existing evidence do not provide specif- ic, detailed guidance about how to address concerning behaviors when they occur. Therefore, there is a critical need to understand how to best respond to these behaviors. The long-term goal of our program of research is to reduce LTOT-related harms, particularly from opioid misuse, and diminish their impact on the U.S. opioid epidemic. As a first step toward accomplishing this goal, we conducted a Delphi study to rigorously establish consensus-based approaches to managing common and challenging concerning behaviors, from which we created algorithms. Identifying and operationalizing implementation strategies using an evidence-based framework are the critical next steps that must occur before any testing of the algorithms. Therefore, we will pursue the following Specific Aims: Aim 1: To a) identify and b) operationalize implementation strategies for the algorithms. Our approach will be guided by the Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC). Optimal implementation strategies will be uncovered through primary care provider experiences with Standardized Patients (SPs) followed by CFIR- and ERIC-guided group interviews. Using our prior expertise developing clinic-wide opioid risk reduction strategies and a Patient-Provider advisory board, we will develop a comprehensive “implementation package” that can be delivered to primary care practices. Aim 2: To conduct a pilot trial of the algorithms. Guided by the CFIR-based implementation plan and using the implementation package developed in Aim 1b, we will con- duct a pilot trial to investigate the algorithms’ feasibility, acceptability, and preliminary effectiveness. This ap- proach is innovative because it involves novel algorithms and uses SPs in a new way, to identify and opera- tionalize implementation strategies. The proposed research is significant because it will lead to an R01 to eval- uate the algorithms and implementation strategies in an effectiveness-implementation type 2 hybrid trial that, if successful, would reduce opioid misuse-related harms and diminish their impact on the opioid epidemic.

项目摘要：尽管人们越来越了解长期阿片类药物治疗 (LTOT) 的风险，但它仍然存在 经常被开出处方，并且仍然是治疗慢性疼痛的主要方法。 为慢性疼痛开阿片类药物是针对初级保健提供者，并已被采用为 重要的是，它鼓励对患者进行监控。 通过实施监测，初级保健提供者可能会发现因阿片类药物相关危害而接受 LTOT 的患者。 令人担忧的行为，有时称为异常药物相关行为或阿片类药物滥用行为， 这些行为（例如，错过预约、使用 LTOT 治疗慢性疼痛）中出现。 比处方更多的阿片类药物、要求增加阿片类药物剂量、攻击性行为和酒精 hol 和其他物质的使用）是常见的、令人担忧的，并且可能代表 LTOT 或开发中的不安全使用 然而，CDC 指南和其他现有证据并未提供具体信息。 因此，有一个关键的指导，说明如何在发生相关行为时进行处理。 我们研究计划的长期目标是了解如何最好地应对这些行为。 减少 LTOT 相关危害，特别是阿片类药物滥用造成的危害，并减少其对美国阿片类药物的影响 作为实现这一目标的第一步，我们进行了德尔菲研究来严格建立。 基于共识的方法来管理常见和具有挑战性的行为，从中我们 使用基于证据的算法来识别和实施实施策略。 框架是对算法进行任何测试之前必须执行的关键后续步骤。 追求以下具体目标： 目标 1：a) 确定和 b) 实施实施战略 我们的方法将以实施研究综合框架为指导。 (CFIR) 和实施变革的专家建议 (ERIC)。 将通过初级保健提供者与标准化患者 (SP) 的经验来发现，然后 CFIR 和 ERIC 指导的小组访谈利用我们先前的专业知识开发诊所范围内的阿片类药物风险降低。 战略和患者提供者咨询委员会，我们将制定全面的“实施方案” 目标 2：对算法进行试点试验。 基于 CFIR 的计划实施并使用目标 1b 中开发的实施包，我们将继续 进行试点，研究算法的可行性、可接受性和初步有效性。 proach 是创新的，因为它涉及新颖的算法并以新的方式使用 SP 来识别和操作 拟议的研究意义重大，因为它将导致 R01 评估- 在有效性实施类型 2 混合试验中使用算法和策略实施，如果 如果成功，将减少阿片类药物滥用相关的危害并减少其对阿片类药物流行的影响。