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

项目概述：尽管人们对长期阿片类药物治疗(LTOT)的风险有了越来越多的了解，但它仍在- UES经常被开出，并且仍然是治疗慢性疼痛的主要药物。疾病控制与预防中心关于 开阿片类药物治疗慢性疼痛是针对初级保健提供者的，并已被采纳为 许多医疗保健组织和保险公司的护理标准。重要的是，它鼓励对PA的监测- 治疗阿片类药物相关危害的LTOT。通过实施监测，初级保健提供者可能会发现- 与行为有关的借条，有时称为异常药物相关行为或阿片类药物滥用行为， 出现在服用LTOT治疗慢性疼痛的个体中。这些行为(例如，错过约会、使用 超过处方的阿片类药物，要求增加阿片类药物剂量，攻击行为，以及酒精中毒 霍尔和其他物质使用)是常见的，令人担忧的，且可能代表不安全的使用LTOT或开发商- ING阿片使用障碍(OUD)。然而，疾控中心的指南和其他现有证据并未提供具体的- IC，关于如何在行为发生时解决这些问题的详细指导。因此，有一个关键的 需要了解如何最好地应对这些行为。我们研究计划的长期目标是 减少与LTOT有关的危害，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 流行病。作为实现这一目标的第一步，我们进行了一项德尔福研究，以严格建立 基于共识的方法来管理常见的和具有挑战性的行为，我们从这些行为中 创造了算法。使用基于证据的方法确定和实施实施战略 框架是在对算法进行任何测试之前必须进行的关键后续步骤。因此，我们将 追求下列具体目标：目标1：a)确定和b)实施战略 对于算法来说。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)。最佳实施策略 将通过初级保健提供商对标准化患者(SP)的体验来揭示，然后是 CFIR和Eric指导的团体采访。利用我们先前的专业知识开发临床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，我们将制定一套全面的“实施方案” 这可以提供给初级保健诊所。目标2：对这些算法进行试点试验。指导原则 基于CFIR的实施计划，并使用目标1b中制定的实施方案，我们将- 进行试点试验，以调查算法的可行性、可接受性和初步有效性。这个AP- Proach是创新的，因为它涉及到新的算法，并以一种新的方式使用SP来识别和操作- 使实施战略合理化。拟议的研究具有重要意义，因为它将导致R01到评估- 在有效性-实施类型2混合试验中评估算法和实施策略，如果 如果成功，将减少与阿片类药物滥用有关的危害，并减少其对阿片类药物流行的影响。

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.