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

项目摘要：尽管对长期阿片类药物治疗（LTOT）的风险有了越来越多的了解，但它仍在继续。 经常使用，并且仍然是治疗慢性疼痛的主要手段。CDC指南 处方阿片类药物治疗慢性疼痛是面向初级保健提供者，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，它鼓励监测pa- LTOT治疗阿片类药物相关危害的患者。通过实施监测，初级保健提供者可以发现各种各样的疾病， 关于行为的法律，有时称为异常药物相关行为或阿片类药物滥用行为， 出现在为慢性疼痛开LTOT处方的个体中。这些行为（例如，错过的约会，使用 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- 持有和其他物质使用）是常见的，涉及并可能代表LTOT或显影剂的不安全使用- 阿片类药物使用障碍（OUD）然而，CDC指南和其他现有证据并没有提供具体的 “行”是指行为发生时，如何处理行为的详细指导。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LTOT相关的危害，特别是阿片类药物滥用，并减少其对美国阿片类药物的影响 疫情作为实现这一目标的第一步，我们进行了一项德尔菲研究， 以共识为基础的方法来管理共同的和具有挑战性的有关行为，从我们 创建算法。利用循证战略确定和实施执行战略 框架是关键的下一步，必须发生在任何测试的算法。所以我们会 目标1：a）确定并B）实施实施战略 为算法。我们的方法将以《实施研究综合框架》为指导 实施变革的专家建议（ERIC）。最佳实施战略 将通过初级保健提供者与标准化患者（SP）的经验发现， CFIR和ERIC指导的小组面试。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 我们将制定一个全面的“实施方案”， that can be delivered交付to primary初级care保健practices做法.目标2：对算法进行试点试验。指导 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 进行一项试点试验，以调查算法的可行性、可接受性和初步有效性。这个ap- 方法是创新的，因为它涉及新颖的算法，并以新的方式使用SP，以识别和操作， 使实施战略合理化。这项研究是重要的，因为它将导致R 01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。

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.