Toward safer opioid prescribing for chronic pain in high risk populations: implementing the Centers for Disease Control Guideline (CDC) guideline in the primary care HIV clinic

项目摘要/摘要 2016年3月，疾病控制中心发布了慢性阿片类药物处方指南(CDCG) 普通初级保健环境中的疼痛，其目的是减少处方阿片类药物相关的伤害，同时 维持疼痛控制和功能。然而，由于缺乏关于处方有效性的数据 阿片类药物风险缓解战略，CDCG的一些建议含糊不清，以及具有挑战性 在患者和提供者之间的阿片类药物对话中，CDCG的成功可能取决于它的方式 在个人护理环境中实施。在这项提案中，我们选择将重点放在艾滋病毒的初级保健上 我们将为其开发一个定制的、算法可测试的CDCG(CDCG干预)版本， 然后在随机对照的可行性研究中进行试点。 开发过程将涉及与利益攸关方的合作。首先，我们将征求建议 来自50名艾滋病毒感染者，采用了一种公众审议程序。接下来，我们将与一个 艾滋病毒医疗保健提供者顾问委员会使用这些建议来制定和反复完善 CDCG干预。在可行性研究中，我们将对10名艾滋病毒初级保健提供者进行随机抽样和培训 (PCP)为自愿接受的患者(每个PCP~5名)提供CDCG干预或常规护理 已经为慢性疼痛开了阿片类药物。干预将提供6个月，在此期间 患者-参与者将被监测阿片类药物滥用的迹象，以及疼痛控制、抗逆转录病毒的变化 忠诚度，以及他们与供应商的关系。将审查可行性的多个方面，包括 但不限于：初级保健医生的招募和随机化，在持续期间保持干预的保真度 研究的适当性，对照组的适当性，以及结果衡量标准的适当性。 这项研究的结果将为未来的大型随机对照试验奠定基础，该试验将提供 CDCG干预在提高HIV处方阿片类药物安全性方面有效性的证据 ，还将提供关于如何最好地在其他地方实施CDCG的见解 设置。

Project Summary/Abstract In March 2016, the Centers for Disease Control issued a guideline (CDCG) for prescribing opioids for chronic pain in general primary care settings, which was intended to reduce prescription opioid-related harms while maintaining pain control and function. However, due to a paucity of data on the effectiveness of prescription opioid risk mitigation strategies, ambiguity in some of the CDCG recommendations, and the challenging nature of the patient-provider opioid conversation, the success of the CDCG may hinge on the manner in which it is implemented in individual care settings. In this proposal, we have chosen to focus on the HIV primary care setting for which we will develop a tailored, algorithmic “testable” version of the CDCG (“CDCG intervention”), and then pilot it in a randomized-controlled feasibility study. The development process will involve collaboration with stakeholders. First we will elicit recommendations from 50 HIV-infected individuals using a process of Public Deliberation. Next we will collaborate with an advisory board of HIV healthcare providers to use these recommendations to develop and iteratively refine the CDCG intervention. For the feasibility study, we will randomize and train 10 HIV primary care providers (PCPs) to provide the CDCG intervention or usual care to consenting patients (~5 per PCP) to whom they already prescribe opioids for chronic pain. The intervention will be provided for 6 months during which time patient-participants will be monitored for signs of opioid misuse, and changes in pain control, antiretroviral adherence, and their relationship with their provider. Multiple aspects of feasibility will be examined, including but not limited to: recruitment and randomization of PCPs, maintenance of intervention fidelity for the duration of the study, appropriateness of the control arm, and appropriateness of the outcome measures. The results of the study will be the basis for a future large, randomized controlled trial which will provide evidence for the effectiveness of the CDCG intervention in improving prescription opioid safety in the HIV primary care setting, and will also provide insights into how the CDCG might best be implemented in other settings.