Prescription Opioid Misuse: A Pharmacist-Led Intervention at Point of Service Efficacy Trial

摘要 本研究探讨了一种以社区药房为基础的干预措施，以减少阿片类药物滥用。 尽管最近全国阿片类药物处方量有所下降，但2018年有1030万美国人报告滥用了前 在这一人群中，>36%的滥用者通过填充阿片类药物获得阿片类药物， 开处方.配药点，即社区药房，是一个未开发的资源 解决处方阿片类药物滥用问题，特别是考虑到超过60，000家药店 在美国有超过17万名药剂师。我们已经建立了初步数据，为 目前的项目：（1）药剂师关注滥用，但需要培训和资源，以成为 （2）社区药房患者可以在这些环境中成功筛查滥用;（3）我们有 建立了符合当前药房实践的综合护理干预措施-简短干预-Medica- 治疗管理（BI-MTM）;（4）我们的试点数据显示支持可行性，可接受性，预 干预效果差。在这些发现的鼓舞下，我们现在的目标是进行一项全面的RCT， BI-MTM在社区药房环境中的干预将实现3个特定目标。第一个目标将 证明药剂师主导的BI-MTM干预上级于标准药物咨询（SMC）， 减少阿片类药物滥用。这将通过进行一项有把握度的单盲随机- 测试BI-MTM（n=175）vs. SMC（n =175）有效性的标准化试验。将筛选/招募参与者， 犹他州14家社区药房配药时的合格性，高阿片类药物处方和阿片类药物不良反应 事件状态。参与者将在基线、2个月和6个月时评估阿片类药物滥用。参与者- 一级州处方药监测数据也将与患者结果联系起来，以评估客观变化 在药物滥用行为中（例如，早期再填充和医生/药房购物）。第二个目标将确定 BI-MTM导致抑郁、疼痛和随后阿片类药物滥用改善的途径。 为了实现这一点，路径分析将评估BI-MTM的关系：（1）抑郁，疼痛和误用， (2)误用时抑郁;（3）误用时疼痛。我们的最终目标将探索基线到后的潜在过渡， 干预组滥用干预类。这将通过使用混合建模来实现，具体如下： 多组潜在变迁分析。我们将采用观察到的误用指标来估计潜在类别 随时间推移的转换，按治疗条件分组并根据基线协变量进行调整。完成SA 1- 3推进对BI-MTM疗效的理解，并为全国多中心试验奠定基础。

ABSTRACT This study examines a community pharmacy-based intervention to reduce opioid medication misuse. Despite a recent national decline in opioid prescribing, 10.3 million Americans in 2018 reported misusing a pre- scribed opioid, and within this population, >36% of those who misused obtained the opioid medication by filling a prescription. The point of medication dispensing, namely the community pharmacy, is a an untapped resource to address prescription opioid misuse—especially when considering the >60,000 pharmacies employing >170,000 pharmacists in the US. We have established preliminary data that provides important support for the current project: (1) pharmacists are concerned about misuse but need training and resources to become in- volved; (2) community pharmacy patients can be screened successfully for misuse in these settings; (3) we have established an integrated care intervention amenable to current pharmacy practice—Brief Intervention-Medica- tion Therapy Management (BI-MTM); and (4) our pilot data has shown support for feasibility, acceptability, pre- liminary intervention efficacy. Encouraged by these findings, we now aim to conduct a fully-powered RCT of the BI-MTM intervention in community pharmacy settings that will accomplish 3 Specific Aims. The first Aim will demonstrate the pharmacist-led BI-MTM intervention is superior to standard medication counseling (SMC) for mitigating opioid medication misuse. This will be accomplished by conducting a powered single-blinded random- ized trial to test the efficacy of BI-MTM (n=175) vs. SMC (n=175). Participants will be screened/recruited for eligibility at point of dispensing in 14 community pharmacies in Utah, a high opioid prescribing and opioid-adverse event state. Participants will be assessed at baseline, 2, and 6 months for opioid medication misuse. Participant- level state prescription drug monitoring data will also be linked with patient outcomes to assess objective changes in medication misuse behaviors (e.g., early refills and doctor/pharmacy shopping). The second Aim will identify the pathway by which BI-MTM results in improvements for depression, pain, and subsequently opioid misuse. To accomplish this, a path analysis will assess relationships of BI-MTM: (1) on depression, pain, and misuse, (2) depression on misuse, and (3) pain on misuse. Our final Aim will explore latent transitions of baseline to post- intervention misuse classes by intervention group. This will be accomplished by using mixture modeling, specif- ically multi-group latent transition analysis. We will employ observed misuse indicators to estimate latent class transitions across time, grouping by treatment condition and adjusting for baseline covariates. Completing SA1- 3 advance the understanding of BI-MTM efficacy and set the stage for a national multisite trial.