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

摘要 这项研究考察了一种以社区药房为基础的干预措施，以减少阿片类药物的滥用。 尽管最近全国阿片类药物处方数量有所下降，但2018年有1030万美国人报告滥用前阿片类药物。 阿片类药物，在这一人群中，36%的滥用者通过填充 一张处方。药品调剂的切入点，即社区药房，是一种尚未开发的资源 解决处方阿片类药物滥用问题--特别是在考虑到60,000家药店雇用 美国有17万名药剂师。我们已经建立了初步数据，为 目前的项目：(1)药剂师担心滥用，但需要培训和资源才能成为- (2)社区药房患者可在这些环境中成功筛查滥用情况；(3)我们有 建立了符合当前药房做法的综合护理干预措施-简短干预-Medica- 治疗管理(BI-MTM)；以及(4)我们的试点数据已显示支持可行性、可接受性、预 临终干预效果。受到这些发现的鼓舞，我们现在的目标是进行一项全面的随机对照试验 BI-MTM在社区药房环境中的干预将实现3个具体目标。第一个目标是 证明药剂师主导的BI-MTM干预优于标准药物咨询(SMC) 减少阿片类药物滥用。这将通过进行有动力的单盲随机数来实现- 对照研究BI-MTM(n=175)与SMC(n=175)的疗效。将对参与者进行筛选/招募 犹他州14家社区药店配药点合格，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个月时接受阿片类药物滥用评估。参与者- 水平状态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 滥用药物行为(例如，早期续药和医生/药房购物)。第二个目标是确定 BI-MTM改善抑郁、疼痛以及随后的阿片类药物滥用的途径。 为了实现这一点，路径分析将评估BI-MTM的关系：(1)关于抑郁、疼痛和滥用， (2)误用后抑郁，(3)误用时疼痛。我们的最终目标是探索从基线到后期的潜在过渡 按干预组分的干预误用类别。这将通过使用混合建模来完成，指定- 多组潜伏跃迁分析。我们将使用观察到的滥用指标来估计潜在的类别 根据治疗情况分组，并根据基线协变量进行调整。正在完成SA1- 3提高对BI-MTM疗效的认识，为全国多点试验奠定基础。

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.