The Ohio Valley Node of the Clinical Trials Network

临床试验网络俄亥俄谷节点

• 批准号: 10621497
• 负责人: T John WINHUSEN
• 金额: $ 50.25万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10621497
• 关键词: Address; Adoption; American; Buprenorphine; Caring; Clinical; Clinical Trials Network; Code; Community Pharmacy; Data; Death Certificates; Drug Prescriptions; Enrollment; Future; Health; Health Services Research; Intervention; Interview; Measures; Methods; Monitor; Naloxone; Narcotics; Ohio; Opioid; Outcome Measure; Output; Overdose; Patients; Pharmacists; Pharmacy facility; Phase; Poverty; Public Health; Randomized; Risk; Service setting; arm; base; clinical decision support; clinically actionable; design; evidence base; follow-up; implementation barriers; implementation facilitators; intervention delivery; opioid epidemic; opioid use; patient engagement; prescription opioid; prescription opioid misuse; primary outcome; screening; secondary outcome; service delivery; support tools; tool; treatment as usual; treatment services; uptake

PUBLIC HEALTH ABSTRACT Approximately 36% of the more than 9 million patients in the US who misused opioid prescriptions in 2019 obtained them through receipt of prescribed medications. Most (>90%) Americans live <5 miles of a community pharmacy—a high potential but under-developed service setting for engagement of patients regarding risky opioid use. The most common tool available to pharmacists for monitoring opioid use among patients is PDMPs. PDMP output data is limited in its clinical utility and does not provide robust decision support. Our team previously identified clinically meaningful risk thresholds and validated the PDMP based Narcotic Score (NS) metric. The NS metric has strong potential to serve as a universal prescription opioid risk screener and entry-point to evidence-based care. This study will implement NS metric thresholds into an existing Clinical Decision Support (CDS) platform and adapt the platform for confirmatory screening and intervention delivery. This study will also assess the impact of the CDS tool on patients as well as examine implementation barriers and facilitators for large-scale rollout. Specifically, this project will conduct a type-1 implementation mixed methods study using a 2-arm parallel group clustered randomized design (randomized by pharmacy, stratified by zip code poverty level). The CDS tool will be evaluated within a division of a large- scale retail pharmacy chain (n=50 CDS pharmacies/n=50 usual care pharmacies). This design includes a 6- month enrollment phase and a 6-month follow up phase. Outcome measures will be drawn from administrative data and include: risky opioid medication use measured by the NS metric as the primary outcome—with secondary outcomes including fatal overdose measured by death certificate data, buprenorphine uptake, and quality of opioid medication care. The primary hypothesis is those within moderate or high NS metric groups will be more likely to reduce risk status to low or moderate-risk following intervention exposure compared to usual care. We will also conduct qualitative interviews with key pharmacy chain (N=15) and PDMP (N=15) leaders to assess facilitators and barriers of CDS adoption and continued utilization. This study establishes a CDS platform for future large-scale community pharmacy-based opioid treatment service delivery and research.

公共卫生摘要 在美国900多万滥用阿片类药物处方的患者中，约36%的人 2019年通过收到处方药获得的。大多数(90%)美国人居住在5英里以外的地方 社区药房--一个潜力很大但不发达的服务场所，可供患者使用 关于危险的阿片类药物使用。药剂师可用来监测阿片类药物使用的最常见工具包括 患者为PDMPs。PDMP输出数据的临床应用有限，不能提供可靠的决策 支持。我们的团队之前确定了具有临床意义的风险阈值并验证了基于PDMP的 麻醉评分(NS)指标。NS指标有很强的潜力作为通用处方阿片类药物风险 循证护理的筛查者和切入点。这项研究将把NS指标阈值实施到 现有的临床决策支持(CDS)平台，并使该平台适用于验证性筛查和 干预性交付。这项研究还将评估CDS工具对患者的影响以及检查 大规模推广的实施障碍和推动者。具体地说，该项目将进行类型1 实施混合方法研究，采用2臂平行组群随机设计(随机 按药房，按邮政编码贫困程度分层)。CDS工具将在大型- 规模零售连锁药店(n=50家CDS药店/n=50家普通护理药店)。这一设计包括一款6- 一个月的注册阶段和6个月的跟踪阶段。结果措施将来自行政部门 数据和包括：以NS指标衡量的高风险阿片类药物使用作为主要结果- 次要结果包括通过死亡证明数据测量的致命过量，丁丙诺啡摄取，以及 阿片类药物治疗的质量。主要假设是那些处于中等或高NS度量组的人 与以下情况相比，干预暴露后更有可能将风险状态降低到低或中等风险 照常照看。我们还将对关键连锁药店(N=15)和PDMP(N=15)进行定性访谈 领导人评估CDS采用和持续利用的促进者和障碍。这项研究建立了一个 CDS平台为未来大规模的社区药房阿片类药物治疗服务提供和 研究。