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 在美国遗漏阿片类药物处方的900万患者中，约有36％ 2019年通过收到规定的药物获得了它们。大多数（> 90％）的美国人居住<5英里 社区药房 - 一种高潜力但不发达的服务环境，用于患者的参与度 关于风险的Ooid使用。药剂师可用的最常见工具用于监视OID的使用 患者是PDMP。 PDMP输出数据的临床实用性受到限制，并且不提供强大的决定 支持。我们的团队先前确定了具有临床意义的风险阈值，并验证了基于PDMP 麻醉分数（NS）度量。 NS度量具有强大的潜力，可以作为普遍处方OID风险 筛选器和基于证据的护理的入口。这项研究将将NS度量阈值实现为 现有的临床决策支持（CDS）平台，并调整平台以进行确认筛查和 干预交付。这项研究还将评估CDS工具对患者的影响，并检查 大规模推出的实施障碍和促进者。具体来说，该项目将进行1型 实施混合方法研究使用2臂并行组聚类的随机设计（随机） 由药房，按邮政编码贫困水平进行分层）。 CDS工具将在大型的一个划分中进行评估 比例零售药房链（n = 50 CDS Pharmacies/n = 50常规护理药房）。该设计包括一个6- 月注册阶段和6个月的随访阶段。结果措施将从行政中得出 数据并包括：NS度量标准衡量的风险的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药物，丁丙诺啡吸收和 阿片类药物护理的质量。主要假设是中度或高NS度量组中的假设 与 通常的护理。我们还将对关键药房链（n = 15）和PDMP（n = 15）进行定性访谈 领导者评估CD采用和持续利用的促进者和障碍。这项研究确立了 未来大规模社区药房的阿片类药物治疗服务的CDS平台交付和 研究。