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 美国超过 900 万患者中约有 36% 滥用阿片类药物处方 2019年通过收到处方药获得它们。大多数 (>90%) 美国人的居住距离小于 5 英里 社区药房——一个潜力巨大但尚未开发的患者参与服务环境 关于阿片类药物的危险使用。药剂师用于监测阿片类药物使用情况的最常用工具 患者是 PDMP。 PDMP 输出数据的临床效用有限，不能提供稳健的决策 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 指标具有作为通用处方阿片类药物风险的巨大潜力 循证护理的筛选器和切入点。本研究将 NS 指标阈值实施到 现有的临床决策支持（CDS）平台，并调整该平台以进行验证性筛查和 干预实施。这项研究还将评估 CDS 工具对患者的影响并检查 大规模推广的实施障碍和促进因素。具体来说，该项目将进行类型 1 使用 2 臂平行组聚类随机设计（randomized 按药房，按邮政编码贫困水平分层）。 CDS 工具将在大型部门内进行评估 规模零售药房连锁店（n=50 个 CDS 药房/n=50 个常规护理药房）。该设计包括一个 6- 一个月的注册阶段和 6 个月的随访阶段。结果措施将从行政措施中得出 数据并包括：以 NS 指标衡量的阿片类药物使用风险作为主要结果 次要结局包括通过死亡证明数据衡量的致命过量用药、丁丙诺啡摄入量和 阿片类药物治疗的质量。主要假设是中等或高 NS 指标组内的假设 与接受干预相比，更有可能将风险状态降低至低风险或中风险 平时的护理。我们还将对主要药房连锁店 (N=15) 和 PDMP (N=15) 进行定性访谈 领导者评估 CDS 采用和持续使用的促进因素和障碍。这项研究建立了一个 CDS 平台，用于未来大规模社区药房为基础的阿片类药物治疗服务提供和 研究。