Clinical Decision Support to Improve System Naloxone Co-prescribing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114,272
- 试验地点
- 1
- 主要终点
- Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone
研究概览
简要总结
The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months.
详细描述
Clinical decision support tools help clinicians make treatment decisions based on routinely collected data and offer a promising strategy to implement evidence-based practices for safe and effective pain management. This project will use clinical decision support tools embedded into electronic health records to help healthcare providers make treatment decisions that align with opioid prescribing guidelines from the Centers for Disease Control and Prevention (CDC). The project will also use information from prescription drug monitoring programs, insurance claims, and mortality data to evaluate patient outcomes. This research will evaluate how prescribing practices that align with CDC guidelines affect patient outcomes and whether clinical decision support tools provide an advantage over standard care practices for pain management.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 12 Years 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Patients receiving an opioid prescription at discharge from inpatient/ED or close visit in outpatient settings where the clinical decision support (CDS) is implemented
排除标准
- Patients <12 and >89 year of age
- Cancer diagnosis
- Hospice care/palliative care
- Sickle cell disease diagnosis
- Patients who arrived in error
- Patients who were triaged to obstetrics
研究组 & 干预措施
Clinical Decision Support (CDS): Naloxone Alert
Encounters where the naloxone clinical decision support (CDS) alert fired. CDS logic is programmed to fire alert when a provider places and order for a high-risk opioid analgesic prescription to a patient without an active naloxone prescription.
High-risk prescription logic to trigger the Naloxone CDS:
[(NOT 1 AND (2 AND AT LEAST 1 OF (3, 4, 5, 6))) AND 7 AND NOT 8]
- ACTIVE OR PENDED NALOXONE PRESCRIPTION ORDER
- OPIOID SCRIPT BEING PLACED CRITERIA
- DAILY Milligram Morphine Equivalent (MME) >=90 UNSIGNED ORDER
- DAILY MME >=90 EXISTING
- DIAGNOSIS OF OPIOID USE DISORDER
- DIAGNOSIS HISTORY OF OPIOID OVERDOSE
- PROVIDER LOGGED INTO ELLIGIBLE DEPARTMENTS
- DISCHARGE TO HOSPICE
干预措施: Naloxone Co-prescribing Clinical Decision Support (CDS) (Other)
Usual Care
Control group of contemporary encounters where clinical decision support (CDS) is not active. Usual care.
结局指标
主要结局
Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone
时间窗: 18 months
The number of high-risk opioid encounters where a naloxone prescription was written with the opioid divided by the total number of encounters where a high-risk opioid prescription was written.
次要结局
- Naloxone dispensed rate(In the 3 days after the naloxone prescription is written)
- Clinical decision support (CDS) acceptance rate(18 months)
- Subsequent opioid overdose/poisonings rates(Six months after an encounter where the naloxone clinical decision support fired for the provider)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT06271668
- 其他研究编号
- 23-2356, R61DA057610
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (11个月前)
- 研究完成日期
- (6个月前)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
De-identified quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.