The Impact of a Web-Based Naloxone Intervention Under Standing Orders to Patients Prescribed Chronic Opioid Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,004
- 试验地点
- 1
- 主要终点
- Change in Opioid-Related Risk Behavior
研究概览
简要总结
In the setting of naloxone standing orders, this study will assess the impact of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. Outcomes are changes in opioid risk behaviors, naloxone uptake, and knowledge about overdose and naloxone.
详细描述
This is a patient level randomized study of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. This study will be conducted in a health system which has implemented naloxone standing orders. Adults prescribed chronic opioid therapy will be identified in the electronic health record, outreached, and recruited for participation. Once enrolled, participants will be randomized to usual care or the intervention. The web-based intervention is an animated video which provides education on what is an opioid overdose, how to prevent and recognize an opioid overdose, and how to respond with naloxone. This video also encourages patients to pick up naloxone from a pharmacy under standing orders. Participants will be given knowledge and risk surveys over the follow-up. The primary outcome is opioid risk behavior. Secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. Patients will also be followed in the electronic health record for naloxone dispensings, changes in opioid dose, aberrant urine toxicology results, and overdose events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or greater
- •Prescribed chronic opioid therapy
- •Have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from.
排除标准
- •Non-English speaking, hospice enrollment, do-not-resuscitate order, no internet access
研究组 & 干预措施
Naloxone Navigator
Targeted, web-based animated video (Naloxone Navigator [NN]):
This arm is a web-based intervention targeted to patients receiving chronic opioid therapy identified in the electronic health record. Participants in this arm have access to naloxone under standing orders from the pharmacy or with a prescription from their providers.
干预措施: Naloxone Navigator (NN) (Behavioral)
Usual Care
Participants in the usual care arm will receive usual care from their health plan, pharmacy and clinicians. As part of usual care, participants can access naloxone through physician prescription or standing orders.
结局指标
主要结局
Change in Opioid-Related Risk Behavior
时间窗: Change from baseline to 4-6 months, and 8-12 months
Risk behavior will be assessed using the Opioid-Related Behaviors in Treatment (ORBIT) scale. The ORBIT is a scale used to identify recent risk behavior among patients receiving chronic opioid therapy. Scores on the single scale range from 0-40, with lower values representing less risk behavior.
次要结局
- Patient reported naloxone pick-up(Baseline to 12 months)
- Overdose and Naloxone Knowledge(Baseline post-intervention and sustained effects at 4-6 and 8-12 months)
- Change in Hazardous Drinking and Alcohol Use Disorders(Change from baseline to 4-6 months, and 8-12 months)
- Rate of Naloxone Dispensings(Baseline to 12 months)
- Change in opioid dose(Baseline to 12 months)
- Change in Drug Use Risk Behavior(Change from baseline to 4-6 months, and 8-12 months)