The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 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 if co-dispensing naloxone with opioids to patients prescribed chronic opioid therapy changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone.
详细描述
This is a pragmatic, pharmacy-based, cluster randomized controlled trial of a naloxone co-dispensing program for adults prescribed chronic opioid therapy. Pharmacies (target N=6) will be randomized to the order in which they are encouraged to implement a naloxone co-dispensing program for patients prescribed chronic opioid therapy. The intent of this program is to provide patients prescribed chronic opioid therapy naloxone for potential opioid overdose reversal under the terms of a standing order. Participants prescribed chronic opioid therapy who use randomized pharmacies will be recruited to receive knowledge and risk surveys at baseline and over the follow-up. The primary outcome is opioid risk behaviors (target enrollment is 200 patients). Secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. Patients who use randomized pharmacies (anticipated n=550 patients) will also be followed in the electronic health record for secondary outcomes: 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
- Health Services Research
- 盲法
- None
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
- 未提供
排除标准
- •(for surveys) Non-English speaking, hospice enrollment, do-not-resuscitate order
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 8-10 months
Among survey participants, 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 up to 10 months)
- Change in Hazardous Drinking or Alcohol Use Disorders(Change from baseline to 4-6 months and 8-10 months)
- Rate of Naloxone Dispensings(Baseline up to 2.5 years)
- Overdose and Naloxone Knowledge(Change from baseline to 4-6 months, and 8-10 months)
- Change in Drug Use Risk Behavior(Change from baseline to 4-6 months and 8-10 months)
- Changes in opioid dose(Baseline up to 2.5 years)