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
- 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 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
- •Study Population:
- •Eligible pharmacies
- •Patients prescribed chronic opioid therapy
- •Inclusion Criteria for pharmacies:
- •Stock naloxone for outpatient dispensing.
- •Pharmacy leadership willing to provide naloxone under a co-dispensing protocol.
- •Pharmacy leadership willing to be randomized to order of implementation.
- •Have or can implement a naloxone standing order.
排除标准
- •for pharmacies:
- •Inclusion Criteria for patients:
- •Prescribed chronic opioid therapy and meet criteria for the pharmacy co-dispensing protocol
- •Receive medications at participating pharmacies
- •Have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from.
- •(for surveys)18 years of age or greater
- •Exclusion Criteria:
- •(for surveys) Non-English speaking, hospice enrollment, do-not-resuscitate order
研究组 & 干预措施
Co-Dispensing
Early implementation of a naloxone co-dispensing pharmacy program. Pharmacies in the phase 1 (early) naloxone co-dispensing arm will be assigned to implement the pharmacy based naloxone co-dispensing program first relative to the phase 2 arm.
干预措施: Co-Dispensing (Behavioral)
Usual Care
Usual care/Phase 2 naloxone co-dispensing:
Pharmacies in the usual care/phase 2 naloxone co-dispensing arm will provide usual pharmacy services to patients receiving chronic opioid therapy (no naloxone co-dispensing). After 10 months, they may implement the pharmacy-based naloxone co-dispensing program.
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)
- Overdose and Naloxone Knowledge(Change from baseline to 4-6 months, and 8-10 months)
- Rate of Naloxone Dispensings(Baseline up to 2.5 years)
- 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)