Evaluation of an Opioid Stewardship Program in Non-Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Incidence of potentially high-risk opioid prescriptions
研究概览
简要总结
The objective of this prospective, non-randomized clinical trial is to evaluate the effectiveness of a pharmacist-led Opioid Stewardship Program (OSP) in outpatient adults with chronic non-cancer pain. This study compared OSP implementation with a historical control to determine whether it reduces the incidence of high-risk opioid prescribing and improves patients' awareness, knowledge, and attitudes about opioid use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients at the Department of Anesthesiology and Pain Medicine or the Department of Physical Medicine & Rehabilitation of the study site who received a prescription for opioid analgesics (oral, transdermal, sublingual, or buccal formulations containing oxycodone, fentanyl, tapentadol, hydrocodone, or morphine) due to chronic non-cancer pain during the study evaluation period (from IRB approval date to September 30, 2025)
- •Adults aged ≥19 years and <80 years
- •Patients who voluntarily signed a written informed consent form after receiving a full explanation of the study and understanding its purpose
排除标准
- •Patients with active cancer
- •Patients diagnosed with sickle cell disease
- •Patients diagnosed with a life-limiting illness eligible for hospice or palliative care as defined in Article 2 of the 'ACT ON HOSPICE AND PALLIATIVE CARE AND DECISIONS ON LIFE-SUSTAINING TREATMENT FOR PATIENTS AT THE END OF LIFE'
- •Pregnant patients
- •Patients who were prescribed opioid analgesics within the past month for postoperative pain management
- •Patients who were prescribed opioid analgesics within the past month for newly developed pain
- •Patients with communication difficulties
- •Patients who were prescribed buprenorphine for the treatment of opioid use disorder
- •Patients who are deemed inappropriate for study participation at the discretion of the investigator
结局指标
主要结局
Incidence of potentially high-risk opioid prescriptions
时间窗: At each outpatient visit during the study evaluation period (up to 4 months per participant)
This outcome measures the proportion of potentially high-risk opioid prescriptions based on predefined criteria: * Prescription (Rx) of ER/SR opioids to patients with no prior opioid use * Rx of certain ER/SR opioid dosages to patients who are not opioid-tolerant * Rx of sublingual/buccal fentanyl * Rx exceeding 50 MME/day * Rx exceeding 10 MME/dose or 30 MME/day to patients with no prior opioid use * Rx with no dose adjustments for the elderly or renally impaired with no prior opioid use * ER/SR opioid conversions outside 50-75% of the prior MME/day * Rx of oral ER/SR opioids more than twice daily * Rx of transdermal fentanyl at intervals less than 72 hours * Rx exceeding 30 days supply * Rx without a pain assessment in the past 3 months in long-term opioid users * No opioid dose adjustment in the last 3 Rx despite additional pain interventions and improved pain in long-term users * No opioid dose adjustment in the last 3 Rx despite the lack of pain improvement in long-term users
次要结局
- Average daily morphine milligram equivalent (MME)(At each outpatient visit during the study evaluation period (up to 4 months per participant))
- Change in opioid knowledge scores after education sessions compared to baseline(At each outpatient visit during the study evaluation period (up to 4 months per participant))
- Change in opioid attitude scores after education sessions compared to baseline(At each outpatient visit during the study evaluation period (up to 4 months per participant))
研究者
Lee, So Hyun
Chief of Pharmacy Department
Korea University Guro Hospital