The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- Number of tablets of oxycodone prescribed
研究概览
简要总结
The overall objective of this clinical trial is to identify the impact of selected package features, known as the Opioid Package Prototype (OPP), on the safe and effective use of opioids. Our specific aims are: (Aim 1) to evaluate the effectiveness of OPP on prescribing, dispensing, and patient use of oxycodone among orthopaedic surgery patients receiving post-operative outpatient oxycodone for post-surgical pain management, and (Aim 2) to determine the feasibility of OPP for orthopaedic surgery prescribers, pharmacists, and orthopaedic surgery patients. Such data can be used to further optimize packaging and labeling design, help patients and caregivers utilize their medication and packaging correctly, and improve prescribing and dispensing habits. The central hypothesis is that the OPP will be more effective than the amber vial in efforts to reduce oxycodone prescribing among patients over 18 receiving short-term management of post orthopedic surgery pain.
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
- •The patient is 18 years and older;
- •The patient is one of the participating surgeons;
- •The patient is receiving orthopaedic surgery that involves the use of opioid medication for post-operative pain;
- •The patient is willing to receive oxycodone medication;
- •The patient is willing and able to receive medication at the UConn Health Specialty Pharmacy, located in the Exchange across the street from the main entrance of UConn Health;
- •The patient is willing and able to use a MyChart account;
- •The patient is able to read and understand English; and
- •The patient is able to understand the study procedures and their involvement in the study.
排除标准
- 未提供
结局指标
主要结局
Number of tablets of oxycodone prescribed
时间窗: 3 months after surgery
Count via medical/pharmacy records
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
时间窗: 3 months after surgery
Mean
Number of oxycodone tablets used by study participants
时间窗: 3 months after surgery
Count via survey/interview/visual inspection/photograph
Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
时间窗: 3 months after surgery
Mean
次要结局
- Amount of dispensing time per oxycodone prescription for each study participant(Time of surgery and any refills up to 1 month after surgery)
- Amount of counseling time per oxycodone prescription for each study participant(Time of surgery and any refills up to 1 month after surgery)
- Awareness of oxycodone medication information(1 week and 1 month after surgery)
- Awareness of oxycodone tablets used(1 week and 1 month after surgery)
- SANE (Single Assessment Numeric Evaluation) score(Baseline, 1 week, 1 month and 3 months after surgery)
- PEG (Pain, Enjoyment of Life and General Activity) score(Baseline, 1 week, 1 month and 3 months after surgery)
- Feasibility of OPP for orthopaedic surgery prescribers(Within 1 month after prescribing the OPP to 30 participants)
- Feasibility of OPP for pharmacists(After dispensing all OPPs (approximately 2 years))
- Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS)(1 week, 1 month and 3 months after surgery)
- Number of requests for additional oxycodone prescriptions(1 week, 1 month and 3 months after surgery)
- Change in knowledge of oxycodone from baseline to 1 week(Baseline (before surgery) and 1 week after surgery)
- Consistency of access to oxycodone medication information(1 week and 1 month after surgery)
- Pain Catastrophizing Scale (PCS)(Baseline, 1 week, 1 month and 3 months after surgery)
- Pain Medication Attitudes Questionnaire (PMAQ-14) score(Baseline, 1 week, 1 month and 3 months after surgery)
- Patient Health Questionnaire-4 (PHQ-4)(Baseline, 1 week and 1 month after surgery)
- Feasibility of OPP for orthopaedic surgery patients(Between 1 and 3 months after surgery)
研究者
Nathaniel Rickles
Professor of Pharmacy Practice
UConn Health