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Opioid Package Prototype (OPP)
Sponsor: UConn Health
Summary
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.
Official title: The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
352
Start Date
2025-09-07
Completion Date
2026-09-30
Last Updated
2025-09-05
Healthy Volunteers
No
Interventions
Opioid Package Prototype (OPP)
The Opioid Package Prototype (OPP) is a child-resistant/senior-friendly, calendar-blister packaging of limited pill counts with flat readable billboard space for medication labeling.
Usual Care (standard amber vial)
The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.
Locations (1)
UConn Health
Farmington, Connecticut, United States