An interventional study of Opioid Package Prototype (OPP) and Usual Care (standard amber vial) in Opioid Use and Opioid Prescribing, Dispensing, and Patient Use, sponsored by UConn Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by UConn Health · Not applicable, Interventional, and Health services research
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 352 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →UConn Health is the lead sponsor of 187 studies on the registry; 18 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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Oxycodone 5mg tablets dispensed in the Opioid Package Prototype (OPP) with frequency and quantities varying, depending on the type of surgical procedure performed, surgeon, and individual patient
Other: Opioid Package Prototype (OPP)
Oxycodone 5mg tablets dispensed in the standard amber vial (usual care) with frequency and quantities varying, depending on the type of surgical procedure performed, surgeon, and individual patient
Other: Usual Care (standard amber vial)
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.
The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.
Number of tablets of oxycodone prescribed
Count via medical/pharmacy records
Time frame: 1 week after surgery
Number of tablets of oxycodone prescribed
Count via medical/pharmacy records
Time frame: 1 month after surgery
Number of tablets of oxycodone prescribed
Count via medical/pharmacy records
Time frame: 3 months after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
Mean
Time frame: 1 week after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
Mean
Time frame: 1 month after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
Mean
Time frame: 3 months after surgery
Number of oxycodone tablets used by study participants
Count via survey/interview/visual inspection/photograph
Time frame: 1 week after surgery
Number of oxycodone tablets used by study participants
Count via survey/interview/visual inspection/photograph
Time frame: 1 month after surgery
Number of oxycodone tablets used by study participants
Count via survey/interview/visual inspection/photograph
Time frame: 3 months after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
Mean
Time frame: 1 week after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
Mean
Time frame: 1 month after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
Mean
Time frame: 3 months after surgery
Number of requests for additional oxycodone prescriptions
Count per patient survey/interview
Time frame: 1 week, 1 month and 3 months after surgery
Amount of dispensing time per oxycodone prescription for each study participant
Log of dispensing start time (received prescription) and dispensing stop time (prescription ready for pick up)
Time frame: Time of surgery and any refills up to 1 month after surgery
Amount of counseling time per oxycodone prescription for each study participant
Log of counseling start time (start to discuss medication information) and counseling stop time (complete discussion of medication information)
Time frame: Time of surgery and any refills up to 1 month after surgery
Awareness of oxycodone tablets used
Amount of time to report number of tablets used via brief inspection of container (not manual count) during interview and various survey questions
Time frame: 1 week and 1 month after surgery
Change in knowledge of oxycodone from baseline to 1 week
Number of correct answers out of 4 knowledge questions
Time frame: Baseline (before surgery) and 1 week after surgery
Awareness of oxycodone medication information
Various survey/interview questions
Time frame: 1 week and 1 month after surgery
Consistency of access to oxycodone medication information
Various survey/interview questions
Time frame: 1 week and 1 month after surgery
SANE (Single Assessment Numeric Evaluation) score
"How would you rate your affected joint/region of interest today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Time frame: Baseline, 1 week, 1 month and 3 months after surgery
PEG (Pain, Enjoyment of Life and General Activity) score
A three-item scale assessing pain intensity and interference from 0-10. The three item scores are averaged for a final score and a higher number indicates greater pain and interference.
Time frame: Baseline, 1 week, 1 month and 3 months after surgery
Pain Medication Attitudes Questionnaire (PMAQ-14) score
Participants indicate the degree to which they agree with 14 statements regarding pain medication from 0 (never true) to 5 (always true). The 14 scores are averaged for a final score and a higher number indicates a more negative attitude toward pain medications,
Time frame: Baseline, 1 week, 1 month and 3 months after surgery
Pain Catastrophizing Scale (PCS)
A 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
Time frame: Baseline, 1 week, 1 month and 3 months after surgery
Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS)
A 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores.
Time frame: 1 week, 1 month and 3 months after surgery
Patient Health Questionnaire-4 (PHQ-4)
A 4-item inventory rated on a 4-point Likert-type scale to assess for anxiety and depression. The minimum score (0) indicates no psychological distress and the maximum score (12) indicates severe psychological distress.
Time frame: Baseline, 1 week and 1 month after surgery
Feasibility of OPP for orthopaedic surgery prescribers
Interview regarding benefits and weaknesses of the OPP design, interest in prescribing OPP in the future, and how OPP design can be improved for the future
Time frame: Within 1 month after prescribing the OPP to 30 participants
Feasibility of OPP for pharmacists
Interview questions regarding benefits and weaknesses of the OPP design, interest in dispensing OPP in the future, and how OPP design can be improved for the future
Time frame: After dispensing all OPPs (approximately 2 years)
Feasibility of OPP for orthopaedic surgery patients
Interview questions regarding benefits and weaknesses of the OPP design, interest in using OPP in the future, and how OPP design can be improved for the future
Time frame: Between 1 and 3 months after surgery
Plan to share: No
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