Opioid Package Prototype (OPP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUConn Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Opioid Package Prototype (OPP)
Other interventionThe 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)
Other interventionThe standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.
Treatment groups
352 Participants
are divided into 2 treatment groupsGroup A: Opioid Package Prototype (OPP)Experimental treatment 1 intervention
Group B: Usual Care (standard amber vial)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of tablets of oxycodone prescribed
Count via medical/pharmacy records
Time frame
1 week after surgery2
Number of tablets of oxycodone prescribed
Count via medical/pharmacy records
Time frame
1 month after surgery3
Number of tablets of oxycodone prescribed
Count via medical/pharmacy records
Time frame
3 months after surgery4
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
Mean
Time frame
1 week after surgerySecondary outcomes
1
Number of requests for additional oxycodone prescriptions
Count per patient survey/interview
Time frame
1 week, 1 month and 3 months after surgery2
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 surgery3
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 surgery4
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
UConn Health
Lead sponsor
University of Connecticut
Collaborator
Food and Drug Administration (FDA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: