The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes
| Registry | NCT04598074 |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, health services research |
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| Enrollment | 352 (Estimated) |
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| Sponsor | UConn Health (Other); collaborators: University of Connecticut, Food and Drug Administration (FDA) |
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| Conditions | Opioid Use, Opioid Prescribing, Dispensing, and Patient Use |
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| Interventions | Opioid Package Prototype (OPP), Usual Care (standard amber vial) (Other) |
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| Dates | start 2025-09-07 (estimated), primary completion 2026-06-01 (estimated), completion 2026-09-30 (estimated), first posted 2020-10-22, last updated 2025-09-05 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Opioid Use All trials for Opioid Prescribing, Dispensing, and Patient Use All trials of Opioid Package Prototype (OPP) All trials of Usual Care (standard amber vial)
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Opioid Package Prototype (OPP) | Experimental | Other: Opioid Package Prototype (OPP) | 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 |
| Usual Care (standard amber vial) | Active comparator | Other: Usual Care (standard amber vial) | 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 |
- Opioid Package Prototype (OPP) (Other): 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) (Other): The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.
+Outcome measures
Primary outcomes
- Number of tablets of oxycodone prescribed [1 week after surgery]: Count via medical/pharmacy records
- Number of tablets of oxycodone prescribed [1 month after surgery]: Count via medical/pharmacy records
- Number of tablets of oxycodone prescribed [3 months after surgery]: Count via medical/pharmacy records
- Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant [1 week after surgery]: Mean
- Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant [1 month after surgery]: Mean
- Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant [3 months after surgery]: Mean
- Number of oxycodone tablets used by study participants [1 week after surgery]: Count via survey/interview/visual inspection/photograph
- Number of oxycodone tablets used by study participants [1 month after surgery]: Count via survey/interview/visual inspection/photograph
- Number of oxycodone tablets used by study participants [3 months after surgery]: Count via survey/interview/visual inspection/photograph
- Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant [1 week after surgery]: Mean
- Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant [1 month after surgery]: Mean
- Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant [3 months after surgery]: Mean
Secondary outcomes
- Number of requests for additional oxycodone prescriptions [1 week, 1 month and 3 months after surgery]: Count per patient survey/interview
- Amount of dispensing time per oxycodone prescription for each study participant [Time of surgery and any refills up to 1 month after surgery]: Log of dispensing start time (received prescription) and dispensing stop time (prescription ready for pick up)
- Amount of counseling time per oxycodone prescription for each study participant [Time of surgery and any refills up to 1 month after surgery]: Log of counseling start time (start to discuss medication information) and counseling stop time (complete discussion of medication information)
- Awareness of oxycodone tablets used [1 week and 1 month after surgery]: Amount of time to report number of tablets used via brief inspection of container (not manual count) during interview and various survey questions
- Change in knowledge of oxycodone from baseline to 1 week [Baseline (before surgery) and 1 week after surgery]: Number of correct answers out of 4 knowledge questions
- Awareness of oxycodone medication information [1 week and 1 month after surgery]: Various survey/interview questions
- Consistency of access to oxycodone medication information [1 week and 1 month after surgery]: Various survey/interview questions
- SANE (Single Assessment Numeric Evaluation) score [Baseline, 1 week, 1 month and 3 months after surgery]: "How would you rate your affected joint/region of interest today as a percentage of normal (0% to 100% scale with 100% being normal)?"
- PEG (Pain, Enjoyment of Life and General Activity) score [Baseline, 1 week, 1 month and 3 months after surgery]: 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.
- Pain Medication Attitudes Questionnaire (PMAQ-14) score [Baseline, 1 week, 1 month and 3 months after surgery]: 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,
- Pain Catastrophizing Scale (PCS) [Baseline, 1 week, 1 month and 3 months after surgery]: A 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
- Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS) [1 week, 1 month and 3 months after surgery]: 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.
- Patient Health Questionnaire-4 (PHQ-4) [Baseline, 1 week and 1 month after surgery]: 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.
- Feasibility of OPP for orthopaedic surgery prescribers [Within 1 month after prescribing the OPP to 30 participants]: 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
- Feasibility of OPP for pharmacists [After dispensing all OPPs (approximately 2 years)]: 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
- Feasibility of OPP for orthopaedic surgery patients [Between 1 and 3 months after surgery]: 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
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
1. The patient is 18 years and older;
2. The patient is one of the participating surgeons;
3. The patient is receiving orthopaedic surgery that involves the use of opioid medication for post-operative pain;
4. The patient is willing to receive oxycodone medication;
5. 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;
6. The patient is willing and able to use a MyChart account;
7. The patient is able to read and understand English; and
8. The patient is able to understand the study procedures and their involvement in the study.
Exclusion Criteria:
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+Locations (1)
| Facility | City | Country | Status |
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| UConn Health | Farmington, Connecticut | United States | |
+Investigators