Opioid Package Prototype (OPP)

Study Overview
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Brief Summary
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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
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The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes

Conditions
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Opioid Use, Opioid Prescribing, Dispensing, and Patient Use

Intervention / Treatment
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* Other: Opioid Package Prototype (OPP)
* Other: Usual Care (standard amber vial)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid Package Prototype (OPP)<br>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)<br>* 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.<br>|
| Active Comparator: Usual Care (standard amber vial)<br>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)<br>* The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of tablets of oxycodone prescribed | Count via medical/pharmacy records | 1 week after surgery | 
| Number of tablets of oxycodone prescribed | Count via medical/pharmacy records | 1 month after surgery | 
| Number of tablets of oxycodone prescribed | Count via medical/pharmacy records | 3 months after surgery | 
| Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant | Mean | 1 week after surgery | 
| Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant | Mean | 1 month after surgery | 
| Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant | Mean | 3 months after surgery | 
| Number of oxycodone tablets used by study participants | Count via survey/interview/visual inspection/photograph | 1 week after surgery | 
| Number of oxycodone tablets used by study participants | Count via survey/interview/visual inspection/photograph | 1 month after surgery | 
| Number of oxycodone tablets used by study participants | Count via survey/interview/visual inspection/photograph | 3 months after surgery | 
| Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant | Mean | 1 week after surgery | 
| Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant | Mean | 1 month after surgery | 
| Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant | Mean | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of requests for additional oxycodone prescriptions | Count per patient survey/interview | 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 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 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 | 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 | Baseline (before surgery) and 1 week after surgery | 
| Awareness of oxycodone medication information | Various survey/interview questions | 1 week and 1 month after surgery | 
| Consistency of access to oxycodone medication information | Various survey/interview questions | 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)? | 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. | 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, | 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. | 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. | 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. | 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 | 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 | 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 | Between 1 and 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxycodone, opioid, opioids, package, packaging, post-surgical pain, post-operative pain, orthopedic, orthopaedic, surgery, dispensing, prescribing, blister, tablets, pain, opioid package prototype, OPP