Opioid Package Prototype (OPP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Opioid Package Prototype (OPP), Usual Care (standard amber vial).
- Who it may be relevant to
- Registry conditions: Opioid Use, Opioid Prescribing, Dispensing, and Patient Use. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes
Overview
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.
Interventions
- Other 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. - Other Usual Care (standard amber vial)
The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.
Primary outcome measures
- Number of tablets of oxycodone prescribed [Time frame: 1 week after surgery]
- Number of tablets of oxycodone prescribed [Time frame: 1 month after surgery]
- Number of tablets of oxycodone prescribed [Time frame: 3 months after surgery]
- Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant [Time frame: 1 week after surgery]
- Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant [Time frame: 1 month after surgery]
- Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant [Time frame: 3 months after surgery]
- Number of oxycodone tablets used by study participants [Time frame: 1 week after surgery]
- Number of oxycodone tablets used by study participants [Time frame: 1 month after surgery]
- Number of oxycodone tablets used by study participants [Time frame: 3 months after surgery]
- Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant [Time frame: 1 week after surgery]
Secondary outcome measures (12)
- Number of requests for additional oxycodone prescriptions [Time frame: 1 week, 1 month and 3 months after surgery]
- Amount of dispensing time per oxycodone prescription for each study participant [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 [Time frame: Time of surgery and any refills up to 1 month after surgery]
- Awareness of oxycodone tablets used [Time frame: 1 week and 1 month after surgery]
- Change in knowledge of oxycodone from baseline to 1 week [Time frame: Baseline (before surgery) and 1 week after surgery]
- Awareness of oxycodone medication information [Time frame: 1 week and 1 month after surgery]
- Consistency of access to oxycodone medication information [Time frame: 1 week and 1 month after surgery]
- SANE (Single Assessment Numeric Evaluation) score [Time frame: Baseline, 1 week, 1 month and 3 months after surgery]
- PEG (Pain, Enjoyment of Life and General Activity) score [Time frame: Baseline, 1 week, 1 month and 3 months after surgery]
- Pain Medication Attitudes Questionnaire (PMAQ-14) score [Time frame: Baseline, 1 week, 1 month and 3 months after surgery]
- Pain Catastrophizing Scale (PCS) [Time frame: Baseline, 1 week, 1 month and 3 months after surgery]
- Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS) [Time frame: 1 week, 1 month and 3 months after surgery]
Eligibility criteria
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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- UConn Health — Farmington
Identifiers
NCT: NCT04598074 · 20-210S-1 · 75F40119C10152