Opioid Package Prototype (OPP)

UConn Health

Status: Not yet enrolling

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

Treatments: Other: Usual Care (standard amber vial); Other: Opioid Package Prototype (OPP)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04598074

75F40119C10152 (Other Grant/Funding Number)

20-210S-1

Details and patient eligibility

About

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.

Enrollment: 352 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

-

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

Opioid Package Prototype (OPP)

Experimental group

Description:

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

Treatment:

Other: Opioid Package Prototype (OPP)

Usual Care (standard amber vial)

Active Comparator group

Description:

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

Treatment:

Other: Usual Care (standard amber vial)