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

Qualifiers

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

Treatments tested in this trial

  • Opioid Package Prototype (OPP)
  • Usual Care (standard amber vial)

Treatment groups

352 Participants
are divided into 2 treatment groups

Sponsors and collaborators

UConn Health

Lead sponsor

University of Connecticut

Collaborator

Food and Drug Administration (FDA)

Collaborator