Clinical trial NCT04598074: Opioid Package Prototype (OPP)
Official title: The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use
Opioid Prescribing, Dispensing, and Patient Use
Keywords: oxycodone
opioid
opioids
package
packaging
post-surgical pain
post-operative pain
orthopedic
orthopaedic
surgery
dispensing
prescribing
blister
tablets
pain
opioid package prototype
OPP
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: University of Connecticut
name: Food and Drug Administration (FDA)
First posted: 2020-10-22
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Number of tablets of oxycodone prescribed
timeFrame: 1 week after surgery
measure: Number of tablets of oxycodone prescribed
timeFrame: 1 month after surgery
measure: Number of tablets of oxycodone prescribed
timeFrame: 3 months after surgery
measure: Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
timeFrame: 1 week after surgery
measure: Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
timeFrame: 1 month after surgery
measure: Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
timeFrame: 3 months after surgery
measure: Number of oxycodone tablets used by study participants
timeFrame: 1 week after surgery
measure: Number of oxycodone tablets used by study participants
timeFrame: 1 month after surgery
measure: Number of oxycodone tablets used by study participants
timeFrame: 3 months after surgery
measure: Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
timeFrame: 1 week after surgery
measure: Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
timeFrame: 1 month after surgery
measure: Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Number of requests for additional oxycodone prescriptions
timeFrame: 1 week, 1 month and 3 months after surgery
measure: Amount of dispensing time per oxycodone prescription for each study participant
timeFrame: Time of surgery and any refills up to 1 month after surgery
measure: Amount of counseling time per oxycodone prescription for each study participant
timeFrame: Time of surgery and any refills up to 1 month after surgery
measure: Awareness of oxycodone tablets used
timeFrame: 1 week and 1 month after surgery
measure: Change in knowledge of oxycodone from baseline to 1 week
timeFrame: Baseline (before surgery) and 1 week after surgery
measure: Awareness of oxycodone medication information
timeFrame: 1 week and 1 month after surgery
measure: Consistency of access to oxycodone medication information
timeFrame: 1 week and 1 month after surgery
measure: SANE (Single Assessment Numeric Evaluation) score
timeFrame: Baseline, 1 week, 1 month and 3 months after surgery
measure: PEG (Pain, Enjoyment of Life and General Activity) score
timeFrame: Baseline, 1 week, 1 month and 3 months after surgery
measure: Pain Medication Attitudes Questionnaire (PMAQ-14) score
timeFrame: Baseline, 1 week, 1 month and 3 months after surgery
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 1 week, 1 month and 3 months after surgery
measure: Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS)
timeFrame: 1 week, 1 month and 3 months after surgery
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Baseline, 1 week and 1 month after surgery
measure: Feasibility of OPP for orthopaedic surgery prescribers
timeFrame: Within 1 month after prescribing the OPP to 30 participants
measure: Feasibility of OPP for pharmacists
timeFrame: After dispensing all OPPs (approximately 2 years)
measure: Feasibility of OPP for orthopaedic surgery patients
timeFrame: Between 1 and 3 months after surgery
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA
role: PRINCIPAL_INVESTIGATOR
References: