Opioid Package Prototype (OPP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use; Opioid Prescribing, Dispensing, and Patient Use
• Intervention / Treatment: Other: Opioid Package Prototype (OPP); Other: Usual Care (standard amber vial)

• Study Type: Interventional
• Enrollment (Estimated): 352
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA; Phone Number: 860-486-6026; Email: nathaniel.rickles@uconn.edu

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Recruiting
      • Uconn Health
      • Contact: Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA; Phone Number: 860-486-6026; Email: nathaniel.rickles@uconn.edu
      • Principal Investigator: Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA
      • Sub-Investigator: Katherine J Coyner, MD, FAOA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: Food and Drug Administration (FDA); University of Connecticut
• Investigators: Principal Investigator: Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA, University of Connecticut

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: opioid; pain; surgery; opioids; oxycodone; orthopedic; post-operative pain; post-surgical pain; tablets; prescribing; orthopaedic; OPP; package; packaging; dispensing; blister; opioid package prototype
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 20-210S-1; 75F40119C10152 (Other Grant/Funding Number: U.S. Food and Drug Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No