Opioid Package Prototype (OPP)

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598074
• Other study ID #: 20-210S-1
• Secondary ID: 75F40119C10152
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: UConn Health
• Contact: Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA
• Phone: 860-486-6026
• Email: nathaniel.rickles[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Opioid Prescribing, Dispensing, and Patient Use
• Opioid Use

Intervention

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.
• Usual Care (standard amber vial)
The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.

Locations

Country	Name	City	State
United States	UConn Health	Farmington	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
UConn Health	Food and Drug Administration (FDA), University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of tablets of oxycodone prescribed	Count via medical/pharmacy records	1 week after surgery
Primary	Number of tablets of oxycodone prescribed	Count via medical/pharmacy records	1 month after surgery
Primary	Number of tablets of oxycodone prescribed	Count via medical/pharmacy records	3 months after surgery
Primary	Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant	Mean	1 week after surgery
Primary	Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant	Mean	1 month after surgery
Primary	Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant	Mean	3 months after surgery
Primary	Number of oxycodone tablets used by study participants	Count via survey/interview/visual inspection/photograph	1 week after surgery
Primary	Number of oxycodone tablets used by study participants	Count via survey/interview/visual inspection/photograph	1 month after surgery
Primary	Number of oxycodone tablets used by study participants	Count via survey/interview/visual inspection/photograph	3 months after surgery
Primary	Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant	Mean	1 week after surgery
Primary	Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant	Mean	1 month after surgery
Primary	Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant	Mean	3 months after surgery
Secondary	Number of requests for additional oxycodone prescriptions	Count per patient survey/interview	1 week, 1 month and 3 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Awareness of oxycodone medication information	Various survey/interview questions	1 week and 1 month after surgery
Secondary	Consistency of access to oxycodone medication information	Various survey/interview questions	1 week and 1 month after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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