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NCT Number: NCT04598074

Opioid Package Prototype (OPP)

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.

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Key information

Conditions

Opioid Use Blister Neurologic Manifestations Opioid Prescribing, Dispensing, and Patient Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UConn Health

Farmington, Connecticut, 06030, United States

Location contact

Katherine J Coyner, MD, FAOA

SUB_INVESTIGATOR

Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA

CONTACT

[email protected]

860-486-6026

Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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;
  • The patient is willing and able to use a MyChart account;
  • The patient is able to read and understand English; and
  • The patient is able to understand the study procedures and their involvement in the study.

Exclusion criteria

-

Treatment and study plan

Opioid Package Prototype (OPP)

Other

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)

Other

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

Primary outcomes

  1. Number of tablets of oxycodone prescribed

    Time frame: 1 week after surgery

    Count via medical/pharmacy records

  2. Number of tablets of oxycodone prescribed

    Time frame: 1 month after surgery

    Count via medical/pharmacy records

  3. Number of tablets of oxycodone prescribed

    Time frame: 3 months after surgery

    Count via medical/pharmacy records

  4. Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant

    Time frame: 1 week after surgery

    Mean

  5. Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant

    Time frame: 1 month after surgery

    Mean

  6. Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant

    Time frame: 3 months after surgery

    Mean

  7. Number of oxycodone tablets used by study participants

    Time frame: 1 week after surgery

    Count via survey/interview/visual inspection/photograph

  8. Number of oxycodone tablets used by study participants

    Time frame: 1 month after surgery

    Count via survey/interview/visual inspection/photograph

  9. Number of oxycodone tablets used by study participants

    Time frame: 3 months after surgery

    Count via survey/interview/visual inspection/photograph

  10. Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant

    Time frame: 1 week after surgery

    Mean

  11. Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant

    Time frame: 1 month after surgery

    Mean

  12. Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant

    Time frame: 3 months after surgery

    Mean

Secondary outcomes

  1. Number of requests for additional oxycodone prescriptions

    Time frame: 1 week, 1 month and 3 months after surgery

    Count per patient survey/interview

  2. Amount of dispensing time per oxycodone prescription for each study participant

    Time frame: Time of surgery and any refills up to 1 month after surgery

    Log of dispensing start time (received prescription) and dispensing stop time (prescription ready for pick up)

  3. Amount of counseling time per oxycodone prescription for each study participant

    Time frame: Time of surgery and any refills up to 1 month after surgery

    Log of counseling start time (start to discuss medication information) and counseling stop time (complete discussion of medication information)

  4. Awareness of oxycodone tablets used

    Time frame: 1 week and 1 month after surgery

    Amount of time to report number of tablets used via brief inspection of container (not manual count) during interview and various survey questions

  5. Change in knowledge of oxycodone from baseline to 1 week

    Time frame: Baseline (before surgery) and 1 week after surgery

    Number of correct answers out of 4 knowledge questions

  6. Awareness of oxycodone medication information

    Time frame: 1 week and 1 month after surgery

    Various survey/interview questions

  7. Consistency of access to oxycodone medication information

    Time frame: 1 week and 1 month after surgery

    Various survey/interview questions

  8. SANE (Single Assessment Numeric Evaluation) score

    Time frame: Baseline, 1 week, 1 month and 3 months after surgery

    "How would you rate your affected joint/region of interest today as a percentage of normal (0% to 100% scale with 100% being normal)?"

  9. PEG (Pain, Enjoyment of Life and General Activity) score

    Time frame: Baseline, 1 week, 1 month and 3 months after surgery

    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.

  10. Pain Medication Attitudes Questionnaire (PMAQ-14) score

    Time frame: Baseline, 1 week, 1 month and 3 months after surgery

    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,

  11. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline, 1 week, 1 month and 3 months after surgery

    A 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.

  12. Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS)

    Time frame: 1 week, 1 month and 3 months after surgery

    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.

  13. Patient Health Questionnaire-4 (PHQ-4)

    Time frame: Baseline, 1 week and 1 month after surgery

    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.

  14. Feasibility of OPP for orthopaedic surgery prescribers

    Time frame: Within 1 month after prescribing the OPP to 30 participants

    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

  15. Feasibility of OPP for pharmacists

    Time frame: After dispensing all OPPs (approximately 2 years)

    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

  16. Feasibility of OPP for orthopaedic surgery patients

    Time frame: Between 1 and 3 months after surgery

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA

CONTACT

[email protected]

860-486-6026

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Food and Drug Administration (FDA)
  • University of Connecticut

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2020
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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