Opioid Package Prototype (OPP)

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Number of tablets of oxycodone prescribed [Срок оценки: 1 week after surgery]
• Number of tablets of oxycodone prescribed [Срок оценки: 1 month after surgery]
• Number of tablets of oxycodone prescribed [Срок оценки: 3 months after surgery]
• Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant [Срок оценки: 1 week after surgery]
• Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant [Срок оценки: 1 month after surgery]
• Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant [Срок оценки: 3 months after surgery]
• Number of oxycodone tablets used by study participants [Срок оценки: 1 week after surgery]
• Number of oxycodone tablets used by study participants [Срок оценки: 1 month after surgery]
• Number of oxycodone tablets used by study participants [Срок оценки: 3 months after surgery]
• Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant [Срок оценки: 1 week after surgery]

Вторичные конечные точки (12)

• Number of requests for additional oxycodone prescriptions [Срок оценки: 1 week, 1 month and 3 months after surgery]
• Amount of dispensing time per oxycodone prescription for each study participant [Срок оценки: Time of surgery and any refills up to 1 month after surgery]
• Amount of counseling time per oxycodone prescription for each study participant [Срок оценки: Time of surgery and any refills up to 1 month after surgery]
• Awareness of oxycodone tablets used [Срок оценки: 1 week and 1 month after surgery]
• Change in knowledge of oxycodone from baseline to 1 week [Срок оценки: Baseline (before surgery) and 1 week after surgery]
• Awareness of oxycodone medication information [Срок оценки: 1 week and 1 month after surgery]
• Consistency of access to oxycodone medication information [Срок оценки: 1 week and 1 month after surgery]
• SANE (Single Assessment Numeric Evaluation) score [Срок оценки: Baseline, 1 week, 1 month and 3 months after surgery]
• PEG (Pain, Enjoyment of Life and General Activity) score [Срок оценки: Baseline, 1 week, 1 month and 3 months after surgery]
• Pain Medication Attitudes Questionnaire (PMAQ-14) score [Срок оценки: Baseline, 1 week, 1 month and 3 months after surgery]
• Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline, 1 week, 1 month and 3 months after surgery]
• Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS) [Срок оценки: 1 week, 1 month and 3 months after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• UConn Health — Farmington

Идентификаторы

NCT: NCT04598074 · 20-210S-1 · 75F40119C10152

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗