Opioid Dispensing Device for Post-Operative Pain in Cancer Patients

Официальное название

Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and to Reduce Refills After Cancer-Related Surgery

Обзор

This research study will evaluate the use of, and participants experience with, a new device called Addinex that safely stores and dispenses opioid medication. The purpose of this study is to evaluate the use of the Addinex device in cancer patients undergoing cancer-related surgery that require pain control with opioids after the surgery. Participants will be asked to answer questions about their medical history and background, fill out questionnaires, use a mobile application associated with the device, and undergo a phone interview one month after stopping use of the device. This study aims to find out how participants like using the Addinex device as opposed to a traditional pill bottle. Results of this study will help determine if the Addinex device could be useful to patients in the future after surgeries, as opposed to typical pill bottles.

Подробное описание

This is a non-randomized pilot study to test the use of the Addinex system among participants receiving opioids following surgery. The Addinex system is designed to dispense opioid medication to participants on a provider-determined schedule, to track participant use of the device, and to allow for return and disposal of unused opioids. This study will determine the feasibility of using Addinex for these purposes.

Вмешательства

• Устройство Addinex Device (ADX-27)
  The device operates without the use of any electronics, wireless or firmware requirements. This is achieved through its mechanical system which uses a different randomized "passcode" for each dose that is loaded into a circular drum inside the device. The "passcodes" are provided by an online server through either a mobile app, web app, text service or call in service. The online server provides "passcodes" on a request basis, while following instructions set by the treating physicians.

Первичные конечные точки

• Rate of Device Return [Срок оценки: 12 weeks]
• Rate of Unused Pill Disposal [Срок оценки: 12 weeks]

Вторичные конечные точки (8)

• Median Pill Consumption [Срок оценки: 12 weeks]
• Duration of Opioid Use [Срок оценки: 12 weeks]
• Opioid Refill Rate [Срок оценки: 12 weeks]
• Change in Brief Pain Inventory (BPI) Score Baseline and 3 Days [Срок оценки: Baseline and Day 3]
• Change in Brief Pain Inventory (BPI) Score Baseline and 7 Days [Срок оценки: Baseline and Day 7]
• Change in Brief Pain Inventory (BPI) Score Baseline and 3 Weeks [Срок оценки: Baseline and Week 3]
• Post Study System Usability Questionnaire (PSSUQ) Score [Срок оценки: 3 weeks]
• Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) Scores [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

• Adult patients (age greater than or equal to 18 years)
• Planned for major cancer-related surgery and expected to receive a postoperative opioid prescription
• Must speak English or Spanish
• Must have access to a smartphone or an alternative smart device (e.g., iPhone, Android phone, iPad, Surface, etc.).
• Co-enrollment in trials involving pharmacologic therapy is allowed

Критерии исключения

• Patients who are taking opioids daily prior to the surgical procedure
• Patients unable to physically utilize the device
• Patients unable to self-administer medications
• Patients uncomfortable with using iPhone or iPad-based technology

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Columbia University Medical Center — New York

Идентификаторы

NCT: NCT05585788 · AAAS8214 · 1R34DA056796-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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