Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and to Reduce Refills After Cancer-Related Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Rate of Device Return
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Addinex system
The Addinex system is designed to dispense opioid medication to patients on a provider-determined schedule, to track patient 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.
干预措施: Addinex Device (ADX-27) (Device)
结局指标
主要结局
Rate of Device Return
时间窗: 12 weeks
The rate of device return will be determined by an online logging of returned devices by a medical waste disposal company.
Rate of Unused Pill Disposal
时间窗: 12 weeks
The number of unused pills disposed will be deduced based on the number of passwords requested from returned devices.
次要结局
- Duration of Opioid Use(12 weeks)
- Opioid Refill Rate(12 weeks)
- Change in Brief Pain Inventory (BPI) Score Baseline and 3 Days(Baseline and Day 3)
- Median Pill Consumption(12 weeks)
- Change in Brief Pain Inventory (BPI) Score Baseline and 7 Days(Baseline and Day 7)
- Change in Brief Pain Inventory (BPI) Score Baseline and 3 Weeks(Baseline and Week 3)
- Post Study System Usability Questionnaire (PSSUQ) Score(3 weeks)
- Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) Scores(3 weeks)
研究者
Dawn L. Hershman
Assistant Professor of Medicine, Division of Hematology/Oncology
Columbia University