Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and to Reduce Refills After Cancer-Related Surgery
Summary
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.
Detailed description
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.
Arms & interventions
- DeviceAddinex 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.
Outcome measures
Primary
Rate of Device Return
The rate of device return will be determined by an online logging of returned devices by a medical waste disposal company.
Time frame: 12 weeks
Rate of Unused Pill Disposal
The number of unused pills disposed will be deduced based on the number of passwords requested from returned devices.
Time frame: 12 weeks
Secondary
Median Pill Consumption
Time frame: 12 weeks
Duration of Opioid Use
Time frame: 12 weeks
Opioid Refill Rate
Time frame: 12 weeks
Change in Brief Pain Inventory (BPI) Score Baseline and 3 Days
Time frame: Baseline and Day 3
Change in Brief Pain Inventory (BPI) Score Baseline and 7 Days
Time frame: Baseline and Day 7
Change in Brief Pain Inventory (BPI) Score Baseline and 3 Weeks
Time frame: Baseline and Week 3
Post Study System Usability Questionnaire (PSSUQ) Score
Time frame: 3 weeks
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) Scores
Time frame: 3 weeks
Eligibility criteria
Study locations (1)
Columbia University Medical Center
New York, New York, 10032