The opioid crisis continues to plague the United States. While great strides have been made nationwide to decrease overprescribing, improvements are still needed to appropriately educate patients on the safe and responsible use, storage and disposal of opioids. Pain after surgery is often treated with opioid medications. Opioid medications can have side effects. Some side effects are relatively minor (constipation, nausea, vomiting), while others are more severe (sedation, abnormal breathing, etc.) and can lead to serious illness or death. Opioid pain medications when used the wrong way may also be addictive. Due to theses side effects, sometimes patients feel uncomfortable about taking these medications, and doctors prescribe them very cautiously. However, when used properly and safely, opioid pain medications are excellent pain relievers. Addinex, a technology company, has developed a device to help patients take opioids more safely. In this study the investigators aim to enroll a total of 30 patients who undergo spine surgery. Half will be randomly assigned to receive a standard pill bottle with opioids at discharge and will download a mobile app so that they can record their daily pain scores and the number of opioids they take for two weeks after surgery. The other half will receive the new opioid dispenser filled with opioids and a mobile app that generates a passcode that opens that device only at designated times. For this group of patients, every time the patient wants to take an opioid, they need to go to the app, enter their pain score before the app generates a passcode. The investigators will be tracking all study patients' opioid use and pain scores for the two weeks after surgery, will count how many pills they have left over 14 days after their surgery during a live telehealth session, and ask patients how they liked using the device. Results from this study will help understand if the Addinex device could potentially be useful to patients in the future after surgeries as opposed to typical pill bottles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Addinex Opioid-Dispensing Device
Addinex App
Standard Opioid Pill Bottle
Hospital for Special Surgery
New York, New York, United States
RECRUITINGCumulative Opioid Consumption at Postoperative Day 14 (POD14)
Cumulative Opioid Consumption at Postoperative Day 14 (POD14) following lumbar decompression (microdiscectomy/laminectomy), expressed as number of tablets and morphine equivalents (MED in mg) and collected via app starting at discharge to 14 days later.
Time frame: Hospital Discharge to Postoperative Day 14
NRS pain intensity ratings
Numerical Rating Scale (NRS) Pain Intensity Ratings from 0-10, with 0 being no pain to 10 being the worst pain possible: patient-reported in app
Time frame: PACU; Daily after Hospital Discharge: Postoperative Day 1 up to Postoperative Day 14
Patient satisfaction with the app and with the dispensing device
Satisfaction survey - Device group patients will rate statements on a 5-point scale, from 1 (strongly disagree) to 5 (strongly agree)
Time frame: Postoperative Day 14
Frequency of reported difficulties using the device
Frequency of reported difficulties using the device assessed via initiation of patient call to study team; activation of device unlocking mechanism.
Time frame: Daily up to Postoperative Day 14
Frequency of reported difficulties using the app
Frequency of reported difficulties using the app assessed via initiation of patient call/email to study team.
Time frame: Daily up to Postoperative Day 14
Opioid prescription refill rates
Opioid prescription refill rates using electronic health records
Time frame: 6 weeks postoperatively
Concordance of app data and medication left in the device or pill bottle (medication reconciliation)
At Postoperative Day 14, the number of pills consumed as documented via the app, compared to actual pills left over in the device/pill bottle (telemedicine medication reconciliation).
Time frame: Postoperative Day 14
Generation of one-time use over-ride code
Device group: Generation of one-time use over-ride code to dispense one opioid tablet, assessed via email to study team
Time frame: Daily up to Postoperative Day 14
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