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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Opioid Pill Bottle with App | Active Comparator |
| |
| Opioid-Dispensing Device with App | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid-Dispensing Device | Device | Addinex Opioid-Dispensing Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative 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. | Hospital Discharge to Postoperative Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | PACU; Daily after Hospital Discharge: Postoperative Day 1 up to Postoperative Day 14 |
| Patient satisfaction with the app and with the dispensing device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Chan, MEng | Contact | 917-260-4788 | chanw@hss.edu | |
| Alexandra Sideris, PhD | Contact | 212-774-2602 | siderisa@hss.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Kramskiy, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Beginning 9 months and ending 36 months following article publication
For researchers who provide a methodologically sound proposal and analyses to achieve aims in the approved proposal. Proposals should be directed to siderisa@hss.edu. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| App | Other | Addinex App |
|
|
| Standard Opioid Pill Bottle | Other | Standard Opioid Pill Bottle |
|
Satisfaction survey - Device group patients will rate statements on a 5-point scale, from 1 (strongly disagree) to 5 (strongly agree) |
| 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. | 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. | Daily up to Postoperative Day 14 |
| Opioid prescription refill rates | Opioid prescription refill rates using electronic health records | 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). | 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 | Daily up to Postoperative Day 14 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |