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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43DA057750-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Prisma Health-Midlands | OTHER |
| University of South Carolina | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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There is an urgent unmet medical need for a cost-effective, environmentally friendly, in-home opioid disposal solution for surgical patients that is clinically proven to reduce opioid use disorder that is substantiated with economic data. SafeMedWaste, Inc. (SMW) has developed the patented SafeMedWaste in-home drug disposal container, that completely destroys opioids within minutes and can be placed in the regular trash, without risk of ground or municipal water contamination.
A pilot randomized clinical trial will evaluate the use of SafeMedWaste in 300 adult patients in outpatient surgery clinics undergoing shoulder and knee surgery.
The trial will evaluate opioid disposal rates and events related to opioid diversion and use disorder in 300 adult patients 18 years of age and older undergoing outpatient knee and shoulder surgery who are prescribed opioids to manage their acute post-surgical pain.
Patients will be randomized into two arms. During the standard of care post op visits (2-, 6- and 10- weeks), when the treating physician has determined that the patient will no longer need opioids to manage their post-surgical pain, all patients will receive general instructions by video on opioid disposal recorded by one of the orthopedic surgeons. Patients in the treatment arm will also be given the SafeMedWaste opioid disposal system and watch an instructional video on how to use the product.
All patients will complete a pre-surgery survey and a post-surgery survey 90 days after surgery. Patients will self-report their disposal or non-disposal of the drugs, documented with pictures uploaded to the patient's MyChart account. Data from the surveys will be statistically analyzed to identify significant factors that influenced patients' behavior vis-Ã -vis opioid disposal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | General Instructions on Opioid Disposal | |
| Treatment | Active Comparator | General Instructions on opioid disposal Device: SafeMedWaste Opioid Disposal Kit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SafeMedWaste | Device | SafeMedWaste opioid disposal kit |
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| Measure | Description | Time Frame |
|---|---|---|
| Opioid disposal compliance | Opioid disposal compliance will be tracked up to 3 months post-surgery, as reported by patients in post-surgery survey and/or documented with pictures uploaded by patient to MyChart. | Within 3 months following surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Reasons for disposal/non- disposal | Reasons why the patient chose to dispose of opioids or chose not to, as reported in the post- surgery survey, will be statistically analyzed and correlated as appropriate to other data. | Within 3 months following surgery |
| Time of disposal |
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justin Stas, B.S Biomedical Engineering | Contact | 9011340 | jstas@safemedwaste.com | |
| Paisley T Myers, PhD Bioanalytical chemistry | Contact | 803-394-8263 | paisley.myers@prismahealth.org |
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When the patients dispose of opioids, as reported by patients in post-surgery survey and/or documented with pictures in MyChart, will be tracked up to 3 months post-surgery. |
| Within 3 months following surgery |
| Amount of opioids used | The amount of opioids used will be tracked at visit weeks 2, 6 and 10, post surgery, through clinic pill counts, or as self-reported by patients up to 3 months. | Within 3 months following surgery |
| Opioid Use Disorder (OUD) | Any OUD reported in the patient medical record will be tracked up to 3 months following surgery. | Within 3 months following surgery |
| Diversion event | Any diversion event as described by patient at clinical visit or in post-surgery survey will be recorded. | Within 3 months following surgery |
| Pre-Surgery Survey | Pre-Surgery Survey, see Ex. 1, Protection of Human Subjects, will be completed by patients at enrollment. Questions include patient past surgical experience and attitudes toward pain. Data will be recorded in REDCap and statistically analyzed. | At enrollment |
| Post-Surgery Survey | Patients will answer post-surgery survey, see Ex. 2, Protection of Human Subjects, within 3 months following surgery. Questions include pain experiences from their surgery and disposal compliance. Data will be recorded in REDCAP and statistically analyzed for correlations of patient attitudes toward and experience with pain and other factors to disposal compliance to create clinician/patient education protocols to be studied in future trial. | 3 months following surgery |
| Provider Satisfaction Survey | Provider participants will answer Provider Satisfaction survey, see Ex. 4, Protection of Human Subjects, upon study completion. Data will be recorded in REDCap and statistically analyzed. | Upon study completion |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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