Drug Prescriptions
Conditions
Keywords
opioid misuse, disposal, disposal pouch, postoperative surgery
Brief summary
The purpose of the study is to determine if opioid disposal bags/pouches are an effective method for disposing of unused opioid medications postoperatively
Detailed description
Opioids are dispensed regularly to manage postoperative pain in patients undergoing surgery in hospitals and same day surgery centers. There has been a rise in the number of opioid misuse and overdoses nationally, with Ohio ranked first in the nation for drug overdose deaths in 2014 and Cuyahoga County leading the state with 666 overdose deaths in 2016(ref) As health care providers, it is our responsibility to respond to this epidemic. One measure to address this is to reduce the number of unused prescription opioids that remain in patients' possession when they no longer need them. (ref) Doing so will maximize safety by decreasing the availability of unused opioids. The purpose of this study is to determine if a product that deactivates opioids will be used as designed after oral opioid medication is no longer needed. The design of this study is a quality initiative project using a randomized control design. The setting is a surgery center in a suburban hospital in Cuyahoga County. The population is all adult surgery center patients that are prescribed opioids postoperatively who are discharged the same day. In addition to usual care, a medication disposal bag with instructions on how to use will be given to the patient prior to discharge. The patient will be called 30-45 days post discharge. The data will be collected on a case report form that will include information about disposal and information obtained from the patients medical record.
Interventions
OTHERDisposal pouch
Medication Disposal Pouch
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
Care provider did not receive communication regarding group assignment; patients allocated to the intervention group received a disposal pouch prior to discharge and after physician discharge orders were finalized.
Intervention model description
Two group design; patients randomized to receive usual postoperative care after discharge or usual postoperative care plus a disposal pouch to safely eliminate opioid medication no longer needed
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (\>18 years) * Scheduled to go home on the day of surgery * Received a prescription for opioids * Willing to provide a telephone number and receive a phone call 30 days after surgery
Exclusion criteria
* Moderate to severe cognitive decline requiring caregiver support * Not able to speak or understand English (instructions only available in English) * Behavioral health diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Disposal of Unused Opioid Medication | 30 days postoperatively | rate of patient reported unused oral opioid medication disposal between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Odds of disposal pouch use after adjusting for group assignment | 30 days postoperatively | Odds of disposal pouch use after adjusting for group assignment (usual care versus disposal pouch group) |
| Odds of disposal pouch use after adjusting for pain level on the worst day of postoperative pain | 30 days postoperatively | Odds of disposal pouch use after adjusting for pain level on the worst day of postoperative pain |
| Odds of disposal pouch use after adjusting for preoperative opioid use | 30 days postoperatively | Odds of disposal pouch use after adjusting for preoperative opioid use |
| Odds of disposal pouch use after adjusting for race | 30 days postoperatively | Odds of disposal pouch use after adjusting for race |
| Odds of disposal pouch use after adjusting for gender | 30 days postoperatively | Odds of disposal pouch use after adjusting for gender |
| Odds of disposal pouch use after adjusting for surgical procedure type | 30 days postoperatively | Odds of disposal pouch use after adjusting for surgical procedure type |
| Odds of disposal pouch use after adjusting for insurance type | 30 days | Odds of disposal pouch use after adjusting for insurance type |
Countries
United States
Outcome results
None listed