Medication Disposal, Behavior
Conditions
Brief summary
This study aims to survey the drug disposal methods of orthopedic foot and ankle patients with excess pain medication following and operation. The study is a randomized control trial comparing the use of FDA approved at home disposal methods to current clinical methods of recommending disposal at medication drop off locations.
Interventions
A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* This study will include foot and ankle orthopedic patients at Brigham and Women's Hospital undergoing a surgical procedure.
Exclusion criteria
* Those under age 18 will be excluded from this study, as their variation in care could affect the data. We will also exclude adults with impaired decision-making capacity and adults who take methadone or have a history of prior opioid dependence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Safely Disposed The Excess Medication | 6 weeks | Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Disposal Instructions These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal. | 37 |
| At Home Disposal With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems. | 38 |
| Total | 75 |
Baseline characteristics
| Characteristic | Standard Disposal Instructions | At Home Disposal | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 36 Participants | 70 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 24 Participants | 27 Participants | 51 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 37 | 0 / 38 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Who Safely Disposed The Excess Medication
Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.
Time frame: 6 weeks
Population: These two populations constitute a subgroup of all patients initially enrolled in the study.~Specifically, these two populations constitute those patients that had leftover medications (as opposed to all patients who were enrolled in the trial).~For this reason, these numbers are disparate from those of the Results Participant Flow.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Disposal Instructions | Number of Participants Who Safely Disposed The Excess Medication | 8 Participants |
| At Home Disposal | Number of Participants Who Safely Disposed The Excess Medication | 22 Participants |