Drug PrescriptionsNCT04553588
Effect of an Opioid Disposal Pouch Versus Usual Care on Post Discharge Disposal of Unused Medication
A study testing Disposal pouch in people with Drug Prescriptions, run by The Cleveland Clinic at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Prescriptions
- What is being tested?
- Disposal pouch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2017to 27 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Moderate to severe cognitive decline requiring caregiver support
- Not able to speak or understand English (instructions only available in English)
- Behavioral health diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Health System
Cleveland, Ohio, 44195
About this study
Official title: Implementation of a Program for Safe Medication Disposal in a Perioperative Unit: A Response to the Opioid Crisis
The purpose of the study is to determine if opioid disposal bags/pouches are an effective method for disposing of unused opioid medications postoperatively
Read the 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.
- Conditions
- Drug Prescriptions
- Being tested
- Disposal pouch
- Keywords
- opioid misuse, disposal, disposal pouch, postoperative surgery
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposal pouchOther
Also called Medsaway Pouch
Medication Disposal Pouch
| Study group | Role | What they receive |
|---|---|---|
| Opioid Disposal Pouch | Active comparator | an opioid disposal pouch to inactivate and dispose of unused opioid medication within the first 30 days after surgery Receives: Other: Disposal pouch |
| Usual Care | No intervention | usual medication disposal includes multiple options as desired by patient; for example, flushing down toilet, giving to local pharmacist, giving to police department etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Disposal of Unused Opioid Medication
rate of patient reported unused oral opioid medication disposal between groups
Measured: 30 days postoperatively
Secondary outcomes (7)
Odds of disposal pouch use after adjusting for group assignment
Odds of disposal pouch use after adjusting for group assignment (usual care versus disposal pouch group)
Measured: 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 pain level on the worst day of postoperative pain
Measured: 30 days postoperatively
Odds of disposal pouch use after adjusting for preoperative opioid use
Odds of disposal pouch use after adjusting for preoperative opioid use
Measured: 30 days postoperatively
Odds of disposal pouch use after adjusting for race
Odds of disposal pouch use after adjusting for race
Measured: 30 days postoperatively
Odds of disposal pouch use after adjusting for gender
Odds of disposal pouch use after adjusting for gender
Measured: 30 days postoperatively
Odds of disposal pouch use after adjusting for surgical procedure type
Odds of disposal pouch use after adjusting for surgical procedure type
Measured: 30 days postoperatively
Odds of disposal pouch use after adjusting for insurance type
Odds of disposal pouch use after adjusting for insurance type
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start15 Jul 2017
- Primary completion31 May 2018
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug PrescriptionsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoinette Zito, The Cleveland Clinic
- Investigators
- Zito Antoinette, MSN, Principal investigator, Cleveland Clinic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553588
- Sponsor's protocol ID
- 17-801
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Program for Safe Medication Disposal in a Perioperative Unit: A Response to the Opioid Crisis
- ClinicalTrials.gov ID
- NCT04553588
- Acronym / sponsor ID
- 17-801
- Conditions
- Drug Prescriptions
- Keywords
- opioid misuse, disposal, disposal pouch, postoperative surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Opioid Disposal Pouch | Active comparator | Other: Disposal pouchan opioid disposal pouch to inactivate and dispose of unused opioid medication within the first 30 days after surgery |
| Usual Care | No intervention | –usual medication disposal includes multiple options as desired by patient; for example, flushing down toilet, giving to local pharmacist, giving to police department etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Moderate to severe cognitive decline requiring caregiver support
- Not able to speak or understand English (instructions only available in English)
- Behavioral health diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disposal pouchAlso: Medsaway PouchMedication Disposal Pouch | Other | Opioid Disposal Pouch |
Primary outcome
Rate of Disposal of Unused Opioid Medication
Time frame: 30 days postoperatively
rate of patient reported unused oral opioid medication disposal between groups
7 secondary outcomes
Odds of disposal pouch use after adjusting for group assignment
Time frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for pain level on the worst day of postoperative pain
Time frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for preoperative opioid use
Time frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for race
Time frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for gender
Time frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for surgical procedure type
Time frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for insurance type
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zito Antoinette, MSN principal investigator
Cleveland Clinic Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposal pouch in people with Drug Prescriptions, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Disposal of Unused Opioid Medication (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.