Opioid Use and DisposalNCT04044105
Impacting the Disposal of Unused Opioid
A study testing Pamphlet education and Pamphlet education + texts in people with Opioid Use and Disposal, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the rates of proper opioid disposal in patients receiving an educational brochure compared to an automated text message delivered directly to patients' cell phones alongside the brochure, compared to no education on the subject. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use and Disposal
- What is being tested?
- Pamphlet education and Pamphlet education + texts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 563 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 31 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient undergoing primary total hip or knee arthroplasty
- Age ≥18 years old
Who cannot join
- Patients allergic to oxycodone
- Patients consuming opioids during the 4 weeks prior to surgery
- Patients with a history of opioid dependence
- Patients undergoing revision total knee or hip arthroplasty
- Non-English speaking patients
- Age <18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Impacting the Disposal of Unused Opioid Analgesics Through Education in the Orthopaedic Population: A Randomized Control Trial
The purpose of this study is to compare the rates of proper opioid disposal in patients receiving an educational brochure compared to an automated text message delivered directly to patients' cell phones alongside the brochure, compared to no education on the subject.
Read the detailed description
Opioids are used to treat acute pain after surgery, but can lead to misuse and abuse. Very few patients properly dispose of unused opioids and the majority of opioids are stored in the home in unlocked containers as opposed to being properly disposed of. Improper disposal of opioid medications is a concern due to the potential for nonmedical use and has the potential to cause injury or death for patients and their family members that can access the medications. The purpose of this study is to compare the rates of proper opioid disposal in patients receiving an educational brochure compared to an automated text message delivered directly to patients' cell phones alongside the brochure, compared to no education on the subject. There is evidence that an educational brochure significantly increases proper disposal rates, albeit only to about 25%. The goal of this study is to evaluate the impact of an educational pamphlet on proper opioid disposal in the total joint arthoplasty population, and to see if the addition of a text messaging system can increase further increase proper disposal rates.
- Conditions
- Opioid Use and Disposal
- Being tested
- Pamphlet education, Pamphlet education + texts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pamphlet educationOther
Patients receive an educational intervention explaining proper opioid disposal
Pamphlet education + textsOther
Patients receive an educational intervention and text message explaining proper opioid disposal
| Study group | Role | What they receive |
|---|---|---|
| No Education | No intervention | Patients in this arm receive no education regarding how to dispose of their opiate medication |
| Pamphlet education | Experimental | Patients receive an educational pamphlet only, to be given at the preoperative teaching class, prior to their standard 3-week postoperative clinic appointment, and prior to their standard 6-week postoperative clinic appointment. Receives: Other: Pamphlet education |
| Pamphlet education + texts | Experimental | Patients receive an educational pamphlet, to be given at the preoperative teaching class, prior to their standard 3-week postoperative clinic appointment, and prior to their standard 6-week postoperative clinic appointment. In addition, 3 automated text messages sent at those same time points. Receives: Other: Pamphlet education + texts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disposal rates
The rate of an arm's disposal is calculated by comparing the number that properly disposed of their excess medication to the number that did not
Measured: 6 weeks after surgery
Secondary outcomes (1)
Continued taking opiate rate
We will also look at whether the education affects the number of patients that continue taking opiates
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Aug 2018
- Primary completion3 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use and DisposalStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig J Della Valle, MD, Rush University Medical Center
- Investigators
- Craig Della Valle, MD, Principal investigator, Rush
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044105
- Sponsor's protocol ID
- 18092505
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2019
- Last updated
- 30 Aug 2021
- 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacting the Disposal of Unused Opioid Analgesics Through Education in the Orthopaedic Population: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04044105
- Acronym / sponsor ID
- 18092505
- Conditions
- Opioid Use and Disposal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Aug 2019 (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 this study is to compare the rates of proper opioid disposal in patients receiving an educational brochure compared to an automated text message delivered directly to patients' cell phones alongside the brochure, compared to no education on the subject.
Detailed description
Opioids are used to treat acute pain after surgery, but can lead to misuse and abuse. Very few patients properly dispose of unused opioids and the majority of opioids are stored in the home in unlocked containers as opposed to being properly disposed of. Improper disposal of opioid medications is a concern due to the potential for nonmedical use and has the potential to cause injury or death for patients and their family members that can access the medications. The purpose of this study is to compare the rates of proper opioid disposal in patients receiving an educational brochure compared to an automated text message delivered directly to patients' cell phones alongside the brochure, compared to no education on the subject. There is evidence that an educational brochure significantly increases proper disposal rates, albeit only to about 25%. The goal of this study is to evaluate the impact of an educational pamphlet on proper opioid disposal in the total joint arthoplasty population, and to see if the addition of a text messaging system can increase further increase proper disposal rates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Education | No intervention | –Patients in this arm receive no education regarding how to dispose of their opiate medication |
| Pamphlet education | Experimental | Other: Pamphlet educationPatients receive an educational pamphlet only, to be given at the preoperative teaching class, prior to their standard 3-week postoperative clinic appointment, and prior to their standard 6-week postoperative clinic appointment. |
| Pamphlet education + texts | Experimental | Other: Pamphlet education + textsPatients receive an educational pamphlet, to be given at the preoperative teaching class, prior to their standard 3-week postoperative clinic appointment, and prior to their standard 6-week postoperative clinic appointment. In addition, 3 automated text messages sent at those same time points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient undergoing primary total hip or knee arthroplasty
- Age ≥18 years old
Key exclusion criteria (6 listed)
- Patients allergic to oxycodone
- Patients consuming opioids during the 4 weeks prior to surgery
- Patients with a history of opioid dependence
- Patients undergoing revision total knee or hip arthroplasty
- Non-English speaking patients
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 |
|---|---|---|
| Pamphlet educationPatients receive an educational intervention explaining proper opioid disposal | Other | Pamphlet education |
| Pamphlet education + textsPatients receive an educational intervention and text message explaining proper opioid disposal | Other | Pamphlet education + texts |
Primary outcome
Disposal rates
Time frame: 6 weeks after surgery
The rate of an arm's disposal is calculated by comparing the number that properly disposed of their excess medication to the number that did not
1 secondary outcome
Continued taking opiate rate
Time frame: 6 weeks after surgery
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 30 Aug 2021.
- 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.
Craig Della Valle, MD principal investigator
Rush
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pamphlet education and Pamphlet education + texts in people with Opioid Use and Disposal, run by Rush University Medical Center 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 2 inclusion and 6 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 30 Aug 2021. 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?
Disposal rates (time frame: 6 weeks after surgery). 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 30 Aug 2021.