Knee Total Joint ReplacementNCT03954964
Increasing Awareness of Opioid Disposal in the Orthopedic Patient Population
A study testing Education on disposal of opioids in people with Knee Total Joint Replacement and Hip Total Joint Replacement, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine if providing education on proper disposal of unused opioid medications to the orthopedic patient undergoing a planned hip or knee total joint replacement will increase the percentage of patients who properly dispose of unused opioids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Total Joint Replacement, Hip Total Joint Replacement
- What is being tested?
- Education on disposal of opioids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2019to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 + years
- Planned total hip or knee replacement surgery
- English speaking
Who cannot join
- Pediatric patients 17 and younger
- Non-English speaking patients
- Total joint replacement surgery other than Hip and Knee
Trial locations and contacts
1 site in 1 country.
About this study
Researchers are trying to determine if providing education on proper disposal of unused opioid medications to the orthopedic patient undergoing a planned hip or knee total joint replacement will increase the percentage of patients who properly dispose of unused opioids.
- Being tested
- Education on disposal of opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on disposal of opioidsBehavioural
Current class curriculum including education about pain management with additional education about the disposal of opioids.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Subjects participating in a total joint class for patients undergoing planned hip and knee total joint replacement. |
| Intervention Group | Experimental | Subjects participating in a total joint class for patients undergoing planned hip and knee total joint replacement will receive additional education about the disposal of opioids. Receives: Behavioral: Education on disposal of opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disposal of unused prescription pain medication
Number of subjects to self-report disposal of unused prescription pain medication on the twelve week post operative visit survey
Measured: 12 weeks post operative
Use of medication deactivation bag
Number of subjects to self-report disposal of unused prescription pain medication via the medication deactivation bag on the twelve week post operative visit survey
Measured: 12 weeks post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start3 Jun 2019
- Primary completion31 Dec 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 Knee Total Joint ReplacementStudies of the same condition, open and under way.
- More trials run by Mayo 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine D. Aliory, Mayo Clinic
- Investigators
- Christine Aliory, APRN, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954964
- Sponsor's protocol ID
- 18-011832
- Status last verified
- Mar 2020
- First submitted
- 16 May 2019
- Last updated
- 26 Mar 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 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Awareness of Opioid Disposal in the Orthopedic Patient Population
- ClinicalTrials.gov ID
- NCT03954964
- Acronym / sponsor ID
- 18-011832
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 May 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.
Researchers are trying to determine if providing education on proper disposal of unused opioid medications to the orthopedic patient undergoing a planned hip or knee total joint replacement will increase the percentage of patients who properly dispose of unused opioids.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Subjects participating in a total joint class for patients undergoing planned hip and knee total joint replacement. |
| Intervention Group | Experimental | Behavioral: Education on disposal of opioidsSubjects participating in a total joint class for patients undergoing planned hip and knee total joint replacement will receive additional education about the disposal of opioids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult 18 + years
- Planned total hip or knee replacement surgery
- English speaking
Key exclusion criteria (3 listed)
- Pediatric patients 17 and younger
- Non-English speaking patients
- Total joint replacement surgery other than Hip and Knee
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 |
|---|---|---|
| Education on disposal of opioidsCurrent class curriculum including education about pain management with additional education about the disposal of opioids. | Behavioural | Intervention Group |
Primary outcome
Disposal of unused prescription pain medication
Time frame: 12 weeks post operative
Number of subjects to self-report disposal of unused prescription pain medication on the twelve week post operative visit survey
Use of medication deactivation bag
Time frame: 12 weeks post operative
Number of subjects to self-report disposal of unused prescription pain medication via the medication deactivation bag on the twelve week post operative visit survey
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 26 Mar 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Christine Aliory, APRN principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education on disposal of opioids in people with Knee Total Joint Replacement and Hip Total Joint Replacement, run by Mayo 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 3 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 26 Mar 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?
Disposal of unused prescription pain medication (time frame: 12 weeks post operative). The study lists 2 primary outcomes in all. 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 26 Mar 2020.