Opioid UseNCT04625231
Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Hand Surgery in Veterans
A study testing Educational Shared-Decision Making Tool in people with Opioid Use and Surgery, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to determine if an educational patient-centered presentation reduced the amount of opioid pills requested and utilized by patients compared to standard of care group. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Opioid Use, Surgery
- What is being tested?
- Educational Shared-Decision Making Tool
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 30 May 2022
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 1. Inclusion Criteria:
- a. 18-89 years of age
- b. Patient at the Orthopedic Department at the Veterans Health Administration
- c. Indicated for upper extremity surgeries: E.g., Carpal Tunnel Release, Trigger Finger Release, Cubital Tunnel Release, Ganglion Cyst Excision
- 2. Exclusion Criteria:
- a. History of opioid use disorder
- b. Had any recent surgery within four weeks of upper extremity procedure
- c. Taking opioids prior to surgery
- d. Returning to an institutionalized setting
- e. Pregnancy
- f. Unable to communicate in the English language
- g. Allergy to any medication recommended for post-operative analgesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
About this study
Official title: Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Orthopedic Surgery in Veterans - A Randomized Controlled Clinical Trial
The purpose of this study is to determine if an educational patient-centered presentation reduced the amount of opioid pills requested and utilized by patients compared to standard of care group.
- Conditions
- Opioid Use, Surgery
- Being tested
- Educational Shared-Decision Making Tool
- Keywords
- orthopedics, hand surgery, opioid use, counseling, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Shared-Decision Making ToolBehavioural
Patients received a short video presentation on pain management, use of over the counter medication, side effects of opioids and over-the-counter medications and ability to choose the amount of opioid pills up to the standard care amount.
| Study group | Role | What they receive |
|---|---|---|
| Shared-Decision Making Tool Group | Experimental | Not described Receives: Behavioral: Educational Shared-Decision Making Tool |
| Standard of Care Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Opioid Pills Dispensed
Measured: 1 day (Once after surgery)
Number of Opioid Pills Consumed
Measured: 4 weeks
Secondary outcomes (2)
Patient-Reported Outcomes Measurement Information System Pain Interference Score
Lower scores are better
Measured: Once a week for 4 weeks after surgery
Patient-Reported Outcomes Measurement Information System Pain Intensity Score
Lower scores are better
Measured: Once a week for 4 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 posted12 Nov 2020
- Study start9 Nov 2018
- Primary completion1 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajshri Bolson, MD, Principal investigator, Rocky Mountain Regional VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625231
- Sponsor's protocol ID
- 18-0160
- Status last verified
- Aug 2022
- First submitted
- 6 Nov 2020
- Last updated
- 12 Aug 2022
- 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 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Orthopedic Surgery in Veterans - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04625231
- Acronym / sponsor ID
- 18-0160
- Conditions
- Opioid Use, Surgery
- Keywords
- orthopedics, hand surgery, opioid use, counseling, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 12 Nov 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 this study is to determine if an educational patient-centered presentation reduced the amount of opioid pills requested and utilized by patients compared to standard of care group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared-Decision Making Tool Group | Experimental | Behavioral: Educational Shared-Decision Making Tool |
| Standard of Care Group | No intervention | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Educational Shared-Decision Making ToolPatients received a short video presentation on pain management, use of over the counter medication, side effects of opioids and over-the-counter medications and ability to choose the amount of opioid pills up to the standard care amount. | Behavioural | Shared-Decision Making Tool Group |
Primary outcome
Number of Opioid Pills Dispensed
Time frame: 1 day (Once after surgery)
Number of Opioid Pills Consumed
Time frame: 4 weeks
2 secondary outcomes
Patient-Reported Outcomes Measurement Information System Pain Interference Score
Time frame: Once a week for 4 weeks after surgery
Patient-Reported Outcomes Measurement Information System Pain Intensity Score
Time frame: Once a week for 4 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 12 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder
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.
Rajshri Bolson, MD principal investigator
Rocky Mountain Regional VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Shared-Decision Making Tool in people with Opioid Use and Surgery, run by University of Colorado, Denver 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?
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 12 Aug 2022. 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?
Number of Opioid Pills Dispensed (time frame: 1 day (Once after surgery)). 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 12 Aug 2022.