Opioid UseNCT06167759
Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers
A study testing Opioid Use Agreement in people with Opioid Use and Inguinal Hernia, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
Trial summary
The effect of pain agreements to reduce opioid misuse is an accepted practice in many settings, but it has never been applied to the acute care setting. Pain agreements are considered the standard of care for chronic pain management reliant on opioid prescribing, and they are a mandated component of care in many… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Inguinal Hernia, Ventral Hernia
- What is being tested?
- Opioid Use Agreement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Dec 2022to 30 Apr 2024
- 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 patients (at least 18 years of age), of any gender, who speak English or Spanish, undergoing general surgery procedures with a high likelihood of receiving an opioid prescription (bariatric, inguinal hernia, or ventral hernia), who have their preoperative appointment at UT Physicians Health Center at Memorial Hermann Sugar Land Medical Plaza, Lyndon Baines Johnson, and Bellaire
Who cannot join
- Patients with a known allergy or contra-indication to opioids, pregnancy, signification cognitive impairment, history of opioid misuse/abuse, chronic opioid use, readmission before the follow up appointment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UT Physicians-MIST Bellaire Clinic
Bellaire, Texas, 77401
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
UT Physicians-MIST Sugar Land Clinic
Sugar Land, Texas, 77478
About this study
The effect of pain agreements to reduce opioid misuse is an accepted practice in many settings, but it has never been applied to the acute care setting. Pain agreements are considered the standard of care for chronic pain management reliant on opioid prescribing, and they are a mandated component of care in many states. Therefore, the adjunct of safe opioid use agreements into acute pain management offers a logical extension of current practices from chronic pain management.
This study will test the use of agreements to improve safe opioid use to prevent misuse and opioid-related harm.
- Conditions
- Opioid Use, Inguinal Hernia, Ventral Hernia
- Being tested
- Opioid Use Agreement
- Medical subject headings
- Hernia, Inguinal, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Use AgreementOther
This was previously developed specifically for surgical patients using a modified Delphi method with a group of experts (including surgeons, nurses, advanced practices providers, quality improvement experts, and patients).
| Study group | Role | What they receive |
|---|---|---|
| Opioid Use Agreement | Experimental | Patients in this group will be administered a safe opioid use agreement by the research coordinator. This agreement is in addition to any routine education and counseling provided by the surgical team. Receives: Other: Opioid Use Agreement |
| Standard of Care | No intervention | Patients in this group will receive standard care which includes safe opioid education from the surgical care team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient self-reported disposal of prescription opioids
Patient self-reported disposal of prescription opioids
Measured: 25-40 days after surgery
Secondary outcomes (5)
Opioid pills used
Number of opioid pill used if opioid prescription was filled
Measured: 25-40 days after surgery
Opioid pills leftover
Number of opioid pills left over if opioid prescription was filled
Measured: 25-40 days after surgery
Storage method
If opioid prescription was filled, how the opioid pills were stored
Measured: 25-40 days after surgery
Disposal method
If opioid prescription was filled, how the opioid pills were disposed
Measured: 25-40 days after surgery
Other pain management strategies
Other pain management strategies that were used
Measured: 25-40 days 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 Dec 2023
- Study start5 Dec 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
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 The University of Texas Health Science Center, HoustonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, Jonah Stulberg, The University of Texas Health Science Center, Houston
- Investigators
- Jonah J Stulberg, MD, Principal investigator, UTHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167759
- Sponsor's protocol ID
- HSC-MS-22-0807
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers
- ClinicalTrials.gov ID
- NCT06167759
- Acronym / sponsor ID
- HSC-MS-22-0807
- Conditions
- Opioid Use, Inguinal Hernia, Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 12 Dec 2023 (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 effect of pain agreements to reduce opioid misuse is an accepted practice in many settings, but it has never been applied to the acute care setting. Pain agreements are considered the standard of care for chronic pain management reliant on opioid prescribing, and they are a mandated component of care in many states. Therefore, the adjunct of safe opioid use agreements into acute pain management offers a logical extension of current practices from chronic pain management.
This study will test the use of agreements to improve safe opioid use to prevent misuse and opioid-related harm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Use Agreement | Experimental | Other: Opioid Use AgreementPatients in this group will be administered a safe opioid use agreement by the research coordinator. This agreement is in addition to any routine education and counseling provided by the surgical team. |
| Standard of Care | No intervention | –Patients in this group will receive standard care which includes safe opioid education from the surgical care team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (at least 18 years of age), of any gender, who speak English or Spanish, undergoing general surgery procedures with a high likelihood of receiving an opioid prescription (bariatric, inguinal hernia, or ventral hernia), who have their preoperative appointment at UT Physicians Health Center at Memorial Hermann Sugar Land Medical Plaza, Lyndon Baines Johnson, and Bellaire
Key exclusion criteria (1 listed)
- Patients with a known allergy or contra-indication to opioids, pregnancy, signification cognitive impairment, history of opioid misuse/abuse, chronic opioid use, readmission before the follow up appointment
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 |
|---|---|---|
| Opioid Use AgreementThis was previously developed specifically for surgical patients using a modified Delphi method with a group of experts (including surgeons, nurses, advanced practices providers, quality improvement experts, and patients). | Other | Opioid Use Agreement |
Primary outcome
Patient self-reported disposal of prescription opioids
Time frame: 25-40 days after surgery
Patient self-reported disposal of prescription opioids
5 secondary outcomes
Opioid pills used
Time frame: 25-40 days after surgery
Opioid pills leftover
Time frame: 25-40 days after surgery
Storage method
Time frame: 25-40 days after surgery
Disposal method
Time frame: 25-40 days after surgery
Other pain management strategies
Time frame: 25-40 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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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.
Jonah J Stulberg, MD principal investigator
UTHealth
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Use Agreement in people with Opioid Use and Inguinal Hernia, run by The University of Texas Health Science Center, Houston at 3 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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?
Patient self-reported disposal of prescription opioids (time frame: 25-40 days 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 12 Dec 2023.