Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers

Study Overview
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Brief Summary
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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.

Official Title
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Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers

Conditions
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Opioid Use, Inguinal Hernia, Ventral Hernia

Intervention / Treatment
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* Other: Opioid Use Agreement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid Use Agreement<br>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. | Other: Opioid Use Agreement<br>* 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).<br>|
| No Intervention: Standard of Care<br>Patients in this group will receive standard care which includes safe opioid education from the surgical care team. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-reported disposal of prescription opioids | Patient self-reported disposal of prescription opioids | 25-40 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid pills used | Number of opioid pill used if opioid prescription was filled | 25-40 days after surgery | 
| Opioid pills leftover | Number of opioid pills left over if opioid prescription was filled | 25-40 days after surgery | 
| Storage method | If opioid prescription was filled, how the opioid pills were stored | 25-40 days after surgery | 
| Disposal method | If opioid prescription was filled, how the opioid pills were disposed | 25-40 days after surgery | 
| Other pain management strategies | Other pain management strategies that were used | 25-40 days after surgery |