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

Not Applicable

Active, not recruiting

• Conditions: Ventral Hernia; Opioid Use; Inguinal Hernia
• Interventions: Other: Opioid Use Agreement

• Registration Number: NCT06167759
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-05
• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Use Agreement	Opioid Use Agreement	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.

Primary Outcome Measures

Name	Time	Method
Patient self-reported disposal of prescription opioids	25-40 days after surgery	Patient self-reported disposal of prescription opioids

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Lyndon B. Johnson General Hospital; 🇺🇸 Houston, Texas, United States

UT Physicians-MIST Sugar Land Clinic; 🇺🇸 Sugar Land, Texas, United States

UT Physicians-MIST Bellaire Clinic; 🇺🇸 Bellaire, Texas, United States