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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06167759
• Other study ID #: HSC-MS-22-0807
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Hernia, Ventral
• Inguinal Hernia
• Opioid Use
• Opioid-Related Disorders
• Ventral Hernia

Intervention

Other:
• Opioid Use Agreement
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).

Locations

Country	Name	City	State
United States	UT Physicians-MIST Bellaire Clinic	Bellaire	Texas
United States	Lyndon B. Johnson General Hospital	Houston	Texas
United States	UT Physicians-MIST Sugar Land Clinic	Sugar Land	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient self-reported disposal of prescription opioids	Patient self-reported disposal of prescription opioids	25-40 days after surgery
Secondary	Opioid pills used	Number of opioid pill used if opioid prescription was filled	25-40 days after surgery
Secondary	Opioid pills leftover	Number of opioid pills left over if opioid prescription was filled	25-40 days after surgery
Secondary	Storage method	If opioid prescription was filled, how the opioid pills were stored	25-40 days after surgery
Secondary	Disposal method	If opioid prescription was filled, how the opioid pills were disposed	25-40 days after surgery
Secondary	Other pain management strategies	Other pain management strategies that were used	25-40 days after surgery