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

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 Overview

• Status: Active, not recruiting
• Conditions: Inguinal Hernia; Ventral Hernia; Opioid Use
• Intervention / Treatment: Other: Opioid Use Agreement

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Bellaire, Texas, United States, 77401
      • UT Physicians-MIST Bellaire Clinic
    • Houston, Texas, United States, 77026
      • Lyndon B. Johnson General Hospital
    • Sugar Land, Texas, United States, 77478
      • UT Physicians-MIST Sugar Land Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).
No Intervention: Standard of Care; Patients in this group will receive standard care which includes safe opioid education from the surgical care team.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Northwestern University
• Investigators: Principal Investigator: Jonah J Stulberg, MD, UTHealth

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Estimated): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pathological Conditions, Anatomical; Hernia, Abdominal; Narcotic-Related Disorders; Hernia; Hernia, Inguinal; Opioid-Related Disorders; Hernia, Ventral; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: HSC-MS-22-0807

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No