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

NCT06167759 | Unknown

• 1 other identifier: HSC-MS-22-0807
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

Opioid Use; Inguinal Hernia; Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• Patient self-reported disposal of prescription opioids

  Patient self-reported disposal of prescription opioids

  25-40 days after surgery

Secondary Outcomes (5)

• Opioid pills used

  25-40 days after surgery

• Opioid pills leftover

  25-40 days after surgery

• Storage method

  25-40 days after surgery

• Disposal method

  25-40 days after surgery

• Other pain management strategies

  25-40 days after surgery

Study Arms (2)

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.

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.

Interventions

Opioid Use Agreement OTHER

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).

Opioid Use Agreement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Northwestern University: collaborator

Study Sites (3)

UT Physicians-MIST Bellaire Clinic

Bellaire, Texas, 77401, United States

Location

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

UT Physicians-MIST Sugar Land Clinic

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonah J Stulberg, MD

  UTHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: December 5, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

US (3)