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

December 4, 2023 updated by: Jonah Stulberg, The University of Texas Health Science Center, Houston

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 25-40 days after surgery
Patient self-reported disposal of prescription opioids
25-40 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Northwestern University

Investigators

  • Principal Investigator: Jonah J Stulberg, MD, UTHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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