Preventing opioid misuse in trauma patients

Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention (STOMP-AI)

This study is testing a new approach to help trauma patients manage their pain and reduce the risk of misusing opioids while in the hospital.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 107 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Wisconsin, Madison (other)
• Locations: 2 sites (Madison, Wisconsin and 1 other locations)
• Trial ID: NCT06527599 on ClinicalTrials.gov

What this trial studies

This pilot trial aims to assess the feasibility and acceptability of an adaptive intervention designed to reduce opioid misuse among individuals hospitalized for traumatic injuries. Participants will be randomized to receive one of four interventions that combine trauma care coordination with pain coping skills training. The study will focus on tailoring the intervention to meet individual patient needs rather than using a one-size-fits-all approach. Approximately 107 participants will be enrolled, and the study will last up to six months, with iterative refinements made to the intervention throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are individuals hospitalized for traumatic injuries who are expected to manage their own medications upon discharge.

Not a fit: Patients with a current diagnosis of opioid use disorder or those unable to provide written consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the rates of opioid misuse and prevent the development of opioid use disorder in trauma patients.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in addressing opioid misuse through tailored interventions.

Eligibility criteria

Inclusion Criteria:

* Able to speak, read, and write fluently in English.
* Admission to site hospital for a traumatic injury at time of screening. A traumatic injury is defined as a physical injury with sudden onset requiring immediate medical attention.
* Injury severity score of 9 or greater.
* Meets at least one of the following descriptions below:

  * Received 40 mg morphine milligram equivalent (MME) within 48 hours of pre-screening; or
  * Discharged with a prescription for an opioid medication.
* Expected to be in control of their own medications at the time of discharge from the controlled environment of hospital or short-term rehabilitation.

Exclusion Criteria:

* Inability to provide written consent for any reason.
* Current self-reported diagnosis of cancer with life expectancy less than 12 months at time of screening.
* Current prescription for opioid use disorder (e.g., suboxone, buprenorphine, methadone, naltrexone), with a current diagnosis of opioid use disorder (OUD) (mild or greater) not in remission.
* History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, or vascular dementia.
* Current significant traumatic brain injury (defined as the presence of any intracranial blood on Computed Tomography scan of the head or best Glasgow Coma Scale Score of less than 13 at the time of screening).
* Current spinal cord injury with persistent neurologic deficit at the time of screening.
* Acute stroke immediately prior to/upon admission, or emergent stroke as a new event during hospitalization.
* Any vision or hearing impairments resulting in an inability to complete study procedures.
* Current pregnancy, as indicated by chart review and self-report.
* Involved in any criminal justice proceedings related to illicit substance use at time of screening.
* Incarcerated or in police custody at time of study enrollment.
* Admitted to the hospital with a burn affecting \>10% total body surface area, as indicated by chart review.
* Any medical, physical, cognitive, or psychiatric conditions that would limit the participant's ability to provide informed consent or complete study procedures, as determined by study staff and/or investigators.

Where this trial is running

Madison, Wisconsin and 1 other locations

• UW Health — Madison, Wisconsin, United States (RECRUITING)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)

Study contacts

• Principal investigator: Randy Brown, MD, PhD — UW School of Medicine and Public Health
• Study coordinator: Ejura Salihu, PhD

Conditions: Opioid Misuse, Trauma Injury