Clinical trial NCT06527599: Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention
Official title: Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention (STOMP-AI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Misuse
Trauma Injury
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Wisconsin Partnership Program
name: Medical College of Wisconsin
First posted: 2024-07-30
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pilot Sequential, Multiple-Assignment Randomized Trial (Pilot SMART)
Primary purpose: TREATMENT

Brief summary: The primary objective of the present pilot, sequential, multiple-assignment randomized trial (Pilot SMART) is to determine feasibility and acceptability of delivering (from the perspective of the treatment/intervention staff) and receiving (from the perspective of the patient) an adaptive intervention for reducing rates of opioid misuse and preventing development of opioid use disorder in individuals hospitalized for traumatic injury. A complimentary secondary objective is to ensure the feasibility of conducting a future, multi-site, full-scale SMART.

Approximately 107 participants will be enrolled and can expect to be on study for up to 6 months.

Detailed description: The proposed project would be the first clinical trial to assess the feasibility of implementing a preventative treatment design that specifically targets the needs of individuals receiving opioid prescriptions following surgery for traumatic injury. The project will operationalize a standardized approach to screening, treating, and monitoring risk of opioid misuse following traumatic injury. If funded, the project would provide a personalized approach to post-injury monitoring and management through an adaptive intervention designed to target the needs of the individual, rather than implementing a rigid, one-size-fits-all intervention model to prevent opioid misuse.

Approximately 107 participants will be enrolled into the study (approximately 54 participants at UW and 53 participants at MCW). At or very shortly after (within 1-2 days) discharge, participants will be randomized using a 2x2 factorial design to initially receive any one of the following four interventions:

1. standard Trauma Care Coordination (sTCC)
2. sTCC + an abbreviated Pain Coping Skills Training (PCST-Lite)
3. enhanced Trauma Care Coordination (eTCC)
4. eTCC + PCST-Lite

Components of the adaptive intervention will be iteratively refined at various points before, during, and after the pilot SMART in order to maximize feasibility and acceptability.

Primary Objective: Determine the feasibility of delivering an adaptive intervention for reducing rates of opioid misuse and preventing development of opioid use disorder in individuals hospitalized for traumatic injury.

Secondary Objective: Obtain the preliminary data necessary for a successful NIH R01 Application.

Exploratory Objective 1: Identify associations between the interventions delivered and opioid use/misuse.

Exploratory Objective 2: Identify associations between the interventions delivered and the physical, social, and psychological antecedents of opioid misuse.

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.

Primary outcomes:
measure: Percent of Target Sample Size Accrued by Study Completion
timeFrame: up to 18 months
measure: Number of Participants Enrolled
timeFrame: baseline to 4 weeks, baseline to 12 weeks
measure: Number of Participants Retained
timeFrame: 4 weeks, 12 weeks
measure: Acceptability of intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of Adverse Events by Grade
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Randy Brown, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: