NCT06527599

Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Misuse
• Trauma Injury

Interventions

Type	Name	Description
OTHER	Opioid Risk Monitoring (ORM)	A brief battery of self-reported screeners for risk factors associated with opioid misuse (e.g., Current Opioid Misuse Measure; Pain, Enjoyment of life, and General activities scale; Pain Catastrophizing Scale). These measures will be administered within seven days of hospital discharge (i.e., baseline), and again at 2-, 4-, 8-, and 12-weeks following discharge to assess for ongoing risk for opioid misuse. Participants will additionally complete the self-reported Opioid Risk Tool within seven days of hospital discharge.
BEHAVIORAL	enhanced Trauma Care Coordination (eTCC)	An enhanced care management model with increased patient contact and embedded interventions based on clinical presentation and collaboration with the patient. eTCC is a telehealth-based care coordinating intervention where a care coordinator assesses the participant, creates a plan of care, collaborates with the eTCC team, follows up with a second virtual visit within a week, and communicates with the participant and care team at least bi-weekly for the 3 month intervention period.
BEHAVIORAL	Pain Coping Skills Training - Brief (PCST-LITE)	PCST-LITE will consist of a single 55-minute videoconference session, in which participants will receive brief psychoeducation grounded in gate control theory, progressive muscle relaxation (PMR), and therapist-guided imagery. Participants will be asked to practice PMR and imagery daily and will receive four weeks of regular (4-5 times per week) text messaging as a reminder.
BEHAVIORAL	Standard Trauma Care Coordination (sTCC)	Standard Trauma Care Coordination (sTCC) will functionally serve as a treatment-as-usual arm, as it will involve no study intervention.
BEHAVIORAL	Pain Coping Skills Training - Plus (PCST+)	PCST+ will include two videoconferencing sessions, in addition to the first videoconferencing session they previously received. In session 1, participants will be taught an activity/rest cycle to schedule activities, so they are productive while avoiding increasing pain severity due to taking insufficient breaks. Session 2 centers around cognitive restructuring, involving brief psychoeducation and skills development surrounding how participants might recognize the influence that cognitions can have on pain intensity and coping. Participants will receive 3 weekly, 15-minute calls to review skills and problem-solve.
BEHAVIORAL	Pain Coping Skills Training - Maintenance (PCST-M)	PCST-M consists of five weekly booster calls from the patient's study therapist to reinforce the techniques covered in the initial PCST-Lite session.

Timeline

• Start date: 2024-08-13
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-07-30
• Last updated: 2025-08-06

Locations

2 sites across 1 country: United States