Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention

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.

Conditions

• Opioid Misuse
• Trauma Injury

Interventions

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.

Sponsors & Collaborators

• Wisconsin Partnership Program

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Randy Brown, MD, PhD · UW School of Medicine and Public Health

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-13

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• United States

Study Locations