Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT06527599
Status
Recruiting
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Conditions

  • Opioid Misuse
  • Trauma Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Opioid Risk Monitoring (ORM) — OTHER
    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.
  • enhanced Trauma Care Coordination (eTCC) — BEHAVIORAL
    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.
  • Pain Coping Skills Training - Brief (PCST-LITE) — BEHAVIORAL
    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.
  • Standard Trauma Care Coordination (sTCC) — BEHAVIORAL
    Standard Trauma Care Coordination (sTCC) will functionally serve as a treatment-as-usual arm, as it will involve no study intervention.
  • Pain Coping Skills Training - Plus (PCST+) — BEHAVIORAL
    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.
  • Pain Coping Skills Training - Maintenance (PCST-M) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 13, 2024
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
107 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus
    Participants initially randomized to Pain Coping Skills Training-Lite (PCST-Lite) plus enhanced Trauma Care Coordination (eTCC) who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive eTCC and Enhanced Pain Coping Skills Training (PCST-Plus).
  • Experimental: PCST-Lite + eTCC re-randomized to eTCC + PCST-M
    Participants initially randomized to PCST-Lite plus eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive eTCC and Pain Coping Skills Training-Maintenance (PCST-M) at 4 weeks.
  • Experimental: PCST-Lite + eTCC Low Risk eTCC + PCST-M
    Participants initially randomized to PCST-Lite plus eTCC who are identified to be at low risk for opioid misuse at week 4 will then receive eTCC and PCST-M.
  • Experimental: eTCC re-randomized to PCST-LITE
    Participants initially randomized to eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to PCST-LITE at 4 weeks.
  • Experimental: eTCC re-randomized to eTCC
    Participants initially randomized to eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive the same intervention at 4 weeks.
  • Experimental: eTCC Low Risk eTCC
    Participants initially randomized to eTCC who are identified to be at low risk for opioid misuse at week 4 will continue eTCC.
  • Experimental: PSCT-LITE re-randomized to PCST+
    Participants initially randomized to PCST-LITE who are identified to be at elevated risk for opioid misuse at week 4 re-randomized to PCST+.
  • Experimental: PCST-LITE re-randomized to PCST-Maintenance
    Participants initially randomized to PCST-LITE and are not re-randomized to an augmented form of PCST will instead receive PCST-Maintenance (PCST-M).
  • Experimental: PCST-Lite Low Risk PCST-M
    Participants initially randomized to PCST-Lite who are identified to be at low risk for opioid misuse at week 4 will be assigned to PCST-M.
  • Experimental: sTCC re-randomized to PCST-LITE
    Participants initially randomized to Standard Trauma Care Coordination (sTCC) who are identified to be at elevated risk for opioid misuse at week 4 will be re-randomized to either PCST-LITE or continued sTCC.
  • Experimental: sTCC re-randomized to sTCC
    Participants initially randomized to sTCC who are identified to be at elevated risk for opioid misuse at week 4 will be re-randomized to either PCST-LITE or continued sTCC.
  • Active Comparator: sTCC Low Risk sTCC
    Participants initially randomized to sTCC who are identified to be at low risk for opioid misuse at week 4 will continued sTCC.

Primary Outcome Measure

Percent of Target Sample Size Accrued by Study Completion [ Time Frame: up to 18 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UW HealthMadisonWisconsin53792-
Medical College of WisconsinMilwaukeeWisconsin53226-

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