Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention

NCT06527599 | Recruiting

• 3 other identifiers: 2024-0157A532050Protocol Version CP004
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

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.

Conditions

Opioid Misuse; Trauma Injury

Outcome Measures

Primary Outcomes (4)

• Percent of Target Sample Size Accrued by Study Completion

  A feasibility goal is to accrue at least 70 percent of the targeted sample size by study completion.

  up to 18 months

• Number of Participants Enrolled

  Number of participants who enrolled

  baseline to 4 weeks, baseline to 12 weeks

• Number of Participants Retained

  Number of participants who completed the study

  4 weeks, 12 weeks

• Acceptability of intervention

  Participants will complete a qualitative interview regarding their experiences in the study. Responses may be used to guide future related studies.

  12 weeks

Secondary Outcomes (1)

• Incidence of Adverse Events by Grade

  up to 6 months

Study Arms (12)

PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus

EXPERIMENTAL

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).

Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Pain Coping Skills Training - Plus (PCST+)

PCST-Lite + eTCC re-randomized to eTCC + PCST-M

EXPERIMENTAL

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.

Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)

PCST-Lite + eTCC Low Risk eTCC + PCST-M

EXPERIMENTAL

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.

Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)

eTCC re-randomized to PCST-LITE

EXPERIMENTAL

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.

Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE)

eTCC re-randomized to eTCC

EXPERIMENTAL

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.

Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC)

eTCC Low Risk eTCC

EXPERIMENTAL

Participants initially randomized to eTCC who are identified to be at low risk for opioid misuse at week 4 will continue eTCC.

Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC)

PSCT-LITE re-randomized to PCST+

EXPERIMENTAL

Participants initially randomized to PCST-LITE who are identified to be at elevated risk for opioid misuse at week 4 re-randomized to PCST+.

Other: Opioid Risk Monitoring (ORM); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Pain Coping Skills Training - Plus (PCST+)

PCST-LITE re-randomized to PCST-Maintenance

EXPERIMENTAL

Participants initially randomized to PCST-LITE and are not re-randomized to an augmented form of PCST will instead receive PCST-Maintenance (PCST-M).

Other: Opioid Risk Monitoring (ORM); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)

PCST-Lite Low Risk PCST-M

EXPERIMENTAL

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.

Other: Opioid Risk Monitoring (ORM); Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)

sTCC re-randomized to PCST-LITE

EXPERIMENTAL

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.

Other: Opioid Risk Monitoring (ORM); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Standard Trauma Care Coordination (sTCC)

sTCC re-randomized to sTCC

EXPERIMENTAL

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.

Other: Opioid Risk Monitoring (ORM); Behavioral: Standard Trauma Care Coordination (sTCC)

sTCC Low Risk sTCC

ACTIVE COMPARATOR

Participants initially randomized to sTCC who are identified to be at low risk for opioid misuse at week 4 will continued sTCC.

Other: Opioid Risk Monitoring (ORM); Behavioral: Standard Trauma Care Coordination (sTCC)

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.

PCST-LITE re-randomized to PCST-Maintenance; PCST-Lite + eTCC Low Risk eTCC + PCST-M; PCST-Lite + eTCC re-randomized to eTCC + PCST-M; PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus; PCST-Lite Low Risk PCST-M; PSCT-LITE re-randomized to PCST+; eTCC Low Risk eTCC; eTCC re-randomized to PCST-LITE; eTCC re-randomized to eTCC; sTCC Low Risk sTCC; sTCC re-randomized to PCST-LITE; sTCC re-randomized to sTCC

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.

Also known as: Trauma Medical Home

PCST-Lite + eTCC Low Risk eTCC + PCST-M; PCST-Lite + eTCC re-randomized to eTCC + PCST-M; PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus; eTCC Low Risk eTCC; eTCC re-randomized to PCST-LITE; eTCC re-randomized to eTCC

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.

PCST-LITE re-randomized to PCST-Maintenance; PCST-Lite + eTCC Low Risk eTCC + PCST-M; PCST-Lite + eTCC re-randomized to eTCC + PCST-M; PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus; PSCT-LITE re-randomized to PCST+; eTCC re-randomized to PCST-LITE; sTCC re-randomized to PCST-LITE

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.

sTCC Low Risk sTCC; sTCC re-randomized to PCST-LITE; sTCC re-randomized to sTCC

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.

PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus; PSCT-LITE re-randomized to PCST+

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.

PCST-LITE re-randomized to PCST-Maintenance; PCST-Lite + eTCC Low Risk eTCC + PCST-M; PCST-Lite + eTCC re-randomized to eTCC + PCST-M; PCST-Lite Low Risk PCST-M

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Wisconsin Partnership Program: collaborator
• Medical College of Wisconsin: collaborator

Study Sites (2)

UW Health

Madison, Wisconsin, 53792, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Accidental Injuries

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Wounds and Injuries

Study Officials

• Randy Brown, MD, PhD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ejura Salihu, PhD

CONTACT

608-265-9300; ejura.salihu@fammed.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Sequential, Multiple-Assignment Randomized Trial (Pilot SMART)

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)