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

University of Wisconsin (UW)

Status

Enrolling

Conditions

Trauma Injury

Opioid Misuse

Treatments

Other: Opioid Risk Monitoring (ORM)

Behavioral: Standard Trauma Care Coordination (sTCC)

Behavioral: Pain Coping Skills Training - Brief (PCST-LITE)

Behavioral: enhanced Trauma Care Coordination (eTCC)

Behavioral: Pain Coping Skills Training - Plus (PCST+)

Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)

Study type

Interventional

Funder types

Other

Identifiers

NCT06527599

Protocol Version CP004 (Other Identifier)

A532050 (Other Identifier)

2024-0157

Details and patient eligibility

About

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.

Full 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:

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

Enrollment

107 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

107 participants in 12 patient groups

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

Experimental group

Description:

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).

Treatment:

Behavioral: Pain Coping Skills Training - Plus (PCST+)

Behavioral: enhanced Trauma Care Coordination (eTCC)

Behavioral: Pain Coping Skills Training - Brief (PCST-LITE)

Other: Opioid Risk Monitoring (ORM)

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

Experimental group

Description:

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.

Treatment:

Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)

Behavioral: enhanced Trauma Care Coordination (eTCC)

Behavioral: Pain Coping Skills Training - Brief (PCST-LITE)

Other: Opioid Risk Monitoring (ORM)

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

Experimental group

Description:

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.

Treatment:

Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)

Behavioral: enhanced Trauma Care Coordination (eTCC)

Behavioral: Pain Coping Skills Training - Brief (PCST-LITE)

Other: Opioid Risk Monitoring (ORM)

eTCC re-randomized to PCST-LITE

Experimental group

Description:

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.

Treatment:

Behavioral: enhanced Trauma Care Coordination (eTCC)

Behavioral: Pain Coping Skills Training - Brief (PCST-LITE)

Other: Opioid Risk Monitoring (ORM)

eTCC re-randomized to eTCC

Experimental group

Description:

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.

Treatment:

Behavioral: enhanced Trauma Care Coordination (eTCC)

Other: Opioid Risk Monitoring (ORM)

eTCC Low Risk eTCC

Experimental group

Description:

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

Treatment:

Behavioral: enhanced Trauma Care Coordination (eTCC)

Other: Opioid Risk Monitoring (ORM)

PSCT-LITE re-randomized to PCST+

Experimental group

Description:

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

Treatment:

Behavioral: Pain Coping Skills Training - Plus (PCST+)

Behavioral: Pain Coping Skills Training - Brief (PCST-LITE)

Other: Opioid Risk Monitoring (ORM)

PCST-LITE re-randomized to PCST-Maintenance

Experimental group

Description:

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

Treatment:

Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)

Behavioral: Pain Coping Skills Training - Brief (PCST-LITE)

Other: Opioid Risk Monitoring (ORM)

PCST-Lite Low Risk PCST-M

Experimental group

Description:

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.

Treatment:

Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)

Other: Opioid Risk Monitoring (ORM)

sTCC re-randomized to PCST-LITE

Experimental group

Description:

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.

Treatment:

Behavioral: Pain Coping Skills Training - Brief (PCST-LITE)

Behavioral: Standard Trauma Care Coordination (sTCC)

Other: Opioid Risk Monitoring (ORM)

sTCC re-randomized to sTCC

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Trauma Care Coordination (sTCC)

Other: Opioid Risk Monitoring (ORM)

sTCC Low Risk sTCC

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Trauma Care Coordination (sTCC)

Other: Opioid Risk Monitoring (ORM)