Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention (STOMP-AI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- Percent of Target Sample Size Accrued by Study Completion
Study Overview
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.
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Pain Coping Skills Training - Brief (PCST-LITE) (Behavioral)
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.
Intervention: Pain Coping Skills Training - Maintenance (PCST-M) (Behavioral)
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.
Intervention: Opioid Risk Monitoring (ORM) (Other)
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.
Intervention: enhanced Trauma Care Coordination (eTCC) (Behavioral)
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.
Intervention: Pain Coping Skills Training - Brief (PCST-LITE) (Behavioral)
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.
Intervention: Pain Coping Skills Training - Maintenance (PCST-M) (Behavioral)
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.
Intervention: Opioid Risk Monitoring (ORM) (Other)
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.
Intervention: enhanced Trauma Care Coordination (eTCC) (Behavioral)
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.
Intervention: Pain Coping Skills Training - Brief (PCST-LITE) (Behavioral)
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.
Intervention: Opioid Risk Monitoring (ORM) (Other)
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.
Intervention: enhanced Trauma Care Coordination (eTCC) (Behavioral)
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.
Intervention: Opioid Risk Monitoring (ORM) (Other)
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.
Intervention: enhanced Trauma Care Coordination (eTCC) (Behavioral)
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+.
Intervention: Opioid Risk Monitoring (ORM) (Other)
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+.
Intervention: Pain Coping Skills Training - Brief (PCST-LITE) (Behavioral)
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+.
Intervention: Pain Coping Skills Training - Plus (PCST+) (Behavioral)
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).
Intervention: Opioid Risk Monitoring (ORM) (Other)
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).
Intervention: Pain Coping Skills Training - Brief (PCST-LITE) (Behavioral)
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).
Intervention: Pain Coping Skills Training - Maintenance (PCST-M) (Behavioral)
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.
Intervention: Opioid Risk Monitoring (ORM) (Other)
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.
Intervention: Pain Coping Skills Training - Maintenance (PCST-M) (Behavioral)
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.
Intervention: Opioid Risk Monitoring (ORM) (Other)
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.
Intervention: Pain Coping Skills Training - Brief (PCST-LITE) (Behavioral)
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.
Intervention: Standard Trauma Care Coordination (sTCC) (Behavioral)
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.
Intervention: Opioid Risk Monitoring (ORM) (Other)
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.
Intervention: Standard Trauma Care Coordination (sTCC) (Behavioral)
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.
Intervention: Opioid Risk Monitoring (ORM) (Other)
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.
Intervention: Standard Trauma Care Coordination (sTCC) (Behavioral)
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).
Intervention: Opioid Risk Monitoring (ORM) (Other)
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).
Intervention: enhanced Trauma Care Coordination (eTCC) (Behavioral)
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).
Intervention: Pain Coping Skills Training - Brief (PCST-LITE) (Behavioral)
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).
Intervention: Pain Coping Skills Training - Plus (PCST+) (Behavioral)
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.
Intervention: Opioid Risk Monitoring (ORM) (Other)
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.
Intervention: enhanced Trauma Care Coordination (eTCC) (Behavioral)
Outcomes
Primary Outcomes
Percent of Target Sample Size Accrued by Study Completion
Time Frame: up to 18 months
A feasibility goal is to accrue at least 70 percent of the targeted sample size by study completion.
Number of Participants Enrolled
Time Frame: baseline to 4 weeks, baseline to 12 weeks
Number of participants who enrolled
Number of Participants Retained
Time Frame: 4 weeks, 12 weeks
Number of participants who completed the study
Acceptability of intervention
Time Frame: 12 weeks
Participants will complete a qualitative interview regarding their experiences in the study. Responses may be used to guide future related studies.
Secondary Outcomes
- Incidence of Adverse Events by Grade(up to 6 months)