An interventional study of Opioid Risk Monitoring (ORM) and enhanced Trauma Care Coordination (eTCC) in Opioid Misuse and Trauma Injury, sponsored by University of Wisconsin, Madison. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
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.
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:
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 118 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Meets at least one of the following descriptions below:
Exclusion Criteria:
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+)
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)
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)
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)
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)
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)
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+)
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)
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)
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)
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)
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)
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.
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 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) will functionally serve as a treatment-as-usual arm, as it will involve no study intervention.
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-M consists of five weekly booster calls from the patient's study therapist to reinforce the techniques covered in the initial PCST-Lite session.
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.
Time frame: up to 18 months
Number of Participants Enrolled
Number of participants who enrolled
Time frame: baseline to 4 weeks, baseline to 12 weeks
Number of Participants Retained
Number of participants who completed the study
Time frame: 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.
Time frame: 12 weeks
Incidence of Adverse Events by Grade
A safety objective is to evaluate the frequency and severity of adverse events associated with each arm of the intervention. Reported here is incidence of adverse events by grade.
Time frame: up to 6 months
Plan to share: No
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Wisconsin, Madison