Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A532050 | Other Identifier | UW Madison | |
| Protocol Version CP004 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wisconsin Partnership Program | OTHER |
| Medical College of Wisconsin | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| 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. |
|
| eTCC re-randomized to PCST-LITE |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 6 months |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Randy Brown, MD, PhD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Health | Madison | Wisconsin | 53792 | United States | ||
| Medical College of Wisconsin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41688015 | Derived | Horton DM, Leinweber DL, Salihu E, Sarwar T, Muller H, Trevino C, Zaborek J, Chen G, Quanbeck A, Somers T, Almirall D, Zarzaur B, Brown RT. Screen-and-treat in trauma for opioid misuse prevention using an adaptive intervention (STOMP-AI): Protocol for a pilot sequential, multiple assignment, randomized trial. Contemp Clin Trials. 2026 Apr;163:108255. doi: 10.1016/j.cct.2026.108255. Epub 2026 Feb 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pilot Sequential, Multiple-Assignment Randomized Trial (Pilot SMART)
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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. |
|
| 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. |
|
| 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+. |
|
| 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). |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
|
| 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. |
|
| Milwaukee |
| Wisconsin |
| 53226 |
| United States |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000081084 | Accidental Injuries |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D014947 | Wounds and Injuries |
Not provided
Not provided