Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention
NCT Number: NCT06527599
Acronym: STOMP-AI
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Misuse|Trauma Injury
Sponsor: University of Wisconsin, Madison
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 107
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2026-04

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.

Primary Outcome Measures: 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|Percent of Anticipated Research Questionnaires and Assessments Completed for Enrolled Participants, A feasibility goal is for at least 70 percent of anticipated research questionnaires and assessments to be completed for enrolled participants., up to 6 months|Percent of Study Procedures Completed per Participant Assigned, The adherence of eTCC and PCST will be measured by calculating the percentage of study procedures completed per participant assigned those procedures., up to 6 months|Acceptability of Intervention Measure (AIM) Score, The AIM is a measure of acceptability of the intervention and is scored on a likert scale from 1-5 where higher scores indicate increased acceptability., 4 weeks, 12 weeks|Interventional Appropriateness Measure (IAM) Score, The IAM is a measure of appropriateness of the intervention and is scored on a likert scale from 1-5 where higher scores indicate increased appropriateness., 4 weeks, 12 weeks|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|Client Satisfaction Questionnaire (CSQ) Score, The CSQ is a measure of acceptability of the intervention and is scored from 8 to 32 with higher numbers indicating greater satisfaction., up to 6 months|Adaptive Treatment Attitudes Questionnaire (ATAQ) Score, The ATAQ is a measure used to athe acceptability by stakeholders from trauma surgical services to incorporate eTCC and PCST into hospital workflow and clinical care. It is scored from -6 to 6 where higher scores indicate increased acceptability., up to 6 months
Secondary Outcome Measures: 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