Contemporary clinical trials · 2026
Screen-and-treat in trauma for opioid misuse prevention using an adaptive intervention (STOMP-AI): Protocol for a pilot sequential, multiple assignment, randomized trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Horton David M, Leinweber David L, Salihu Ejura, Sarwar Tehseen, Muller Hannah, Trevino Colleen, Zaborek Jen, Chen Guanhua, Quanbeck Andrew, Somers Tamara, Almirall Daniel, Zarzaur Ben, Brown Randall T
Аннотация
BACKGROUND: Approximately 75% of individuals hospitalized for traumatic injury receive prescription opioids and experience poorly controlled pain, psychological distress, and polysubstance use, placing these individuals at elevated risk for opioid misuse. Risk factors for opioid misuse vary considerably, following traumatic injury, suggesting similarly variable responses to risk-mitigation attempts. Such heterogeneity necessitates the development of an adaptive intervention, yet no previous trials have evaluated the feasibility of researching nor delivering adaptive interventions to mitigate pain and misuse-related risk, in this population.
METHODS: A pilot sequential, multiple-assignment randomized trial (SMART) will be conducted to determine the feasibility of delivering an adaptive intervention initiated within one week of hospital discharge, comprising opioid risk monitoring, trauma care coordination, and pain coping skills training for patients hospitalized for traumatic injury. 107 patients across two Level I trauma centers will be included in the study. Feasibility of conducting the proposed SMART will also be evaluated, including processes for recruitment, retention, randomization and re-randomization, data collection, and qualitative methods. Self-report research surveys, clinical and research visit tracking, fidelity, and qualitative data will be collected at multiple timepoints throughout the trial to inform feasibility and acceptability of the adaptive intervention's components.
ANTICIPATED RESULTS: Pilot data will be used to ensure the feasibility and acceptability of the adaptive intervention components, as well as the SMART design.
DISCUSSION: Pilot data will be used to develop and refine a manualized adaptive intervention, as well as a fully developed SMART protocol, for optimization-effectiveness testing in a future, full-scale trial.
TRIAL REGISTRATION: Registered with clinicaltrials.gov (NCT06527599).
METHODS: A pilot sequential, multiple-assignment randomized trial (SMART) will be conducted to determine the feasibility of delivering an adaptive intervention initiated within one week of hospital discharge, comprising opioid risk monitoring, trauma care coordination, and pain coping skills training for patients hospitalized for traumatic injury. 107 patients across two Level I trauma centers will be included in the study. Feasibility of conducting the proposed SMART will also be evaluated, including processes for recruitment, retention, randomization and re-randomization, data collection, and qualitative methods. Self-report research surveys, clinical and research visit tracking, fidelity, and qualitative data will be collected at multiple timepoints throughout the trial to inform feasibility and acceptability of the adaptive intervention's components.
ANTICIPATED RESULTS: Pilot data will be used to ensure the feasibility and acceptability of the adaptive intervention components, as well as the SMART design.
DISCUSSION: Pilot data will be used to develop and refine a manualized adaptive intervention, as well as a fully developed SMART protocol, for optimization-effectiveness testing in a future, full-scale trial.
TRIAL REGISTRATION: Registered with clinicaltrials.gov (NCT06527599).