Screen-and-treat in trauma for opioid misuse prevention using an adaptive intervention (STOMP-AI): Protocol for a pilot sequential, multiple assignment, randomized trial

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2026-04-01 Epub Date: 2026-02-11 DOI:10.1016/j.cct.2026.108255

M. Horton David , L. Leinweber David , Salihu Ejura , Sarwar Tehseen , Muller Hannah , Trevino Colleen , Zaborek Jen , Chen Guanhua , Quanbeck Andrew , Somers Tamara , Almirall Daniel , Zarzaur Ben , T. Brown Randall

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引用次数: 0

Abstract

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).

查看原文本刊更多论文

使用适应性干预预防阿片类药物滥用的创伤筛查和治疗（STOMP-AI）：一项先导顺序、多任务、随机试验方案

背景：大约75%因创伤性损伤住院的个体接受处方阿片类药物治疗，并经历控制不佳的疼痛、心理困扰和多种物质使用，使这些个体面临阿片类药物滥用的高风险。在创伤性损伤后，阿片类药物滥用的危险因素差异很大，这表明对减轻风险的尝试的反应也同样不同。这种异质性需要适应性干预的发展，但之前没有试验评估研究或提供适应性干预的可行性，以减轻这一人群的疼痛和滥用相关风险。方法进行一项先导顺序、多任务随机试验（SMART），以确定在出院一周内启动适应性干预的可行性，包括阿片类药物风险监测、创伤护理协调和创伤性损伤住院患者疼痛应对技能培训。来自两个一级创伤中心的107名患者将被纳入研究。还将评估实施拟议的SMART的可行性，包括招聘、保留、随机化和再随机化、数据收集和定性方法的过程。自我报告研究调查、临床和研究访问跟踪、保真度和定性数据将在整个试验期间的多个时间点收集，以告知适应性干预组成部分的可行性和可接受性。预期结果将使用ot数据来确保自适应干预组件以及SMART设计的可行性和可接受性。试点数据将用于开发和完善手动自适应干预措施，以及完全开发的SMART协议，以便在未来的全面试验中进行优化有效性测试。在clinicaltrials.gov注册（NCT06527599）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.