Department of Medicine, Division of Health Systems Science, University of Massachusetts Chan Medical School, Worcester, MA, USA.
Department of Medicine, Division of Health Systems Science, University of Massachusetts Chan Medical School, Worcester, MA, USA.
Contemp Clin Trials. 2024 Oct;145:107668. doi: 10.1016/j.cct.2024.107668. Epub 2024 Aug 18.
The opioid epidemic disproportionately affects individuals with co-occurring opioid use and mental health disorders (COD), who often have poor treatment engagement. Multicomponent treatment models are popular solutions to increase treatment access and engagement for those with COD. Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION) is a hybrid multicomponent linkage and treatment approach that provides assertive community outreach combined with psychosocial treatment. This protocol paper describes a randomized controlled trial comparing MISSION and medication for opioid use disorder (MOUD), its multicomponent parts along with MOUD, and MOUD treatment as usual (TAU) to assess improvements in health and social outcomes.
This study will use a half fractional factorial design and randomize 1000 patients with COD to one of five treatment conditions: (1) the full MISSION intervention plus MOUD; (2-4) a combination of two out of three MISSION components plus MOUD; or (5) TAU. Secondary aims include examination of mechanisms of action, economic evaluation of the implementation of MISSION and/or its components plus MOUD versus TAU, and exploratory predictive modeling to match optimal MISSION parts with patient needs.
This randomized controlled trial will help determine the effectiveness of MISSION (or its parts) and MOUD compared to TAU to improve engagement in treatment, substance use, and mental health symptoms. This trial is the first to compare MISSION and its parts with MOUD versus TAU in a real-world treatment scenario to determine which components are necessary and sufficient to drive treatment outcomes according to patient needs.
阿片类药物流行对同时患有阿片类药物使用和精神健康障碍（COD）的个体产生了不成比例的影响，这些人通常治疗参与度较低。多组分治疗模式是增加 COD 患者治疗机会和参与度的流行解决方案。通过系统整合、外展和网络（MISSION）保持独立性和清醒度是一种混合多组分连接和治疗方法，提供坚定的社区外展服务，同时结合心理社会治疗。本研究方案描述了一项随机对照试验，比较 MISSION 和阿片类药物使用障碍（MOUD）治疗、其多组分部分以及 MOUD 常规治疗（TAU），以评估改善健康和社会结局。
本研究将采用半因子设计，将 1000 名 COD 患者随机分为五种治疗条件之一：（1）完整的 MISSION 干预加 MOUD；（2-4）MISSION 三个部分中的两个与 MOUD 的组合；或（5）TAU。次要目标包括检验作用机制、实施 MISSION 和/或其部分加 MOUD 与 TAU 的经济评估，以及探索性预测建模，以匹配最佳的 MISSION 部分与患者需求。
这项随机对照试验将有助于确定 MISSION（或其部分）和 MOUD 与 TAU 相比，改善治疗参与度、物质使用和心理健康症状的有效性。这项试验是首次在真实治疗环境中比较 MISSION 及其部分与 MOUD 与 TAU，以确定根据患者需求，哪些组件是必要和充分的，以推动治疗结果。
