Supporting Treatment Access and Recovery for Co-Occurring Opioid Use and Mental Health Disorders (STAR-COD)

支持同时发生的阿片类药物使用和精神健康障碍的治疗获取和康复 (STAR-COD)

• 批准号: 10373400
• 负责人: Gerardo Gonzalez
• 金额: $ 315.52万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-16 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10373400
• 关键词: Affect; Assertiveness; Behavior Therapy; Capital; Characteristics; Client; Clinic; Clinical; Clinical Practice Guideline; Combination Medication; Combined Modality Therapy; Communities; Community Services; Complex; Criminal Justice; Drug Screening; Educational Curriculum; Effectiveness; Evidence based practice; Future; Goals; Gold; Group Therapy; Health; Health Services Accessibility; Healthcare; Homelessness; Hybrids; Individual; Intervention; Investments; Massachusetts; Measures; Mediating; Medical; Mental Health; Mental disorders; National Institute of Mental Health; Opiate Addiction; Opioid; Outcome; Outpatients; Overdose; Participant; Partnership Practice; Patient Self-Report; Patients; Population; Protocols documentation; Provider; Psychosocial Assessment and Care; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Recovery; Relapse; Research Personnel; Service setting; Services; Severities; Strategic Planning; Structure; Suicide; Symptoms; System; Systems Integration; Testing; Therapeutic; Therapeutic Effect; Time; United States; United States Department of Veterans Affairs; addiction; arm; base; care systems; cost; cost effective; cost estimate; cost-effectiveness evaluation; demographics; design; economic evaluation; effective intervention; effectiveness evaluation; empowered; improved; improved outcome; innovation; multi-component intervention; opioid overdose; opioid use; opioid use disorder; outreach; peer support; personalized intervention; personalized medicine; predictive modeling; prescription opioid; profiles in patients; programs; psychosocial; research to practice; response; sobriety; standard of care; substance use; treatment as usual; uptake

PROJECT SUMMARY / ABSTRACT Opioid use has dramatically increased in the United States since 2000, and disproportionally affects individuals with co-occurring mental health disorders (COD). Individuals with COD are vulnerable to substance use relapses, mental health symptom exacerbations, opioid overdoses, suicide, homelessness, and criminal justice involvement. Although medication for opioid use disorder (MOUD) is the gold standard of care, engagement rates are as low as 18% which negatively impact outcomes. In addition, there is mixed evidence regarding the incremental therapeutic benefit of adding single behavioral interventions to improve MOUD outcomes, despite being recommended in clinical practice guidelines. Furthermore, while multi-component interventions exist, little is known about their incremental therapeutic effect on outcomes in conjunction with MOUD and standard medical management for those with a COD. Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION) is one such multi-component, cross-disciplinary, team-based treatment approach, combining 3 evidence-based practices along with MOUD: 1) Dual Recovery Therapy (DRT), which is integrated group therapy for COD; 2) Peer Support (PS), offering support for people in recovery by people in recovery; and 3) Critical Time Intervention (CTI), a time-limited form of assertive community treatment. Although the effectiveness of MISSION is well established, given the difficulty with implementation uptake in large systems due to its complexity and the need to improve outcomes for those with a COD who receive MOUD, a critical next step is to understand the incremental therapeutic benefit of MISSION + MOUD, and identify highest value MISSION components that drive the largest clinical improvement and offer the greatest return on investment. In response to RFA-MH-21-145, the proposed 4-year study with a half fractional factorial design, “Supporting Treatment Access and Recovery for Co-occurring Opioid Use and Mental Health Disorders (STAR-COD),” will randomize 1,000 patients with COD across 9 MOUD programs to the following 5 conditions: 1) MOUD alone; 2) full MISSION protocol (CTI & DRT & PS) + MOUD; 3) CTI & DRT + MOUD; 4) PS & DRT + MOUD; or 5) CTI & PS + MOUD. There are four specific aims. Aim 1: To evaluate the effectiveness of MISSION or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or bundled parts + MOUD to improve engagement, substance use and mental health symptoms. Aim 2: To examine mechanisms of action of MISSION in COD. Aim 3: To conduct a comprehensive economic evaluation of MISSION or its parts and MOUD. Exploratory Aim: 4. To construct a predictive model to match optimum combined use of MISSION parts with patient needs to improve health outcomes. This proposal is aligned with NIMH’s strategic plan goal 4 “to increase the public health impact of services studies, investigators test ways to adapt, implement, and scale effective interventions for varied populations across multiple service settings in a cost-effective manner.” Upon completion, it could offer more cost effective, robust, personalized treatments.

项目摘要/摘要 自2000年以来，阿片类药物的使用在美国急剧增加，对个人的影响不成比例 患有共生的精神健康障碍(COD)。患有COD的人很容易复发使用药物， 精神健康症状恶化、阿片类药物过量、自杀、无家可归和刑事司法 参与其中。尽管治疗阿片使用障碍(MOUD)的药物是护理的黄金标准，但参与 这一比率低至18%，这对结果产生了负面影响。此外，有混合的证据关于 增加单一行为干预以改善Moud结果的增量治疗收益，尽管 在临床实践指南中被推荐。此外，虽然存在多组成部分的干预措施，但很少 已知它们与Moud和标准医学一起对预后的递增治疗效果 对死亡者的管理。通过系统集成保持独立性和清醒， 外联和联网(特派团)是这样一种多组成部分、跨学科、以团队为基础的治疗 方法，结合3种循证实践和Moud：1)双重恢复疗法(DRT)，这是 综合团体疗法；2)同伴支持(PS)，为康复者提供支持 康复；以及3)关键时间干预(CTI)，一种有时间限制的自信社区治疗形式。虽然 考虑到在大型系统中实施的困难，特派团的有效性是确定的 由于其复杂性以及需要改善接受Moud的COD患者的预后，Moud是下一步的关键 一步是了解任务+Moud的增量治疗收益，并确定最高价值 推动最大临床改进并提供最大投资回报的任务组件。 针对RFA-MH-21-145，拟议的为期4年的研究采用半部分析因设计，“支持 共生阿片类药物使用和精神健康障碍(STAR-COD)的治疗途径和康复，“Will 将9个Moud项目中的1,000名COD患者随机分为以下5种情况：1)单独使用Moud；2) 全任务协议(CTI&DRT&PS)+Moud；3)CTI&DRT+Moud；4)PS&DRT+Moud；或5)CTI& PS+Moud。有四个具体目标。目标1：评价特派团或其构成部分的效力 Moud与Moud相比，以及使命或捆绑部件+Moud to带来的增量优势 改善参与度、物质使用和精神健康症状。目标2：检查行动机制 在科德岛执行任务。目标3：对特派团或其组成部分进行全面经济评价，并 穆德。探索目标：4.构建预测模型，以匹配任务部件的最佳组合使用 患者需要改善健康状况。该提案与NIMH的战略计划目标4相一致 增加服务对公共健康的影响研究，调查人员测试适应、实施和扩展的方法 以具有成本效益的方式为多个服务环境中的不同人群提供有效的干预。vt.在.的基础上 完成后，它可以提供更具成本效益、更强大、更个性化的治疗。