A Randomized Controlled Trial of a Telementoring Program, Project ECHO, to increase Clozapine Prescribing

项目总结 精神分裂症是世界范围内导致残疾的主要原因之一，这种疾病对 个人健康和整个社会都是实质性的。虽然新的药物疗法正在涌现，但没有 治疗方法尚未与氯氮平的疗效相媲美。然而，精神分裂症患者的数量 全国范围内氯氮平的处方使用率为5%，尽管约30%-50%的患者推荐使用氯氮平。 难治性精神分裂症。可以说，氯氮平是最未得到充分利用的循证证据之一 精神病学的治疗和优化使用将改善患者的结果并降低治疗成本。 许多障碍导致氯氮平利用不足；然而，我们的试点数据和其他人的数据表明 缺乏使用氯氮平的处方能力和对中性粒细胞绝对计数(ANC)的后勤挑战 办公室外的监测是氯氮平使用的两个最大障碍。此外，试点数据显示， 处方者自我报告的氯氮平使用能力与他们的氯氮平处方相关。 因此，如果不提高能力，氯氮平的处方就不太可能发生变化。 在过去的15年里，出现了一种独特的、结构化的、经过经验验证的远程指导模式 名为Echo项目(社区医疗保健成果的扩展)。Echo是一个“中心”和“分支”共享 由专家学术团队(中心)领导的网络，使用多点视频会议进行虚拟 位于学术中心外的诊所，设有非专家处方医生(“辐条”)。对.的使用 Echo已被证明可以显著改善缺乏专业知识的站点的最佳实践专科护理 各种疾病状态。重要的是，多项研究已经证实了它在改善处方者方面的有效性 能力，“靶向机制”，我们假设与氯氮平处方的增加有关。 在一项为期12个月、每两周26次的随机对照设计中，我们建议测试 基于回声的干预的有效性，“冠军”，包括1.25小时的疗程，包括： 1)由专家“中心”积极传播知识和信息，然后是氯氮平病例 “发言人”提交的演示文稿和小插曲。要最大限度地减少ANC监控障碍并最大限度地 招募，我们将提供食品和药物管理局(FDA)批准的ANC护理点(POC) 所有研究现场的监测设备，包括那些处于控制条件下的现场(PI已被广泛 参与PoC设备的开发和测试)。我们将从60名处方医生中招募300名 门诊精神卫生诊所(OMHC)；一半的OHMC将被随机分配到冠军和一半 随机接受常规强化治疗(Etau)。我们的主要成果是增加氯氮平的使用和 氯氮平的持久性(通过分析医疗补助处方数据来衡量)，以衡量 使用氯氮平的处方知识和自我报告的能力评分，并测试是否自我报告 能力分数调解氯氮平处方为我们确定的“目标”。

PROJECT SUMMARY Schizophrenia is one of the leading causes of disability worldwide and the burden of this disease on individual health and society at large is substantial. While new pharmacological treatments are emerging, no treatment has yet to rival the efficacy of clozapine. Yet the number of people with schizophrenia who are prescribed clozapine is <5% nationally, despite its recommended use in about 30-50% of people with treatment-resistant schizophrenia. Arguably, clozapine is one of the most underutilized evidence-based treatments in psychiatry and optimization of its use would improve patient outcomes and lower treatment costs. Many barriers contribute to clozapine underutilization; however, our pilot data and data from others show that lack of prescriber competence to use clozapine and challenging logistics for absolute neutrophil counts (ANC) monitoring outside of the office are two of the greatest barriers to clozapine use. Further, pilot data shows that prescriber self-reported competence in using clozapine correlates with their prescription of clozapine. Therefore, without improving competence, changes in prescribing of clozapine are unlikely to occur. In the last 15 years, a unique, structured and empirically validated tele-mentoring model has emerged called Project ECHO (Extension for Community Healthcare Outcomes). ECHO is a “hub” and “spoke” sharing network led by an expert academic team (the “hub”) that uses multipoint video conferencing to conduct virtual clinics with non-expert prescribers (the “spokes”) located in areas outside the academic hub site. The use of ECHO has been shown to significantly improve best-practice specialty care in sites that lack expertise in a variety of disease states. Importantly, multiple studies have established its efficacy in improving prescriber competence, the “target mechanism,” we hypothesize to be linked to increased clozapine prescribing. In a randomized controlled design with 26 biweekly sessions over 12 months, we propose to test the effectiveness of an ECHO-based intervention, “CHAMPION”, that includes 1.25 hours sessions which include: 1) active dissemination of knowledge and information by an expert “hub” followed by 2) clozapine case presentations and vignettes submitted by the “spokes”. To minimize ANC monitoring barriers and maximize recruitment, we will provide Food and Drug Administration (FDA)-approved ANC point of care (POC) monitoring devices to all study sites, including those in the control condition (the PI has been extensively involved with the development and testing of the POC device). We will enroll 300 prescribers from 60 outpatient mental health clinics (OMHCs); half the OHMCs will be randomized to CHAMPION and half randomized to enhanced treatment as usual (ETAU). Our primary outcomes are to increase clozapine use and persistence of clozapine (measured by analysis of Medicaid prescription data), to measure changes in prescriber knowledge and self-reported competence scores for using clozapine, and to test if self-reported competence scores mediate clozapine prescribing as our identified “target.”