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

远程指导计划 ECHO 项目的随机对照试验，以增加氯氮平处方

• 批准号: 10088483
• 负责人: DEANNA L KELLY
• 金额: $ 77.02万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10088483
• 关键词: Address; African American; Area; Behavior; Caring; Clinic; Clinical Trials Design; Clozapine; Community Healthcare; Competence; Consultations; Data; Development; Devices; Disease; Enrollment; Ensure; Evidence based practice; Evidence based treatment; Exhibits; Exposure to; Health; Hour; Improve Access; Individual; Intervention; Knowledge; Link; Logistics; Maryland; Measures; Mediating; Medicaid; Medical Education; Mental Health; Mentors; Minority; Modeling; Monitor; National Institute of Mental Health; Outcome; Outpatients; Patient Self-Report; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Positioning Attribute; Psychiatry; Race; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Resistance; Schizophrenia; Site; Societies; Structure; Testing; Treatment Cost; United States Food and Drug Administration; Videoconferencing; base; burden of illness; care outcomes; disability; effectiveness testing; improved; improved outcome; innovation; innovative technologies; medical specialties; monitoring device; neutrophil; novel; point of care; point of care testing; primary outcome; programs; randomized controlled design; recruit; success; treatment as usual; treatment comparison; virtual

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.”

项目摘要 精神分裂症是全世界拒绝的主要原因之一，是这种疾病的负担 个人健康和整个社会是实质的，而新的药理治疗 治疗尚未与氯氮平的疗效相抗衡。 尽管大约30-50％的患者使用建议使用，但在全国范围内，规定的氯氮平在全国范围内<5％。 可以说，氯氮平是抗治疗的精神分裂症。 精神病学和优化的治疗方法将改善PATCOMES并降低治疗成本。 许多障碍会导致氯氮平未充分利用； 缺乏使用氯氮平和具有挑战性的物流来绝对中性粒细胞计数（ANC） 办公室外的监视是氯氮平使用的两个最大障碍。 使用闭合papine的预先报告自我报告的COMP能力与氯氮平的处方相关。 因此，如果不提高能力，则不太可能发生施辛甲辛切林的变化。 在过去的15年中，出现了一个独特的，结构化的和经验的电信模型 称为Echo（社区医疗保健结果的扩展）。 由专业学术团队（“枢纽”）领导的网络，美国多点视频会议进行虚拟会议 在学术中心的区域中，有非专业处方者的诊所（“辐条”） Echo已显示可显着改善缺乏专业知识的网站最佳实践专业护理 各种疾病状态。 能力，“目标机制”，我们假设与增加的氯氮平处置相关。 在一个随机控制的设计中，在12个月内举行了26个每两周一次的会议，我们建议测试您 基于回声的干预措施“ Champion”的有效性，其中包括1.25小时的课程，其中包括： 1）专家“集线器”，然后是2）氯氮平案例的知识和信息积极传播 “辐条”提交的演示和小插图。 招聘，我们将提供食品药品监督管理局（FDA）协调的ANC Point Point（POC） 监视所有研究站点，包括控制条件的设备 涉及POC设备的开发和测试）。 门诊诊所（OMHC）； 像往常一样，随机加强治疗（ETAU）。 氯氮平的持久性（通过对医疗补助处方数据的分析进行衡量），以衡量变化 使用氯氮平的预科知识和自我报告的能力得分，并测试是否自我报告 能力得分介导了氯氮平处方药施加了施法的“目标”。