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 精神分裂症是世界范围内残疾的主要原因之一， 个人健康和整个社会都是重要的。虽然新的药物治疗正在出现，但没有 治疗的效果还不能与氯氮平相媲美。然而，患有精神分裂症的人数， 处方氯氮平是<5%的国家，尽管它的推荐使用约30-50%的人， 难治性精神分裂症可以说，氯氮平是最未充分利用的循证药物之一， 精神病学治疗和优化其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数据显示， 处方者缺乏使用氯氮平的能力，并对中性粒细胞绝对计数（ANC）的后勤工作提出挑战 办公室外的监测是使用氯氮平的两个最大障碍。此外，试点数据显示， 处方者自我报告的使用氯氮平的能力与他们的氯氮平处方相关。 因此，在不提高能力的情况下，不太可能发生氯氮平处方的变化。 在过去的15年里，出现了一种独特的、结构化的和经过经验验证的远程指导模式 ECHO项目（社区医疗成果扩展）ECHO是一个“枢纽”和“辐射”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 位于学术中心站点以外地区的非专家处方医生诊所（“辐条”）。使用 ECHO已被证明可以显著改善缺乏专业知识的临床试验机构的最佳实践专科护理， 各种疾病状态。重要的是，多项研究已经确定了其在改善处方者 能力，“目标机制”，我们假设与增加氯氮平处方。 在一项随机对照设计中，在12个月内进行了26次双周一次的治疗，我们建议测试 基于ECHO的干预措施“CHAMPION”的有效性，包括1.25小时的课程，其中包括： 1)由专家“中心”积极传播知识和信息，然后是2）氯氮平病例 “发言者”提交的发言和小插曲。最大限度地减少ANC监测障碍， 招募，我们将提供食品和药物管理局（FDA）批准的ANC护理点（POC） 监测设备到所有研究中心，包括那些在控制条件（PI已广泛 参与POC设备的开发和测试）。我们将招募300名开处方者， 门诊心理健康诊所（OMHC）;一半的OMHC将被随机分配至CHAMPION组，另一半将被随机分配至CHAMPION组。 随机接受常规强化治疗（ETAU）。我们的主要结果是增加氯氮平的使用， 氯氮平的持续性（通过分析医疗补助处方数据测量），以测量 处方者知识和自我报告的使用氯氮平的能力评分，并测试是否自我报告 能力评分介导氯氮平处方作为我们确定的“目标”。