Optimizing the Clinical Management of Polypharmacy for Children with Medical Complexity

项目摘要/摘要 患有医疗复杂性(CMC)的儿童的最佳健康通常取决于接触儿科 多药联用(≥5同时用药)。药物相关问题(MRP)，如不适当的治疗， 未得到充分治疗的症状或药物不良事件可能导致紧急就诊或住院。然而，在 对于CMC的常规临床护理，综合用药很少被评估，也很少得到全面的管理。至 改善与药物相关的患者结果、安全性和价值，需要一种新的方法来管理 CMC优先人群中的多药联用。药师主导的药物治疗管理(MTM)是一种 成熟有效的管理成人和老年综合药房的工具。我们的科学前提是 结构化药剂师领导的儿科药物治疗管理(PMTM)干预将改善 通过直接解决当前实践中的主要差距，积极主动地管理多药房。这个 因此，实施pMTM以解决儿科MRP代表了基于已建立的 基金会。我们提出了一项PMTM干预的混合型2型随机对照试验(RCT)。本5年期 一项研究比较了PMTM干预和常规护理在减少PMTM主要结局方面的有效性 MRP，以及症状负担和急性医疗保健利用的次要结果。在目标1中，我们 使用混合型2型随机对照试验来定量衡量母婴传播干预措施的覆盖范围和有效性。我们会 在学术中心的门诊综合护理中招募有多个药房的CMC及其父母 每年为5600名CMC提供服务的计划。在目标2中，我们将定量和定性地检查重要的 修改PMTM干预效果的患者和家长特征。在《目标3》中，我们将 评估医疗保健部门采用、实施和维护PMTM干预措施的可能性 供应商，包括程序复制成本。科罗拉多大学安舒茨医学院提供 一个独特的研究环境，能够进行儿科综合药房研究，由 成人和儿童健康结果研究中心与 递送科学(ACCODS)、斯卡格斯药学和药学学院以及 科罗拉多州儿童医院为有医疗复杂性的儿童开设的特别护理诊所。詹姆斯·范斯坦博士，一位 儿科综合护理和多药研究方面的专家，将领导一支经验丰富的合作调查团队 包括Allison Kempe博士(实用试验和实施科学)、Chris Feudtner博士(卫生服务 和复杂护理研究)、Lucas Orth博士(儿科药剂学)、John Rice博士(生物统计和纵向 方法)、Megan Morris博士(定性研究)和Mark Gritz博士(经济分析)完成 拟开展的研究。如果PMM被证明是有效的，它可以迅速在全国范围内传播，作为 药剂师融入门诊综合护理计划，这可能会对公众产生巨大影响 通过预防与药物有关的安全问题、随行人员发病率和相关成本，改善CMC的健康状况。

PROJECT SUMMARY/ABSTRACT Optimal health for children with medical complexity (CMC) often depends on exposure to pediatric polypharmacy (≥5 concurrent medications). Medication-related problems (MRPs), like inappropriate therapy, undertreated symptoms, or adverse drug events, can lead to emergency visits or hospitalizations. Yet, during routine clinical care for CMC, polypharmacy is infrequently assessed and rarely managed comprehensively. To improve medication-related patient outcomes, safety, and value, a new approach is needed to manage polypharmacy in the priority population of CMC. Pharmacist-led medication therapy management (MTM) is a proven and effective tool for managing adult and geriatric polypharmacy. Our scientific premise is that a structured pharmacist-led Pediatric Medication Therapy Management (pMTM) intervention will improve the proactive management of polypharmacy by directly addressing major gaps in current practice. The implementation of pMTM to address pediatric MRPs thus represents innovation based on an established foundation. We propose a hybrid type 2 randomized controlled trial (RCT) of a pMTM intervention. This 5-year study compares the effectiveness of a pMTM intervention to usual care for reducing the primary outcome of MRPs, as well as the secondary outcomes of symptom burdens and acute healthcare utilization. In Aim 1, we use a hybrid type 2 RCT to quantitatively measure reach and effectiveness of the pMTM intervention. We will recruit CMC with polypharmacy and their parents within an academic center’s outpatient complex care program that serves >5600 CMC annually. In Aim 2, we will quantitatively and qualitatively examine important patient and parent characteristics that modify the effectiveness of the pMTM intervention. In Aim 3, we will assess adoption, implementation, and potential for maintenance of the pMTM intervention by healthcare providers, including program replication costs. The University of Colorado Anschutz Medical Campus provides a unique research environment enabling the conduct of pediatric polypharmacy research, supported by collaborative research partnerships between the Adult and Child Center for Health Outcomes Research and Delivery Science (ACCORDS), the Skaggs School of Pharmacy and Pharmaceutical Sciences, and the Children’s Hospital Colorado Special Care Clinic for children with medical complexity. Dr. James Feinstein, an expert in pediatric complex care and polypharmacy research, will lead an experienced team of co-investigators including, Dr. Allison Kempe (pragmatic trials and implementation science), Dr. Chris Feudtner (health services and complex care research), Dr. Lucas Orth (pediatric pharmacy), Dr. John Rice (biostatistics and longitudinal methods), Dr. Megan Morris (qualitative research), and Dr. Mark Gritz (economic analysis) to complete the proposed research. If pMTM is proven effective, it could be rapidly disseminated nationally as a model for pharmacist integration into outpatient complex care programs and it could have enormous impact on the public health of CMC by preventing medication-related safety issues, attendant morbidity, and associated costs.