Improving Transplant Medication Safety through a TEchnology and Pharmacist (ISTEP) Intervention in Veterans

退伍军人医疗保健的预期影响：退伍军人管理局列出的前三项基本战略 卓越蓝图包含改善对脆弱退伍军人的护理、提供高质量护理的计划 通过实现三个目标和利用技术来提高护理效率 送货。这项拨款建议的干预措施侧重于改善用药安全和护理 在高风险易受伤害的退伍军人群体中进行协调，利用信息学和分析 支持这一干预措施，并旨在通过以下方式证明以更低的成本改善保健 药剂师的干预；因此，完全符合蓝图的这三个基本组成部分。这个 这项研究的总体目标是开发一种可行的、可部署的、技术支持的干预措施，将 在免疫抑制剂用药安全性、临床结果和 退伍军人器官移植受者的医疗费用；通过随机对照研究证明了这一点 试验将为进一步发展退伍军人管理局特定药剂师合作学习提供足够的证据 在整个退伍军人管理局系统中，为退伍军人器官移植接受者改善护理和降低成本。 背景：器官移植是治疗老年终末期器官疾病的金标准。 肾、肝、心和肺，因为它极大地提高了生存和生活质量。在过去的20年里 多年来，现代免疫抑制剂的使用通过以下方式降低了急性排斥反应的风险 超过80%；然而，同种异体移植物的长期存活率仍然不理想。研究表明， 晚期移植物丢失的原因主要是免疫抑制、不良事件和晚期同种异体移植。 因用药错误和不坚持而导致的排斥事件，包括与以下方面直接相关的问题 用药安全。我们的研究表明，近三分之二的患者出现用药差错 移植受者，导致每8名受者中就有1人住院。收件人发展成显著的 用药失误导致移植物丢失的风险相当高，从而导致更高的成本和死亡率。因此，在 为了改善移植受者的用药安全性和长期结果，在 需要进行免疫抑制治疗管理。 目标：ISTEP研究的中心假设(通过 技术和药剂师干预)是药剂师领导的免疫抑制治疗管理， 通过使用创新技术来促进，将显著提高免疫抑制剂的安全性和 资深移植受者的临床结果。 方法：这是一项为期24个月的前瞻性、多中心、整群随机对照临床试验，在10个地点进行， 随机选择5个地点接受标准临床护理，5个地点接受标准护理和科技药剂师 干预。此干预的技术部分包括使用扩展的仪表板 该系统已经证明在改进免疫抑制监测方面是有效的。这个 Dashboard对移植受者进行人群水平的监测，并确定哪些人有潜力 与药物有关的问题，包括不遵守、药物相互作用、实验室缺失和令人担忧的趋势； 然后向药剂师提供实时警报，药剂师将确定其相关性并干预 适当的礼仪指导方式。有效性将通过比较以下比率来确定 组之间的住院和急诊率，同时根据基线患者、提供者和设施进行调整 特点。次要措施包括比较医疗成本和确定仪表板 功能、仪表板可操作性、药剂师干预类型和接受率。我们还将 评估与药物有关的问题的总体发生率和严重程度以及移植物和患者存活率 在干预点和控制点之间进行比较。

Anticipated Impacts on Veterans Health Care: The first three essential strategies listed within the VA's Blueprint for Excellence encompass plans to improve care to vulnerable Veterans, deliver high quality care through achieving the “Triple Aim” and leverage the use of technology to improve the efficiency of care delivery. The intervention this grant proposes focuses on improving medication safety and care coordination within a high risk vulnerable Veteran population, leverages the use of informatics and analytics to support this intervention, and aims to demonstrate improved care at reduced costs through the pharmacist intervention; thus, perfectly aligning with these three essential components of the Blueprint. The overarching goal of this study is to develop a feasibly deployable, technology-enabled intervention that will demonstrate substantial improvements in immunosuppressant medication safety, clinical outcomes and health care costs in Veteran organ transplant recipients; demonstrating this through a randomized controlled trial will provide sufficient evidence to further develop a VA-specific pharmacist learning collaborative aimed at improving care and reducing costs for Veteran organ transplant recipients across the entire VA system. Background: Organ transplant is the gold-standard treatment for patients with end organ diseases of the kidney, liver, heart and lungs, as it substantially improves survival and quality of life. Over the past 20 years, the use of contemporary immunosuppression has reduced the risk of acute rejection rates by upwards of 80%; yet long-term allograft survival remains suboptimal. Studies have demonstrated that causes of late graft loss is predominantly driven by immunosuppression adverse events and late allograft rejection episodes from medication errors and non-adherence, which encompass issues directly related to medication safety. Our research demonstrates that medication errors occur in nearly two-thirds of transplant recipients, leading to hospitalization in 1 in 8 recipients. Recipients that develop significant medication errors are at considerably higher risk of graft loss, leading to higher costs and mortality. Thus, in order to improve medication safety and long-term outcomes in transplant recipients, enhancements in immunosuppressant therapy management is needed. Objectives: The central hypothesis for the ISTEP study (Improving Transplant Medication Safety through a TEchnology and Pharmacist Intervention) is that pharmacist-led immunosuppressant therapy management, facilitated through the use of innovative technology, will significantly improve immunosuppressant safety and clinical outcomes in Veteran transplant recipients. Methods: This is a 24-month, prospective, multicenter, cluster-randomized controlled clinical trial at 10 sites, randomizing 5 sites to standard clinical care and 5 to standard care and the technology-enabled pharmacist intervention. The technology component of this intervention consists of the use of an expanded dashboard system that has already demonstrated effectiveness in improving immunosuppression monitoring. The dashboard performs population-level surveillance of transplant recipients and identifies those with potential drug-related problems, including non-adherence, drug interactions, missing and worrisome trends in labs; then providing a real-time alert to the pharmacist, who will determine its relevance and intervene in an appropriate protocol-guided manner. Effectiveness will be determined by comparing the rates of hospitalizations and ER visits between groups, while adjusting for baseline patient, provider and facility characteristics. Secondary measures include comparing healthcare costs and determining dashboard functionality, dashboard actionability and pharmacist intervention types and acceptance rates. We will also assess the overall incidence and severity of drug-related problems and graft and patient survival rates and compare these between the intervention and control sites.