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

对退伍军人医疗保健的预期影响：VA中列出的前三个基本战略 卓越蓝图包括改善弱势退伍军人护理的计划，提供高质量的护理 通过实现“三重目标”，利用技术提高护理效率， 交付.这项补助金提出的干预措施侧重于改善药物安全和护理 在高风险脆弱的退伍军人群体中进行协调，利用信息学和分析 以支持这一干预措施，并旨在通过 药剂师干预;因此，完美地与蓝图的这三个基本组成部分保持一致。的 这项研究的首要目标是开发一种可行的、可部署的、技术支持的干预措施， 证明免疫抑制剂药物安全性、临床结局和 退伍军人器官移植受者的医疗保健费用;通过一项随机对照研究证明这一点 试验将提供足够的证据，以进一步开发VA特定的药剂师学习协作， 在改善护理和降低成本的退伍军人器官移植接受者在整个VA系统。 背景：器官移植是终末器官疾病患者的金标准治疗方法， 肾脏、肝脏、心脏和肺，因为它大大提高了生存率和生活质量。过去20 多年来，现代免疫抑制剂的使用降低了急性排斥反应的风险， 80%以上;但长期同种异体移植物存活率仍不理想。研究已经证明 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物 药物错误和不依从导致的排斥反应，包括与以下直接相关的问题： 药物安全。我们的研究表明，近三分之二的患者发生用药错误。 移植受者，导致八分之一的受者住院。发展显著的接受者 药物治疗错误导致移植物丢失的风险相当高，从而导致更高的费用和死亡率。因此在 为了改善移植受者的用药安全性和长期结局， 需要免疫抑制剂治疗管理。 目的：ISSTEP研究的中心假设（通过药物治疗改善移植药物安全性） 技术和药剂师干预）是药剂师主导的免疫抑制剂治疗管理， 通过使用创新技术，将大大提高免疫抑制剂的安全性， 退伍军人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、随机分组对照临床试验，在10个地点进行， 将5家研究中心随机分配至标准临床护理组，将5家研究中心随机分配至标准护理和技术支持药剂师组 干预这一干预措施的技术部分包括使用一个扩大的仪表板 该系统已经证明在改善免疫抑制监测方面的有效性。的 仪表板对移植受者进行人群水平的监测，并识别那些有潜力的人。 药物相关问题，包括不依从、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进行干预， 适当的方案指导方式。将通过比较以下比率来确定有效性： 两组之间的住院和ER访视，同时对基线患者、提供者和设施进行调整 特色次要措施包括比较医疗保健成本和确定仪表板 功能、仪表板可操作性和药剂师干预类型和接受率。我们还将 评估药物相关问题的总体发生率和严重程度以及移植物和患者存活率， 比较干预和对照部位之间的差异。

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.