Woller Scott C, Stevens Scott M, Bledsoe Joseph R, Hellewell James, Kraft Adam, Butler Allison M, Fazili Masarret, Lloyd James F, Christensen Paige S, Peltan Ithan D, Barnes Geoffrey D, Horne Benjamin D
Intermountain Medical Center Department of Medicine, Intermountain Health, Salt Lake City, Utah, USA.
Department of Medicine, University of Utah, Salt Lake City, Utah, USA.
Res Pract Thromb Haemost. 2024 Aug 21;8(6):102549. doi: 10.1016/j.rpth.2024.102549. eCollection 2024 Aug.
Venous thromboembolism (VTE) is the third leading cause of preventable hospital-associated (HA) death. Most HA-VTE, including fatal pulmonary emboli, occur among medically ill patients. The rate of symptomatic VTE more than doubles over the first 21 days after hospital discharge. Trials have demonstrated that the burden of HA-VTE may be reduced with postdischarge thromboprophylaxis; however, few patients receive this therapy. We formerly validated the ability of eVTE (eVTE is the abbreviation for a risk assessment tool constituted by 2 calculations: one predicts 90-day VTE and the other predicts 30-day major bleeding derived from only elements of the complete blood count and basic metabolic panel and age) to identify medical patients being discharged with both an elevated risk of VTE and a low risk of bleeding.
Implement a cluster-randomized, stepped wedge, type II hybrid implementation/effectiveness trial generating an alert among select at-risk patients upon discharge for implementation of thrombosis chemoprophylaxis in a 23-hospital not-for-profit healthcare system.
We use the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to guide implementation and outcomes reporting.
The primary outcome for aim 1 (implementation) is the prescription of rivaroxaban 10 mg daily for 30 days as postdischarge thromboprophylaxis among at-risk patients. The primary efficacy and safety outcomes (effectiveness) are the 90-day composite of symptomatic VTE, myocardial infartcion, nonhemorrhagic stroke, all-cause mortality, and 30-day major bleeding.
The eVTE trial will provide high-quality, real-world evidence on the effectiveness and safety of a pragmatic intervention to implement targeted postdischarge thromboprophylaxis using decision support embedded in the electronic health record.
静脉血栓栓塞症（VTE）是可预防的医院相关（HA）死亡的第三大原因。大多数医院获得性VTE，包括致命性肺栓塞，发生在患有内科疾病的患者中。出院后前21天内，有症状VTE的发生率增加一倍多。试验表明，出院后进行血栓预防可减轻医院获得性VTE的负担；然而，很少有患者接受这种治疗。我们之前验证了电子VTE（eVTE是一种风险评估工具的缩写，由两种计算方法构成：一种预测90天VTE，另一种仅根据全血细胞计数、基本代谢指标和年龄预测30天大出血）识别出院时VTE风险升高且出血风险低的内科患者的能力。
开展一项整群随机、阶梯楔形、II型混合实施/有效性试验，在一个由23家非营利性医疗系统组成的机构中，对选定的高危患者出院时发出警报，以实施血栓化学预防。
我们使用推广、有效性、采用、实施和维持框架来指导实施和结果报告。
目标1（实施）的主要结果是高危患者出院后30天每日服用10mg利伐沙班作为血栓预防用药。主要疗效和安全性结果（有效性）是90天有症状VTE、心肌梗死、非出血性卒中、全因死亡率以及30天大出血的综合情况。
电子VTE试验将提供高质量的真实世界证据，证明利用电子健康记录中嵌入的决策支持实施针对性出院后血栓预防这一务实干预措施的有效性和安全性。
