Methods of a cluster-randomized, type II hybrid implementation effectiveness trial to prospectively assess extended-duration thromboprophylaxis for at-risk medical patients being discharged to prevent hospital-associated venous thromboembolism

• Published in: Research and practice in thrombosis and haemostasis Vol. 8; no. 6; p. 102549
• Main Authors: 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.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2024; Elsevier
• Subjects: extended-duration thromboprophylaxis; medical patients; Methodological; prophylaxis; risk score; thrombosis; venous thromboembolism; thrombosis; extended-duration thromboprophylaxis; prophylaxis; venous thromboembolism; medical patients; risk score
• ISSN: 2475-0379; 2475-0379
• DOI: 10.1016/j.rpth.2024.102549

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. •Medical patients being discharged are at in increased risk for blood clots however it has proven difficult to identify those patients that benefit from medicine to prevent blood clots.•We report the methods for a prospective step-wedge implementation study to assess the effect of an alert of blood clot risk presented to the discharging clinician in a 23-hospital not-for-profit healthcare system.•We will report the discharging clinician interaction with the alert and the rate at which medicine is prescribed for the prevention of blood clots.•We will report clinical outcomes of thrombosis and bleeding among patients that are risk-stratified at the time of hospital discharge.