Electronic Strategies to Enhance Venous Thromboprophylaxis in Hospitalized Medical Patients: A Randomized Controlled Trial

Abstract

<p>Venous thromboembolism (VTE), which encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE), is the most preventable cause of death in hospitalized patients. Due to its high mortality, morbidity, and cost, health care providers are obligated to not only effectively diagnose and treat VTE, but also to prevent it if possible. This has been reinforced by a number of national and international quality initiatives to prevent hospital-acquired VTE. Despite the existence of well-accepted clinical practice guidelines on VTE prophylaxis, 1 in 3 hospitalized medical patients receives an inappropriate VTE prophylaxis strategy. Both underuse of prophylaxis in patients with VTE risk, and overuse of prophylaxis in patients without VTE risk are problems. The use of inappropriate VTE prophylaxis strategies is likely due to the complexity and heterogeneity of hospitalized medical patients, and the difficulty of applying “one size fits all” practice guidelines to this group. Institution-wide knowledge translation strategies are required to close the gap between evidence and practice, and promote evidence-based VTE prophylaxis strategies in hospitalized medical patients. The objective of this thesis is to design a cluster randomized controlled trial to determine if a standardized electronic order set, with an embedded computerized decision support system and audit and feedback component, affects the use of appropriate VTE prophylaxis in hospitalized medical patients. The unit of randomization in this study is the hospital, which serves as the cluster. The unit of observation in this study is the individual patient. The primary outcome of this study is the proportion of in-hospital days during which appropriate VTE prophylaxis is administered, in intervention versus control hospitals. Secondary outcomes are the rates of hospital-acquired VTE, major bleeding and mortality, in intervention versus control hospitals. Design, analytic and ethical challenges unique to cluster randomized trials will also be discussed. Strategies to overcome them in this trial will be presented.</p>