Study protocol for a multicentre implementation trial of monotherapy anticoagulation to expedite home treatment of patients diagnosed with venous thromboembolism in the emergency department

Jeffrey Kline, Emergency Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA
David Adler, Emergency Medicine, University of Rochester Medical Center, Rochester, New York, USA.
Naomi Alanis, Emergency Medicine, University of North Texas Health Science Center, Fort Worth, Texas, USA.
Joseph Bledsoe, Emergency Medicine, Intermountain Health Care Inc, Salt Lake City, Utah, USA.
Daniel Courtney, Emergency Medicine, University of Texas Southwestern Medical School, Dallas, Texas, USA.
James D'Etienne, Emergency Medicine, John Peter Smith Hospital, Fort Worth, Texas, USA.
Deborah B Diercks, Emergency Medicine, University of Texas Southwestern Medical School, Dallas, Texas, USA.
John Garrett, Emergency Medicine, Baylor University Medical Center at Dallas, Dallas, Texas, USA.
Alan E. Jones, Emergency Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.
David MacKenzie, Emergency Medicine, Maine Medical Center, Portland, Maine, USA.
Troy Madsen, Emergency Medicine, University of Utah, Salt Lake City, Utah, USA.
Andrew Matuskowitz, Emergency Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
Bryn Mumma, Emergency Medicine, University of California Davis, Davis, California, USA.
Kristen Nordenholz, Emergency Medicine, University of Colorado Denver, Denver, Colorado, USA.
Justine Pagenhardt, Emergency Medicine, West Virginia University - Health Sciences Campus, Morgantown, West Virginia, USA.
Michael Runyon, Emergency Medicine, Atrium Health, Charlotte, North Carolina, USA.
William Stubblefield, Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Christopher Willoughby, Internal Medicine, Louisiana State University, New Orleans, Louisiana, USA.


INTRODUCTION: In the USA, many emergency departments (EDs) have established protocols to treat patients with newly diagnosed deep vein thrombosis (DVT) as outpatients. Similar treatment of patients with pulmonary embolism (PE) has been proposed, but no large-scale study has been published to evaluate a comprehensive, integrated protocol that employs monotherapy anticoagulation to treat patients diagnosed with DVT and PE in the ED. METHODS AND ANALYSIS: This protocol describes the implementation of the Monotherapy Anticoagulation To expedite Home treatment of Venous ThromboEmbolism (MATH-VTE) study at 33 hospitals in the USA. The study was designed and executed to meet the requirements for the Standards for Reporting Implementation Studies guideline. The study was funded by investigator-initiated awards from industry, with Indiana University as the sponsor. The study principal investigator and study associates travelled to each site to provide on-site training. The protocol identically screens patients with both DVT or PE to determine low risk of death using either the modified Hestia criteria or physician judgement plus a negative result from the simplified PE severity index. Patients must be discharged from the ED within 24 hours of triage and treated with either apixaban or rivaroxaban. Overall effectiveness is based upon the primary efficacy and safety outcomes of recurrent VTE and bleeding requiring hospitalisation respectively. Target enrolment of 1300 patients was estimated with efficacy success defined as the upper limit of the 95% CI for the 30-day frequency of VTE recurrence below 2.0%. Thirty-three hospitals in 17 states were initiated in 2016-2017. ETHICS AND DISSEMINATION: All sites had Institutional Review Board approval. We anticipate completion of enrolment in June 2020; study data will be available after peer-reviewed publication. MATH-VTE will provide information from a large multicentre sample of US patients about the efficacy and safety of home treatment of VTE with monotherapy anticoagulation.