Outpatient Treatment of PE and DVT in the Emergency Department

Massachusetts General Hospital400 enrolled

Overview

Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment.

In the current protocol, we will study the outcomes most likely to influence emergency physician behavior, such as improved Emergency Department (ED) throughput, and decreased ED and Emergency Department Observation Unit (EDOU) length of stay. Metrics such as decreased admissions are also very important to hospital administrators so our results will have impact outside the ED as well. At the end of this study we will demonstrate that a carefully planned and data-driven approach to the outpatient treatment of Pulmonary Embolism (PE) is safe, improves operational metrics, and reduces cost.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Pulmonary Embolism Deep Vein Thrombosis

Interventions

Telephone follow-upOTHER

Prospectively enrolled subjects will have a 7- and 30-day phone call.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is 18 years of age or older at time of enrollment. * Subject is diagnosed with acute VTE (DVT or PE) in the MGH or BWH ED or transferred to the MGH or BWH ED (e.g from a clinic or outside hospital) with a diagnosis of acute VTE. * Subject is treated as an outpatient (i.e. discharged) directly from the ED or admitted to the ED Observation Unit/ED Short Stay Unit on the outpatient treatment protocol. Exclusion Criteria: * Subjects admitted from the ED to an inpatient service will not be enrolled as study subjects, but will be used as contemporary controls. * Subjects who are unable to understand or provide informed consent. * Subjects unable or unlikely to follow up (e.g. prisoners).

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Efficiency & cost of clinical protocol

To compare patients diagnosed with VTE after protocol implementation to those diagnosed with VTE prior to protocol implementation in terms of four measures of efficiency: A) ED length of stay - defined as time from ED registration to departure from the ED (to either the inpatient floor or to the EDOU). B) ED disposition time - defined as time from ED registration to bed request. C) Hospital length of stay - defined as time from ED registration to departure from the hospital. D) Cost - defined as the estimated cost of care including diagnostic testing, imaging, hospital inpatient/observation unit stay, medication/pharmacy costs.

Time frame: Up to 30 days

Safety of clinical protocol

To assess the safety of outpatient VTE treatment, specifically with regards to: A) recurrent venous thromboembolism; B) bleeding (major or minor); C) unscheduled return to hospital for any reason; D) death from any cause: occurring up to 30 days after their discharge.

Time frame: Up to 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.