Outpatient Treatment of PE and DVT in the Emergency Department

NCT ID: NCT02532387

Last Updated: 2019-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-02-28

Brief Summary

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

Detailed Description

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.

Conditions

Pulmonary Embolism; Deep Vein Thrombosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

MGH ED/EDOU patients

Subjects who present to the Massachusetts General Hospital (MGH) ED or EDOU who meet all inclusion and no exclusion criteria.

Intervention: Telephone follow-up at 7 and 30 days.

Telephone follow-up

Intervention Type: OTHER

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

BWH ED/EDOU patients

Subjects who present to the Brigham and Women's Hospital (BWH) ED or EDOU who meet all inclusion and no exclusion criteria.

Intervention: Telephone follow-up at 7 and 30 days.

Telephone follow-up

Intervention Type: OTHER

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

Control subjects

1. Contemporary controls: subjects diagnosed with Venous Thromboembolism (VTE) in the ED and who are not eligible for outpatient treatment

2. Historical controls:

1. Subjects enrolled in the prospective and retrospective SPEED-D study (PI: Kabrhel) and diagnosed with PE between 2006-2012.

2. Subjects diagnosed with VTE in the MGH and BWH ED in the 18 months prior to the use of the clinical outpatient treatment of PE protocol.

No interventions assigned to this group

Interventions

Telephone follow-up

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christopher Kabrhel

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Kabrhel, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2015P000877

Identifier Type: -

Identifier Source: org_study_id