Outpatient Treatment of PE and DVT in t… | Clinical Trial

Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Deep Vein Thrombosis Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Telephone Follow-up

Other

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

Primary outcomes

Efficiency & cost of clinical protocol

Time frame: Up to 30 days

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.
Safety of clinical protocol

Time frame: Up to 30 days

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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Outpatient Treatment of Pulmonary Embolism and Deep Vein Thrombosis: Impact of a New Protocol on Emergency Department Efficiency and Patient Safety

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Aug 25, 2015
Registry last updated: Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed