Outpatient Treatment of PE and DVT in the Emergency Department

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532387
• Other study ID #: 2015P000877
• Status: Completed
• Start date: August 2015
• Est. completion date: February 2017

Study information

• Verified date: March 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Emergencies
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Telephone follow-up
Prospectively enrolled subjects will have a 7- and 30-day phone call.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 30 days
Primary	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.	Up to 30 days