Outpatient Treatment of PE and DVT in the Emergency Department

NCT02532387 | Completed

• 1 other identifier: 2015P000877
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pulmonary Embolism; Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

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.

Other: Telephone follow-up

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.

Other: Telephone follow-up

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.

Interventions

Telephone follow-up OTHER

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

BWH ED/EDOU patients; MGH ED/EDOU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a multi-center prospective, observational study of MGH or BWH patients with PE or DVTwith historical and contemporary controls.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Study Officials

• Christopher Kabrhel, MD MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 25, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

US (2)