Outpatient Treatment of PE and DVT in the Emergency Department

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

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

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis; Pulmonary Embolism
• Intervention / Treatment: Other: Telephone follow-up

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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: Telephone follow-up; Prospectively enrolled subjects will have a 7- and 30-day phone call.
Control subjects; Contemporary controls: subjects diagnosed with Venous Thromboembolism (VTE) in the ED and who are not eligible for outpatient treatment; Historical controls:Subjects enrolled in the prospective and retrospective SPEED-D study (PI: Kabrhel) and diagnosed with PE between 2006-2012.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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Christopher Kabrhel, MD MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Embolism and Thrombosis; Emergencies; Embolism; Thrombosis; Venous Thrombosis; Pulmonary Embolism
• Other Study ID Numbers: 2015P000877