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Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| Control subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone follow-up | Other | Prospectively enrolled subjects will have a 7- and 30-day phone call. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This is a multi-center prospective, observational study of MGH or BWH patients with PE or DVTwith historical and contemporary controls.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Kabrhel, MD MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham and Women's Hospital |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| Boston |
| Massachusetts |
| 02115 |
| United States |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |