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This study is looking at the safety and effectiveness of treating Patients diagnosed with a low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient hospitalization. Patients have several medical tests done during their Emergency Department visit. Based on those tests, those who are determined to have a low-risk PE are eligible to participate in the study. Those choosing to participate are discharged after 12 hours of medical observation. Patients who choose to participate are followed up by telephone approximately 90 days later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient Treatment | All patients eligible for the study will have their PE treated in the outpatient setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient Treatment of Pulmonary Embolism | Other | Patients who participate in the study will be treated for their pulmonary embolism in an outpatient setting instead of being hospitalized. |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE | This is a composite outcome of the above. | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of medical costs due to outpatient treatment. | 90 Days | |
| Level of patient satisfaction as measured by survey. | 90 Days Post study enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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The subject population is drawn from patients arriving in the Emergency Department who are then diagnosed with a lower risk pulmonary embolism (PESI score <86).
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Bledsoe, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16020800 | Background | Aujesky D, Obrosky DS, Stone RA, Auble TE, Perrier A, Cornuz J, Roy PM, Fine MJ. Derivation and validation of a prognostic model for pulmonary embolism. Am J Respir Crit Care Med. 2005 Oct 15;172(8):1041-6. doi: 10.1164/rccm.200506-862OC. Epub 2005 Jul 14. | |
| 16207738 | Background | Aujesky D, Roy PM, Le Manach CP, Verschuren F, Meyer G, Obrosky DS, Stone RA, Cornuz J, Fine MJ. Validation of a model to predict adverse outcomes in patients with pulmonary embolism. Eur Heart J. 2006 Feb;27(4):476-81. doi: 10.1093/eurheartj/ehi588. Epub 2005 Oct 5. |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| 19132186 | Background | Squizzato A, Ageno W. The 8(th) American College of Chest Physicians Guidelines - a perspective on venous thromboembolism guidelines. Thromb Haemost. 2009 Jan;101(1):31-5. No abstract available. |
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| 16432084 | Background | Aujesky D, Obrosky DS, Stone RA, Auble TE, Perrier A, Cornuz J, Roy PM, Fine MJ. A prediction rule to identify low-risk patients with pulmonary embolism. Arch Intern Med. 2006 Jan 23;166(2):169-75. doi: 10.1001/archinte.166.2.169. |
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| 11214399 | Background | Roberts R, Graff LG 4th. Economic issues in observation unit medicine. Emerg Med Clin North Am. 2001 Feb;19(1):19-33. doi: 10.1016/s0733-8627(05)70166-8. |
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| 9862943 | Background | Farkouh ME, Smars PA, Reeder GS, Zinsmeister AR, Evans RW, Meloy TD, Kopecky SL, Allen M, Allison TG, Gibbons RJ, Gabriel SE. A clinical trial of a chest-pain observation unit for patients with unstable angina. Chest Pain Evaluation in the Emergency Room (CHEER) Investigators. N Engl J Med. 1998 Dec 24;339(26):1882-8. doi: 10.1056/NEJM199812243392603. |
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| 12377877 | Background | Dalen JE. Pulmonary embolism: what have we learned since Virchow? Natural history, pathophysiology, and diagnosis. Chest. 2002 Oct;122(4):1440-56. doi: 10.1378/chest.122.4.1440. No abstract available. |
| 14656907 | Background | Goldhaber SZ, Elliott CG. Acute pulmonary embolism: part I: epidemiology, pathophysiology, and diagnosis. Circulation. 2003 Dec 2;108(22):2726-9. doi: 10.1161/01.CIR.0000097829.89204.0C. No abstract available. |
| 29410163 | Derived | Bledsoe JR, Woller SC, Stevens SM, Aston V, Patten R, Allen T, Horne BD, Dong L, Lloyd J, Snow G, Madsen T, Elliott CG. Management of Low-Risk Pulmonary Embolism Patients Without Hospitalization: The Low-Risk Pulmonary Embolism Prospective Management Study. Chest. 2018 Aug;154(2):249-256. doi: 10.1016/j.chest.2018.01.035. Epub 2018 Feb 2. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |