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| Name | Class |
|---|---|
| United States Naval Medical Center, Portsmouth | FED |
| United States Naval Medical Center, San Diego | FED |
| University of Colorado, Denver | OTHER |
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The goal of this project is to compare the efficiency of pelvic ultrasounds performed by emergency medicine residents and attending physicians to the efficiency of pelvic ultrasounds performed by the department of radiology.
This study is a randomized, prospective interventional study of pregnant patients presenting to the emergency department with complaints of pelvic pain and/or vaginal bleeding. This study will be conducted at 4 sites across the United States. Patients who are eligible and consent to participate will be randomized to one of two conditions; 1) a pelvic ultrasound that is performed by a certified emergency department attending or physician, or 2) a pelvic ultrasound that is performed by a certified radiology technician (standard-of-care). The time to diagnosis and emergency department length of stay between the two groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergency Medicine Physician Ultrasound | Experimental | Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound. |
|
| Radiology Tech Ultrasound | Active Comparator | Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency Medicine Physician Ultrasound | Other | An ultrasound will be performed by an emergency medicine resident or attending physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Definitive Diagnosis | The time the patient is placed in room to the time that results of the ultrasound (and/or consultative impression made by radiology or obstetrics and gynecology) are documented in patient chart | 24 hours |
| Emergency Department Length-of-Stay | The time the patient is placed in room to the time that the patient is discharged/admitted. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Kendall, MD | Denver Health and Hospital Authority | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17446770 | Result | Kendall JL, Hoffenberg SR, Smith RS. History of emergency and critical care ultrasound: the evolution of a new imaging paradigm. Crit Care Med. 2007 May;35(5 Suppl):S126-30. doi: 10.1097/01.CCM.0000260623.38982.83. | |
| 9055772 | Result | Durham B, Lane B, Burbridge L, Balasubramaniam S. Pelvic ultrasound performed by emergency physicians for the detection of ectopic pregnancy in complicated first-trimester pregnancies. Ann Emerg Med. 1997 Mar;29(3):338-47. doi: 10.1016/s0196-0644(97)70345-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Emergency Medicine Physician Ultrasound | Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound. Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician Ultrasound: An ultrasound will be performed by a radiology department technician |
| FG001 | Radiology Tech Ultrasound | Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care. Ultrasound: An ultrasound will be performed by a radiology department technician |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Emergency Medicine Physician Ultrasound | Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound. Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician Ultrasound: An ultrasound will be performed by a radiology department technician |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Definitive Diagnosis | The time the patient is placed in room to the time that results of the ultrasound (and/or consultative impression made by radiology or obstetrics and gynecology) are documented in patient chart | Posted | Median | Inter-Quartile Range | minutes | 24 hours |
|
Adverse event data was collected for 72 hours after receipt of the intervention.
Ectopic pregnancies and intrauterine fetal demise are expected in the given study population, and have been deemed unrelated to the research intervention by the Principal Investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Emergency Medicine Physician Ultrasound | Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound. Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician Ultrasound: An ultrasound will be performed by a radiology department technician |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| intrauterine fetal demise | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
This is not a blinded study. As such the performers may have been biased to complete these procedures more quickly than they would be if the study were not taking place.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Kendall | Denver Health and Hospital Authority | (303)602-5187 | John.Kendall@dhha.org |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Open Label
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| Ultrasound | Device | An ultrasound will be performed by a radiology department technician |
|
| 9715242 | Result | Burgher SW, Tandy TK, Dawdy MR. Transvaginal ultrasonography by emergency physicians decreases patient time in the emergency department. Acad Emerg Med. 1998 Aug;5(8):802-7. doi: 10.1111/j.1553-2712.1998.tb02507.x. |
| 10036346 | Result | Dart RG. Role of pelvic ultrasonography in evaluation of symptomatic first-trimester pregnancy. Ann Emerg Med. 1999 Mar;33(3):310-20. doi: 10.1016/s0196-0644(99)70368-9. |
| 15347539 | Result | Tayal VS, Cohen H, Norton HJ. Outcome of patients with an indeterminate emergency department first-trimester pelvic ultrasound to rule out ectopic pregnancy. Acad Emerg Med. 2004 Sep;11(9):912-7. doi: 10.1197/j.aem.2004.03.017. |
| 11043992 | Result | Blaivas M, Sierzenski P, Plecque D, Lambert M. Do emergency physicians save time when locating a live intrauterine pregnancy with bedside ultrasonography? Acad Emerg Med. 2000 Sep;7(9):988-93. doi: 10.1111/j.1553-2712.2000.tb02088.x. |
| 9055773 | Result | Shih CH. Effect of emergency physician-performed pelvic sonography on length of stay in the emergency department. Ann Emerg Med. 1997 Mar;29(3):348-51; discussion 352. doi: 10.1016/s0196-0644(97)70346-9. |
| BG001 | Radiology Tech Ultrasound | Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care. Ultrasound: An ultrasound will be performed by a radiology department technician |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care. Ultrasound: An ultrasound will be performed by a radiology department technician |
|
|
| Primary | Emergency Department Length-of-Stay | The time the patient is placed in room to the time that the patient is discharged/admitted. | Posted | Median | Inter-Quartile Range | minutes | 48 hours |
|
|
|
| 0 |
| 118 |
| 2 |
| 118 |
| 4 |
| 118 |
| EG001 | Radiology Tech Ultrasound | Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care. Ultrasound: An ultrasound will be performed by a radiology department technician | 0 | 106 | 2 | 106 | 2 | 106 |
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