EASiUR: Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial
Study Details
Study Description
Brief Summary
The purpose of the study is to determine if using ultrasound to diagnosis and confirm reductions of shoulder dislocations impacts the length of an emergency department visit for this condition.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of the study is to determine if the length of the emergency department visit can be decreased and if patient exposure to x-rays can be reduced by utilizing an ultrasound to diagnose and confirm reduction in shoulder dislocations.
This study also seeks to determine if patients prefer ultrasound to x-ray when used to treat their shoulder dislocation.
Participants will be randomly assigned to one of two groups: either x-rays or ultrasound for the diagnosis and reduction confirmation of your shoulder dislocation.
Participant's shoulder dislocation will be treated per standard of care.
Participants will be asked to complete a short survey at the end of their visit.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: X-Ray
|
Diagnostic Test: X-Ray
Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction
|
| Active Comparator: Ultrasound
|
Diagnostic Test: Ultrasound
Initial evaluation with ultrasound; may also evaluate nearby areas for concern of fracture. Order x- rays after ultrasound as seen fit for other injuries of diagnostic uncertainty.
|
Outcome Measures
Primary Outcome Measures
- Length of stay in the Emergency Department (ED) [up to 8 hours or time to admission]
Length of stay in the ED will be calculated from time of first provider contact to time of discharge from the ED.
Secondary Outcome Measures
- Patient satisfaction [at discharge or admission - up to 8 hours]
Patient satisfaction will be assessed using a 6 item scale. Each item is rated from 1 (extremely dissatisfied) to 5 (extremely satisfied). Scores are summed yielding scores ranging from 6 (most dissatisfied) to 30 (most satisfied).
- Time to diagnosis [up to 8 hours or time to admission]
Time to diagnosis will be calculated from time of first provider contact to time of x-ray or time of ultrasound per treatment condition
- Confirmation of reduction [up to 8 hours or time to admission]
As documented by x-ray or ultrasound per treatment condition
- Cost of treatment [up to 8 hours or time to admission]
Calculated as total billing cost of procedures related to shoulder dislocation ED visit
- Total number of xrays [up to 8 hours or time to admission]
Total number of xrays ordered during time in ED
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients who are 18 years of age or older; and
-
Present to the VCU Emergency Department; and
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Have clinical signs of uncomplicated shoulder dislocation; and
-
Agree to participation in the study; and
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Provides a written consent to be included in the study.
Exclusion Criteria:
-
Patients who have a level 1 or 2 trauma activation, and/or;
-
Patients who are pregnant, incarcerated, or unable to consent, and/or;
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Patients who have a past medical history of shoulder replacement in dislocated shoulder; and/or
-
Provider Discretion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
Investigators
- Principal Investigator: Jordan Tozer, MD, Virginia Commonwealth University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HM20019991