Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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EASiUR Trial: Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial

Conditions
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Shoulder Dislocation

Intervention / Treatment
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* Diagnostic Test: X-Ray
* Diagnostic Test: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are 18 years of age or older; and Present to the VCU Emergency Department; and Have clinical signs of uncomplicated shoulder dislocation; and Agree to participation in the study; and 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; Patients who have a past medical history of shoulder replacement in dislocated shoulder; and/or Provider Discretion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: X-Ray<br> | Diagnostic Test: X-Ray<br>* Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction<br>|
| Active Comparator: Ultrasound<br> | Diagnostic Test: Ultrasound<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay in the Emergency Department (ED) | Length of stay in the ED will be calculated from time of first provider contact to time of discharge from the ED. | up to 8 hours or time to admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | 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). | at discharge or admission - up to 8 hours | 
| Time to Diagnosis | Time to diagnosis will be calculated from time of first provider contact to time of x-ray or time of ultrasound per treatment condition | up to 8 hours or time to admission | 
| Confirmation of Reduction | As documented by x-ray or ultrasound per treatment condition | up to 8 hours or time to admission | 
| Cost of Treatment | Calculated as total billing cost of procedures related to shoulder dislocation ED visit | up to 8 hours or time to admission | 
| Total Number of Xrays | Total number of xrays ordered during time in ED | up to 8 hours or time to admission |