Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial (EASiUR)
Primary Purpose
Shoulder Dislocation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
X-Ray
Ultrasound
Sponsored by
About this trial
This is an interventional health services research trial for Shoulder Dislocation
Eligibility Criteria
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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
X-Ray
Ultrasound
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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
Confirmation of Reduction
As documented by x-ray or ultrasound per treatment condition
Cost of Treatment
Calculated as total billing cost of procedures related to shoulder dislocation ED visit
Total Number of Xrays
Total number of xrays ordered during time in ED
Full Information
NCT ID
NCT04820491
First Posted
March 25, 2021
Last Updated
October 21, 2022
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT04820491
Brief Title
Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial
Acronym
EASiUR
Official Title
EASiUR Trial: Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
October 21, 2021 (Actual)
Study Completion Date
October 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
X-Ray
Arm Type
Active Comparator
Arm Title
Ultrasound
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
X-Ray
Intervention Description
Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of Stay in the Emergency Department (ED)
Description
Length of stay in the ED will be calculated from time of first provider contact to time of discharge from the ED.
Time Frame
up to 8 hours or time to admission
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
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 Frame
at discharge or admission - up to 8 hours
Title
Time to Diagnosis
Description
Time to diagnosis will be calculated from time of first provider contact to time of x-ray or time of ultrasound per treatment condition
Time Frame
up to 8 hours or time to admission
Title
Confirmation of Reduction
Description
As documented by x-ray or ultrasound per treatment condition
Time Frame
up to 8 hours or time to admission
Title
Cost of Treatment
Description
Calculated as total billing cost of procedures related to shoulder dislocation ED visit
Time Frame
up to 8 hours or time to admission
Title
Total Number of Xrays
Description
Total number of xrays ordered during time in ED
Time Frame
up to 8 hours or time to admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Tozer, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial
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