Shoulder Dislocation
Conditions
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.
Interventions
DIAGNOSTIC_TESTX-Ray
Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction
DIAGNOSTIC_TESTUltrasound
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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who are 18 years of age or older; and 2. Present to the VCU Emergency Department; and 3. Have clinical signs of uncomplicated shoulder dislocation; and 4. Agree to participation in the study; and 5. Provides a written consent to be included in the study.
Exclusion criteria
1. Patients who have a level 1 or 2 trauma activation, and/or; 2. Patients who are pregnant, incarcerated, or unable to consent, and/or; 3. Patients who have a past medical history of shoulder replacement in dislocated shoulder; and/or 4. Provider Discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| X-Ray X-Ray: Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction | 5 |
| Ultrasound 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. | 4 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Ultrasound | Total | X-Ray |
|---|---|---|---|
| Age, Customized Unknown | 4 participants | 9 participants | 5 participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 4 participants | 9 participants | 5 participants |
| Sex/Gender, Customized Unknown | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
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.
Time frame: up to 8 hours or time to admission
Population: Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA Minimum Necessary standard.
Secondary
Confirmation of Reduction
As documented by x-ray or ultrasound per treatment condition
Time frame: up to 8 hours or time to admission
Population: Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA Minimum Necessary standard.
Secondary
Cost of Treatment
Calculated as total billing cost of procedures related to shoulder dislocation ED visit
Time frame: up to 8 hours or time to admission
Population: Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA Minimum Necessary standard.
Secondary
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 frame: at discharge or admission - up to 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| X-Ray | Patient Satisfaction | 29.25 score on a scale | Standard Deviation 0.96 |
| Ultrasound | Patient Satisfaction | 27.75 score on a scale | Standard Deviation 2.06 |
Secondary
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
Time frame: up to 8 hours or time to admission
Population: Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA Minimum Necessary standard.
Secondary
Total Number of Xrays
Total number of xrays ordered during time in ED
Time frame: up to 8 hours or time to admission
Population: Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA Minimum Necessary standard.