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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X-Ray | Active Comparator |
| |
| Ultrasound | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X-Ray | Diagnostic Test | Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Tozer, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | X-Ray | X-Ray: Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographic data was not collected directly from participants but was to be extracted from participant charts. Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA "Minimum Necessary" standard.
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| ID | Title | Description |
|---|---|---|
| BG000 | X-Ray | X-Ray: Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Demographic data was not collected directly from participants but was to be extracted from participant charts. Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA "Minimum Necessary" standard. |
| 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 | 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. | Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA "Minimum Necessary" standard. | Posted | up to 8 hours or time to admission |
|
Up to 8 hours
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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 | X-Ray | X-Ray: Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Tozer | Virginia Commonwealth University | 804-828-5250 | jordan.tozer@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2020 | Oct 18, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2021 | Oct 18, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012783 | Shoulder Dislocation |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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| Ultrasound | Diagnostic Test | 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. |
|
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 |
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex/Gender, Customized | Demographic data was not collected directly from participants but was to be extracted from participant charts. Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA "Minimum Necessary" standard. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | at discharge or admission - up to 8 hours |
|
|
|
| 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 | Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA "Minimum Necessary" standard. | Posted | up to 8 hours or time to admission |
|
|
| Secondary | Confirmation of Reduction | As documented by x-ray or ultrasound per treatment condition | Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA "Minimum Necessary" standard. | Posted | up to 8 hours or time to admission |
|
|
| Secondary | Cost of Treatment | Calculated as total billing cost of procedures related to shoulder dislocation ED visit | Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA "Minimum Necessary" standard. | Posted | up to 8 hours or time to admission |
|
|
| Secondary | Total Number of Xrays | Total number of xrays ordered during time in ED | Data was not extracted from patient charts due to termination of the study and in compliance with the HIPAA "Minimum Necessary" standard. | Posted | up to 8 hours or time to admission |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D000070599 |
| Shoulder Injuries |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |