Trial Outcomes & Findings for Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial (NCT NCT04820491)

Results Overview

Length of stay in the ED will be calculated from time of first provider contact to time of discharge from the ED.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

up to 8 hours or time to admission

Results posted on

2022-11-16

Participant Flow

Participant milestones

Participant milestones
Measure	X-Ray X-Ray: Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction	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.
Overall Study STARTED	5	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	X-Ray X-Ray: Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction	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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	X-Ray n=5 Participants X-Ray: Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction	Ultrasound n=4 Participants 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.	Total n=9 Participants Total of all reporting groups
Age, Customized Unknown	5 participants n=5 Participants	4 participants n=4 Participants	9 participants n=9 Participants
Sex/Gender, Customized Unknown	5 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=9 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=4 Participants	9 participants n=9 Participants

PRIMARY outcome

Timeframe: 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.

Length of stay in the ED will be calculated from time of first provider contact to time of discharge from the ED.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	X-Ray n=4 Participants X-Ray: Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction	Ultrasound n=4 Participants 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.
Patient Satisfaction	29.25 score on a scale Standard Deviation 0.96	27.75 score on a scale Standard Deviation 2.06

SECONDARY outcome

Timeframe: 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.

Time to diagnosis will be calculated from time of first provider contact to time of x-ray or time of ultrasound per treatment condition

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

As documented by x-ray or ultrasound per treatment condition

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Calculated as total billing cost of procedures related to shoulder dislocation ED visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Total number of xrays ordered during time in ED

Outcome measures

Outcome data not reported

Adverse Events

X-Ray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jordan Tozer

Virginia Commonwealth University

Phone: 804-828-5250

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place