The goal of this study is to investigate the impact of integrating handheld abdominal ultrasound into the current gastroenterology and hepatology consultation model at our hospital, particularly in terms of the speed of diagnostic evaluation and the impact of hospital length of stay.
The utilization of handheld ultrasound in the diagnosis and treatment of acute diseases has been practiced for many years, and in certain scenarios, its efficacy is comparable to that of traditional ultrasound. The portability and real-time bedside application of handheld ultrasound have made it increasingly significant in the clinical practice of subspecialties such as cardiovascular, thoracic, and hepato- gastroenterology. Consequently, the use of handheld ultrasound during hospitalizations or emergencies may shorten the time required for accurate diagnosis, enabling patients to receive timely treatment. To investigate the impact of integrating handheld abdominal ultrasound into the current gastroenterology and hepatology consultation model at our hospital, particularly in terms of the speed of diagnostic evaluation and the commencement of treatment. This study employs a prospective design with an anticipated enrollment of 200 patients over approximately one year (December 2024 to November 2025). A clustered-randomized controlled trial design will be used to fit real-world clinical scenario, with participants allocated to either an intervention group (current consultation model supplemented with handheld ultrasound) or a control group by odd/even-numbered calendar days. The primary outcome will be the speed of diagnostic imaging between the two groups. Secondary outcomes will include other indicators of inpatient care quality, such as length of hospital stay and diagnostic accuracy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
225
A handheld portable ultrasound sponsored by Aco Healthcare Co., Ltd company
National Taiwan University Hospital
Taipei, Taiwan
Time to diagnostic imaging
This outcome evaluates the clinical efficiency of the diagnostic workflow by measuring the time interval (in minutes) required to complete the initial diagnostic imaging. The exact measurement endpoints are defined by the study arm: Start point (Both arms): The exact time the gastroenterology consultation is initiated. End point (Intervention group): The execution of the point-of-care evaluation using the handheld ultrasound device (HUD) by the consultant at the bedside. End point (Control group): The execution of the first formally scheduled diagnostic imaging study (e.g., computed tomography \[CT\], magnetic resonance imaging \[MRI\], or conventional cart-based ultrasound) ordered as part of standard care following the consultation.
Time frame: From the initiation of the consultation to the execution of the diagnostic imaging study, assessed up to hospital discharge (an average of 14 to 30 days).
Post-Consultation Hospital Length of Stay (LOS)
This outcome evaluates the impact of the intervention on overall hospital resource utilization by measuring the post-consultation length of stay. The post-consultation LOS is defined as the time interval (measured in days) starting from the exact date the gastroenterology consultation is initiated (baseline) to the date the patient is officially discharged from the hospital. Data will be collected for both the intervention group (HUD) and the control group (standard care). Group differences will be analyzed to determine if the expedited point-of-care diagnostic workflow associated with the intervention effectively reduces the remaining hospitalization days. To account for skewed clinical data, comparisons will be reported using median days with interquartile ranges (IQR) and adjusted rate ratios.
Time frame: From the initiation of the gastroenterology consultation to the date of hospital discharge, assessed up to a maximum of 1 year.
Diagnostic Accuracy of the Targeted Organ by Handheld Ultrasound Device (HUD)
This outcome evaluates the diagnostic accuracy of the initial point-of-care evaluation using a HUD. Accuracy is determined by comparing HUD findings (Index Test) against the final definitive diagnosis (Reference Standard). Index Test: The primary pathology recorded by the consultant immediately following the bedside HUD examination. Reference Standard: The final clinical diagnosis of the targeted organ (e.g., biliary tract, liver, pancreas) established prior to discharge. This is confirmed by subsequent formal imaging (e.g., comprehensive ultrasound, CT, MRI). Accuracy is reported as the percentage of HUD evaluations correctly matching the reference standard.
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Time frame: From the time of initial HUD evaluation up to hospital discharge (an average of 2 to 4 weeks).