Evaluation of a Pocket-Sized Ultrasound Device As an Aid to the Physical Examination
The 40 resident study subjects will be randomized to either receive a training session on use of a pocket-sized ultrasound or to receive training on physical exam skills. Following these sessions the subjects will have the opportunity to practice their skills during clinical rounds at BWH inpatient and outpatient settings. Four weeks after the training session all study subjects will take part in an assessment of their diagnostic skills. During this assessment they will be asked to complete an exam on a patient subject. Those randomized to the ultrasound group will be allowed to use their devices while the control group will use the traditional physical exam. Following the exams, resident study subjects will be asked to indicate whether they detected any of the following abnormalities on their exams: pleural effusion, hepatomegaly, cirrhotic liver, splenomegaly, ascites, aortic stenosis, mitral regurgitation, right atrial pressure, abdominal aortic aneurysm, deep vein thrombosis. Resident study subjects will also complete a questionnaire about the physical exam and use of the ultrasound. Prior to the assessment, all patients will undergo ultrasound by an attending radiologist, and these results will serve as the "gold standard" for our study.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Use of a Pocket-sized Ultrasound Device as an Aid to the Physical Examination for Internal Medicine Residents|
- Number of physical findings correctly identified as present or absent [ Time Frame: one month ] [ Designated as safety issue: No ]The primary outcome is the comparison of the diagnostic ability of the intervention group using combination of physical exam and the ultrasound device and the control group using traditional physical examination techniques. We used two metrics for comparison between the two groups: (1) an overall diagnostic ability score for physical abnormalities that were present (''present score") and (2) an overall diagnostic ability score for identifying the absence of physical abnormalities ("absent score"). The former is a gauge of a resident's ability to correctly identify present abnormalities while the latter is an assessment of correctly identifying a normal examination when findings are absent. The residents used a examination form to indicate whether or not they felt the physical abnormality was present or absent and how confident he or she was in their answer. This was compared with the gold standard which was presence or absence of the abnormality on professional ultrasound.
- Improvement in diagnostic ability within the intervention group [ Time Frame: one month ] [ Designated as safety issue: No ]For the secondary outcome, we assessed whether there was an improvement in the diagnostic ability of those in the intervention group using traditional physical examination techniques as compared to using the ultrasound device. The same metrics, the "present score" and "absent score", were used in this comparison. The residents used a examination form to indicate whether or not they felt the physical abnormality was present or absent and how confident he or she was in their answer. This was compared with the gold standard which was presence or absence of the abnormality on professional ultrasound.
- Confidence in diagnostic ability [ Time Frame: one month ] [ Designated as safety issue: No ]We compared the diagnostic confidence of residents using the physical exam (control group) with residents using a hand-held ultrasound (intervention group). We also calculated a confidence-weighted diagnostic score for each finding and compared the control and intervention groups on this metric as well.
|Study Start Date:||September 2012|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: resident without GE vscan
baseline physical exam use
Active Comparator: resident with GE vscan
residents with augmentation of physical exam by ultrasound
Device: resident with GE vscan
resident with GE vscan
Other Name: vscan
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01948076
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Maria Yialamas, MD||Brigham and Women's Hospital|