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Trial record 5 of 18 for:    "Splenomegaly"

Evaluation of a Pocket-Sized Ultrasound Device As an Aid to the Physical Examination

This study has been completed.
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Maria Yialamas, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01948076
First received: September 16, 2013
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Splenomegaly
Pleural Effusion
Device: resident with GE vscan

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   24 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All interns and residents in the BWH internal medicine residency program who responded to a recruitment email and agreed to participate.

Exclusion Criteria:

  • • Radiology Preliminary residents

    • Residents with previous formalized ultrasound training that included a practical component
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948076

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
General Electric
Investigators
Principal Investigator: Maria Yialamas, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Maria Yialamas, Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01948076     History of Changes
Other Study ID Numbers: 2011P-002845
Study First Received: September 16, 2013
Last Updated: September 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
splenomegaly
pleural effusion

Additional relevant MeSH terms:
Pleural Effusion
Splenomegaly
Hypertrophy
Pathological Conditions, Anatomical
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014