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

NCT01948076 | Completed Results

• 1 other identifier: 2011P-002845
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Splenomegaly; Pleural Effusion

Keywords

splenomegaly; pleural effusion

Outcome Measures

Primary Outcomes (1)

• Comparison of Diagnostic Ability of the Intervention Group's Ultrasound Exam to the Control Group's Physical Exam

  The primary outcome is a comparison of the diagnostic ability of the intervention group as recorded after performing an ultrasound exam and the control group using traditional physical examination techniques. We compared the two groups using the average physical findings correctly identified as present or absent as reflected by a "Present Score" (average # of findings identified out of 17 possible findings) and "Absent Score" (average # of findings identified out of 95 possible). 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.

  one month

Secondary Outcomes (1)

• Improvement in Diagnostic Ability Within the Intervention Group

  one month

Study Arms (2)

resident without GE vscan

PLACEBO COMPARATOR

baseline physical exam use

resident with GE vscan

ACTIVE COMPARATOR

residents with augmentation of physical exam by ultrasound

Device: resident with GE vscan

Interventions

resident with GE vscan DEVICE

resident with GE vscan

Also known as: vscan

resident with GE vscan

Eligibility Criteria

• Age: 24 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Radiology Preliminary residents
• Residents with previous formalized ultrasound training that included a practical component

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• General Electric: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Ojeda JC, Colbert JA, Lin X, McMahon GT, Doubilet PM, Benson CB, Wu J, Katz JT, Yialamas MA. Pocket-sized ultrasound as an aid to physical diagnosis for internal medicine residents: a randomized trial. J Gen Intern Med. 2015 Feb;30(2):199-206. doi: 10.1007/s11606-014-3086-4. Epub 2014 Nov 12.

  PMID: 25387438 DERIVED

MeSH Terms

Conditions

Splenomegaly; Pleural Effusion

Condition Hierarchy (Ancestors)

Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pleural Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Maria Yialamas
• Organization: Brigham and Women's Hospital

myialamas@partners.org

617-732-5500

Study Officials

• Maria Yialamas, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 23, 2013
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 19, 2015
• Results First Posted: February 26, 2015

Record last verified: 2015-02

Locations

US (1)