Evaluation of a Pocket-Sized Ultrasound Device As an Aid to the Physical Examination
Condition: Splenomegaly; Pleural Effusion
MeSH terms: Pleural Effusion; Splenomegaly
Study type: Interventional

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.
    

Detailed description: 
      II. Specific Aims:

      Study population: Internal medicine residents at an academic center

      Patient population: A broad population of patients with diverse clinical conditions including
      cardiac and vascular disease, malignancy, rheumatologic disease, liver disease, renal
      failure, and others. This population will reflect the diversity of patients seen by internal
      medicine residents during their training.

      Physical findings being studied:

        1. Abdominal: hepatomegaly, cirrhotic liver, splenomegaly, ascites, abdominal aortic
           aneurysm

        2. Lungs: pleural effusion, pneumothorax, paralyzed hemidiaphragm.

        3. Cardiac: pericardial effusion, mitral regurgitation, tricuspid regurgitation, aortic
           insufficiency, aortic stenosis, right atrial pressure.

      Primary Aim:

      Determine the diagnostic accuracy of residents using a pocket-sized ultrasound device
      compared with residents using more traditional physical exam techniques for the physical
      findings mentioned above.

      Secondary Aims:

        -  Determine whether medicine residents improve their physical exam diagnostic skills after
           receiving training with pocket-sized ultrasound devices.

        -  Determine the additional diagnostic benefit of pocket-sized ultrasound versus a
           traditional physical exam.

        -  Assess the diagnostic physical exam skills of medicine residents as compared with expert
           diagnosticians.

        -  Assess the diagnostic ultrasound skills of medicine residents as compared with trained
           radiologists using pocket-sized ultrasounds.

        -  Assess the degree of agreement between expert physical diagnosticians and trained
           radiologists using pocket-sized ultrasound.

        -  Evaluate the ability of residents to integrate ultrasound examination into their daily
           patient care routines

      III. Subject Selection:

      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

      Resident Recruitment Methods:

      All interns and residents in the BWH internal medicine residency program will be invited to
      participate in the study. The study will be advertised via email and announcements at
      residency educational conferences. Because Dr. Katz and Dr. Yialamas are part of the BWH
      residency leadership, they will not participate in the recruitment of residents to avoid a
      potential undue pressure to participate.

      Patient Recruitment Methods:

      Advertisements will be sent to selected faculty within the departments of medicine and
      radiology with details of patient involvement and the selected physical findings which will
      be studied. Patients will be asked by their treating physician or radiologist involved in
      their care if they can be contacted by the study coordinator. The coordinator will then
      assess interest and availability. Patients will then be consented if they agree to
      participate. Fourteen patient-subjects will ultimately be selected to participate in our
      assessment program. They will be compensated $350 for participating.

      IV. Subject Enrollment

      Forty of the residents who responded to the email advertisement will be randomly selected to
      be enrolled. Each resident enrolled will be consented by one of the investigators prior to
      participating in the study. The verbal consent process will assure subjects that study data
      and results will not appear in their residency record, or be used in any way by the residency
      program. They will therefore remain wholly within the purview of the investigation staff, and
      will not form any part of their residency evaluation. Each of the forty residents who
      participates in our study will receive a compensation of $150 for their time.

      V. Study Procedures

      Randomization and Curricular Training The 40 participating residents will be randomized to
      either the control or intervention group by having them blindly pick small pieces of paper
      with numbers out of a paper bag. All residents will participate in a 2 hour physical exam
      education session led by senior internal medicine faculty. Those randomized to the ultrasound
      group will also attend a 2 hour pocket-ultrasound training session which will be run by a BWH
      faculty radiologist and a BWH faculty echocardiographer. Following this training session,
      each of the 20 residents will be given a pocket-sized ultrasound device which they will be
      able to use as an adjunct to their physical exam while in clinic or on inpatient wards.
      Because the resident physicians are not trained ultrasound radiologists, these ultrasound
      studies will be informal and the results will not become part of any patient's medical
      record. Participants in the control arm of the study will not receive pocket-sized ultrasound
      devices nor will they receive training on how to use the machines.

      Physical Exam Assessment Session Four weeks after randomization, all 40 of the resident
      subjects will attend a half-day physical exam assessment. This assessment will take place in
      the Brigham Circle Medical Associates Clinic on the Third Floor of the BWH Shapiro
      Cardiovascular Building. The assessment will also include the participation of 14 patient
      subjects who will be recruited ahead of time.

      At the start of the day, each of the 14 patient subjects will be examined by two senior
      internal medicine clinicians to determine the presence of the physical exam findings being
      studied. Each patient subject will also undergo ultrasound evaluation by two BWH radiologists
      or echocardiographers to radiographically confirm the presence of the abovementioned physical
      findings. The "gold standard" for this study will be clinically detectable physical findings
      (as confirmed by senior clinicians) that are also confirmed by an ultrasound study performed
      by a radiologist or echocardiographer.

      Patient study subjects will each be assigned to a clinic room and study subjects will rotate
      through each of the 14 rooms over the course of the half-day session. Each interaction will
      last 5 minutes and will consist of a focused physical examination of the patient. All 40
      medicine residents will perform a routine physical exam on each patient and will document
      their findings. The 20 residents in the intervention group will also perform an exam on the
      same patients using a pocket-sized ultrasound and will document their findings.

      Following the assessment, those study subjects randomized to the control group will have the
      opportunity to participate in a brief ultrasound training session, and they will also have a
      chance to practice using the ultrasounds during clinical practice over the following week.

      VI. Biostatistical Analysis

      Data collected during the assessment will include both binary variables for the presence of
      the aforementioned physical exam findings as well as to categorize the severity of each
      finding (mild, moderate, severe). Clinical definitions for these categories will be defined
      ahead of time. In addition, a short questionnaire will be distributed to all of the subjects
      and patient study subjects. The questionnaire will ask subjects about their comfort in
      performing various aspects of the physical exam, their use of handheld ultrasound devices, as
      well as their experiences teaching medical students and residents the physical exam. Patient
      study subjects will answer a questionnaire about their attitude towards being examined by a
      physician using a handheld ultrasound device.

      Primary outcome measure: Physical exam diagnostic accuracy of residents compared with the
      diagnostic accuracy of residents using pocket-sized ultrasound devices.

      Secondary outcome measures:

        1. For the sub-group of residents with pocket-sized ultrasounds: comparing the diagnostic
           accuracy of routine physical exam versus with the ultrasound (i.e. how much additional
           diagnostic yield did the ultrasound provide?).

        2. Comparing the diagnostic accuracy of physical exams by medical residents with the exams
           performed by the expert clinicians.

        3. Comparing the diagnostic accuracy of pocket-sized ultrasounds performed by medical
           residents with the studies performed by expert radiologists and echocardiographers.

        4. Assess the degree of agreement between expert physical diagnosticians and trained
           radiologists using pocket-sized ultrasound.

      VII. Risks and Discomforts

      We see no potential for harm to either study subjects or patient study subjects in this
      study. Ultrasound is a safe modality that does not involve ionizing radiation. We do not
      anticipate any pain or discomfort to our patient study subjects.

      If any previously-unknown abnormalities are noted by our faculty radiologists or study
      subjects while performing an ultrasound on patient study subjects, the patient's primary care
      physician will be notified.

      VIII. Potential Benefits The benefits of our study for participants will be the satisfaction
      of participating in a research study that has the potential to ultimately improve patient
      care.

      We believe the potential global benefits from our study are significant. If handheld
      ultrasound devices prove to be helpful to internal medical residents in their physical
      assessment of patients, we would recommend that these machines be made available through the
      residency program. We hypothesize that handheld ultrasounds will enable internists to augment
      their physical exam skills with a direct impact on improving patient care.

      IX. Monitoring and Quality Assurance

      Because our study does not involve any potential harm to participants we do not anticipate
      the need for an independent safety monitoring board. All participants will, however, be
      encouraged to report any possible adverse events to our study coordinator, and participants
      will have the option of withdrawing from the study at any time.
    

Intervention name(s): resident with GE vscan
Intervention type(s): Device
Intervention description(s): resident with GE vscan
Other intervention name(s): vscan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: splenomegaly; pleural effusion