|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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|
|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
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:
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.
III. Subject Selection:
All interns and residents in the BWH internal medicine residency program who responded to a recruitment email and agreed to participate.
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:
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948076
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948076
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Maria Yialamas, MD||Brigham and Women's Hospital|