- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04553640
Virtual Patient Education From Real Cases (ViPER)
Virtual Patient Education From Real Cases (ViPER) to Improve ED Diagnosis of Dizziness and Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diagnostic errors and resulting misdiagnosis-related harms represent a major public health problem. Most diagnostic errors result from failures in bedside diagnostic reasoning. Gaps in expertise (ultimately linked to faulty knowledge, inadequate training, or lack of feedback) account for many of these failures. Current systems of medical education, residency training, and licensure requirements have proven insufficient to prevent harms from diagnostic errors. The National Academy of Medicine recommends using simulation training with early exposure to a variety of typical/atypical cases to improve diagnostic performance. A systematic review found strong positive associations between simulation training and improved outcomes of knowledge, skills, and behaviors. Training in bedside diagnosis could be dramatically enhanced through symptom-specific virtual patient (VP) curricula that expose learners to real-world cases in a deliberate practice framework - practice that is motivated, purposeful, and systematic. This approach allows the appropriate mix of cases and difficulty to be presented to learners sequentially, potentially enhancing clinical skills.
Clinical presentations with nonspecific symptoms and diagnoses with wide differentials are especially prone to diagnostic errors; dizziness may be the epitome of this conundrum. Dizziness is a symptom that is common, costly, and associated with missed stroke. Isolated dizziness is the most common clinical context for missed stroke. Stroke is a leading cause of major long-term disability in the United States and an enormous source of global disease burden. It is listed as the fourth most common diagnostic errors among those reported by physicians. In fact, closed-claims analyses focused on neurologic conditions found stroke as the most common misdiagnosis, and more than 20% occurred in the ED. A hospital records analyses indicated that deaths due to cerebrovascular events result from diagnostic error far more frequently than those due to myocardial infarction. The ED is a high-risk site for diagnostic errors and indiscriminate use of neuroimaging for diagnosis of dizziness is neither accurate nor cost-effective. Risk stratification using symptoms and signs at the bedside offer the potential to provide cost-effective reductions in misdiagnosis-related harms. There is evidence to suggest that providers are currently ill-equipped and harbor misconceptions about the best approach to dizzy patients. Therefore, the investigators chose dizziness as the "model symptom" for study.
Even at Johns Hopkins Medicine, where dizziness diagnosis has been studied extensively, this remains a problem. The Center for Diagnostic Excellence group recently showed that (a) <5% of dizziness charts have correct documentation of standard bedside examination techniques; (b) 40% of patients leave the ED with a symptom-only diagnosis (at least half of whom could have been correctly diagnosed and treated); and (c) 39% receive a CT (>90% of which are inappropriate). Emergency medicine residents overwhelmingly express the need for better training in dizziness diagnosis.
The investigators recently demonstrated that <10 hours' worth of simulation-based deliberate practice training using a dizziness-focused ViPER (Virtual Patient Education from Real Cases) curriculum made internal medicine interns twice as accurate as senior resident colleagues on VP cases. The investigators now seek to do the same for emergency medicine residents and demonstrate real-world impact.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susrutha Kotwal, MD
- Phone Number: 5708672288
- Email: skotwal1@jhmi.edu
Study Contact Backup
- Name: Gina Kauffman
- Phone Number: 4105504534
- Email: rhess4@jhmi.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All internal medicine interns (PGY 1) and residents (PGY 2 and 3) at Johns Hopkins Hospital (JHH) and Johns Hopkins Bayview Medical Center (JHBMC) will be invited to participate voluntarily.
- JHBMC and JHH Hospitalists, Physician Assistants, Nurse Practitioners, Emergency Medicine Residents.
Exclusion Criteria:
- Interns and residents not associated with the internal medicine or emergency medicine residency programs at JHH and JHBMC.
- Hospitalists, Physician Assistants, Nurse Practitioners not associated with JHBMC or JHH.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A/Intervention Curriculum
Virtual patient (VP) cases and feedback available through solving VP cases and participants' self-report on the diagnosis of dizzy patients in the emergency department.
|
Virtual patient cases and feedback
Other Names:
Online articles on dizziness and emergency department clinical experience
|
Active Comparator: Group B/Control curriculum
Online articles on dizziness AND regular emergency department clinical rotations
|
Virtual patient cases and feedback
Other Names:
Online articles on dizziness and emergency department clinical experience
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy as determined by the percentage of proportion of correct virtual patient cases from the total number of virtual patient cases
Time Frame: 6 months
|
Diagnostic accuracy on virtual patient cases in a pretest-posttest study and then participants will be exposed to a 2nd posttest after a time delay - evaluated with Phase 1
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic process assessed with quality of EHR notes for dizzy patients as assessed by a rubric (intervention vs. control group)
Time Frame: 6 months
|
EHR (electronic health record) notes for ED dizzy patients will be assessed for intervention vs. control group by two blinded raters using a rubric - evaluated with Phase 2
|
6 months
|
Diagnostic Utilization as determined by percentage of neuroimaging utilization in ED
Time Frame: 6 months
|
Number/percentage of CT/MRI scans ordered for dizzy patients in the ED (intervention vs. control group) - evaluated with Phase 2.
|
6 months
|
Self-Confidence as determined by online self assessment survey
Time Frame: 6 months
|
at the beginning and end of the study, the investigators will use an online self assessment survey with a range of score of 1 to 5 (1=extremely incompetent, 2=somewhat incompetent, 3=neither incompetent nor competent, 4=somewhat competent, and 5=extremely competent) to gauge learners' confidence in evaluating dizzy patients and perceived strengths and weaknesses in diagnostic approach, history, and examination
|
6 months
|
Satisfaction as determined by a self assessment score
Time Frame: 6 months
|
The self assessment survey score will range from 1 to 5 (1=extremely dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied, and 5=extremely satisfied); Software usability and satisfaction data from participants will be collated for this scoring system.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susrutha Kotwal, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00167998
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Group A/Intervention Curriculum
-
Ohio State UniversityRecruitingBreast CancerUnited States
-
Haute Ecole de Santé VaudCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipSwitzerland
-
Indiana UniversityCompleted
-
Unity Health TorontoCompletedColorectal CancerCanada
-
University of Missouri-ColumbiaNorthern Arizona UniversityTerminatedPhysical ActivityUnited States
-
University of North Carolina, Chapel HillUniversity of North Carolina, GreensboroCompletedPadres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their ChildrenMental DisordersUnited States
-
Laura Comendador-VazquezUniversitat Autonoma de BarcelonaRecruiting
-
Thomas Jefferson UniversityNorthwestern UniversityCompletedEmergency Medicine | Uncertainty | Communication ResearchUnited States
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedMental Health DisordersNorway
-
University of Alabama at BirminghamActive, not recruitingMultiple MyelomaUnited States