Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04553640 |
| Other study ID # |
IRB00167998 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2021 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Misdiagnosis of neurological conditions is common in healthcare settings, sometimes with
devastating consequences. Most diagnostic errors result from failures in bedside diagnostic
reasoning. Dizziness is a symptom that is common, costly, and frequently associated with
missed stroke. Too often healthcare providers have misconceptions about diagnostic approaches
to dizziness. Current systems of medical education, residency training, and licensure
requirements have proven insufficient to prevent harms from diagnostic error. Traditional
lectures do not change physician behavior but active learning strategies with the use of
simulation do. The investigators built and hope to expand a simulation-based curriculum to
improve diagnosis of dizziness (SIDD) that will mirror real-world encounters and clinical
practice. Using the tenets of deliberate practice with rapid, real-time feedback, the
investigators hope to improve the approach to dizziness of healthcare providers and correct
knowledge deficits that contribute to diagnostic errors. Investigators have chosen dizziness
as the "model symptom" for this study. Future plans include expanding this approach to other
symptoms that are also common, costly, and associated with a high misdiagnosis rate (e.g.
abdominal pain, dyspnea, or chest pain).
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.
