Virtual Patient Education From Real Cases (ViPER)

July 11, 2023 updated by: Johns Hopkins University

Virtual Patient Education From Real Cases (ViPER) to Improve ED Diagnosis of Dizziness and Stroke

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).

Study Overview

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

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Simulation-based curriculum to Improve Diagnosis of Dizziness (SIDD)
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:
  • Simulation-based curriculum to Improve Diagnosis of Dizziness (SIDD)
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susrutha Kotwal, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

September 11, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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