SimulationViPERNCT04553640
Virtual Patient Education From Real Cases
A study testing Group A/Intervention Curriculum in people with Simulation and Dizziness, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation, Dizziness, Vertigo
- What is being tested?
- Group A/Intervention Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
About this study
Official title: 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).
Read the 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.
- Conditions
- Simulation, Dizziness, Vertigo, Stroke
- Being tested
- Group A/Intervention Curriculum, Group B/Control Curriculum
- Keywords
- virtual education, medical education
- Medical subject headings
- Dizziness, Vertigo, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A/Intervention CurriculumOther
Also called Simulation-based curriculum to Improve Diagnosis of Dizziness (SIDD)
Virtual patient cases and feedback
Group B/Control CurriculumOther
Online articles on dizziness and emergency department clinical experience
| Study group | Role | What they receive |
|---|---|---|
| Group A/Intervention Curriculum | Experimental | 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. Receives: Other: Group A/Intervention Curriculum; Other: Group B/Control Curriculum |
| Group B/Control curriculum | Active comparator | Online articles on dizziness AND regular emergency department clinical rotations Receives: Other: Group A/Intervention Curriculum; Other: Group B/Control Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy as determined by the percentage of proportion of correct virtual patient cases from the total number of virtual patient cases
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
Measured: 6 months
Secondary outcomes (4)
Diagnostic process assessed with quality of EHR notes for dizzy patients as assessed by a rubric (intervention vs. control group)
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
Measured: 6 months
Diagnostic Utilization as determined by percentage of neuroimaging utilization in ED
Number/percentage of CT/MRI scans ordered for dizzy patients in the ED (intervention vs. control group) - evaluated with Phase 2.
Measured: 6 months
Self-Confidence as determined by online self assessment survey
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
Measured: 6 months
Satisfaction as determined by a self assessment score
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start15 May 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SimulationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Phase 1: A stratified randomized controlled delayed intervention trial to assess the effectiveness of the "intervention" relative to a "control" condition. Participants will undergo a pretest \& then stratified randomization to groups A or B (depending on clinical experience). Participants in group A will be exposed to the intervention (virtual patient curriculum + Feedback) and participants in group B will be exposed to the control (Online articles on dizziness and traditional ED residency training). The groups will then reverse so that now group B is exposed to the intervention. Outcomes will be measured for all participants at T0 (pretest), T1 (crossover point), and T2 (intervention end). Phase 2: This will be a non-randomized study between intervention group (those ED providers who participated in our curriculum) vs. new control group (matched ED providers who did not participate in our curriculum).
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susrutha Kotwal, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553640
- Sponsor's protocol ID
- IRB00167998
- Acronym
- ViPER
- Status last verified
- Jul 2023
- First submitted
- 11 Sep 2020
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Patient Education From Real Cases (ViPER) to Improve ED Diagnosis of Dizziness and Stroke
- ClinicalTrials.gov ID
- NCT04553640
- Acronym / sponsor ID
- ViPER / IRB00167998
- Conditions
- Simulation, Dizziness, Vertigo, Stroke
- Keywords
- virtual education, medical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1: A stratified randomized controlled delayed intervention trial to assess the effectiveness of the "intervention" relative to a "control" condition. Participants will undergo a pretest \& then stratified randomization to groups A or B (depending on clinical experience). Participants in group A will be exposed to the intervention (virtual patient curriculum + Feedback) and participants in group B will be exposed to the control (Online articles on dizziness and traditional ED residency training). The groups will then reverse so that now group B is exposed to the intervention. Outcomes will be measured for all participants at T0 (pretest), T1 (crossover point), and T2 (intervention end). Phase 2: This will be a non-randomized study between intervention group (those ED providers who participated in our curriculum) vs. new control group (matched ED providers who did not participate in our curriculum).
| Arm | Type | Receives |
|---|---|---|
| Group A/Intervention Curriculum | Experimental | Other: Group A/Intervention Curriculum, Other: Group B/Control CurriculumVirtual patient (VP) cases and feedback available through solving VP cases and participants' self-report on the diagnosis of dizzy patients in the emergency department. |
| Group B/Control curriculum | Active comparator | Other: Group A/Intervention Curriculum, Other: Group B/Control CurriculumOnline articles on dizziness AND regular emergency department clinical rotations |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A/Intervention CurriculumAlso: Simulation-based curriculum to Improve Diagnosis of Dizziness (SIDD)Virtual patient cases and feedback | Other | Group A/Intervention Curriculum, Group B/Control curriculum |
| Group B/Control CurriculumOnline articles on dizziness and emergency department clinical experience | Other | Group A/Intervention Curriculum, Group B/Control curriculum |
Primary outcome
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
4 secondary outcomes
Diagnostic process assessed with quality of EHR notes for dizzy patients as assessed by a rubric (intervention vs. control group)
Time frame: 6 months
Diagnostic Utilization as determined by percentage of neuroimaging utilization in ED
Time frame: 6 months
Self-Confidence as determined by online self assessment survey
Time frame: 6 months
Satisfaction as determined by a self assessment score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
Related trials for Simulation
Active, not recruiting
Enhancing Male Nursing Students' Competence in Maternity Care: A Quasi-Experimental Study in Egypt
Maternity Nursing Obstetric Nursing Clinical Competence Education, Nursing Simulation Training
Enrolling by invitation
Virtual Reality-Based Simulation Training for Retrograde Anterior Column Acetabular Screw Placement in Orthopedic Residents
Virtual Reality Simulation
Not yet recruiting
The Effect Of Low-Fidelity Simulation Education Pressure Injuries
Nursing Education Research, Simulation Based Learning
Not yet recruiting
MAGICS - Multi-Agent Generative AI in Clinical Simulation for Clinical Deterioration Training
Clinical Reasoning in Nursing Education, Virtual Simulation
Not yet recruiting
Low-Cost Model Versus Airway Part-Task Trainer for Flexible Bronchoscope-Guided Tracheal Intubation Training
Simulation Based Medical Education, Tracheal Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susrutha Kotwal, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A/Intervention Curriculum in people with Simulation and Dizziness, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023; AzTrials last refreshed its copy on 26 Oct 2026.