NCT04553640

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

September 11, 2020

Last Update Submit

July 11, 2023

Conditions

Keywords

virtual educationmedical education

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    6 months

  • Diagnostic Utilization as determined by percentage of neuroimaging utilization in ED

    6 months

  • Self-Confidence as determined by online self assessment survey

    6 months

  • Satisfaction as determined by a self assessment score

    6 months

Study Arms (2)

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.

Other: Group A/Intervention CurriculumOther: Group B/Control Curriculum

Group B/Control curriculum

ACTIVE COMPARATOR

Online articles on dizziness AND regular emergency department clinical rotations

Other: Group A/Intervention CurriculumOther: Group B/Control Curriculum

Interventions

Virtual patient cases and feedback

Also known as: Simulation-based curriculum to Improve Diagnosis of Dizziness (SIDD)
Group A/Intervention CurriculumGroup B/Control curriculum

Online articles on dizziness and emergency department clinical experience

Group A/Intervention CurriculumGroup B/Control curriculum

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

DizzinessVertigoStroke

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Susrutha Kotwal, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 17, 2020

Study Start

May 15, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations