Back to resultsAcute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT) (AVERT)
Primary Purpose
Vertigo, Dizziness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VRT Care
Sponsored by
About this trial
This is an interventional diagnostic trial for Vertigo focused on measuring Vertigo, Dizziness, Unsteadiness, Stroke, Vestibular neuritis, Benign paroxysmal positional vertigo, Vestibulo-ocular reflex, Video-oculography, Emergency department
Eligibility Criteria
Inclusion criteria:
Adult (18 years and older) ED patients with all of the following (all determined pre-randomization):
VESTIBULAR SYMPTOMS: presenting symptom of "vertigo" OR "dizziness" OR "unsteadiness" (as defined by consensus expert definitions in the International Classification of Vestibular Disorders).
RELEVANT EXAM SIGNS*: pathologic nystagmus (spontaneous, gaze-evoked, or positional) by bedside VOG testing OR pathologic ataxia (gait, trunk, stance, limbs) by bedside ataxia examination.
RECENT ONSET: symptoms AND signs* appear to be new or markedly worse in the past month
* Exam signs are required for randomization, but not for the observational arm
Exclusion Criteria
Excluded from Pre-Randomization Screening
Level 1 trauma or critical illness Altered mental status (e.g., delirium, dementia) that would preclude active study participation (this includes patients with abnormal mental state due to alcohol intoxication or illicit substance, which are known, easily-recognized causes of dizziness or vertigo presentations to the ED) Non-English speaking (enrollment of non-English speakers is not feasible given the logistics of identifying a translator and the need for rapid recruitment and randomization in the AVERT study; furthermore, the terms vertigo, dizziness, and unsteadiness may have different meanings in other languages) Known pregnancy (all women of childbearing age who are enrolled will undergo a urine or serum beta-HCG pregnancy test prior to MRI to confirm no pregnancy, per local institutional guidelines)
Unable or unsafe to participate in screening, including VOG tests (as deemed by specific pre-enrollment risk assessment questions or ED provider and/or Study Coordinator judgment) including, but not limited to:
visual impairment sufficient to prevent visual fixation during the VOG testing clinically-perceived risk to patient of participating in study (ED provider or staff concerns) clinically-perceived risk to research staff (e.g., violence, blood/body fluid/respiratory precautions) unstable cardiac status (given a single reported case of bradycardia with impulse testing) acute cranio-cervical trauma or other condition (e.g., rheumatoid arthritis) that might lead to instability of the cervical spine that would be a contraindication to neck rotation during VOG testing Obvious general medical cause (as judged by treating ED provider) including, but not limited to, acute myocardial infarction, pulmonary embolus, pneumonia, urinary tract infection, drug intoxication, etc.
- Excluded from Randomization (Eligible for Observational Arm Follow-up)
Patient previously randomized in the AVERT Trial (previously screened but not randomized are eligible)
Unable to participate fully with study follow-up (particularly MRI) including, but not limited to:
unable to return for follow-up testing within 30 days unable to undergo MRI because of contraindications (e.g., pacemaker, metallic foreign body, pregnancy) or other reasons (severe claustrophobia, too large or too heavy for MRI scanner)
Sites / Locations
- University of Illinois
- Johns Hopkins Hospital - Bayview
- Massachusetts General Hospital
- University of Michigan
- Mt. Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
VRT Care
Standard of Care (SOC)
Observational
Arm Description
Patients randomized to VRT (VOG-guided Rapid Triage) care will have an algorithm-determined patient-specific diagnosis and treatment pathway in the emergency department. Patients will complete a 1 week in-person follow up and a 1 and 6 month phone follow up.
Patients randomized to Standard of Care will undergo usual emergency department care without revealing results of VOG testing. Patients will complete a 1 week in-person follow up and a 1 and 6 month phone follow up.
Patients who signed an informed consent but did not meet inclusion/exclusion criteria and don't randomize will enter a parallel track observational sub-study with limited 1 and 6 month phone follow-up.
Outcomes
Primary Outcome Measures
Six-Category Diagnosis Accuracy (all, VRT vs. SOC)
Total diagnosis accuracy VRT vs. SOC using 30-day adjudicated final diagnoses categorized in one of six possible diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). We will use "Index VRT Diagnosis" and "ED Physician Diagnosis" compared to the "Adjudicated Final Diagnosis" based on ED index visit and 30-day follow-up clinical assessments. Also analyzed for each diagnosis category will be sensitivity, specificity, predictive values, likelihood ratios.
Index Visit Total Diagnostic Utilization Costs (all, VRT vs. SOC)
Total dollar costs VRT vs. SOC for diagnostic tests and consultations obtained during the ED index visit and hospital admission (for those admitted at the index visit). For the VRT arm, this does not include costs of protocol safety MRIs or any tests ordered off-protocol by ED physicians. It does include tests ordered on-protocol by consultants or ED physicians in the VRT 'equivocal' pathway. Total costs will be calculated by multiplying fixed cost estimates (most recent year available average Medicare reimbursement in US dollars) by utilization rates for each ED index visit service tracked.
Odds of Short-Term Serious Medical Events (SMEs) after Misdiagnosis (SOC arm only, correct vs. incorrect diagnoses)
We will use 30-day adjudicated final diagnoses categorized in one of six possible categories to determine "correct" vs. "incorrect" diagnoses. We will consider SMEs occurring between the time of ED index visit disposition and 1-week research follow-up visit. Events diagnosed at the ED index visit will not be counted. Events newly diagnosed at the 1-week follow-up or in the interval prior to follow-up will be counted, regardless of their relatedness to the ED index dizziness symptoms, with the exception of test or treatment complications. Diagnostic test or treatment complications must be related directly or indirectly to the dizziness symptoms. To avoid 'double counting' misdiagnoses as SMEs that are pursuant to misdiagnosis, 1-week stroke diagnoses not rendered at the ED index visit will not be counted as SMEs unless neurologic or vestibular symptoms/signs worsen after ED index discharge.
Secondary Outcome Measures
Expert VOG Six-Category Diagnosis Accuracy (all, expert VOG vs. SOC)
Total diagnosis accuracy adjudicated expert VOG diagnosis vs. SOC using 30-day adjudicated final diagnoses categorized in one of six possible diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). We will use "Index VOG Diagnosis" and "ED Physician Diagnosis" compared to the "Adjudicated Final Diagnosis" based on ED index visit and 30-day follow-up clinical assessments. This outcome measure reflects the theoretical maximum diagnostic accuracy performance (i.e., expert level) of any future algorithms.
Stroke-No Stroke Diagnosis Accuracy (all, VRT vs. SOC)
Total diagnosis accuracy VRT vs. SOC using 30-day adjudicated final diagnoses categorized as stroke vs. no stroke (posterior fossa mass lesion, encephalitis, etc.). Also analyzed for the stroke diagnosis category will be sensitivity, specificity, predictive values, likelihood ratios.
Full Information
NCT ID
NCT02483429
First Posted
March 3, 2015
Last Updated
August 16, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), GN Otometrics
1. Study Identification
Unique Protocol Identification Number
NCT02483429
Brief Title
Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)
Acronym
AVERT
Official Title
Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
March 17, 2023 (Actual)
Study Completion Date
March 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), GN Otometrics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
AVERT is a randomized controlled trial comparing video-oculography (VOG)-guided care to standard care to assess accuracy of diagnoses and initial management decisions for emergency department (ED) patients with a chief symptom of vertigo or dizziness suspected to be of vestibular cause. The trial will test the hypothesis that VOG-guided rapid triage (VRT) will accurately, safely, and efficiently differentiate peripheral from central vestibular disorders in ED patients presenting acute vertigo or dizziness, and that doing so has the potential to improve post-treatment clinical outcomes for these patients.
Detailed Description
AVERT is a multicenter, Phase II clinical trial comparing a novel diagnostic strategy (VRT) to standard ED diagnostic care at three performance sites. The Specific Aims are to assess diagnostic accuracy, diagnostic workup costs, and estimate the short-term impact of correct diagnosis in anticipation of a larger, definitive Phase III trial. Adult ED patients with a chief symptom of vertigo, dizziness, or unsteadiness, new or clearly worse in the previous 30 days, will undergo on-site vestibular function tests by trained research personnel using a portable, quantitative VOG recording device. Research personnel will also record a focused symptom history and bedside hearing tests. Eligible patients with at least one pathologic vestibular eye movement finding or pathologic ataxia will be randomized to VRT or standard ED care. Patients eligible for pre-randomization testing but excluded from randomization will be slated for the Observational Arm of the study and will undergo limited 1 and 6 month phone follow-up. The VRT arm relies on an automated algorithm to interpret VOG results, thereby determining a patient-specific clinical care pathway. For safety, all VRT-arm study subjects will undergo stroke protocol MRI before release. All randomized subjects will undergo confirmatory testing at one week, including vestibular specialist exam and 1.5 or 3-Tesla research MRI combining stroke and internal auditory canal protocols. All randomized patients will also undergo 1 month and 6 month phone follow-up and medical record review to confirm diagnoses. Clinical findings, ED diagnoses, diagnostic resource utilization, treatments applied, and clinical events during follow-up will be recorded. A multidisciplinary, masked, expert panel will adjudicate final diagnoses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo, Dizziness
Keywords
Vertigo, Dizziness, Unsteadiness, Stroke, Vestibular neuritis, Benign paroxysmal positional vertigo, Vestibulo-ocular reflex, Video-oculography, Emergency department
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VRT Care
Arm Type
Experimental
Arm Description
Patients randomized to VRT (VOG-guided Rapid Triage) care will have an algorithm-determined patient-specific diagnosis and treatment pathway in the emergency department. Patients will complete a 1 week in-person follow up and a 1 and 6 month phone follow up.
Arm Title
Standard of Care (SOC)
Arm Type
No Intervention
Arm Description
Patients randomized to Standard of Care will undergo usual emergency department care without revealing results of VOG testing. Patients will complete a 1 week in-person follow up and a 1 and 6 month phone follow up.
Arm Title
Observational
Arm Type
No Intervention
Arm Description
Patients who signed an informed consent but did not meet inclusion/exclusion criteria and don't randomize will enter a parallel track observational sub-study with limited 1 and 6 month phone follow-up.
Intervention Type
Device
Intervention Name(s)
VRT Care
Other Intervention Name(s)
GN Otometrics (Instrumentation & Control Systems, Inc)
Intervention Description
The VOG report includes direct device output (physiologic traces, quantitative measures) plus most likely diagnosis, category, and clinical trial care pathway (peripheral, equivocal, central) instructions. The VOG report becomes part of the patient's emergency department clinical record.
Primary Outcome Measure Information:
Title
Six-Category Diagnosis Accuracy (all, VRT vs. SOC)
Description
Total diagnosis accuracy VRT vs. SOC using 30-day adjudicated final diagnoses categorized in one of six possible diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). We will use "Index VRT Diagnosis" and "ED Physician Diagnosis" compared to the "Adjudicated Final Diagnosis" based on ED index visit and 30-day follow-up clinical assessments. Also analyzed for each diagnosis category will be sensitivity, specificity, predictive values, likelihood ratios.
Time Frame
6 months after last patient/last visit
Title
Index Visit Total Diagnostic Utilization Costs (all, VRT vs. SOC)
Description
Total dollar costs VRT vs. SOC for diagnostic tests and consultations obtained during the ED index visit and hospital admission (for those admitted at the index visit). For the VRT arm, this does not include costs of protocol safety MRIs or any tests ordered off-protocol by ED physicians. It does include tests ordered on-protocol by consultants or ED physicians in the VRT 'equivocal' pathway. Total costs will be calculated by multiplying fixed cost estimates (most recent year available average Medicare reimbursement in US dollars) by utilization rates for each ED index visit service tracked.
Time Frame
6 months after last patient/last visit
Title
Odds of Short-Term Serious Medical Events (SMEs) after Misdiagnosis (SOC arm only, correct vs. incorrect diagnoses)
Description
We will use 30-day adjudicated final diagnoses categorized in one of six possible categories to determine "correct" vs. "incorrect" diagnoses. We will consider SMEs occurring between the time of ED index visit disposition and 1-week research follow-up visit. Events diagnosed at the ED index visit will not be counted. Events newly diagnosed at the 1-week follow-up or in the interval prior to follow-up will be counted, regardless of their relatedness to the ED index dizziness symptoms, with the exception of test or treatment complications. Diagnostic test or treatment complications must be related directly or indirectly to the dizziness symptoms. To avoid 'double counting' misdiagnoses as SMEs that are pursuant to misdiagnosis, 1-week stroke diagnoses not rendered at the ED index visit will not be counted as SMEs unless neurologic or vestibular symptoms/signs worsen after ED index discharge.
Time Frame
9 months after last patient/last visit
Secondary Outcome Measure Information:
Title
Expert VOG Six-Category Diagnosis Accuracy (all, expert VOG vs. SOC)
Description
Total diagnosis accuracy adjudicated expert VOG diagnosis vs. SOC using 30-day adjudicated final diagnoses categorized in one of six possible diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). We will use "Index VOG Diagnosis" and "ED Physician Diagnosis" compared to the "Adjudicated Final Diagnosis" based on ED index visit and 30-day follow-up clinical assessments. This outcome measure reflects the theoretical maximum diagnostic accuracy performance (i.e., expert level) of any future algorithms.
Time Frame
6 months after last patient/last visit
Title
Stroke-No Stroke Diagnosis Accuracy (all, VRT vs. SOC)
Description
Total diagnosis accuracy VRT vs. SOC using 30-day adjudicated final diagnoses categorized as stroke vs. no stroke (posterior fossa mass lesion, encephalitis, etc.). Also analyzed for the stroke diagnosis category will be sensitivity, specificity, predictive values, likelihood ratios.
Time Frame
6 months after last patient/last visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Adult (18 years and older) ED patients with all of the following (all determined pre-randomization):
VESTIBULAR SYMPTOMS: presenting symptom of "vertigo" OR "dizziness" OR "unsteadiness" (as defined by consensus expert definitions in the International Classification of Vestibular Disorders).
RELEVANT EXAM SIGNS*: pathologic nystagmus (spontaneous, gaze-evoked, or positional) by bedside VOG testing OR pathologic ataxia (gait, trunk, stance, limbs) by bedside ataxia examination.
RECENT ONSET: symptoms AND signs* appear to be new or markedly worse in the past month
* Exam signs are required for randomization, but not for the observational arm
Exclusion Criteria
Excluded from Pre-Randomization Screening
Level 1 trauma or critical illness Altered mental status (e.g., delirium, dementia) that would preclude active study participation (this includes patients with abnormal mental state due to alcohol intoxication or illicit substance, which are known, easily-recognized causes of dizziness or vertigo presentations to the ED) Non-English speaking (enrollment of non-English speakers is not feasible given the logistics of identifying a translator and the need for rapid recruitment and randomization in the AVERT study; furthermore, the terms vertigo, dizziness, and unsteadiness may have different meanings in other languages) Known pregnancy (all women of childbearing age who are enrolled will undergo a urine or serum beta-HCG pregnancy test prior to MRI to confirm no pregnancy, per local institutional guidelines)
Unable or unsafe to participate in screening, including VOG tests (as deemed by specific pre-enrollment risk assessment questions or ED provider and/or Study Coordinator judgment) including, but not limited to:
visual impairment sufficient to prevent visual fixation during the VOG testing clinically-perceived risk to patient of participating in study (ED provider or staff concerns) clinically-perceived risk to research staff (e.g., violence, blood/body fluid/respiratory precautions) unstable cardiac status (given a single reported case of bradycardia with impulse testing) acute cranio-cervical trauma or other condition (e.g., rheumatoid arthritis) that might lead to instability of the cervical spine that would be a contraindication to neck rotation during VOG testing Obvious general medical cause (as judged by treating ED provider) including, but not limited to, acute myocardial infarction, pulmonary embolus, pneumonia, urinary tract infection, drug intoxication, etc.
Excluded from Randomization (Eligible for Observational Arm Follow-up)
Patient previously randomized in the AVERT Trial (previously screened but not randomized are eligible)
Unable to participate fully with study follow-up (particularly MRI) including, but not limited to:
unable to return for follow-up testing within 30 days unable to undergo MRI because of contraindications (e.g., pacemaker, metallic foreign body, pregnancy) or other reasons (severe claustrophobia, too large or too heavy for MRI scanner)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Newman-Toker, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61656
Country
United States
Facility Name
Johns Hopkins Hospital - Bayview
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33675203
Citation
Kotwal S, Fanai M, Fu W, Wang Z, Bery AK, Omron R, Tevzadze N, Gold D, Garibaldi BT, Wright SM, Newman-Toker DE. Real-world virtual patient simulation to improve diagnostic performance through deliberate practice: a prospective quasi-experimental study. Diagnosis (Berl). 2021 Mar 8;8(4):489-496. doi: 10.1515/dx-2020-0127. Print 2021 Nov 25.
Results Reference
derived
Links:
URL
http://braininjuryoutcomes.com
Description
Brain Injury OutcomeS (BIOS) website
Learn more about this trial
Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)
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