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Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT) (AVERT)

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ClinicalTrials.gov Identifier: NCT02483429
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : August 6, 2021
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
GN Otometrics
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE March 3, 2015
First Posted Date  ICMJE June 29, 2015
Last Update Posted Date August 6, 2021
Actual Study Start Date  ICMJE December 4, 2017
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
  • Six-Category Diagnosis Accuracy (all, VRT vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    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) [ Time Frame: 6 months after last patient/last visit ]
    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) [ Time Frame: 9 months after last patient/last visit ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Central-Peripheral Diagnosis Accuracy (all, VRT vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    Total diagnosis accuracy VRT vs. SOC using 30-day adjudicated final diagnoses categorized as central (stroke, posterior fossa mass lesion, encephalitis, demyelinating disease, etc.) vs. non-central (peripheral vestibular, medical, psychiatric, non-diagnoses, etc.). Also analyzed for each diagnosis category will be sensitivity, specificity, predictive values, likelihood ratios.
  • Stroke-No Stroke Diagnosis Accuracy (all, VRT vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    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.
  • Preventable Six-Category Diagnosis Error (all, VRT vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    Total diagnosis inaccuracy (error) VRT vs. SOC using adjudicated index diagnoses categorized in one of six possible diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). Adjudicated index diagnoses will be determined using only ED index visit data that 'would have been' available clinically (i.e., excluding safety MRI, index hospital admission data, and all follow-up data).
  • VRT vs. MRI Stroke-No Stroke Diagnosis Accuracy (VRT arm only, VRT vs. MRI) [ Time Frame: 6 months after last patient/last visit ]
    Total diagnosis accuracy VRT vs. index imaging using 30-day adjudicated final diagnoses categorized as stroke vs. no stroke (posterior fossa mass lesion, encephalitis, etc.). The VRT arm is chosen here because all VRT arm patients will undergo MRI at the index visit (protocol, clinical, or safety), eliminating diagnostic ascertainment bias that may be present in the SOC arm.
  • Algorithm-Only VRT Six-Category Diagnosis Accuracy (all, initial VRT output vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    Total diagnosis accuracy "as computed in real time," algorithm-only VRT 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 VRT 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 weighted average diagnostic accuracy of the various versions of the automated algorithm as it would have been absent human double-check during the course of the trial.
  • Optimized Six-Category Within-Subject Accuracy (SOC arm only, optimized VRT vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    Total diagnosis accuracy optimized 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 "Optimized VRT Diagnosis" and "ED Physician Diagnosis" compared to the "Adjudicated Final Diagnosis" based on ED index visit and 30-day follow-up clinical assessments. Optimized VRT diagnoses are re-run using the final (end-of-trial) version of the VRT algorithm. Only SOC-arm subjects are used for this outcome. VRT diagnoses in the SOC arm (algorithm not run during the trial), will be assigned based on the final, optimized algorithm; for this purpose, the ED SOC diagnosis will be assigned as the VRT diagnosis for algorithm results in the VRT-E group. Also analyzed for each diagnosis category will be sensitivity, specificity, predictive values, likelihood ratios.
  • Expert VOG Six-Category Diagnosis Accuracy (all, expert VOG vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
  • Central-Peripheral Diagnosis Accuracy (all, VRT vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    Total diagnosis accuracy VRT vs. SOC using 30-day adjudicated final diagnoses categorized as central (stroke, posterior fossa mass lesion, encephalitis, demyelinating disease, etc.) vs. non-central (peripheral vestibular, medical, psychiatric, non-diagnoses, etc.). Also analyzed for each diagnosis category will be sensitivity, specificity, predictive values, likelihood ratios.
  • Stroke-No Stroke Diagnosis Accuracy (all, VRT vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    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.
  • Preventable Six-Category Diagnosis Error (all, VRT vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    Total diagnosis inaccuracy (error) VRT vs. SOC using adjudicated index diagnoses categorized in one of six possible diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). Adjudicated index diagnoses will be determined using only ED index visit data that 'would have been' available clinically (i.e., excluding safety MRI, index hospital admission data, and all follow-up data).
  • Optimized Six-Category Within-Subject Accuracy (SOC arm only, optimized VRT vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    Total diagnosis accuracy optimized 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 "Optimized VRT Diagnosis" and "ED Physician Diagnosis" compared to the "Adjudicated Final Diagnosis" based on ED index visit and 30-day follow-up clinical assessments. Optimized VRT diagnoses are re-run using the final (end-of-trial) version of the VRT algorithm. Only SOC-arm subjects are used for this outcome. VRT diagnoses in the SOC arm (algorithm not run during the trial), will be assigned based on the final, optimized algorithm; for this purpose, the ED SOC diagnosis will be assigned as the VRT diagnosis for algorithm results in the VRT-E group. Also analyzed for each diagnosis category will be sensitivity, specificity, predictive values, likelihood ratios.
  • VRT vs. MRI Stroke-No Stroke Diagnosis Accuracy (VRT arm only, VRT vs. MRI) [ Time Frame: 6 months after last patient/last visit ]
    Total diagnosis accuracy VRT vs. index imaging using 30-day adjudicated final diagnoses categorized as stroke vs. no stroke (posterior fossa mass lesion, encephalitis, etc.). The VRT arm is chosen here because all VRT arm patients will undergo MRI at the index visit (protocol, clinical, or safety), eliminating diagnostic ascertainment bias that may be present in the SOC arm.
  • Central Discharge Proportion (central subgroup only, VRT vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    Total discharge proportion of central causes VRT vs. SOC. Central causes determined based on 30-day adjudicated final diagnosis.
  • Peripheral Admission Proportion (peripheral subgroup only, VRT vs. SOC) [ Time Frame: 6 months after last patient/last visit ]
    Total admission proportion of peripheral causes VRT vs. SOC. Peripheral causes determined based on 30-day adjudicated final diagnosis.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)
Official Title  ICMJE Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Vertigo
  • Dizziness
Intervention  ICMJE Device: VRT Care
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.
Other Name: GN Otometrics (Instrumentation & Control Systems, Inc)
Study Arms  ICMJE
  • Experimental: VRT Care
    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.
    Intervention: Device: VRT Care
  • No Intervention: Standard of Care (SOC)
    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.
  • No Intervention: Observational
    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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2020)
195
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2015)
226
Actual Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

  1. 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.

  2. 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)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02483429
Other Study ID Numbers  ICMJE IRB00044228
1U01DC013778-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • GN Otometrics
Investigators  ICMJE
Principal Investigator: David Newman-Toker, MD, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP