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

Phase 2

Completed

Conditions: Dizziness
Vertigo

Interventions: Device: VRT Care

Registration Number: NCT02483429

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 195

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VRT Care	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.

Primary Outcome Measures

Name	Time	Method
Six-Category Diagnosis Accuracy (all, VRT vs. SOC)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Stroke-No Stroke Diagnosis Accuracy (all, VRT vs. SOC)	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.
Expert VOG Six-Category Diagnosis Accuracy (all, expert VOG vs. SOC)	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.

Trial Locations

Locations (5): Johns Hopkins Hospital - Bayview
🇺🇸
Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
University of Illinois
🇺🇸
Peoria, Illinois, United States
Mt. Sinai Medical Center
🇺🇸
New York, New York, United States