Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo (ED-VeRT)

A Pilot Feasibility Trial of Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo

ED-VeRT will enroll up to 125 adult emergency department (ED) patients presenting with a chief complaint of dizziness or vertigo to collect longitudinal outcomes over 3 months of follow-up. This will include 50 patients who were evaluated by an ED physical therapist (ie, vestibular rehabilitation) during their ED visit and 50 patients who received usual care. The aims of this trial are to: (1) obtain initial estimates of participant recruitment and retention, intra-cluster correlation, and between-group outcome differences that will inform sample size calculation for a future randomized clinical trial, and (2) assess feasibility and fidelity of a clinical classification protocol for undifferentiated dizziness among patients receiving ED vestibular rehabilitation.

Study Overview

• Status: Active, not recruiting
• Conditions: Vertigo; Dizziness
• Intervention / Treatment: Behavioral: Vestibular Rehabilitation; Other: Usual Care

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ED patients presenting with a chief complaint relating to dizziness or vertigo.

Description

Inclusion Criteria:

• Chief complaint relating to dizziness or vertigo
• Ability to complete follow-up data collection electronically or by telephone
• English-speaking

Exclusion Criteria:

• Severe neurologic deficit concerning for ischemic or hemorrhagic stroke
• Known pregnancy, under police custody, unable to consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ED Physical Therapy; Patients in the ED physical therapy group will have been evaluated by an emergency department physical therapist for dizziness/vertigo during their index ED visit.	Behavioral: Vestibular Rehabilitation; Vestibular Rehabilitation refers to the specific interventions that physical therapists provide to patients with dizziness and vertigo symptoms. These interventions can involve repositioning maneuvers, habituation exercises, gaze stabilization, and/or balance training exercises, depending on the specific etiology of dizziness and vertigo per an established clinical protocol utilizing a patient's history and exam findings. Physical therapists instruct patients in how to perform these exercises at home and provide instructions and referral for patients to follow-up with an outpatient physical therapist for further care.
Usual Care; Patients in the usual care group will NOT have received an evaluation by an ED physical therapist for dizziness/vertigo symptoms during their index ED visit.	Other: Usual Care; Usual Care refers to any combination of diagnostic testing, medications, and patient education or counseling provided by a patient's treating ED physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dizziness Handicap Inventory (DHI)	The DHI contains 25 items quantifying self-perceived handicapping effects of dizziness symptoms.	Three months after the index ED visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vestibular Activities Avoidance Instrument (VAAI-9)	The VAAI-9 identifies fear avoidance beliefs in persons with dizziness. The VAAI-9 is the 9-item short form version of the VAAI.	Three months after the index ED visit.
ED Diagnostic Imaging Utilization	The proportion of ED visits in which any diagnostic imaging of the brain was performed, including computed tomography and magnetic resonance imaging.	Index ED visit (one day)
ED Length of Stay	Total length of stay, inclusive of hospitalizations and observation stays.	Index ED visit (up to one week)
Patient-Reported Medication Use in Last 24 Hours	Patient-reported medication use for dizziness will be collected using a standardized instrument assess whether participants have taken any dizziness medication in the last 24 hours (binary yes/no). The 24-hour timeframe was selected to maximize accuracy in patient recall. In brief, dizziness medications are listed by brand and generic names; a "yes" response to any medication triggers an additional query asking the participant to specify the medication dose (e.g., meclizine 25mg) and quantity (e.g., one pill).	Three months after the index ED visit.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Rating of Change (GROC)	The GROC is a single-item survey used to evaluate overall recovery from the time that symptoms began until now. Responses are provided on a 15-point Likert scale ranging from "a very great deal worse" to "a very great deal better."	Three months after the index ED visit.
Numeric Rating Scale (NRS)	The NRS measures intensity of dizziness symptoms from 0 to 10. Participants will report average dizziness intensity over the last 24 hours.	Three months after the index ED visit.
Advanced Healthcare Utilization	Proportion of participants who utilized any advanced healthcare resources for dizziness after their index ED visit, defined as advanced imaging (e.g., computed tomography, magnetic resonance imaging) or procedures/surgery.	Three months after the index ED visit.
Benzodiazepine Prescription Filling	Benzodiazepine prescription filling data will be queried in the state prescription monitoring database.	Three months after the index ED visit
Follow-up with Outpatient Physical Therapy	Proportion of participants who reports outpatient physical therapy follow-up for vestibular rehabilitation	Three months after the index ED visit

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): May 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Emergencies; Vertigo; Dizziness
• Other Study ID Numbers: STU00215925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No