Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo

Dizziness Clinical Trial

— ED-VeRT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05122663
• Other study ID #: STU00215925
• Status: Active, not recruiting
• Start date: November 16, 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: December 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Emergencies
• Vertigo

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	Benzodiazepine Prescription Filling	Benzodiazepine prescription filling data will be queried in the state prescription monitoring database.	Three months after the index ED visit
Other	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
Primary	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	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.
Secondary	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)
Secondary	ED Length of Stay	Total length of stay, inclusive of hospitalizations and observation stays.	Index ED visit (up to one week)
Secondary	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.