What side effects are associated with this type of intervention?

The most common treatments for vertigo, particularly BPPV, include canalith repositioning maneuvers such as the Epley maneuver, which generally have minimal side effects but can occasionally cause transient dizziness or nausea. For unilateral vestibulopathy, treatments often involve vestibular rehabilitation exercises, which are typically well-tolerated but may initially increase symptoms of dizziness as the body adjusts. In cases of vertigo due to stroke, management focuses on addressing the underlying stroke, which may involve medications like anticoagulants or antiplatelets, with side effects including bleeding risks. Overall, these treatments are aimed at improving balance and reducing dizziness with relatively few adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for vertigo, particularly for conditions like benign paroxysmal positional vertigo (BPPV). These treatments often include medications such as antihistamines (e.g., meclizine), anticholinergics (e.g., scopolamine), and benzodiazepines (e.g., diazepam) to manage symptoms. Additionally, non-pharmacological treatments like vestibular rehabilitation therapy (VRT) are widely recognized and recommended. The Enhanced BPPV-Centric Implementation Strategy focuses on improving the application of these evidence-based practices, particularly VRT, which has shown effectiveness in managing BPPV by promoting vestibular compensation and reducing dizziness symptoms.

What other types of research exist?

Promising novel alternatives for vertigo management in 2024 include: 1) Virtual reality-based vestibular rehabilitation, which uses immersive environments to improve balance and reduce dizziness. 2) Wearable vestibular devices that provide real-time feedback and assist with balance training. 3) Advanced telemedicine platforms for remote diagnosis and management of vertigo, enhancing accessibility and patient compliance. 4) Pharmacological advancements such as new vestibular suppressants or neuroprotective agents that target underlying pathophysiological mechanisms of vertigo.

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Evidence-Based Practice Education for Dizziness (DIZZTINCT2 Trial)

N/A

Recruiting

Led By Kevin Kerber, MD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English or Spanish speaker

Age >= 18 years

Must not have

Does not demonstrate capacity to consent assessed by the Older Adults' Capacity to Consent to Research (OACCR) scale48

Level 1 trauma diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cumulative 4 weeks following index ed visit

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the care of patients with dizziness in emergency departments by educating doctors and patients about the best practices for diagnosis and treatment. Doctors will receive training through online courses, websites, and printed materials, while patients will get personalized information through a website. The goal is to reduce unnecessary tests and ensure effective treatment.

Who is the study for?

This trial is for adults over 18 who've been discharged from certain emergency departments in the last 48 hours with a primary diagnosis of dizziness or related vestibular disorders. Participants must be Kaiser Permanente members, speak English or Spanish, and able to consent. Those with severe trauma, previous study enrollment, or inability to consent are excluded.

What is being tested?

The study tests how well evidence-based practices for managing dizziness (like BPPV) are implemented in emergency departments. It uses an enhanced strategy developed from prior research and assesses its effectiveness through a stepped-wedge design and randomized patient-level dissemination.

What are the potential side effects?

Since this trial focuses on educational interventions rather than medications, traditional side effects aren't expected. However, participants may experience discomfort or anxiety when discussing medical conditions or during assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English or Spanish.

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I am 18 years old or older.

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I was diagnosed with dizziness or balance issues as my main health problem.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to understand and agree to participate in research.

Select...

I have been diagnosed with a major injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cumulative 4 weeks following index ed visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cumulative 4 weeks following index ed visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and cumulative 4 weeks following index ed visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dizziness Handicap Inventory

Documentation of Dix-Hallpike Test/Canalith Repositioning Maneuver

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Group 6: Post-CME with Chart Review OnlyExperimental Treatment1 Intervention

Physicians in hospitals that have received the DIZZTINCT educational intervention. Eligible patient will have their medical records abstracted to assess the main study outcome

Group II: Group 5: Post-CME with Standard Patient CareExperimental Treatment1 Intervention

Physicians in hospitals that have received the DIZZTINCT educational intervention. Patients have not receive the DIZZTINCT educational intervention

Group III: Group 4: Post-CME with Patient EducationExperimental Treatment2 Interventions

Physicians in hospitals that have received the DIZZTINCT educational intervention. Patients have receive the DIZZTINCT educational intervention

Group IV: Group 1: Pre-CME with Patient EducationExperimental Treatment1 Intervention

Physicians in hospitals that have not received the DIZZTINCT educational intervention. Patients have received the DIZZTINCT educational intervention

Group V: Group 2: Pre-CME with Standard Patient CareActive Control1 Intervention

Physicians in hospitals that have not received the DIZZTINCT educational intervention. Patients have not received the DIZZTINCT educational intervention

Group VI: Group 3: Pre-CME with Chart Review OnlyActive Control1 Intervention

Physicians in hospitals that have not received the DIZZTINCT educational intervention. Eligible patient will have their medical records abstracted to assess the main study outcome

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for vertigo, particularly benign paroxysmal positional vertigo (BPPV), include canalith repositioning maneuvers such as the Epley maneuver. These maneuvers work by moving the dislodged calcium carbonate crystals (canaliths) from the semicircular canals of the inner ear back to their correct location in the utricle, where they can no longer cause vertigo symptoms. This is crucial for vertigo patients as it directly addresses the root cause of BPPV, providing rapid and effective symptom relief. Additionally, vestibular rehabilitation therapy (VRT) is used to improve balance and reduce dizziness through exercises that promote central nervous system compensation for inner ear deficits. Implementing these evidence-based practices effectively can significantly enhance patient outcomes and reduce the burden of vertigo.

Meta-analyses of randomized controlled trials.No short-cut in assessing trial quality: a case study.