Implementation of Evidence-Based Practice for Dizziness

Dizziness Clinical Trial

— DIZZTINCT2  

Official title:

Dizziness Treatment Through Implementation & Clinical Strategy Tactics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05634902
• Other study ID #: KPSC IRB 12548
• Secondary ID: R01DC012760-08
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: Kevin Kerber, MD
• Phone: 734-478-2678
• Email: Kevin.Kerber[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates the implementation of evidence-based practice for the management of patients with dizziness in the emergency department (ED) within a large integrated health care system. The clinical focus is on benign paroxysmal positional vertigo (BPPV), unilateral vestibulopathy (e.g., vestibular neuritis), and stroke - which are disorders with established evidence-base practices for evaluation and management. Evidence-based practices for these clinical topics have not properly disseminated regarding dizziness visits, and this results in missed opportunities for effective and efficient care delivery.

The investigators propose a hybrid type 3 effectiveness-implementation trial to evaluate an enhanced BPPV-centric implementation strategy and clinical intervention. The overall strategy, initially developed in Dizziness Treatment through Implementation & Clinical strategy Tactics-1 (DIZZTINCT-1), will be improved to increase generalizability, convenience, exposures, sustainability, and dissemination. We use an innovative design of a stepped-wedge trial for the ED-level implementation strategy and an embedded randomized patient-level dissemination strategy. As a result, we can closely assess the individual and additive impact of study components. We will evaluate effectiveness of the implementation strategy and also confirm clinical outcomes.

Description:

Current management of dizziness in the ED often leads to expensive, time consuming, and unnecessary tests, but not appropriate evidence-based and guideline concordant evaluation & management. The Dix-Hallpike Test (DHT) and Canalith Repositioning Maneuver (CRM) are used to diagnose and treat Benign Paroxysmal Positional Vertigo (BPPV). BPPV processes have an evidence base that is at the clinical practice guideline level. The DHT is the gold standard test for DHT and the CRM is supported by numerous randomized controlled trials and systematic reviews. Gaze stabilization exercises are also evidence-based treatment for unilateral vestibulopathy.

The problem is that evidence based processes of care for dizziness visits are frequently underutilized.

An ED- level stepped wedge randomized clinical trial with an embedded patient- level randomized controlled dissemination strategy will be used to increase the use of evidence based care using a theory-based education intervention within a large integrated health care system.

The trial will begin with an initial no intervention period followed by a randomized staggered intervention at the 14 EDs in 11 waves (some medical centers will be paired based on the medical service area). The physician-based intervention consists of a recorded continuing medical education (CME) session, a mobile responsive website with the recommended algorithm of care, print materials (posters and note cards) and a dot phrase for dizziness. We will evaluate documentation of the DHT and CRM in approximately 80,000 dizziness visits.

Concurrently, eligible patients with a dizziness-related emergency department visit will be identified from the electronic medical records (EMR) system before and after the physician level intervention is implemented at each ED. Enrolled subjects will be randomized individually to the intervention or control arm using central computerized randomization. The patient-based intervention includes patient-oriented materials focused on evidence based care incorporated into a patient-specific website. We plan to have 800 patients for the analysis.

The primary outcome for the ED-level implementation strategy is DHT or CRM documentation. The primary outcome measure for the patient-level intervention is the Dizziness Handicap Inventory (DHI).

The overall potential public health impact of improved ED dizziness care is substantial based on the volume of visits, underuse of effective management, and inefficiencies from overuse of typically unnecessary tests.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18 years

• Dizziness diagnosis as the primary discharge diagnosis (ICD-10 codes: R42.xx "Dizziness"; H81.xx "Disorders of vestibular system" (e.g., BPPV, vestibular neuritis); H82.xx "Other vertiginous syndromes"; H83.xx "Other diseases of inner ear"; R26.0 "Ataxic gait"; R26.2 "Difficulty in walking"; R26.81 "Unsteadiness on feet"; R26.89 "Other abnormalities of gait"; R27.xx "Other lack of coordination"; A88.1 "Epidemic vertigo")

• Discharged home from ED or Observation from one of 14 Kaiser Permanente Southern California (KPSC) Emergency Departments within the last 48 hours (Enrolled population)

• Continuous health plan membership in the last 31 days prior to the encounter

• English or Spanish speaker

Exclusion Criteria:

• Prisoners

• Death

• Level 1 trauma diagnosis

• Previously enrolled in study

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

Related Conditions & MeSH terms

• BPPV
• Dizziness
• Vertigo
• Vestibular Diseases

Intervention

Behavioral:
• CME Educational Intervention
The educational materials for physicians include a recorded CME session, a mobile responsive website with the recommended algorithm of care, print materials (posters and note cards) and a dot phrase for dizziness.
• Study Developed Educational Materials for Patients
Patient-oriented materials are incorporated into a mobile responsive website with information/instruction about BPPV, and self-management resources; information/instruction on gaze stabilization exercises for vestibular neuritis

Locations

Country	Name	City	State
United States	Kaiser Permanente Southern California	Pasadena	California

Sponsors (4)

Lead Sponsor	Collaborator
Ohio State University	Kaiser Permanente, National Institute on Deafness and Other Communication Disorders (NIDCD), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of Dix-Hallpike Test/Canalith Repositioning Maneuver	To determine whether patient received a BPPV Care Process. Pre-CME vs Post CME. The primary endpoint is measured at the individual patient level and is the presence of documentation of either the Dix-Hallpike Test or the Canalith Repositioning Maneuver	Index ED 1 day visit
Primary	Dizziness Handicap Inventory	To assess patient dizziness disability over time. The primary endpoint is a patient reported outcome collected weekly for 4 weeks using computerized surveys.	Cumulative 4 weeks following index ED visit