Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05634902
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-13
First Post:
2022-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation of Evidence-Based Practice for Dizziness
Sponsor:
Ohio State University
Organization:
Study Overview
Official Title:
Dizziness Treatment Through Implementation & Clinical Strategy Tactics
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIZZTINCT2
Brief 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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DC012760-08 | NIH | None | https://reporter.nih.gov/quic… | View |