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. 2025 Sep 29;26(1):378.
doi: 10.1186/s13063-025-09055-7.

DIZZiness treatment through implementation and clinical strategy Tactics-2 (DIZZTINCT-2) project-a clinical trial protocol

William J Meurer  1 , Stacy Park  2 , Huong Nguyen  2 , Silvia R Paz  3 , Molly O Jancis  4 , Julliane Bacerdo  5 , Aileen S Baecker  3 , Prasanth Manthena  6 , Navdeep S Sangha  7 , Chengyi Zheng  2 , Lawrence C An  8 , Terry D Fife  9 , Adam L Sharp  10 , James F Burke  11 , Kevin A Kerber  11
Affiliations

DIZZiness treatment through implementation and clinical strategy Tactics-2 (DIZZTINCT-2) project-a clinical trial protocol

William J Meurer et al. Trials. .

Abstract

Background: The evaluation and management of acute vertigo presentations is challenging for both patients and physicians. Benign paroxysmal positional vertigo (BPPV), acute unilateral vestibulopathy (e.g., vestibular neuritis), and stroke are priority diagnostic considerations in this circumstance. Existing evidence can be used to guide the diagnosis and treatment, however high value care opportunities-such as the Dix-Hallpike test (DHT), canalith repositioning maneuver (CRM), and gaze stabilization exercises (GSE)-are often underused, while neuroimaging studies are often overused.

Methods: This trial contains a health system focused stepped wedge intervention and an embedded individually patient randomized clinical trial. The study will start with a 6-month pre-intervention period. This will be followed by staggered intervention at the engaged EDs in 11 waves and then an approximately 6-month post-intervention period. Concurrently, patients will be recruited before and after the physician level intervention is implemented at each ED. Enrolled participants will complete baseline survey and then be randomized individually, stratified by sex, age, and medical center, to the intervention or control arm patient materials using central computerized randomization. The intervention arm will be sent intervention materials and the control arm will be sent the hospital's standard post-discharge materials. The primary outcome of the physician-based part of the trial is use of evidence-based care practices during the index ED visit. The primary outcome of the patient focused part of the trial is the dizziness handicap index over 4 weeks.

Discussion: The DIZZTINCT-2 trial addresses key areas of uncertainty in how to improve the care of emergency department patients with acute vertigo. In addition, follow up data on how much and how fast patients improved was needed. DIZZTINCT-2 will address these key knowledge gaps efficiently.

Trial registration: Clinicaltrials.gov NCT05634902. Registered on November 2022.

Keywords: Emergency department; Randomized controlled trial; Stepped-wedge; Vertigo.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate {24}: The trial received initial approval on September 10th, 2020. Consent for publication {32}: We provide the model consent form in the supplemental material. Competing interests {28}: The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The Dix-Hallpike test
Fig. 2
Fig. 2
An overview of the timeline of ED (specific aim 1) and participant level (specific aim 2) interventions
See this image and copyright information in PMC

References

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