Implementation of Evidence-Based Practice for Dizziness
DIZZTINCT2
Dizziness Treatment Through Implementation & Clinical Strategy Tactics
2 other identifiers
interventional
90,135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2022
CompletedFirst Submitted
Initial submission to the registry
November 23, 2022
CompletedFirst Posted
Study publicly available on registry
December 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedApril 30, 2026
April 1, 2026
2.3 years
November 23, 2022
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (6)
Group 1: Pre-CME with Patient Education
EXPERIMENTALPhysicians in hospitals that have not received the DIZZTINCT educational intervention. Patients have received the DIZZTINCT educational intervention
Group 2: Pre-CME with Standard Patient Care
NO INTERVENTIONPhysicians in hospitals that have not received the DIZZTINCT educational intervention. Patients have not received the DIZZTINCT educational intervention
Group 3: Pre-CME with Chart Review Only
NO INTERVENTIONPhysicians in hospitals that have not received the DIZZTINCT educational intervention. Eligible patient will have their medical records abstracted to assess the main study outcome
Group 4: Post-CME with Patient Education
EXPERIMENTALPhysicians in hospitals that have received the DIZZTINCT educational intervention. Patients have receive the DIZZTINCT educational intervention
Group 5: Post-CME with Standard Patient Care
EXPERIMENTALPhysicians in hospitals that have received the DIZZTINCT educational intervention. Patients have not receive the DIZZTINCT educational intervention
Group 6: Post-CME with Chart Review Only
EXPERIMENTALPhysicians in hospitals that have received the DIZZTINCT educational intervention. Eligible patient will have their medical records abstracted to assess the main study outcome
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- National Institute on Deafness and Other Communication Disorders (NIDCD)collaborator
- Kaiser Permanentecollaborator
- University of Michigancollaborator
Study Sites (1)
Kaiser Permanente Southern California
Pasadena, California, 91101, United States
Related Publications (1)
Meurer WJ, Park S, Nguyen H, Paz SR, Jancis MO, Bacerdo J, Baecker AS, Manthena P, Sangha NS, Zheng C, An LC, Fife TD, Sharp AL, Burke JF, Kerber KA. DIZZiness treatment through implementation and clinical strategy Tactics-2 (DIZZTINCT-2) project-a clinical trial protocol. Trials. 2025 Sep 29;26(1):378. doi: 10.1186/s13063-025-09055-7.
PMID: 41024017DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Kerber, MD
Ohio State University
- PRINCIPAL INVESTIGATOR
Will Meurer, MD
University of Michigan
- PRINCIPAL INVESTIGATOR
Huong Nguyen, PhD
Kaiser Permanente
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Co-Director of Health Services Research
Study Record Dates
First Submitted
November 23, 2022
First Posted
December 2, 2022
Study Start
November 11, 2022
Primary Completion
February 28, 2025
Study Completion
March 31, 2025
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- We plan to submit data to the repository approximately one year after the primary manuscript of the trial is accepted for publication
- Access Criteria
- We plan to make the data publicly available in accordance with approval and regulations of Kaiser Permanente and the funding Institute. The location of study data repository will be arranged with the Institute and Kaiser Permanente. The public use dataset will be stripped of any and all personal identifiers and will undergo a deidentification process. Our HIPAA compliant de-identification plan is to remove study identification (ID) numbers and assignment of a random number to each subject/visit, delete facility numbers and assignment of a random number to each facility, delete any investigator or assessor name/ID, delete the randomization date but retain the month and year and the order of visits and enrollment, and convert when necessary dates and times to the number of days/minutes from the date and time of randomization. Derived variables necessary to reproduce the primary analysis will be included.
The investigators are committed to resource and data sharing with the clinical research community. Optimally effective data sharing is carefully planned. The specific contents and strategy for creating and sharing a public use dataset will be established at the beginning of the trial, rather than at the end. The primary results of the study will be disseminated by publication in the peer reviewed medical literature. In accordance with the NIH Public Access Policy, the investigators will submit an electronic version of their final, peer-reviewed manuscripts (directly or through the publisher) to the National Library of Medicine's PubMed Central, no later than 12 months after the official date of publication. The trial will be registered with http://www.ClinicalTrials.gov, and results of the study will be reported there within a year of study completion.