BPPVDIZZTINCT2NCT05634902
Implementation of Evidence-Based Practice for Dizziness
A study testing CME Educational Intervention and Study Developed Educational Materials for Patients in people with BPPV and Vestibular Diseases, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BPPV, Vestibular Diseases, Vertigo
- What is being tested?
- CME Educational Intervention and Study Developed Educational Materials for Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90,135 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Southern California
Pasadena, California, 91101
About this study
Official title: Dizziness Treatment Through Implementation & Clinical Strategy Tactics
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.
Read the 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.
- Conditions
- BPPV, Vestibular Diseases, Vertigo, Dizziness
- Being tested
- CME Educational Intervention, Study Developed Educational Materials for Patients
- Medical subject headings
- Vestibular Diseases, Vertigo, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CME Educational InterventionBehavioural
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 PatientsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pre-CME with Patient Education | Experimental | Physicians in hospitals that have not received the DIZZTINCT educational intervention.
Patients have received the DIZZTINCT educational intervention Receives: Behavioral: Study Developed Educational Materials for Patients |
| Group 2: Pre-CME with Standard Patient Care | No intervention | Physicians 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 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 |
| Group 4: Post-CME with Patient Education | Experimental | Physicians in hospitals that have received the DIZZTINCT educational intervention.
Patients have receive the DIZZTINCT educational intervention Receives: Behavioral: CME Educational Intervention; Behavioral: Study Developed Educational Materials for Patients |
| Group 5: Post-CME with Standard Patient Care | Experimental | Physicians in hospitals that have received the DIZZTINCT educational intervention.
Patients have not receive the DIZZTINCT educational intervention Receives: Behavioral: CME Educational Intervention |
| Group 6: Post-CME with Chart Review Only | Experimental | Physicians in hospitals that have received the DIZZTINCT educational intervention.
Eligible patient will have their medical records abstracted to assess the main study outcome Receives: Behavioral: CME Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Cumulative 4 weeks following index ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start11 Nov 2022
- Primary completion28 Feb 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BPPVStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90,135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Kaiser Permanente, University of Michigan
- Responsible party
- Principal investigator, Kevin Kerber, Ohio State University
- Investigators
- Kevin Kerber, MD, Principal investigator, Ohio State UniversityWill Meurer, MD, Principal investigator, University of MichiganHuong Nguyen, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634902
- Sponsor's protocol ID
- KPSC IRB 12548
- Other IDs
- R01DC012760-08
- Acronym
- DIZZTINCT2
- Status last verified
- Apr 2026
- First submitted
- 23 Nov 2022
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41024017
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dizziness Treatment Through Implementation & Clinical Strategy Tactics
- ClinicalTrials.gov ID
- NCT05634902
- Acronym / sponsor ID
- DIZZTINCT2 / KPSC IRB 12548
- Conditions
- BPPV, Vestibular Diseases, Vertigo, Dizziness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90,135 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Kaiser Permanente, University of Michigan
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pre-CME with Patient Education | Experimental | Behavioral: Study Developed Educational Materials for PatientsPhysicians 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 intervention | –Physicians 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 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 |
| Group 4: Post-CME with Patient Education | Experimental | Behavioral: CME Educational Intervention, Behavioral: Study Developed Educational Materials for PatientsPhysicians in hospitals that have received the DIZZTINCT educational intervention. Patients have receive the DIZZTINCT educational intervention |
| Group 5: Post-CME with Standard Patient Care | Experimental | Behavioral: CME Educational InterventionPhysicians 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 | Experimental | Behavioral: CME Educational InterventionPhysicians in hospitals that have received the DIZZTINCT educational intervention. Eligible patient will have their medical records abstracted to assess the main study outcome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CME Educational InterventionThe 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. | Behavioural | Group 4: Post-CME with Patient Education, Group 5: Post-CME with Standard Patient Care, Group 6: Post-CME with Chart Review Only |
| Study Developed Educational Materials for PatientsPatient-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 | Behavioural | Group 1: Pre-CME with Patient Education, Group 4: Post-CME with Patient Education |
Primary outcome
Documentation of Dix-Hallpike Test/Canalith Repositioning Maneuver
Time frame: Index ED 1 day visit
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
Dizziness Handicap Inventory
Time frame: Cumulative 4 weeks following index ED visit
To assess patient dizziness disability over time. The primary endpoint is a patient reported outcome collected weekly for 4 weeks using computerized surveys.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 41024017Meurer 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for BPPV
Recruiting
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Not yet recruiting
Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
Benign Paroxysmal Positional Vertigo (BPPV)
Enrolling by invitationObservational study
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
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Not yet recruiting
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
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Active, not recruiting
Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme
Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Kerber, MD principal investigator
Ohio State University
Will Meurer, MD principal investigator
University of Michigan
Huong Nguyen, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CME Educational Intervention and Study Developed Educational Materials for Patients in people with BPPV and Vestibular Diseases, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documentation of Dix-Hallpike Test/Canalith Repositioning Maneuver (time frame: Index ED 1 day visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05634902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.