Implementation of Evidence-Based Practice for Dizziness
NCT ID: NCT05634902
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
80000 participants
INTERVENTIONAL
2022-11-11
2025-03-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Group 1: Pre-CME with Patient Education
Physicians in hospitals that have not received the DIZZTINCT educational intervention.
Patients have received the DIZZTINCT educational intervention
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
Group 2: Pre-CME with Standard Patient Care
Physicians in hospitals that have not received the DIZZTINCT educational intervention.
Patients have not received the DIZZTINCT educational intervention
No interventions assigned to this group
Group 3: Pre-CME with Chart Review Only
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
No interventions assigned to this group
Group 4: Post-CME with Patient Education
Physicians in hospitals that have received the DIZZTINCT educational intervention.
Patients have receive the DIZZTINCT educational intervention
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
Group 5: Post-CME with Standard Patient Care
Physicians in hospitals that have received the DIZZTINCT educational intervention.
Patients have not receive the DIZZTINCT educational intervention
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.
Group 6: Post-CME with Chart Review Only
Physicians in hospitals that have received the DIZZTINCT educational intervention.
Eligible patient will have their medical records abstracted to assess the main study outcome
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.
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Kaiser Permanente
OTHER
University of Michigan
OTHER
Ohio State University
OTHER
Responsible Party
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Kevin Kerber
Professor, Co-Director of Health Services Research
Principal Investigators
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Kevin Kerber, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Will Meurer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Huong Nguyen, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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Kaiser Permanente Southern California
Pasadena, California, United States
Countries
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References
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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.
Other Identifiers
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KPSC IRB 12548
Identifier Type: -
Identifier Source: org_study_id
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