Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evidence Based Best Care Practice for Benign Paroxysmal Positional Vertigo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02809599
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
William J Meurer, University of Michigan

Brief Summary:
The study evaluates a theory-based educational intervention and implementation strategy on the use of the Dix-Hallpike test (DHT) and Canalith Repositioning Maneuver (CRM) in a community Emergency Department (ED) setting. The DHT and CRM are used to diagnose and treat Benign Paroxysmal Positional Vertigo (BPPV).

Condition or disease Intervention/treatment Phase
Benign Paroxysmal Positional Vertigo Behavioral: DIZZTINCT Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7635 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Partnered Implementation of Evidence Based Best Care Practice for Benign Paroxysmal Positional Vertigo: A Stepped Wedge, Randomized Controlled Clinical Trial
Actual Study Start Date : October 13, 2016
Actual Primary Completion Date : April 14, 2018
Actual Study Completion Date : April 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Pre-intervention
Patients in hospitals that have not received the intervention (DIZZTINCT) and that meet eligibility criteria will have their medical charts abstracted to assess BPPV processes at the ED Index visit. A random sample of these patients will be contacted by phone for a brief phone interview regarding their recent visit to the Emergency Department for dizziness.
Experimental: Post-intervention
Patients in hospitals that have received the intervention (DIZZTINCT) and that meet eligibility criteria will have their medical charts abstracted to assess the main study outcome, behavior change in medical providers. A random sample of these patients will be contacted by phone for a brief phone interview regarding their recent visit to the Emergency Department for dizziness.
Behavioral: DIZZTINCT
The intervention, DIZZTINCT, is a multi-faceted educational and care-process based intervention designed to improve the guideline-concordant care of patients with BPPV in the emergency department. The intervention includes six main components: the recruitment and training of local champions who will serve as colleague experts in the community; interactive hands-on educational sessions that address BPPV mechanisms, evidence and practice; a high-yield decision-aid web application for self study and point of care use; development of a referral network for follow up care; follow-up educational sessions to review successes and barriers amongst the intervention group; and other resources developed locally in partnership with the community medical providers.




Primary Outcome Measures :
  1. Likelihood of Receiving a BPPV Care Process [ Time Frame: Index ED Visit (within hours to 2 days) ]
    Pre-intervention (no intervention) vs. post-intervention (under intervention).The primary endpoint is measured at the individual patient level, and is the presence of documentation of either the Dix-Hallpike test, the Epley Maneuver (or CRM) (since the first step of the CRM is the diagnostic maneuver).


Secondary Outcome Measures :
  1. Outpatient Referral to a BPPV Provider [ Time Frame: Index ED Visit (within hours to 2 days) ]
    Pre-intervention (no intervention) vs. post-intervention (under intervention) rate of referral to a BPPV provider

  2. 90-day Cumulative Incidence of Stroke [ Time Frame: 90 days following initial ED discharge home visit for dizziness ]
    Stroke diagnosed on the index dizziness visits and for post index visit strokes (delayed diagnosis) within the dizziness population aged 45 and older seen in EDs that have received the intervention versus patients seen in EDs that have not received the intervention.


Other Outcome Measures:
  1. Stroke at Index ED Dizziness Visit [ Time Frame: Index ED Visit (within hours to 2 days) ]
  2. ED Length of Stay [ Time Frame: Index ED Visit (within hours to 2 days) ]
  3. Neuroimaging utilization [ Time Frame: Index ED Visit (within hours to 2 days) ]
    Was CT, MRI, or vascular imaging performed in the ED

  4. Inpatient hospitalization Utilization [ Time Frame: Index ED Visit (within hours to 2 days) ]
    Was the patient admitted to the hospital from the ED



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ED patient seen at one of six full service non-freestanding Emergency Departments in Nueces County, Texas
  • Principal dizziness case: the triage reason for visit is a dizziness symptom OR a dizziness symptom is one of first three listed complaints in physician medical record OR a dizziness diagnosis (e.g., dizziness or vertigo NOS, BPPV, vestibular neuritis) is recorded as one of the first three final ED diagnoses.

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809599


Sponsors and Collaborators
University of Michigan
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Layout table for investigator information
Principal Investigator: Kevin A Kerber, MD University of Michigan
Principal Investigator: William Meurer, MD University of Michigan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: William J Meurer, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02809599     History of Changes
Other Study ID Numbers: HUM00109306
R01DC012760 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by William J Meurer, University of Michigan:
vertigo
dizziness
Additional relevant MeSH terms:
Layout table for MeSH terms
Vertigo
Benign Paroxysmal Positional Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders