NCT02809599

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,635

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 13, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

June 16, 2016

Last Update Submit

April 16, 2019

Conditions

Keywords

vertigodizziness

Outcome Measures

Primary Outcomes (1)

  • Likelihood of Receiving a BPPV Care Process

    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).

    Index ED Visit (within hours to 2 days)

Secondary Outcomes (2)

  • Outpatient Referral to a BPPV Provider

    Index ED Visit (within hours to 2 days)

  • 90-day Cumulative Incidence of Stroke

    90 days following initial ED discharge home visit for dizziness

Other Outcomes (4)

  • Stroke at Index ED Dizziness Visit

    Index ED Visit (within hours to 2 days)

  • ED Length of Stay

    Index ED Visit (within hours to 2 days)

  • Neuroimaging utilization

    Index ED Visit (within hours to 2 days)

  • +1 more other outcomes

Study Arms (2)

Pre-intervention

NO 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.

Post-intervention

EXPERIMENTAL

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

Interventions

DIZZTINCTBEHAVIORAL

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.

Post-intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kerber KA, Damschroder L, McLaughlin T, Brown DL, Burke JF, Telian SA, Tsodikov A, Fagerlin A, An LC, Morgenstern LB, Forman J, Vijan S, Rowell B, Meurer WJ. Implementation of Evidence-Based Practice for Benign Paroxysmal Positional Vertigo in the Emergency Department: A Stepped-Wedge Randomized Trial. Ann Emerg Med. 2020 Apr;75(4):459-470. doi: 10.1016/j.annemergmed.2019.09.017. Epub 2019 Dec 20.

  • Meurer WJ, Beck KE, Rowell B, Brown D, Tsodikov A, Fagerlin A, Telian SA, Damschroder L, An LC, Morgenstern LB, Ujhely M, Loudermilk L, Vijan S, Kerber KA. Implementation of evidence-based practice for benign paroxysmal positional vertigo: DIZZTINCT- A study protocol for an exploratory stepped-wedge randomized trial. Trials. 2018 Dec 22;19(1):697. doi: 10.1186/s13063-018-3099-0.

MeSH Terms

Conditions

Benign Paroxysmal Positional VertigoVertigoDizziness

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSensation Disorders

Study Officials

  • Kevin A Kerber, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • William Meurer, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 22, 2016

Study Start

October 13, 2016

Primary Completion

April 14, 2018

Study Completion

April 16, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share