Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02809599
Other study ID # HUM00109306
Secondary ID R01DC012760
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2016
Est. completion date April 16, 2018

Study information

Verified date April 2019
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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.

The problem is that BPPV processes are substantially underutilized.

This study looks to increase the use of BPPV processes within a community ED setting by implementing a theory-based educational intervention. The unit of randomization and target of intervention is the hospital. After an initial observation period, the six community hospitals will undergo the intervention in five waves (the smallest two hospitals will be paired). The order will be randomized. This is a partnered research project with local physicians engaging in best practice implementation.

Sample Size

The trial will start with an initial no intervention period of approximately 4 months followed by randomized staggered intervention with a new hospital entering approximately every 2 months, finalized by approximately 4 post-intervention months will result in the approximately balanced number of 867 visits occurring without intervention and 933 visits occurring under (post) intervention. This calculation assumes the average anticipated total patient visit rate of 100 patients per month. Based on our pilot studies and the literature we expect the DHT or CRM procedure to be done in 5% patients before the intervention. With the expected number of visits calculated above, we will be able to detect the increased DHT or CRM rate of 9% and above with 90% power by a two-sided test at the significance level of 5%. We expect a much bigger difference of 5% vs. 20% pre- vs. post-intervention DHT/CRM rates, respectively. Under this expected difference, we will have the power exceeding 99%. In fact, an order of magnitude smaller visit rate of 10.4 patients per month would be sufficient for 90% power under the anticipated difference. The reserves of power will be used to provide more power to fine-tune the multivariate mixed regression models and associated secondary analyses.

Data Analyses

The intervention is delivered to hospitals. Intervention is a binary variable with two levels, pre-intervention (no intervention), post-intervention (under intervention).

The primary analysis will use binary logistic regression and will include covariates for hospital, month (to handle secular trends), and intervention (see below). For a set of new patient visits, the binary random variable DHT/CRM/referral yes/no will serve as the primary response. Patient visits will be supplied with patient-, hospital- and provider-level covariates as well as the calendar time variable modeling the secular trend, and the intervention yes/no variable measuring whether the visit occurs under intervention or not. To take hospital- and provider-specific unmeasured features into account, hospital and provider categorical variables will be included in the analysis. Due to the fact that the number of hospitals and providers is much smaller than the number of patient visits, adjusting for hospital and provider effects by way of categorical variables will not lead to bias. Secondary analyses will explore alternative approaches using random effects (Gaussian) models. A two-sided model-based test for the intervention variable will be used to test the primary hypothesis at the significance level of 5%.

The secondary analysis (safety) will numerically summarize the 90-day stroke rate - cumulatively and stratified for stroke diagnosed on the index dizziness visits and for post index visit strokes (delayed diagnosis) in patients seen at EDs with and without the intervention. This is anticipated to be very rare. The intervention does not target improving stroke diagnosis. However, evaluating both the index visit stroke diagnosis rate and the delayed diagnosis rate should allow for determination of major changes. We anticipate the index visit stroke diagnosis rate to be approximately 2% and the delayed diagnosis rate approximately to be 1%.


Recruitment information / eligibility

Status Completed
Enrollment 7635
Est. completion date April 16, 2018
Est. primary completion date April 14, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institute on Deafness and Other Communication Disorders (NIDCD)

Outcome

Type Measure Description Time frame Safety issue
Other Stroke at Index ED Dizziness Visit Index ED Visit (within hours to 2 days)
Other ED Length of Stay Index ED Visit (within hours to 2 days)
Other Neuroimaging utilization Was CT, MRI, or vascular imaging performed in the ED Index ED Visit (within hours to 2 days)
Other Inpatient hospitalization Utilization Was the patient admitted to the hospital from the ED Index ED Visit (within hours to 2 days)
Primary 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 Outpatient Referral to a BPPV Provider Pre-intervention (no intervention) vs. post-intervention (under intervention) rate of referral to a BPPV provider Index ED Visit (within hours to 2 days)
Secondary 90-day Cumulative Incidence of Stroke 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. 90 days following initial ED discharge home visit for dizziness
See also
  Status Clinical Trial Phase
Completed NCT03425786 - Benign Paroxysmal Positional Vertigo (BPPV) Training for Sports Medicine Providers in a Pediatric Concussion Program N/A
Completed NCT02046980 - Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo Phase 2
Withdrawn NCT00978809 - Effects of Physical Treatment on Postural Stability in Benign Paroxysmal Positional Vertigo (BPPV) Patients N/A
Completed NCT02029508 - The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo Phase 3
Completed NCT03230513 - Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms N/A
Completed NCT03643354 - Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes N/A
Completed NCT00641797 - Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients N/A
Recruiting NCT06001047 - Head Acupuncture Treat Residual Symptoms After Canalith Repositioning Procedure for BPPV N/A
Not yet recruiting NCT04578262 - Epley Manoeuvre in Participants With Multiple Sclerosis Diagnosed From Benign Paroxysmal Positional Vertigo N/A
Not yet recruiting NCT04578470 - Benign Paroxysmal Positional Vertigo (BPPV) in Older Patients Phase 2
Completed NCT05748249 - Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence Phase 1
Active, not recruiting NCT06314581 - Effect of a Multifaceted Educational Intervention on the Implementation of Evidence-based Practices for Benign Paroxysmal Positional Vertigo in an Emergency Department
Completed NCT04715282 - The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV) N/A
Terminated NCT03161470 - Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV) N/A
Completed NCT05425199 - Habituation Exercises Versus Proprioceptive Training in Benign Paroxysmal Positional Vertigo N/A
Recruiting NCT05922774 - Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo
Recruiting NCT05013684 - Benign Paroxysmal Positional Vertigo in Older Adults N/A
Not yet recruiting NCT05863949 - Clinical Trial of Vit D and Calcium for Recurrent BPPV N/A
Completed NCT05127694 - Treatment In Acute Benign Paroxysmal Positional Vertigo N/A
Suspended NCT04026516 - CAVA: Dizziness Trial N/A