Clinical Trial: Evidence Based Best Care Practice for Benign Paroxysmal Positional Vertigo

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Partnered Implementation of Evidence Based Best Care Practice for Benign Paroxysmal Positional Vertigo: A Stepped Wedge, Randomized Controlled Clinical Trial

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).

Detailed Summary:

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
Sponsor: University of Michigan

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: June 16, 2016
Date Started: September 2016
Date Completion: February 2018
Last Updated: June 17, 2016
Last Verified: June 2016