Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000699662
Ethics application status
Approved
Date submitted
16/05/2023
Date registered
30/06/2023
Date last updated
18/08/2024
Date data sharing statement initially provided
30/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Educational interventions targeting Management of Benign paroxysmal positional vertigo in the Emergency Department
Scientific title
Pre- and post-intervention retrospective chart review of dizzy patients presenting to ED to assess performance rates of the Dix-Hallpike manoeuvre
Secondary ID [1] 309408 0
None
Universal Trial Number (UTN)
Trial acronym
EMBED study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign paroxysmal positional vertigo 329752 0
Dizziness 329753 0
Condition category
Condition code
Emergency medicine 326643 326643 0 0
Other emergency care
Ear 327062 327062 0 0
Other ear disorders
Neurological 327063 327063 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is an observational study. These exposures were rolled out regardless of this study. This study is a retrospective chart review not providing an intervention.

1. Three hour dizziness workshop
This workshop was delivered from 10:00am to 1:00pm on Thursday 11th May during ED Registrar teaching in meeting room 2H/I in the Emergency Department at Royal North Shore Hospital (RNSH).

The workshop was made up of two separate components, a 2-hr didactic and 1-hr practical section presented by the Emergency Department, Physiotherapy and Neurology staff members who were involved with EMBED.

The 2-hr didactic component was made up of a PowerPoint presentation titled “Acute dizziness in the ED”. This presentation delivered a comprehensive approach to acute dizziness and introduces the EMBED Study clinical decision tool. During this presentation ED Trainees and FACEMs learned about dizziness syndromes, how to recognise and differentiate between posterior strokes, vestibular neuritis and BPPV. To facilitate knowledge acquisition and retention, a pre-education case-based quiz was conducted followed by discussion of the same cases during the presentation.

2. Clinical decision support tool, EMBED study flowchart
The clinical decision support tool was made available for ED doctors to use when seeing a patient with dizziness. It has been made available on the ED Intranet and NSLHD Intranet Neurology sub-section. Flowchart development was iterative with feedback from both the Emergency Department and the Neurology Department. Use of this tool/flowchart was introduced during the dizziness workshop delivered on 11th May. The case-based discussions during the presentation served as an opportunity to utilise the flowchart with practical examples.

3. Auto Text (Template) on FirstNet
Auto Text is a function available on FirstNet (electronic medical record solution used by NSW Health) to assist with medical documentation. The EMBED investigators formulated a template to be used by ED doctors to assist them with documentation of their vestibular assessment. This template was also introduced during the dizziness workshop delivered on 11th May.

4. Dizziness local champions & super-users
An expression of interest was gathered from the senior registrar group on the 10th of March 2023 with the aim of training a group of super-users to become local champions for dizziness education.

Over a 6-week period, ten senior registrars were provided further training and assessed by the vestibular physiotherapists in the performance and interpretation of provocative manoeuvres for BPPV. Each super-user attended two sessions as part of this training.

The first session involved a competency assessment of the ability to perform BPPV manoeuvres

The second session involved interpretation of examination findings to identify the different causes of dizziness such as posterior stroke, vestibular neuritis and BPPV. This session utilised audio-visual resources demonstrating the different pathologies and comprised of case-based discussions surrounding each case.

The purpose of the senior ED registrar vertigo superuser group is to develop a core group of ED doctors who are passionate about assessment of acute dizziness and to sustain the educational innovation. The superuser group is encouraged to provide ongoing teaching to junior ED doctors and disseminate their knowledge at the bedside in the appropriate clinical context.
Intervention code [1] 325905 0
Diagnosis / Prognosis
Comparator / control treatment
Pre-intervention/exposure group (Period 1) will be compared with the post-intervention/exposure group (Period 2).

Period 1 will be 6th February 2023 to 7th May 2023.
Period 2 will be 8th May 2023 to 6th August 2023.
Control group
Historical

Outcomes
Primary outcome [1] 334513 0
Performance rate of provocative manoeuvres – Dix-Hallpike (DH) test (%)

Manual audit of patient electronic medical records will be used to assess this outcome.
Timepoint [1] 334513 0
6th February 2023 to 7th May 2023 compared to 8th May 2023 to 6th August 2023
Secondary outcome [1] 420962 0
Performance rate of provocative manoeuvres – Supine Head Turn (SHT) test (%)

Manual audit of patient electronic medical records will be used to assess this outcome.
Timepoint [1] 420962 0
6th February 2023 to 7th May 2023 compared to 8th May 2023 to 6th August 2023
Secondary outcome [2] 422441 0
The following outcomes will be determined from a manual audit of patient electronic medical records.

Compliance rate to BPPV guidelines (Bhattacharyya et al., 2017) if DH/SHT diagnostic of BPPV
o Managed by canalith repositioning manoeuvres (CRM) (%)
o Re-assessment post CRM (%)
o Provided with BPPV education (%)
o Vestibular suppressant without CRM (%)
o Use of neuroimaging (%)
Timepoint [2] 422441 0
6th February 2023 to 7th May 2023 compared to 8th May 2023 to 6th August 2023
Secondary outcome [3] 422442 0
Hospital admission rate (%)

Manual audit of patient electronic medical records will be used to assess this outcome.
Timepoint [3] 422442 0
6th February 2023 to 7th May 2023 compared to 8th May 2023 to 6th August 2023
Secondary outcome [4] 422443 0
Hospital length of stay (days)

Manual audit of patient electronic medical records will be used to assess this outcome.
Timepoint [4] 422443 0
6th February 2023 to 7th May 2023 compared to 8th May 2023 to 6th August 2023
Secondary outcome [5] 422444 0
Cost of hospital presentations ($AUD)

Manual audit of patient electronic medical records will be used to assess this outcome.
Timepoint [5] 422444 0
6th February 2023 to 7th May 2023 compared to 8th May 2023 to 6th August 2023
Secondary outcome [6] 422445 0
Safety outcome – Represent in less than 7 days (with same complaint) (%)

Manual audit of patient electronic medical records will be used to assess this outcome.
Timepoint [6] 422445 0
6th February 2023 to 7th May 2023 compared to 8th May 2023 to 6th August 2023
Secondary outcome [7] 422446 0
Safety outcome – Stroke <90 days from original visit (%)

Manual audit of patient electronic medical records will be used to assess this outcome.
Timepoint [7] 422446 0
6th February 2023 to 7th May 2023 compared to 8th May 2023 to 6th August 2023

Eligibility
Key inclusion criteria
• Age >18
• Pre-intervention = Period 1 (6th February 2023 to 7th May 2023)
• Post-intervention = Period 2 (8th May 2023 to 6th August 2023)

AND

• ED SNOMED CT diagnosis code of one of the following
o Benign paroxysmal positional vertigo
o Benign paroxysmal positional vertigo nystagmus
o Dizziness
o Dizziness and giddiness
o Dizziness of unknown cause
o Dizzy spells
o Epidemic vertigo
o Lightheadedness
o Peripheral positional vertigo
o Peripheral vertigo
o Positional vertigo
o Postural dizziness
o Vertigo
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Dizziness attributed to isolated non-neurological or non-vestibular cause
• No ED documentation available for retrospective review

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
The primary outcome is the documented performance rate of Dix-Hallpike. Therefore, the sample size determination will be carried out based on a test for differences in the proportion of Dix-Hallpike performance rate between the pre-and post-intervention periods. The baseline estimate of the performance rate of Dix-Hallpike is assumed as 20% given the broad inclusion criteria. A study by Neely, P. et al (2023) indicated an improvement of 27% (from 60% to 87%) in the performance of Dix-Hallpike after an educational intervention. For the sample size determination, we are assuming a conservative improvement of 15% in the performance rate.

The sample size analysis indicated that at 0.05 level of significance and 0.80 power, a total of 200 subjects must be enrolled (100 per group) to detect a difference of 15% in the performance rate of provocative manoeuvres between the pre-and post-intervention periods. The study sample size is therefore set as 200 (100 per group).

Analysis of a pilot study (n = 50), we found 46% met the exclusion criteria, thus 54% remained for analysis. From another analysis, we identified approximately 180-200 patients met the inclusion criteria in each 13-week period in 2022. Therefore, to achieve a sample size of 100 in each group as per the sampling size calculations, we have estimated a 13-week period for data collection for each group.

The data will be summarized and presented as the mean and standard deviation for symmetrically distributed data, median and interquartile range (IQR) for skewed or categorical data, and proportions with 95% confidence intervals.

The primary outcome is the performance rate of provocative manoeuvres - Dix-Hallpike. A Chi-square test (or Fisher’s exact test to account for sparse distribution of data if any) will be used to test the difference in performance rates between pre- and post-intervention periods.

A binary linear mixed effect model based on the logistic link function will be used and odds ratio effect measure along with 95% confidence intervals will be computed to quantify the change over time (pre- to post-intervention). First, an unadjusted model will be fitted and tested, followed by estimating and testing the effect after adjusting for covariates.

The analysis of the primary outcome will be based on the intention-to-treat (ITT) principle. Missing values will be reported and for the primary outcome analysis, the missing values will be handled using multiple imputation analysis methods using Monte-Carlo Markov-Chain (MCMC) method.

The secondary outcomes will be analysed. The performance rate of provocative manoeuvres – SHT will be compared using a generalised linear mixed model based on the logistic link function. Similarly, changes in each factor of the compliance to BPPV guidelines (if DH/SHT diagnostic of BPPV) will be tested using a generalised linear mixed model.
Hospital admission rates will be compared using the Chi-square test (Fisher’s exact test to account for the sparse distribution of data if any). The length of hospital stay will be compared using Wilcoxon’s rank-sum test. The safety data will be summarized using descriptive statistical measures.

All statistical tests will be performed at an overall significance level of .05. The statistical analysis will be performed using R, SPSS version 27.0 or STATA, version 17.0.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/08/2023
Actual
8/09/2023
Date of last participant enrolment
Anticipated
Actual
8/09/2023
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
200
Accrual to date
Final
499
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24556 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 40150 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 313603 0
Hospital
Name [1] 313603 0
Royal North Shore Hospital, Northern Sydney Local Health District
Country [1] 313603 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital, Northern Sydney Local Health District
Address
Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 315393 0
None
Name [1] 315393 0
Address [1] 315393 0
Country [1] 315393 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312779 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 312779 0
Ethics committee country [1] 312779 0
Australia
Date submitted for ethics approval [1] 312779 0
16/05/2023
Approval date [1] 312779 0
11/07/2023
Ethics approval number [1] 312779 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125886 0
Dr George She
Address 125886 0
Emergency Department Research Fellow
Emergency Department, Level 2, Acute Services Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 125886 0
Australia
Phone 125886 0
+61 02 9463 2256
Fax 125886 0
Email 125886 0
[email protected]
Contact person for public queries
Name 125887 0
George She
Address 125887 0
Emergency Department Research Fellow
Emergency Department, Level 2, Acute Services Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 125887 0
Australia
Phone 125887 0
+61 02 9463 2256
Fax 125887 0
Email 125887 0
[email protected]
Contact person for scientific queries
Name 125888 0
George She
Address 125888 0
Emergency Department Research Fellow
Emergency Department, Level 2, Acute Services Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 125888 0
Australia
Phone 125888 0
+61 02 9463 2256
Fax 125888 0
Email 125888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.