Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001587291
Ethics application status
Approved
Date submitted
7/09/2018
Date registered
25/09/2018
Date last updated
25/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of introducing specialised vestibular physiotherapy in the Emergency Department - Dizzy PT
Scientific title
Feasibilty of introducing specialised vestibular physiotherapy in the Emergency Department: A pilot evaluation
Secondary ID [1] 295876 0
Nil known
Universal Trial Number (UTN)
U1111-1219-3299
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Benign paroxsymal positional vertigo (BPPV) 309341 0
Peripheral Vestibulopathy 309342 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308204 308204 0 0
Physiotherapy
Ear 308205 308205 0 0
Other ear disorders
Public Health 308206 308206 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention element of this project will involve a specialised vestibular trained Physiotherapist assessing and treating patients presenting to the emergency department with dizziness/vertigo/imbalance in the emergency department(ED). This is a novel service delivery approach. The intervention will be completed by a senior physiotherapist with more than 5 years experience and post-graduate training in vestibular physiotherapy. The intervention period will run for an 8 week block and the interventions will be performed in the ED. The assessment and subsequent treatments that patients will recieve are based upon the Clinical Practice Guideline: Benign Paroxysmal Positional Vertigo (Update) Bhattacharyya et al 2017. The interventions will consist of a one off assessment anticipated to be 30-60minutes in duration, with treatments as indicated by the assessment findings. Treatments that are likely to be provided included positioning techniques and rehabilitation exercise prescription. Patients will also be referred for follow-up assessments as per clinical practice guideline recommendations. Fidelity of interventions will be monitored by use of and recording on standardised assessment forms as well as a consistent interventional therapist.
Intervention code [1] 312210 0
Early detection / Screening
Intervention code [2] 312211 0
Treatment: Other
Comparator / control treatment
The control group for this study will be standard care sampled over an 8 week block prior to the intervention period. For the purposes of this study, standard care is defined as care currently being provided as a comparission to the implementation of guideline based care processes in the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 307180 0
Number of patients presenting to ED with symptoms of dizziness/vertigo/imbalance who are eligible, willing and able to participate in Vestibular Physiotherapy Assessment in the ED (as obtained from hospital records and physiotherapist case notes)
Timepoint [1] 307180 0
on presentation to ED
Primary outcome [2] 307181 0
Reasons for ineligibilty and inability to participate in Vestibular Physiotherapy Assessment (out of hours, NESB, declined, too symptomatic etc) - as obtained from hospital records and physiotherapist case notes
Timepoint [2] 307181 0
At initial contact with project team in ED
Secondary outcome [1] 351002 0
Representation to ED with in 5 days (as obtained from scanning hospital records)
Timepoint [1] 351002 0
At 5 days post ED presentation
Secondary outcome [2] 351003 0
Dizziness Handicap Inventory (DHI) scores
Timepoint [2] 351003 0
At 5 days post ED presentation
Secondary outcome [3] 351005 0
Number of patients returned to usual activity levels (Y/N question)
Timepoint [3] 351005 0
At 5 days post ED presentation
Secondary outcome [4] 351006 0
Patient satisfaction with clinical care provided (via 10 point VAS)
Timepoint [4] 351006 0
At 5 days post ED presentation
Secondary outcome [5] 351007 0
Number of patients requiring admission to inpatient ward and subsequent length of inpatient stay (composite outcome) - obtained from hospital records
Timepoint [5] 351007 0
At time of admission to ward/discharge from ward
Secondary outcome [6] 351008 0
Number of patients requiring specialized medical outpatient follow-up (other than GP) - as per medical records
Timepoint [6] 351008 0
At discharge from ED
Secondary outcome [7] 351009 0
Emergency Department length of stay (in hours) - obtained from EDIS hospital record system
Timepoint [7] 351009 0
At discharge from ED
Secondary outcome [8] 351010 0
Total number of patients undergoing CTB or MRI-B (composite outcome) - obtained from hospital medical records system
Timepoint [8] 351010 0
At discharge from ED
Secondary outcome [9] 351011 0
Number of patients with positive test result for BPPV treated with gold standard CRT (as documented in medical record)
Timepoint [9] 351011 0
At discharge from ED
Secondary outcome [10] 351012 0
Number of patients with documented positive test result for BPPV (as documented in medical records)
Timepoint [10] 351012 0
At discharge from ED
Secondary outcome [11] 351013 0
Number and proportion (%) of patients presenting with target symptoms who recieve gold standard assessments for BPPV (Dix Hallpike or Supine roll test) - as obtained from the medical records
Timepoint [11] 351013 0
At Discharge from ED
Secondary outcome [12] 351014 0
Total number of patients able to successfully complete vestibular physiotherapy assessment in ED ( as per physiotherapist records in medical records)
Timepoint [12] 351014 0
At discharge from ED
Secondary outcome [13] 351015 0
Reasons for non-completion of Physiotherapy asessment (NESB, out of hours, declined, too symptomatic etc) - as per physiotherpay documentation following contact with patient
Timepoint [13] 351015 0
At point of PT contact in ED
Secondary outcome [14] 351016 0
Direct costs of provision of Dizzy-PT service measured by clinician time spent assessing and treating patients
Timepoint [14] 351016 0
Project close out point
Secondary outcome [15] 351017 0
Total number of patients requiring interpreting services - as per clinician interaction with patients and/or documented in medical records
Timepoint [15] 351017 0
At discharge from ED
Secondary outcome [16] 351018 0
Number of patients able to be contacted by phone post-discharge
Timepoint [16] 351018 0
5 days post-discharge
Secondary outcome [17] 351019 0
Number of patients declining to participate in follow-up phone call - as part of consent process at point of phone follow up call
Timepoint [17] 351019 0
At 5 days post discharge
Secondary outcome [18] 351020 0
Number of patients who participate in follow-up physiotherapy assessment as taken from medical/physiotherapy records
Timepoint [18] 351020 0
30 days post discharge from ED

Eligibility
Key inclusion criteria
Presenting to Sunshine Emergency Department with symptoms of dizziness/vertigo/imbalance.
Inclusion in intervention arm will also require them to be present in ED during the clinician business hours (8am -4pm Monday - Friday)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients given a primary diagnosis by a medical officer at initial assessment (or thereafter) of a clear non-vestibular cause (e.g. a cardiac, endocrine, respiratory, psychological or central neurological event, disease or disorder).
2) Patient unable to understand instructions and willingly participate in vestibular assessment with the physiotherapist (whether due to language, cognition, symptoms or any other reason).
3) Patients not able to provide written informed consent (whether due to NESB, cognition, symptoms or any other reason)
4) Patients present in ED outside vestibular physiotherapy service hours

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a prospective pilot feasibility study, sample size will be opportunisitic across the dedicated sampling period.
As such analysis and statistical methodology will be primarily descriptive in nature, and will apply counts (proportions) for categorical data and mean (SD) or median [IQ range] for continuous data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
8/03/2019
Actual
Date of last data collection
Anticipated
8/04/2019
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11708 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 23789 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 300472 0
Hospital
Name [1] 300472 0
Western Health
Country [1] 300472 0
Australia
Primary sponsor type
Individual
Name
Melanie Lloyd
Address
Western Health
Sunshine Hospital
176 Furlong Road St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 299941 0
Individual
Name [1] 299941 0
Professor Anne-Maree Kelly
Address [1] 299941 0
c/o Joseph Epstein Centre for Emergency Medicine Research Centre
Western CHRE
Furlong Road St Albans VIC 3021
Country [1] 299941 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301274 0
Western Health Low Risk Human Ethics Panel
Ethics committee address [1] 301274 0
Western Health Office of Research
3rd Floor Western CHRE
176 Furlong Road St Albans VIC 3021
Ethics committee country [1] 301274 0
Australia
Date submitted for ethics approval [1] 301274 0
29/06/2018
Approval date [1] 301274 0
16/08/2018
Ethics approval number [1] 301274 0
HREC/18/WH/120

Summary
Brief summary
The Dizzy PT project is looking at the feasibility of a new model of service, whereby a vestibular trained Physiotherapist is able to assess and treat patients in the ED who are presenting with dizziness, vertigo or imbalance. The feasibility of this will be established by comparing the new model (intervention period) with current practice (control period). We hypothesise that not only will the new model of care be feasible, it will also provide better outcomes for these patients, and improve adherence to evidence-based best practice clinical care.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3047 3047 0 0
/AnzctrAttachments/375848-WH LR PICF Dizzy-PT control arm.doc (Participant information/consent)
Attachments [2] 3048 3048 0 0
/AnzctrAttachments/375848-WH LR PICF Dizzy-PT intervention arm.doc (Participant information/consent)
Attachments [3] 3049 3049 0 0
/AnzctrAttachments/375848-HREC18WH120 WH LREP Approval Letter_Kelly_Lloyd_16Aug18.pdf (Ethics approval)
Attachments [4] 3086 3086 0 0
/AnzctrAttachments/375848-Low Risk Ethics Protocol LREP version 3 FINAL.doc (Protocol)

Contacts
Principal investigator
Name 86450 0
Ms Melanie Lloyd
Address 86450 0
Sunshine Hospital 176 Furlong Road St Albans Victoria 3021
Country 86450 0
Australia
Phone 86450 0
+613 8345 6666
Fax 86450 0
Email 86450 0
[email protected]
Contact person for public queries
Name 86451 0
Ms Allison Luscombe
Address 86451 0
Sunshine Hospital
176 Furlong Road
St Albans Victoria 3021
Country 86451 0
Australia
Phone 86451 0
+613 8345 6666
Fax 86451 0
Email 86451 0
[email protected]
Contact person for scientific queries
Name 86452 0
Ms Melanie Lloyd
Address 86452 0
Sunshine Hospital 176 Furlong Road St Albans Victoria 3021
Country 86452 0
Australia
Phone 86452 0
+613 8345 6666
Fax 86452 0
Email 86452 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23672Informed consent form  [email protected]
23673Study protocol  [email protected] 375848-(Uploaded-12-09-2019-13-51-57)-Study-related document.doc

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4726Study results articleYes Lloyd et al 2020. Specialised Vestibular Physiothe... [More Details] 375848-(Uploaded-27-08-2020-12-18-46)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.