Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001434583
Ethics application status
Approved
Date submitted
12/11/2024
Date registered
9/12/2024
Date last updated
9/12/2024
Date data sharing statement initially provided
9/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of point-of-care ultrasound conducted by physiotherapists for the diagnosis of ankle syndesmosis injuries in the acute care setting: an economic evaluation
Scientific title
The feasibility of point-of-care ultrasound conducted by physiotherapists for the diagnosis of ankle syndesmosis injuries in the acute care setting: an economic evaluation
Secondary ID [1] 313368 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FOCUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syndesmosis injury 335725 0
Condition category
Condition code
Public Health 332293 332293 0 0
Health service research
Musculoskeletal 332292 332292 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients that have sustained an acute ankle injury (within seven days of their presentation) and meet the eligibility criteria will be recruited to the study. Consenting participants will be assigned to either the point of care ultrasound (POCUS) group or usual care group. Participant recruitment will be non-randomised, with convenience sampling based on the availability of a POCUS trained Emergency Physiotherapy Practitioner (EPP). If a POCUS trained EPP is available and if a musculoskeletal sonographer is available on the day or the following day, the participant will be assigned to the POCUS group. A POCUS trained EPP will be available on 92% of rostered shifts between the hours 0800 to 1800, therefore we expect no difficulties recruiting to the POCUS intervention. If a POCUS trained EPP is unavailable (e.g. not rostered, out of hours) and a musculoskeletal sonographer is unavailable on the day or the following day, they will be assigned to the usual care group. Participants in the usual care group can be seen by any treating clinician (i.e. doctor, nurse practitioner, EPP not POCUS trained).

All participants in the POCUS group will receive both POCUS by the EPP and a focused radiology ultrasound by a musculoskeletal sonographer. The EPP POCUS scan will be performed on a GE Venue (or equivalent ultrasound machine) and the sonographers will perform the same scan on their standard machine (Philips Epic Elite). The EPP POCUS assessment and sonography ultrasound will happen within their 4 hours of their presentation to the emergency department.

Patients that have an anterior inferior tibiofibular ligament (AITFL) injury on radiology ultrasound will be referred for Magnetic Resonance Imaging (MRI) and will be referred to orthopaedic fracture clinic for follow up. The MRI will be completed as an outpatient scan at the Wynnum or Cleveland Queensland xray clinics. These scans will take 15 minutes to 1 hour. The MRI scan will be performed by a radiographer and reported by a radiologist. This scan will be recommended to be performed within 1 week of leaving the emergency department. The patients will be seen at the fracture clinic within 2 weeks of their emergency department presentation. Patients that do not have an AITFL injury on radiology ultrasound will be seen in a physiotherapy soft tissue clinic at two weeks.

Adherence to the interventions will be monitored by the principal investigator or research assistant via their electronic medical record, which displays their appointments and scans they have attended. Patients that have not attended their MRI scan, fracture clinic appointment or soft tissue clinic will receive a call from the principal investigator or research assistant to determine the reason. If patients have not attended their fracture clinic or physiotherapy soft tissue clinic appointments, they will be offered another appointment as per the hospital fail to attend policy. Patient's will be discharged from the service if they fail to attend two appointments.
Intervention code [1] 329951 0
Treatment: Other
Intervention code [2] 329950 0
Diagnosis / Prognosis
Comparator / control treatment
All patients recruited to the control arm of the study will receive treatment as directed by their treating clinician (doctor, nurse practitioner or EPP not POCUS trained). Standard care for patients that sustain acute ankle injuries that present to the ED does not involve a POCUS assessment by a physiotherapist or a radiology ultrasound. Standard care for patients that are suspected to have syndesmosis injuries are referred to fracture clinic and the orthopaedic team can organise an MRI if they feel it is indicated. ED clinicians often recommend to patients that are suspected to have syndesmosis injuries that they get their GP to organise an ankle MRI to expedite the process of getting an MRI. Ultrasounds are also commonly organised by GPs following an ankle sprain. Standard care for acute ankle injuries routinely involves the recommendation for physiotherapy follow up, however this is not routinely offered by the hospital services unless there are certain concerns about the patient accessing private follow up or concerns about the severity of their injury.
Control group
Active

Outcomes
Primary outcome [1] 339864 0
An economic evaluation (cost-utility analysis) will be undertaken from a government perspective. Data from both cohorts supported with audit data and estimates from the literature, will be used to populate a decision tree analysis comparing usual care against the POCUS group intervention. This will be assessed as a composite primary outcome, namely an incremental cost-utility ratio (cost per Quality-Adjusted Life Year - QALY).
Timepoint [1] 339864 0
Quality of life will be assessed at baseline and 3 months post their initial presentation at either the Emergency Department or the Minor Injury and Illness Clinic. This assessment may be extrapolated to 2 years if evidence from the literature is available on longer-term costs and outcomes.
Secondary outcome [1] 442402 0
Pain visual analogue Scale (VAS) results between POCUS group and usual care will be compared at baseline, 1 month and 3 months post injury,
Timepoint [1] 442402 0
Pain VAS results will be assessed at baseline, one month post initial visit and three months post initial visit.
Secondary outcome [2] 442401 0
Foot and ankle disability index (FADI) results between POCUS group and usual care will be assessed at baseline, 1 month and 3 months post injury
Timepoint [2] 442401 0
FADI results will be assessed at baseline, initial visit, one month post initial visit and three months post initial visit.
Secondary outcome [3] 442400 0
The economic evaluation (cost-utility analysis) will be undertaken from a societal perspective (rather than government, as per the primary outcome) as a secondary analysis. Data from both cohorts, supported with audit data and estimates from the literature, will be used to populate a decision tree analysis comparing usual care against the POCUS group intervention. This will be assessed as a composite secondary outcome, namely an incremental cost-utility ratio (cost per Quality-Adjusted Life Year – QALY).
Timepoint [3] 442400 0
Quality of life will be assessed at baseline and 3 months post their initial presentation at either the Emergency Department or the Minor Injury and Illness Clinic, this assessment may be extrapolated to 2 years if evidence from the literature is available on longer-term costs and outcomes.

Eligibility
Key inclusion criteria
• Adults greater than or equal to 18 years presenting to the Redlands Emergency Department or Redland Satellite Hospital Minor Injury Illness Clinic
• Symptomatic acute (within 7 days) traumatic ankle injury with clinical examination suggestive of syndesmosis injury
- Positive anterior inferior tibiofibular ligament palpation test, and/or
- Positive dorsiflexion lunge test
• No other major injuries that require inpatient management or urgent surgical intervention
• No fracture identified on x-ray (except for avulsion fractures around the ankle joint)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Clinical examination shows negative AITFL palpation test and dorsiflexion lunge test
• Open injury (i.e. open wound)
• Ankle fracture or dislocations (except for avulsion fracture)
• Previous surgery to the ankle
• Neurovascular compromise
• Osteoarthritis of ankle
• Diabetic neuropathy
• Active rheumatological joint disease
• Non-English speaking patients without an available translator (e.g. phone interpreter or family member / friend)
• Ultrasound or MRI has already been completed in the community
• Patients with contraindication to MRI (e.g. pacemaker)
• unable to provide informed consent

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A budget impact analysis will be undertaken from a government perspective, with a secondary analysis taking a societal perspective. Data from both cohorts, supported with audit data and estimates from the literature, will be used to populate a decision tree analysis comparing usual care, with a subgroup analysis of nurse practitioner and/or doctor led care versus non POCUS trained EPP care, against the POCUS group intervention. The outcomes of interest will be a self-reported outcome measure indicating if further care is required, following the ED diagnosis and ongoing sequalae. This is in addition to the pain VAS, FADI and quality of life (QOL) outcomes of interest collected at baseline and post-discharge surveys.
Service costs will be available from Queensland Health and broader treatment costs will be based on patient health care resource survey results at 1-month and 3-months, including general practitioner (GP) or private specialist visits, private physiotherapy visits, ultrasound and/or medical imaging undertaken, medication or equipment (e.g. moonboot) costs, any other out of pocket costs and productivity losses. The cost of surgery and misdiagnosis (due to more intensive treatment) will be estimated from the data collected in the surveys and audits. The time horizon of the within trial analysis will be 3 months, which may be extrapolated to 2 years if evidence from the literature is available on longer-term costs and outcomes. Net monetary benefit will be calculated, assuming implied Australian willingness-to-pay thresholds. Uncertainty will be accounted for through sensitivity analyses including worst case/best case analysis, univariate and multivariate sensitivity analyses and Monte-Carlo simulation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
268
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 43414 0
4163 - Cleveland

Funding & Sponsors
Funding source category [1] 317808 0
Charities/Societies/Foundations
Name [1] 317808 0
Emergency Medicine Foundation
Country [1] 317808 0
Australia
Primary sponsor type
Government body
Name
Metro South
Address
Country
Australia
Secondary sponsor category [1] 320138 0
None
Name [1] 320138 0
Address [1] 320138 0
Country [1] 320138 0
Other collaborator category [1] 283296 0
University
Name [1] 283296 0
University of Queensland
Address [1] 283296 0
Country [1] 283296 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316491 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 316491 0
Ethics committee country [1] 316491 0
Australia
Date submitted for ethics approval [1] 316491 0
12/09/2024
Approval date [1] 316491 0
11/11/2024
Ethics approval number [1] 316491 0
HREC/2024/QMS/105217

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

Contacts
Principal investigator
Name 138066 0
Mrs Laura Hayes
Address 138066 0
Redland Hospital, 21 Weippin Street, Cleveland, QLD, 4163
Country 138066 0
Australia
Phone 138066 0
+61 7 3488 4046
Fax 138066 0
Email 138066 0
[email protected]
Contact person for public queries
Name 138067 0
Laura Hayes
Address 138067 0
Redland Hospital, 21 Weippin Street, Cleveland, QLD, 4163
Country 138067 0
Australia
Phone 138067 0
+61 7 3488 4046
Fax 138067 0
Email 138067 0
[email protected]
Contact person for scientific queries
Name 138068 0
Laura Hayes
Address 138068 0
Redland Hospital, 21 Weippin Street, Cleveland, QLD, 4163
Country 138068 0
Australia
Phone 138068 0
+61 7 3488 4046
Fax 138068 0
Email 138068 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• The data can be made available to researchers upon reasonable request and this will be on a case-by-case basis at discretion.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the individual participant data collected during the trial, after de-identification, may be shared upon reasonable request.

What types of analyses could be done with individual participant data?
• The data will be available for any research with methodologically sound proposal.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately after publication and ending at 15 years following main results publication, as recommended by the NHMRC.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access to the data will be subject to approval by the principal investigator and Metro South Research. Please contact the principal investigator at [email protected].

Are there extra considerations when requesting access to individual participant data?
No


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.