Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000130167p
Ethics application status
Submitted, not yet approved
Date submitted
17/01/2019
Date registered
29/01/2019
Date last updated
13/03/2019
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of A Fast Track Giant Cell Arteritis Clinic in Western Australia
Scientific title
Clinical and cost effectiveness of a Fast Track Giant Cell Arteritis (GCA) Clinic in Western Australia compared with standard management of patients clinically suspected to have GCA
Secondary ID [1] 297049 0
Nil known
Universal Trial Number (UTN)
U1111-1226-5764
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Giant Cell Arteritis 311040 0
Condition category
Condition code
Inflammatory and Immune System 309684 309684 0 0
Other inflammatory or immune system disorders
Cardiovascular 309898 309898 0 0
Diseases of the vasculature and circulation including the lymphatic system
Eye 309899 309899 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to assess the effectiveness of a Fast Track Giant Cell Arteritis (GCA) Clinic in Western Australia, in terms of both health outcomes for patients and healthcare cost savings. Patients suspected of having GCA will be seen in the Fast Track Clinic (FTC) within approximately 72 hours of referral. The FTC will initially service the East and South Metropolitan Health Services of Western Australia. Patients will be assessed by a consultant rheumatologist during an approximately 60 minute clinic appointment. This will include history, physical examination, questionnaires, blood tests, and ultrasound of the temporal, occipital, axillary +/- carotid arteries. Ultrasound is expected to take between 15 - 30 minutes depending on operator. All patients will then be seen by ophthalmology within one week for bilateral temporal artery biopsy. Full ophthalmological assessment will be performed more urgently if visual symptoms are present. The overall aim is to assess validity of ultrasound in replacing biopsy as the primary diagnostic investigation in GCA. If this approach is proven valid, costs will be deducted accordingly to demonstrate health care savings if biopsy were not routinely required. PET scan will also be organised for a subgroup of patients to assess burden of vasculitis at baseline and explore the relationship between GCA and cardiovascular events. Patients with confirmed GCA will be commenced or continued on treatment with corticosteroids as per the Australian Therapeutic Guidelines. There will be repeat appointments at the Fast Track Clinic at week 2, week 4, week 12, and week 24. At these visits, assessment will again include history, physical examination, ultrasound, blood tests, and questionnaires for patient reported outcomes. Repeat PET scan will be arranged at the 24 week appointment for the PET subgroup.
Intervention code [1] 313325 0
Treatment: Other
Comparator / control treatment
Analysis of 12 months of retrospective data (pre-intervention) from the same health services will be used as the comparator. Usual management for the presumed diagnosis of GCA may include an inpatient stay, temporal artery biopsy, corticosteroid therapy, and referral to ophthalmology. Data including clinical parameters (inflammatory markers, time to diagnosis, rate of complications) as well as associated costs will be collected and compared to that of the Fast Track Clinic.
Control group
Historical

Outcomes
Primary outcome [1] 318657 0
The Fast Track GCA Clinic data will be analysed in comparison to retrospective pre-intervention data to assess cost difference to the state healthcare system (Western Australian Department Of Health) within 12 months. This includes costs (in AUD) incurred from inpatient bed stays, readmissions, temporal artery biopsies and stay extending complications.
Timepoint [1] 318657 0
12 months post intervention commencement
Secondary outcome [1] 365599 0
The Fast Track GCA Clinic data will be analysed to compare clinical parameters with the restrospective control group, including: time to diagnosis of GCA (days from referral).
Timepoint [1] 365599 0
12 months post intervention commencement
Secondary outcome [2] 365600 0
The Fast Track GCA Clinic data will be analysed to compare clinical parameters with the retrospective group, including: time to normalisation of inflammatory markers (CRP < 5 mg/L, ESR < 20 mm/hr)
Timepoint [2] 365600 0
12 months post intervention commencement
Secondary outcome [3] 366219 0
The Fast Track GCA Clinic data will be analysed to compare clinical parameters with the pre-intervention group, including frequency of visual loss (%)
Timepoint [3] 366219 0
12 months post intervention commencement
Secondary outcome [4] 366220 0
The Fast Track GCA Clinic data will be analysed to compare diagnostic certainty based on temporal artery ultrasound with temporal artery biopsy results. If proven to be diagnostically valid (equal or superior to temporal artery biopsy), the cost of temporal artery biopsy will be deducted from overall clinic costs to demonstrate cost reductions using temporal artery ultrasound without biopsy in the future.
Timepoint [4] 366220 0
12 months post intervention commencement

Eligibility
Key inclusion criteria
Clinical suspicion of giant cell arteritis, including but not limited to: new onset headaches / localised pain in the head, scalp tenderness, swelling over the temporal artery, pain over the temporal artery, jaw claudication, tongue claudication, reduced or lost vision, double vision and amaurosis fugax, anorexia, fatigue, fever/night sweats,
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 50 years
Unable to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
31/10/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12869 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 12870 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 25344 0
6000 - Perth
Recruitment postcode(s) [2] 25345 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 301618 0
Government body
Name [1] 301618 0
Department of Health Western Australia
Country [1] 301618 0
Australia
Funding source category [2] 301623 0
Other Collaborative groups
Name [2] 301623 0
Goatcher Clinical Research Unit
Country [2] 301623 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Murray Street
Perth WA
6000
Country
Australia
Secondary sponsor category [1] 301321 0
None
Name [1] 301321 0
Address [1] 301321 0
Country [1] 301321 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302344 0
Royal Perth Hospital Human Research Committee
Ethics committee address [1] 302344 0
Level 2, Kirkman House
Royal Perth Hospital
10 Murray Street, Perth
Western Australia 6000
AUSTRALIA
Ethics committee country [1] 302344 0
Australia
Date submitted for ethics approval [1] 302344 0
30/01/2019
Approval date [1] 302344 0
Ethics approval number [1] 302344 0

Summary
Brief summary
Giant Cell Arteritis (GCA) is a condition of inflammation of blood vessels which commonly affects the blood supply to the eyes. Left undetected, GCA can rapidly cause irreversible blindness. Other potential complications include stroke, aortic dissection and death. Therefore, early diagnosis and intervention is imperative.

Traditionally, diagnosis has relied on early suspicion of the disease, urgent review by a physician and an ophthalmologist, along with a surgical procedure (temporal artery biopsy). Following diagnosis of the disease, prompt treatment with potent immune suppressant medication is required.

Biopsies are a relatively expensive procedure with a low positive yield. Additionally, biopsies can often take weeks to organise, but treatment needs to be given relatively urgently, so delay in obtaining biopsy means that diagnosis can be obscured by the treatment. Better ways of screening and managing patients are needed.

Recently, international models of care have recommended an alternative approach to deliver assessment and care for GCA through “Fast Track” GCA Clinics, which have demonstrated improved outcomes for patients. These are collaborative clinics between rheumatologists and ophthalmologists that provide clinical review followed by assessment using ultrasound imaging of the arteries instead of biopsy. This approach avoids hospital admission but produces quick, accessible and reliable diagnostic yield and only a subgroup will require progression to biopsy.

Fast Track GCA Clinics have not yet been implemented in the Australian health care setting. We aim to establish a collaborative Fast Track GCA Clinic in Western Australia and demonstrate direct health care savings, validity of ultrasound at the primary diagnostic tool over temporal artery biopsy, improved clinical outcomes for patients, and further the research agenda in this relatively common, potentially devastating, but treatable condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89898 0
Dr Julia Murdoch
Address 89898 0
Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 89898 0
Australia
Phone 89898 0
+61 861522222
Fax 89898 0
Email 89898 0
[email protected]
Contact person for public queries
Name 89899 0
Dr Julia Murdoch
Address 89899 0
Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 89899 0
Australia
Phone 89899 0
+61 861522222
Fax 89899 0
Email 89899 0
[email protected]
Contact person for scientific queries
Name 89900 0
Dr Julia Murdoch
Address 89900 0
Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 89900 0
Australia
Phone 89900 0
+61 861522222
Fax 89900 0
Email 89900 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
Decision may be changed as trial progresses.


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23711Study protocol  [email protected]
23712Ethical approval  [email protected]
23713Ethical approval  [email protected]

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
4742Other filesNo Murdoch J, Tedja C, Taylor A, DeSousa J, Francis R... [More Details]
4743Conference abstractNo Murdoch J, Taylor A, DeSousa J, Jao K, Keen H. 12-... [More Details]
4744Study results articleYes Mathake M, Murdoch J, DeSousa JL, Taylor A, Keen H... [More Details]

Documents added automatically
No additional documents have been identified.