Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000428965
Ethics application status
Approved
Date submitted
9/03/2020
Date registered
31/03/2020
Date last updated
2/06/2023
Date data sharing statement initially provided
31/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A comprehensive analysis of implementing a triaging phase to the foot and ankle orthopaedic service: a pragmatic randomised controlled trial
Scientific title
A comprehensive analysis of implementing a triaging phase to the foot and ankle orthopaedic service: a pragmatic randomised controlled trial
Secondary ID [1] 300590 0
Nil known
Universal Trial Number (UTN)
U1111-1248-5017
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot pain 316323 0
Ankle pain 316652 0
Condition category
Condition code
Musculoskeletal 314591 314591 0 0
Other muscular and skeletal disorders
Public Health 314592 314592 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pragmatic randomised controlled trial (RCT) design will be used, with a cross-over waiting-list group. Participants will be allocated with either Group (1): immediate access to the podiatry-triage clinic, or Group (2): 6-month waiting-list allocation prior to accessing the podiatry-triage clinic.

A podiatry-led triage clinic will be provided to participants. This is a pragmatic intervention, where the podiatrist will undertake assessments (clinical and radiographic) provide non-surgical treatments (e.g. physical therapy, footwear modification, orthoses, injections) aimed at managing a specific complaint, rather than a standardised treatment. The intervention will be recorded, and may include no treatment. The podiatrist’s responsibilities will be to evaluate the participant, provide a diagnosis and provide non-surgical treatments where indicated. Participants will be discharged from the orthopaedic waiting-list, with their consent if; (i) their symptoms resolve with non-surgical treatment, (ii) their condition is not amenable to surgical intervention, or (iii) they do not want surgery. Participants will be referred for an orthopaedic consultation if; (i) there is no indication for non-surgical treatment, (ii) they fail non-surgical treatment, or (iii) they request an appointment with a surgeon following their triage appointment(s).

The frequency of the assessment and intervention will be determined by the condition being managed during the 6-month period. Each appointment will be scheduled for 30 minutes.
Intervention code [1] 316895 0
Treatment: Other
Intervention code [2] 316896 0
Treatment: Devices
Intervention code [3] 316897 0
Rehabilitation
Comparator / control treatment
Participants allocated to the waiting-list control (Group 2) will remain on the waiting-list for 6-months. No treatment will be provided for their referred complaint by the orthopaedic department during this time.
Control group
Active

Outcomes
Primary outcome [1] 322924 0
Manchester-Oxford Foot/Ankle Questionnaire
Timepoint [1] 322924 0
Group 1: Baseline, T1 (6-months post allocation), T2 (12-months post allocation)

Group 2: Baseline, T1 (6-months post allocation), T2 (12-months post allocation)

T1 is primary timepoint.
Secondary outcome [1] 380243 0
Numerical rating scale (for pain)
Timepoint [1] 380243 0
Group 1: Baseline, T1 (6-months post allocation), T2 (12-months post allocation)

Group 2: Baseline, T1 (6-months post allocation), T2 (12-months post allocation)
Secondary outcome [2] 380244 0
Patient-Reported Outcomes Measurement Information System (PROMIS) Profile-29
Timepoint [2] 380244 0
Group 1: Baseline, T1 (6-months post allocation), T2 (12-months post allocation)

Group 2: Baseline, T1 (6-months post allocation), T2 (12-months post allocation)
Secondary outcome [3] 380245 0
Patient Health Questionnaire-4 (PHQ-4)
Timepoint [3] 380245 0
Group 1: Baseline, T1 (6-months post allocation), T2 (12-months post allocation)

Group 2: Baseline, T1 (6-months post allocation), T2 (12-months post allocation)
Secondary outcome [4] 380246 0
Patient global impression of change (PGIC)
Timepoint [4] 380246 0
Group 1: T1 (6-months post allocation), T2 (12-months post allocation)

Group 2: T1 (6-months post allocation), T2 (12-months post allocation)
Secondary outcome [5] 380248 0
Incremental cost-effectiveness ratio (ICER) for the triage clinic compared with no triage clinic

Resource use will be calculated from clinic costs (room use and medical imaging)
Out-of-pocket costs for participants will be calculated using a study-specific survey
QALYs will be calculated from EQ-5D-5L
Timepoint [5] 380248 0
Group 1: T1 (6-months post allocation), T2 (12-months post allocation)

Group 2: T1 (6-months post allocation), T2 (12-months post allocation)
Secondary outcome [6] 380505 0
Adverse events experienced during the study period, including (but not limited to); new painful episodes, injuries, thromboses, infections and hospitalisations will be recorded in a study log. Change in medication use, out-of-range laboratory values, adverse events and withdrawals due to adverse events will be recorded and categorised according to the likelihood that they are related to the study intervention.
Timepoint [6] 380505 0
Throughout the study period

Eligibility
Key inclusion criteria
i) Referred to see foot/ankle orthopaedic surgeon
ii) Categorised as non-urgent following paper triage by orthopaedic surgeon
iii) Aged >= 18 years
iv) Report foot pain of >= 3/10 on a 0-10 rating scale on most days for >=3 months.
v) Willing to see a podiatrist at Gold Coast University Hospital (either immediately or after 6-months)
vi) Willing to complete questionnaires at 6-months and 12-months post group allocation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) History of cognitive impairment,
ii) An inability to understand English or an inability to provide consent.

In relation to participants having “adequate English”, this will be determined during the initial screening process. In accordance with contemporary research, two Single-Item Literacy Screening (SILS) questions will be asked during the screening interviews:

1. How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy? (Never, Rarely, Sometimes, Often, Always)

2. How confident are you filling out medical forms by yourself? (Not at all, A little bit, Somewhat, Quite a bit, Extremely)

Patients who answer “Sometimes”, “Often”, “Always” to the first question and “Somewhat”, “A little bit”, “Not at all” to the second question will be excluded from this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to the intervention and control groups. Randomisation will be achieved via central randomisation in a password-protected web-based service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Waiting-list controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Aim 1 – foot pain
Comparisons will be made between the change in foot pain, between baseline and 6-month follow-up for the two groups (immediate clinical triage or delayed clinical triage). Measures at 6-months will be analysed using a linear mixed model, with group, participants and baseline measures as fixed factors, a random effect and covariate, respectively. Consistent with the Consolidated Standards of Reporting Trials (CONSORT) guidelines, an intention-to-treat approach will be taken.

Additionally, descriptive statistics will be used to summarise the characteristics of the participants. All data distributions will be explored for normality (visualization and Shapiro-Wilk normality test) to determine the suitability of parametric or nonparametric statistical tests. Between groups differences will be analysed using the independent samples t-test, or the Mann-Whitney U test depending on normality. Gender counts will be compared using the chi-squared test.

Furthermore, differences in age and IRSD between the participants and those that declined to participate will be analysed using the independent samples t-test, or the Mann-Whitney U test depending on normality. Gender counts will be compared using the chi-squared test.

Aim 2 – cost-effectiveness
The cost effectiveness analysis will be conducted using within-trial analysis. The incremental cost-effectiveness ratio (ICER) for the triage clinic compared with no triage clinic will be calculated based on cost/QALY. The cost of the podiatry clinic will be measured from a health system perspective and will be based on clinician wages (podiatrist) and administrative wages in addition to participant specific use of medical imaging and consumables. The podiatrist will be employed 0.2 FTE and appointment times will be standardised. All costs will be measured in 2022 Australian dollars. The health-related utility values from the ED-5D-5L will be used to calculate the QALYs. The model that will be used to assess cost-effectiveness will be a decision tree with a time horizon of 12-months. Uncertainty analysis will be assessed using probabilistic uncertainty analysis as one-way and multi-way uncertainty analysis. The ICER will be assessed as cost-effective based on willingness to pay of $64,000/QALY. The number of appointments for each patient and the discharge rate will be counted and reported descriptively.

In all analyses, a p-value (two-sided) less than 0.05 will be deemed to be statistically significant. All data will be analysed with SPSS v26.0 or Stata 15.

Aim 3 – chronic musculoskeletal pain domains
The within-group change in pain, physical function, psychological health and sleep, will be analysed using paired t-tests or Wilcoxon signed-rank test, depending on normality.

Sample size calculation
The PASS sample size software was used to determine an a priori power analysis for this study. Using a one tail-test of independent groups at a significance level of p < 0.05 and a power of 80%, 59 participants per group are required to detect a clinically significant reduction in foot pain (13 points), assuming a standard deviation of 25.1. Accounting for up to a 20% attrition rate, a total sample size of 148 participants (74 in each group) has been calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2020
Actual
1/02/2021
Date of last participant enrolment
Anticipated
Actual
9/08/2021
Date of last data collection
Anticipated
11/07/2022
Actual
6/10/2022
Sample size
Target
148
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 15981 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 29472 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 305011 0
Hospital
Name [1] 305011 0
Gold Coast Health Collaborative Research Grant Scheme
Country [1] 305011 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Blvd
Southport, QLD, 4215
Country
Australia
Secondary sponsor category [1] 305716 0
None
Name [1] 305716 0
Address [1] 305716 0
Country [1] 305716 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305408 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 305408 0
Ethics committee country [1] 305408 0
Australia
Date submitted for ethics approval [1] 305408 0
09/03/2020
Approval date [1] 305408 0
08/05/2020
Ethics approval number [1] 305408 0
62096
Ethics committee name [2] 305451 0
QUT University Human Research Ethics Committee
Ethics committee address [2] 305451 0
Ethics committee country [2] 305451 0
Australia
Date submitted for ethics approval [2] 305451 0
30/04/2020
Approval date [2] 305451 0
22/05/2020
Ethics approval number [2] 305451 0
2000000367

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

Contacts
Principal investigator
Name 100278 0
Dr Simon Platt
Address 100278 0
Department of Orthopaedics
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Country 100278 0
Australia
Phone 100278 0
+61 1300 744 284
Fax 100278 0
Email 100278 0
[email protected]
Contact person for public queries
Name 100279 0
Tom Walsh
Address 100279 0
Office for Research Governance and Development, Gold Coast Hospital and Health Service 1 Hospital Blvd Southport QLD 4215
Country 100279 0
Australia
Phone 100279 0
+61 7 5687 8310
Fax 100279 0
Email 100279 0
[email protected]
Contact person for scientific queries
Name 100280 0
Tom Walsh
Address 100280 0
Office for Research Governance and Development, Gold Coast Hospital and Health Service 1 Hospital Blvd Southport QLD 4215
Country 100280 0
Australia
Phone 100280 0
+61 7 5687 8310
Fax 100280 0
Email 100280 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
After trial completion with no end date determined
Available to whom?
Researchers upon reasonable request
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.