Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000947505
Ethics application status
Approved
Date submitted
24/07/2024
Date registered
5/08/2024
Date last updated
5/08/2024
Date data sharing statement initially provided
5/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
WAIT-less: The effectiveness of a physiotherapist-led triage and treatment service on WAITing time for adults with musculoskeletal pain referred to Australian public hospital outpatient physiotherapy clinics.
Scientific title
WAIT-less – Targeting WAITing times with stratified blended physiotherapy for adults with musculoskeletal pain: a randomised control trial
Secondary ID [1] 312293 0
None
Universal Trial Number (UTN)
U1111-1305-9431
Trial acronym
WAIT-less Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal condition 334025 0
Condition category
Condition code
Musculoskeletal 330695 330695 0 0
Other muscular and skeletal disorders
Public Health 330696 330696 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Initial contact with patients referred to the outpatient physiotherapy clinic will be made as soon as possible after a referral is received by a screening physiotherapist via telephone. During this call, patients will be invited to participate in the trial, and will be asked to complete the study consent form and the baseline assessment. A second phone call will inform patients of their group allocation. For participants randomised to the physiotherapist-led triage and treatment service, the screening physiotherapist will match them to different modes and types of care during the call informing them of their trial arm allocation.

Physiotherapist-led Triage and Treatment Service (Intervention Group)
Participants at low risk of poor outcome (Keele STarT MSK tool score 0-4 and absence of potential non-progressive radiculopathy) will be offered brief advice and education via telephone with a physiotherapist. This advice and education (including advice on activity modification, analgesia if necessary and education that condition has a good prognosis) will be provided during the phone call where participants are informed of their trial arm allocation. Participants in this treatment subgroup will be asked to call the screening physiotherapist back if their symptoms have not improved in 6 weeks. Participants will be discharged from the outpatient physiotherapy service if no contact is received after 6 weeks. Participants at medium-risk of poor outcome (Keele STarT MSK tool score 5-8 with absence of potential non-progressive radiculopathy) or requiring post-operative rehabilitation will be offered physiotherapy via telehealth. An appointment with a telehealth physiotherapist will be organised by the screening physiotherapist during the phone call where participants are informed of their trial arm allocation. The duration and frequency of the appointment with the telehealth physiotherapist will be at the discretion of the treating physiotherapist. Telehealth physiotherapy will consist of assessment, advice, education to support self-management, and a tailored home exercise program (via the PhysioTherapy Exercise App - PTX). Physiotherapy treatment forms will be used to monitor adherence and session attendance. Participants at high-risk of poor outcome (Keele STarT MSK tool score 9-12) and/or as having potential non-progressive radiculopathy will be offered a course of clinic-based (in-person) physiotherapy as is usually provided at the participating public hospital clinics. Clinic-based physiotherapy may include a combination of any advice and education to support self-management (e.g., advice to exercise, modify activities, lose weight, or take simple pain medications if needed), exercise tailored to patients’ activity goals and level of function, graded activity, graded exposure, and manual therapy. The duration and frequency of the clinic-based physiotherapy appointments will be at the discretion of the treating physiotherapist. Physiotherapy treatment forms will also be used to monitor adherence and clinic-based session attendance.
Intervention code [1] 328756 0
Rehabilitation
Comparator / control treatment
Usual clinic-based care (control group):
After the screening physiotherapist informs participants of their trial arm allocation, they will join the clinic waiting list for the next available clinic-based appointment with a physiotherapist. Clinic-based physiotherapy will be provided as is usually provided at the participating public hospital clinics. Clinic-based physiotherapy may include a combination of any advice and education to support self-management (e.g., advice to exercise, modify activities, lose weight, or take simple pain medications if needed), exercise tailored to patients’ activity goals and level of function, graded activity, graded exposure, and manual therapy. The duration and frequency of the clinic-based appointments will be at the discretion of the treating physiotherapist. Participants in either group can be referred to a specialist pain clinic or to see a psychologist if the treating physiotherapist believes it would be valuable.
All trial activities across both trial arms will be conducted within weekday business hours.
Control group
Active

Outcomes
Primary outcome [1] 338449 0
Function at 6-months
Timepoint [1] 338449 0
At 6-months post-randomisation.
Primary outcome [2] 338477 0
Treatment waiting time (days)
Timepoint [2] 338477 0
At the first appointment with a study physiotherapist post-randomisation.
Secondary outcome [1] 435986 0
Average pain intensity over the last 24-hours
Timepoint [1] 435986 0
Every 2 weeks until 12 months, following randomisation.
Secondary outcome [2] 435987 0
Time to recovery (time in days): Time in days from randomisation to the first day of 7 consecutive days with <2/10 average pain.
Timepoint [2] 435987 0
Every 2 weeks until 12 months, following randomisation.
Secondary outcome [3] 435988 0
Patient-reported outcome - Quality of life
Timepoint [3] 435988 0
At 3-, 6-, and 12-months post-randomisation.
Secondary outcome [4] 435989 0
Risk of poor outcomes
Timepoint [4] 435989 0
At 3-, 6-, and 12-months post-randomisation.
Secondary outcome [5] 435990 0
Satisfaction with care
Timepoint [5] 435990 0
At 3-, 6-, and 12-months post-randomisation.
Secondary outcome [6] 435991 0
Number of clinic-based appointments (health resource use)
Timepoint [6] 435991 0
At 4-weeks, 3-, 6-, and 12-months post-randomisation.
Secondary outcome [7] 435992 0
Number of telehealth appointments (health resource use)
Timepoint [7] 435992 0
At 4-weeks, 3-, 6-, and 12-months post-randomisation.
Secondary outcome [8] 435993 0
Physiotherapy appointment duration (health resource use)
Timepoint [8] 435993 0
At every physiotherapy appointment
Secondary outcome [9] 435994 0
Did not attend rate (health resource use)
Timepoint [9] 435994 0
At the conclusion of study
Secondary outcome [10] 435995 0
Healthcare use (health resource use)
Timepoint [10] 435995 0
At 3-, 6-, and 12-months post-randomisation
Secondary outcome [11] 435996 0
Healthcare use Medicare Benefit Scheme (MBS) - (health resource use)
Timepoint [11] 435996 0
At 12-months post randomisation.
Secondary outcome [12] 435997 0
Medication use (health resource use)
Timepoint [12] 435997 0
At 3-, 6-, and 12-months post-randomisation
Secondary outcome [13] 435998 0
Medication use Pharmaceutical Benefit Scheme (PBS) - (health resource use)
Timepoint [13] 435998 0
At 12-months post randomisation.
Secondary outcome [14] 435999 0
Pain self-efficacy (mediator outcome)
Timepoint [14] 435999 0
At 4-week post-randomisation.
Secondary outcome [15] 436000 0
Recovery expectations (mediator outcome)
Timepoint [15] 436000 0
At 4-week post-randomisation.
Secondary outcome [16] 436001 0
Reassurance condition is not serious (mediator outcome)
Timepoint [16] 436001 0
At 4-week post-randomisation.
Secondary outcome [17] 436002 0
Reassurance activity is safe (mediator outcome)
Timepoint [17] 436002 0
At 4-week post-randomisation.
Secondary outcome [18] 436003 0
Reassurance of a good prognosis (mediator outcome)
Timepoint [18] 436003 0
At 4-week post-randomisation.
Secondary outcome [19] 436004 0
Reassurance there’s management options (mediator outcome)
Timepoint [19] 436004 0
At 4-week post-randomisation.
Secondary outcome [20] 436005 0
Anxiety (mediator outcome)
Timepoint [20] 436005 0
At 4-week post-randomisation.
Secondary outcome [21] 436006 0
Fear of movement (mediator outcome)
Timepoint [21] 436006 0
At 4-week post-randomisation.
Secondary outcome [22] 436007 0
Adherence (process measure)
Timepoint [22] 436007 0
At 3-, 6-, and 12-months post-randomisation.
Secondary outcome [23] 436008 0
Usability of PT eXercises App (process measure)
Timepoint [23] 436008 0
At 12-months post-randomisation
Secondary outcome [24] 436009 0
Clinician intervention fidelity (process measure)
Timepoint [24] 436009 0
Recorded after every physiotherapy appointment
Secondary outcome [25] 436010 0
Adverse event reporting
Timepoint [25] 436010 0
At 4-weeks, 3-, 6-, and 12-months post randomisation
Secondary outcome [26] 436011 0
Healthcare costs (based on local costing models)
Timepoint [26] 436011 0
At the end of the trial.
Secondary outcome [27] 436012 0
Intervention costs (clinician time and wage, and other resources required to deliver the intervention)
Timepoint [27] 436012 0
At the end of the trial.
Secondary outcome [28] 437669 0
Treatment waiting time (days)
Timepoint [28] 437669 0
At the first appointment with a study physiotherapist post-randomisation.
Secondary outcome [29] 437795 0
Success of blinding
Timepoint [29] 437795 0
At 12-months post randomisation

Eligibility
Key inclusion criteria
- Adult patient (equal to or greater than 18 years); and

- New referral (defined as being referred within the last 6 weeks) to a public hospital physiotherapy outpatient clinic with a musculoskeletal condition or musculoskeletal pain (hereafter referred to as ‘musculoskeletal pain’) that would usually be managed by a physiotherapist. Examples include but are not limited to:
o Back/neck pain.
o Osteoarthritis.
o Whiplash-associated disorders.
o Ankle sprains.
o Post-fracture.
o Sporting injury (e.g. ankle sprains).
o Post orthopaedic surgery (e.g. hip or knee replacement, rotator cuff repair surgery); and

- Willing to participate and provide follow-up data; and

- Can speak and read English to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Suspected serious underlying pathology or musculoskeletal conditions requiring urgent medical care (e.g., malignancy, fracture, infection, inflammatory arthritis, joint dislocation); or

- Compensable injuries or conditions; or

- New referral strongly suggestive of concerning neurological features (e.g., progressive radiculopathy or upper motor neuron lesion); or

- Is on a postoperative exercise regimen prescribed by a surgeon that specifies the model of care delivery (e.g., needs to be provided in a clinic supervised by a physiotherapist); or

- Requiring mobility progression or assistance weaning from a walking aid(s) whereby the person is at an increased falls risk and needs to be seen in the clinic; or

- Pregnant women.

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)
Online randomisation using the REDCap software. Allocation will be concealed as the biostatistician generating the sequence will not be involved in the recruitment of participants and the screening physiotherapist will not know the participants group allocation until their baseline data are entered into REDCap. The allocation sequence will also be concealed from potential participants and from all on-site staff associated with the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 1:1 random allocation sequence will be independently generated in Stata by the team’s biostatistician and uploaded to REDCap. The randomisation sequence will use randomly permuted blocks of variable size (2 and 4) to help ensure equal numbers in both groups. Stratification variables for the randomisation sequence include trial sites and the three treatment subgroups. This will ensure the intervention and control group have a similar proportion of participants across different trial sites. The screening physiotherapist will telephone participants who consent and complete their baseline assessment to inform them of their group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
A total sample of 368 participants will provide 90% power to detect a non-inferiority margin of 0.7 points on the 11-point PSFS with a 15% loss to follow-up, a standard deviation of 1.9, 2-sided alpha of 5%, PSFS at 6 months in the control arm participants of 5.8 – based on a recent trial conducted in the same setting. A between-group difference of less than or equal to 0.7 points will indicate that the new physiotherapy model of care is non-inferior (as good as or better) compared to usual clinic-based care. We chose a standard deviation of 1.9 as this is between the mean value of the standard deviation for the PSFS at follow-up in published studies of similar patient populations that range from 1.7, 2.0, and 2.1. The minimal important difference (MID) for the PSFS ranges from 1.3 (small change) to 2.7 (large change). Guidelines suggest using a non-inferiority margin of 50% (or less preferably) of the expected treatment effect. Thus, we chose a between-group non-inferior margin of 0.7 (50% of the MID of 1.3).
If our physiotherapist-led triage and treatment service is non-inferior for improving function at 6-months compared to usual care, we will interpret the findings for treatment waiting time as a co-primary outcome. This hierarchical approach to our co-primary outcomes was selected because consumer feedback suggested reducing waiting times is not valuable if patient outcomes are adversely affected. Our sample size of 368 participants will provide >80% power to detect a conservative 14 day mean reduction in waiting time (about half of the reduction found in the PhysioDirect trial; calculated from medians and interquartile ranges with this formula), using a SD of 43 (conservative SD from participating public hospital outpatient clinics over the past 5 years), 2-sided alpha of 5% and 15% loss to follow up.(1)

Analysis Plan
A detailed Statistical Analysis Plan (SAP) and Health Economics Analysis Plan (HEAP) including mock tables will be developed prior to unblinding and shared with the Data Monitoring and Safety Board (DMSB). Pre-specified analyses will be programmed using randomly scrambled treatment allocations. Unblinded results will be presented to the study team once all analyses have been programmed and validated.

Primary analysis
The purpose of our trial is to assess whether the physiotherapist-led triage and treatment service is as good as or better than usual clinic-based care for improving function and better than usual care in terms of reducing treatment waiting time. The between-arm difference in PSFS scores at 6 months post-randomisation is a co-primary outcome and we have prospectively defined a non-inferiority margin of -0.7 points for this analysis. This is the maximal compromise on outcome we are prepared to tolerate (based on guidelines and consumer feedback) and still consider the physiotherapist-led triage and treatment service to be clinically non-inferior to usual clinic-based care. We will test the null hypothesis that the mean difference in PSFS scores (intervention minus usual care) is no greater than -0.7 (H0: Mean difference less than or equal to -0.7). To declare non-inferiority for the new model of care when compared to usual clinic-based care, the 95% confidence interval around the mean difference should be entirely above the non-inferiority margin i.e. the lower bound of the 95% confidence interval must be higher than -0.7. A repeated-measure linear mixed model including all post-randomisation PSFS measurements will be used to generate an adjusted mean difference and 95% confidence interval representing the comparison of PSFS scores between the intervention and usual care arms at each time point. The model will be adjusted for the baseline PSFS value (to improve statistical precision), hospital site and treatment subgroup allocation.
The between-arm difference in treatment waiting time is the other co-primary outcome, provided function is non-inferior (hierarchical approach). We have prospectively defined an effect size of 14 days or greater to be clinically important (approximately half the reduction found in the PhysioDirect trial). This is the difference our consumers and clinician partners consider meaningful. A generalised linear model will be used to generate an adjusted mean difference and 95% confidence interval representing the comparison of treatment waiting times between the intervention and usual care group. The model will be adjusted for hospital site and treatment subgroup allocation.
Imputation techniques may be considered if more than 5% of any outcome data are missing, depending on patterns within missing data.

Secondary analysis
Similar linear models will be used to analyse between-group differences in other continuous outcomes, while logistic regression will be used to estimate the treatment effect for binary outcomes. All analyses of secondary outcomes will be adjusted for baseline values (if applicable), hospital site and treatment sub-group allocation as per the primary analysis.

Cost-effectiveness analysis
Costs will be measured using a combination of trial records, administratively linked data, health care diaries and published data. Healthcare costs (based on local costing models) and intervention costs (clinician time and wage, and other resources required to deliver the interventions). Comparisons made between the new model of care and usual care arms will be generated through the economic evaluation which will estimate the difference in the cost and benefits between the arms of the trial.

(1). Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Medical Research Methodology 2014;14(1):135. doi: 10.1186/1471-2288-14-135

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2024
Actual
Date of last participant enrolment
Anticipated
30/12/2025
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
368
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26654 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 26655 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 26657 0
Balmain Hospital - Balmain
Recruitment hospital [4] 26658 0
The Sutherland Hospital - Caringbah
Recruitment hospital [5] 26659 0
Prince of Wales Hospital - Randwick
Recruitment hospital [6] 26660 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 42694 0
2050 - Camperdown
Recruitment postcode(s) [2] 42695 0
2139 - Concord
Recruitment postcode(s) [3] 42697 0
2041 - Balmain
Recruitment postcode(s) [4] 42698 0
2229 - Caringbah
Recruitment postcode(s) [5] 42699 0
2031 - Randwick
Recruitment postcode(s) [6] 42700 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 316676 0
Government body
Name [1] 316676 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 316676 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318878 0
None
Name [1] 318878 0
Address [1] 318878 0
Country [1] 318878 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315454 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 315454 0
Ethics committee country [1] 315454 0
Australia
Date submitted for ethics approval [1] 315454 0
26/03/2024
Approval date [1] 315454 0
12/06/2024
Ethics approval number [1] 315454 0
X24-0090 & 2024/ETH00585

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

Contacts
Principal investigator
Name 134758 0
Dr Joshua Zadro
Address 134758 0
School of Public Health, The University of Sydney Level 10, North, King George V Building, Missenden Rd, Camperdown NSW 2050
Country 134758 0
Australia
Phone 134758 0
+61 0449 906 121
Fax 134758 0
Email 134758 0
joshua.zadro@sydney.edu.au
Contact person for public queries
Name 134759 0
Joshua Zadro
Address 134759 0
School of Public Health, The University of Sydney Level 10, North, King George V Building, Missenden Rd, Camperdown NSW 2050
Country 134759 0
Australia
Phone 134759 0
+61 0449 906 121
Fax 134759 0
Email 134759 0
joshua.zadro@sydney.edu.au
Contact person for scientific queries
Name 134760 0
Joshua Zadro
Address 134760 0
School of Public Health, The University of Sydney Level 10, North, King George V Building, Missenden Rd, Camperdown NSW 2050
Country 134760 0
Australia
Phone 134760 0
+61 0449 906 121
Fax 134760 0
Email 134760 0
joshua.zadro@sydney.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24016Study protocol  joshua.zadro@sydney.edu.au
24017Ethical approval  joshua.zadro@sydney.edu.au 387925-(Uploaded-18-07-2024-12-49-13)-X24-0090 - Full Approval - signed.pdf.pdf
24018Statistical analysis plan  joshua.zadro@sydney.edu.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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