Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000262404
Ethics application status
Approved
Date submitted
18/02/2025
Date registered
9/04/2025
Date last updated
9/04/2025
Date data sharing statement initially provided
9/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of a PAthway of CarE for people with chronic musculoskeletal conditions living in rural, regional and remote Australia using allied telehealth (PACE-RURAL)
Scientific title
Implementation of a PAthway of CarE for people with chronic musculoskeletal conditions living in rural, regional and remote Australia using allied telehealth (PACE-RURAL)
Secondary ID [1] 313782 0
None
Universal Trial Number (UTN)
Trial acronym
PACE-RURAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee pain 336409 0
Chronic primary musculoskeletal pain 336407 0
Lower Limb Pain 336899 0
Whiplash associated disorder (WAD) 336408 0
Hip pain 336900 0
Spinal Pain 336898 0
Condition category
Condition code
Musculoskeletal 332929 332929 0 0
Other muscular and skeletal disorders
Public Health 333368 333368 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PACE-RURAL pathway comprises 3 steps.
1. Prognostic risk stratification. The patient’s score from the Short-Form Örebro Musculoskeletal Pain Screening Questionnaire (SF-ÖMPQ) will be used to stratify the patient into low risk (good outcome, scores <50/100) and high risk (poor outcome, =50/100). This will be completed online via REDCap as part of the baseline questionnaire.

2. Low risk pathway. Participants at low risk will be reassured by their treating primary clinician that they have a good prognosis and are likely to do well with minimal management supported by their clinician and a high-quality e-resource www.mypainhub.com).

3. High risk pathway. Participants at high risk of poor outcome will be referred to an allied health specialist by their treating primary clinician, who will undertake a telehealth (or in-person if preferred) consultation with the participant and their rural clinician in attendance (whenever possible). The examination will be tailored to the individual’s presentation and may include assessment of physical impairments, co-morbidities, pain features, cognitive and affective factors, social and lifestyle considerations, and patients’ values and preferences. Following this, the clinician team will collaboratively determine further care pathways with the patient. Further care will depend on the individual’s risk factors and impairments and may involve further consultations with the specialist or interdisciplinary virtual care when required (e.g., 1-3 sessions with psychologists, dieticians or medical specialists as indicated). Specialist consultations will be approximately 1 hour duration.

Each participant will be followed up for 12 months. Duration of clinical care will be determined collaboratively with the patient participant and their primary clinician.

Adherence to the intervention will be evaluated by clinical audit at 6 months post implementation.

Clusters are eligible to participate if considered regional, rural, or remote (Modified Monash Model). Accordingly, our eight participating clusters are determined according to Australian regions and are:

Cluster 1: Far North Queensland and Cluster 2: Central Queensland will transition to implementation phase in July 2026.

Cluster 3: Far North NSW and Cluster 4: Mid North Coast NSW will transition to implementation phase in September 2025.

Cluster 5: South East Victoria and Cluster 6: South West Victoria will transition to implementation phase in April 2026.

Cluster 7: South West WA and Cluster 8: Midwest WA will transition to implementation phase in January 2026.
Intervention code [1] 330369 0
Treatment: Other
Comparator / control treatment
During the usual care period, rural clinicians in the cluster will manage patients as they usually would with the usual referral pathways. In public health services, people with MSK conditions are most commonly placed on a clinic waitlist. For the purposes of this study, our participating public health services have indicated these are either physiotherapy outpatient clinics, osteoarthritis chronic care programme (OACCP) clinic or community health services. People on these waitlists will be provided with care as would usually occur. For example, these patients are usually triaged to determine if they are urgent, and if non-urgent will receive allied health care when their name reaches the top of the waitlist. As stated, often in this period whilst waiting for care they often seek health services such as present to the emergency department if their pain flares up.

In primary care clinics, people with MSK conditions will usually be assessed by the physiotherapist, GP or chiropractor. They will typically be provided with care such as manual therapy, education, physical activity advice and/or exercise interventions.

All patients who participate in this period will be provided with information about the trial and generic information about their condition (accessible on the generic page of Mypainhub).
Control group
Active

Outcomes
Primary outcome [1] 340463 0
The co-primary implementation outcome is rural clinician acceptance of PACE-RURAL, measured by difference between the usual care and PACE-RURAL periods.
Timepoint [1] 340463 0
6 months from enrolement, in both usual care and implementation time periods.
Primary outcome [2] 340462 0
The co-primary effectiveness outcome is the Pain Self Efficacy Questionnaire (PSEQ) measured as the difference between usual care and PACE-RURAL care.
Timepoint [2] 340462 0
6 months from enrolment, in both usual care and implementation time periods.
Secondary outcome [1] 445581 0
Adoption (uptake) of PACE-RURAL by clinicians/specialists
Timepoint [1] 445581 0
6 months from start of implementation time period.
Secondary outcome [2] 444166 0
Patient reported global perceived recovery will be calculated as the mean-difference between usual care and PACE-RURAL periods.
Timepoint [2] 444166 0
Baseline, 3, 6 and 12 months from enrolment, in both usual care and implementation time periods.
Secondary outcome [3] 445877 0
Feasibility of PACE-RURAL model of care.
Timepoint [3] 445877 0
6 months from start of implementation time period.
Secondary outcome [4] 444167 0
Patient reported psychological distress will be calculated as the mean-difference between usual care and PACE-RURAL periods.
Timepoint [4] 444167 0
Baseline, 3, 6 and 12 months from enrolment, in both usual care and implementation time periods.
Secondary outcome [5] 445579 0
Perceived acceptance of PACE-RURAL by patients and specialists
Timepoint [5] 445579 0
6 months from start of implementation time period.
Secondary outcome [6] 444164 0
Patient reported pain will be calculated as the mean-difference between usual care and PACE-RURAL periods.
Timepoint [6] 444164 0
Baseline, 3, 6 and 12 months from enrolment, in both usual care and implementation time periods.
Secondary outcome [7] 444170 0
Secondary healthcare utilisation measures [this will be assessed as a composite outcome]
Timepoint [7] 444170 0
Baseline, 3, 6 and 12 months from enrolment, in both usual care and implementation time periods.
Secondary outcome [8] 444169 0
Secondary cost measures [this will be assessed as a composite outcome]
Timepoint [8] 444169 0
Baseline, 3, 6 and 12 months from enrolment, in both usual care and implementation time periods.
Secondary outcome [9] 444163 0
Health Related Quality of Life (HRQoL) will be calculated as the mean-difference between usual care and PACE-RURAL periods.
Timepoint [9] 444163 0
Baseline, 3, 6 and 12 months from enrolment, in both usual care and implementation time periods.
Secondary outcome [10] 444165 0
Patient reported disability will be calculated as the mean-difference between usual care and PACE-RURAL periods.
Timepoint [10] 444165 0
Baseline, 3, 6 and 12 months from enrolment, in both usual care and implementation time periods.
Secondary outcome [11] 445582 0
Fidelity
Timepoint [11] 445582 0
6 months from start of implementation time period.
Secondary outcome [12] 445585 0
Feasibility of implementation strategies for PACE-RURAL trial.
Timepoint [12] 445585 0
6 months from start of implementation time period.
Secondary outcome [13] 444171 0
Reach of PACE-RURAL
Timepoint [13] 444171 0
6 months from start of implementation time period.
Secondary outcome [14] 445580 0
How appropriate was PACE-RURAL for patients/clinicians/specialists
Timepoint [14] 445580 0
6 months from start of implementation time period.
Secondary outcome [15] 444168 0
Trust and expectations of care
Timepoint [15] 444168 0
Baseline, 6 months from enrolment, in both usual care and implementation time periods.
Secondary outcome [16] 444544 0
Sustainability/Maintanence
Timepoint [16] 444544 0
12 months post ceasing trial recruitment

Eligibility
Key inclusion criteria
Patient participants are eligible to be included in the study if they have one of the musculoskeletal conditions listed below and present for care to a primary HCP working within the cluster. Patient participants are required to have been experiencing symptoms for >3 months and receiving care for no longer than 4 weeks for the current episode of symptoms.

1) International Classification of Diseases-Version 11 classifications for spinal musculoskeletal pain (low back pain and cervical spine pain; ME84), pain arising from the lower limb joints and soft tissue (ME82, FB 56.4), or chronic primary MSK pain (MG30).

2) Grade I-III whiplash associated disorder (WAD) as classified by the Quebec Task Force Classification of Grades of WAD.

3) Knee or hip joint pain: activity-related joint pain, with either no morning joint-related stiffness or morning stiffness lasting 18 years, and proficient in written and spoken English.

Clinician participants: Rural clinicians in clusters will be eligible to participate if they are clinicians who regularly manage people with chronic MSK conditions (e.g., physiotherapists, GPs, chiropractors, osteopaths), work within the participating public health services or primary clinics in the cluster and are registered with the Australian Health Practitioner Regulation Agency (Ahpra).

Allied Health Specialist participants are defined in this study as “a health care professional with expertise in the management of complex MSK conditions”. Allied health specialists will be most commonly physiotherapists, but can also include psychologists, chiropractors and medical practitioners. Specialist physiotherapists are those that fulfil one of the following: i) completed fellowship with a professional college in MSK, pain or sports sub-speciality (e.g., Fellow of the Australian College of Physiotherapists); ii) have been independently appointed to a government regulator or insurer to perform peer reviews for people with complex MSK conditions; iii) have a higher degree (PhD) in the field and still practise clinically; or iv) appointed as a clinical specialist in a public hospital (e.g., Level 6 physiotherapist).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for patient participants: known or suspected serious spinal pathology (e.g., metastatic disease of the spine), confirmed fracture or dislocation at time of injury (WAD IV), or extreme depression defined as at risk of self-harm. Patients with osteoarthritis will be excluded if they have undergone or are scheduled for joint replacement surgery for the joint for which they are seeking care.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation has been conducted. The state site commencement order will be NSW, WA, VIC and QLD. This was necessary to enable sufficient lead time for the Stage 1 process and recruitment of staff in each cluster.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Hybrid type II effectiveness-implementation trial using stepped-wedge cluster randomisation.

Single blind (statistician)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size and power calculation is based on the known PSEQ mean (SD) of the control group in the PACE-MSK urban trial [mean (SD), 40.2 (14.1)]. Clinically important differences reported for the PSEQ are 5.5 (9% of the scale range).

Sample size was calculated for an incomplete stepped-wedge design involving 8 clusters, each having 2 time periods of recruitment under control conditions followed by 2 time periods for recruitment under intervention conditions. The design involves four steps, with two clusters transitioning to intervention at each step. In total, a minimum of 552 participants are required to achieve 80% power at significance level 0.05, allowing for intraclass correlation 0.02 and 15% loss to follow up. Thus, individual clusters will need to recruit an average of 17-18 participants during each of the four time periods.

One of the researchers in the team is an experienced biostatistician and will lead the analysis of health outcome data in a blinded manner. A detailed statistical analysis plan (SAP) will be made publicly available prior to completion of the trial. All analyses will be conducted on an intention-to-treat basis. Assuming normality for the PSEQ, the primary outcome will be analysed using linear mixed models. Proportions will be used to examine adoption, acceptability and other implementation outcomes at both patient and clinician level. Aspects of evidence-based management will be compared between control and intervention arms using proportions and chi-squared tests. The SAP will outline all other planned analyses (e.g., per-protocol sensitivity analyses, sub-group analyses).

Recruitment and retention rates will be monitored during the course of the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2025
Actual
Date of last participant enrolment
Anticipated
1/04/2027
Actual
Date of last data collection
Anticipated
1/04/2028
Actual
Sample size
Target
552
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 318248 0
Government body
Name [1] 318248 0
Department of Health and Aged Care - MRFF Primary Health Care Research Initiative - 2023 Primary Health Care Research Grant Opportunity - Stream 1
Country [1] 318248 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321034 0
None
Name [1] 321034 0
Address [1] 321034 0
Country [1] 321034 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316887 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316887 0
Ethics committee country [1] 316887 0
Australia
Date submitted for ethics approval [1] 316887 0
24/10/2024
Approval date [1] 316887 0
31/01/2025
Ethics approval number [1] 316887 0

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

Contacts
Principal investigator
Name 139326 0
Prof Trudy Rebbeck
Address 139326 0
Kolling Institute, Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
Country 139326 0
Australia
Phone 139326 0
+61 2 9036 4040
Fax 139326 0
Email 139326 0
[email protected]
Contact person for public queries
Name 139327 0
Trudy Rebbeck
Address 139327 0
Kolling Institute, Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
Country 139327 0
Australia
Phone 139327 0
+61 2 9036 4040
Fax 139327 0
Email 139327 0
[email protected]
Contact person for scientific queries
Name 139328 0
Trudy Rebbeck
Address 139328 0
Kolling Institute, Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
Country 139328 0
Australia
Phone 139328 0
+61 2 9036 4040
Fax 139328 0
Email 139328 0
[email protected]

Data sharing statement
Will the study consider sharing 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.