Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001104842p
Ethics application status
Submitted, not yet approved
Date submitted
28/06/2021
Date registered
18/08/2021
Date last updated
18/08/2021
Date data sharing statement initially provided
18/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Stratified care integrated with eHealth for low back pain: a feasibility randomised controlled trial
Scientific title
The feasibility of delivering and evaluating stratified care integrated with eHealth (‘Rapid Virtual Stratified Care’) for patients with low back pain: a randomised controlled trial
Secondary ID [1] 304635 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-specific low back pain 322571 0
radicular low back pain/sciatica 322819 0
Condition category
Condition code
Musculoskeletal 320186 320186 0 0
Other muscular and skeletal disorders
Public Health 320409 320409 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rapid virtual stratified care group:

The mode and type of care will be matched to the patient’s risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool), as well as the presence of worrisome radicular symptoms.

• Patients at low risk of persistent pain (Keele STarT MSK score 0–4) will receive a telephone call (~10 minutes) by a Rheumatology Advanced trainee. Patients without suspected serious spinal pathology or worrisome radicular symptoms (as assessed by a study-specific screening questionnaire, score of 3 or more) will be told their condition does not warrant further formal treatment as they have a good prognosis and their back pain will likely resolve on its own. They will be encouraged to gradually increase their daily walking as pain permits, temporarily modify their activities to manage their symptoms, take paracetamol if required, and receive written educational material on low back pain from the Agency for Clinical Innovation. Participants will be instructed to call back if their condition does not improve over the next 6 weeks. The Rheumatology Advanced trainee will then decide whether the participants needs to be managed according to a different risk sub-group.
• Patients at medium risk of persistent pain (score 5–8) will receive a telephone call (~10 minutes) by a Rheumatology Advanced trainee. Patients without suspected serious spinal pathology or worrisome radicular symptoms (as assessed by a study-specific screening questionnaire, score of 3 or more) will be offered a virtual consultation with a physiotherapist. The physiotherapist will provide advice and education to support self-management (e.g. advice to exercise, modify activities, lose weight, or take simple pain medications if needed), and an App-based exercise program (PhysiTrack) if necessary. PhysiTrack has over 5,000 physiotherapy exercises and over 1,000 specific to low back pain. The physiotherapist will tailor the exercise program to patients’ activity goals and level of function and be free to select any type (e.g. flexibility, aerobic, resistance) and dosage of exercise. The physiotherapist will have the option to print out the exercises for the patient if the patients is not comfortable using the app. The duration and number of virtual physiotherapy consultations will be at the discretion of the treating physiotherapists but limited to a maximum of 12 appointments (max duration 30 minutes per appointment) over 6 months
• Patients at high risk of persistent pain (9–12) will receive a telephone call (~10 minutes) by a Rheumatology Advanced trainee. Patients without suspected serious spinal pathology or worrisome radicular symptoms (as assessed by a study-specific screening questionnaire, score of 3 or more) will be offered a virtual consultation with a physiotherapist. The physiotherapist will provide advice and education to support self-management (e.g. advice to exercise, modify activities, lose weight, or take simple pain medications if needed), and may provide interventions to address psychological barriers to recovery (e.g. Cognitive Behavioural Therapy, graded exposure), and an App-based exercise program (PhysiTrack - as per the medium risk sub-group). The physiotherapist will also direct participants to complete an online self-directed pain education program developed by the Agency for Clinical Innovation. The program (Pain Management: For Everyone https://www.aci.health.nsw.gov.au/chronic-pain/for-everyone) is publicly available and includes seven modules:
1. Introduction to pain (6:47 minutes)
2. Getting help from your healthcare team (5:56 minutes)
3. Pain and physical activity (12:43 minutes)
4. Pain: Lifestyle and nutrition (8:41 minutes)
5. Pain and role of medications (9:57 minutes)
6. Pain and thoughts (10:27 minutes)
7. Pain and sleep (11:08 minutes)
Patients will be encouraged to go through the program at their own pace and bring any questions to their next virtual consultation if necessary. The duration and number of virtual physiotherapy consultations will be at the discretion of the treating physiotherapists but limited to a maximum of 12 appointments (max duration 30 minutes per appointment) over 6 months. Patients can also be referred to see a psychologist if the Rheumatology Advanced trainee and physiotherapist agree it would be valuable. The duration and number of psychology appointments will be up to the treating psychologist (with no restrictions imposed by our study).
• Patients with worrisome radicular symptoms (as assessed by a study-specific screening questionnaire, score of 3 or more) will be prioritised for a face-to-face consultation with a rheumatologist in the Back Clinic (~30 minutes). If necessary, the rheumatologist will refer patients to receive a course of face-to-face physiotherapy. Patients at high-risk of persistent pain will receive interventions to address psychological barriers to recovery (e.g. Cognitive Behavioural Therapy, graded exposure) and can be referred to see a psychologist if necessary. The duration and number of follow-up physiotherapy consultations will be at the discretion of the treating physiotherapists but limited to a maximum of 12 appointments (max duration 1 hour per appointment) over 6 months. The duration and number of psychology appointments will be up to the treating psychologist (with no restrictions imposed by our study).

Participants' adherence to the interventions provided by the physiotherapists will not be assesed because the exact management protocol (within each treatment subgroup) is at the discretion of the treating physiotherapist. The PhysiTrack App will not collect exercise adherence data from participants.
Intervention code [1] 320983 0
Treatment: Other
Comparator / control treatment
Usual care group: Participants will join a waiting list to receive a face-to-face consultation with a rheumatologist in the Back Clinic (~30 minutes). If necessary, the rheumatologist will refer patients to receive a course of face-to-face physiotherapy as typically provided in Sydney government hospitals. The number of follow up appointments will be at the discretion of the treating physiotherapists but limited to a maximum of 12 appointments (max 1 hour duration per appointment) over 6 months. Keele STarT MSK scores or the presence of worrisome radicular symptoms will not inform the type of care provided to participants in this group.
Control group
Active

Outcomes
Primary outcome [1] 328067 0
Composite feasibility outcomes for delivering Rapid Virtual Stratified Care include:
• Clinician and patient acceptability of the intervention (through semi-structured interviews with clinicians and focus groups with patients)
• Percentage of participants who are only provided care according to their risk sub-group as recorded by the treating physiotherapist
• Mean or median appointment time for each stratified group (treatment stage) and whether this changes over time as assessed by the treating clinicians
• Self-reported useability of the PhysiTrack App provided to participants in the Rapid Virtual Stratified Care group (medium- and high-risk) assessed using the System Usability Scale (SUS) at 6 months, 0 to 100 score. A score above 70 indicates above-average usability
• Percentage of participants in Rapid Virtual Stratified Care group (high-risk) who complete all modules of the self-directed online pain education program as recorded by the treating physiotherapist
Timepoint [1] 328067 0
At the conclusion of the study
Primary outcome [2] 328243 0
Composite feasibility outcomes for ‘evaluating’ Rapid Virtual Stratified Care in a future multi-centre randomised controlled trial include:
• Number of participants recruited per week as assessed by audit of study records
• Number of eligible participants per week as assessed by audit of study records
• Percentage of participants who consent to be part of the study from those who were eligible (consent rate) as assessed by audit of study records
Timepoint [2] 328243 0
At the conclusion of the study
Primary outcome [3] 328443 0
Composite feasibility outcomes for ‘evaluating’ Rapid Virtual Stratified Care in a future multi-centre randomised controlled trial include:
• Percentage of participants lost to follow-up at 6 weeks and 6 months as assessed by audit of study records
• Percentage of missing data for outcome measures at 6 weeks and 6 months as assessed by audit of study records
Timepoint [3] 328443 0
6 weeks and 6 months post-randomisation
Secondary outcome [1] 397439 0
Treatment waiting time (i.e. time from Back Clinic receiving referral to first treatment; either face-to-face or virtual/telephone) as assessed by audit of study records
Timepoint [1] 397439 0
At the conclusion of the study
Secondary outcome [2] 398235 0
Number of consultations patients receive as assessed by audit of study records
Timepoint [2] 398235 0
At the conclusion of the study
Secondary outcome [3] 398236 0
Intervention costs. Intervention costs will be estimated based on clinician time and wage, and the cost of PhysiTrack licences.
Timepoint [3] 398236 0
At the conclusion of the study
Secondary outcome [4] 398237 0
Physical function as assessed by the Roland Morris Disability Questionnaire
Timepoint [4] 398237 0
6 weeks and 6 months post-randomisation
Secondary outcome [5] 398238 0
Pain as assessed using a Numeric Rating Scale 0-10
Timepoint [5] 398238 0
6 weeks and 6 months post-randomisation
Secondary outcome [6] 398239 0
Quality of life as assessed using the PROMIS-29
Timepoint [6] 398239 0
6 weeks and 6 months post-randomisation
Secondary outcome [7] 398240 0
Satisfaction as assessed using a Numeric Rating Scale 0-10
Timepoint [7] 398240 0
6 weeks and 6 months post-randomisation
Secondary outcome [8] 398241 0
Healthcare use assessed by a survey designed specifically for this study (either hard copy, online or telephone). Participants will be asked if they have used or are currently using any healthcare services (e.g. GP, physiotherapy, imaging), or community health or other services (e.g. meals on wheels) for their low back pain. Participants will also be asked whether they are currently taking any prescription or over the counter medication for their low back pain, and to specify the type and dose of their medication.
Timepoint [8] 398241 0
6 weeks and 6 months post-randomisation
Secondary outcome [9] 398242 0
Adverse events (AE) assessed by participant self-report. An AE is any untoward medical occurrence in a participant. AEs do not necessarily have a causal relationship with the treatment including but not limited to any pain; skin, muscle or other soft tissue injuries; fractures, falls, dizziness, heart attacks or angina; fever or illness that was not pre-existing at the time of screening.
Timepoint [9] 398242 0
2 weeks, 6 weeks and 6 months post-randomisation
Secondary outcome [10] 398243 0
Serious adverse events (SAE) assessed by participant self-report or review of medical records. A SAE is an unforeseen adverse event that occurs to a participant in the course of the trial and
• Results in death
• Is life threatening
• Requires inpatient hospitalisation
• Results in significant disability or incapacity
Timepoint [10] 398243 0
2 weeks, 6 weeks and 6 months
Secondary outcome [11] 399031 0
Healthcare costs. Healthcare costs will be based on patient-level costing data from a health district perspective (i.e. emergency department and hospital care including imaging tests, pathology tests, medications, nursing, medical, allied health, admin, and hospital overheads). These costs will be obtained from the performance management unit of the Sydney Local Health District. This costing data is calculated based on the activity-based funding model used in NSW Health hospitals.
Timepoint [11] 399031 0
At the conclusion of the study

Eligibility
Key inclusion criteria
A person will be eligible to participate if he or she:
• is 18 years or over
• has LBP (non-specific LBP or radicular LBP/sciatica)
• is a new referral to the Back Clinic from primary care (i.e. has not been on the waiting list prior to enrolment)
• is willing to participate for up to 6 months and provide follow-up data at 6 weeks and 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A person will be excluded if he or she:
• has a suspected serious underlying pathology (e.g. cancer, fracture, infection, inflammatory arthritis, cauda equina syndrome)
• is pregnant

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)
The secure random allocation schedule will be computer-generated independently and kept off site. The allocation schedule will be concealed from potential participants and from all staff associated with the trial. Randomisation will occur following the collection of baseline data. The trial physiotherapist (study coordinator) will contact the central randomisation unit by telephone or email to be notified of the treatment assignment. This assignment will not be disclosed to the blinded assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be blocked to ensure equal numbers in both groups. Risk sub-groups, as assessed by the Keele STarT MSK tool (low vs. medium vs. high risk), will be used as a stratification variable.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The main analysis will focus on feasibility (process) outcomes and will investigate feasibility outcomes for delivering Rapid Virtual Stratified Care and feasibility outcomes for evaluating Rapid Virtual Stratified Care in a future multi-centre randomised controlled trial. This data will be summarised using descriptive statistics (means and standard deviations, median and interquartile ranges and counts and percentages, as appropriate).

The research team will review the feasibility outcomes at the completion of the study and make a judgement about whether to proceed to planning an adequately powered, multi-site trial. Meeting the following criteria would justify proceeding to a full trial:
i) Acceptable to clinicians and patients (according to qualitative interviews)
ii) Percentage of participants in the intervention who are only provided care according to their treatment subgroup >75%
iii) Percentage of participants in the Rapid Virtual Stratified Care group (medium- and high-risk) who are comfortable using the App-based exercise program >75%
iv) Percentage of participants in Rapid Virtual Stratified Care group (high-risk) who complete all modules of the self-directed online pain education program >75%
v) Recruitment rate of three of more participants per week over 6 months
vi) Consent rate of 50% or more over 6 months
vii) Loss to follow up <25% at 6 months
viii) Missing data in questionnaires <15%

Waiting times, number of appointments, clinical outcomes, healthcare use and adverse events will be compared between Rapid Virtual Stratified Care and usual care using descriptive statistics (means and standard deviations, median and interquartile ranges and counts and percentages, as appropriate) in STATA version 16.0. No statistical inference testing will be performed as this is a feasibility study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
1/09/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19811 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 34460 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 308995 0
Other
Name [1] 308995 0
NSW Agency For Clinical Innovation Research Grant Scheme
Country [1] 308995 0
Australia
Primary sponsor type
Individual
Name
Joshua Zadro
Address
Level 10N, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 309932 0
None
Name [1] 309932 0
Address [1] 309932 0
Country [1] 309932 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308887 0
Sydney Local Health District (RPA zone) Human Research Ethics Committee
Ethics committee address [1] 308887 0
Ethics committee country [1] 308887 0
Australia
Date submitted for ethics approval [1] 308887 0
25/06/2021
Approval date [1] 308887 0
Ethics approval number [1] 308887 0

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

Contacts
Principal investigator
Name 112222 0
Dr Joshua Zadro
Address 112222 0
Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Level 10N, King George V Building, Missenden Rd, Camperdown, NSW, 2050
Country 112222 0
Australia
Phone 112222 0
+61 449906121
Fax 112222 0
Email 112222 0
[email protected]
Contact person for public queries
Name 112223 0
Joshua Zadro
Address 112223 0
Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Level 10N, King George V Building, Missenden Rd, Camperdown, NSW, 2050
Country 112223 0
Australia
Phone 112223 0
+61 449906121
Fax 112223 0
Email 112223 0
[email protected]
Contact person for scientific queries
Name 112224 0
Joshua Zadro
Address 112224 0
Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Level 10N, King George V Building, Missenden Rd, Camperdown, NSW, 2050
Country 112224 0
Australia
Phone 112224 0
+61 449906121
Fax 112224 0
Email 112224 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?
Baseline and post-intervention data as required
When will data be available (start and end dates)?
Following publication of this study (anticipated Sept 2022)
Available to whom?
Anyone who requests it with a reasonable reason and will put in a formal ethics request to use the data
Available for what types of analyses?
To be decided based on the request
How or where can data be obtained?
By contacting the principal investigator, Dr Joshua Zadro, via email [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
SourceTitleYear of PublicationDOI
EmbaseFeasibility of delivering and evaluating stratified care integrated with telehealth (Rapid Stratified Telehealth') for patients with low back pain: Protocol for a feasibility and pilot randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-056339
N.B. These documents automatically identified may not have been verified by the study sponsor.