Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001268538
Ethics application status
Approved
Date submitted
4/09/2024
Date registered
18/10/2024
Date last updated
18/10/2024
Date data sharing statement initially provided
18/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing integrated psychological and physical care in routine physiotherapy practice for patients with musculoskeletal road traffic injury (PICOT): a hybrid implementation-effectiveness type III cluster randomised controlled trial.
Scientific title
Implementing integrated psychological and physical care in routine physiotherapy practice for patients with musculoskeletal road traffic injury (PICOT): a hybrid implementation-effectiveness type III cluster randomised controlled trial.
Secondary ID [1] 312385 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PICOT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal spinal (neck and/or back) pain following a road traffic injury 334301 0
Condition category
Condition code
Musculoskeletal 330955 330955 0 0
Other muscular and skeletal disorders
Injuries and Accidents 330956 330956 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 330957 330957 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As this is a hybrid implementation-effectiveness type III cluster RCT, the intervention is an implementation strategy designed to upskill physiotherapists in the delivery of integrated psychological and physical care (StressModex) for patients with musculoskeletal spinal pain following road traffic injury: PICOT (Physiotherapists bIopsyChosocial On-line Training).

PICOT comprises a blended learning approach over 6 weeks, including 1) online self-paced modules, 2) real-time zoom sessions co-facilitated by a clinical psychologist and expert physiotherapist, and 3) practice feedback.
Online self-paced modules: The physiotherapists will complete 6 online self-paced modules weekly over 6 weeks, with each module taking 20-30 minutes to complete. The modules reflect the content of the StressModex treatment manual and include: (1) pain education and the influence of stress on pain, (2) stress-management strategies, e.g., relaxed breathing, muscle relaxation, (3) problem solving skills, (4) use of positive coping statements, (5) real-world practice of skills, and (6) relapse prevention. These online modules will be presented via an engaging format that includes quizzes, short videos of experts delivering StressModex, Q&A video session, and downloadable written resources. All modules are integrated with guideline recommended exercise.
Real time zoom sessions: The weekly group online sessions (each 1 hour), co-facilitated by a clinical psychologist and expert physiotherapist, will include skills role play in small break-out groups, case studies and general discussion/questions. Following the 6-week program, online facilitated discussion sessions (each 1 hour) will be held fortnightly for a further 6 weeks, to support physiotherapist training through discussion of issues that may arise as they implement StressModex into practice.
Practice feedback: After each training session delivered through online platforms, the physiotherapist will be asked to videotape the relevant practice session with a patient or colleague. The clinical psychologist will provide feedback on each of the 6 sessions to the physiotherapists.
Adherence to the online training platform modules will be monitored using analytics from the training platform. Attendance at the zoom sessions will be monitored by the research assistant recording attendance at each session.

After the physiotherapists have completed the training, the physiotherapists will recruit eligible patients from their respective clinics and deliver 6 individual sessions of StressModex over 8 weeks (StressModex is a 6-week intervention, but we will allow an additional 2 weeks for delivery to account for interruptions such as patient/physiotherapist illness, holidays, rescheduling of appointments etc.). Duration of each session will be as per standard physiotherapy consultation session with both being up to 50 minutes duration. Please see an overall outline of the week-to-week delivery of StressModex below:
Week 1: Patient education about stress and pain, relaxation techniques of abdominal breathing and exercise;
Week 2: Relaxation techniques of progressive muscle relaxation (body scans) and Exercise
Week 3: Problem Solving techniques (the physiotherapist will teach the patient problem solving techniques of identifying a problem, brainstorming solutions and weighing up options) and Exercise
Week 4: Positive coping statements (the physiotherapist will teach the patient about the effect of unhelpful thoughts on pain and stress and how these can be replaced with more helpful thoughts) and Exercise
Week 5: Developing a coping plan (the physiotherapist will teach the patient how to develop a plan to deal with individual like stressors using the skills they have learnt in the first 4 sessions) and Exercise
Week 6: Maintenance/relapse prevention (the physiotherapist will teach the patient about how to prevent relapses in their stress and pain) and Exercise.

The exercise component will include low load exercises to encourage movement, progressing to strengthening exercise as tolerated, exercises to improve eye head co-ordination, balance exercises and will advise the patient on returning to aerobic exercise (e.g. walking) and relevant daily activities. The exercises will be tailored and then progressed in individual patients as deemed appropriate by the physiotherapist. They are guideline recommended exercises of which physiotherapists are very familiar with. Some examples of the exercises include: range of movement exercises for the neck, lifting the head off the treatment bed commencing with pillows under the head progressing to lying flat, overhead press exercise with light weights progressing weight as tolerated, following a laser pointer on the wall with head and eyes, standing on one leg progressing from eyes open to eyes closed.

Focus groups will be held with physiotherapists from both training groups and champion physiotherapists at each site at the end of the patient recruitment phase (one focus group for each trial arm). Each focus group will last ~1.5 hours. To ensure a range of experiences in the focus groups, up to 10 physiotherapists from each trial arm will be purposively selected from those who opt in for the additional focus group. Selection will be based on factors such as gender, years of practice, seniority level, clinic roles (e.g., manager), geographic location, and patient volumes. A qualitative researcher in the team will conduct the focus group to gather information about the clinical setting (e.g., organisation and interpersonal dynamics, care practice) and explore physiotherapists’ experiences and barriers/facilitators to delivering StressModex within the trial. For example, questions will include physiotherapists’ experience participating in this trial, and receiving training either online or in person, recruiting and identifying eligible patient-participants, experience in delivering StressModex, considering what factors made it easy or difficult to deliver StressModex in their clinical practice, and what contextual factors or resources helped or hindered such delivery.
Intervention code [1] 328975 0
Rehabilitation
Intervention code [2] 328976 0
Behaviour
Comparator / control treatment
A 2-day in-person training workshop delivered to physiotherapists facilitated by a clinical psychologist and expert physiotherapist. The duration of the workshop is 14 hours (7 hours each day). The same material will be covered as in the PICOT implementation strategy (the physiotherapist on-line training). Attendance will be monitored by the research assistant recording attendance the commencement of each day.

Focus groups will be held with physiotherapists from both training groups and champion physiotherapists at each site at the end of the patient recruitment phase (one focus group for each trial arm). Each focus group will last ~1.5 hours. To ensure a range of experiences in the focus groups, up to 10 physiotherapists from each trial arm will be purposively selected from those who opt in for the additional focus group. Selection will be based on factors such as gender, years of practice, seniority level, clinic roles (e.g., manager), geographic location, and patient volumes. A qualitative researcher in the team will conduct the focus group to gather information about the clinical setting (e.g., organisation and interpersonal dynamics, care practice) and explore physiotherapists’ experiences and barriers/facilitators to delivering StressModex within the trial. For example, questions will include physiotherapists’ experience participating in this trial, and receiving training either online or in person, recruiting and identifying eligible patient-participants, experience in delivering StressModex, considering what factors made it easy or difficult to deliver StressModex in their clinical practice, and what contextual factors or resources helped or hindered such delivery.

Similar to those in the PICOT implementation strategy, physiotherapists in the comparator arm will recruit eligible patients from their clinics after completing in-person training. They will then deliver 6 individual sessions of StressModex over an 8-week period.
Control group
Active

Outcomes
Primary outcome [1] 338725 0
Reach of StressModex to physiotherapy clinic patients per trial arm
Timepoint [1] 338725 0
At 8 months following the 6-week implementation strategies (physiotherapist training).
Secondary outcome [1] 437135 0
Sustainable reach of StressModex to physiotherapy clinic patients per trial arm
Timepoint [1] 437135 0
At 12 months following the 6-week implementation strategies (physiotherapist training).
Secondary outcome [2] 437136 0
Adoption of StressModex by physiotherapists per trial arm
Timepoint [2] 437136 0
1) At 8 and 12 months following the 6-week implementation strategies (physiotherapist training).
2) Immediately after the 6-week implementation strategies.
Secondary outcome [3] 437137 0
Dose of StressModex delivered per trial arm
Timepoint [3] 437137 0
At 8 and 12 months following the 6-week implementation strategies (physiotherapist training).
Secondary outcome [4] 437138 0
Fidelity 1 - Physiotherapists' adherence to StressModex treatment manual per trial arm
Timepoint [4] 437138 0
At 8 and 12 months following the 6-week implementation strategies (physiotherapist training).
Secondary outcome [5] 437140 0
Fidelity 2 – Physiotherapists’ confidence and competency to deliver StressModex per trial arm
Timepoint [5] 437140 0
At 8 and 12 months following the 6-week implementation strategies (physiotherapist training).
Secondary outcome [6] 437141 0
Reach of the implementation strategies to physiotherapy clinics per trial arm
Timepoint [6] 437141 0
Following randomisation and prior to commencement of the 6-week implementation strategies (physiotherapist training).
Secondary outcome [7] 437142 0
Adoption of the implementation strategies by physiotherapists per trial arm
Timepoint [7] 437142 0
Following completion of the 6-week implementation strategies (physiotherapist training).
Secondary outcome [8] 437143 0
Dose delivered of implementation strategies per trial arm
Timepoint [8] 437143 0
Following completion of the 6-week implementation strategies (physiotherapist training).
Secondary outcome [9] 437144 0
Fidelity of the implementation strategies by training facilitators per trial arm
Timepoint [9] 437144 0
For the PICOT arm (on-line training group), assessments will be conducted weekly during the 6-week implementation strategy period (physiotherapist training).
For the in-person training arm, assessments will be conducted daily throughout 2-day in-person training scheduled towards the end of the 6-week implementation strategy period (physiotherapist training).
Secondary outcome [10] 437145 0
Sustainability of implementation strategies per trial arm
Timepoint [10] 437145 0
At the 12-months following the 6-week implementation strategies (physiotherapist training).
Secondary outcome [11] 437146 0
Patient outcome 1 - Difference in pain-related function between the two arms of the trial
Timepoint [11] 437146 0
Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment.
Secondary outcome [12] 437147 0
Patient outcome 2 - Difference in pain severity between the two arms of the trial
Timepoint [12] 437147 0
Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment.
Secondary outcome [13] 437148 0
Patient outcome 3 - Difference in pain self-efficacy between the two arms of the trial
Timepoint [13] 437148 0
Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment.
Secondary outcome [14] 437149 0
Patient outcome 4 - Difference in depression, anxiety, and stress symptoms between the two arms of the trial
Timepoint [14] 437149 0
Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment.
Secondary outcome [15] 437150 0
Patient outcome 5 - Difference in posttraumatic stress symptoms between the two arms of the trial
Timepoint [15] 437150 0
Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment
Secondary outcome [16] 437151 0
Patient outcome 6 - Difference in health-related quality of life between the two arms of the trial
Timepoint [16] 437151 0
Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment
Secondary outcome [17] 437152 0
Patient outcome 7 - Difference in therapeutic alliance between the two arms of the trial
Timepoint [17] 437152 0
After physiotherapist-participants deliver the last session of the StressModex treatment (8 weeks post patient baseline assessment).
Secondary outcome [18] 437153 0
Cost-effectiveness of the two implementation strategies.
Timepoint [18] 437153 0
Following completion of the 6-week implementation strategies, at the 8-month and 12-month periods following the 6-week implementation strategies (physiotherapist training).
Secondary outcome [19] 437154 0
Implementation determinant 1: Physiotherapists’ self-rated confidence to deliver StressModex
Timepoint [19] 437154 0
Before and after the 6-week implementation strategies (physiotherapy training).
Secondary outcome [20] 437155 0
Implementation determinant 2: Physiotherapists’ self-rated competency to deliver StressModex.
Timepoint [20] 437155 0
Before and after the 6-week implementation strategies (physiotherapy training).
Secondary outcome [21] 437156 0
Implementation determinant name 3: Physiotherapists’ Attitudes and Beliefs about pain. This will be assessed as a composite outcome.
Timepoint [21] 437156 0
Before and after the 6-week implementation strategies (physiotherapy training).
Secondary outcome [22] 437157 0
Implementation determinant 4: Satisfaction with the implementation strategy (physiotherapy training).
Timepoint [22] 437157 0
Immediately after the 6-week implementation strategies (physiotherapy training).
Secondary outcome [23] 437158 0
Implementation determinant 5: Difficulty involved with the implementation strategy (undertaking the training).
Timepoint [23] 437158 0
Immediately after the 6-week implementation strategies (physiotherapy training).
Secondary outcome [24] 440308 0
Implementation determinant 6: Effort required with the implementation strategy (undertaking the training).
Timepoint [24] 440308 0
Immediately after the 6-week implementation strategies (physiotherapy training).
Secondary outcome [25] 440309 0
Implementation determinant 7: Experience, barriers, and facilitators to deliver StressModex. This will be assessed as a composite outcome.
Timepoint [25] 440309 0
At 6 months following completion of implementation strategies (the end of the patient recruitment phase)

Eligibility
Key inclusion criteria
Inclusion criteria for the primary care physiotherapy clinics (clusters):
• Employ at least three physiotherapists.
• See approx. 30 patients with spinal musculoskeletal road traffic injury annually.

Inclusion criteria for patient participants:
• Musculoskeletal spinal (neck and/or back) pain following road traffic injury.
• Spinal pain is < /= 12 weeks in duration.
• Screened at medium to high risk of poor recovery on a validated tool appropriate for the clinical presentation (e.g., WhipPredict, Orebro, or StarTBack).
• Aged >/= 18 years.
• Proficient in written and spoken English.
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:
• Serious spinal pathology (e.g., metastatic disease, spinal fracture or dislocation).
• Diagnosed inflammatory or neurological conditions.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To implement the allocation sequence, the trial statistician will generate the allocation sequence and email them to members of the research team organising and delivering the training. The group allocation will be kept by the trial statistician and only be disclosed to members of the research team organising and delivering the training who are not involved in data collection and analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be generated using a web-based randomisation service at Griffith University. The randomisation will be conducted at the cluster (physiotherapy clinic) level. Physiotherapy clinics will be stratified by state, location (urban/regional) to ensure balance across these factors. Within each stratum, clinics will be ordered by the volume of patients and paired. The volume of patients will be determined by the estimated total number of annual patients encounters monthly. Within each pair of clinics, one clinic will be randomised to receive the PICOT implementation strategy and one clinic to usual in-person training, in a 1:1 ratio.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
3/02/2025
Actual
Date of last data collection
Anticipated
2/02/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316793 0
Government body
Name [1] 316793 0
NHMRC Medical Research Future Fund (MRFF) – 2022 Clinician Researchers: Nurses, Midwives and Allied Health
Country [1] 316793 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 319125 0
None
Name [1] 319125 0
Address [1] 319125 0
Country [1] 319125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315562 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 315562 0
Ethics committee country [1] 315562 0
Australia
Date submitted for ethics approval [1] 315562 0
31/05/2024
Approval date [1] 315562 0
14/06/2024
Ethics approval number [1] 315562 0

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

Contacts
Principal investigator
Name 135082 0
Prof Michele Sterling
Address 135082 0
RECOVER Injury Research Centre, The University of Queensland Level 7, STARS Building 296 Herston Road, HERSTON, QLD, 4029.
Country 135082 0
Australia
Phone 135082 0
+61 7 33464793
Fax 135082 0
Email 135082 0
[email protected]
Contact person for public queries
Name 135083 0
Yanfei Xie
Address 135083 0
RECOVER Injury Research Centre, The University of Queensland Level 7, STARS Building 296 Herston Road, HERSTON, QLD, 4029.
Country 135083 0
Australia
Phone 135083 0
+61 7 3365 5560
Fax 135083 0
Email 135083 0
[email protected]
Contact person for scientific queries
Name 135084 0
Michele Sterling
Address 135084 0
RECOVER Injury Research Centre, The University of Queensland Level 7, STARS Building 296 Herston Road, HERSTON, QLD, 4029.
Country 135084 0
Australia
Phone 135084 0
+61 7 33464793
Fax 135084 0
Email 135084 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?
De-identified Individual Participant Data, along with the code books and statistic codes for generating the results will be made available to available to researchers upon reasonable request.
When will data be available (start and end dates)?
No more than two years after study completion, the data will be available.
Available to whom?
Access to trial Individual Participant Data can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA).
Available for what types of analyses?
Meta-analysis, individual participant data meta-analysis.
How or where can data be obtained?
By contacting the Principal Investigator Professor Michele Sterling through 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
No additional documents have been identified.